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X Series™ Operator`s Guide

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1. Lead Selects the ECG input source for the first waveform trace 12 lead Displays the 12 lead monitoring screen COs Turns CO on and off Treatment Displays the current clinical treatment options Sync Activates the synchronized cardioversion mode Print Starts or stops a continuous chart print ws More Back Goes to the next or previous level of quick access keys Brightness Changes the brightness setting toggles through high contrast D display white background color display black background and D night vision goggle NVG friendly display IBP Displays IBP setup and zero buttons Alarms Displays the Limits option to allow the user to view set all parameter ry alarm limits and the alarm suspend button Log Opens the Log Control panel Setup Displays the Setup menu to allow the user to configure settings such as ECG display volume printer trends operational checklist and supervisor Treatment Summary Displays treatment summary cases which you can print Manual Mode Manual Mode Allows user to change from AED Mode to Manual Mode Pause Allows user to Pause the rescue cycle 9650 001355 01 Rev B X Series Operator s Guide CHAPTER 2 PRODUCT OVERVIEW Table 2 3 X Series Quick Access Keys Quick access key Description Print Trends Print Trends Prints the trends that are displayed in the Trend Summary window Trend Settings
2. h Ih j iy hea h fl CPR n CPR yw Wl yy Wy 17 12 17 24 Coarse VF F N A A N A i I i I Raw ECG la n y A 4 n is j H vE te i A f Y J N Wane AMAN Raw ECG f i V i o r Filter OFF EEE EEE Filtered ECG WW AAMA Nay Miev Tay MAAV ih Wea Ti Mallet ba SATIN ET j V W Wms ow SANA J VNE ETIES Filtered ECG CPR l hh l hh hh q ae Lh ct ah CPR Wu te Py N ARAU M ab J Y Y l W ane Na W y W 17 24 17 36 12 5 mmeg 5 mim Y Copirigh Masachosedis Insidute of Techmtogy D011 Al nights reserved www zoll com 9650 001355 01 Rev B 20 4 Using See Thru CPR The following figure shows a patient in PEA which could easily be mistaken for Fine VF because enough of the compression artifact leaks through to distort this signal When the CPR filter turns on the PEA is still not obvious because of the left over ripples from the CPR signal About 14 seconds into this chart the rhythm changes to asystole which could easily be mistaken for coarse VF When the CPR filter turns on the CPR compression ripples are still obvious making the rhythm look like Fine VF PEA L 4 1 W Pe j t Pi he a i a TE 7 ee Fill ered E CG j e i A k a omy oe ee EOR A h s 4 ___ Af Aum a i F iitered EC ty n J 2s f J CPR ipik arran es ae ma ote RI e e ee ee o ee ne ng CPR ElI 1 24 PEA A
3. 5 6 www zoll com 9650 001355 01 Rev B Alarm Options Alarm Options The X Series unit provides alarm options that you can specify through the Supervisor parameter control panel access to Supervisor is passcode controlled Press the More quick access key Fd press the Setup quick access key Ed and select Supervisor Using the navigation keys select the four digits in the Supervisor passcode Press SAVE when you are finished Once you have entered your supervisor passcode you will be able to access the configurable options in the Supervisor menu Select Alarms to display the alarms parameter control panel Setup gt Supervisor gt Alarms Default Adult Default Pediatric Default Neonate Figure 5 1 Alarms Parameter Control Panel 9650 001355 01 Rev B X Series Operator s Guide 5 7 CHAPTER 5 ALARMS selecting Default Alarm Limits The first three options Default Adult Default Pediatric Default Neonate allow you to set all alarm limits to the X Series unit s factory specified default values by patient type Warning e A potential hazard exists if different alarm limits are used for the same or similar equipment in any single area e Confirm the alarm limits are appropriate for the patient each time there is a new patient case e Do not set alarm limits to such extreme values that render the alarm system useless setting Alarm Limits Relative to the Patient Stat Set Option The X Series unit al
4. Note Clearing the log during patient treatment results in the loss of all patient data and events recorded prior to clearing the log Clearing the log creates a New Patient record and all patient specific parameters alarm limit defibrillation energy etc are set to their default values To clear the log Press ei mete 1 2 Press tm 3 Press the Clear Log quick access key fil 3 Use the navigation keys to select Yes Note An UNABLE TO READ LOG message indicates that the log contains no information This message can occur if you clear the log and then immediately enter the Treatment screen or the Trend Summary screen 21 4 www zoll com 9650 001355 01 Rev B Chapter 22 Wireless Communications The X Series unit can send data through a wireless connection to remote locations It can send 12 lead report snapshots including trend data to a recipient via a ZOLL server Full disclosure cases which also contain trend data can be automatically retrieved from the X Series unit using ZOLL RescueNet or ePCR software If installed the unit is equipped to send data through a WiFi access point Bluetooth equipped device or USB cellular modem You can set up a temporary Bluetooth connection or wireless access point on the X Series unit by selecting the wireless icon on the display screen Supervisors can set up permanent WiFi Bluetooth or Cellular profiles up to 255 in the Setup Communications menu which requires a pass
5. The CPR Compression Indicator also known as Perfusion Performance Indicator PPI is first displayed as an empty diamond This indicator starts to fill as compressions begin filling from the inside and becomes completely filled when consistent chest compression depth exceeding AHA ERC 2005 1 75 AHA ERC 2010 2 0 inches and rate exceeding 90 compressions per minute cpm are achieved simultaneously Should the chest compression rate or depth begin to fall below the configured target levels the indicator will only partially fill to indicate the need www zoll com 9650 001355 01 Rev B CPR Metronome for more rigorous efforts Following the cessation of compressions the indicator s fill level gradually decreases until a hollow outline is displayed after a short period of time CPR Metronome The X Series unit includes a CPR metronome feature that can be used to encourage rescuers to perform chest compressions at the AHA ERC recommended rate of 100 compressions per minute This metronome can be configured to operate in both AED and Manual modes or is AED mode only It can also be disabled for all modes When activated the metronome beeps at the AHA ERC recommended rate to provide a compression rhythm for rescuers to follow The metronome is silent when chest compressions stop being detected by CPR equipped hands free therapy electrodes If CPR is active in Manual mode the metronome only beeps when chest compressions are detected
6. Clinical Trial Results for the Biphasic Waveform Results The study population of 165 patients had a mean age of 66412 years with 116 male patients The total efficacy of consecutive rectilinear biphasic shocks was significantly greater than that of monophasic shocks The following table displays the Kaplan Meier product limit survival curves for each of the two waveforms As all patients begin in the failure mode the estimated life table probabilities refer to the chance of still being in failure after the k shock k 1 2 3 4 Table A 3 Kaplan Meier Estimate for the Probability of Shock Failure Shock Biphasic Monophasic 0 1 000 1 000 1 0 318 0 792 2 0 147 0 558 3 0 091 0 324 4 0 057 0 208 As can be seen from the table the Biphasic experience is superior over the entire course of shocks delivered The one degree of freedom chi square statistic for the Mantel Haenszel test is 30 39 p lt 0 0001 Similarly the log rank test also a one degree of freedom chi square statistic is 30 38 p lt 0 0001 The residual number of patients not successfully treated after four shocks is 5 7 for biphasic compared to 20 8 for monophasic There was a significant difference between the first shock efficacy of biphasic shocks at 70J of 68 and that of monophasic shocks at 100J of 21 p 0 0001 95 confidence interval of the difference of 34 1 to 60 7 Successful cardioversion with rectilinear biphasic sho
7. Displays settings for trend display format trend on interval and trend on alarm Transfer Log Transfers the current data in the log to a USB drive Clear Log Deletes the current data in the log Acquire led RC 2 Collects 10 seconds of 12 lead data for print Stop Acquisition Stops acquisition of 12 lead data Patient Information Allows you to enter information to accompany 12 lead data patient name age gender and ID Allows you to move to the previous row when entering patient information Allows you to move to the next row when entering patient information Reviews all your 12 lead captured data 12 Lead Review Next gi Goes to the next page of the 12 lead snapshot you are reviewing Transmit bs Transmits 12 lead data Exit 12 Lead Exits the 12 lead monitoring screen Stat Set Sets all alarm limits relative to the patient s current vital signs Alarm Cancel Suspends the current alarm Limits Limits B amp Displays the current alarm settings www zoll com 9650 001355 01 Rev B Common Tasks Table 2 3 X Series Quick Access Keys Quick access key Description Disarm Safely discharges the defibrillator internally No energy is delivered to the patient IBP Setup Brings up the IBP Control Panel for the corresponding channel P1 P2 or P3 IBP Zero Zeroes
8. Filtered ECG TA iah hi nl Pa pu Arash Ta V Wy WAA f i iv PA NOESIS ANAA AAN EAE SAAE ee A A Prod ape Vi Prat T F a KERLI i f u A ft ri A ye Ir W 4 Fi Fan WN 4 A A VEO AL AEA w P l Fa i Lf 7i j Raw ECG pa Muy Filtered ECG i CPR 4 36 AT ate ee eR Py pat ey A Raw ECC T ta zA laan m l p ri P F A py F F oF ee F if fered E t d x NV WANA i AMin ead Fated way i ayy yl PIAA a EAS A NaN Poa ayo N yd f il tered At C I Ih AAA ci aR NI Va LA pu 7 w zi n A EF a Lf i 1 4 36 i apyrphi 9650 001355 01 Rev B Wy l N T a N N l rhe en pull ki TATRY TA Miissschuseils inais of fechmology 200 1 AU nglis rserved ZOLL X Series Operator s Guide CPR 4 48 12 5 msee 5 movin 20 3 CHAPTER 20 SEE THRU CPR OPTIONAL The following figure shows a patient in VF which during compressions is slightly more difficult to discern When viewing this ECG it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact Coarse VF i Al oa nf AON J j j M A l1 j i i Meri en nie I Raw ECG RYE Ve ATM alo AYN Pra f An N l J J Y A J J J 1 j Raw ECG i an ha aan i y ya ae Filter ON Filtered ECG hanna Man eV alla wn Naan Nery VW Ma Name Filtered ECG NUNN
9. 9650 001355 01 Rev B X Series Operator s Guide A 23 Specifications Temperature Number of Channels 2 Measurement Range 0 to 50 C Accuracy 0 1 C from 10 C to 50 C 0 2 C from 0 C to 10 C Resolution 0 1 C Scale Fahrenheit or Celsius Temperature Display Signal 20Hz no averaging Probe YSI 400 and 700 series Display T1 T2 AT Minimum Measurement Time See the probe s Instructions for Use to obtain minimum measurement times for accurate readings The X Series does not add any clinically significant time to obtain accurate readings A 24 www zoll com 9650 001355 01 Rev B Clinical Trial Results for the Biphasic Waveform Clinical Trial Results for the Biphasic Waveform The efficacy of the ZOLL Rectilinear Biphasic waveform has been clinically verified during a study of defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT A feasibility study was performed initially for defibrillation of VF VT n 20 on two separate groups of patients to ensure waveform safety and energy selection Subsequently a separate multicenter randomized clinical trial was performed to verify the waveform s efficacy A description of this study is provided below The study was performed using ZOLL defibrillation systems consisting of ZOLL defibrillators the ZOLL Rectilinear Biphasic waveform and ZOLL defibrillation electrodes Randomized Multicenter Clinical Trial for Defibrillation of Ventri
10. Do not discharge the defibrillator except as indicated in the instructions Discharge the defibrillator only when defibrillation electrodes or paddles are properly applied to the patient To avoid risk of electrical shock do not touch the gelled area of the hands free therapy electrodes during pacing or defibrillation To avoid risk of electrical shock do not allow electrolyte gel to accumulate on hands or paddle handles To avoid risk of electrical shock do not allow patient connectors to contact other conductive parts including earth For defibrillation using paddles use only high conductivity electrolyte gel specified for such use by the manufacturer When using paddles for defibrillation use your thumbs to operate the SHOCK buttons Doing so avoids inadvertent shock to the operator The use of accessory equipment that does not comply with the equivalent safety requirements of the X Series defibrillator could reduce the level of safety of the combined system When choosing accessory equipment consider the following e Use of the accessory in the patient vicinity e Evidence that the safety certification of the accessory has been performed in accordance with the appropriate IEC EN 60601 1 and or IEC EN 60601 1 1 harmonized national standards Always check that the equipment functions properly and is in proper condition before use Disconnect all electro medical equipment that is not defibrillation protected from the pati
11. Invasive Pressures Typical Determination time without Artifact Measurements on the deflation 30 to 45 seconds Measurements on the inflation SureBP 15 to 30 seconds using dual lumen cuffs Maximum Determination Time Measurement on the Inflation Adult 150 seconds Pediatric 120 seconds Neonatal 80 seconds Blood Pressure Validation Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method for adults and pediatric patients and equivalent to an intra arterial measurement for neonatal patients within the limits prescribed by the American National Standards Institute ANSI AAMI SP10 To receive a copy of the report containing the AAMI SP10 results contact the ZOLL Technical Service Department Invasive Pressures Number of Channels 3 Pressure range 30 to 300 mmHg Pressure Accuracy 2 mmHg or 2 of reading whichever is greater plus transducer error Pulse Rate Range 25 to 250 BPM Pulse Rate Accuracy 3 BPM or 3 of value whichever is greater Pulse Rate Display Average of last 4 beat to beat intervals Zero Adjust 200 mmHg Transducer Sensitivity 5uV V mmHg Offset 125 mmHg including transducer offset Excitation Impedance Range 150 to 10 000 ohms Excitation Voltage 4 75 0 25 VDC Connector 6 pin circular MS3100 series Connect to A B C D E Signal Type Sig Exc Sig Exc shield
12. Resp imin Resp Off Provider Name New Ka The unit will then scan for nearby Bluetooth devices that are in discoverable mode Use the navigation keys to select the desired device a green check mark indicates which device has been selected 11 30 2011 14 17 14 Adult Cp Pads Paddles Imp Not Calibrated TA D IBP NIBP mmHg Cellular gt Configure Bluetooth gt Pair New Device Scan Complete ocan compiete A AT Available Devices Bluetooth Name DOCSM6400 REILLYM6400 Resp Off Dell Wireless 410 BI TM506 Start Scan o PairNow Current PIN Change PIN Resp min 9650 001355 01 Rev B X Series Operators Guide 22 15 CHAPTER 22 WIRELESS COMMUNICATIONS Select Pair Now to pair the device The unit then returns to the list of paired devices 11 30 2011 14 17 31 Adult 7 Printer Self Test Failed TA aia Cy II 1 0 cm m IBP NIBP mmHg a Log Cellular gt Configure Bluetooth gt Pair New Device Available Devices cd Bluetooth Name DASCOLIM4600 Es ZOLL 2311M01196 Spo2 s Start Scan Pair Now Spo2 eee Disabled Current PIN 1234 Change PIN bits Temp You can then edit the settings of the paired device and give the device an optional nickname or provider Press the back arrow L to return to the list of paired devices 11 30 2011 14 17 48 Adult 4 SpO2 Self Test Failed T ia Cy II 1 0 cm m IBP NIBP mmH
13. Signature 9650 001355 01Rev B X Series Operator s Guide ss iti is CHAPTER 24 MAINTENANCE 24 12 www zoll com 9650 001355 01 Rev B Appendix A Specifications This chapter provides specification information for the X Series Monitor Defibrillator Defibrillator on page A 2 Monitor Display on page A 14 Impedance Pneumography on page A 15 Alarms on page A 16 Recorder on page A 17 Battery on page A 17 General on page A 18 Pacer on page A 19 CO on page A 19 Pulse Oximeter on page A 20 Non Invasive Blood Pressure on page A 22 Invasive Pressures on page A 23 Temperature on page A 24 Electromagnetic Compatibility Guidance and Manufacturer s Declaration on page A 29 9650 001355 01 Rev B X Series Operator s Guide A 1 Specifications Defibrillator Charge Time e Less than 7 seconds with a new fully charged battery first 15 charges to 200 joules e For the sixteenth discharge at maximum energy the charge time is less than 10 seconds Depleted batteries result in a longer defibrillator charge time e Less than 15 seconds when operating without a battery using AC power alone at 90 of the rated mains voltage e Less than 25 seconds from the initial power on with a new fully charged battery pack depleted by up to fifteen 200 joule discharges or when operating without a battery using AC power alone at 90 of the rated main
14. Warning statements alert you to conditions or actions that can result in personal injury or death Caution statements alert you to conditions or actions that can result in damage to the unit X Series Indications for Use The X Series is intended for use by trained medical personnel who are familiar with basic monitoring vital sign assessment emergency cardiac care and the use of the X Series The X Series is also intended for use by or on the order of physicians at the scene of an emergency or in a hospital emergency room intensive care unit cardiac care unit or other similar areas of a hospital The usage may be in an ambulance or at the scene of an emergency It is also intended to be used during the transport of patients The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation It may also be used whenever it is required to monitor any of those functions that are included as options in the device The X Series unit can be used on pediatric patients as described in the following table and on adult patients 21 years of age or older with and without heart dysfunction Pediatric Patient Subpopulation Approximate Age Range Newborn neonate Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12 to 21 years of age 9650 001355 01 Rev B X Series Operator s Guide 1 7 CHAPTER 1 GENERAL INFORMATION
15. ZOLL X Series Operator s Guide 9650 001355 01 Rev B The issue date for the X Series Operator s Guide REF 9650 001355 01 Rev B is February 2012 If more than 3 years have elapsed since the issue date contact ZOLL Medical Corporation to determine if additional product information updates are available Copyright 2012 ZOLL Medical Corporation All rights reserved CPR D padz pedi padz OneStep Real CPR Help Rectilinear Biphasic RescueNet See Thru CPR stat padz SurePower X Series and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and or other countries Masimo Rainbow SET SpCO and SpMet are trademarks or registered trademarks of Masimo Corporation in the United States and or other countries Propaq Smartcuf and SureBP are trademarks or registered trademarks of Welch Allyn or its subsidiaries in the United States and or other countries Oridion Microstream FilterLine and CapnoLine are trademarks or registered trademarks of Oridion Systems Ltd in the United States and or other countries IC Model XSCP 1 ZOLL Medical Corporation 269 Mill Road Chelmsford MA USA 01824 4105 ZOLL International Holding B V Newtonweg 18 6662 PV ELST The Netherlands CE 0197 Table of Contents Chapter 1 General Information PROGUGE DISSEHIOU ON ae eaa diet eeccetara E one enctanataaeNnitadhiea a 1 1 X Series Optional Features cccccccccssssccccce
16. cccccceeeeeeeeeees Quick Access Keys Navigation Keys Display Brightness COMMON TASKS iineoa a Changing the Display Brightness Replacing a Battery Pack on the X Series Using Treatment Buttons www zoll com 9650 001355 01 Rev B Chapter 3 Monitoring Overview X Series Monitoring FUNCIONS serres sacrsataussncbaadebtcrabh ses dneuseeand oousdexshus dectevebiawdushaedheatadtevens 3 1 EGO Rrra ee een EEE ene ne ete me eee ne eee a ee eee ete ene eee 3 2 ICAI IRALC senamesnsdurcaaues E A en Gant unto sake N 3 2 PASSDIFALON Rale lt thiuntaascitianetieneceinciatemunsiiacsatteesniaiieeie a tian haeet 3 2 Temperature sea o T a EE 3 2 mMvasive Fressure s IBEN amini T tates a A 3 2 Non Invasive Blood Pressure NIBP cccccccccceececeeeeeceeeesseseeseeeesseeeessueesaaeesseeeees 3 2 Gapnographiy GO 2 rsa caso occas ile EE 3 3 PUISG OXIMeIy SNOZ moete ee an EET ER EET EEEE AEE EEANN 3 3 Monitoring Display pions cerir e E N A ee hieeerioes 3 3 Configuring the Waveform Display ccccccecccceceesecceeceeeeeeceeeeeeesseaeecesseaeeeesaeeeeeseaaeeees 3 7 Chapter 4 Trends Displaying the Trends Status Window cccccccceeeccecseeeeeeeeeeeeeeseeeeeeeseeeeeeeeeeeeeeeeseeeeeeeeeas 4 1 Displaying and Printing Trend INformation ccccccssccccseeeceeeeeeeeeeeeeeeseeeeeeeeeeseeseneneeeseeeens 4 2 Changing the Trends Status Window Display cccccccsseeeceeeeeeeeeese
17. 1 Turn on unit WARNING Press the green power switch located on the top of the unit The green yellow and red lights on the top of the unit flash on and off and the unit displays the message SELF TEST PASSED If the unit is in AED mode press the Manual Mode quick access key on the front panel of the unit to enter the Manual mode of operation Using the navigation keys select the four digits in the Manual Mode pass code Press SAVE when you are finished Once you have entered your pass code you will be able to enter Manual mode Note Ifthe unit has been not been configured to enter a pass code the message Exit to Manual Mode is displayed Use the navigation keys to select Yes to enter the Manual mode of operation If you do not press Yes within 10 seconds the unit will revert back to AED operation If no hands free therapy electrodes have been attached to the patient and connected to the X Series unit the ATTACH PADS message and voice prompt will be issued Energy Select The default energy selections for adult patients are Shock 1 120 joules Shock 2 150 joules Shock 3 200 joules The default energy selections for pediatric patients are Shock 1 50 joules Shock 2 70 joules Shock 3 85 joules Note Pediatric defibrillator energy levels should be selected based on site specific protocols Use only pediatric electrodes to defibrillate patients under 8 years of age in Advisory mode and make sure the patient m
18. A 28 www zoll com 9650 001355 01 Rev B Electromagnetic Compatibility Guidance and Manufacturer s Declaration Electromagnetic Compatibility Guidance and Manufacturer s Declaration In Flight Use RTCA DO 160 The X Series unit complies with RTCA DO 160 Environmental Conditions and Test Procedures for Airborne Equipment using the methods in Section 21 Category M for Radiated and Conducted Radio Frequency Energy General Use Environments IEC 60601 1 2 The X Series unit is intended for use in the electromagnetic environment specified below The customer or the user of the X Series unit should assure that it is used in such an environment Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The X Series unit uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CSPR 11 Class B Harmonic Emission IEC Class A The X Series unit is suitable for use in all establishments 6100 3 2 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage Fluctuations Flicker Complies Emissions IEC 61000 3 3 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document 9650 00135
19. Bluetooth Cell Device Enabled Configure Configure Cell Provider Spo2 Spo2 Disabled Temp You can use the arrow keys to enable or disable all cellular functions and configure your cell phone provider information Configuring Cell Phone Provider Information Use the arrow keys to enter information about your cell phone provider Provider Name Call Number Account Name and Password You can create up to three cell phone providers 11 30 2011 14 15 21 Adult 7 Log Full D a CH II 1 0 cmim 72 7 Pr IBP NIBP mmHg Communications gt Cellular gt Configure Cell Provider amp Configured Cell Providers Provider Name Log TMobil ODIIE Verizon E Call Number 777 Account Name sis Password aia Spo2 a cco Spo2 Disabled Temp 22 14 www zoll com 9650 001355 01 Rev B Setting uo Communications in the Supervisor Menu Configuring and Pairing Bluetooth Devices Bluetooth devices can also be paired from the main wireless menu which does not require a password see Setting up and Viewing Paired Devices on page 22 7 To pair Bluetooth devices select Bluetooth Cell Device Configure in the Cellular menu To pair a new device use the navigation keys and select New 11 30 2011 14 16 13 Adult Pads Paddles Imp Not Calibrated IBP NIBP mmHg Communications gt Cellular gt Configure Bluetooth Paired Devices Bluetooth Name Nickname No Paired Devices
20. Diagnostic frequency response setting Other frequency response settings may cause misinterpretation of the patient s ECG Use only ZOLL approved accessories to ensure the Type CF defibrillator proof rating of the 12 Lead input Implanted pacemakers may cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or other arrhythmias Carefully observe pacemaker patients Check the patient s pulse do not rely solely on heart rate meters Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes Patient history and physical exam are important in determining the presence of an implanted pacemaker Entering Patient Information 14 2 To enter patient information press the 12 Lead quick access key i then the Patient Info quick access key al The screen displays the Patient Info parameter panel in which you can enter the patients s name age gender and identification number 14 49 08 Adult Patient Age 45 Patient Gender M Patient First Name JOHN Patient Middle Name Q Patient Last Name DOE j Physician Patient ID Patient 0022 Figure 14 1 Patient Info Control Panel The X Series unit uses the name that you enter in the Patient Info panel to label the 12 lead ECG monitoring snapshots that it saves www zoll com 9650 001355 01 Rev B Entering Patient Information To enter patient information use the navigation keys to highlight and select a parameter o
21. motion tolerant technology The X Series unit must perform ECG monitoring when using Smartcuf The SureBP monitoring software allows the X Series unit to take an NIBP measurement as the cuff is inflating which saves time the measurement takes about 15 seconds and improves patient comfort The Smartcuf monitoring software enables the X Series unit to make accurate NIBP measurements in the presence of extreme artifact weak pulses and some dysrhythmias by synchronizing the NIBP measurements with the patient s R wave Observe the patient s limb periodically to ensure that circulation is not impaired for a prolonged period of time Never use the X Series to monitor NIBP on one patient while simultaneously monitoring ECG on another patient If a non invasive blood pressure measurement is suspect repeat the measurement If you are still uncertain about the measurement use another method 9650 001355 01 Rev B X Series Operator s Guide 8 1 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP Do not use NIBP without proper training Check that the correct patient mode has been selected to ensure that the initial inflation pressure is set correctly Patient movement very low pulse volume or vibration from outside sources can influence the accuracy of blood pressure measurements Do not attempt to take NIBP measurements on patients during cardiopulmonary bypass procedures Some or all NIBP safety functions are disabled wh
22. setting Upper and Lower Mean Arterial Pressure MEAN Alarm Limits Lower 30 mmHg Upper 70 mmHg Lower 30 to 298 mmHg Upper 28 to 300 mmHg Initially the IBP MEAN Alarm Settings menu specifies that IBP MEAN alarms are enabled ON or disabled OFF and displays the default Upper and Lower MEAN limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default MEAN alarm limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type IBP Mean Limit Default Lower 50 mmHg Upper 120 mmHg IBP Mean Limit Range Lower 30 to 298 mmHg Upper 28 to 300 mmHg 9650 001355 01 Rev B Lower 50 mmHg Upper 110 mmHg X Series Operator s Guide Lower 30 to 298 mmHg Upper 28 to 300 mmHg Lower 30 to 298 mmHg Upper 28 to 300 mmHg CHAPTER 11 MONITORING INVASIVE PRESSURES IBP setting IBP Source Label In the IBP channel menu you can select a label that identifies the source of the channel s IBP measurement By default the channels are labeled P1 P2 and P3 At the Source Label prompt you can specify that the unit display one of the following labels to identify the IBP channel Description Description Abdominal Aorta Pressure Aorta Arterial Pressure Brachial Artery Pressure Central Venous Pressure Femoral Artery Pressure Intracranial Pressure Labial Artery Pressure
23. value of 5 ppm for rates below 100 and by 10 ppm for rates above 100 Note The initial pacing rate can be set in Defib Pacer Default settings in the Supervisor Setup menu 6 Turn On Pacer Use the arrow keys to navigate to Start Pacer and press the Select button to select it The Pacing window displays behind the Pacer Settings window Rate 60 pon 7 Set Pacer Output In the Pacer Settings window use the arrow keys and the Select button to adjust the pacer output The pacer output is adjustable in 10 mA increments when increasing the output and in 9650 001355 01 Rev B X Series Operator s Guide 18 7 CHAPTER 18 EXTERNAL PACING 5 mA increments when decreasing the output Observe the ECG for evidence of electrical capture Select the lowest output current that achieves both electrical and mechanical capture Note Ifthe Pacer Settings window disappears before you have set the output current press the Pacer button again to display the settings window 8 Determine Capture WARNING It is important to recognize when pacing stimulation has produced a ventricular response capture Determination of capture must be assessed both electrically and mechanically in order to ensure appropriate circulatory support of the patient Electrical capture is determined by the presence of a widened QRS complex the loss of any underlying intrinsic rhythm and the appearance of an extended and sometimes enlarged T wave Ventricular
24. 230 J 249 J 253 J 269 J 261 J 260 J 15 For all energy levels accuracy is equal to either 15 or 3 joules whichever is greater The X Series Rectilinear Biphasic waveform employs the same first and second phase timing similar first and second phase currents voltages and essentially the same mechanisms for controlling defibrillation waveshape as the ZOLL R Series defibrillator The R Series and X Series defibrillation waveforms are considered substantially equivalent Figures A 1 through A 20 show the Rectilinear Biphasic waveforms that are produced when the X Series defibrillator is discharged into loads of 25 50 75 100 125 150 and 175 ohms at each energy setting 9650 001355 01 Rev B X Series Operator s Guide A 3 Specifications The vertical axis shows the current in amperes A the horizontal axis shows the duration of time in milliseconds ms 40 30 20 aN Be e 25 Ohm 50 Ohm 75 Ohm me 100 Ohm 4 2 4 6 8 10 Eo eee p e 150 Ohm z _ a 175 Ohm 10 a 200 Ohm 20 30 40 ms Figure A 1 Rectilinear Biphasic Waveform at 200 Joules 30 25 Ohm 50 Ohm 75 Ohm 100 Ohm ib 7 125 Ohm a e 150 Ohm 175 Ohm 200 Ohm 20 30 ms Figure A 2 Rectilinear Biphasic Waveform at 150 Joules A 4 www zoll com 9650 001355 01 Rev B Defibrillat
25. 9 7 Setting CO2 and Respiration Rate Alarms cccccccccccccssseceeeeeeseeesseeeceeeeeeeeessaeeeeeeseaaeeees 9 8 Enabling Disabling Alarms and Setting CO2 Alarm Limits cccseeeeeeeeeeeeeeeeeeees 9 8 Using the CO2 Parameter Control Panel cccccccseecceeeeceesseeeeeeseeeseeeeessaaaeeeeess 9 10 DV SICMMCSSAG CS ccc dese a ane Me sh wesemaushonee daxaabbatsent S 9 11 PAON S cice a A manda udnerdewiadaatadee 9 12 www zoll com 9650 001355 01 Rev B Chapter 10 Pulse CO Oximetry SpO2 SPCO and SpMet Warnings S005 General arenie a a a haus 10 2 Warnings SpO Oximeter SQNSOM c eeeeeeeeee tere ee eeeeeeeeeeeaeaesaeeaaaaaeneeseeeeeeeeeeeeeees 10 3 DOs SSID and USE eccaig oie ete E ainemhar ac tuauehstaiteneiattbantadundein tad euinmmh tates 10 4 Selecting The SOOs SENSOM aranense a e e E 10 4 Applying NE SPO SENSO rer EE E enieitmedides 10 4 Applying a Two Piece Single Use Sensor Cable ccccccccecccssseeeeeeeeaeeseeeeeeenaaeees 10 5 Applying a Reusable SpO Sensor Cable cccccccccseeeeeeeeeeeeeeceeaeeeeeeeeeeeeeeeeaaeneeeees 10 7 Cleaning and REUSS Of SENSONS aeram a a a aR 10 8 Connecting the SPOS SCMSOM cenne arri e A ORe ERREAREN 10 8 Displaying SpO gt SpCO and SpMet Measurements ccseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaes 10 8 Enabling Disabling SoO Alarms and Setting Alarm Limits ccceeeeeeeeeeeeeeeeeeeeeeeaeees 10 9 Setting Upper and L
26. B X Series Operators Guide 6 5 CHAPTER 6 MONITORING ECG selecting ECG Waveforms for Display You can fit up to four waveforms on the X Series display The first waveform at the top of the display is always an ECG waveform In the following example Lead I RA LL is the source of the ECG waveform trace 06 06 2011 12 34 56 00 17 43 The are two ways to specify which ECG lead is the source of the primary waveform trace One way is to press the ECG lead selection quick access key F to display the available ECG waveform sources The available waveform sources are determined by the type of ECG cable connected to the unit The other way to specify the source of the primary waveform trace is to navigate to and select the source label for the primary ECG waveform Lead I in the screen below The X Series unit then displays the available ECG waveform sources The following example illustrates the waveform source list that the X Series unit displays when a 5 lead ECG cable is connected to it The list of available ECG waveform sources includes Leads I Il Ill aVR aVL aVF and V You can select Lead Il the default or use the navigation keys to highlight and select another displayed ECG lead as the source for the waveform trace 6 6 www zoll com 9650 001355 01 Rev B ECG Monitoring Setup 06 06 2011 12 34 56 Select a current waveform source and the unit displays the waveform immediately If you select a waveform source
27. CO levels present in the patient s expired breath WARNING The disposable Smart CapnoLine nasal and nasal oral cannula sets are intended for single patient use Do NOT reuse or sterilize any part of this product as the monitor may be damaged by reuse of the sampling line e If oxygen is being delivered while using sidestream CO be sure to use a CO sampling with O delivery Using a different type of cannula will not enable oxygen delivery Remove the cannula from the package Verify that the cannula is clean dry and undamaged Replace if necessary Placing the Cannula onto the Patient Place the oral nasal cannula onto the patient as follows Caution Dispose of Microstream EtCO consumables according to standard operating procedures or local regulations for the disposal of contaminated medical waste 9 6 www zoll com 9650 001355 01 Rev B Measuring CO2 Measuring CO Once setup is complete press to begin monitoring CO The numeric CO display appears on the screen and displays the message INITIALIZING The CO display gives the current EtCO value and after a delay of approximately 1 minute the patient s Respiration Rate in Breaths Minute identified as BR Check that connections have been made correctly by verifying the display a proper capnogram the waveform is inserted automatically on the waveform display window 06 06 2011 12 34 56 00 d 7 43 ll CO SYNC lt 9650 001355 01 Rev B
28. Limit Numeric 5 Neo nate SpCO Entire range Limit Numeric 2 Limit Numeric 2 Upper limit 40 Lower limit 0 a range Limit Numeric 2 Limit Numeric 2 a limit 15 Lower limit 0 EtCO2 Entire range Limit Numeric 10 Limit Numeric 5 mmHg mmHg unless the numeric falls below the lower alarm limit range in which case Stat Set sets the lower limit to 15 mmHg mmHg C F 9650 001355 01 Rev B X Series Operator s Guide 5 9 CHAPTER 5 ALARMS 5 10 www zoll com 9650 001355 01 Rev B Warning Chapter 6 Monitoring ECG This chapter describes how to use the X Series unit to monitor ECG X Series units can perform ECG monitoring through 3 5 or 12 lead ECG patient cables Multi Function Pads or standard defibrillation paddles The use of an ECG patient cable and electrodes is required however to monitor ECG during pacing You can use a 3 lead 5 lead or 12 Lead wire configuration for ECG monitoring see Running H F 1 for more information on 12 lead monitoring Excessive body hair or wet sweaty skin may interfere with electrode adhesion Remove the hair and or moisture from the area where the electrode is to be attached Use only electrodes that are well within the expiration date indicated on the package Remove ECG electrodes from their sealed package immediately prior to use Using previously opened or out of date electrodes may degrade the ECG signal quality Monitorin
29. MONITORING CO2 Setting Upper and Lower Respiratory Rate RR BR Limits Initially the RR BR Alarm menu specifies that RR BR alarms are enabled ON or disabled OFF and displays the default Upper and Lower respiratory limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default Respiratory limits for adult pediatric and neonate patients in Breaths Minute and gives the range in which you can set these limits Patient Type Respiration Rate Default Lower 3 BPM Upper 50 BPM Respiration Rate Range Lower 0 to 145 BPM Upper 5 to 150 BPM Pediatric Lower 3 BPM Lower 0 to 145 BPM Upper 50 BPM Upper 5 to 150 BPM Neonate Lower 12 BPM Lower 0 to 145 BPM Upper 80 BPM Using the CO2 Parameter Control Panel Upper 5 to 150 BPM Use the navigation keys to highlight and select the CO2 numeric display to display the CO2 Parameter Control Panel Lower EtCO2 Alarm 28 RR BR Alarm 10 FiCO2 Alarm No Breath Alarm CO2 Resp Sweep Speed Figure 9 2 CO2 Parameter Control Menu M N 12 5 mm s On the CO2 Parameter Control Panel you can select a CO alarm EtCO2 Breath Rate or FiCO2 On the selected alarm settings menu you can enable disable alarms and set alarm limits as described previously You can also set the CO sweep speed 9 10 www zoll com 9650 001355 01 Rev B System Messages Setting the CO Sweep Speed The EtCO sweep spee
30. Mean 2 seconds Temperature 2 seconds www zoll com 9650 001355 01 Rev B Recorder Recorder Battery Type High resolution thermal array Annotation Time date ECG lead ECG gain heart rate defibrillation and pacing parameters and treatment summary events Paper Width 80 mm Paper Speed 25 mm sec 50 mm sec Delay 6 seconds Frequency Response Automatically set to monitor s frequency response Treatment Summary 10 switches to record key ACLS events IV INTUB EPI LIDO ATROP etc Automatically logs into memory the type of event time and ECG sample Patient Data Log A combination of 24 hours of trends at 1 minute intervals 1000 time stamped events and 32 snapshots including monitor defibrillator pacer and treatment snapshots The actual number of trends events or snapshots stored could be more or less depending on the use profile Record Modes Manual and automatic User configurable Type Rechargeable Lithium Ion 11 1Vdc 6 6 Ah 73 Wh Capacity With a new fully charged battery operating at room temperature e At least 6 hours of continuous monitoring of ECG SpO2 CO2 three Invasive Pressure channels and 2 channels of Temperature with NIBP measurements every 15 minutes and 10 200 J shocks display set to 30 e Atleast 100 discharges at maximum shock energy 200 joules e Atleast 3 5 hours pacing with ECG SPO2 CO2 three Invasive Pressures temperature NIBP every 15 minutes an
31. NIBP measurement result is questionable or motion indication is displayed repeat the measurement If the repeated measurement result is still questionable use another blood pressure measurement method Do not use the NIBP on cardiopulmonary bypass patients To ensure compatibility and electrical safety accessory pressure sensors should comply with ANSI AAMI BP 22 and IEC 60601 2 34 for IBP or ANSI AAMI NS28 for ICP Follow instructions supplied with any accessory pressure sensor regarding calibration and removal of trapped air Avoid touching metal parts of any transducer while it is in contact with the patient Do not reuse any components that are labeled for single use only Transducers should be rated to withstand an accidental drop of at least a meter onto a hard surface Transducers that are subject to immersion in liquids should be rated as watertight www zoll com 9650 001355 01 Rev B Warnings CO During MRI scanning the monitor must be placed outside the MRI suite When the monitor is used outside the MRI suite EtCO monitoring can be implemented using a long FilterLine which permits placement of the monitor outside the MRI suite When using the monitor with anesthetics nitrous oxide or high concentrations of oxygen connect the gas outlet to a scavenger system Use only Oridion Microstream CO sampling lines Microstream CO sampling lines are labeled for single patient use only Do not reuse sampling l
32. Operators Guide 14 13 CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS specifying the 12 Lead Frequency Response This option allows you to specify the frequency response of the 12 lead waveform display You can specify the following trace display ranges Display Type Frequency Response Diagnostic 0 05 to 150 Hz Filtered Diagnostic 0 25 to 40 Hz Note The display and the recording present the waveform according to the filter setting Diagnostic or Filtered Diagnostic but the 12 Lead Interpretive Analysis is always performed using the diagnostic bandwidth with a 50 60 Hz notch filter Chapter 15 Manual Defibrillation J Paddles are a defibrillation protected Type BF patient connection 4 g L ECG leads are a defibrillation protected Type CF patient connection Emergency Defibrillation Procedure with Paddles Warning To avoid risk of electrical shock do not allow electrolyte gel to accumulate on hands or paddle handles When defibrillating with paddles use your thumbs to operate the SHOCK buttons in order to avoid inadvertent operator shock No portion of the hands should be near the paddle plates Be sure to use the proper paddles electrodes based on the size of the patient adult large pediatric small 9650 001355 01 Rev B X Series Operator s Guide 15 1 MANUAL DEFIBRILLATION Determine the Patient s Condition Following Local Medical Protocols Verify the following e Unconsciousness e Absen
33. Paper 9650 001355 01 Rev B X Series Operators Guide 24 9 CHAPTER 24 MAINTENANCE 2 Refer to the illustration inside of the paper compartment for proper paper orientation and place a new roll of recorder paper on the empty spool 3 Pull enough paper off the spool so that paper extends out of the unit when the printer cover is closed 4 Close the printer door Be sure the cover is flush with the side of the unit Figure 24 2 Inserting the Paper and Closing Printer Door 5 After the paper is loaded press the Print quick access key EA to resume printing Cleaning the Print Head To clean the recorder print head perform the following steps 1 Pull the printer door open see Fig 24 1 then remove any paper 2 Locate the print head along the front floor of the printer compartment 3 Gently wipe the print head with a cotton swab moistened with isopropyl alcohol and dry any residual alcohol with another dry cotton swab Figure 24 3 Cleaning the Print Head 4 Place the paper back into the unit and close the cover see Fig 24 2 24 10 www zoll com 9650 001355 01 Rev B X Series OPERATOR S SHIFT CHECKLIST Date Shift Location Mfr Model No Serial No or Facility ID No At the beginning of each shift inspect the unit Indicate whether all requirements have been met Note any corrective actions taken Sign the form Siz TOUR Corrective oR a S ean noss andeasng undamaged O G Zemes o a Inspect for
34. Press the CHARGE button twice if defibrillator is charging At the completion of the defibrillator window has disappeared the charge cycle the tone is continuous The charge time should be less than 7 seconds Verify that the CHARGE light on the Apex handle illuminates when the defibrillator is charged and ready to deliver energy While the defibrillator is charged press the Verify that the defibrillator does not paddles electrodes together and then press discharge and hold the SHOCK button on the Apex paddle only 9650 001355 01 Rev B X Series Operator s Guide 24 5 CHAPTER 24 MAINTENANCE 24 6 12 While the defibrillator is still charged press the paddles electrodes together then press and hold the SHOCK button on the Sternum paddle only While the defibrillator is charged press the paddles electrodes together then simultaneously press and hold both the Apex and Sternum paddle SHOCK buttons www zoll com Verify that the defibrillator does not discharge Verify that the defibrillator discharges and that a DEFIB SHORT TEST PASSED message displays Ifthe message DEFIB SHORT TEST FAILED displays contact the appropriate technical personnel or the ZOLL Technical Service Department 9650 001355 01 Rev B Recommended Minimum Preventive Maintenance Schedule Recommended Minimum Preventive Maintenance Schedule Operational Tests should be performed at regular intervals The Operational Tests augment
35. Pulmonary Artery Pressure Radial Artery Pressure Umbilical Artery Pressure Umbilical Venous Pressure In the following example source labels are specified for all three IBP channels www zoll com 9650 001355 01 Rev B IBP System Messages IBP System Messages The X Series unit may display the following messages when monitoring IBP System Message TRANSDUCER FAILURE INCOMPATIBLE TRANSDUCER CHECK PROBE The IBP probe is damaged and needs to be replaced The IBP probe is not compatible See the Appendix B Accessories for a list of ZOLL approved IBP probes The IBP probed has become disconnected ZERO PROBE The IBP probe is connected and needs to be zeroed The IBP probe is zeroing IBP DISABLED A system error has occurred and the X Series unit should be serviced ZERO REJECTED The IBP probe was not removed due to a pulsatile pressure signal excessive IBP artifact or excessive transducer offset 9650 001355 01 Rev B X Series Operator s Guide 11 9 CHAPTER 11 MONITORING INVASIVE PRESSURES IBP 11 10 www zoll com 9650 001355 01 Rev B Chapter 12 Monitoring Temperature The X Series Temperature inputs are Type CF defibrillator proof This chapter describes how to use the X Series unit to monitor temperature The X Series unit provides two temperature channels When both channels are in use the unit displays each channel s temperature successively followed by th
36. Rev B X Series Operator s Guide 2 5 CHAPTER 2 PRODUCT OVERVIEW Battery Status and Auxiliary Power Indicators 2 6 The battery status indicator displays various battery icons to indicate the approximate remaining unit run time based on the charged state of the battery Additionally these icons provide indications of the status of the battery connection and communication with the unit The auxiliary power indicator indicates that the unit is being powered by the auxiliary power adapter Note Upon powering up the X Series unit the battery capacity will be displayed within approximately 15 seconds under normal conditions Under some circumstances such as activating the defibrillator immediately after the unit is turned on the battery icon may display less than one hour battery capacity for up to two minutes after exiting the defibrillation mode Icon Status Indication Action Auxiliary power adapteris The unit is being powered by the connected auxiliary power adapter No battery detected Either there is no battery in the unit while it is being powered by the auxiliary power adapter or the device cannot detect that the battery is connected U Low battery capacity Replace the battery soon Communication failure The unit is unable to establish communication with the battery and the battery capacity is unknown Check the battery contacts Battery fault A battery fault has been detected Replace the b
37. Series unit displays are produced by the Audicor software of Inovise Medical Inc For more information on these interpretive statements see the Audicor 200 Physician s Guide Software Version 1 00 To display Analysis Page 2 press the 12 Lead Review Next quick access key Eg 9650 001355 01 Rev B X Series Operators Guide 14 9 CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS Analysis Page 2 displays the identifying information that has been entered for the patient and additional analysis statements 06713711 14 49 47 Adult Real Time Date 06 13711 Time 14 49 21 Name DOE J Q ID Patient 0022 Physician Age 45 Dept HR PR Interval QRS Duration QT Interval QTc P Axis QRS Axis T Axis 12 Lead ECG Monitoring Setup You can then view four 12 Lead snapshot pages by pressing to step through them sequentially For example the unit displays the following 12 Lead snapshot after the Analysis Page 2 06713711 14 50 15 Adult Fault Conditions Affecting 12 Lead Interpretive Analysis The X Series unit will not perform Interpretive Analysis 1f it detects one of the following fault conditions when attempting to acquire 12 Lead data e A pacer signal is present e A lead fault is detected in the ECG cable e An invalid cable is in use If the X Series unit detects one of these fault conditions Analysis Page 1 indicates that there is No data available for Interpretive Analysis and lists the fault c
38. Setting Upper and Lower Temperature Alarm Limits Initially the Temperature Alarm Settings menu specifies that the Temperature alarms are enabled or disabled and displays the default upper and lower limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default Temperature limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type Temperature Limit Default Temperature Limit Range Lower 35 C 95 0 F Lower 0 0 48 0 C 32 0 120 0 F Upper 37 8 C 100 F Upper 2 0 50 0 C 34 0 122 0 F Pediatric Lower 35 C 95 0 F Lower 0 0 48 0 C 32 0 120 0 F Upper 37 8 C 100 F Upper 2 0 50 0 C 34 0 122 0 F Lower 35 C 95 0 F Lower 0 0 48 0 C 32 0 120 0 F Upper 37 8 C 100 F Upper 2 0 50 0 C 34 0 122 0 F 9650 001355 01 Rev B X Series Operator s Guide 12 3 CHAPTER 12 MONITORING TEMPERATURE Setting Upper and Lower a Temperature Alarm Limits Initially the 4 Temperature Alarm Settings menu specifies that the 4Temperature alarms are enabled ON and displays the default upper and lower limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default 4 Temperature limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patie
39. Sterilizable Internal Handle black without Switch 2 0 spoon 10 cable ZOLL Sterilizable Internal Handle black without Switch 2 7 spoon 10 cable ZOLL Sterilizable Internal Handle black without Switch 3 0 spoon 10 cable ZOLL Defibrillation Gel ZOLL OneStep cable CPR stat padz HVP Multifunction CPR Electrodes 8 pair case CPR stat padz HVP Multifunction CPR Electrodes 1 pair Electrode pedi padz Il NO OVERBOX single Electrode pedi padz Il NO OVERBOX 6 case 9650 001355 01 Rev B X Series Operator s Guide B oo ACCESSORIES B 4 OneStep Resuscitation Electrode 8 per case OneStep Pacing Resuscitation Electrode 8 per case OneStep CPR Resuscitation Electrode 8 per case OneStep Complete Resuscitation Electrode 8 per case OneStep CPR AA Electrode 8 per case Electrodes OneStep Basic Single R Series Electrodes OneStep Pacing Single R Series Electrodes OneStep CPR Single R Series Electrodes OneStep Complete Single R Series Electrodes OneStep CPR AA Single Electrodes OneStep Pediatric 1 PAIR Electrodes OneStep BASIC Single CPR D padz One Piece Electrode Pad With Real CPR Help Electrodes CPR D padz w o Accessory Kit Set of 12 electrodes stat padz Single stat padz IBP Accessories Transducer Interface cable Abbott Transducer Interface cable Edwards Transducers 5 uV V mm Hg IEC 60601 2 34 and AAMI BP 22 compliant CPR Accessories CPR D padz CPR stat padz CPR
40. TUKOM UNI errar ene reenter samstoee retin nteae eae re ee ee ree ire ea ene ere CR meer me ae ilies 216 WM ol 1608 ja LEVEI eee eee eee eee 2 Gia rOS WD COMIN Al Ol car aia ares psa R a Petal ah T teen enon SIDSIVER SNOCK fcostecccsnotuaet ciel a a Ucn e ceo nosh eacc take raat asian Emergency Defibrillation Procedure with Hands Free Therapy Electrodes Determine the Patient s Condition Following Local Medical Protocols Begin CPR Following Medical Protocols cccccccseeeeeeeeeeeeeeeeaeeeeeeeaeeeeeeeeaeees Prepa rete Aesiny ree antiasicea intend ad einen id ake ian een TETN DEAK a Geweeereemrerten eesti terror erre ay Sommer etch trace san leor cnn PLR ecm rer een Toes t eMC ee mCree Selec Eneray LEVEI iarainn E N 2 GAGS DenpnllatOr sicecesater cr tendnassettoodmnstuntecUadtea otetietantecnuenssatbyaaditint snemaocacwesioat BHDGIVE IOS MOCK a rae ar hod ole aetna ae kth ase ee ae Hemma Padd O ecactecc cents a ass ea ueee a diteaeitbaneeean dee hatel nad oven a a eD VGELITICATIONAP OU TOSS a iiatet Sorte Gahas Sachi eta a i toes eta Synchronized GardiOVersS iON nesisuka ae Synchronized CardioverSion Procedure ccccccseseececeeeeeceseeeeeeeeseeeeeeeesueseeeesaaaeeess Determine the Patient s Condition and Provide Care Following Local Medical PIOIOCO S arne E xannunsal enna Gieeeataanueinntxaneenannets Propao Palon srstaieurets qamuicantaecniuiats elosaauiahh a a E etn TUTO
41. The following are the default energy selections e Adult 120 joules e Pediatric 50 joules e Neonate 50 joules Note Neonatal and pediatric defibrillator energy levels should be selected based on site specific protocols SHOCK The selected energy level is shown on the display 9650 001355 01 Rev B X Series Operator s Guide 15 7 MANUAL DEFIBRILLATION 2 Charge Defibrillator Press the CHARGE button on the front panel SHOCK To increase or decrease the selected energy after you have pressed the CHARGE button use the defibrillator Energy Select arrows on the front panel Caution Changing the selected energy while the unit is charging or charged causes the defibrillator to disarm itself Press the CHARGE button again to charge the unit to the newly selected energy level A charging message displays at the bottom of the screen and a distinctive charging tone sounds indicating that the unit is charging The energy range bar graph on the right side of the display highlights the charge level until it reaches the selected energy When the unit is fully charged the tone changes to a continuous charge ready tone the highlighted energy bar graph includes the selected energy and the shock button lights up Selected Energy 15 8 www zoll com 9650 001355 01 Rev B Internal Paddles 3 Deliver Shock Warning Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do n
42. Vesphene H e Enviroquat e Staphene e Misty e Glutaraldehyde Cleaning the NIBP Blood Pressure Cuff Clean the cuff with common hospital disinfectants including Clorox 1 10 solution isopropyl alcohol Lysol solution Phisohex Quatricide Virex and Vesphene Wash gently with the solution then rinse DO NOT allow solution to enter cuff tubes Allow the cuff and hose to completely dry before patient use 24 8 www zoll com 9650 001355 01 Rev B Cleaning instructions Cleaning SpO Sensors Clean the SpO gt sensors with a cloth that has been slightly dampened with one of the recommended agents listed above DO NOT submerge the probe or its connector in any liquids or cleaning agents Thoroughly wipe off any excess cleaning solution with a dry cloth Allow the sensor to completely dry before patient use Cleaning Cables and Accessories Cables cuff tubing paddles and other accessories can be wiped clean with a damp cloth moistened in a mild detergent solution Loading Recorder Paper The unit displays the message PRINTER OUT OF PAPER when the printer is activated without recorder paper or if the supply runs out during printing Use ZOLL recorder paper part number 001739 U To load the recorder paper into the printer 1 Insert your fingers into the indentations on the sides of the printer door pull the door open then remove any paper from the spool Figure 24 1 Opening the Printer Door and Removing
43. When the pediatric patient is less than 8 years of age or weighs less than 55 lbs 25 kg use ZOLL pedi padz pediatric defibrillation electrodes Do not delay therapy to determine the patient s exact age or weight Manual Defibrillation Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by e Unconsciousness e Absence of breathing e Absence of pulse This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias Qualified medical personnel must decide when synchronized cardioversion is appropriate The patient population will range from newborn neonate to adult semiautomatic Operation AED 1 8 X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR transportation and definitive care are in
44. X Series Operator s Guide 9 7 CHAPTER 9 MONITORING CO2 Setting CO and Respiration Rate Alarms The X Series unit sounds alarms whenever measurements are outside set limits for the following e High and Low EtCO e High and Low Respiration Rate in Breaths Minute e High FiCO e No Breath Alarm Note Use the Resp Parameter Control Panel to set the duration of the No Breath Alarm or to disable it see Using the Resp Parameter Control Panel on page 7 4 Enabling Disabling Alarms and Setting CO Alarm Limits You can enable or disable CO alarms and set upper and lower alarm limits through the Alarms quick access key A or the CO2 Parameter Control Panel To configure CO alarms through the Alarms quick access key 1 Press the More quick access key BB 2 Press ry 3 Press the Limits quick access key BB 4 Use the navigation buttons to select appropriate alarm menu For CO the alarm menus are EtCO2 Alarm FiCO2 Alarm or RR BR Alarm 5 On the alarm settings menu use the navigation keys to select the fields that you want to change The fields are e Upper Limit Enable e Lower Limit Enable only EtCO2 and RR BR Alarms e Upper Limit e Lower Limit only EtCO2 and RR BR Alarms FEE 6 When you are finished changing values on the alarm menu select the Backarrow key to exit h the menu 9 8 www zoll com 9650 001355 01 Rev B Caution Setting CO2 and Respiration Rate Alarms Setting Upp
45. alarm occurs and when you press 3 To configure the display of the Trends status window press E3 and press the Trend Settings quick access key to display the Trends Settings control panel On the Trends Settings control panel select Trend Display Format to specify the following monitored vital signs that appear in the Trends status window Trend Format Vital Signs Displayed Resp HR SpO2 RR EtCO2 FiCO2 NIBP HR Sp02 NIBP RR IBP1 HR SpO2 IBP1 RR IBP2 HR Sp02 IBP2 RR IBP3 HR SpO2 IBP3 RR temp HR SpO2 T1 T2 AT 9650 001355 01 Rev B X Series Operators Guide 4 3 CHAPTER 4 TRENDS 4 4 www zoll com 9650 001355 01 Rev B Chapter 5 Alarms The X Series unit supports the detection and indication of patient alarms and technical alerts A patient alarm is any alarm condition that is caused by a monitored patient related variable such as a measured vital sign that falls outside of a configured alarm limit You can configure patient alarm limits for each of the physiologic monitoring functions A technical alert is monitored equipment related variable that the X Series unit can detect such as a disconnected sensor internal diagnostics failures and so on Technical alerts are always enabled and are not user configurable Patient alarms are always classified as high priority alarms Technical alerts are classified as medium or low priority alarms Alarm conditions from patien
46. and announced when the ECG analysis starts automatically or after pressing the ANALYZE button They indicate that an active ECG analysis is in progress SHOCK ADVISED A shockable rhythm has been detected and defibrillation is advised The selected energy level is displayed PRESS SHOCK This message is displayed and announced when the ECG analysis has determined that a shock is advised and the selected energy is ready to be delivered SHOCKS XX This message displays the number of shocks that have been delivered by the unit since it was powered on It resets to 0 after the unit has been off for more than two minutes NO SHOCK ADVISED When ECG analysis detects a nonshockable rhythm this message is announced and displays for 10 seconds following completion of the analysis www zoll com 9650 001355 01 Rev B AED Operation CHECK PULSE If configured to do so this message is displayed and announced in the following situations e After a No Shock Advised analysis result e During the CPR interval after a No Shock Advised analysis result e After the final shock is delivered IF NO PULSE PERFORM CPR If configured to do so this message is displayed and announced in the following situations e During the CPR interval after a No Shock Advised analysis result e During the start of extra CPR interval PERFORM CPR If configured to do so this message is displayed and announced during the CPR interval after a No Shock Advised ana
47. and using this system the Purchaser signifies agreement to and acceptance of the following terms and conditions 1 Grant of License In consideration of payment of the software license fee which is part of the price paid for this product ZOLL Medical Corporation grants the Purchaser a non exclusive license without right to sublicense to use the system software in object code form only 2 Ownership of Software Firmware Title to ownership of and all rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer and Licensors to ZOLL Medical Corporation and they do not pass to purchaser 3 Assignment Purchaser agrees not to assign sublicense or otherwise transfer or share its rights under the license without the express written permission of ZOLL Medical Corporation 4 Use Restrictions As the Purchaser you may physically transfer the products from one location to another provided that the software firmware is not copied You may not disclose publish translate release or distribute copies of the software firmware to others You may not modify adapt translate reverse engineer decompile crosscompile disassemble or create derivative works based on the software firmware NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would alone or in combination with this device fall with
48. battery charging fault has been detected No light Battery is not installed Visual alarm indicators Red yellow and green lights located on the top of the unit that flash on and off when the unit is powered up and are used to indicate a patient alert equipment alert and data transfer 5 Pacer butto Displays pacer settings window to start stop pacing activity or change the rate output or mode settings ANALYZE button gt Z z lt N m Displays in Manual mode only Initiates ECG analysis to determine whether or not a shockable rhythm is present ENERGY SELECT buttons gt ENERGY SELECT v Two sets of up down arrow buttons control the selection of defibrillator energy one set is located on the front panel and the other set is located on the STERNUM paddle CHARGE Button Q x gt a O m Charges the defibrillator to the selected energy In addition to the CHARGE button on the front panel there is one located on the APEX paddle handle Shock Butto 5 The front panel Shock button is only active when using hands free therapy electrodes or internal defibrillation paddles without a discharge button The Shock button illuminates when the device is charged and ready To discharge the defibrillator when using paddles internal or external with discharge buttons press and hold the SHOCK buttons on the paddles NIBP button E Starts stops an NIBP measure
49. causes the defibrillator to disarm itself Press the CHARGE button again to charge the unit to the newly selected energy level A charging message displays at the bottom of the screen and a distinctive charging tone sounds indicating that the unit is charging The energy range bar graph on the right side of the display highlights the charging progress until it reaches the selected energy When the unit is fully charged the tone changes to a continuous charge ready tone the highlighted energy bar graph includes the selected energy and the SHOCK button lights up 9650 001355 01 Rev B X Series Operators Guide 15 13 MANUAL DEFIBRILLATION 3 Deliver Shock Warning 15 14 Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Verify that no one is in contact with the patient monitoring cable or leads bed rails or any other potential current pathways Verify that the ECG waveform is stable and that sync markers appear over each R wave Press and hold the illuminated SHOCK button on the front panel or simultaneously press and hold both paddle SHOCK buttons until energy is delivered to the patient The defibrillator will discharge with the next detected R wave The delivered energy level is displayed at the bottom of the screen and the shock number 1 displays at the top of the screen Note Ifat any time you want to cancel the defibrillation press the Disarm quick access key If the de
50. confirm the charge 06 06 2011 12 34 56 Defibrillator A charging message displays at the bottom of the screen and a distinctive charging tone sounds indicating that the unit is charging The energy range bar graph on the right side of the display highlights the charge level until it reaches the selected energy When the unit is fully charged the tone changes to a continuous charge ready tone the highlighted energy bar graph includes the selected energy and the charge indicator on the APEX paddle lights up 06 06 2011 12 34 56 Defibrillator 4 Selected Energy 15 4 www zoll com 9650 001355 01 Rev B Emergency Defibrillation Procedure with Paddles 3 Deliver Shock Warning Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come into contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Apply a force of 10 12 kilograms 22 26 4 pounds to each paddle in order to minimize patient impedance and achieve optimal results Using your thumbs simultaneously press and hold both SHOCK buttons one on each paddle until energy is delivered to the patient Note The front panel SHOCK button Q is inactive when using external paddles Pressing this b
51. damaged insulation frayed broken wires or bent connector pins b Connectors engage securely 3 Sensors pulse oximetry NIBP cuff and hose temperature sensors a a Inspect for signs of damage or excessive wear b Connectors engage securely a Clean not pitted or damaged b Switches operate freely c Cables and connectors free of damage and engage securely a Therapy pads in sealed pouches 2 sets not expired b Defib gel or gel pads c ECG monitoring electrodes d Alcohol wipes e Razors scissors f Recorder paper a Fully charged battery installed in unit b Fully charged spare battery available T7 ee For Use Indicator shows Ready No flashing or Do Not Use symbol CT ft a Battery charge and AC indicators illuminate with AC power b Audio beeps heard and Visual Alarm indicators briefly illuminate c Self Test passed B Hands Free Defibrillation Test with only battery power cL S a CHECK THERAPY ELECTRODES and PADS SHORT DETECTED messages display b Charge time lt 7 seconds c DEFIB SHORT TEST passed at 30 Joules a Printer prints Pace markers every 25 mm at 60 ppm b PACING SHORT DETECTED message displays no error messages at 100 mA c PACING CHECK THERAPY ELECTRODES message displays a APPLY PADDLES TO PATIENT message displays when paddles are connected to MFC b Paddle switches functional Recorder Energy Select Charge Shock c DEFIB SHORT TEST passed at 30 Joules
52. default and configurable CIT presets for each patient type are indicated in the following table default values are in bold Note You can configure the CIT pressure from the Setup gt NIBP menu Pediatric Neonate 120 mmHg 80 mmHg 60 mmHg 140 mmHg 90 mmHg 70 mmHg 160 mmHg 100 mmHg 80 mmHg 180 mmHg 110 mmHg 90 mmHg 200 mmHg 120 mmHg 100 mmHg 220 mmHg 130 mmHg 110 mmHg 8 8 www zoll com 9650 001355 01 Rev B Warning Configuring NIBP Alarms and Settings Pediatric Neonate 240 mmHg 140 mmHg 120 mmHg 260 mmHg 150 mmHg 130 mmHg In order to accurately measure systolic pressure the CIT pressure must be high enough to occlude the underlying artery However setting the CIT pressure too high may unnecessarily increase the reading determination time and patient discomfort After each NIBP measurement the X Series unit adjusts the cuff inflation pressure to optimize the next NIBP measurement Note The maximum cuff inflation pressure for neonates is 153 mmHg Before using the X Series unit to monitor a new patient power down the unit for at least 2 minutes to reset all patient parameters and eliminate all adjustments made for the previous patient Configuring NIBP Alarms and Settings The last step in preparing to perform NIBP measurements is to ensure that the necessary alarms are enabled or disabled that alarm limits are appropriate and that the NIBP settings are correct Enablin
53. destroyed distributed to another organization new location and or organization if known and different from originator s organization company name address contact name and contact phone number 4 Date when the change took effect Please address the information to ZOLL Medical Corporation Attn Tracking Coordinator 269 Mill Road Chelmsford MA 01824 4105 Fax 978 421 0025 Telephone 978 421 9655 9650 001355 01 Rev B X Series Operator s Guide 1 25 CHAPTER 1 GENERAL INFORMATION Notification of Adverse Events As a health care provider you may have responsibilities under the Safe Medical Devices Act SMDA for reporting to ZOLL Medical Corporation and possibly to the FDA the occurrence of certain events These events described in 21 CFR Part 803 include device related death and serious injury or illness In addition as part of our Quality Assurance Program ZOLL Medical Corporation requests to be notified of device failures or malfunctions This information is required to ensure that ZOLL Medical Corporation provides only the highest quality products Software License 1 26 Note Read this Operator s Guide and License agreement carefully before operating any of the X Series products Software incorporated into the system is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties This software is licensed not sold By taking delivery of
54. device to dry thoroughly prior to use Grounding reliability can be achieved only when the equipment is connected to a receptacle marked HOSPITAL ONLY HOSPITAL GRADE or equivalent If the grounding integrity of the line cord or ac receptacle is questionable operate the defibrillator using battery power only Do not connect to an electrical outlet controlled by a wall switch or dimmer To protect the unit from damage during defibrillation for accurate ECG information and to protect against noise and other interference use only internal current limiting ECG cables specified or supplied by ZOLL For continued safety and EMI performance use only the line cord supplied by ZOLL Electrical installation of the room or the building in which the monitor is to be used must comply with regulations specified by the country in which the equipment is to be used Dispose of battery packs in accordance with national regional and local regulations Battery packs should be shipped to a reclamation facility for recovery of metal and plastic compounds as the proper method of waste management Do not place the device where the controls can be changed by the patient www zoll com 9650 001355 01 Rev B Restarting the Defibrillator Restarting the Defibrillator Certain events require the X Series products to be restarted after they shut off or become inoperative for example when the battery runs down and the unit shuts off In such
55. displayed ECG waveforms can be adaptively filtered using the See Thru CPR feature to reduce the artifact caused by chest compressions The unit has a large colorful LCD display of numerics and waveform data that provides easy visibility from across the room and at any angle ECG plethysmograph and respiration waveform traces can be displayed simultaneously giving easy access to all patient monitoring data at once The display screen is configurable so you can choose the best visual layout to fit your monitoring needs The X Series includes a transcutaneous pacemaker consisting of a pulse generator and ECG sensing circuitry Pacing supports both demand and fixed noninvasive pacing for adult patients and adolescent child and infant pediatric patients The X Series has a patient data review and collection system that allows you to view store and transfer patient data The X Series unit contains a printer and USB port which you can use to print the data and transfer it to a PC The X Series unit can send data through a wireless connection to remote locations The X Series unit can send 12 lead report snapshots including trend data to a recipient via a ZOLL server Full disclosure cases which also contain trend data can be automatically retrieved from the X Series unit using ZOLL RescueNet or ePCR software X Series Optional Features 1 2 The following features are optional in the X Series unit Figure 1 1 X Series Optional Featur
56. fall on the patient To ensure patient safety connect the X Series only to equipment with circuits that are electrically isolated Use only high quality ECG electrodes ECG electrodes are for rhythm acquisition only you cannot use ECG electrodes for defibrillation or pacing Do not use therapy or ECG electrodes if the gel is dried separated torn or split from the foil patient burns may result from using such electrodes Poor adherence and or air pockets under therapy electrodes can cause arcing and skin burns Check the expiration date on the electrode packaging Do not use electrodes after their expiration date Excessive body hair or wet diaphoretic skin can inhibit electrode coupling to the skin Clip excess hair and dry any moisture from the area where an electrode is to be attached Therapy electrodes should be replaced periodically during continuous pacing Consult electrode directions for proper replacement instructions Prolonged pacing more than 30 minutes particularly in neonates or adults with severely restricted blood flow may cause burns Periodically inspect the skin under the electrodes Carefully route the patient cables away from the patient s neck to reduce the possibility of patient entanglement or strangulation To avoid electrosurgery burns at monitoring sites ensure proper connection of the electrosurgery return circuit so that a return path cannot be made through monitoring electrodes or probes 96
57. filter synchronizes the NIBP reading with the R wave of the patient s ECG to eliminate noise created by patient motion or vibration Note The X Series unit must perform ECG monitoring when using Smartcuf If artifact is severe a special symbol appears on the display and printouts Figure 8 5 High Artifact Symbol 8 12 www zoll com 9650 001355 01 Rev B Configuring NIBP Alarms and Settings By default Smartcuf is Enabled There are situations where you may choose to disable Smartcuf These may include e Very extreme motion artifact e Certain types of arrhythmias e Situations that prevent getting a ECG signal NIBP measurements can still be performed with Smartcuf disabled Start Stop TurboCuf Selecting Start TurboCuf starts Short term Automatic STAT NIBP measurements The X Series unit begins its first NIBP measurement after which it continues to perform as many NIBP measurements as possible over a 5 minute period Select Stop TurboCuf to immediately stop STAT measurements WARNING Repeated use of STAT measurements on the same patient over a short time interval can affect blood pressure readings limit circulation to the limb and cause injury to the patient Setting the NIBP Display Format You can specify the appearance of the NIBP numeric display format The display format allows you to choose whether or not you will display MAP measurement M with the Systolic S and Diastolic D measurements in one of the fol
58. gt Limit Default SpO Limit Range Lower 85 Lower 50 Upper 100 Upper 52 Pediatric Lower 85 Lower 50 Upper 100 Upper Lower 85 Lower Upper 95 Upper 9650 001355 01 Rev B X Series Operators Guide 10 9 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET setting Upper and Lower SpCO and SpMet Alarm Limits Patient Type The following table lists the default SoCO and SpMet limits for adult pediatric and neonate patients and gives the range in which you can set these limits SpCO Limit Defau Lower Upper It 0 10 SpCO Limit Range Lower Upper 0 98 2 100 SpMet Limit Defau Lower Upper It 0 3 SpMet Limit Range Lower Upper 0 98 2 100 Pediatric Lower Upper 0 10 Lower Upper 0 98 2 100 Lower Upper 0 3 Lower Upper 0 98 2 100 Neonate Lower Upper 0 10 Lower Upper 0 98 2 100 Lower Upper 0 3 Lower Upper 0 98 2 100 Using the SoO Parameter Control Panel Use the navigation keys to highlight and select the SpO numeric display to display the SpO Parameter Control Panel on which you can select options that optimize the use of SpO for the patient Lower SpO2 Alarm 85 SpCO Alarm 0 SpMet Alarm 0 0 SpCO Monitoring SpMet Monitoring Averaging
59. hemoglobin SpO2 pulse rate carboxyhemoglobin saturation SpCO and or methemoglobin saturation SpMet The pulse CO oximeter and accessories are indicated for use on adult pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals hospital type facilities or in mobile environments Respiration Monitoring The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator Because the measurement method actually measures respiratory effort apnea episodes with continued respiratory effort such as obstructive apnea may not be detected It is not intended to be used as an apnea monitor The patient population will range from newborn neonate to adult CO Monitoring The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate The patient population will range from newborn neonate to adult Invasive Pressure Monitoring The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer The primary intended uses are arterial blood pressure central venous pressure and intracranial pressure monitoring Any contra indications of the particular transducer selected by the user shall apply The patient
60. it powers the unit and charges the battery that is installed inside it When the power cord is plugged in and the auxiliary power connector is inserted into the back of the X Series unit the auxiliary power LED on the front panel illuminates and the auxiliary power icon displays at the top of the display screen rs Jy Figure 2 10 Auxiliary Power Adapter 9650 001355 01 Rev B X Series Operators Guide 2 11 CHAPTER 2 PRODUCT OVERVIEW To connect the auxiliary power adapter insert the auxiliary power connector into the black input connector on the back of the unit To disconnect the auxiliary power adapter grasp the connector collar turn it to the left and pull it out Figure 2 11 Connecting the Auxiliary Power Adapter Navigating the Display Screen You can access the X Series functions using the quick access keys that are located on the left side of the display screen and the navigation keys that are located on the right side of the front panel Quick Access Keys The seven quick access keys on the left side of the display screen are an easy way to access the functionality of the X Series When you press the last key left arrow five more keys are displayed First level keys Second level keys Ea gt VOUS 2 12 www zoll com 9650 001355 01 Rev B Navigating the Display Screen Table 2 3 X Series Quick Access Keys Quick access key Description
61. multiwavelength calibration equations to estimate the percentages of carboxyhemoglobin and methemoglobin in arterial blood The quality of measurements depends on the correct size and application of the sensor adequate blood flow through the sensor site and the sensor s exposure to ambient light For correct placement and location of the sensors refer to the Directions for Use contained with all Rainbow oximetry sensor packages 9650 001355 01 Rev B X Series Operator s Guide 10 1 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET Warnings 10 2 S005 General SpO style pulse oximeter measurements may be affected by numerous factors such as bright lights improperly applied probes use of non ZOLL approved sensors patient conditions movements The clinician should use good clinical judgment when interpreting SpO measurements Should the clinician question an SpO measurement an arterial blood gas oxygen saturation measurement should be obtained Interfering substances Carboxyhemoglobin and methemoglobin can erroneously alter SpO readings The level of change is approximately equal to the amount of carboxyhemoglobin or methemoglobin present Dyes or any substance containing dyes that alter arterial pigmentation might cause erroneous readings Do not use the X Series pulse oximeter or oximeter sensors during magnetic resonance imaging MRI Induced current could cause burns The pulse oximeter might affect the MRI
62. on The X Series unit performs a number of power on self tests Verify that the unit displays SELF TEST PASSED If the message SELF TEST FAILED appears on the display contact the appropriate technical personnel or the ZOLL Technical Service Department Disconnect the external AC adapter from the Verify that the unit continues to operate without X Series rear panel interruption on battery power and that the displayed battery icon indicates that a fully charged battery is installed Verify that no error messages are displayed With no ECG cables attached to the unit Verify that a LEAD FAULT message displays in select Lead II or Ill as the waveform display the waveform window source Select Pads as the waveform display source Verify thata CHECK THERAPY and connect the multifunction cable to the ELECTRODES message displays in the unit Do not connect the test connector to the waveform window Connect the multi function cable MFC to the Verify that the CHECK THERAPY test connector ELECTRODES message is replaced by a SHORT DETECTED message 9650 001355 01 Rev B X Series Operator s Guide 24 3 CHAPTER 24 MAINTENANCE Press the Select Energy arrow up or down Verify that the defibrillation window displays and the following message appears 24 4 PADS SHORT DETECTED SELECT 30J TO TEST Press the Select Energy arrow up or down Verify that the defibrillator window shows to select 30 Joules on the X
63. options in Fig 1 1 Optional features are specified as optional within this guide The product is designed for use in both the hospital and the rugged EMS environment The device is a versatile automated external defibrillator with manual capabilities and may be configured to operate in Manual Advisory or Semiautomatic modes It can be configured to start up in Semiautomatic AED mode or manual mode When operating in manual configuration the device operates as a conventional defibrillator where the device s charging and discharging is fully controlled by the operator In Advisory and AED modes some features of the device are automated and a sophisticated detection algorithm is used to identify ventricular fibrillation and determine the appropriateness of defibrillator shock delivery Units may be configured to automatically charge analyze recharge and prompt the operator to PRESS SHOCK depending on local protocols The unit is switched from AED mode to Manual mode for ACLS use by pressing the appropriate key on the front panel 9650 001355 01 Rev B X Series Operator s Guide 1 1 CHAPTER 1 GENERAL INFORMATION The X Series unit assists caregivers during cardiopulmonary resuscitation CPR by evaluating the rate and depth of chest compressions and providing feedback to the rescuer Real CPR Help requires the use of ZOLL OneStep CPR electrodes OneStep Complete electrodes or CPR D padz When using these pads the
64. prints vertical dashed lines to indicate the detected pacemaker signals If the Pacer Indicator setting is OFF the X Series does not perform the following actions e detect the implantable pacemaker pulses e blank the pacemaker pulses from the waveform e display or print the vertical dashed line pacer markers You can turn the Pacer Indicator ON OFF from the Setup gt ECG menu There are situations where ECG artifact could simulate pacemaker signals which could cause false pacemaker detection and blanking These situations may cause inaccurate QRS detection and it may be desirable to turn the Pacer Indicator off Inversely when the Pacer Indicator setting is OFF implantable pacemaker signals may cause inaccurate QRS detection and it may be desirable to turn the Pacer Indicator on ECG System Messages When monitoring ECG the X Series unit may display the following messages System Message LEAD FAULT The current ECG source lead is defective check lead and replace if necessary JOR Se An unavailable waveform source has been specified for the trace display check specified waveform source and correct if necessary PADDLE FAULT or CABLE FAULT Check the pad paddle or cable and replace if necessary 9650 001355 01 Rev B X Series Operator s Guide 6 9 CHAPTER 6 MONITORING ECG 6 10 www zoll com 9650 001355 01 Rev B Chapter 7 Monitoring Respiration Resp and Heart Rate HR This chapter describes how to use
65. response is normally characterized by suppression of the intrinsic QRS complex Determination of electrical capture should only be performed by viewing the ECG trace on the X Series display with its ECG connection directly attached to the patient Use of other ECG monitoring devices might provide misleading information due to the presence of pacer artifacts Mechanical capture is assessed by palpation of the peripheral pulse To avoid mistaking muscular response to pacing stimuli for arterial pulsations use ONLY the following locations for palpating pulse during pacing e femoral artery e right brachial or radial artery Effective pacing Changing ECG leads and size can sometimes be helpful in determining capture Note The shape and size of the paced ECG waveforms can vary depending on the ECG lead configuration chosen variation from patient to patient can be expected 9 Determine Optimum Threshold 18 8 The ideal pacer current is the lowest value that maintains capture it is usually about 10 above threshold Typical threshold currents range from 40 to 80 mA Location of the hands free or therapy electrodes affects the current required to obtain ventricular capture Typically the lowest threshold is obtained when the position of the electrodes provides the most direct current pathway through the heart while avoiding large chest muscles Lower stimulation currents produce less skeletal muscle contraction and are better tolerated
66. right heart failure tricuspid regurgitation or obstructed venous return SpO measurements may be affected when using intravascular dyes in extreme vasoconstriction or hypovolemia or under conditions where there is no pulsating arterial vascular bed SpO measurements may be affected in the presence of strong EMI fields electrosurgical devices IR lamps bright lights improperly applied sensors the use of non ZOLL sensors or damaged sensors in patients with smoke inhalation or carbon monoxide poisoning or with patient movement Tissue damage can result if sensors are applied incorrectly or left in the same location for an extended period of time Move sensor every 4 hours to reduce possibility of tissue damage Do not use any oximetry sensors during MRI scanning MRI procedures can cause conducted current to flow through the sensors causing patient burns Do not apply SpO gt sensor to the same limb that has an NIBP cuff The SpO alarm may sound when the arterial circulation is cut off during NIBP measurements and may affect SpO measurements 9650 001355 01 Rev B X Series Operator s Guide 1 19 CHAPTER 1 GENERAL INFORMATION In some instances such as obstructed airway the patient s breathing attempts may not produce any air exchange These breathing attempts can still produce chest size changes creating impedance changes which can be detected by the respiration detector It is best to use the pulse oximeter whenever m
67. ring on the hose connector Eliminate kinks or replace hose if necessary NIBP DISABLED NIBP CALIBRATION CHECK DUE PLEASE WAIT www zoll com A system error has occurred and the X Series unit should be serviced The annual calibration check is due You can continue to use the device however we recommend that you contact your trained specialist or the ZOLL Technical Service Department or a ZOLL authorized service representative as soon as possible to perform the recommended annual NIBP calibration check After completing an NIBP request in Automatic mode or STAT TurboCuf mode the unit must wait up to 30 seconds before initiating the next NIBP measurement request 9650 001355 01 Rev B NIBP System Messages System Message PRESS LIMIT EXCEEDED The cuff pressure has exceeded the allowable limit Restrict patient movement and check the hose for kinks Eliminate kinks or replace the hose if necessary TEMP OUT OF RANGE The NIBP module is outside of its operating temperature range Move unit to proper operating temperature and reattempt the NIBP measurement WEAK PULSE The patient s pulse is too weak to obtain an NIBP measurement or the cuff requires adjustment 9650 001355 01 Rev B X Series Operator s Guide 8 15 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP 8 16 www zoll com 9650 001355 01 Rev B Chapter 9 Monitoring COs This chapter describes how to use the X Series unit t
68. specification is maintained to within 4 for the following gas mixtures all values are in Vol Anesthetic Agents 1 0 to 13 0 to 97 5 O to 100 0 to 80 Dry to saturated According to EN 21647 Respiration Range 0 to 149 breaths per minute Respiration Rate Accuracy 0 to 70 bpm 1 bpm 71 to 120 bpm 2 bpm 121 to 149 bpm 3 bpm Flow rate 50 ml min 7 5 15 ml min flow measured by volume Total System Response Time 2 9 seconds typical 3 9 seconds maximum 9650 001355 01 Rev B X Series Operator s Guide A 19 Specifications Pulse Oximeter Range Oxygen Saturation SpO2 1 100 Carboxyhemoglobin Saturation SpCO 0 99 Methemoglobin Saturation SpMet 0 99 Pulse Rate bpm 25 240 beats per minute Accuracy Oxygen Saturation SpO2 During No Motion Conditions Adults Pediatrics 70 100 2 digits 0 69 unspecified Neonates 70 100 3 digits 0 69 unspecified Oxygen Saturation SpO2 During Motion Conditions Adults Pediatrics 70 100 3 digits 0 69 unspecified Neonates 70 100 3 digits 0 69 unspecified Oxygen Saturation SpO2 During Low Perfusion Conditions Adults Pediatrics 70 100 2 digits Neonates 70 100 3 digits Carboxyhemoglobin Saturation SpCO 1 40 3 digits Methemoglobin Saturation SpMet 1 15 1 digit Pulse Rate bpm During No Motion Conditions Adults Pediatrics Neonates 25 240 3 digi
69. the automated self tests that the X Series unit performs to help ensure readiness For more information see the Operational Tests in the X Series Service Manual Annually In addition to Daily Shift Check Procedure and Operational Tests the following is recommended Perform NIBP calibration check Perform CO calibration check The NIBP and CO calibration checks should be performed annually or according to local requirements to be performed by a qualified Biomedical Equipment Technician BMET as described in the X Series Service Manual Guidelines for Maintaining Peak Battery Performance Each battery should be identified with a number or letter An identification mark is useful in tracking battery performance Keep extra batteries in the SurePower Charger Station where their status can be quickly determined Illumination of the Ready light is the most positive indication of a fully charged battery Always carry at least one fully charged spare battery If no other source of back up power is available two spare batteries are advisable Rotate spare batteries routinely The charge level gradually diminishes in a battery after it is removed from the charger even if it is not used Regular battery rotation helps to avoid incidents where a low battery condition is encountered because the battery has not been recharged or used in more than 30 to 90 days Whenever possible recharge a partially depleted battery This can be accomplis
70. the X Series unit to monitor Respiration Resp and Heart Rate HR The X Series unit displays Respiration Resp and Heart Rate HR meters The Respiration and Heart Rate meters display values that the X Series unit derives from measurements taken by other X Series monitoring functions 06 06 2011 12 34 56 Heart Rate Meter Respiration Meter 9650 001355 01 Rev B X Series Operator s Guide 7 1 Chapter 7 Monitoring Respiration Resp and Heart Rate HR Note The respiration rate is disabled during defibrillation During defibrillation the respiration rate will display on the snapshot Respiration Breath Rate Meter If enabled the X Series unit displays the patient s respiration in the Respiration Breath Rate Meter The respiration meter displays the respiration rate that it derives by default from the unit s CO monitoring function If CO monitoring is not available the unit derives the respiration rate through impedance pneumography using a specified ECG electrode configuration If ECG monitoring isn t functioning the Resp BR meter will not display a respiration rate Using Impedance Pneumography to Measure Respiration Warning 1 2 Impedance pneumography detects respiration by applying a high frequency low current AC signal to the patient and measuring the changes in impedance through ECG electrode Lead RA LA or Lead II RA LL As the patient inhales and chest volume expands impedance incr
71. well as the optional features SpCO and SpMet The X Series pulse CO Oximeter continuously and noninvasively measures the oxygen saturation of arterial hemoglobin SpO gt carboxyhemoglobin saturation SpCO and methemoglobin saturation SpMet at a peripheral site such as the foot toe or finger This monitoring gives information about the cardiac and respiratory systems and provides details of oxygen transportation in the body It is widely used because it is noninvasive continuous easily applied and painless The X Series pulse CO oximetry option is intended for use only with ZOLL Masimo Rainbow sensors The CO oximetry sensor contains light emitting diodes LEDs that transmit various visible and infrared light through the body s extremities The transmitted light is then received by a photodetector which converts it to an electronic signal The signal is then sent to the X Series unit for processing Oxygen saturated blood absorbs light differently than unsaturated blood Thus the amount of visible and infrared light absorbed by blood flowing through a suitable peripheral area of the body typically the finger in adults and the foot in neonates can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood The monitor displays this ratio as percent SpO alternating with SpCO and SpMet values Normal SpO values typically range from 95 to 100 at sea level The SpCO and SpMet measurements rely on
72. while in Advisory CPR Protocol mode the unit transitions to Manual mode If the unit is charged when you transition from Advisory CPR Protocol to Manual mode the unit disarms and halts any analysis that is taking place Non Shockable Rhythm When a nonshockable rhythm is detected the unit displays a NO SHOCK ADVISED message The unit then leads you through a CPR interval and then restarts ECG analysis automatically The Advisory CPR Protocol mode repeats the Analysis and CPR intervals as long as Advisory CPR Protocol is active You can press the Exit quick access key at any time to return to Manual mode Note When a nonshockable rhythm is detected the X Series does not prevent the user from manually defibrillating the patient Shockable Rhythm If the patient s rhythm is shockable the unit displays the SHOCK ADVISED and PRESS SHOCK messages The defibrillator automatically prompts the operator to shock the patient at the preconfigured energy level and the SHOCK button illuminates A continuous tone sounds for 20 or 50 seconds depending on configuration followed by a higher pitch tone for 10 seconds You must deliver the shock within this 30 or 60 second interval depending on configuration or the defibrillator will disarm itself 3 Press SHOCK button WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the patie
73. will preempt the display of the valid invasive pressure numerics www zoll com 9650 001355 01 Rev B Displaying IBP Measurements Displaying IBP Measurements After attaching and zeroing a transducer the X Series unit displays the invasive pressure s systolic diastolic and MEAN values in the IBP channel s numeric display and optionally 1f enabled through the unit s Waveform Select menu the waveform for that IBP channel P3 mmHg The X Series unit allows you to specify a label that identifies the channel s IBP measurement and to select a display format for the numeric display The unit displays the waveform scales after you zero the transducer When the unit accepts the zero reference value it determines the waveform scales and displays them Conditions Affecting IBP Measurements When reading blood pressure measurements on the IBP numeric display keep in mind that the following conditions can affect the accuracy of IBP measurements e Catheter placement in the vasculature Artifact such as catheter whip should be handled per your established clinical protocols e Position of the transducer stopcock catheter and flush port e Saline line flushes which will temporarily interrupt accurate pressure measurement e Position of the transducer relative to the patient s phlebostatic axis or catheter tip e Patient movement e Catheter clogging e Air bubbles in catheter or transducer dome Caution Flush cathet
74. with major divisions vertical dotted lines every 5 mm CO2 Waveform CO2 waveforms are printed on a grid with major divisions vertical dotted lines every 5 mm and the pressure scale grids are printed horizontally RESP Waveform Respiration waveforms are printed with major divisions vertical dotted lines every 5 mm Printing Reports Print on Snapshot Prints snapshot including numerics and waveform each time a snapshot is acquired Print on Patient Alarm You can print a report each time an alarm occurs This report is called the Print on Patient Alarm Report The Print on Patient Alarm setting must be turned on in the Setup gt Print window Print on NIBP You can print the results of an NIBP measurement each time one occurs This report is called the NIBP Ticket Report The Print on NIBP setting must be turned on in the Setup gt Print window Print on Trend Prints numeric trend values each time a trend data snapshot is taken Printing Treatment Summary Report To print a treatment summary report do the following 1 Press the More quick access key icy 1 Press the Log quick access key 6 2 Press the Treatment Summary quick access key ED The Treatment Summary window displays 3 Use the navigation keys to highlight and select the treatment summary you want to print Note The Treatment Summary Report that you selected has a check mark next to it 4 Use the navigation keys to highlight and select Print Trea
75. www zoll com 9650 001355 01 Rev B Pediatric Pacing Pacing in Fixed Mode Noninvasive pacing of pediatric patients is performed in an identical manner to adult pacing Smaller size pediatric therapy electrodes are available for patients weighing less than 33 Ibs 15 kg If it is necessary to pace for more than 30 minutes periodic inspection of the underlying skin is strongly advised Carefully follow all instructions on electrode packaging Pace Fault The X Series unit may display the following messages when pacing System Message Description The pacer has paused pacing the patient The pacer is pacing the patient PACING CHECK THERAPY ELECTRODES Therapy pads are not connected or are not making good contact with the patient Apply therapy pads to the patient ECG FAULT PACING IN FIXED MODE The pacer is pacing in Fixed mode because the ECG lead displayed in the primary waveform is faulted PACING SHORT DETECTED 9650 001355 01 Rev B The pacer output is short circuited due a test plug connection or a device MFC fault X Series Operator s Guide 18 9 CHAPTER 18 EXTERNAL PACING 18 10 www zoll com 9650 001355 01 Rev B Chapter 19 Real CPR Help J Real CPR Help is defibrillation proof Type BF equipment WARNING The Real CPR Help function is not intended for use on patients under 8 years of age When used with CPR D padz or OneStep CPR electrodes the X Series unit can provide r
76. 0 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm ms Figure A 16 Rectilinear Biphasic Waveform at 5 Joules 9650 001355 01 Rev B X Series Operator s Guide A 11 Specifications 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 17 Rectilinear Biphasic Waveform at 4 Joules e 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 18 Rectilinear Biphasic Waveform at 3 Joules A 12 www zoll com 9650 001355 01 Rev B Defibrillator 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm t 175 Ohm 200 Ohm ms Figure A 19 Rectilinear Biphasic Waveform at 2 Joules 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm ms Figure A 20 Rectilinear Biphasic Waveform at 1 Joule 9650 001355 01 Rev B X Series Operator s Guide A 13 Specifications Monitor Display A 14 Input 3 lead 5 lead or 12 lead patient cable paddles or Multifunction electrodes Type Color LCD 640 x 480 pixels 800 MCD Sweep Speed 25 mm sec or 50 mm sec User Selectable Lead Selections Paddles Pads I II HI AVR AVL AVF V1 6 Frequency Response User selectable 0 67 to 20 Hz Limited mode 0 67 t
77. 011 13 53 34 Adult 1 l Pads Paddles Imp Not Calibrated 00 17 11 NIBP mmHg ee DHCP 7 Static IP Profile Name Temporary Profile SSID CiscoN Authentication WPA2 PSK Security Key LetMelnit sMe Network Setting Use the navigation keys to select either DHCP or Static IP If you select Static IP use the numeric keypad to enter values for the IP Address Subnet Mask Default Gateway Preferred SDNS Server and Alternate DNS Server Of 27 11 14 34 03 Adult j Some Alarm Limits Disabled 02 43 27 Row M Row i NIBP mmHg NV A Select Access Point Profile gt Edit AP Profile gt Configure Stat IP Addres Subnet Ma BIS F 10 mers Preferred Alternate o fpor o joy o Backspace Clear Clear Cancel Cancel Profile Name The profile name is Temporary Profile and cannot be changed 22 4 www zoll com 9650 001355 01 Rev B The Wireless Menu SSID Use the alphabetical keypad to enter the SSID name Press SAVE to save changes and return to the Temporary Profile menu press Cancel to return to the Temporary Profile menu without saving changes Of f 26 11 17 43 15 Adult Authenication Use the navigation keys to select the authentication type Encryption Type Use the navigation keys to select the encryption type 9650 001355 01 Rev B X Series Operator s Guide 22 5 CHAPTER 22 WIRELESS COMMUNICATIONS Security Key Use the alphabetical keypad to enter the
78. 01Rev B X Series Operator s Guide ti C AA CHAPTER 21 PATIENT DATA Capturing a Data Snapshot Press the Snapshot button 3 on the front panel to capture a 24 second period of numeric and waveform patient data The unit captures 12 seconds proceeding and 12 seconds following the button press The X Series unit can store a minimum of 32 snapshots including e Monitor snapshots e Defibrillator snapshots e Treatment snapshots e Pacer snapshots e Alarm snapshots e Presenting Rhythm snapshots Note Presenting Rhythm snapshots are only taken at the start of a new patient The snapshot will not be retaken if the unit is shut off for less than two minutes Reviewing and printing snapshots You can perform this procedure from any main display screen 1 Press the Home Display button 68 repeatedly until the Trends window displays 2 Use the navigation keys to get to the Trends window 3 Press the Select button to scroll through the list of trends Note The snapshots have a snapshot icon next to the time stamp 4 Select the desired snapshot from the Trends list and press Select The snapshot numeric data displays 5 To print the data and the snapshot waveforms highlight Print this Snapshot and press Select Note If you attempt to print a snapshot before the unit has finished storing the snapshot in the log a NO DATA AVAILABLE message is printed To print the snapshot correctly wait until the snapshot is co
79. 1355 01 Rev B X Series Operator s Guide A 15 Specifications Alarms A 16 Heart Rate Alarms Audible 5 pulse 900 Hz tone with a PW of 125 msec a PRI of 250 msec and a repetition interval of 15 seconds Visual Heart Rate Alarm causes the heart rate to be displayed in red with a white background The red device status LED will flash a rate of 1 7 Hz Lead Fault Alarm Audible 3 pulse 500 Hz triplet tone with a PW of 200 msec a PRI of 200 msec The lead fault tone repeats at a repetition interval of 30 seconds Visual Lead Fault condition causes a LEAD FAULT message to be displayed on the trace along with a dashed line the width of the trace Physiological Alarms NIBP SpO2 Resp CO2 IP amp Temp Audible Same as Heart Rate Alarm Visual Physiological alarms cause the alarming parameter to be displayed in Red with a white background The red device status LED will flash at a rate of 1 7 Hz Silence Duration 90 seconds Invalid Operation Alert Tone A short low pitched tone is audible when a selected control button is unavailable for use or an invalid entry is detected Tone frequency is 160 Hz Duration is 250 msec Delays hold off time Heart rate pulse rate e if source is ECG 5 seconds e if source is SpO gt 10 seconds e if source is IBP 5 seconds e if source is NIBP no hold off SpO SpCO and SpMet Saturation 10 seconds EtCO 7 seconds FiCO 5 seconds IBP Systolic Diastolic
80. 2 30 21 12 25 21 12 20 21 12 15 21 12 34 56 Adult NIBP Trends X Series Operator s Guide Monitoring Display Options Ml 00 17 43 3 5 CHAPTER 3 MONITORING OVERVIEW Press the Home Display button when viewing the Trends Status window and the Large Numerics Display window appears The patient s vital signs measurements appear in large labeled numeric displays no waveform trace appears on this screen 06 06 2011 12 34 56 ML rA Mh Press the Home Display button to redisplay the Primary Display window Note When the X Series unit is displaying the Defibrillation or Pacing Control panels the unit will not allow the display the Large Numerics Display window 3 6 www zoll com 9650 001355 01 Rev B Configuring the Waveform Display Configuring the Waveform Display You can display up to four waveform traces on the Waveform Display window The first waveform trace always uses an ECG lead as its source such Pads or Leads I Il or III and so on As you insert the remaining three traces you can specify that the traces use an ECG lead as the waveform source or that the trace derive its waveform from other available monitoring functions such as Resp CO2 SpO2 or IBP channels P1 P2 or P3 The X Series unit can also cascade a trace onto the adjoining trace area to double the duration of the trace display On the Waveform Display window to insert a new trace Insert or cascade Cascade a displayed t
81. 5 01 Rev B X Series Operator s Guide A 29 Specifications A 30 Guidance and Manufacturer s Declaration Electromagnetic IEC 60601 1 2 Table 202 The X Series unit is intended for use in the electromagnetic environment specified below The customer or the user of the X Series should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 V contact 6k 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Uy 60 dip in Uy for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 sec 3 A m V contact 6k 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Uy 60 dip in Uy for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 sec 3 A m Floors should be wood concrete or ceramic tile If floors are covered with syn
82. 50 001355 01 Rev B X Series Operator s Guide 1 23 CHAPTER 1 GENERAL INFORMATION During electrosurgery observe the following guidelines to minimize electrosurgery unit ESU interference and provide maximum operator and patient safety e Keep all patient monitoring cables away from earth ground ESU knives and ESU return wires e Use electrosurgical grounding pads with the largest practical contact area Always ensure proper application of the electrosurgical return electrode to the patient Check electrical leakage levels before use Leakage current might be excessive if more than one monitor or other piece of equipment is connected to the patient Cautions 1 24 If the unit is to be stored longer than 90 days remove the battery pack Do not sterilize the defibrillator or its accessories unless the accessories are labelled as sterilizable Do not immerse any part of the defibrillator in water Do not use the defibrillator if excessive condensation is visible on the device Wipe only the outside with a damp cloth Do not use ketones such as acetone or MEK on the defibrillator Avoid using abrasives including paper towels on the display window To achieve the specified level of protection against spilled or splashed liquids thoroughly dry all exposed surfaces of this device prior to operation or connections to auxiliary power If liquids enter the device connectors remove all liquid from the connectors and allow the
83. 6 Raw ECG Filter OFF i j A i A 3E 1 PN ely ae Lani Lele i eee ia Filtered ECG CPR 14 48 12 5 momsec 5 mm m W 9650 001355 01 Rev B WARNING Storing Chapter 21 Patient Data This chapter describes procedures for storing viewing and transferring patient data from the X Series to an external system such as a personal computer or handheld device Note Before deleting log files from the X Series view the files on a personal computer to verify that they have been successfully transferred Note Data transfers will not be successful if the USB flash storage device is full or does not have sufficient memory available Always use a USB flash storage device that has at least 128 MB available Do not connect non isolated equipment to the USB port while monitoring a patient Data The X Series unit stores a combination of 24 hours at one minute intervals of patient trend information one thousand time stamped events and 32 snapshots 24 second duration for the patient being monitored The actual number of trends events or snapshots stored could be more or less depending on the use profile When the data storage is at capacity the log becomes full and the patient data must be cleared or transferred before the X Series unit can store additional patient data Data will not be lost if the X Series unit is turned off or if the battery or auxiliary power adapter is removed 9650 001355
84. 72 MHz 32 mW OFDM 6 9 12 24 36 48 54 Mbps 802 11n 2412 2472 MHz 32 mW OFDM 6 5 13 19 5 26 39 52 58 5 65 Mbps Bluetooth 2400 2483 5 MHz 10mW FHSS GFSK 1 3 Mbps DQPSK 8DPSK 802 11a 5180 5320 MHz 32 mW 6 9 12 24 36 48 54 Mbps 5500 5700 MHz 9745 5825 MHz 802 11n 5180 5320 MHz 6 5 13 19 5 26 39 52 5500 5700 MHz 98 5 65 Mbps 9745 5825 MHz FCC Notice ZOLL Medical Corporation has not approved any changes or modifications to this device by the user Any changes or modifications could void the user s authority to operate the equipment See 47 CFR Section 15 21 This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation See 47 CFR Section 15 19 a 3 The user is cautioned to maintain 20cm 8 inches of space from the product to ensure compliance with FCC requirements Canada Industry Canada IC Notices This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device A 34 www zoll com 9650 001355 01 Rev B Appendix B Accessories The following accessories are
85. APTER 3 MONITORING OVERVIEW Inserting a capnogram CO2 into the fourth trace area 06 06 2011 12 34 56 Adult 00 47 80 NIBP mmHg 121 79 96 Cascade Remove 12 CO eA 06 06 2011 12 34 56 E 00 We 1 cm mV g o 5 se re ane a 97 T1 F 98 6 3 10 www zoll com 9650 001355 01 Rev B Chapter 4 Trends The X Series unit accumulates a patient s trend information by logging all monitored vital sign measurements to memory at a user configurable interval It also logs all monitored vital sign measurements when the following occurs e An NIBP measurement is taken and the Trend on NIBP option is on e You press the Snapshot button fta on the front panel e A patient alarm occurs and the Trend on Alarm option is on The X Series unit can store at least 24 hours of trend information when logged at a 1 minute trend interval You can view print or save to external memory all logged trend information Displaying the Trends Status Window The X Series unit displays the logged trend information in the Trends status window Press the Display Home button to display the Trends window the primary ECG trace and the small numeric displays for each monitoring function 9650 001355 01Rev B X Series Operator s Guide ti i i s sSD CHAPTER 4 TRENDS 06 06 2011 12 34 56 00 17 43 NIBP Trends Time CO SYNC 12 30 21 Die 12 15 21 Navigate Here to Scroll Through Trend
86. Apply the paddles firmly to the anterior wall of the chest Place the STERNUM paddle to the right of the patient s STERNUM patient s right just below the clavicle Place the APEX paddle on the chest wall just below and to the left of the patient s left nipple along the anterior axillary line STERNUM APEX Rub the paddles against the skin to maximize the paddle to patient contact Warning Do not permit gel to accumulate between the paddle electrodes on the chest wall gel bridge This could cause burns and reduce the amount of energy delivered to the heart If using defibrillator gel pads make sure that the size of the pad is large enough to cover the entire paddle electrode area The paddles may be used for ECG monitoring in emergency situations when time does not allow connection of standard ECG monitoring electrodes 2 Charge Defibrillator Press the CHARGE button on the APEX handle or on the front panel or To increase or decrease the selected energy after you have pressed the CHARGE button use the defibrillator Energy Select buttons on either the STERNUM paddle or the defibrillator front panel 9650 001355 01 Rev B X Series Operators Guide 15 3 MANUAL DEFIBRILLATION Caution Changing the selected energy while the unit is charging or charged causes the defibrillator to disarm itself Press the CHARGE button again to charge the unit to the newly selected energy level Press the CHARGE button again to
87. C 2005 1 5 and 2 0 AHA ERC 2010 2 0 and 2 4 inches The unit displays a minimum of 12 seconds of compression data at a rate of approximately 133 compressions per minute 19 4 www zoll com 9650 001355 01 Rev B WARNING Chapter 20 see Thru CPR Optional See Thru CPR is an optional feature in the X Series The See Thru CPR filter works only when the X Series defibrillator is monitoring CPR in Manual mode The See Thru CPR filter stops if The unit is in pace mode Patient impedance is invalid ZOLL OneStep CPR electrodes OneStep Complete electrodes or CPR D padz are no longer detected The See Thru CPR filter will not remove all CPR artifact Always stop CPR to verify the patient s ECG rhythm before making treatment decisions The See Thru CPR filter does not operate during ECG rhythm analysis Always stop chest compressions during ECG rhythm analysis to avoid incorrect results caused by the presence of CPR artifact Diagnostic bandwidth is never applied to the See Thru CPR waveform See Thru CPR enables the rescuer to see a close approximation of the patient s underlying ECG rhythm while performing CPR See Thru CPR is available if the X Series is monitoring CPR Chest compressions introduce CPR artifact into the ECG signal See Thru CPR uses a filter that relies on the correlation between CPR compressions as detected by the ZOLL Onestep OneStep Complete or CPR D padz and the CPR artifact to remo
88. CG INTERPRETIVE ANALYSIS Observing the 12 Lead Waveform Traces To observe the 12 Lead waveform traces press A The screen displays all twelve waveform traces with the size displayed above the waveform traces 06 06 2011 12 34 56 00 17 43 SpMet 20 0 12 Lead Interpretive Analysis After observing the patient s ECG and determining that all 12 lead traces display correctly you can initiate 12 Lead Interpretive Analysis Note 12 Lead Interpretive Analysis works for only Adult patients To begin 12 Lead Interpretive Analysis press the Acquire quick access key ED The X Series unit displays the Acquiring 12 Lead Status bar as it collects 10 seconds of 12 Lead ECG data Acquiring 12 Lead C MD 12 Lead ECG Monitoring Setup After acquiring the ECG data the unit saves the data and displays the Saving 12 Lead Status Bar in the following manner saving 12 Lead After saving the data the unit performs the post acquisition Interpretive Analysis and displays the first page of 12 Lead Interpretive Analysis information 06713711 14 47 01 Adult Real Time Abnormal finding for 40 male Sinus rhythm Low QRS voltage in chest leads QRS deflection lt 1 0 m in chest leads i Acute ST elevation anterior infarct marked STE in Y2 3 In the example above the interpretive statement STEMI indicates the occurrence of ST Elevation Myocardial Infarction The interpretive statements that the X
89. CO monitoring of intubated patients Before attaching the airway adapter to the breathing circuit verify that the adapter is clean dry and undamaged Replace if necessary Caution The disposable FilterLine set is intended for single patient use Do NOT reuse or sterilize any part of the FilterLine Set as the monitor may be damaged by cleaning or reuse 1 Place the airway adapter at the proximal end of the airway circuit between the elbow and the ventilator circuit wye Do NOT place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter 2 If pooling does occur the airway adapter may be removed from the circuit rinsed with water and reinserted into the circuit To prevent moisture from draining into the sample tubing ensure that the sampling tube exits from the top of the airway adapter not its bottom or sides See the following figure 9650 001355 01 Rev B X Series Operators Guide 9 5 CHAPTER 9 MONITORING CO2 Applying a Smart CapnoLine Nasal or Nasal Oral Cannula The nasal and nasal oral cannulas are intended for monitoring CO in non intubated patients Oral nasal sampling cannulas are especially valuable for patients who are prone to mouth breathing since most if not all of the CO is exhaled through the mouth If a standard nasal CO sampling cannula is used on such patients the EtCO values and capnogram displayed will be substantially lower than the actual
90. Cable Rainbow DCl dc8 8 Adult Reusable Patient Cable Sensor www zoll com 9650 001355 01 Rev B Rainbow DCl dc12 12 Adult Reusable Patient Cable Sensor Rainbow DCIP dc8 8 Pediatric Reusable Patient Cable Sensor Rainbow DCIP dc12 12 Pediatric Reusable Patient Cable Sensor Red DBI dc8 8 Reusable Direct Connect Sensor Masimo Rainbow Set Temperature Accessories YSI Reusable Adult Skin Probe YSI Reusable Pediatric Skin Probe YSI Reusable Adult Esophageal Rectal YSI Reusable Pediatric Esophageal Rectal Sensor Adapter Cable for Disposable Probes YSI Disposable Esophageal Rectal Probe YSI Disposable Skin Probe Defibrillation Accessories X Series Multifunction Therapy Cable allows use of disposable multifunction electrodes and ZOLL M Series CCT External and Internal paddles sold separately M Series External Paddles set with controls and built in pediatric electrodes ZOLL Sterilizable Internal Handle black with Switch 1 0 spoon 10 cable ZOLL Sterilizable Internal Handle black with Switch 1 6 spoon 10 cable ZOLL Sterilizable Internal Handle black with Switch 2 0 spoon 10 cable ZOLL Sterilizable Internal Handle black with Switch 2 7 spoon 10 cable ZOLL Sterilizable Internal Handle black with Switch 3 0 spoon 10 cable ZOLL Sterilizable Internal Handle black without Switch 1 0 spoon 10 cable ZOLL Sterilizable Internal Handle black without Switch 1 6 spoon 10 cable ZOLL
91. D to MFC Connector Sstat padz pedi padz ll OneStep electrodes Power Accessories ZOLL SurePower II Rechargable Battery SurePower Charger Station SurePower II Battery Charger X Series Battery Adapter www zoll com 9650 001355 01 Rev B Auxiliary Power Adapter 8300 0004 Replacement Power Cord U S Other Accessories X Series Molded Carrying Case ECG 72mm Chart Recorder Paper USB Communications Cable 9650 001355 01 Rev B X Series Operator s Guide B 5 ACCESSORIES B 6 www zoll com 9650 001355 01 Rev B
92. L DEFIBRILLATOR AED OPERATION 13 4 04 17 11 08 24 32 Adult Adult Mode 120 J Selected Energy Select The default energy selections for adult patients are Shock 1 120 joules Shock 2 150 joules Shock 3 200 joules The default energy selections for pediatric patients are Shock 1 50 joules Shock 2 70 joules Shock 3 85 joules Note Pediatric defibrillator energy levels should be selected based on site specific protocols Note Ifthe X Series unit has been configured to begin CPR upon start up it will automatically begin with the CPR interval www zoll com 9650 001355 01 Rev B 2 Analyze WARNING WARNING AED Operation Do not analyze the patient ECG during patient movement A patient must be motionless during ECG analysis Do not touch the patient during analysis Cease all movement via stretcher or vehicle before analyzing the ECG The X Series automatically begins the analysis of the patient s ECG rhythm displays an ANALYZING ECG message for 5 seconds and announces and displays a STAND CLEAR message If therapy electrodes have not been properly connected to the patient an ATTACH PADS or CHECK PADS message is displayed and analysis will be inhibited Note You can press Pause to suspend the CPR Protocol mode If a shockable wave is detected while the unit is Paused the unit initiates a CHECK PATIENT voice prompt and displays the message Press Analyze to resume the analysis process Not
93. M Lower 20 to 298 BPM Upper 120 BPM Upper 22 to 300 BPM Pediatric Lower 50 BPM Lower 20 to 298 BPM Upper 150 BPM Upper 22 to 300 BPM Lower 100 BPM Lower 20 to 298 BPM Upper 200 BPM Upper 22 to 300 BPM www zoll com 9650 001355 01 Rev B Configuring Heart Rate HR Meter Alarms Using the Heart Rate Parameter Control Panel To configure alarms through the Heart Rate Parameter Control Panel use the navigation keys to highlight and select the Heart Rate meter and display the HR PR Parameter Control Panel HRPR Alarm 50 Extreme Brady Tachy Alarms 10 LTA Monitoring Off HRIPR Tone Ort HRIPR Selected Source ECG Current Source ECG ECG Sweep Speed 25 mms Figure 7 2 HR PR Parameter Control Panel 120 20 Selecting the HR PR Alarm prompt displays the HR PR Alarm Settings menu on which you can enable disable Heart Rate alarms and set alarm limits 9650 001355 01 Rev B X Series Operator s Guide 1 1 Chapter 7 Monitoring Respiration Resp and Heart Rate HR 7 8 www zoll com 9650 001355 01 Rev B Chapter 8 Monitoring Non Invasive Blood Pressure NIBP Warning The X Series NIBP input is Type CF defibrillator proof This chapter describes how to use the X Series unit to perform Non Invasive Blood Pressure NIBP measurements using an inflatable cuff to measure arterial pressure The X Series uses the enhanced NIBP features of Welch Allyn s SureBP and patented Smartcuf
94. N 60601 1 Enclosure Protection Solid Foreign Object IEC 60529 IP5X Water IEC 60529 IPX5 Auxiliary Operating Power Auxiliary Power Adapter 8300 0004 Input 100 240V J 50 60 Hz 2A 100 115V J 400 Hz 2A 80W peak IP Rating IP23 www zoll com 9650 001355 01 Rev B Pacer Pacer CO Type External transcutaneous pacing Pacer Rate 30 to 180 BPM 1 5 Output Current 0 to 140 mA 5 or 5 mA whichever is greater Modes Demand and Fixed Status Indicators ECG lead fault pace marker on monitor and chart start stop indicator on display Pulse Type Rectilinear constant current Pulse Width 40 ms 2 ms Range 0 to 150 mmHg Accuracy CO 39 99 mmHg 5 of reading 0 08 for every 1 mmHg above 38 mmHg 100 150 mmHg 5 of reading 0 08 for every 1 mmHg above 38 mmHg At sea level Accuracy applies for breath rates of up to 80 bpm For breath rates above 80 bpm accuracy is 4 mmHg or 12 of reading whichever is greater for EtCO2 values exceeding 18 mmHg This is tested according to and is compliant with ISO 21647 To achieve the specified accuracies for breath rates above 60 breaths minute the Microstream FilterLine H Set for Infant Neonatal must be used Above 40 C ImmHg or 2 5 whichever is greater has to be added to the tolerance of the accuracy specs Drift of Measurement Accuracy Over any 24 hour period the accuracy claims listed above are maintained The accuracy
95. N UDIT serrera Ok ye uacntoueneoundsetarac dncenarmeananoadenmeeeneys Pross ING SYNC KEV saursa a eet Al TP Select Energy LEVEI cntie eia a A 2 Charge Depilator serred ener eaaa E E vedas ecdesteiaes S ICIVEN SMOOK aAa a a N a name nnenarcd Chapter 16 Advisory Defibrillation Advisory Defibrillation ProC Qure cccccssccccssseecceseeccseeeecceeeecseeeessseeesseeesseneesssags Determine the Patient s Condition Following Local Medical Protocols Begin CPR Following Local Medical Protocols cccccccssseeeeeeeeeeeeeeeeeeeeeeneees Prepare IP ALION aiathichecivuiiiextchanantensisi a a a ai t TURNON UN oseca a tea aoueaneeeesmacgantouss 2 PTSS ANALY ZE BUTON tereira a a e a e S Press SHOOK DUWOM srynriniao nea ee e a E E Ee 9650 001355 01 Rev B X Series Operator s Guide vii TABLE OF CONTENTS Chapter 17 Advisory CPR Protocol Defibrillation Advisory CPR Protocol Defibrillation Procedure cccececeeeceeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeeeeeaas 17 2 Determine the Patient s Condition Following Local Medical Protocols 17 2 Begin CPR Following Local Medical Protocols ccccccccseeeeeeeeeeeeeeeeeeeeeeeesaaeseees 17 2 PRED ale Paucnt iani ruri a ethan anal hiet a E iaaieln 17 2 De WEEE OM UN srera e a seaman seuateeueaedvGaeee 17 3 ZA FSSS AINA eZ as BUTON suoatane a tare ce tits Caden Valine idan era 17 4 S PrESS SHOCK BUOM ianed a teeta amiiawncha tiene stawveanenabaeca
96. Reports Configure 11 30 2011 14 12 23 Adult q Log Full i HR bpm CA Il 1 0 cm mv IBP NIBP mmHg S Supervisor gt Communications gt Reports Serer DNS Name rn12 zoll com Port 8000 Password MySecretPassword Customer ID 29842234 View Distribution List Update Distribution List Spo2 6 Spo2 Disabled Temp 9650 001355 01 Rev B X Series Operator s Guide 22 17 CHAPTER 22 WIRELESS COMMUNICATIONS 12 lead reports are sent to recipients via a ZOLL server Use the alphanumeric keypads to enter the correct server information Sending a 12 lead report The connected wireless icon gi at the top of the screen indicates that wireless connectivity is available Once a 12 lead report has been acquired or a previously acquired 12 lead has been selected for review The Transmit quick access key f displays To send a 12 lead report to a preconfigured distribution list 1 Press the 12 lead quick access key Me 2 If desired press the snapshot button Ta to take a 12 lead snapshot see Chapter 14 12 Lead ECG Interpretive Analysis for more information about acquiring 12 lead data 3 Press the 12 lead review next quick access key Ea A list of snapshots appears select the desired snapshot 4 Press A A list of preconfigured distribution lists appears 07 27411 17 17 37 Adult Te a ad 00 41 01 Real Time No data available due to insufficient ECG f gt data from lead fault or invalid cabl
97. SR number from the service representative Remove the battery pack from the unit Pack the unit with its cables and battery in the original containers if available or equivalent packaging Be sure the assigned service request number appears on each package For customers Return the unit to In the U S A ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Attention Technical Service Department SR number Telephone 1 800 348 9011 9650 001355 01 Rev B X Series Operator s Guide 1 27 CHAPTER 1 GENERAL INFORMATION For customers Return the unit to In Canada ZOLL Medical Canada Inc 1750 Sismet Road Unit 1 Mississauga ON L4W 1R6 Attention Technical Service Department SR number Telephone 1 866 442 1011 In other locations The nearest authorized ZOLL Medical Corporation representative To locate an authorized service center contact the International Sales Department at ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Telephone 1 978 421 9655 The ZOLL Serial Number 1 28 Each ZOLL product displays a serial number that contains information about that product From left to right ZOLL serial numbers are structured as follows e A two character product code e A three character date of manufacture code e A product serial number of six or more alphanumeric characters The first two characters of the date of manufacture code give the last two digits of the year for exam
98. Sampling Line Connector to the CO Inlet Port 9 4 www zoll com 9650 001355 01 Rev B CO2 Monitoring Setup and Use WARNING The exhaust port for the Microstream sidestream CO apparatus is an output for only expired gases from the patient and any connected breathing apparatus The exhaust port is intended only for connection to gas collection equipment such as gas scavenger devices there should be no other connections to the exhaust port e When connecting the Microstream sidestream CO accessory to patients who are receiving or have recently received anesthetics connect the CO exhaust port to a scavenging system or to the patient s anesthetic machine or ventilator to prevent exposing medical staff to anesthetics e Do not lift the monitor by the FilterLine as it could disconnect from the monitor causing the monitor to fall on the patient e The FilterLine may ignite in the presence of high O concentrations when directly exposed to laser or ESU devices Use caution when performing these procedures Note If you use a gas scavenging system ensure that it is installed according to the manufacturers instructions The gas scavenging system should comply with ISO 8835 3 1997 E Note In order to avoid moisture buildup and sampling line occlusion during nebulization or suction for intubated patients remove the sampling line luer connector from the monitor Applying a FilterLine Set The FilterLine set is intended for the
99. Series unit 30 J as the selected energy 10 Press the Charge button on the front panel Verify that a periodic tone sounds while the defibrillator is charging At the completion of the charge cycle the tone is continuous The charge time should be less than 7 seconds Verify that the Shock button on the front panel illuminates when the defibrillator is charged Verify that the defibrillator discharges and that a DEFIB SHORT TEST PASSED message displays Ifthe message DEFIB SHORT TEST FAILED displays contact the appropriate technical personnel or the ZOLL Technical Service Department Press and hold on the front panel until the unit discharges After the defibrillator display panel closes Verify that the Pacer Settings dialog displays press the Pacer button on the front panel to with the pacer status bar behind it display the Pacer Settings dialog box Perform the following steps Verify that the green pace indicator on the Set the Pacer mode to Fixed pacer status bar flashes once each second Set the Pacer Rate to 60 ppm Verify that pace markers are printed every 25 Set the Output to 100 mA mm on the chart recorder printout Select the Start Pacer button Note If a printout does not automatically begin after starting the pacer select the Print quick access key to start a continuous printout Press the Print quick access key again to stop the printout Press the Pacer button on the front panel Ve
100. Series unit may display the following messages when monitoring Temperature Note The temperature function performs a self test when initially powered on and also performs system tests automatically every 10 seconds while this function is active System Message CHECK PROBE The temperature probe is disconnected Check probe and reconnect it PROBE FAILURE The temperature probe is defective Replace the Temperature probe TEMP DISABLED A system error has occurred The X Series unit cannot 9650 001355 01 Rev B take temperature measurements and should be serviced X Series Operator s Guide 12 5 CHAPTER 12 MONITORING TEMPERATURE 12 6 www zoll com 9650 001355 01 Rev B Chapter 13 Automated External Defibrillator WARNING AED Operation J T l ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection Use only pediatric electrodes to defibrillate patients under 8 years of age in AED mode and make sure the patient mode is set to pediatric Use of adult electrodes or adult mode with pediatric patients can result in the delivery of excessive energy doses This chapter describes the recommended method of operation in AED Mode The X Series unit is configured to operate in compliance with the American Heart Association and European Resuscitation Council Guidelines for Adult Basic Life Support and Use of Automated External Defibrillators 34 If your local protocol require
101. Time 8 seconds Sensitivity HR PR Tone Figure 10 4 SPO2 Parameter Control Menu Selecting the SoCO and SpMet Monitoring If SpCO and SpMet are installed the X Series unit allows you enable or disable SpCO and SpMet monitoring 10 10 www zoll com 9650 001355 01 Rev B SpO s System Messages Specifying the SpO Averaging Time The Masimo SpO module in the X Series unit provides three different time periods over which SpO2 values are averaged 4 seconds 8 seconds default and 16 seconds The averaging period is rarely changed from the 8 second default setting For high risk patients with rapidly changing SpO2 conditions use the 4 second setting Use the 16 second setting only when the 8 second setting default is inadequate due to extremely high artifact conditions selecting the SpO2 Sensitivity You can select either normal or high sensitivity for SpO2 monitoring The Normal sensitivity setting is recommended setting for most patients The High sensitivity setting allows you to monitor SpO2 even under very low perfusion conditions Such conditions may include severe hypotension or shock With the High sensitivity setting however SpO2 results are more easily contaminated by artifact To ensure accurate SpO2 readings when using the High sensitivity setting observe the patient carefully and continuously selecting the Heart Rate Pulse Rate HR PR Tone The unit allows you enable or disable the tone that the monitor uses to in
102. V5 V6 with ECG cable PADDLES or PADS e ECG size 0 125 0 25 0 50 1 0 2 0 4 0 cm mV AUTO e status messages The ECG bandwidth is user selectable The X Series units will defibrillate cardiovert and monitor ECG using hands free therapy electrodes The X Series unit will pace using ZOLL hands free therapy electrodes Energy Select Charge and Shock controls are located on the paddles and front panel When using hands free therapy electrodes you must use the controls on the front panel of the unit To switch between paddles and hands free therapy electrodes remove the multifunction cable MFC from the apex paddle and connect the hands free therapy electrodes to the cable You should always check the expiration date on the electrode packaging Do not use expired electrodes which might result in false patient impedance readings and affect the level of delivered energy or cause burns This symbol on the electrode package is accompanied by the expiration date For stat padz ll this symbol does not appear the expiration date appears on the lower right corner of the label below the lot number Note ZOLL electrodes contain no hazardous materials and may be disposed of in general trash unless contaminated with pathogens Use appropriate precautions when disposing of contaminated electrodes X Series models use an easily replaced rechargeable lithium ion battery pack the SurePower IT Battery Pack A new fully charged batte
103. a Heart Rate tone 9650 001355 01 Rev B X Series Operator s Guide 7 5 Chapter 7 Monitoring Respiration Resp and Heart Rate HR Enabling Disabling HR Alarms and Setting Alarm Limits 7 6 F k When enabled the X Series unit sounds alarms whenever the patient s heart rate is above or below the specified heart rate alarm limits To enable or disable HR alarms and set Upper and Lower alarm limits you can either do so through the Alarms quick access key A or the HR PR Parameter Control Panel To configure HR alarms through the Alarms quick access key Press ppd Press ry Press fig Use the navigation buttons to highlight and select HR PR Alarm On the HR PR Alarm Settings menu use the navigation keys to select the fields that you want to change a a E e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit When you are finished changing values on the alarm menu navigate to the Backarrow key to confirm your choices and exit the menu Heart Rate HR PR Alarm Limits Initially the HR PR Alarm Settings menu specifies that alarms are enabled ON or disabled OFF and displays the default Upper and Lower heart rate alarm limits The upper and lower limits can be ON or OFF default 1s OFF The following table lists the default HR alarm limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type HR Default HR Rate Range Lower 50 BP
104. a case always try to restore defibrillator operation as follows 1 Press the power switch on the top of the unit to turn it off 2 Ifnecessary replace a depleted battery with a fully charged pack or connect the defibrillator to auxiliary power 3 Press the power switch on the top of the unit to turn it back on This sequence is necessary to restart the defibrillator and can also be used to clear some fault messages when immediate use of the defibrillator is required If the X Series unit is powered off for less than 2 minutes all patient monitoring parameter settings will be retained If the unit has been powered off for at least two minutes it will be considered a New Patient and all of the patient specific parameters alarm limits defibrillator energy etc will be reset to their default values FDA Tracking Requirements U S Federal Law 21 CFR 821 requires the tracking of defibrillators Under this law owners of this defibrillator must notify ZOLL Medical Corporation if this product is e received e lost stolen or destroyed e donated resold or otherwise distributed to a different organization If any such event occurs contact ZOLL Medical Corporation in writing with the following information 1 Originator s organization Company name address contact name and contact phone number 2 Model number and serial number of the defibrillator 3 Disposition of the defibrillator for example received lost stolen
105. a site with sufficient perfusion to ensure accurate oximetry values Certain nail aberrations nail polish fungus and so on might cause inaccurate oximetry readings Remove any nail polish or move the sensor to an unaffected digit Exposure to high ambient light from surgical lamps especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight can affect the accuracy of oximetry readings To prevent interference from ambient light ensure that the sensor is properly applied If necessary cover the sensor with opaque material Always remove the sensor from the patient and completely disconnect the patient from the pulse CO Oximeter before bathing the patient Do not attempt to reprocess recondition or recycle any Masimo sensors or patient cables as these processes may damage the electrical components potentially leading to harm Do not modify or alter the sensor in any way Alterations or modification may affect performance and or accuracy To avoid cross contamination only use Masimo single use sensors on the same patient 9650 001355 01 Rev B X Series Operator s Guide 10 3 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET SpO gt s Setup and Use To take accurate SpO measurements using the X Series unit you must perform the following steps each of which corresponds to a section in this chapter 1 Select the correct SpO sensor 2 Apply the SpO sensor to the pa
106. a tame reserpine ye ere meen eRe eanD Ne A 14 impedance PMCUIMOGKAD MY sser nene area E aD E LERE ER A BESA EEN A 15 TANS AA ko CRE ate ee Renae TRC DE Bea ROPE A CE OT RSPR de A en Penn ADE a ne ere eae ate A 16 aS 0 21 ante ei ne ce e Pe ne Oto a A 17 DAUG sraeap Anata A E E Mika t Sanh oiety E este asin A 17 General inae E E E E A 18 RACOT saien E EE wpe bnlemiannaae see EEEE A 19 GO 2 ee E GO Ser ee RP RR a er eae ae A 19 PUSE COXIMEION rman nea ete ook oe eect rhe cee Lae etch tet Ghat ala Rie ho een hae A 20 Non Invasive Blood Pressu Gosses nea neesh iad e eea A 22 INIVESIV CIP RCSSUC S naii a ubouiadmianndtaeaeenn A 23 SIDS Fa OS eae tsi alen ado aederead banaue goat ce ni eieenenll ecoudenend none cea eae tuhontunsideveneniebeanteamans A 24 X www zoll com 9650 001355 01 Rev B Clinical Trial Results for the Biphasic Waveform cccccccccecesseeeeesseseceeeseeeeeeeseaeeeesaeees A 25 Randomized Multicenter Clinical Trial for Defibrillation of Ventricular Fibrillation VF and Ventricular Tachycardia VT ccccccccsecceceseseeseeeseeeeseeeseeeeseeesseeeseneeees A 25 Randomized Multi Center Clinical trial for Cardioversion of Atrial EDIAN AF lissa a teawcetiouns A 26 Synchronized Cardioversion of Atrial Fibrillation ccccccccccecsseeeeeeeeeeeeeeseeeseeeeeaees A 28 Electromagnetic Compatibility Guidance and Manufacturer s Declaration 0 006 A 29 EGG Analysis Algorithm Accuracy yactencch acut
107. abling SpO gt Alarms and Setting Alarm Limits When enabled the X Series unit sounds alarms whenever measurements are outside set limits for the high and low SpO values and if installed SpCO and SpMet values You can enable or disable SpO SpCO and SpMet alarms and set Upper and Lower alarm limits through the Alarms quick access key Mor through the SpO Parameter Control Panel To configure SpO SpCO and SpMet alarms through the Alarms quick access key 1 2 3 4 Fem O h Press the More quick access key Be Press ry Press the Limits quick access key 0 Use the navigation buttons to highlight and select the appropriate alarm menu selection SpO gt SpCO SpMet On the selected Alarm Settings menu use the navigation keys to select the fields that you want to change The fields are e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit When you are finished changing values on the alarm menu navigate to the Backarrow key to exit the menu Setting Upper and Lower SpO Alarm Limits Initially the SpO Alarm Settings menu specifies whether the SpO gt alarms are enabled ON or disabled OFF and displays the default upper and lower SpO limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default SpO limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type SpO
108. algorithm in a single analysis sequence satisfies the applicable requirements specified in ANSI AAMI DF80 section 6 8 3 and the recommendations by Kerber et al Circulation 1997 95 6 1677 Table A 4 Clinical Performance Results Sample Performance Goals Observed 90 One sided Size Performance Lower Confidence Limit Shockable Coarse VF Rapid VT Non shockable NSR AF SB SVT Heart block idioventricular PVCs Asystole Intermediate Fine VF Other VT References Sensitivity gt 90 gt 5 Specificity gt 99 gt 95 gt 95 Report only Report only Sensitivity gt 89 gt 96 Young KD Lewis RJ What is confidence Part 2 Detailed definition and determination of confidence intervals Annals of Emergency Medicine September 1997 30 311 218 William H Beyer Ph D CRC Standard Mathematical Tables 28 Edition CRC Press Inc Boca Raton FL 1981 Percentage Points F Distribution Table pg 573 9650 001355 01 Rev B X Series Operator s Guide A 33 Specifications Wireless Outout Guidance and Manufacturer s Declaration RF Transmission Emitted IEC 60601 1 2 The X Series unit complies with IEC 60601 1 2 for medical electrical equipment and medical electrical systems that include RF transmitters as specified below Standard Frequency Effective Radiated Modulation Type Data Rates Range Power 802 11b 2412 2472 MHz 100 mW DSSS 1 2 5 5 11 Mbps 802 11g 2412 24
109. and their rate falls below the AHA ERC recommended levels When compressions are being performed at 80 compressions per minute or higher the metronome is silent Should the detected compression rate fall below this level the metronome will begin beeping until recommended compression rates are consistently achieved over several compression cycles The metronome stops beeping approximately 2 seconds after the last chest compression 1s detected In AED mode the metronome is enabled during all CPR periods It begins to beep during the CPR period and continues to beep until the CPR period has ended If compressions are resumed during a CPR period the metronome resumes beeping following the first few compressions However if CPR pads are not detected the metronome will be active throughout the CPR period in AED mode FULLY RELEASE Prompt The X Series unit can be configured to display the text prompt FULLY RELEASE which instructs rescuers to lift fully release their hands from the patient s chest after compressions to allow full recoil This prompt occurs 45 seconds into the CPR interval By default the FULLY RELEASE text prompt is not enabled CPR Voice Prompts Optional The X Series unit can be configured to issue voice prompts related to the depth of chest compressions as feedback to rescuers performing CPR Two voice prompts are available for this purpose e Push Harder e Good Compressions When chest compressions are detected b
110. apture is determined by the presence of a widened QRS complex the loss of any underlying intrinsic rhythm and the appearance of an extended and sometimes enlarged T wave Ventricular response is normally characterized by suppression of the intrinsic QRS complex www zoll com 9650 001355 01 Rev B WARNING Pacing in Demand Mode Determination of electrical capture should only be performed by viewing the ECG trace on the X Series display with its ECG connection directly attached to the patient Use of other ECG monitoring devices might provide misleading information due to the presence of pacer artifacts Mechanical capture is assessed by palpation of the peripheral pulse To avoid mistaking muscular response to pacing stimuli for arterial pulsations use ONLY the following locations for palpating pulse during pacing e femoral artery e right brachial or radial artery Effective pacing Changing ECG leads and size can sometimes be helpful in determining capture Note The shape and size of the paced ECG waveforms can vary depending on the ECG lead configuration chosen variation from patient to patient can be expected 9 Determine Optimum Threshold The ideal pacer current is the lowest value that maintains capture it is usually about 10 above threshold Typical threshold currents range from 40 to 80 mA Location of the hands free or therapy electrodes affects the current required to obtain ventricular capture Typically the
111. arameter Control Panel 6 Select Zero Probe The unit displays the message ZEROING in the IBP Channel s numeric display 7 The message ZEROED appears in the IBP channel s numeric display 8 Close the transducer s stopcock 9 If the unit was unable to zero the transducer the message ZERO REJECTED appears in the IBP channel s numeric display The unit will not display pressure values for the IBP channel until it has successfully zeroed the transducer and established an acceptable zero reference Check that the unit is open to atmospheric air and that it is properly connected to the unit then try zeroing the transducer again The X Series unit will not zero the transducer if it detects pulsation in the pressure channel if there is too much noise in the signal or if transducer s offset is too great If you cannot zero the transducer after several attempts replace the transducer or the transducer cable Rezeroing a Transducer Warning You can re zero a transducer at any time by opening the transducer stopcock to atmospheric air If the unit accepts the new zero reference value the unit displays pressure values that are based on that value and adjusts the waveform according to the new scale If you attempt to zero an IBP channel after the channel has been successfully zeroed and is currently monitoring a pressure waveform the unit will display the message ZERO REJECTED in the IBP channel s numeric window This message
112. arameters have failed self test NIBP SpO2 CO2 IBP or Temp The front panel button self test failed The speech database self test failed Install a fully charged battery in the unit and check the RFU indicator again If the RFU indicator continues to flash remove the unit from service and contact the appropriate technical personnel or the ZOLL Technical Service Department Do Not Use One or more of the following has occurred e The battery is not properly installed No battery is installed and auxiliary power is not present A very low battery below software shutdown limit was installed ECG defibrillator or pacer self tests have failed or other critical self tests have failed www zoll com Install a fully charged battery in the unit and check the RFU indicator again If the RFU indicator continues to display the Do Not Use symbol remove the unit from service and contact the appropriate technical personnel or the ZOLL Technical Service Department 9650 001355 01 Rev B Safety Considerations Safety Considerations A All operators should review these safety considerations before using the X Series unit X Series units are high energy defibrillators capable of delivering 200 joules To completely deactivate the unit press the power switch to turn the unit off To manually disarm a charged or charging defibrillator do one of the following e Press the Disarm quick access key e Cha
113. ation associated with endocardial pacing Suppression of tachycardia Increased heart rates in response to external pacing often suppress ventricular ectopic activity and might prevent tachycardia Pediatric pacing Pacing can be performed on pediatric patients weighing 33 Ibs 15 kg or less using ZOLL pediatric hands free therapy electrode pads Prolonged pacing in excess of 30 minutes particularly in neonates could cause burns Periodic inspection of underlying skin is recommended 9650 001355 01 Rev B X Series Operator s Guide 1 9 CHAPTER 1 GENERAL INFORMATION Non Invasive Blood Pressure Monitoring The X Series is intended for use to make non invasive measurements of arterial pressure and heart rate and to alarm if either parameter is outside of the limits set by the user Measurements are made using an inflatable cuff on the patient s arm or leg The patient population will range from newborn neonate to adult Temperature Monitoring The X Series is intended for use to make continuous temperature measurements of rectal esophageal or surface temperatures and to alarm if the temperature is outside of the limits set by the user The patient population will range from newborn neonate to adult SpO Monitoring The X Series pulse CO oximeter with Masimo Rainbow SET technology and the Rainbow series of sensors is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial
114. attery Battery Level 1 The battery has less than one hour of remaining battery capacity Battery Level 2 The battery has greater than one hour of remaining battery capacity Battery Level 3 The battery has greater than two hours of remaining battery Capacity Battery Level 4 The battery has greater than three hours of remaining battery capacity Battery Level 5 The battery is fully charged www zoll com 9650 001355 01 Rev B Defibrillator Controls and Indicators Patient Cables and Connectors The left and right sides of the unit include sets of connectors for patient cables Note The SPO NIBP CO Temperature and IBP functions are optional If your unit does not include these options it does not have the applicable connectors ECG SpO NIBP CO CO Exhaust Figure 2 3 Patient Cable Connectors on Left Side of Unit MFC IBP Figure 2 4 Patient Cable Connectors on Right Side of Unit 9650 001355 01 Rev B X Series Operator s Guide 2 7 CHAPTER 2 PRODUCT OVERVIEW Connector Description ECG For connecting 3 or 5 lead ECG cable 12 lead monitoring is optional SpO gt s For connecting Masimo SpO CO cable NIBP For connecting NIBP hose COs For connecting CO sampling line Temp For connecting temperature probe s Multifunction Cable MFC For connecting paddles or ZOLL hands free therapy and pacing electrodes IBP For connecting IBP cabl
115. aution high voltage Earth ground Negative input terminal Positive input terminal Power On Off Protective earth ground DC lt A J Oy T w Contains lithium Recycle or dispose of properly amp Keep away from open flame and high heat Do not open disassemble or intentionally damage Do not crush 9650 001355 01 Rev B X Series Operators Guide 1 5 CHAPTER 1 GENERAL INFORMATION Symbol Description Do not discard in trash Recycle or dispose of properly Return to a collection site intended for waste electrical and electronic equipment WEEE Do not dispose of in unsorted trash Date of manufacture Use by Latex free Do not reuse Do not fold Not sterile Manufacturer Authorized representative in the European Community Serial Number Catalogue number Consult instructions for use Bale EO LE Conventions Symbol Description RX ONLY Prescription only Battery charging status Conventions Warning Caution This guide uses the following conventions Within text the names and labels for physical buttons and softkeys appear in boldface type for example Press the Charge button or press the Pacer button This guide uses uppercase italics for audible prompts and for text messages displayed on the screen for example LEAD FAULT
116. avigate to Rate press the Select button and then use the arrow keys and the Select button to set the Pacer Rate to a value 10 20 ppm higher than the patient s intrinsic heart rate If no intrinsic rate exists use 100 ppm You can increase or decrease the pacer rate by a value of 5 ppm for rates below 100 and by 10 ppm for rates above 100 Note The initial pacing rate can be set in Defib Pacer Default settings in the Supervisor Setup menu 6 Turn On Pacer Use the arrow keys to navigate to Start Pacer then press the Select button to select it The Pacing window displays behind the Pacer Settings window WV Foye Demand 7 Set Pacer Output In the Pacer Settings window use the arrow keys and the Select button to adjust the pacer output The pacer output is adjustable in 10 mA increments when increasing the output and in 5 mA increments when decreasing the output Observe the ECG for evidence of electrical capture Select the lowest output current that achieves both electrical and mechanical capture Note Ifthe Pacer Settings window disappears before you have set the output current press the Pacer button again to display the settings window 8 Determine Capture 18 4 It is important to recognize when pacing stimulation has produced a ventricular response capture Determination of capture must be assessed both electrically and mechanically in order to ensure appropriate circulatory support of the patient Electrical c
117. be s 1 4 plug into one of the two connection jacks on the side of the X Series unit o t Figure 12 1 Connecting the Temperature Probe to the X Series Unit Displaying Temperature When you connect the probe the unit displays the temperature after a brief pause The X Series unit displays temperature as a numeric value in the Temperature window You can specify that the unit display the temperature in C or F 12 2 www zoll com 9650 001355 01 Rev B Enabling Disabling Temperature Alarms and Setting Alarm Limits Enabling Disabling Temperature Alarms and Setting Alarm Limits When enabled the X Series unit sounds alarms whenever temperature measurements are outside set limits You can enable or disable temperature alarms and set the upper and lower alarm limits through the Alarms quick access key or the Temp Parameter Control Panel To configure temperature alarms through the Alarms quick access key Fi 5 k 1 Press the More quick access key B 2 Press Al 3 4 Use the navigation keys to highlight and select the T1 Alarm T2 Alarm or AT Alarm Press the Limits quick access key B menu selection On the Alarm Settings menu use the navigation keys to select the fields that you want to change The fields are e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit When you are finished changing values on the alarm menu navigate to the Backarrow key to exit the menu
118. ble 7 1 Oridion Microstream CO Sampling Lines for use with X Series units Accessory FilterLine Set Adult Pediatric box of 25 Intubated sampling line and airway adapter for short term monitoring Part Number 8300 0520 01 FilterLine H Set Adult Pediatric box of 25 Intubated sampling line and airway adapter for humid environments 8300 0521 01 FilterLine H Set Infant Neonate box of 25 Intubated sampling line and airway adapter for humid environments 8300 0522 01 VitaLine H Set Adult Pediatric box of 25 Intubated sampling line and airway adapter for high ambient humidity 8300 0523 01 Smart Capnoline Plus with Os Adult box of 25 Non Intubated Oral Nasal sampling with O delivery 8300 0524 01 Smart Capnoline Plus with O Pediatric box of 25 Warning Use only CO Microstream accessories authorized by ZOLL Medical Corporation ZOLL Medical Corporation does not guarantee the use of non authorized accessories 9650 001355 01 Rev B Non Intubated Dual Purpose X Series Operator s Guide 8300 0525 01 9 3 CHAPTER 9 MONITORING CO2 Connecting the CO Sampling Lines To connect the FilterLine or Smart CapnoLine 1 Slide open the X Series unit s CO inlet port cover 2 Put the fitting at the end of the sidestream tubing over the CO inlet port connector 3 Turn the fitting clockwise to tighten i Figure 9 1 Connecting the
119. cations in the Supervisor Menu Setting up Communications in the Supervisor Menu You can set up wireless profiles in the Communications setup menu This is located in the Supervisor Setup menu which requires a password In this menu you can set up the following e WiFi access points e Bluetooth connections DUN or PAN NAP profiles only e USB cellular modems Note Communications setup is not available in AED mode To access the Communications menu 1 Press the More quick access key EA 2 Press the Setup quick access key ED Use the navigation keys to scroll down to Supervisor Press 3 Enter the password The Supervisor menu appears 4 Use the navigation keys to highlight and select Communications The options for Communications are displayed 11 30 2011 14 06 04 Adult 1 IBP i Setup gt Supervisor gt Communications Wireless Enabled Bluetooth Enabled WiFi Enabled Configure Cellular Configure Reports Configure Wireless Use the navigation keys to enable or disable this function When disabled all wireless capabilities are disabled in the X Series unit Bluetooth Use the navigation keys to enable or disable this function When disabled all Bluetooth capabilities are disabled in the X Series unit WiFi Use the navigation keys to enable or disable this function and to configure access point profiles see WiFi Access Point Profiles on page 22 10 When disabled all WiFi ac
120. cator appears at the top of the display screen and a green light next to the indicator flashes with each Sync marker Note Ifthe marker does not appear over the R wave select a different ECG lead If the sync marker doesn t display the defibrillator will not discharge www zoll com 9650 001355 01 Rev B Synchronized Cardioversion Procedure Unless otherwise configured the unit automatically exits Sync mode after each shock To reactivate SYNC mode press the Sync quick access key on the front panel again Changing the selected energy levels does not cause the unit to leave SYNC mode Note The unit can be configured to stay in SYNC mode after defibrillation in Defib Pacer default settings in the Setup gt Supervisor menu 1 Select Energy Level Press the Energy Select arrows up or down to select the desired energy level These buttons are located either on the front of the unit or on the STERNUM paddle Warning When used with pedi padz defibrillator energies must be set manually based on site specific institutional protocols for pediatric defibrillation SHOCK CHARGE 2 Charge Defibrillator Press the CHARGE button on the front panel or on the APEX paddle handle SHOCK or To increase or decrease the selected energy after you have pressed the CHARGE button use the defibrillator Energy Select arrows on the front panel or sternum panel Caution Changing the selected energy while the unit is charging or charged
121. ccess Point Profile Use the navigation keys to highlight and select Add You can enter the type of network setting profile name SSID authentication and security key 11 30 2011 14 07 45 Adult 3 l An 24 ot 3 00 31 22 am Communications gt Configure WiFi gt Add AP Profile IBP Network Setting Static IP Profile Name SSID Authentication WPA2 PSK Security Key Network Setting Use the navigation keys to select either DHCP or Static IP If you select Static IP use the numeric keypad to enter values for the IP Address Subnet Mask Default Gateway Preferred SDNS Server and Alternate DNS Server Of 27 11 14 36 02 Adult i s 3 Row tT 4 1 Configure WiFi gt Edit AP Profile gt Configure Static IP IP Addres Subnet Ma SSS Default Ga SAVE SAVE Colro o o o Preferred Clear Alternate a Clear Backspace Cancel Cancel 9650 001355 01 Rev B X Series Operators Guide 22 11 CHAPTER 22 WIRELESS COMMUNICATIONS Profile Name Use the alphabetical keypad to enter the profile name Press SAVE to save changes and return to the WiFi configuration menu press Cancel to return to the WiFi configuration menu without saving changes Of 27 11 14 27 54 Adult Some Alarm Limits Disabled Row NIBP mmHg Profile Name Backsp LowellGen_ReadyRoom Cancel SSID Use the alphabetical keypad to enter the SSID name Press SAVE to save changes and r
122. ce Daily Suit GneCk Procedure visia E A aE aA aae a a a e A i 24 2 MSpPOCION miari a a A A 24 2 Defibrillator Pacing Test with Hands Free Therapy Electrodes ccccseceecseeeeaeeeeneeees 24 3 Defibrillator Testing with External Paddles cccccssscccccseseeeeseeeseeesseeeseesseeeseeessegseeeeeas 24 5 Recommended Minimum Preventive Maintenance Schedule ccccccsseeeeeeeeeeeeeeees 24 7 PATNA stevia aassnsravasduaiutanG yu E oan naeaitaloanG ncaa A E 24 7 Guidelines for Maintaining Peak Battery Performance ccccceecceeeeseeeeeeseeeteeeeeesaneees 24 7 GCIEAMINGANSIFUCTONS crissuesesdeedvounusuinorsunwencuassgunidsanieddmestonsieustuemntdbausivenennanstnneamenessentanenseds 24 8 Cleaning the X SOMES UNG estst vests atnen ae ials diaausinscir sean E wiv aun usa se 24 8 Cleaning the NIBP Blood Pressure Cuff cccccsssseeeceeeeessseeeeceeeeeseeeeessaneseeeeesenees 24 8 CIE ANING SOO2 SENSORS riar eer R E ambos EEE 24 9 Cleaning Cables and Accessories ccccsssecccecceseeeeeececeeeeeeeeseauaaaeeeesessageeeesessaeaaes 24 9 LOAGING IRCCOLGS IP ADSM eanne a e r sciceunintant 24 9 Gleaning the Print Head svnitunainiceitainennscta dmg tens anerioa aoe eae ltien 24 10 Appendix A Specifications DONO cic Gaeveennre renee eee Mecttn Prete mtn E E Tee Rear MEET Tee meee Reon en ere A 2 MOKON B Key 0 eh earners camer rere ce mmrsmss cre tance ett tree rivers eee te nares greiner as ecme tant
123. ce of breathing e Absence of pulse Begin CPR Following Local Medical Protocols Request additional assistance Turn On Unit Press the green power switch located on the top of the unit The green yellow and red lights at the top of the unit flash on and off and the unit displays the message SELF TEST PASSED 1 Select Energy Level Press the Energy Select arrows up or down to select the desired energy level These buttons are located either on the front of the unit or on the STERNUM paddle Note The initial defibrillator pad external paddle energy selection can be set in Defib Pacer default settings in the Setup gt Supervisor menu The following are the default energy selections e Adult 120 joules e Pediatric 50 joules e Neonate 50 joules Note Neonatal and pediatric defibrillator energy levels should be selected based on site specific protocols SHOCK or The selected energy level is displayed at the bottom of the display screen Prepare Paddles Ensure that the paddles are connected to the multi function cable MFC and that the MFC is connected to the X Series unit Apply a liberal amount of electrolyte gel to the electrode surface of each paddle and rub the electrode surfaces together to evenly distribute the applied gel You can substitute electrode gel patches for the gel 15 2 www zoll com 9650 001355 01 Rev B Emergency Defibrillation Procedure with Paddles Apply Paddles to Chest
124. ceccccccsssecceeeeeeeeseeeeeeeseeeeeeeeseeeeeeeeseeaeeessaaaes 18 8 Pediat Pacing access cua un e ac aetna ade ea acl ae A Dal lo a a ela ee ns 18 9 www zoll com 9650 001355 01 Rev B Chapter 19 Real CPR Help ORR ASIN Oeste A Mees eccamearuecteabedenseeuee 19 2 Rate and Depth Measurement ccccccccseccceseeceeseeceeeecseseeceueesseseessueesseesessaeesnes 19 2 CPRIRCIEASeINGICAIOL rispis aar NE TEE enced i E h 19 2 Chest Compression INGICAION issnin oe della aa aa 19 2 CPR MErONOME gates on viecronaecauacntesunaltoiueilenuneauttoncadiansetat dounsaqeuinaansnasunedmantaieetaaeneacodaenaen at 19 3 FOLEY RELEASE PIOMD i ereenn e sheaxtigcnc iuestewecte measeeeto te eacaeenccteens 19 3 OPR VOICe Prompts ODUOMAl siiset atin tives euihdanbtinariind pla haiian bleedin eacatoeinayrsaneharianett 19 3 CPA Ide Time DISOl ay cossire E a 19 4 GPR COUMGOWN TIMET apine a a a 19 4 CPR Gompression Bar Graph iessncseniinniian e a aa 19 4 Chapter 20 See Thru CPR Optional usihooce I MmU CP Braer aE mre ait apnen Mein te ere eee an ee ne eT 20 2 EXAMDPICS tte wstnde a E e a E 20 2 Chapter 21 Patient Data SOng DAA sa E eaten eae Pe RR EEC eer ee ee ee 21 1 Capturing a Data Smaps nO lixiiccctiecatacaseiattbcitbneie aeai 21 2 Reviewing and printing snapshots cceecccseeeeceeeeeeeeeceeeeeeeeeeceeeeeseeeeseeeeeseeeeseeeesaes 21 2 Treatment Summary REDON cize c20ts bevencteeseccdeeses e a e aie 21 2 Printing Treatment Summary R
125. ceceaeeeeeeseeeeeeessueeeeeesseeeeeessaaeeees 6 6 Selecting the Waveform Trace Size o cccceeeeccccceceseeeeeeeecaaeeeeeeesenaeseeeeeeesaaaseseseeananees 6 8 ECG Monitoring and PaGe makers serseri meike e e eds 6 9 ECG System WESSAGCS werechvaccintviarcnsetduanucintetrousiatnainlassnbeenet saved yaliuhetineold aaeuoiieanumitaniatOudsis 6 9 9650 001355 01 Rev B X Series Operator s Guide jii TABLE OF CONTENTS Chapter 7 Monitoring Respiration Resp and Heart Rate HR Respiration Breath Rate Meter ccccsccccsscecsececeseecceeeceseeeceeeesneesseeeeseeeesseeeeseeessaeeess 7 2 Using Impedance Pneumography to Measure Respiration ccccceeceeeseeeeeeeeeeeeaees 7 2 Configuring Respiration RR BR Alarms and Settings ccccceccseeeesseeeeeseeeeeeseeeeeseeeeeees 7 3 Enabling Disabling RR BR Alarms and Setting Alarm Limits ccccseeeeeeeeeeeeeees 7 3 Using the Resp Parameter Control Panel ccccccccsecceecceeeeeeeseeeeeeeeseeeeeesseeeeeeeeeas 7 4 Hean Rate Mele enee T a a acesccuaae 7 5 Configuring Heart Rate HR Meter Alarms cccccccccsseeeeeceeeeeeesaeeeecesaeeeeeessaeeeeeeeseaeess 7 5 Enabling Disabling HR Alarms and Setting Alarm Limits cccccccccseseseeeeeeeeeeeeeees 7 6 Using the Heart Rate Parameter Control Panel cccccceeccecsseeeeseeeeeeseeeseeeeeeeaes 7 7 Chapter 8 Monitoring Non Invasive Blood Pressure NIBP FIOWCOCS INIDE WORK se scca
126. cess points are disabled in the X Series unit 9650 001355 01 Rev B X Series Operator s Guide 22 9 CHAPTER 22 WIRELESS COMMUNICATIONS Cellular Use the navigation keys to configure USB cellular modem or Bluetooth devices see Setting up Cellular Communications on page 22 14 Reports Storage and management of 12 lead reports and full disclosure case files on the X Series unit can be managed from third party software such as ZOLL RescueNet In this menu you can configure the ZOLL server and view or update distribution lists see Configuring Report Transmissions on page 22 17 Press the back arrow K to exit the Communications menu WiFi Access Point Profiles 22 10 To select and modify WiFi Access Point Profiles use the navigation keys to highlight and select Configure WiFi 07 26 11 18 22 34 Adult TCE iv IBP i Supervisor gt Communications gt Configure WiFi WiFi Band Configured Access Point Profiles EMS Remote EMS 1 ALS Ambulance 2 ALS Ambulance 1 ALS Ambulance 3 EMS 2 Add Edit Delete i A green check mark indicates the active access point Use the navigation keys to select a different profile or to add edit or delete other profiles Use the navigation keys to select the correct WiFi Band The options are Any 5 0 GHz A N or 2 4 GHz B G N www zoll com 9650 001355 01 Rev B Setting uo Communications in the Supervisor Menu To add a new A
127. ciceiacictocd eaten duua banat carsmiren a Scant Suaseneobabaeeeiee 8 2 TMS NIBP N merc DIS DIAY aec enan E A E ia aan A 8 3 NIBP SOUP ANG USO snein e a N 8 3 Selecting THE NIBP CU wticutotictonsattedustwiannidieid at vinisteesuwiauas E 8 4 Connecting ne NIBP CUM sxiseisinecideishoratioatieuertivawiawndl bohacionsthoniiaalhiohshetadiggtiaventininssie 8 5 Applying the Guill tothe PASM erissa a a aia a ai ia ea 8 7 Ensuring Gorrect Cuf Inflation Seting S sacs e e A 8 8 Configuring NIBP Alarms and Settings ccccccsssseceeeeeeeseeeeeeeeeaeeeeeeeeeeeeeeeeeeeseaaageeeeeeesaas 8 9 Enabling Disabling NIBP Alarms and Setting Alarm Limits cccccssssseeeeeseeeeeeeees 8 9 Using the NIBP Parameter Control Panel cccccccccsseceeeeseeeeseeeeesaeeeeesaaeeeeaeeeeeas 8 11 NIBP System Messages sicoui aa a aa aaa Ea a a a i i raaa 8 14 Chapter 9 Monitoring CO2 OV OTV TONN o E EEE EV E A ETEA 9 1 CO2 MOnitOring Setup and US Ercnisairioiiareninninai a a e EE a E E eE e iA 9 2 Selecting the GO Sampling Line enson a a Maine 9 3 Connecting the CO2 Sampling LINES cccccecsssssseeeececeeeseeeeeeeeeesaeeeeseeauaeeeeeeeessanees 9 4 AODIVING a RINGING SOU seas acsealcaai lade aaa and shaecerrabo ath Soeghaess tu mien cated ten Sauternes 9 5 Applying a Smart CapnoLine Nasal or Nasal Oral Cannula cccceeseeeeeeeeeeeeeees 9 6 Measuring GOZ sorire e a lad ac tates tudenenacentalen ue scat alana Sareea al ectea edocs
128. cigeaaienc stein tebeaebseaiteeilaisehiceicai ieee iedoeeachidaalcheteateielee lected iventenndals 1 12 Ready For Usex REU INGICAIOR cererea acteneteceueceaseatiecacnieeesiaeceecteks 1 14 Sale COMSIGC IE ONS aceasta eather eine A ae ETON 1 15 9650 001355 01 Rev B X Series Operator s Guide TABLE OF CONTENTS Chapter 2 Defibrillator Controls and Indicators e ecee0 Wan S ssveussateniebaenetuacininansiaiawialatavaaisheluenteimnseiagies General ECG Monitoring Defibrillation PACINO sas tia tents Ph weak eee eaa a oaeaetttadae re ieee races CPR Pulse Oximeter Noninvasive Blood Pressure csceceeeeees IBP CO2 PIC SDINAUION eria Ferromagnetic Equipment Battery Operator Safety Patient Safety GAUL ONS aeea enon EE eE Restarting the Defibrillator cccccseeeeeeeeeeeeeeees FDA Tracking Requirement cccccceeeseeeeeeeees Notification of Adverse Events aasan Software LICENSE ccccececececcecececececececacacaecececes SIG Gai nacewisscietiencemesncateausvninee susan aencedatesuteasenaacuentoanes The ZOLL Serial NUMbEfL 2ccccccececececececeeees Product Overview The Front Panel Display SCION sictas ke cicteteictetachintetieeisl tee Battery Status and Auxiliary Power Indicators Patient Cables and Connectors External Paddles ccccccccececcccccccceccacacaces Auxiliary Power Adapter Navigating the Display SCreen
129. cks was achieved with 48 less delivered current than with monophasic shocks 11 1 vs 21 4 A p lt 0 0001 One half of the patients who failed cardioversion after four consecutive escalating monophasic shocks were subsequently successfully cardioverted using a biphasic shock at 170J No patient was successfully cardioverted using a 360J monophasic shock after the patient had failed cardioversion with biphasic shocks Conclusion The data demonstrate the superior efficacy of low energy rectilinear biphasic shocks compared to high energy monophasic shocks for transthoracic cardioversion of atrial fibrillation There were no unsafe outcomes or adverse events due to the use of Rectilinear Biphasic Waveform 9650 001355 01 Rev B X Series Operator s Guide A 27 Specifications Synchronized Cardioversion of Atrial Fibrillation Cardioversion of atrial fibrillation AF and overall clinical effectiveness is enhanced by proper pad placement Clinical studies refer to above of the M Series Biphasic Defibrillator Waveform demonstrated that high conversion rates are achieved when defibrillation pads are placed as shown in the following diagram Recommended Anterior Posterior Placement Front Apex Back Posterior T f Place the front apex pad on the third intercostal space mid clavicular line on the right anterior chest The back posterior pad should be placed in the standard posterior position on the patient s left as shown
130. compatible for use with the X Series unit To order any of these items contact your local ZOLL representative ECG Accessories ECG 3 Lead Cable AAMI ECG 3 Lead Cable IEC ECG 5 Lead Cable AAMI ECG 5 Lead Cable IEC ECG 12 Lead Breakaway Patient Cable Complete Trunk Cable 4 lead wire set with detachable 6 V precordial lead wire set AAMI ECG 12 Lead Breakaway Patient Cable Complete Trunk Cable 4 lead wire set with detachable 6 V precordial lead wire set IEC ECG 4 Lead Breakaway Trunk Cable and 4 lead wire set only AAMI ECG 4 Lead Breakaway Trunk Cable and 4 lead wire set only IEC ECG Detachable 6 precordial lead wire set for Breakaway 12 Lead Patient Cable AAMI ECG Detachable 6 precordial lead wire set for Breakaway 12 Lead Patient Cable IEC CO2 Accessories Oridion Filterlines Smart CapnoLine Plus Non intubated filterline with O2 Delivery Adult box of 25 Smart CapnoLine Plus Non intubated filterline with O2 Delivery Pediatric box of 25 9650 001355 01 Rev B X Series Operator s Guide B 1 ACCESSORIES B 2 FilterLine H Set Adult Pediatric box of 25 FilterLine H Set Infant Neonate box of 25 FilterLine Set Adult Pediatric box of 25 VitaLine H set Adult Pediatric box of 25 NIBP Accessories Hoses Hose Infant Neonate 8 w female luer cuff connector single lumen Hose Adult Pediatric 10 w twist lock cuff connector dual lumen Reusable Cuffs Welch Allyn B
131. corporated into a medically approved patient care protocol Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by e Unconsciousness e Absence of breathing e Absence of pulse Specifications for the ECG rhythm analysis function are provided in the section ECG Analysis Algorithm Accuracy on page A 33 When the patient is less than 8 years of age or weighs less that 55 Ibs 25 Kg you must use ZOLL pediatric defibrillation electrodes Do not delay therapy to determine patient s exact age or weight www zoll com 9650 001355 01 Rev B X Series Indications for Use ECG Monitoring The X Series is intended for use to monitor and or record 3 5 or 12 lead ECG waveform and heart rate and to alarm when heart rate is above or below limits set by the operator The patient population will range from newborn neonate to adult with and without heart dysfunction CPR Monitoring The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA ERC recommended rate of 100 compressions per minute Voice and visual prompts encourage a minimum compression depth of at least 1 5 3 8 cm or 2 0 inches 5 0 cm depending on the configuration for adult patients The CPR monitoring function is not intended for use on patients under 8 years of age External Tra
132. ction cable MFC Therapy Electrode Application WARNING Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient 2 Roll the pad smoothly from the applied edge to the other being careful not to trap any air pockets between the gel and skin 3 Ensure that hands free therapy electrodes are making good contact with the patient s skin and are not covering any part of any other ECG electrodes 4 Press the Lead quick access key and select I II or III to provide the largest amplitude QRS complex Note When the Pacer is on the lead selection is restricted to Leads I II or HI 5 Verify that R waves are being properly detected by confirming that a QRS tone occurs with each displayed R wave or by verifying that the X Series unit s heart rate display accurately reflects the patient s pulse rate 3 Press Pacer button Press the Pacer button on the front panel of the unit The Pacer Settings window displays Mode Rate 60 Output 9650 001355 01 Rev B X Series Operators Guide 18 3 CHAPTER 18 EXTERNAL PACING 4 Set Mode Use the arrow keys to navigate to Mode press the Select button and then use the arrow keys and the Select button to set the Pacer Mode to Demand Note The initial pacing mode can be set in Defib Pacer Default settings in the Supervisor Setup menu 5 Set Pacer Rate Use the arrow keys to n
133. ctrode package External Pacemaker X Series defibrillators include a transcutaneous pacemaker consisting of a pulse generator and ECG sensing circuitry Noninvasive transcutaneous pacing NTP is an established and proven technique This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated The output current of the pacemaker is continuously variable from 10 to 140 mA the output current is 0 mA when paused The rate is continuously variable from 30 to 180 pulses per minute ppm by increments of 5 ppm 10 bpm when greater than 100 ppm The pacing output pulse is delivered to the heart via ZOLL hands free defibrillation pacing electrodes placed on the patient s back and the precordium Proper operation of the device together with correct electrode placement is critical to obtaining optimal results Every operator must be thoroughly familiar with these operating instructions 9650 001355 01Rev B X Series Operator s Guide tti s DS CHAPTER 1 GENERAL INFORMATION ECG Monitoring Electrodes Batteries The patient s ECG is monitored by connecting the patient to the unit via a 3 5 or 12 lead patient cable or hands free therapy electrodes The ECG waveform is presented on the display along with the following information e averaged heart rate derived by measuring R to R intervals e lead selection I H II aVR aVL aVF V1 V2 V3 V4
134. cular Fibrillation VF and Ventricular Tachycardia VT Overview The defibrillation efficacy of the ZOLL Rectilinear Biphasic waveform was compared to a monophasic damped sine waveform in a prospective randomized multicenter study of patients undergoing ventricular defibrillation for VF VT during electrophysiological studies ICD implants and test A total of 194 patients were enrolled in the study Ten patients who did not satisfy all protocol criteria were excluded from the analysis leaving a study population of 184 Objectives The primary goal of this study was to compare the first shock efficacy of the 120 J rectilinear biphasic waveform with a 200 J monophasic waveform The secondary goal was to compare all shock three consecutive 120 150 and 170 joules efficacy of the rectilinear biphasic waveform with that of a monophasic waveform three consecutive 200 300 and 360 joules A significance level of p 0 05 or less was considered statistically significant using Fischer s Exact test Also differences between the two waveforms were considered statistically significant when the customary 95 or AHA recommended 90 confidence interval between the two waveforms was greater than 0 Results The study population of 184 patients had a mean age of 63 14 years Of these 143 patients were male 98 patients were in the biphasic group ventricular fibrillation flutter n 80 ventricular tachycardia n 18 and 86 patients were in the monophas
135. d determines the X axis scale of the capnogram For patients with slower respiration rates a slower sweep speed will make the capnogram easier to view You can specify sweep speeds of 3 13 6 25 and 12 5 mm second The default sweep speed is 6 25 mm second system Messages When monitoring CO the X Series unit may display the following messages System Message INITIALIZING The unit is initializing the CO monitoring function measurement is functioning normally and will display CO measurement after a brief delay CHECK FILTERLINE FILTERLINE OCCLUSION The sampling line is not connected Check sampling line connection Replace airway adaptor or cannula if defective The sampling or exhaust line is blocked Check sampling and exhaust lines Make sure that the sampling line and any inputs to the patient breathing apparatus are not connected to the exhaust port If the current FilterLine is correctly attached replace the FilterLine AUTO ZERO The X Series unit displays AUTO ZERO when the CO module performs periodic self maintenance During self maintenance the CO module performs one or more of the following tests ambient pressure measurement auto zero and a flow test The CO module completes its self maintenance tests in approximately 10 seconds The CO module performs a purging whenever it detects an occlusion in the line or airway adaptor and displays PURGING while it tries to clear the
136. d digit over the sensor window making sure that the sensor cable runs over the top of the patient s hand 2 On finger sites make sure the tip of the finger touches the raised digit stop inside the sensor If the fingernail is long it may extend over and past the finger stop WAS TUD JN N 3 Check the sensor position to ensure that the top and bottom halves of the sensor are parallel To ensure accurate data you must have complete coverage of the detector window Note With smaller digits the digit may not need to be pushed all the way to the stop to completely cover the detector window 4 Based on the type of patient cable you are using do one of the following e Ifyou are using a direct one piece patient cable see Connecting the SpO Sensor on page 10 8 e If you are using the two piece patient cable lift the clear plastic protective cover from the female end of the extension cable then plug the sensor cable s male connector into the extension cable connector make sure that the plug is all the way into the connector see Figure 10 1 5 Lower the clear plastic cover over the connection to secure it see Figure 10 2 6 See Connecting the SpO Sensor on page 10 8 to connect the cable to the unit 9650 001355 01 Rev B X Series Operator s Guide 10 7 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET Cleaning and Reuse of Sensors Reusable sensors can be cleaned as follows Disconnect
137. d pacing at 180 ppm and 140 mA e Atleast 10 discharges at maximum shock setting 200 joules after a Low Battery indication Note Proper battery care is required to maintain maximum available capacity Battery Indicators 5 Battery capacity LED indicators Fault indicator Recalibration indicator Recharge Rate 100 in 4 hours when initiated at Low Battery indication 9650 001355 01 Rev B X Series Operator s Guide A 17 Specifications General A 18 Weight 10 6 Ibs without battery and paper 11 7 lbs with battery and paper Dimensions Without Handle 8 9 x 8 75 x 7 9 With Handle 8 9 x 10 4 x 7 9 Operating Temperature 0 to 50 C Humidity 15 to 95 RH non condensing Vibration e EN ISO 9919 per IEC 60068 2 64 e RTCA DO 160G multiple helicopter frequencies e EN 1789 for ambulance Shock IEC 60068 2 27 100g 6ms half sine Bump IEC 60068 2 29 Drop EN 1789 30 functional drop IEC 60601 1 Tested at 2 meters Altitude 170 M to 4572 M 557 feet to 15 000 feet Transport and Storage Temperature 30 to 70 C Note The X Series device may not perform to specifications when stored at the upper or lower extreme limits of storage temperature and immediately put into use Humidity 15 to 95 RH non condensing Atmospheric pressure 572 mbar to 1034 mbar Shock vibration MIL STD 810G Method 514 6 4 4 2 Procedure II Safety Classification Class 1 and internal power per IEC E
138. d to flow through the cuff and into the monitored limb As blood flows through the partially deflated cuff it produces pressure oscillations that are transmitted to the X Series unit through the hose The X Series unit measures the oscillometric pulses and uses them to calculate the corresponding systolic diastolic and mean blood pressure This measurement takes about 30 seconds www zoll com 9650 001355 01 Rev B The NIBP Numeric Display 3 The NIBP option automatically adjusts the blood pressure measurement procedure in response to certain error conditions such as Condition Adjustment Response The unit cannot detect systolic The unit automatically increases the cuff inflation pressure pressure and completes the blood pressure mea surement The unit cannot detect systolic The unit aborts the blood pressure measurement and diastolic or mean pressure after deflates the cuff 180 seconds The unit detects a fault The unit displays a corresponding error message on the monitor and aborts the measurement The NIBP Numeric Display When NIBP monitoring has been set up and the X Series unit has begun taking NIBP measurements the systolic diastolic and mean blood pressure measurements appear on the NIBP numeric display as follows The following sections describe how to set up NIBP monitoring NIBP Setup and Use To take safe and accurate NIBP measurements using the X Series unit you must perform the following
139. device Before you begin insert a USB device into the X Series USB device port USB Device Port D oe CO Figure 21 1 USB Port To transfer data through the USB port 1 Press the power switch to turn the unit on 2 Press ea Eole 3 Press EJ 4 Press the Transfer Log quick access key AD ensure that the USB drive is connected to the device Note Do not remove the USB data drive from the X Series unit during transfer 5 Use the navigation keys to select Transfer from the Transfer the Log menu 6 The green LED on the top of the device turns on while data 1s transferred to the USB device Note Wait for the log transfer to complete and for the green light on the top of the X Series to turn off before removing the USB drive Note Printing and logging snapshots is disabled during the log transfer 9650 001355 01 Rev B X Series Operators Guide 21 3 CHAPTER 21 PATIENT DATA After transferring data you must remove the USB drive and reinsert it before attempting another transfer If the USB device does not establish communication with the X Series unit try powering off the unit and then on again to establish communication Warning To avoid a possible shock hazard do NOT make any electrical connections to the USB port except to connect a USB flash drive while in the vicinity of the patient Clearing the Log You should clear the patient data log after transferring data to the USB device or when the log is full
140. dicate detection of the patient s pulse On or Off no tone sounds The default tone is Off SpO System Messages The X Series unit may display the following system messages when monitoring SpO gt System Message INITIALIZING The SpOs pulse oximeter is initializing SEARCHING The unit is searching for a pulse CHECK SENSOR The SpOs sensor has become disconnected from the unit or the sensor is no longer on the patient Check sensor and then reconnect it to the unit or reapply it to the patient SENSOR FAILURE The SpOs sensor is defective Replace the sensor LOW PERFUSION Perfusion has dropped below 20 SPO2 DISABLED A system error has occurred The X Series unit cannot take SpO measurements and should be serviced 9650 001355 01 Rev B X Series Operator s Guide 10 11 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET Functional Testers and Patient Simulators 10 12 Some models of commercially available bench top functional testers and patient simulators can be used to verify the proper functionality of Masimo pulse oximeter sensors cables and monitors See the individual testing device s operator s manual for the procedures specific to the model of tester that you are using While such devices may be useful for verifying that the pulse oximeter sensor cable and monitor are functional they are incapable of providing the data required to properly evaluate the accuracy of a system s SpO measurem
141. different lead sets AHA Color Coding IEC Color Coding Placement of Electrodes RA White Electrode R Red Electrode Place near patient s right mid clavicular line directly below clavicle LA Black Electrode L Yellow Electrode Place near patient s left mid clavicular line directly below clavicle LL Red Electrode F Green Electrode Place between 6th and 7th intercostal space on patient s left mid clavicular line RL Green Electrode N Black Electrode Place between 6th and 7th intercostal space on patient s right mid clavicular line V Brown Electrode C White Electrode Single movable chest electrode Place this electrode in one of the positions V1 V6 as shown in the following figure V1 4th intercostal space at right sternal margin V2 4th intercostal space at left sternal margin V3 Midway between V2 and V4 leads V4 5th intercostal space at mid clavicular line V5 Same transverse level as V4 at left anterior axillary line V6 Same transverse level as V4 at left mid axillary line 6 4 www zoll com 9650 001355 01 Rev B ECG Monitoring Setup Figure 6 2 5 Lead Electrode Placement Connecting the ECG Cable To the X Series Unit The X Series unit accepts Welch Allyn Propaq ECG cables as well as ZOLL X Series ECG cables Connect the ECG cable to the ECG connector on the left side of the X Series unit as follows Figure 6 3 Connecting ECG Cable to X Series Unit 9650 001355 01 Rev
142. ducers and ensure that the transducers are connected properly Before you use the X Series unit on a new patient always turn it off for at least 2 minutes This clears the previous patient s trend values alarm limit settings and NIBP cuff inflation pressure Use only ZOLL approved IBP sensors Use of non approved sensors may result in inaccurate IBP measurements To take safe and accurate IBP measurements using the X Series you must perform the following steps each of which corresponds to a section in this chapter Read each section carefully before you perform IBP measurements l Attach the invasive pressure transducer to the X Series unit 2 Zero the transducer 3 4 Select a label for the invasive pressure channel Set the invasive pressure alarms according to your organization s standards Attaching the Invasive Pressure Transducer Follow these steps when attaching the invasive pressure transducer l Inspect the transducer cable If the cable shows any signs of wear breakage or fraying replace the cable Replace the transducer dome if necessary Apply the transducer according to your organization s procedures Always refer the manufacturer s Directions for Use before using a transducer If the transducer is a disposable unit with a separate cable connect the transducer to the transducer cable Plug the transducer cable into one of the three six pin IBP cable connectors on the side of th
143. during analysis Cease all movement via stretcher or vehicle before analyzing the ECG Press the ANALYZE button to begin the analysis of the patient s ECG rhythm and to determine if a shockable rhythm is present The ANALYZING ECG and STAND CLEAR messages alternate at the bottom of the screen while the patient s ECG is analyzed Once the analysis is completed the unit indicates whether or not a shock is advised Note You can terminate the Advisory CPR Protocol mode and return to Manual mode at any time by pressing the Exit quick access key 11 16 2011 15 40 39 Adult p EE 00 28 58 i L gt 5 __ANALYZING Ece 120s Stis E o This analysis normally consists of up to three consecutive 3 second ECG rhythm analyses If at least two of the three analyses determine that the patient has a shockable rhythm the unit automatically prompts the operator to shock the patient at the preconfigured energy level If two or more of the three 3 second ECG analyses do not detect a shockable rhythm the unit alerts the operator that no shock is advised If the first two segments are in agreement with each other the final shock or no shock rhythm decision is made and a third segment is not processed ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm www zoll com 9650 001355 01 Rev B Advisory CPR Protocol Defibrillation Procedure When you press the Energy Select Up Down arrow keys or Charge button
144. e X Series unit www zoll com 9650 001355 01 Rev B Zeroing the Transducer Figure 11 1 Plugging the Transducer into the X Series When you plug the transducer cable into the unit the message ZERO PROBE appears in the numeric display window for that IBP channel Zeroing the Transducer To ensure that the X Series unit measures pressure accurately you must zero the transducer before each use If you change or disconnect a transducer you must zero the new transducer before use If you move a transducer to a different monitor you must zero the transducer again even if you have already done so on another unit In addition to the procedure below follow the transducer manufacturer s Directions for Use and your organization s established clinical protocol Follow these steps when zeroing a transducer 1 Place the transducer at the same height as the patient s left atrium 2 Close the transducer stopcock to the patient 3 Open the transducer s venting stopcock to atmospheric air 4 Allow the transducer a few seconds to settle 5 Use the navigation keys to highlight and select the tranducer s IBP channel and display the IBP channel s parameter control panel 9650 001355 01 Rev B X Series Operators Guide 11 3 CHAPTER 11 MONITORING INVASIVE PRESSURES IBP Lower P1 Systolic Alarm 90 NN P1 Diastolic Alarm P1 Mean Alarm Source Label Display Format S D M Zero Probe Figure 11 2 IBP Channel P
145. e Ifthe X Series has been configured to perform extra CPR at startup it displays a CHECK PULSE voice prompt and the message appears for 10 seconds Then it displays a PERFORM CPR message along with a voice prompt for the configured duration before analysis begins You can start an ECG analysis during the CPR interval by pressing the ANALYZE button 04 17 11 08 25 03 Adult STAND CLEAR An ANALYZING ECG message is displayed while the patient s ECG is analyzed Once the analysis is completed the unit indicates whether or not a shock is advised ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm 9650 001355 01 Rev B X Series Operators Guide 13 5 CHAPTER 13 AUTOMATED EXTERNAL DEFIBRILLATOR AED OPERATION When a nonshockable rhythm is detected the unit displays a NO SHOCK ADVISED message Immediately begin chest compressions and continue other treatment per protocol 04 17 11 08 31 51 Adult lt NO SHOCK ADVISED If the patient s rhythm is shockable the unit displays the SHOCK ADVISED and PRESS SHOCK messages The defibrillator automatically prompts the operator to shock the patient at the preconfigured energy level and the SHOCK button illuminates A continuous tone sounds for 20 or 50 seconds depending on configuration followed by a higher pitch tone for 10 seconds You must deliver the shock within this 30 or 60 second interval depending on configuration or the def
146. e frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ZOLL X Series unit is used exceeds the applicable RF compliance level above the X Series unit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the X Series unit d Over the frequency range 150 kHz to 80 MHz field strengths should be less than V 14 V m Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the X Series IEC 60601 1 2 Table 205 The X Series unit is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the X Series unit can help prevent electromagnetic interference by mainta
147. e amount of CO present during inhalation it also serves as an indicator for rebreathing in non intubated patients CO monitoring can be used for both intubated and non intubated patients The EtCO breath rate and FiCO measurements appear in a labeled EtCO5 numeric display The EtCO and FiCO measurements can appear as values given in millimeters of mercury mmHg You can also specify that the X Series unit display a CO capnogram in the waveform trace display area Pulse Oximetry SpO gt Pulse Oximetry monitoring measures the oxygen saturation SpO gt of arterial blood at a peripheral site such as a finger or toe If optional features SpCO and SpMet are installed it also monitors carboxyhemoglobin saturation SpCO and methemoglobin saturation SpMet SpO monitoring determines the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood and displays this ratio as percent SpO gt in a labeled SpO3 numeric display If optional features SpCO and SpMet are installed these values alternate and display as SoCO and SpMet under the SpO display You can also specify that the X Series unit display an SpO plethysmograph in the waveform trace display area Monitoring Display Options The X Series unit gives you great flexibility in how you display a patient s vital signs information By pressing the Display Home button 4 on the front panel you can successively display the patient s vital signs information in these
148. e cuachactde det undteventauedent cites tela ceceericussectadecumeee A 33 GlnicalPenormance RESUS skenare n AA A 33 Wireless Output Guidance and Manufacturer s Declaration cccccccseeeeeeeeeeeeeeeneeees A 34 RF Transmission Emitted IEC 60601 1 2 0 0 cece ccecccceeceeeseeeseeeesaeeesseseeseeeeeaes A 34 FOG NOICE morsan eraro EE R EE E EE A 34 Canada Industry Canada IC Notices cccccecccccseeceeceseeeseeseeeteeeeeeseneeesseeeeesanes A 34 Appendix B Accessories 9650 001355 01 Rev B X Series Operator s Guide xi TABLE OF CONTENTS xii www zoll com 9650 001355 01 Rev B Chapter 1 General Information Product Description The ZOLL X Series unit is an easy to use portable defibrillator that combines defibrillation and external pacing with the following monitoring capabilities ECG CO Oximeter Non invasive Blood Pressure IBP CO2 Temperature and Respiration It has been designed for all resuscitation situations and its rugged compact lightweight design makes it ideal for transport situations It is powered by auxiliary power and an easily replaced battery pack that is quickly recharged in the device when it is connected to auxiliary power In addition the unit s battery may be recharged and tested using a ZOLL SurePower Battery Charger Station Note The X Series has defibrillation and pacing functionality but some of the monitoring functions are optional features See the complete list of
149. e difference between the temperatures labeled AT Temperature Monitoring Setup To monitor temperature using the X Series unit perform the following steps 1 Select the temperature probe and apply it to the patient 2 Connect the temperature probe to the X Series unit 3 Configure Temperature alarms and settings if the current Temperature alarms and settings are not appropriate Selecting and Applying Temperature Probes You should use only temperature probes that are approved for use with the X Series unit See Appendix B Accessories for a list of ZOLL approved temperature probes The use of other probes that do not match the performance specifications of the ZOLL approved probes may produce incorrect temperature readings To apply the temperature probe to the patient follow your organization s standard procedures Always refer to probe manufacturer s Directions for Use before using the probe 9650 001355 01 Rev B X Series Operator s Guide 12 1 CHAPTER 12 MONITORING TEMPERATURE Warning e The application and use of metal jacketed temperature probes that come in contact with conductive objects or clinical personnel during electrocautery may cause burns at the point of contact between the patient and the temperature probe e Use only ZOLL approved temperature probes The use of non approved probes may result in accurate measurements Connecting the Temperature Probe To connect the temperature probe insert the pro
150. e direction of the arrow and unplug the MFC Refer to Chapter 14 Manual Defibrillation before using paddles for defibrillation The paddles include controls for selecting defibrillation energy charging and delivering a shock l SHOCK Buttons CHARGE Button pe ENERGY E al SELECT Charge Ready fe Indicator 3 Buttons w ad a A if A jf Ls ALA _ Connector gt J and RELEASE p button for TRN MFC INN 4 U E o L STERNUM Paddle APEX Paddle Figure 2 8 External Paddles 2 10 www zoll com 9650 001355 01 Rev B Defibrillator Controls and Indicators Pediatric size electrodes are built in to the paddle assembly beneath the standard electrode plates The user must manually adjust energy settings to pediatric levels consistent with their institution s protocols PEDI button To expose the pediatric plate press the PEDI button at the top of the paddle then slide the Adult plate upward Before replacing the Adult plate be sure to clean the pediatric plate and surrounding area thoroughly Slide the Adult plate onto the paddle until it locks into place Figure 2 9 Pediatric Plate Note The X Series defibrillator also supports ZOLL autoclavable internal handles for use during open chest defibrillation procedures Auxiliary Power Adapter The auxiliary power adapter is used as backup power to operate the X Series unit When it is connected to the unit
151. e list of paired devices 9650 001355 01 Rev B X Series Operator s Guide 22 7 CHAPTER 22 WIRELESS COMMUNICATIONS 22 8 You can then edit the settings of the paired device and give the device an optional nickname or provider Press the back arrow Kum to return to the list of paired devices 11 30 2011 14 02 44 Adult TO Log Full Cy ll 1 0 cm m HR bpm IBP NIBP mmHg a Wireless gt Configure Bluetooth gt Edit Bluetooth Name Nokia 5300 Nickname Joe s Phone Provider Not Required Spo2 Spo2 Disabled Temp Note Use Bluetooth devices with DUN or PAN NAP profiles only Not all cellular phones transmit reliably contact your local ZOLL Medical Corporation sales representative for a list of approved devices Changing the PIN It may be necessary to change the PIN on the X Series unit check your device s documentation To change the PIN select Change Pin in the Bluetooth menu then use the numerical keypad to enter the desired PIN 12 01 2011 15 11 58 Adult a iar 1 Some Alarm Limits Disabled 02 59 24 D NIBP mmHg a Pad 1 0 cm mV ads U cmim Ta a Wireless gt Configure Bluetooth gt Pair New Device Backsp Backspace Ors sles Cancel Change PIN When finished pairing all Bluetooth devices press the back arrow K to return the wireless menu Press the arrow again to exit to the main screen www zoll com 9650 001355 01 Rev B Setting uo Communi
152. e patient s left sternal margin Midway between V2 C2 and V4 C4 Fifth intercostal space on the patient s midclavicular line Patient s left anterior axillary line at the horizontal level of V4 Patient s left midaxillary line at the same horizontal level as V4 and V5 12 Lead ECG Monitoring Setup Locating the V1 C1 position fourth intercostal space is critically important because it is the reference point for locating the placement of the remaining V leads To locate the V1 C1 position 1 Place your finger on top of the jugular notch see figure below 2 Move your finger slowly downward about 1 5 inches 3 8 centimeters until you feel a slight horizontal ridge or elevation This is the Angle of Louis where the manubrium joins the body of the sternum Jugular Notch Angle of Louis 3 Locate the second intercostal space on the patient s right side lateral to and just below the Angle of Louis 4 Move your finger down two more intercostal spaces to the fourth intercostal space which is the V1 position Note When placing electrodes on female patients always place leads V3 V6 under the breast rather than on the breast Connecting the 12 Lead Cable Connect the 12 Lead ECG cable to the ECG input connector on the left side of the unit as follows g Figure 14 2 Connecting the 12 Lead ECG Cable 9650 001355 01 Rev B X Series Operator s Guide 14 7 CHAPTER 14 12 LEAD E
153. e s Multifunction Cable MFC The unit ships with an MFC that is used to defibrillate the patient Any other cables that ship with your unit depend on the options you have purchased Figure 2 5 MFC Inserting MFC into Unit Plug the MFC connector into the therapy input connector on the right side of the unit Push the connector in with the arrows aligned The connector will click when it locks into place 1 Insert MFC into unit 2 Connector is locked into place 2 8 www zoll com 9650 001355 01 Rev B Defibrillator Controls and Indicators Removing MFC from Unit Twist the connector to the left to unlock it and pull out the MFC connector 1 Twist MFC connector 2 Pull out connector to the left External Paddles Paddles are defibrillation proof Type BF equipment The external paddles on the X Series device are used for defibrillation and synchronized cardioversion Caution You cannot use paddles for external transcutaneous pacing Attach the MFC from the X Series unit to the connector at the base of the APEX paddle 1 Align MFC as shown 2 Insert MFC into APEX handle Figure 2 6 Attaching the MFC to the APEX Paddle 9650 001355 01 Rev B X Series Operator s Guide 2 9 CHAPTER 2 PRODUCT OVERVIEW MFC Connected to APEX Paddle Figure 2 7 MFC Connected to APEX Paddle If you need to detach the MFC from the APEX paddles push the RELEASE button see Figure 2 8 in th
154. e type 12 Lead Transmission Select destination from the list below k Brigham and Women s Massachusetts General Hospital Lowell General Children s Hospital Transmit Use the navigation keys to highlight and select the desired distribution list A green check box indicates the selected list When a destination has been selected the Transmit button is enabled 5 Press Transmit to initiate the 12 lead transmission While the transmission is in process the green LED on top of the unit is illuminated 22 18 www zoll com 9650 001355 01 Rev B Communications System Messages Communications System Messages The X Series unit may display one of the following status messages during the transmission System Message TRYING TO CONNECT TO NETWORK The unit is connecting to the network TRYING TO CONNECT TO SERVER The unit is connecting to the ZOLL server TRANSMITTING The data transfer is in progress TRANSMISSION COMPLETE The data transfer is complete TRANSMISSION FAILED 9650 001355 01 Rev B The data transfer has failed To correct the problem check the following X Series Operator s Guide Verify that wireless communications is enabled on your X Series unit Verify that the WiFi settings are correct in the Communications setup menu Verify that the ZOLL server is configured correctly Verify that your cellular device is configured correctly Make sure that
155. eases as the patient exhales impedance decreases Impedance pneumography detects respiratory effort through changes in chest volume However No Breath episodes with continued respiratory effort may go undetected Always monitor and set alarms for SpO when using impedance pneumography to monitor respiratory function With any monitor that detects respiratory effort through impedance pneumography artifact due to patient motion apnea mattress shaking or electrocautery use may cause apnea episodes to go undetected Always monitor and set alarms for SpO when using impedance pneumography to monitor respiratory function When using impedance pneumography don t use the X Series unit with another respiration monitor on the same patient because the respiration measurement signals may interfere with one another Impedance pneumography is not recommended for use on paced patients because pacemaker pulses may be falsely counted as breaths Impedance pneumography is not recommended for use with high frequency ventilation Since impedance pneumography uses the same leads as the ECG channel the X Series unit determines which signals are cardiovascular artifact and which signals are the result of respiratory effort If the breath rate is within five percent of the heart rate the monitor may ignore breaths and trigger a respiration alarm www zoll com 9650 001355 01 Rev B Configuring Respiration RR BR Alarms and Settings Configurin
156. easurements Turbocuf Specify NIBP Mode You can specify that the X Series unit operate in either Manual or Automatic Mode In Manual Mode the X Series unit takes a single NIBP measurement when you press the NIBP button on the front panel To repeat the NIBP measurement you must press the NIBP key again select Manual In Automatic Mode the X Series unit takes the first of a series of NIBP measurements when the Auto Interval timer expires and then repeats the NIBP measurement at this specified interval Note You can press the NIBP button and manually initiate an NIBP reading at any time while in Automatic Mode Manually initiated NIBP readings will not affect the timing of subsequent NIBP readings in Automatic Mode Specify the Automatic NIBP Measurement Interval You can specify the time interval between NIBP measurements in Automatic Mode The default interval between measurements is 5 minutes You can specify intervals of 1 2 3 5 10 15 30 and 60 minutes between NIBP measurements Enable Disable Smartcuf Motion Artifact Filter Enabling the use of the Smartcuf motion artifact filter increases the accuracy of NIBP measurements when motion artifact or weak pulses are present NIBP measurements can be adversely affected by many factors such as cardiac arrthythmias sudden changes in blood pressure body motions such as shivering and convulsions bumping the cuff vibration vehicle motion or weak pulses The Smartcuf
157. ect the four digits in the Manual Mode pass code Press SAVE when you are finished Once you have entered your pass code you will be able to enter Manual mode Note Ifthe unit has been not been configured to enter a pass code the message Exit to Manual Mode is displayed Use the navigation keys to select Yes to enter the Manual mode of operation If you do not press Yes within 10 seconds the unit will revert back to AED operation If no hands free therapy electrodes have been attached to the patient and connected to the X Series unit the ATTACH PADS message and voice prompt will be issued Energy Select The default energy selections for adult patients are Shock 1 120 joules Shock 2 150 joules Shock 3 200 joules The default energy selections for pediatric patients are Shock 1 50 joules Shock 2 70 joules Shock 3 85 joules Note Pediatric defibrillator energy levels should be selected based on site specific protocols Use only pediatric electrodes to defibrillate patients under 8 years of age in Advisory CPR Protocol mode and make sure the patient mode is set to pediatric Use of adult electrodes or adult mode with pediatric patients can result in the delivery of excessive energy doses 9650 001355 01 Rev B X Series Operator s Guide 17 3 CHAPTER 17 ADVISORY CPR PROTOCOL DEFIBRILLATION 2 Press ANALYZE Button WARNING WARNING 17 4 Keep patient motionless during ECG analysis Do not touch the patient
158. ed by cardiogenic oscillations and artifact The X Series is equipped with automatic barometric pressure compensation 9650 001355 01 Rev B X Series Operator s Guide 9 1 CHAPTER 9 MONITORING CO2 Warning Caution When using a sampling line for intubated patients with a closed suction system do not place the airway adapter between the suction catheter and endotracheal tube This is to ensure that the airway adapter does not interfere with the functioning of the suction catheter Do not cut or remove any part of the sample line Cutting the sample line could lead to erroneous readings If too much moisture enters the sampling line i e from ambient humidity or breathing of unusually humid air the message Clearing FilterLine will appear in the message area If the sampling line cannot be cleared the message FilterLine Blockage will appear in the message area Replace the sampling line once the FilterLine Blockage message appears Do NOT use the Microstream sidestream CO accessories in the presence of flammable anesthetics or other flammable gases Loose or damaged connections may compromise ventilation or cause an inaccurate measurement of respiratory gases Securely connect all components and check connections for leaks according to standard clinical procedures Always ensure the integrity of the patient breathing circuit after insertion of the airway adapter by verifying a proper CO waveform capnogram on the monitor disp
159. eeeeeeceeeeeesaueeessaueeeeaaeeeesaaes 11 5 Enabling Disabling IBP Alarms and Setting Alarm Limits ccccccccessseeeeeeeseeeeseeeeeees 11 6 Setting Upper and Lower Systolic SYS Alarm Limits c cc ceeecccseeeeeeeeeeeeeeeeeeanees 11 6 Setting Upper and Lower Diastolic DIA Alarm Limits cccccceceseeeeeeeeeeeeeeeeeees 11 7 Setting Upper and Lower Mean Arterial Pressure MEAN Alarm Limits 11 7 Seuing IBF SOURCE LADS Jacrscctnce en cecttaneer testis ec a aa 11 8 IBP OY SIC MMIC SSAGSS nets Goh ece a as ttc creed it ase eid enc oueneeee ce 11 9 9650 001355 01 Rev B X Series Operator s Guide V TABLE OF CONTENTS Chapter 12 Monitoring Temperature Temperature Monitoring Setup ccccccccsseeccceseceeceeeeeceeseecsenseeceacesseaeeesseeesssgeeessageeeeas 12 1 Selecting and Applying Temperature Probes cccccccsesecceceseeeeeeeeeeeeeseeeeeeeesaaeeeesaaees 12 1 Connecting the Temperature Probe cccccsccccseecccceeeeecseeseeseueeeeseuseeeseueeeseaeeessaaeessaaaees 12 2 Displaying TemperatU e tive cts occcenecurderinciied scnceduincedstteiadesn E E EE R E TE 12 2 Enabling Disabling Temperature Alarms and Setting Alarm Limits cccccseeessseeeeees 12 3 Setting Upper and Lower Temperature Alarm Limits cccsscccecseeeeeseeeeesaeeeeseeeeeesseaees 12 3 Setting Upper and Lower Temperature Alarm Limits ccccccesseeeeeeeeeeseeeeeesaeeeeesaa
160. eeeeeeesaeeeeeesaeaeeeesanees 4 3 Chapter 5 Alarms Visual Alann GC ALORS ena a tala oe 5 1 Audible Alann NACIO S enri tcudaidtasblacesyauncnbuhanneseiietenaadeerueueceuasowts 5 2 Alann Indicator Sel TeSteredanii a a a 5 2 PatientAlarm DiS Play annenin i e ai 5 3 Life Threatening Rhythm Alarms cccccsccecsseceeceeeeecsesecenseeeesesecessaeeeenenesessasereneaseseneneees 5 4 Egu ipmMentAlert DISP a Vra N 5 4 Responding to Active Alarms Silencing the Alarm cccccecsseeeeeeseeeeeeeeeeeeeeesseneeeeeens 5 5 FO SNADING AIM AIANIM cue beass sans tides teat atnandseatlenated bianca dcadediay E E es 5 5 DUSDEMOING AIINS aiee a a a a oeeiens 5 5 Tne Alarm Suspension TIMET sennen na a 5 6 AIE ODUN S arar a a E ee enn Ee ra 5 7 Selecting Default Alarm Limits cccccccsssseeececeeeeseeeeeeeeaeseeeeeeseeeeseeeeesesauagesesesenagees 5 8 Setting Alarm Limits Relative to the Patient Stat Set Option ceeeeeee eens 5 8 Chapter 6 Monitoring ECG EGO MO MIRON ING SE UD ieran teieat cee chn thar sees teas cuts E E E come aieeus 6 2 Preparing the Patient for Electrode Application cccccssccesseeeceeeeenseeeseeeeeseeessaees 6 2 Applying Electrodes to the Patient ccccccssccccccseseeccceesseeceseseeeesseseeessseeeessaaegeees 6 3 Connecting the ECG Cable To the X Series Unit ce ceeececeeeeeeeeeeeeeeeeeeeeeeeeaeeees 6 5 Selecting ECG Waveforms for Display ccccccecseeee
161. een compromised and that it may not be ready for therapeutic use Located on the top of the unit this button turns the unit on and off Located on the APEX paddle this light turns on when the defibrillator is charged and ready The front panel includes a color display which shows Date and time Patient mode Battery status indicator Time elapsed since unit was turned on Quick access keys Waveform source Color coded waveforms and ECG lead identifiers SpO gt numeric data Heart rate numeric data Respiration rate numeric data Temperature numeric data Non invasive blood pressure numeric data www zoll com 9650 001355 01 Rev B Defibrillator Controls and Indicators e EtCO numeric data e Invasive pressure numeric data e The selected energy charging status and delivered energy for defibrillation and synchronized cardioversion e The output current and stimulus rate for pacing e Messages and prompts Figure 2 2 shows the layout of parameter values waveforms system data and quick access key labels Date and time Patient mode Battery status Time elapsed 06 06 2011 12 34 56 Status queue Quick access keys Waveform SpO2 data Heart rate NIBP data COs data Current temp Respiration rate Figure 2 2 X Series Display Screen Color coding To differentiate information for various parameters the unit displays each type of information in a specific user configurable color 9650 001355 01
162. een detected for at least 3 seconds or if the compressions fall below the display range of rate and depth indicators the rate Depth and Rate fields display dashes Rate and Depth Measurements The rate and depth measurements are displayed in green good while the operator meets or exceeds the respective rate and depth targets When CPR performance is diminished the rate measurement is displayed in yellow needs improvement when it drops below the target rate Likewise the depth measurement is displayed in yellow when it drops below the target depth This color coding is intended to assist the rescuer in determining whether chest compression rate or depth should be increased or maintained When an appropriate rate and depth are achieved these labels return to green CPR Release Indicator The CPR Release Indicator is intended to provide feedback on the rescuer s ability to fully lift his hands off the sternum during the upstroke of the compression The release indicator is filled when rescuers release compressions more quickly whereas the indicator will only fill partially if chest compression release is slow In addition a text prompt to FULLY RELEASE is periodically displayed while compressions are being performed Chest Compression Indicator 19 2 This diamond shaped figure provides a quick overall indicator of how well the rescuer s combined rate and depth of chest compressions match the AHA ERC recommendations for adult CPR
163. ees 12 4 Selecting the Temperature Labelin eiue ei A a 12 4 Temperature System Messages ccccseeccceceesececeseeseeeeceeeeeeeseaeaeeeesseuseeeeseaeeeeeseaaeeeeesaaaes 12 5 Chapter 13 Automated External Defibrillator AED Operation AED OperatiON esca a a a ss deLereadebere iedods 13 2 Determine Patient Condition Following Medical Protocols ccccccceeseeeeeeeeeeeees 13 2 Begin CPR Following Medical Protocols cccccccccseeeeeceeeeeeeeeseeeeeeeeeseeeeseeeeeeess 13 2 Preparo PALL irasra ina int dunncloon nat a oa 13 3 C FUTON GN enra a E eee ae 13 3 DAVIN ZO naa a T a a 13 5 CU ad Kolo oe Or arena a a ne ees ato ROE en 13 7 ODE rating MESSAGCS siactases scnnmetetsencddannte chat mencuted a eanbsseanshed ncsnaete aaunindeyaaed 13 8 Audio and Display Messages taini cesietaniGee anae a ai 13 8 Switching to Manual Mode Operation cccccccceseeeceeeeeeeeeeeeeeeeeseeeeeseeeseeeeeeeseeeeeeeeeas 13 10 Chapter 14 12 Lead ECG Interpretive Analysis Entering Patent inornatlomssseri an a a incised area eects 14 2 Entering the Patient Name and ID an nannnnnnnnnnnnnnnnnnnnnnnsnnnsnnrsnnrsnrrsnnernnrrnrrrnnrrnrerenernnee 14 3 Entering Patient Age and Gender secissinr arrinte ina e A EE EEE 14 4 12 Lead ECG Monitorning Set erssresienank nnen e ea 14 4 Preparing the Patient for Electrode Application ssesneneennennnneennsnenenernrnernrrsrrereennee 14 4 Applying Electrodes to th Patient srcunsknc
164. efibrillate patients under 8 years of age in Advisory mode and make sure the patient mode is set to pediatric Use of adult electrodes or adult mode with pediatric patients can result in the delivery of excessive energy doses 9650 001355 01 Rev B X Series Operator s Guide 16 1 CHAPTER 16 ADVISORY DEFIBRILLATION Advisory Defibrillation Procedure Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse Begin CPR Following Local Medical Protocols Request additional assistance Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach hands free therapy electrodes according to instructions on the electrode packaging and as described in Therapy Electrode Application on page 15 6 Ensure that the electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes If therapy electrodes are not making good contact with the patient s skin the unit issues the message CHECK PADS and does not allow delivery of energy Note Since analysis is only done using Pads as a lead even if an ECG cable is connected and Lead II is available the unit still displays a CHECK PADS message 16 2 www zoll com 9650 001355 01 Rev B Advisory Defibrillation Procedure
165. electrodes according to instructions on the electrode packaging Ensure that the therapy electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes Therapy Electrode Application Warning Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient 2 Roll the pad smoothly from the applied edge to the other being careful not to trap any air pockets between the gel and skin 15 6 www zoll com 9650 001355 01 Rev B Emergency Defibrillation Procedure with Hands Free Therapy Electrodes Note If it is not possible to place the BACK electrode on the patient s back place the electrodes in the standard apex sternum positions Effective defibrillation results but pacing will usually be less effective Turn On Unit Press the green power switch located on the top of the unit The green yellow and red lights at the top of the unit flash on and off and the unit displays the message SELF TEST PASSED If defibrillation electrodes are not making good contact with the patient s skin and the lead selection is ECG Lead the unit issues the message CHECK THERAPY ELECTRODES and does not allow the delivery of energy 1 Select Energy Level Press the Energy Select arrows up or down to select the desired energy level These buttons are located on the front panel of the unit
166. en performing the NIBP test in the Service menu Do not conduct NIBP tests when the cuff is attached to a patient How does NIBP Work The blood pressure cuff and hose connect to the X Series unit through the NIBP connector on the side panel of the unit The NIBP button on the front panel of the unit allows you to initiate and terminate blood pressure measurements which are displayed in the NIBP area of the monitor 8 2 The X Series unit s NIBP module measures the oscillometric pulses transmitted through the blood pressure cuff and hose and calculates the blood pressure measurements accordingly The pressure measurement proceeds as follows l The cuff inflates to a preconfigured pressure determined by patient type above the patient s systolic blood pressure As the cuff inflates the X Series unit measures the oscillometric pulses transmitted from the cuff through the hose and the SureBP monitoring software calculates the patient s systolic diastolic and mean blood pressure Once these measurements are taken the cuff deflates The X Series unit takes these measurements in about 15 seconds The SureBP feature requires the use of a cuff and dual lumen hose If high artifact prevents an accurate measurement during cuff inflation or if you use a cuff and single lumen hose the cuff inflates to its target pressure to occlude blood flow through the arteries in the monitored limb The cuff deflates incrementally allowing bloo
167. ennacotenin i 14 5 Connecting the 12 Lead Cable sinisisi rooi aea adaa aik 14 7 Observing the 12 Lead Waveform Traces cccccccsseeceeeeeeeseeeeseeeeeeseueeseeesaaeeeeesaaaes 14 8 12 Lead Interpretive Analysis ccccccccccssececceeseeceeeeeeceeeeesaueecseaseessaeeessueeesseneeseas 14 8 Fault Conditions Affecting 12 Lead Interpretive Analysis ccccceecceeeeeeseeeeeeeees 14 11 Printing 12 Lead Waveform Traces cccsccccsseecceseeecseeeeecsecessaeeessegeeesseeeesseeeeessaeeeess 14 12 12 Lead Print and DiSplay ODUONS sireci EE RE 14 13 Selecting 12 LEad ACQUE ccccceeeececeeeeeeceeceeeeceeseeeceeseeeeeeessseaeseeseaeeeeeesseeeeeeeeas 14 13 Specifying the Number of 12 Lead Print Copies cccceeceeecessseeeeeeeeeeeeeeeneeeeeees 14 13 Specifying the 12 Lead Print FOrMat ccccccecccccssseeceeeeeeeeeeeeeeeeeeeseeeeeeeeeseeeeeeeeas 14 13 Printing 10 Seconds of the Lead II Waveform Trace cccsesseceeeecseeeeeeeeeeaaeeeeees 14 13 Specifying the 12 Lead Frequency Response ccccccssseeeeceeeseeeeseesseeeenseeeeeees 14 14 vi www zoll com 9650 001355 01 Rev B Chapter 15 Manual Defibrillation Emergency Defibrillation Procedure with Paddles ccccccseeeeceeeeeeeeeeseeeeeneeensaees Determine the Patient s Condition Following Local Medical Protocols Begin CPR Following Local Medical Protocols ccccccssseeeeeeeeeeeeeeeeeeeeeesneees
168. ent 4 Adjust the cuff so that the artery marker on the cuff is over the artery pointing to the hand or foot Check that the cuff ends between the range lines marked on the cuff If they do not line up use a different size cuff Wrap the deflated cuff snugly around the limb without impeding blood flow oO N HD N Ensure that the hose is routed to avoid kinking or compression 9650 001355 01 Rev B X Series Operator s Guide 8 7 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP Caution e Using a cuff that is loosely applied or too small results in measurements higher than the patient s actual blood pressure e Using a cuff that is too large results in values lower than the patient s actual blood pressure e Ideally the cuff should be at the same level as the heart Cuff placement substantially above or below heart level will result in blood pressure measurements that are erroneously low or high The following illustrates one possible cuff placement for adult pediatric patients and to the right possible cuff placements for neonates Figure 8 3 Applying Cuff to the Patient Ensuring Correct Cuff Inflation Settings Before taking an NIBP measurement for a new patient ensure that the cuff inflation settings are appropriate for that patient Check that the correct patient mode is selected The initial Cuff Inflation Target CIT pressure is dependent on the patient type and the configured CIT preset The
169. ent prior to defibrillation Before discharging the defibrillator warn everyone to STAND CLEAR of the patient www zoll com 9650 001355 01 Rev B Warnings Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result To avoid hazardous pathways for the defibrillation current do not allow exposed portions of the patient s body to touch any metal objects such as a bed frame To avoid risk of electrical shock do not allow printer to come into contact with other conducive parts such as equipment connected to the USB port Patient Safety Inappropriate defibrillation or cardioversion of a patient for example with no malignant arrhythmia may precipitate ventricular fibrillation asystole or other dangerous arrhythmias Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns particularly when repeated shocks are necessary Erythema or hyperemia of the skin under the paddles or electrodes often occurs this effect is usually enhanced along the perimeter of the paddles or electrodes This reddening should diminish substantially within 72 hours This equipment should be connected to only one patient at a time Neonatal and pediatric defibrillation energy level settings should be based on site specific clinical protocols To ensure patient safety do not place the monitor in any position that might cause it to
170. ent cable multifunction cable MFC pulse oximetry sensor blood pressure cuff and hose and temperature sensors for signs of damage or excessive wear Replace if damaged Inspect the defibrillator paddles for damage or excessive wear Check that paddle surfaces are clean and free of electrolyte gel or other contaminants Verify that all paddle controls operate freely when pressed and released Inspect the external AC adapter and its power cords for signs of damage Replace if damaged Supplies Verify the presence proper condition and appropriate quantities of all disposable supplies hands free therapy electrodes ECG monitoring electrodes defibrillator gel recorder paper alcohol swabs razors scissors etc Verify that two sets of hands free therapy pads are available Ensure that the therapy and monitoring electrodes are sealed within the packages and within the expiration dates printed on the packages Open the recorder door on the left side of the X Series unit and verify that an adequate supply of paper is available in the unit Batteries Verify that a charged battery is fully inserted into the battery compartment of the X Series unit Ensure that a fully charged spare battery pack is available Ready For Use Indicator Check the Ready For Use RFU indicator on the X Series front panel Verify that the RFU symbol is displayed If the RFU indicator is flashing or displaying the Do Not Use symbol then either an
171. ents Fully evaluating the accuracy of the SpO measurements requires at a minimum accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the patient s tissue These capabilities are beyond the scope of known bench top testers including known devices which claim to measure sensor LED wavelength SpO measurement accuracy can only be evaluated in vivo by comparing pulse oximeter readings with values traceable to SpO measurements obtained from simultaneously sampled arterial blood using a laboratory CO oximeter Many functional testers and patient simulators have been designed to interface with the pulse oximeter s expected calibration curves and may be suitable for use with Masimo monitors and or sensors Not all such devices however are adapted for use with the Masimo digital calibration system While this will not affect use of the simulator for verifying system functionality displayed SpO measurement values may differ from the setting of the test device For a properly functioning monitor this difference will be reproducible over time and from monitor to monitor within the performance specifications of the test device www zoll com 9650 001355 01 Rev B Chapter 11 Monitoring Invasive Pressures IBP The X Series IBP inputs are Type CF defibrillator proof This chapter describes how to use the X Series unit to monitor invasive pressures IBP The X Ser
172. epending upon configuration of the unit it generates visible and audible alarms as needed Note LTA monitoring is not available in AED mode Equipment Alert Display Warning 5 4 When a problem with the X Series unit or an attached sensor triggers an alert in addition to sounding an equipment alert the X Series unit displays an alert message yellow background black text Always respond immediately to a system alarm since the patient may not be monitored during certain alert conditions In the following example an equipment alert message indicates that the SpO sensor has become unattached SpO2 Check Sensor from the unit a 12 34 56 O 00 1 7 43 www zoll com 9650 001355 01 Rev B Responding to Active Alarms Silencing the Alarm Responding to Active Alarms Silencing the Alarm When a patient alarm is triggered and the alarm tone sounds 1 Check the patient and provide appropriate care 2 Press the Alarm Silence Reset button Cmon the X Series unit s front panel to silence the alarm briefly 90 seconds 3 After caring for the patient check that the appropriate alarms are set for more information about setting and enabling alarms see appropriate monitoring chapters later in this manual Note Pressing suspends the alarm tone for all active alarms If the patient s vital signs measurements trigger another different alarm the patient alarm tone will sound even if the first alarm silence period
173. eplaced periodically Consult electrode directions for specific recommendations Prolonged pacing in excess of 30 minutes particularly in adolescent child and infant pediatric patients or adults with severely restricted blood flow may cause burns Periodic inspection of the underlying skin is recommended When pacing in demand mode the pacer may be adversely affected from EMI RFI or ESU Move patient away from any potential sources of interference 9650 001355 01 Rev B X Series Operator s Guide 18 1 CHAPTER 18 EXTERNAL PACING External Pacing X Series defibrillators contain a pacemaker for the emergency treatment of hemodynamically compromising bradycardia bradycardia with escape rhythms that are unresponsive to pharmacological therapy refractory tachycardia supraventricular or ventricular and bradyasystolic cardiac arrest Proper demand pacing requires a reliable high quality surface ECG signal For best results apply both standard ECG monitoring electrodes and hands free pacing therapy electrodes to the patient Pacer Modes The X Series has two pacer mode settings Demand and Fixed The default factory mode setting is Demand In Demand mode pacing pulses are inhibited by the patient s QRS complexes that occur during an interval that is dependent on the setting of the rate control If during that interval no QRS complexes are detected a pacing pulse is delivered to the patient In the demand mode the pacer supplie
174. eport ccecccceseeeeeeeceeeeeeceaeeeeeeseaeeeeeeeseseeesaeaeeees 21 3 Transferring Data to a USB Devit cossenicicinnn ieia ET a 21 3 GIG QNING Ne LOO sser an O Na 21 4 Chapter 22 Wireless Communications MG WV ICIS S ICOM a a a ican Daren tare geass 22 2 TNS Wireless MON UiccteinnessveariunthiawieedantduiacscnasnOiatacienbitaiseesa r 22 3 Selecting and Creating a Temporary Access Point Profile ccccccseeeeeeeeeeeeeees 22 3 Setting up and Viewing Paired Devices ccccccccsseeeeceeeeeeeeeeeeeceeseeneeeeesuaeeeeeeaaaes 22 7 Setting up Communications in the Supervisor Menu cccccceeeeeeeeeeeeeeeeeeeeeeeaaeeeeeeeeaes 22 9 VVIFIACGESS POINT Profile S i tcedcisgareetsd tos sevesdeesieer teak e E E 22 10 Setting up Cellular COMMUNICATIONS cece ceeeeceecceeeeeeeeeeeeeeeeaeeeeeeseaeeeeeessaeeeeeeeas 22 14 Configuring Repon TranSMiSSiONS minsin A AE A 22 17 Sending a T2 lead Tepora E cents tonuacaeeh 22 18 Communications System Messag S sarsii a a 22 19 9650 001355 01 Rev B X Series Operator s Guide iX TABLE OF CONTENTS Chapter 23 Printing FTAA Patent LOA crash c tesiwtaa ex cence vais a tutu ysientarcluntsuuid enuedensbolacuenautiatuuanens 23 1 PRONO 0 aena seen rence Merten te earn a ee ee meena eee eee 23 2 AUO MINS sorga T A inet aeteienectaunbeiunes 23 2 PMMUING VVAVCIONMNG se a E 23 2 PANINO REDONS aprou ea E O O 23 3 PANINO TERAS seeti T O a 23 4 Chapter 24 Maintenan
175. equipment fault has been detected or the unit s battery is low or not properly installed Install a fully charged battery in the unit and check the RFU indicator again If the RFU indicator continues to flash or display the Do Not Use symbol remove the unit from service and contact the appropriate technical personnel or the ZOLL Technical Service Department www zoll com 9650 001355 01 Rev B Defibrillator Pacing Test with Hands Free Therapy Electrodes Defibrillator Pacing Test with Hands Free Therapy Electrodes Note If alow battery message appears during any of this testing the battery is close to depletion and should be replaced or recharged Warning Keep hands fingers and other conductive materials away from paddle electrode plates when discharging the defibrillator or pacing Function Response Connect the external Be A adapter to a working ee that the green Auxiliary Power LED AC outlet and to the X Series rear panel illuminates on the X Series front panel Insert a battery into the unit if a battery is not Verify that the Battery Charge LED on the X already in the slot Series front panel illuminates yellow When the battery pack has been fully charged the battery status indicator light is green Press the unit s power on switch Verify the unit issues two audio beeps and that the red yellow and green Visual Alarm indicators illuminate for 2 to 3 seconds Note The yellow LED may remain lit after the unit powers
176. er and Lower EtCO Limits Initially the EtCO2 Alarm menu specifies that the EtCO alarms are enabled ON or disabled OFF and displays the default Upper and Lower EtCO Limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default EtCO limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type EtCO Limit Default EtCO Limit Range Lower 8 mmHg Lower 0 145 mmHg Upper 60 mmHg Upper 5 150 mmHg Pediatric Lower 8 mmHg Lower 0 145 mmHg Upper 60 mmHg Upper 5 150 mmHg Lower 8 mmHg Lower 0 145 mmHg Upper 60 mmHg Upper 5 150 mmHg In high altitude environments EtCO values may be lower than values observed at sea level as described by Dalton s law of partial pressures When using the X Series unit in high altitude environments it is advisable to adjust EtCO alarm settings accordingly Setting Upper FiCO Limits Initially the FiCO2 Alarm menu specifies that the FiCO alarms are enabled ON or disabled OFF and displays the default upper limit The upper limit can be ON or OFF default is OFF The following table lists the default FiCO upper limits for adult pediatric and neonate patients and gives the range in which you can set these limits Upper FiCO Limit Upper FiCO Limit goulenlalyng Default Range Pediatric 9650 001355 01 Rev B X Series Operator s Guide 9 9 CHAPTER 9
177. er regularly while taking IBP measurements Always view the IBP waveform to ensure that pressure measurements are based on a physiological waveform 9650 001355 01 Rev B X Series Operators Guide 11 5 CHAPTER 11 MONITORING INVASIVE PRESSURES IBP Enabling Disabling IBP Alarms and Setting Alarm Limits When enabled the X Series unit sounds alarms whenever IBP measurements are outside set limits for the following e High and Low Systolic Pressure e High and Low Diastolic Pressure e High and Low Mean Arterial Pressure MEAN To enable or disable IBP alarms and set Upper and Lower alarm limits and IBP channel you can either use the navigation buttons to highlight and select the IBP channel display or 1 Press the More quick access key BD 2 Press 3 Press the Limits quick access key BB 4 Use the navigation buttons to highlight and select the appropriate alarm menu selection For each IBP channel there are alarm menus for systolic Systolic Alarm diastolic Diastolic Alarm and mean arterial pressure Mean Alarm alarm settings On the selected Alarm Settings menu use the navigation keys to select the fields that you want to change The fields are e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit FEE 5 When you are finished changing values on the alarm menu navigate to the Backarrow key h to exit the menu Setting Upper and Lower Systolic SYS Alarm Limits Initially the IBP Systolic Alarm Set
178. eries unit is configured for Advisory CPR Protocol defibrillation the unit guides you through a cardiac event by performing ECG analysis preparing the device for a shock if needed and leading you through a CPR interval This cycle is repeated as long as Advisory CPR Protocol is active and pads are attached to the patient If pads become detached from the patient or shorted during rescue protocol the protocol halts until the pads are reattached or continues through the CPR interval and then halts and waits for the pads to be reattached If you press the Energy Select Up Down arrow keys or Charge button while in Advisory CPR Protocol mode the unit transitions to Manual mode If the unit is charged when you transition from Advisory CPR Protocol to Manual mode the unit disarms and halts any analysis that is taking place The Advisory CPR Protocol function can be activated only when e The unit is configured for Analysis CPR Protocol e The unit is on and in manual mode e Hands free therapy electrodes are properly connected to the patient e Valid impedance is detected and pacer is off e Patient mode is not set to neonate 9650 001355 01 Rev B X Series Operator s Guide 17 1 CHAPTER 17 ADVISORY CPR PROTOCOL DEFIBRILLATION WARNING Use only pediatric electrodes to defibrillate patients under 8 years of age in Advisory CPR Protocol mode and make sure the patient mode is set to pediatric Use of adult electrodes or adult mode with pedia
179. es Optional Feature 12 Lead ECG with Interpretation SpO gt Masimo with SpCO and SpMet NIBP with Smartcuf and SureBP EtCO2 Oridion Microstream Temperature Invasive Pressures 3 Channels Advanced CPR Help Pacing www zoll com 9650 001355 01 Rev B How to Use This Manual How to Use This Manual The X Series Operator s Guide provides information operators need for the safe and effective use and care of the X Series product It is important that all persons using this device read and understand all the information contained within Please thoroughly read the safety considerations and warnings section Procedures for daily checkout and unit care are located in the Chapter 24 Maintenance Operator s Guide Updates An issue or revision date for this manual is shown on the front cover If more than three years have elapsed since this date contact ZOLL Medical Corporation to determine if additional product information updates are available All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference Product documentation is available through the ZOLL website at www zoll com From the Products menu choose Product Manuals Unpacking Carefully inspect each container for damage If the shipping container or cushion material is damaged keep it until the contents have been checked for compl
180. escuers with feedback about the quality of CPR they are delivering to their patients The way in which feedback is provided varies with respect to the operational mode and user configuration but is derived from compression rate and depth measurements When applied according to package instructions ZOLL CPR D padz and OneStep CPR electrodes provide a chest compression sensor that is located between the rescuer s hands and the patient s lower sternum This sensor monitors the rate and depth of chest compressions and sends this information to the X Series unit for processing and display The X Series defibrillator displays the CPR rate and depth information on the Real CPR Dashboard and provides feedback to the rescuer in one or more of the following forms e Chest Compression Indicator e CPR Release Indicator e Rate and Depth Measurements e CPR Rate Metronome e FULLY RELEASE Prompt e CPR Voice Prompts e CPR Idle Time Display 9650 001355 01 Rev B X Series Operator s Guide 19 1 CHAPTER 19 REAL CPR HELP CPR Dashboard Whenever CPR D padz or OneStep electrodes are connected to the X Series defibrillator and it senses compression the unit illuminates the CPR Dashboard in the lower center portion of the display This field includes the CPR feedback indicators described in the following sections CPR CPRTime 1 48 Depth in Rate cpm Release CPR Release Indicator Chest Compression Indicator Note If no compressions have b
181. essceeeeeeeeeeceeeeeeeeseeseeesseeseeeesaeeeeesseaeeees 1 2 Howto yse Ths IVAN All ic2ds 22 ocneracsacisdend onei a E e e e 1 3 Operator S cude YpdaleSriinsisissainn n a a a tad 1 3 UNPACKING 1 3 symbols Used on the Equipment aneta ea AA 1 4 Conventions esea a a a a maw torah Paudinuetllats 1 7 X S6NeES Ndicatons 1Ol USC sririsineanoor gnien e E EAE E A TAN a a A 1 7 Manual STON ONY srorcensesessn a a e aa ort eieaeaehentee 1 8 Semiautomatic Operation AED ssennosannnsannnsennnserrnrerrnsenrrnsrrrrnnrrsnrrrsnrrrrnnrrenrrreerenne 1 8 EGOLNONLONDO aar E E EA 1 9 GPR MONHONNO icasenaiemetate a a 1 9 External Transcutaneous Pacing enics a a a 1 9 Non Invasive Blood Pressure Monitoring ccccceeeeeesseeeeeeeeeeeeeeeeeeseeseeeseeeeesaeeeeess 1 10 Temperature Monitorning orsreeri eni a d a E E 1 10 SPOOZ MONHOTINO seanina r e cere etree a ea 1 10 Respiration MOnitoring ressirrese aea a E E E eA 1 10 CGO2IMONILOMO crenn r a bana are ieladenseeeesetie tae 1 10 Invasive Pressure Monitoring n nnnonnnonnneennsnnesnnnnnnrsnnrnrnrrnnrrnnrrsrrrsrrrsrersrererersnrrnne 1 10 I2 Lead ANAYSSI S a a teed a a te eater te 1 11 X Series ProduUCkEUNCHONS esie a aal 1 11 DENDRO FUNCION aericia lee a aetna 1 11 Defibrillator QUPUtCENETOY srce E ER 1 11 Extemal Pacemaker osre a E e a 1 11 EGO MONONA asst seeaceuienecgcesgtelee crotatanesewnnceediedie es tuaaagena a a 1 12 al 5 6 1 6 Ne ae ea ee tc ear ee oe eee ne 1 12 BANENE Sati ce
182. eteness and the instrument has been checked for mechanical and electrical integrity If the contents are incomplete if there is mechanical damage or if the defibrillator does not pass its electrical self test U S A customers should call ZOLL Medical Corporation 1 800 348 9011 Customers outside of the U S A should contact the nearest ZOLL authorized representative If the shipping container is damaged also notify the carrier 9650 001355 01 Rev B X Series Operator s Guide 1 3 CHAPTER 1 GENERAL INFORMATION symbols Used on the Equipment Any or all of the following symbols may be used in this manual or on this equipment 1 4 Symbol J Ha gt i a AN a a z a aft Description Dangerous voltage Attention consult accompanying documents Fragile handle with care Keep dry This end up B Temperature limitation ee ee oe gt e be gt im T T roa Ld Conformit Europ enne Complies with medical device directive 93 42 EEC Type B patient connection Type BF patient connection Type CF patient connection Defibrillator proof type BF patient connection Defibrillator proof type CF patient connection Fusible link www zoll com 9650 001355 01 Rev B Symbols Used on the Equipment Symbol Description v Equipotentiality Sf Alternating current ac o Direct current dc Auxiliary power adapter operation A N C
183. eturn to the WiFi configuration menu press Cancel to return to the WiFi configuration menu without saving changes O7 427 11 14 29 54 Adult Some Alarm Limits Disabled NIBP mmHg SSID acer LG_Public Cancel 22 12 www zoll com 9650 001355 01 Rev B Setting uo Communications in the Supervisor Menu Authenication Use the navigation keys to select the authentication type Security Key Use the alphabetical keypad to enter the security key Press SAVE to save changes and return to the WiFi configuration menu press Cancel to return to the WiFi configuration menu without saving changes 07 2711 14 40 58 Adult Security Key ItsABigSecret Cancel When finished editing your WiFi profile press the back arrow to return to return to the list of configured access point profiles From this menu you can also edit or delete existing profiles Press im to return to the Communications menu 9650 001355 01 Rev B X Series Operators Guide 22 13 CHAPTER 22 WIRELESS COMMUNICATIONS Setting up Cellular Communications You can configure your USB cellular modem or Bluetooth device to work with the X Series unit Under the Communications menu select Cellular Configure The Cellular menu appears 11 30 2011 14 15 46 Adult C SpO2 Self Test Failed CA II 1 0 cm m T HR bpm IBP LAL mmHg Supervisor gt Communications gt Cellular Connection Method USB Cell Modem Enabled Provider Verizon
184. ev B ECG Monitoring Setup Applying Electrodes to the Patient The following sections show where to place electrodes when using 3 and 5 Lead cables to perform ECG monitoring For 3 Lead ECG cables apply electrodes as in Figure 4 1 3 Lead Electrode Placement For 5 Lead ECG cables apply electrodes as in Figure 4 2 5 Lead Electrode Placement Avoid placing electrodes over tendons and major muscle masses Make sure that the ECG electrodes are placed to allow defibrillation if necessary 3 Lead Electrode Placement Depending upon local usage the ECG leads are marked either RA LA and LL or R L and F The following table shows the markings and color codes for the different lead sets AHA Color AHA Color Coding IEC Color IEC Color Coding Placement of Electrodes of Electrodes b malasar a Electrode Electrode near patient s right mid clavicular line directly below clavicle LA Black Electrode L Yellow Electrode Place near patients left mid clavicular line directly below clavicle LL Red Electrode F Green Electrode Place between 6th and 7th intercostal space on patient s left mid clavicular line Figure 6 1 3 Lead Electrode Placement 9650 001355 01 Rev B X Series Operators Guide 6 3 CHAPTER 6 MONITORING ECG 5 Lead Electrode Placement Depending upon local usage the ECG leads are marked either RA LA LL RL and V or R L F N and C The following table shows the markings and color codes for the
185. f this manual for disclosure of the pacemaker pulse rejection capability of this instrument Use only ECG electrodes that meet the AAMI standard for electrode performance AAMI EC 12 Use of electrodes not meeting this AAMI standard could cause the ECG trace recovery after defibrillation to be significantly delayed Prior to attempting synchronized cardioversion ensure the ECG signal quality is good and that sync markers are displayed above each QRS complex Do not place electrodes directly over an implanted pacemaker The X Series unit detects ECG electrical signals only It does not detect a pulse effective circulatory perfusion Always verify pulse and heart rate by physical assessment of the patient Never assume that the display of a nonzero heart rate means that the patient has a pulse Excessive artifact can result due to improper skin preparation of the electrode sites Follow skin preparation instructions in Chapter 6 Monitoring ECG www zoll com 9650 001355 01 Rev B Warnings Do not operate the X Series in conjunction with electrocautery or diathermy equipment Such equipment as well as equipment that emits strong radio frequency signals can cause electrical interference and distort the ECG signal displayed by the monitor thereby preventing accurate rhythm analysis Shock Hazard Use of accessories other than those specified in the operating instructions may adversely affect patient leakage currents Certain l
186. fibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself If additional countershocks are needed and the Sync after Cardioversion setting is disabled press the Syne quick access key again and follow steps 1 through 3 of this procedure starting on page 15 13 to readjust the energy settings charge the unit and deliver shock You can configure the Sync after Cardioversion setting through the Setup gt Supervisor gt Defib Pacer gt Default Settings menu www zoll com 9650 001355 01 Rev B WARNING Chapter 16 Advisory Defibrillation ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection When the X Series unit is configured for Advisory or single analysis defibrillation the X Series unit can identify shockable rhythms using its built in ECG analysis capability You must read the advisory messages charge the defibrillator to the preconfigured or user selected energy level if automatic charge is disabled and deliver treatment to the patient when required by protocol and patient condition The advisory function can be activated only when e The unit is configured for Single Analysis e The unit is on and in manual mode e Hands free therapy electrodes are properly connected to the patient e Valid impedance is detected and pacer is off e Patient mode is not set to neonate Use only pediatric electrodes to d
187. for example as a result of externally applied coloring such as nail polish dye or pigmented cream to permit appropriate light transmission If any of these situations occurs reposition the sensor or choose an alternate sensor for use on a different site 4 Lift the clear plastic protective cover from the female end of the extension cable then plug the sensor cable s male connector into the extension cable connector make sure that the plug is all the way into the connector 9650 001355 01 Rev B X Series Operators Guide 10 5 CHAPTER 10 PULSE CO OXIMETRY SPO2 SPCO AND SPMET Sensor Cable Connector Connector Figure 10 1 Plug the Sensor Connectors Together 5 Lower the clear plastic cover over the connection to secure it Clear Protective v4 Cover Figure 10 2 Lower Plastic Cover Over Cable Connection 6 See Connecting the SpO Sensor on page 10 8 to connect the cable to the unit 10 6 www zoll com 9650 001355 01 Rev B Applying the SoO s Sensor Applying a Reusable SpQO Sensor Cable The following instructions describe how to apply a reusable Rainbow sensor For all other reusable sensors refer to the sensor packaging and the manufacturer s Directions for Use for instructions on how to apply the sensor Note A reusable sensor is not intended for use on the thumb or across a child s hand or foot After selecting a monitoring site apply the reusable sensor as follows 1 Place the selecte
188. g Communications gt Cellular gt Configure Bluetooth a Paired Devices Log i ____ Bluetooth Name Nickname Nokia 5300 Nokia 5300 dia 7 7P j D r a i 1 Spo2 lt Provider Name Not Required Spo2 Disabled New edit 7 Belete Temp Note Use Bluetooth devices with DUN or PAN NAP profiles only Not all cellular phones transmit reliably contact your local ZOLL Medical Corporation sales representative for a list of approved devices 22 16 www zoll com 9650 001355 01 Rev B Setting uo Communications in the Supervisor Menu Changing the PIN It may be necessary to change the PIN on the X Series unit check your device s documentation To change the PIN select Change Pin in the Pair New Device menu then use the numerical keypad to enter the desired PIN 12 01 2011 16 09 10 Adult to Par Some Alarm Limits Disabled I 03 56 36 NIBP mmHg Cellular gt Configure Bluetooth gt Pair New Device ss Available DO Backsp Backspace Or sles Cancel Change PIN Configuring Report Transmissions The X Series unit can send 12 lead reports to an email or fax machine using a Bluetooth equipped cellular device or a USB cell modem You can configure the X Series unit to select a particular device and also update or view distribution lists that have been created from third party software such as ZOLL RescueNet or CodeNet In the Communications menu select
189. g Disabling NIBP Alarms and Setting Alarm Limits When enabled the X Series unit sounds alarms whenever measurements are outside set limits for the following e High and Low Systolic Pressure e High and Low Diastolic Pressure e High and Low Mean Arterial Pressure MAP To enable or disable NIBP alarms and set upper and lower alarm limits you can do so through the Alarms quick access key A or the NIBP Parameter Control Panel To configure NIBP alarm limits through the Alarms quick access key Press the More quick access key Fd Press the Alarms quick access key Ty Press the Limits quick access key Use the navigation keys to highlight and select the appropriate alarm menu selection For NIBP the alarm menu selections are NIBP Systolic Alarm NIBP Diastolic Alarm and NIBP MAP Alarm i E 9650 001355 01 Rev B X Series Operators Guide 8 9 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP 8 10 F h 5 On the selected NIBP alarm settings menu use the navigation keys to select the fields that you want to change The fields are e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit 6 When you are finished changing values on the alarm settings menu select the back arrow to exit the menu Setting Upper and Lower Systolic Alarm Limits Initially the NIBP Systolic Alarm Settings menu specifies that the NIBP systolic pressure alarms are enabled ON or disabled OFF and dis
190. g Respiration RR BR Alarms and Settings The X Series unit allows you to enable and disable the Respiration RR BR Rate alarm to set alarm limits and to specify the ECG monitoring source for the Respiration rate Enabling Disabling RR BR Alarms and Setting Alarm Limits When enabled the X Series unit sounds alarms whenever the patient s respiration rate is above or below the specified respiration rate alarm limits To enable or disable Resp alarms and set Upper and Lower alarm limits you can either do so through the Alarms quick access key AN or the Resp Parameter Control Panel To configure RR BR alarms through the Alarms quick access key 1 Press Lel 2 Press Al 3 Press the Limits quick access key g Use the navigation keys to highlight and select the RR BR Alarm menu selection 4 On the RR BR Alarm Settings menu use the navigation keys to select the fields that you want to change e Upper Limit Enable e Lower Limit Enable e Upper Limit e Lower Limit fmm 5 When you are finished changing values on the alarm menu navigate to the Backarrow key h to confirm your choices and exit the menu 9650 001355 01 Rev B X Series Operator s Guide 7 3 Chapter 7 Monitoring Respiration Resp and Heart Rate HR Respiration Rate Alarm Limits Initially the Resp Alarm Settings menu specifies that Resp alarms are enabled ON or disabled OFF and displays the default Upper and Lower respiration rate alarm limits The up
191. g electrodes may become polarized during defibrillator discharge causing the ECG waveform to briefly go off screen ZOLL Medical Corporation recommends the use of high quality silver silver chloride Ag AgCl electrodes to minimize this effect the circuitry in the instrument returns the trace to the monitor display within a few seconds To assure protection against the effects of defibrillator discharge use only ZOLL approved accessories 9650 001355 01 Rev B X Series Operator s Guide 6 1 CHAPTER 6 MONITORING ECG To avoid a shock hazard and interference from nearby electrical equipment keep electrodes and patient cables away from grounded metal and other electrical equipment To avoid electrosurgery burns at monitoring sites ensure proper connection of the electrosurgery return circuit so that the return paths cannot be made through monitoring electrodes or probes Check the operation and integrity of the X Series unit and ECG cable regularly by performing the Daily Operational Verification Test Implanted pacemakers may cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or other arrhythmias Carefully observe pacemaker patients Check the patient s pulse do not rely solely on heart rate meters Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes Patient history and physical exam are important in determining the presence of an implanted pacemaker ECG Monito
192. h the ECG R wave to avoid the induction of ventricular fibrillation In this case a synchronizing SYNC circuit within the defibrillator detects the patient s R waves When the SHOCK button or buttons if using paddles is pressed and held the unit discharges with the next detected R wave thus avoiding the vulnerable T wave segment of the cardiac cycle When in the SYNC mode the unit displays markers S above the ECG trace to indicate the points in the cardiac cycle R waves where discharge can occur _ S marker indicates each detected R wave during synchronization Verify that markers are clearly visible on the monitor and their location is appropriate and consistent from beat to beat The synchronized cardioversion procedure for ZOLL hands free therapy electrodes 1s identical to that for paddles with the exception of the SHOCK button location 9650 001355 01Rev B X Series Operator s Guide ti 1501 MANUAL DEFIBRILLATION Synchronized Cardioversion Procedure Determine the Patient s Condition and Provide Care Following Local Medical Protocols Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach ECG electrodes see Chapter 6 for instructions on attaching ECG electrodes to the patient A standard ECG cable and ECG electrodes are recommended for use during card
193. hasn t expired Re enabling an Alarm Warning To re enable an alarm before the alarm silence period has expired press the Alarm Silence Reset button Do not silence the audible alarm if patient safety may be compromised Suspending Alarms Warning When caring for a patient you may want to suspend potential or current patient alarms and equipment alerts for a period of time To suspend patient alarms 1 Press the More quick access key ie to access the second set of quick access keys and press the Alarms quick access key 2 Press the Alarms Suspend quick access key amp No alarms will sound while alarms are suspended however if an alarm occurs during the suspension period the X Series unit will display visual alarm indicators alarm messages in the message area white text on a red background and red white numeric displays The duration of the alarm suspension can be configured to be for 2 4 or 15 minutes or for an indefinite period of time The ability to suspend alarms can also be disabled When audible alarms are disabled make sure that the patient is closely observed 9650 001355 01 Rev B X Series Operators Guide 5 5 CHAPTER 5 ALARMS The Alarm Suspension Timer During an alarm suspension the window displays an alarm suspension timer at the top of the display next to the message area Alarm Suspension Timer 06 06 2011 12 34 56 Adult f z GED Eco Lowa eae 00 17 43 CO SYNC gt amp
194. he X Series unit s auxiliary power source is connected to an aircraft AC power operating at a frequency of 400 Hz The use of accessories transducers and cables other than those specified in this manual and related X Series option manual inserts may result in increased emissions or decreased immunity of the X Series Perform functional test of internal paddles prior to use Do not use or place the unit in service if the Ready For Use indicator at the upper right of the front panel displays a red circle with a line through it Carefully route patient cables to avoid tripping over them or inadvertently pulling the unit onto the patient Always inspect the unit for damage if it has been dropped Only authorized personnel should use the Supervisor menus If uncertain about the accuracy of any measurement first check the patient s vital signs by alternate means and then make sure the monitor is functioning correctly ECG Monitoring Implanted pacemakers might cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or other arrhythmias Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes Check the patient s pulse do not rely solely on heart rate meters Patient history and physical examination are important factors in determining the presence of an implanted pacemaker Pacemaker patients should be carefully observed See Pacemaker Pulse Rejection on page A 15 o
195. hed following any incident that involves patient monitoring It ensures maximum operating time for each use without reliance on spares The need for a spare can then serve as an alert when an aging battery fails to provide normal operating time Keep discharged batteries separated from spare batteries that are charged When removing a discharged battery from the monitor never place it in the location intended to carry a charged spare Caution DO NOT leave X Series battery packs in a depleted state Damage to the battery packs can occur if they are left in a depleted state for more than 30 days 9650 001355 01 Rev B X Series Operator s Guide 24 7 CHAPTER 24 MAINTENANCE Cleaning instructions Cleaning the X Series unit To clean the X Series unit use a nearly dry cloth containing one of the mild cleaning agents listed below DO NOT allow cleaning agent or water to run into the crevices or connector openings at any time Thoroughly wipe off any excess cleaning solution from the X Series unit with a dry cloth Always check monitor and connector opening for unusual wear damage or dampness while cleaning Use only these recommended cleaning agents e Warm water e Hydrogen peroxide solution e Liquid soap e Wex cide Windex T B Q Never use these cleaning agents e Butyl alcohol e Denatured ethanol e Freon e Mild chlorine bleach solution e Isopropyl alcohol e Trichloroethane trichloroethylene e Acetone e
196. her the final shock or no shock rhythm decision is made and a third segment is not processed ECG rhythm analysis does not warn of patient asystole which is not a shockable rhythm When a nonshockable rhythm is detected the unit displays a NO SHOCK ADVISED message Follow the local protocols to continue CPR or other life support and re analyze the ECG at appropriate intervals www zoll com 9650 001355 01 Rev B Advisory Defibrillation Procedure Note When a nonshockable rhythm is detected the X Series does not prevent the user from manually defibrillating the patient process Press Analyze to resume the analysis process When a shockable rhythm is detected ventricular fibrillation or wide complex tachycardia with heart rate gt 150 the unit will display the SHOCK ADVISED message Press the CHARGE button and press the Select Energy arrows up or down to select the desired energy level if needed Press CHARGE again to confirm Regardless of the analysis result the user can control the defibrillator manually For example the user can defibrillate the patient even if the advisory function issues a NO SHOCK ADVISED message 3 Press SHOCK button WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body
197. hol pad e Rub site briskly to dry www zoll com 9650 001355 01 Rev B 12 Lead ECG Monitoring Setup Applying Electrodes to the Patient Depending on local usage ECG lead wires are marked with certain labels Refer to the following table for labels and color codes for the different lead sets Right Arm RA white Left Arm LA black Right Leg RL green Left Leg LL red Chest V1 l American Heart Association 2 International Electrotechnical Commission Patients should be in a resting supine position when performing 12 Lead ECG monitoring ZOLL Medical Corporation recommends placing the limb electrodes anywhere along the ankles and wrists When it is difficult for the patient to remain motionless due to shivering muscle tremors or transport vehicle movement place limb electrodes on the patient s thorax for better results Refer to the following two diagrams for limb electrode placement RL LL 9650 001355 01 Rev B X Series Operators Guide 14 5 CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS LA L O O O S ka RL N LL F Avoid placing electrodes over tendons and major muscle masses Make sure that the ECG electrodes are placed to allow defibrillation if necessary Place the precordial electrodes across the chest in the following locations Electrode Placement Fourth intercostal space at the patient s right sternal margin Fourth intercostal space at th
198. i fi 5 M P r s ae ry i i Min M A rhe j alt AA pa pes ane sy Fafa Y me e fs M Mia P ran a E ERa j a Fia 7 x ape B i T oaf a l y il l ere d E E ar ri il we A af i aT ae J la ae ye T A apy Wal ve a f 1 f EN po a igh I J A i i A F il i ere vl E L t i F n Y 1 i r s i a f i I h 1 i R EEE T l1 1 LT l I i i l i A a age ad imame ee ee PR f pe Y ASO mr _ he my La anal iita W lae 1 ka 7 aoa heres bait Y aai ht yea SET 1 1 i i iT i i VW il i p L r i l 7 24 7 36 we zM Copyrigh Miossochaseiis Ineiuie of Techoelogy 3011 All nights reserved 12 5 mmeg 5 mnim Y 9650 001355 01 Rev B ZOLL X Series Operator s Guide 20 5 CHAPTER 20 SEE THRU CPR OPTIONAL The following figure shows a patient with an organized rhythm where See Thru CPR effectively filters out artifact created by CPR SinusRhythm Raw ECG Aaram i Filtered ECG me a MANM JANE CPR 4 74 SinusRhythm i A K fi A iy pl DA al WO f kf Arial F Raw ECG N F K f G J J Kf f aa t W f i Filter ON us F es Filtered ECG ii I CPRI NX VAI WN 4 36 Copyrigh Missschusens insinte of Technology 2001 AD nights reserved 20 6 ON fe a fn E A Aani www zoll com i i mo A Aeaee eaa N Raw ECG j We nd na fod f Filtered ECG CPR m mili ailiiemenins 4 3
199. ibrillator will disarm itself 04 17 11 08 30 29 Adult SHOCK ADVISED 13 6 www zoll com 9650 001355 01 Rev B AED Operation 3 Press SHOCK WARNING Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge Do not touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come in contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Press and hold the illuminated SHOCK button on the front panel until energy is delivered to the patient Observe the patient or ECG response to verify that the shock has been delivered The delivered energy level and the shock number 1 are displayed in the panel at the bottom of the screen 04 17 36 08 31 24 Adult Perform CPR Begin chest compressions and rescue breathing per local protocol as prompted by the unit Note If ZOLL OneStep CPR pads OneStep Complete pads or CPR D padz are connected the unit monitors the rate and depth of chest compressions and can display PUSH HARDER and GOOD COMPRESSIONS messages and voice prompts Repeat Analysis After performing CPR for the configured period of CPR the unit will restart ECG analysis automatically Note Reanalysis of the ECG rhythm is inhibited for 3 seconds after a shock Stop CPR After performing CPR for the configured pe
200. ic group ventricular fibrillation flutter n 76 ventricular tachycardia n 10 There were no adverse events or injuries related to the study The first shock first induction efficacy of biphasic shocks at 120 J was 99 versus 93 for monophasic shocks at 200 J p 0 0517 95 confidence interval of the difference of 2 7 to 16 5 and 90 confidence interval of the difference of 1 01 to 15 3 Monophasic Biphasic First shock efficacy 93 99 p value 0 0517 95 confidence interval 2 to 16 5 90 confidence interval 1 01 to 15 8 1 Kerber RE et al Automated External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety Circ J Am Heart Assoc 1997 95 1677 1682 the task force suggests that to demonstrate superiority of an alternative waveform over standard waveforms the upper boundary of the 90 confidence interval of the difference between standard and alternative waveforms must be lt 0 ie alternative is greater than standard 9650 001355 01 Rev B X Series Operator s Guide A 25 Specifications Successful defibrillation with rectilinear biphasic shocks was achieved with 58 less delivered current than with monophasic shocks 14 1 amperes versus 33 7 amperes p 0 0001 The difference in efficacy between the rectilinear biphasic and
201. ies device includes the display screen quick access keys battery and auxiliary power indicators Ready For Use RFU indicator and the defibrillation front panel buttons Pacer Analyze Energy Select Charge and Shock Q See Figure 2 1 Refer to Table 2 2 on page 2 3 for information about the controls and indicators Visual Alarm Indicators T aa Power button n Display screen RFU indicator Silence reset Display Seven quick Navigation keys access keys 9 y Snapshot NIBP SELECT Auxiliary power LED m E Shock Battery charge LED Charge Pacer Energy Select Analyze Figure 2 1 X Series Front Panel 2 2 www zoll com 9650 001355 01 Rev B Defibrillator Controls and Indicators Table 2 2 X Series Controls and Indicators 9650 001355 01 Control or Indicator Description Display screen Quick access keys Auxiliary power LED Shows therapeutic settings physiological waveforms and other information for each monitored parameter messages time and quick access key labels Seven buttons control different functions of the unit Labels for the quick access keys appear on the monitor display to the right of each key Illuminated when the unit is plugged in to an auxiliary power adapter Battery charge LED Indicates battery status Steady yellow Battery is charging Steady green Battery is charged Alternating green and yellow The charge state cannot be determined or a
202. ies unit has three invasive pressure channels P1 P2 and P3 You can use these channels to measure arterial venous or intracranial pressures using invasive transducers with SuV V mmHg sensitivity Each channel requires its own connector cabling and pressure transducer Invasive Pressure Transducers The X Series unit is compatible with many types of invasive pressure transducers including non disposable disposable dome and fully disposable transducers See Appendix B Accessories for a list of compatible transducers Do not use light sensitive disposable transducers Use the invasive pressure transducers according to your organization s established clinical protocol and follow the manufacturer s recommendations Always refer the manufacturer s Directions for Use before using a transducer 9650 001355 01 Rev B X Series Operator s Guide 11 1 CHAPTER 11 MONITORING INVASIVE PRESSURES IBP Warning IBP Setup If electrocautery is used always avoid using any transducer with a conductive metal case connected to its ground shield Using a conductive transducer case that is connected to its cable shield risks high frequency burns at the ECG electrodes if the transducer case becomes grounded to earth Normal alarm functions will detect complete disconnections of invasive pressure transducers however the alarm functions will not detect a partial disconnection or the use of some incompatible transducers Use only approved trans
203. ill not display run time for that battery For best performance of the battery you should recalibrate the battery as soon as possible To manually recalibrate the SurePower II Battery Pack you can insert the battery into the SurePower Charger Station and perform a Manual Test for more information see the ZOLL SurePower Charger Station Operator s Guide After you recalibrate the battery the Recalibration LED will only flash when you press the Display button 9650 001355 01 Rev B X Series Operator s Guide 1 13 CHAPTER 1 GENERAL INFORMATION Ready For Use RFU Indicator The X Series has an RFU indicator on the front panel that indicates if the device is ready for use The RFU indicator has three states which are described in the following table Ready for Use m 4 Description The device is ready for use Patient monitoring defibrillation and pacing parameters are functional and the battery is above the low battery capacity Note If the device is plugged into the auxiliary power adapter the Ready for Use indicator may display even if the battery is depleted Check the status of the battery before removing the device from the auxiliary power adapter None required One or more of the following has occurred e The battery is not properly installed A low battery is installed A battery fault has occurred There is no battery installed while connected to auxiliary power One or more patient monitoring p
204. image and the MRI unit might interfere with the accuracy of oximetry measurements Carefully arrange patient cabling to reduce the possibility of patient entanglement or strangulation Inaccurate measurements may be caused by venous pulsations The pulse oximeter can be used during defibrillation but the readings may be inaccurate for a short time Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis Severe anemia may cause erroneous SpO2 readings If using pulse CO oximetry during full body irradiation keep the sensor out of the irradiation field If the sensor is exposed to the irradiation the reading might be inaccurate or the unit might read zero for the duration of the active irradiation period Elevated levels of Total Bilirubin may lead to inaccurate SpO2 SpMet SpCO measurements Very low arterial Oxygen Saturation SpO2 levels may cause inaccurate SpCO and SpMet measurements Loss of pulse signal can occur when The sensor is too tight The patient has hypotension severe vasoconstriction severe anemia or hypothermia There is arterial occlusion proximal to the sensor The patient is in cardiac arrest or is in shock The pulsations from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse
205. in the scope of one or more of the patents relating to this device www zoll com 9650 001355 01 Rev B Service Service The X Series only requires recalibration of the CO module Service is required after 20 000 hours of use of the CO module Appropriately trained and qualified personnel should however perform periodic tests of the defibrillator functionality to verify proper operation If a unit requires service contact the ZOLL Technical Service Department For customers In the U S A For customers outside the U S A Telephone 1 800 348 9011 1 978 421 9655 Fax 1 978 421 0010 Call the nearest authorized ZOLL Medical Corporation representative To locate an authorized service center contact the International Sales Department at ZOLL Medical Corporation 269 Mill Road Chelmsford MA 01824 4105 Telephone 1 978 421 9655 When requesting service please provide the following information to the service representative e Unit serial number e Description of the problem e Department using the equipment and name of the person to contact e Purchase order to allow tracking of loan equipment e Purchase order for a unit with an expired warranty e Sample ECG or other stripcharts demonstrating the problem if available and applicable less any confidential patient information Returning a unit for service Before sending a unit to the ZOLL Technical Service Department for repair obtain a service request
206. ine isolation monitors may cause interference on the ECG display and may inhibit heart rate alarms Monitoring ECG through the paddles may result in inaccurate heart rate display due to artifact Defibrillation The ZOLL X Series can deliver 200 joules of electrical energy If this electrical energy is not discharged properly as described in the this manual the electrical energy could cause personal injury or death to the operator or bystander To avoid possible damage to the X Series unit turn off pacing before defibrillating the patient with a second defibrillator After a synchronized cardioversion the SYNC mode may be cleared after each shock or disarm The user may have to reselect press the SYNC button after each synchronized cardioversion shock performed on a patient In Defib Pacer Default settings in the Supervisor Setup menu the X Series can be configured to remain in the SYNC mode after each synchronized cardioversion Synchronized cardioversion can be performed in the paddle monitoring mode However it is possible that artifact can be produced by the moving paddles which could cause the defibrillator to trigger on the artifact It is recommended that monitoring in leads I II or III be used during synchronized cardioversion Paddle monitoring should not be used for elective cardioversions procedures To avoid stress to the defibrillator or the tester never attempt to repeatedly charge and discharge the defibrillator in ra
207. ines If using the CO Monitor for extended critical care replace the airway adapter every 24 hours or when it becomes occluded CO readings and respiratory rate can be affected by sensor application errors certain ambient environmental conditions and certain patient conditions Respiration Do not operate the X Series with any other monitor with respiration measurements on the same patient The two devices could affect the respiration accuracy The device should not be used as an apnea monitor Ferromagnetic Equipment Biomedical equipment and accessories such as ECG electrodes cables and oximeter probes contain ferromagnetic materials Ferromagnetic equipment must not be used in the presence of high magnetic fields created by magnetic resonance imaging MRI equipment The large magnetic fields generated by an MRI device can attract ferromagnetic equipment with an extremely violent force which could cause serious personal injury or death to persons between the equipment and the MRI device Battery Although the device can operate with auxiliary power alone ZOLL strongly recommends that you operate the unit with a battery installed at all times Operating the unit with a battery provides a backup in case of ac power shortage and results in faster charge time The battery can be automatically recharged while it is installed in the unit Keep a fully charged spare battery pack with the defibrillator at all times Test battery
208. ining a minimum distance between portable and mobile RF communications equipment transmitters and the X Series unit as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter meters Rated 150 kHz to 150 kHz to 80 MHz to 800 MHz to maximum 80 MHz 80 MHz in 800 MHz 2 5 GHz output outside ISM ISM bands power of bands transmitter W d 3 5 3 P d 12 3 P d 12 10 P d 23 10 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 Hz and 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note 4 These g
209. ioversion Hands free therapy electrodes may be used as an ECG source Signal quality will be equal to that of standard leads except immediately following a discharge when there may be more noise due to muscle tremors especially if an electrode is not in complete contact with the skin Attach hands free therapy electrodes according to instructions on the electrode packaging and as described in Therapy Electrode Application on page 15 6 Ensure that the therapy electrodes are making good contact with the patient s skin and are not covering any part of any other electrodes If paddles are being used for synchronized cardioversion refer to Emergency Defibrillation Procedure with Paddles on page 15 1 for preparing paddles applying paddles charging the defibrillator and delivering a shock Note however that synchronized discharge with paddles as an ECG source is discouraged since the artifact induced by moving the paddles may resemble an R wave and trigger defibrillator discharge at the wrong time Turn On Unit Press the green power switch located on the top of the unit The green yellow and red lights at the top of the unit flash on and off and the unit displays the message SELF TEST PASSED Press the Sync Key 15 12 Press the Syne quick access key on the front panel The system will now be in SYNC mode A sync marker S appears on the monitor above each detected R wave to indicate where discharge will occur A Sync indi
210. it Mesh the threads carefully so that the connector turns easily and then turn the connector in a clockwise direction until it is snug Attach a double lumen hose as follows Figure 8 1 Attaching a Dual Lumen Hose to the X Series Unit 9650 001355 01 Rev B X Series Operators Guide 8 5 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP Attach a single lumen hose as follows 1 Figure 8 2 Attaching Single Lumen Hose to the X Series Unit 8 6 www zoll com 9650 001355 01 Rev B Applying the Cuff to the Patient 2 Insert the plastic connectors on the NIBP hose into the cuff hose connector and twist the connectors until they lock The connectors are the same you can insert either of the plastic connectors into either of the cuff hose connectors in any order 4 E Applying the Cuff to the Patient To apply the cuff to the patient 1 Ensure the patient is sitting or lying down with the limb relaxed extended and placed on a smooth surface for support 2 Squeeze as much air from the cuff as possible before placing it on the patient 3 Place the cuff 2 to 5 cm above the elbow crease or 5 to 10 cm 1 9 to 3 9 in above the knee crease Warning Do not place the NIBP cuff on the same arm or leg as an SpO sensor Inflation of the cuff causes the SpO monitor to read incorrectly Also do not attach the cuff to a limb being used for IV infusion Cuff inflation might block the infusion causing harm to the pati
211. l not to trap any air pockets between the gel and skin 3 Ensure that hands free therapy electrodes are making good contact with the patient s skin and are not covering any part of any other ECG electrodes 4 Press the Lead quick access key and select I II or III to provide the largest amplitude QRS complex Note When the Pacer is on the lead selection is restricted to Leads I II or HI 5 Verify that R waves are being properly detected by confirming that a QRS tone occurs with each displayed R wave or by verifying that the X Series unit s heart rate display accurately reflects the patient s pulse rate 18 6 www zoll com 9650 001355 01 Rev B Pacing in Fixed Mode 3 Press Pacer button Press the Pacer button on the front panel of the unit The Pacer Settings window displays Mode Rate 60 Output 4 Set Mode Use the arrow keys to navigate to Mode press the Select button then use the arrow keys and Select button to set the Pacer Mode to Fixed The selected mode is displayed in the pacing window Note The initial pacing mode can be set in Defib Pacer Default settings in the Supervisor Setup menu 5 Set Pacer Rate Use the arrow keys to navigate to Rate press the Select button then use the arrow keys and the Select button to set the Pacer Rate to a value 10 20 ppm higher than the patient s intrinsic heart rate If no intrinsic rate exists use 100 ppm You can increase or decrease the pacer rate by a
212. lay Microstream EtCO sampling lines are designed for single patient use and are not to be reprocessed Do not attempt to clean disinfect sterilize or flush any part of the sampling line as this can cause damage to the monitor Dispose of sampling lines according to standard operating procedures or local regulations for the disposal of contaminated medical waste Before use carefully read the Microstream EtCO sampling line s Directions for Use CO Monitoring Setup and Use 9 2 Follow these steps to set up CO monitoring l Select the correct CO sampling line for the patient 2 Attach the sampling line to the unit s CO inlet port 3 Apply the Filterline airway adaptor or Smart CapnoLine Nasal or Nasal Oral cannula to the patient Check that the X Series unit is set up for the correct patient type Adult Pediatric or Neonate 5 Configure alarms if the current alarm settings are not appropriate and other CO features 6 Press the CO quick access key BD to initiate CO monitoring www zoll com 9650 001355 01 Rev B selecting the CO Sampling Line CO2 Monitoring Setup and Use To select the correct CO sampling line you must determine the following e Is the patient adult pediatric or neonate e Is the patient intubated ventilated or non intubated non ventilated You can use the following Oridion Microstream accessories for sidestream CO monitoring with the X Series unit Ta
213. le MFC if not already connected The message ATTACH PADS or CHECK PADS will be displayed and energy will not be delivered if the therapy electrodes are not making good contact with the patient The message SHORT DETECTED 1s displayed if a short circuit exists between the therapy electrodes Note Since analysis is only done using Pads as a lead even if an ECG cable is connected and Lead II is available the unit still displays a CHECK PADS message Therapy Electrode Application Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient 2 Roll the pad smoothly from the applied edge to the other being careful not to trap any air pockets between the gel and skin Note If it is not possible to place the BACK pad on the patient s back the pads should be placed in the standard apex sternum positions Effective defibrillation will result but pacing will usually be less effective 1 Turn on unit Press the green power switch located on the top of the unit The green yellow and red lights on the top of the unit flash on and off and then displays the message SELF TEST PASSED If no hands free therapy electrodes have been attached to the patient and connected to the X Series unit the ATTACH PADS message and voice prompt will be issued 9650 001355 01 Rev B X Series Operator s Guide 13 3 CHAPTER 13 AUTOMATED EXTERNA
214. lood Pressure Flexiport Cuffs Neonate 1 3 3 5 6 cm single tube w male luer connector box of 10 Neonate 2 4 2 7 1 cm single tube w male luer connector box of 10 Neonate 3 5 4 9 1 cm single tube w male luer connector box of 10 Neonate 4 6 9 11 7 cm single tube w male luer connector box of 10 Neonate 5 8 9 15 0 cm single tube w male luer connector box of 10 Neonatal Cuff Kit one each of sizes 1 5 single tube w male luer connector bag of 5 Welch Allyn REUSE 07 2MQ Cuff Infant 2 Tube Twist lock connector Welch Allyn REUSE 08 2MQ Cuff Small Child 2 Tube Twist lock connector Welch Allyn REUSE 09 2MQ Cuff Child 2 Tube Twist lock connector Welch Allyn REUSE 10 2MQ Cuff Small Adult 2 Tube Twist lock connector Welch Allyn REUSE 11 2MQ Cuff Adult 2 Tube Twist lock connector Welch Allyn REUSE 11L 2MQ Cuff Adult Long 2 Tube Twist lock connector Welch Allyn REUSE 12 2MQ Cuff Lg Adult 2 Tube Twist lock connector Welch Allyn REUSE 12L 2MQ Cuff Lg Adult Long 2 Tube Twist lock connector Welch Allyn REUSE 13 2MQ Cuff Thigh 2 Tube Twist lock connector SpO2 Accessories Rainbow R25 Single use sensor for patients gt 30 kg Rainbow R25 L Single use sensor for patients lt 3kg gt 30 kg Rainbow R20 Single use sensor for Pediatrics 10 50 kg Rainbow R20 L Single use sensor for Infants 3 10 kg Rainbow Patient Cable RC 4 4 Reusable Patient Cable Rainbow Patient Cable RC 12 12 Reusable Patient
215. lowest threshold is obtained when the position of the electrodes provides the most direct current pathway through the heart while avoiding large chest muscles Lower stimulation currents produce less skeletal muscle contraction and are better tolerated 9650 001355 01 Rev B X Series Operator s Guide 18 5 CHAPTER 18 EXTERNAL PACING Pacing in Fixed Mode If ECG electrodes are not available or there is some circumstance that prevents or interferes with the surface ECG the X Series delivers pacemaker pulses at a fixed rate Fixed pacing should be performed only in an emergency when no alternative is available 1 Turn On Unit Press the green power switch located on the top of the unit The green yellow and red lights at the top of the unit flash on and off and the unit displays the message SELF TEST PASSED 2 Apply ECG Electrodes Hands Free Therapy Electrodes Apply ECG electrodes attach lead wires and connect the ECG cable to the X Series side panel see Chapter 6 for instructions on attaching ECG electrodes to the patient Attach hands free therapy electrodes according to instructions on the electrode packaging Connect these therapy electrodes to the MFC Therapy Electrode Application WARNING Poor adherence and or air under the therapy electrodes can lead to the possibility of arcing and skin burns 1 Apply one edge of the pad securely to the patient 2 Roll the pad smoothly from the applied edge to the other being carefu
216. lowing formats e S D e S D M default display e M S D Note Ifa MAP alarm is active when the S D format is selected the display format will be S D M until you clear the MAP alarm 9650 001355 01 Rev B X Series Operator s Guide 8 13 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP NIBP System Messages 8 14 When monitoring NIBP the X Series unit may display the following messages System Message READING IN PROGRESS The unit is taking an NIBP measurement and functioning normally READING STOPPED The unit has stopped an NIBP measurement because the operator has pressed the NIBP button and cancelled the measurement READING FAILED The patient s pulse is too weak to obtain an NIBP measurement or the cuff requires adjustment ARTIFACT Excessive artifact is preventing the NIBP measurement If ECG is available consider turning SmartCuf on NEONATE ALERT The unit has detected a neonate cuff when in Adult mode Replace cuff or correct patient mode as appropriate If the detection is in error dismiss the alert and reattempt the NIBP measurement A major air leak is preventing cuff inflation Check hose and cuff connections replace a defective hose or cuff as necessary and reattempt NIBP measurement KINKED HOSE An air obstruction is preventing the correct operation of the unit Check hose for kinks If using a dual lumen hose verify the correct placement of the O
217. lt in inaccurate measurements Do not select an SpO sensor site on the same arm leg as an NIBP cuff Inflation of the cuff will cause the SpO values to read incorrectly www zoll com 9650 001355 01 Rev B Applying the SoO s Sensor Applying a Two Piece Single Use Sensor Cable When applying a single use SpO sensor be careful not to wrap the adhesive too tightly as this can cause venous pulsations that could lead to inaccurate saturation measurements 1 Remove plastic backing from the sensor and locate transparent windows on the adhesive side The transparent windows cover the optical components An index finger is the preferred sensor location Alternatively apply the sensor to a small thumb smaller finger or great toe Note When selecting a sensor site priority should be given to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line 2 Orient the sensor so the dashed line in the middle of the sensor is centered on the tip of the digit Wrap adhesive flaps on non cable end around the digit Note that the cable must be positioned on the top of the hand Detector Window 3 Fold cable end over top of digit so that windows are directly opposite each other Wrap adhesive securely around sides of digit Note Ifthe sensor does not track the pulse reliably it may be incorrectly positioned or the sensor site may be too thick thin or deeply pigmented or otherwise deeply colored
218. lysis result STOP CPR After performing CPR for the configured period the unit will issue a STOP CPR prompt while it restarts ECG analysis PUSH HARDER This message is announced when the chest compressions applied during CPR are not deep enough GOOD COMPRESSIONS This message is announced when the chest compressions applied during CPR are deep enough CHECK PADS This message is displayed and announced when the therapy pads have been disconnected from the patient CHECK PATIENT This message is displayed and announced when the unit is paused and detects a shockable rhythm during continuous background ECG analysis The prompt persists as long as a shockable rhythm is being detected Press the ANALYZE button to resume ECG analysis 9650 001355 01 Rev B X Series Operator s Guide 13 9 CHAPTER 13 AUTOMATED EXTERNAL DEFIBRILLATOR AED OPERATION Switching to Manual Mode Operation Press the Manual Mode quick access key on the front panel of the unit to enter the Manual mode of operation Using the navigation keys select the four digits in the Manual Mode pass code Press SAVE when you are finished Once you have entered your pass code you will be able to enter Manual mode Note Ifthe unit has not been configured to enter a pass code the message Exit to Manual Mode is displayed Use the navigation keys to select Yes to enter the Manual mode of operation If you do not press Yes within 10 seconds the unit will revert back
219. ment Snapshot button Rev B Records 24 seconds of numeric and waveform data X Series Operators Guide 2 3 CHAPTER 2 PRODUCT OVERVIEW Table 2 2 X Series Controls and Indicators continued Control or Indicator Description Navigation keys og A The up clockwise arrow will cause the cursor to travel in an upward direction if the cursor is being used to navigate through a vertical list or in a clockwise direction if the cursor is being used to navigate around the full screen Likewise the down counterclockwise arrow will cause the cursor to travel in a downward direction if the cursor is being used to navigate through a vertical list or in a counterclockwise direction if the cursor is being used to navigate around the full screen The up clockwise and down counterclockwise arrows may also be used to modify parameter settings e The Select button acts based on what is highlighted Display Home button Silence Reset button Cycles through three available display modes or functions as a Home button when in a menu Silences the current alarm tone for 90 seconds or resets a silenced alarm tone RFU indicator 4 Ready Do Not Use Power button Charge Indicator Light not shown Display Screen Shows the status of the unit based on its most recent readiness check A red circle with a line through it indicates that the unit s readiness has b
220. mplete then select and print it again Treatment Summary Report 21 2 The Treatment Summary Report is a report that shows all of the treatment events related to a patient such as defibrillation pacer events alarm events and treatment snapshots It is helpful to print out this report at the end of a case TREATMENT SUMARY REPORT Name Phillip Davies 06 06 14 New Case ID ID Patient 0015 Patient Mode Adult 06 06 14 System On Start Time 06 06 11 06 06 14 06 06 14 Patient Mode Adult Last Event 06 06 11 09 43 40 06 06 14 Some Alarm Limits Disabled Elapsed Time 00 29 48 Events 06 06 20 Self Test Passed Total Shocks 1 06 06 43 Treatment Snapshot ASA Total Pace Time 00 00 00 Total 12 Leads 0 Dept ICU Unit S N 0 SW 00 00 00 00 www zoll com 9650 001355 01 Rev B Transferring Data to a USB Device Printing Treatment Summary Report To print a treatment summary report do the following 1 Press the More quick access key icy 1 Press the Log quick access key 63 2 Press the Treatment Summary quick access key ED The Treatment Summary window displays 3 Use the navigation keys to highlight and select the treatment summary you want to print Note The Treatment Summary Report that you selected has a check mark next to it 4 Use the navigation keys to highlight and select Print Treatment Summary Transferring Data to a USB Device You can transfer patient data from the unit using a USB transfer
221. n the Patient Info panel then press the Select key Entering the Patient Name and ID When you select the Patient Last Name field or the Patient First Middle Name ID or Physician fields the screen displays an information entry panel Patient Last Name CD oo OG st BGG BEG oo8 806 OG SHB So ee Backspace oo oB oo 56 ae eo eo 8 G oo Cancel i lt m To enter a character into the parameter highlight the character then press Select The screen displays the selected character in the area below the parameter name To navigate through the information entry panel use the following keys e Use the Row Up quick access key E to move to the previous row on the panel e Use the Row Down quick access key E to move down one row on the panel Use the navigation keys on the front panel to highlight the next or previous character on the information entry panel You can also select the following function keys on the information entry panel Backspace Erases the last character entered Clear Erases all characters entered SAVE Saves the characters entered for that parameter and returns you to the Patient Info panel Cancel Returns you to the Patient Info panel without saving the characters 9650 001355 01 Rev B entered X Series Operators Guide 14 3 CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS Entering Patient Age and Gender The Patient Info parameter panel provides default values fo
222. nd Display Options The X Series unit provides additional 12 Lead print and display options that you can specify through the Supervisor parameter control panels access to Supervisor is passcode controlled Press the Setup quick access key E2 then select Supervisor Using the navigation keys select the four digits in the Supervisor passcode Press SAVE when you are finished Once you have entered your supervisor passcode you will be able to access the configurable options in the Supervisor menu Select the Supervisor gt ECG gt 12 Lead option to display the 12 Lead parameter control panel Print on 12 Lead Acquire Print 10s Ld Il 12 Ld Frequency Response Filtered Diagnostic Selecting 12 Lead Acquire When enabled the unit automatically prints the 12 Lead report when you press ER By default this feature is not enabled Specifying the Number of 12 Lead Print Copies This option allows you to specify that the X Series unit print up to five copies of the 12 lead waveform trace set after pressing amp l By default the unit prints only one 12 lead snapshot Specifying the 12 Lead Print Format This option allows you to specify the print format for the 12 lead waveform traces 3 x 4 the default or 2 x 6 Printing 10 Seconds of the Lead II Waveform Trace This option allows you to specify that the unit print 10 seconds of the Lead Il waveform trace after printing a 12 Lead snapshot 9650 001355 01 Rev B X Series
223. ng automatically restarts after 3 to 6 chest compressions Note There is a delay of approximately 1 16 second between the See Thru CPR waveform and the Trace 1 ECG waveform Examples The following examples show the effects of See Thru CPR filtering on ECG signals contaminated with CPR artifacts Each example includes e ECG signal with CPR artifact e ECG signal after the See Thru CPR filter has removed CPR artifact e Indication of the period during which See Thru CPR is active e CPR signal to show when CPR activity occurred 20 2 www zoll com 9650 001355 01 Rev B Using See Thru CPR The following figure shows a patient in Fine VF It is difficult for a rescuer to discern this rhythm during CPR compressions When the CPR filter turns on the Fine VF rhythm becomes more obvious FineVF i j m i l AA i j PE n a fi nl p i hs fi R tf ti E F C G f WJ Fal ra le dl y S y A i h n ra Lo Le fi 1 wh 2 d ry fl i ci R 4 P l A S ij i Ny Wy I Ei Fa 1i ry 4 24 FineVF 1 i J i il i p F l a 1 Raw ECG AM Wi A we iY A is r r ri apa A ra k hy hall Mei j i Ald y N Ie mar eel lank eae ee a ae real a Nay ye W T Ae frat va al i amd a Pi ee X _ M IiI IMIolMlMi8 5 Mli ML oe I 1 Pan a i Filter OFF ERD 5 Filter ON a wu A lit A Ap h
224. nge the selected energy e Press the power switch to turn the unit off For safety the X Series automatically disarms if left charged for more than 60 seconds if the shock button is not pressed Warnings General Federal U S A law restricts this defibrillator to sale by or on the order of a physician Only appropriately trained skilled personnel who are familiar with equipment operation should perform emergency defibrillation The prescribing physician should determine what training such as Advanced Cardiac Life Support ACLS or Basic Life Support BLS certification is appropriate Only skilled personnel trained in Advanced Cardiac Life Support ACLS and who are familiar with equipment operation should perform synchronized cardioversion The precise cardiac arrhythmia must be determined before attempting defibrillation These operating instructions describe the functions and proper operation of the X Series products They are not a substitute for a formal patient care training course Operators should obtain formal training from an appropriate authority before using this defibrillator for patient care Proper operation of the unit and correct electrode placement is critical to obtaining optimal results Operators must be thoroughly familiar with proper device operation The use of external pacing defibrillation electrodes accessories or adapter devices from sources other than ZOLL is not recommended ZOLL makes no represe
225. ngle short beep tone not Volume is 3 to 6 dBA below the Technical Alert repeated medium priority alert Audible alarms can be silenced or suspended More detailed information about how to silence and suspend audible alarms is included later in this chapter Alarm Indicator Self Test The X Series unit performs a self test of the audio and visual alarm indicators upon power up To ensure that the alarms and alerts are functioning properly verify that two alarm tones are heard and the green yellow and red LEDs are illuminated upon power up 5 2 www zoll com 9650 001355 01 Rev B Patient Alarm Display Patient Alarm Display When a patient s vital signs measurements trigger an alarm in addition to sounding the patient alarm the X Series unit displays an alarm message and changes the display characteristics of the monitoring function s numeric display the alarming parameter appears in red against a white background In the following example the EtCO measurement 22 mmHg has dropped below the lower alarm limit EtCO2 Low Alarm 06 06 2011 12 34 56 Adult GED FcoztowAlm SSSC S Mi 00 17 43 9650 001355 01 Rev B X Series Operators Guide 5 3 CHAPTER 5 ALARMS Lite Threatening Rhythm Alarms When LTA monitoring is enabled the X Series will monitor for the following life threatening ECG rhythms asystole ventricular fibrillation ventricular tachycardia extreme bradycardia and extreme tachycardia D
226. nly Reusable Newborn 6 and Infant 7 cuffs use the Adult Hose Selection of the correct cuff is critical to the accuracy of NIBP measurements Using a cuff that is too small results in measurements higher than the patient s actual blood pressure Using a cuff that is too large results in measurements lower than the patient s actual blood pressure The X Series unit uses the same definitions of Neonates Pediatrics and Adults as defined in the AAMI SP10 2002 standard Neonate or Newborn Children 28 days or less of age if born at term 37 weeks gestation or more otherwise up to 44 gestational weeks Pediatric or Child Individuals between 29 days and 12 years of age other than newborn Adult Individuals greater than 12 years of age www zoll com 9650 001355 01 Rev B Connecting the NIBP Cuff Connecting the NIBP Cuff Connecting the NIBP cuff requires you to attach the inflation hose to the X Series unit and the NIBP cuff To use the SureBP feature which enables the X Series unit to measure blood pressure on cuff inflation you must use the FlexiPort cuff and dual lumen two tube adaptor and hose You can also use a single lumen one tube hose and adaptor with the X Series unit but the unit will only measure blood pressure on cuff deflation To connect the NIBP cuff to the X Series unit 1 Attach the inflation hose s threaded metal connector to the NIBP connector on the side panel of the X Series un
227. nscutaneous Pacing This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation The purposes of pacing include Resuscitation from standstill or bradycardia of any etiology Noninvasive pacing has been used for resuscitation from cardiac standstill reflex vagal standstill drug induced standstill due to procainamide quinidine digitalis b blockers verapamil etc and unexpected circulatory arrest due to anesthesia surgery angiography and other therapeutic or diagnostic procedures It has also been used for temporary acceleration of bradycardia in Stokes Adams disease and sick sinus syndrome It is safer more reliable and more rapidly applied in an emergency than endocardial or other temporary electrodes As a standby when standstill or bradycardia might be expected Noninvasive pacing can be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction drug toxicity anesthesia or surgery It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy In standby pacing applications noninvasive pacing might provide an alternative to transvenous therapy that avoids the risks of displacement infection hemorrhage embolization perforation phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrill
228. nt View Configure Paired Devices View Distribution List and Update Distribution List Use the navigation keys to navigate the menu items press the back arrow L to exit the wireless menu 11 30 2011 13 50 15 Adult GE Pads Paddles Imp Not Calibrated L IES 12 NIBP mmHg a Wireless Hostname ZOLL AIO9LOO0109 WiFi Connected Bluetooth Not Connected Resp min Cellular Not Connected iFi i R Off WiFi Access Point esp View Configure Paired Devices View Distribution List Update Distribution List Wireless Icons Connected Not Connected Failed Disabled T i no icon selecting and Creating a Temporary Access Point Profile In the wireless menu use the navigation keys to highlight and select WiFi Access Point You can now view preconfigured Access Point Profiles 11 30 2011 13 57 15 Adult i Pads Paddles Imp Not Calibrated a E IBP NIBP mmHg a Wireless gt Select Access Point Profile Selected Access Point Ambulance01 Configured Access Point Profiles Resp imin Resp Off Temporary Access Point Profile L empora Profile Edit Use the navigation keys to highlight and select Temporary Profile A green check mark appears to show that the profile has been selected 9650 001355 01 Rev B X Series Operator s Guide 22 3 CHAPTER 22 WIRELESS COMMUNICATIONS To edit the profile use the navigation keys to highlight and select Edit The unit displays the Edit AP Profile menu 11 30 2
229. nt Type A Temperature Limit Default 4 Temperature Limit Range Lower 0 0 F 0 0 C Lower 0 0 89 8 F 0 0 32 1 C Upper 5 0 F 15 C Upper 0 2 90 0 F 17 7 32 2 C Lower 0 0 F 0 0 C Lower 0 0 89 8 F 0 0 32 1 C Upper 5 0 F 15 C Upper 0 2 90 0 F 17 7 32 2 C Lower 0 0 F 0 0 C Lower 0 0 89 8 F 0 0 32 1 C Upper 5 0 F 15 C Upper 0 2 90 0 F 17 7 32 2 C Selecting the Temperature Label Through the Temp Parameter Control Panel you can configure alarms as described previously and select descriptive Temperature channel labels that will appear on the numeric display and on the trend report Lower T1 Alarm 90 IIN T2 Alarm 85 AT Alarm T1 Source Label T2 Source Label Figure 12 2 Temp Parameter Control Panel You can select one of the following labels for each temperature channel 12 4 www zoll com 9650 001355 01 Rev B Source Label Description Temperature System Messages Arterial temperature probe Central body temperature or tympanic membrane temperature probe Esophageal temperature probe Rectal temperature probe Skin temperature probe Surface application Ventilator airway temperature probe Nasopharynx or nasal oral temperature probe If you don t select a label the Temperature channels appear with the default labels of T1 and 2 Temperature System Messages The X
230. nt during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come in contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Press and hold the illuminated SHOCK button on the front panel until energy is delivered to the patient The delivered energy level is displayed at the bottom of the screen and the shock number 1 displays at the top of the screen and in the Defib Control panel at the bottom of the screen The unit then leads you through a CPR interval and then restarts ECG analysis automatically The Advisory CPR Protocol mode repeats the Analysis and CPR intervals as long as Advisory CPR Protocol is active You can press the Exit quick access key at any time to return to Manual mode 9650 001355 01 Rev B X Series Operator s Guide 17 5 CHAPTER 17 ADVISORY CPR PROTOCOL DEFIBRILLATION 17 6 www zoll com 9650 001355 01 Rev B WARNING Chapter 18 External Pacing J When ZOLL hands free therapy electrodes are used the patient connection is considered to be defibrillation protected Type BF 4 g L ECG leads are a defibrillation protected Type CF patient connection Pacing is intended for use on adult patients and on adolescent child and infant pediatric patients To avoid risk of electrical shock do not touch the gelled area of the hands free therapy electrodes while pacing Therapy electrodes should be r
231. ntae tears 17 5 Chapter 18 External Pacing viii External NC niasa a G a a 18 2 Facer Modes eaor S E ee ee eee ee eee 18 2 Pacino lit Demand ModE usuan E E dante leans 18 2 Determine Patient Condition and Provide Care Following Local Medical Protocols 18 2 Prepare the Patient sxcccssectel pares tabi eeren a E aa 18 2 TTU COT AN a a a n 18 2 2 Apply ECG Electrodes Hands Free Therapy Electrodes ccccseeeeeeeeeeeeeeeeeeees 18 3 Z PrESS FACON DURON sirra a E R A E EA TER 18 3 SS POS e E E A 18 4 OCP CCM Qe irria a teetaia se aeateaieetets 18 4 6 PUI OMGP ACO usean aen N 18 4 TSCM PaACen O UIOUL sya ccna arcana i hse neh eae a palette a ius Nasa 18 4 6 DELenMIne Gale a vigeiccre ec etieintned epenate a a 18 4 9 Determine OptiMUM Threshold c cccccccccssseceeseeeeeesceeseeeeeeeeeceeseeeeeeeeseaeeeeesaanes 18 5 FACING WM FIXE MOOG uiine ane a une a a 18 6 1 TU ONUDI E ee a bees wane dacsaxcendoeece ceasewaasseectde 18 6 2 Apply ECG Electrodes Hands Free Therapy Electrodes cccceeeeeeeeeeeeeeeeeeees 18 6 I Press PacenDURON siriene E a a eN 18 7 A ELMO gt Ree eo re ee a a ee ee eee 18 7 DOU PACE N URNS aera tate cata rannte cance tsetse end tee ele sert cena T awit aia 18 7 6 RGR ORTP ACO siamea tee ieee E eae eee 18 7 TSC PaACel OUIOUE veseactecsanecceintone ast a 18 7 S Determine Capire oare citi ciebacee tastes teach at ieee ion h eieaed tee Gcntawist 18 8 9 Determine OptiMUM Threshold ccc
232. ntations or warranties regarding the performance or effectiveness of its products when used with pacing defibrillation electrodes or adapter devices from other sources Defibrillator failures attributable to the use of pacing defibrillation electrodes or adapters not manufactured by ZOLL might void ZOLL s warranty At receipt of shipment check pacing defibrillation electrodes to ensure compatibility Allow ample slack in cables to make sure that cables do not tug at electrodes Do not disassemble the unit A shock hazard exists Refer all problems to authorized service personnel Follow all recommended maintenance instructions If a problem occurs obtain service immediately Do not use the defibrillator until it has been inspected by appropriate personnel 9650 001355 01 Rev B X Series Operators Guide 1 15 CHAPTER 1 GENERAL INFORMATION The X Series unit might not perform to specifications when stored at the upper or lower extreme limits of storage temperature and then immediately put into use The X Series unit should not be stored or used outside of the environmental limits provided in Appendix A of this manual Avoid using the X Series adjacent to or stacked on other equipment If unavoidable verify that the unit operates normally in this configuration before clinical use The X Series unit should be installed and put into service according to the EMC information in Appendix A of this manual Do not use internal paddles while t
233. o 40 Hz Monitor Mode 0 25 to 40 Hz Filtered Diagnostic Mode 0 05 to 150 Hz Diagnostic mode Per methods a b and c of EC11 3 2 7 2 Automatically sets chart recorder response Common Mode Rejection Complies with AAMI EC13 2002 section 4 2 9 10 Tall T Wave Rejection Meets AAMI EC13 2002 section 4 1 2 1c for 0 9 mV T wave 0 8 mV with diagnostic response and ImV QRS Diagnostic Signals Applied to Patient Connections Leads off active noise suppression sensing circuit is lt 0 1 microamps DC The impedance respiration detector signal frequency is 72 7 kHz at 77 microamps RMS pseudo sinewave into 100 ohms Heart Rate Range 30 to 300 BPM Displayed Heart Rate Average of last 5 beat to beat intervals Heart Rate Alarms User selectable Size 0 125 0 25 0 5 1 2 4 cm mv and auto ranging Heart Rate Meter Response Time Responds to a 40 BPM step increase in heart rate within 4 5 seconds per AAMI EC 13 2002 section 4 1 2 1 f Responds to a 40 BPM step decrease within 3 9 seconds per AAMI EC 13 2002 section 4 1 2 1 f Response times include a 1 0 second display update interval www zoll com 9650 001355 01 Rev B Impedance Pneumography Heart Rate Response to Irregular Rhythm AAMI EC13 2002 section 4 1 2 1 e Ventricular Bigeminy 80 BPM expected Slow Alternating Ventricular Bigeminy 60 BPM expected Rapid Alternating Ventricular Bigeminy 120 BPM expected Bidirectional Systole 45 BPM expected Tachycardia Re
234. o a maximum of 50 joules For step by step procedures for open chest defibrillation as well as important cleaning and sterilization information regarding the autoclavable electrodes refer to the Autoclavable Internal Handle and Electrode Operator s Guide 9650 001355 01 Rev B X Series Operators Guide 15 9 MANUAL DEFIBRILLATION Verification Prior to Use Warning 15 10 Before each use with the X Series verify the proper operation of the ZOLL internal paddles using the following procedure This procedure requires a second person if you are using internal handles without a Discharge button When performing internal paddle verification keep hands away from the electrode plates while pressing the SHOCK button 1 Inspect the connector contact sockets for damage or corrosion If you observe damage or corrosion in the connector contact sockets remove the handle set from use 2 Connect the Autoclavable Internal Handles to the X Series unit Use the Lead quick access key Pe to verify that the X Series unit correctly identifies the Internal Handle and Electrode set by displaying Int Pdls 3 Before charging the defibrillator press the Discharge button on the handle set if present and verify that there is an audible click and that the button springs back upon release Verify that the defibrillator window displays the message APPLY PADDLES TO PATIENT This message verifies that the Discharge button located on the right handle is
235. o monitor End Tidal Carbon Dioxide EtCO breath rate and Fractional Inspired Carbon Dioxide FiCO These options use the same connector on the X Series unit and may be used interchangeably Overview The X Series unit uses the Oridion Microstream FilterLine and Smart CapnoLine sidestream systems to monitor CO3 The FilterLine and Smart CapnoLine sidestream systems draw small samples of gas from the patient s airway via a nasal oral cannula or airway adapter and pass these gases through a solid state infrared sensor located away from the patient s airway that measures CO The Microstream system can be used for CO measurements on intubated and non intubated infant pediatric and adult patients The Microstream CO sensor generates infrared light and beams it through the sampled breathing gases and determines CO concentration by measuring the amount of light absorbed by gases The X Series unit displays EtCO the concentration of carbon dioxide detected at the end of each exhalation and FiCO as a numerical value in millimeters of mercury mmHg In addition the unit can display a capnogram The capnogram is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal ET tube placement The unit calculates respiration rate by measuring the time interval between detected peaks of the CO waveform The technology differentiates between waveforms caused by breathing and those caus
236. o toggle through the brightness options until you find your selection Note Selecting a higher brightness setting such as 70 will deplete the battery pack at a faster rate than when choosing a lower brightness setting such as 30 To select the brightness setting go to the Setup gt Display Volume gt Display Brightness menu to adjust the display percentage Replacing a Battery Pack on the X Series 2 16 This section describes how to replace a battery pack on the X Series Replacing a Battery Pack on the X Series To remove a battery pack use your fingers to grasp and raise the latch and pull the battery pack out of the compartment Figure 2 12 Removing a Battery Pack To install a battery pack 1 Line up the battery so it will slide into the battery well 2 Push the battery into place Figure 2 13 Installing a Battery Pack www zoll com 9650 001355 01 Rev B Common Tasks Using Treatment Buttons Pressing the Treatment quick access key Ee causes the unit to display preconfigured buttons that contain clinical actions These buttons allow you to add a treatment snapshot which itemizes drugs or treatments administered to the patient to a Treatment Summary Report You can do this by selecting Print on Treatment Snapshot from Setup gt Supervisor gt Printer The following 1s a list of preconfigured treatment buttons e 02 e ASA e Nitro e Morph e IV e B Block e Lido e MgS04 e Valium e Sedate Cust
237. occlusion If the CO module cannot clear the occlusion within 30 seconds the X Series unit issues an equipment alert and displays the message FILTERLINE OCCLUSION At this point if the current FilterLine is correctly attached replace the FilterLine VALUE OVER RANGE The COs value exceeds the specified range CO2 DISABLED An error has occurred with the CO module and the X Series unit has disabled the module for the duration of the unit s power cycle If the problem persists the unit may require servicing 9650 001355 01 Rev B X Series Operator s Guide 9 11 CHAPTER 9 MONITORING CO2 Patents The capnography component of the X Series unit is covered by one or more of the following US patents 6 428 483 6 997 880 5 3000 859 6 437 316 7 488 229 and their foreign equivalents Additional patent applications pending NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to the device with unauthorized consumable CO sampling consumable products which would alone or in combination with this device fall within the scope of one or more of the patents relating to this device and or CO sampling consumable products 9 12 www zoll com 9650 001355 01 Rev B Chapter 10 Pulse CO Oximetry SpO SPCO and SpMet The X Series SpO input is Type CF defibrillator proof This chapter describes how to use the X Series unit to monitor Pulse CO Oximetry SpO3 as
238. ode is set to pediatric Use of adult electrodes or adult mode with pediatric patients can result in the delivery of excessive energy doses If medical protocols allow you may select a different energy level using the energy select up and down arrow buttons on the front panel The new energy setting displays on the monitor 9650 001355 01 Rev B X Series Operator s Guide 16 3 CHAPTER 16 ADVISORY DEFIBRILLATION 2 Press ANALYZE Button WARNING WARNING 16 4 Keep patient motionless during ECG analysis Do not touch the patient during analysis Cease all movement via stretcher or vehicle before analyzing the ECG Press the ANALYZE button to begin the analysis of the patient s ECG rhythm and to determine if a shockable rhythm is present An ANALYZING message is displayed at the top of the screen for 6 to 12 seconds while the patient s ECG is analyzed Once the analysis is completed the unit indicates whether or not a shock is advised 12 34 56 F 00 17 43 This analysis normally consists of up to three consecutive 3 second ECG rhythm analyses If at least two of the three analyses determine that the patient has a shockable rhythm the unit automatically prompts the operator to shock the patient at the preconfigured energy level If two or more of the three 3 second ECG analyses do not detect a shockable rhythm the unit alerts the operator that no shock is advised If the first two segments are in agreement with each ot
239. oidable skeletal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours Erythema or hyperemia of the skin under the hands free therapy electrodes often occurs this effect is usually enhanced along the perimeter of the electrode This reddening should lessen substantially within 72 hours There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen The pacing rate determination can be adversely affected by artifact If the patient s pulse and the heart rate display are significantly different external pacing pulses may not be delivered when required Artifact and ECG noise can make R wave detection unreliable affecting the HR meter and the demand mode pacing rate Always observe the patient closely during pacing operations Consider using asynchronous pacing mode if a reliable ECG trace is unobtainable Transcutaneous pacing should not be used to treat V FIB ventricular fibrillation In cases of V FIB immediate defibrillation is advised www zoll com 9650 001355 01 Rev B Warning CPR Warnings Transcutaneous
240. omizing Treatment Buttons You can also customize up to 9 treatment buttons by pressing the Setup quick access key Ed and then selecting Supervisor gt Log gt Treatment Options Highlight Define Custom Labels and then can customize up to 9 buttons 9650 001355 01 Rev B X Series Operator s Guide 2 17 CHAPTER 2 PRODUCT OVERVIEW 2 18 www zoll com 9650 001355 01 Rev B Chapter 3 Monitoring Overview This chapter provides an overview of the X Series unit s monitoring functions It describes the types of vital sign monitoring that X Series provides and the flexibility that the X Series unit gives you in displaying a patient s vital signs information X Series Monitoring Functions The X Series unit provides an array of standard and optional monitoring functions and allows you to view the vital signs measurements that these functions provide in a variety of formats The X Series unit also allows you to set alarm limits for each monitoring function Should a patient s vital signs measurements go outside of these limits the X Series issues an audible alarm tone and displays visual alarm indications to alert you If the X Series unit is powered off for less than 2 minutes all patient monitoring parameter settings are retained If the X Series unit is powered off for 2 minutes or longer the unit operates as if there is a New Patient and all patient specific parameters alarm limits defibrillator energy etc are reset to their defa
241. ondition all measurements on Analysis Page 2 appear as N A Once you have corrected the fault condition press to confirm the correction and perform the 12 Lead Interpretive Analysis 9650 001355 01 Rev B X Series Operators Guide 14 11 CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS Printing 12 Lead Waveform Traces Once you have determined that the X Series unit is correctly setup for 12 Lead ECG monitoring you can print the 12 Lead ECG traces for review and analysis Press to collect 10 seconds of 12 Lead data for print Press the Print quick access key 6 to print a 12 lead snapshot which begins with a header that gives the date time and patient information followed by 3 3 second samples of all twelve waveform traces The waveform traces print in either a 3 x 4 format the default CEA ee ee eee A 25 mm sec A 1 or a 2 x 6 format 1 cm mV 25 mm sec f h an eS Ces a i The X Series unit stores a minimum of 32 12 Lead snapshots in a separate log Once 32 12 lead snapshots are stored the oldest snapshot in the log is overwritten by subsequent snapshots Note that if a patient data log is full you will not be able to store12 lead snapshots The 12 lead snapshots are erased when you clear the log When you are done viewing and printing the 12 Lead waveform traces press the Exit 12 quick access key ED to restore the display of other monitoring functions 12 Lead Print and Display Options 12 Lead Print a
242. onitoring respirations to accurately depict the patient s respiratory condition Noninvasive Blood Pressure IBP 1 20 Only a physician can interpret pressure measurements Blood pressure measurement results may be affected by the position of the patient his or her physiological condition and other factors Substitution of a component different from that supplied by ZOLL e g cuff hoses etc may result in measurement error Use only ZOLL approved cuffs and hoses To avoid the risk of intravenous line misconnection and possible introduction of air into a patient s blood do not modify the NIBP system or hoses with Luer Lock adapters Do not use a blood pressure cuff on the limb being used for IV infusion or for SpO monitoring Accurate pressure readings may not be achieved on a person experiencing arrhythmias shaking convulsions or seizures Medication may also affect pressure readings The correct size cuff is essential for accurate blood pressure readings Blood pressure hoses must be free of obstructions and crimps If the patient s cuff is not at heart level an error in measurement may result When monitoring blood pressure at frequent intervals observe the cuffed extremity of the patient for signs of impeded blood flow Do not monitor one patient s NIBP while monitoring another patient s ECG Blood pressure measurement may be inaccurate if taken while accelerating or decelerating in a moving vehicle If an
243. operating correctly 4 Press the Energy Select arrows located on the front panel of the X Series unit up or down to select 30 Joules 5 Press the CHARGE button on the defibrillator front panel to charge the unit to the selected energy level Wait for the READY tone 6 Press the electrode plate surfaces firmly together and away from any person or object 7 Discharge the energy in the following manner e For internal handles with a Discharge button Press and hold the Discharge button on the apex handle to deliver the test energy to the electrodes e For internal handles without a Discharge button Have a second person press and hold on the defibrillator front panel to deliver the test energy to the electrodes The X Series device unit discharges and displays the message DEFIB SHORT TEST PASSED www zoll com 9650 001355 01 Rev B Synchronized Cardioversion Synchronized Cardioversion Warning Only skilled personnel trained in Advanced Cardiac Life Support and familiar with equipment operation should perform synchronized cardioversion The precise cardiac arrhythmia must be determined before attempting defibrillation or cardioversion Before attempting synchronized cardioversion ensure that ECG signal quality is sufficient to minimize the risk of synchronizing on artifact Certain arrhythmias such as ventricular tachycardia atrial fibrillation and atrial flutter require synchronizing the defibrillator discharge wit
244. or Figure A 3 Rectilinear Biphasic Waveform at 120 Joules ms Figure A 4 Rectilinear Biphasic Waveform at 100 Joules 9650 001355 01 Rev B X Series Operator s Guide e 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm A 5 Specifications 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm ms Figure A 5 Rectilinear Biphasic Waveform at 85 Joules 25 Ohm 50 Ohm amp 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm Figure A 6 Rectilinear Biphasic Waveform at 70 Joules A 6 www zoll com 9650 001355 01 Rev B Defibrillator ms Figure A 7 Rectilinear Biphasic Waveform at 50 Joules Figure A 8 Rectilinear Biphasic Waveform at 30 Joules 9650 001355 01 Rev B X Series Operator s Guide 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm 25 Ohm 50 Ohm 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm Specifications 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm t 175 Ohm 200 Ohm ms Fig
245. or and a Masimo simulator with signal strengths of greater than 0 02 and a transmission of greater than 5 for saturations ranging from 70 to 100 This variation equals plus or minus one standard deviation which encompasses 68 of the population 5 The Masimo SET Rainbow Technology with Rainbow DC dc sensors have been validated in human blood on healthy adult volunteers against a laboratory CO oximeter from 1 40 for carboxyhemoglobin and 1 15 for methemoglobin This variation equals plus or minus one standard deviation which encompasses 68 of the population 9650 001355 01 Rev B X Series Operator s Guide A 21 Specifications Non Invasive Blood Pressure Technique Non invasive oscillometric method Operating Modes Automatic and manual Automatic Intervals 1 2 3 5 10 15 30 and 60 minute intervals Turbocuf Maximum measurements allowable in a 5 minute period Pressure Measurement Range Systolic 20 to 260 mmHg Diastolic 10 to 220 mmHg Mean 13 to 230 mmHg Static Pressure Accuracy 3 mmHg Pulse Rate Range Adult 30 to 200 5 BPM Pediatric 30 to 200 5 BPM Neonatal 35 to 220 5 BPM Default Cuff Inflation Pressure Adult 160 mmHg Pediatric 120 mmHg Neonatal 90 mmHg Maximum Cuff Inflation Pressure Adult 270 mmHg Pediatric 170 mmHg Neonatal 130 mmHg Single Fault Backup Overpressure Limit Adult 308 mmHg Pediatric 205 mmHg Neonatal 154 mmHg A 22 www zoll com 9650 001355 01 Rev B
246. ormally consists of up to three consecutive 3 second ECG rhythm analyses If at least two of the three analyses determine that the patient has a shockable rhythm the unit automatically prompts the operator to shock the patient at the preconfigured energy level If two or more of the three 3 second ECG analyses do not detect a shockable rhythm the unit alerts the operator that no shock is advised If the first two segments are in agreement with each other the final shock or no shock rhythm decision is made and a third segment is not processed If the shock button is pressed and a shock is successfully delivered the shock count increments by one and is displayed on the screen AED Operation Determine Patient Condition Following Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse Begin CPR Following Medical Protocols Request additional assistance 13 2 www zoll com 9650 001355 01 Rev B AED Operation Prepare Patient WARNING Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach hands free therapy electrodes according to instructions on the electrode packaging Ensure that the electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes Connect the hands free therapy electrodes to the multi function cab
247. ot touch the bed patient or any equipment connected to the patient during defibrillation A severe shock can result Do not allow exposed portions of the patient s body to come into contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Press and hold the button on the front panel until energy is delivered to the patient SHOCK 2 3 The delivered energy level is displayed at the bottom of the screen and the shock number 1 displays at the top of the screen and in the Defib Control panel at the bottom of the screen Note Ifat any time you want to cancel the defibrillation press the Disarm softkey If the defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself If additional countershocks are needed follow steps 1 through 3 of this procedure starting on page 15 7 to readjust the energy settings charge the unit and deliver shock Internal Paddles ZOLL internal paddles are designed for use with the ZOLL X Series defibrillator to defibrillate the heart during open chest procedures Two types of Autoclavable Internal Handles are available e Molded Autoclavable Internal Handles with integrated electrodes e Autoclavable Internal Handles with removable internal defibrillation electrodes When an internal handle set is connected to the X Series it automatically limits defibrillator energy output t
248. ower SpO2 Alarm Limits 00 nnn0nnnnnn0nnnnnennnnnnennnnnnennnnnnneneennenee 10 9 Setting Upper and Lower SpCO and SpMet Alarm Limits cccceeeeeeseeeeeeeees 10 10 Using the SpO Parameter Control Panel ccccccccccsssssssseesseseeeeeeeeeeeeeeeeseeeeseeananeaaaaes 10 10 Selecting the SoCO and SpMet Monitoring cccceeccecseeeeceeeseeeeeeseeeeeeeeseeeeeeeeeas 10 10 Specifying the SpO Averaging Time cccccceecceeceseeeeeeseeeeeeeeeseeenaeaseceeeeeeeeeeeeanes 10 11 SEIECIING THE SPOZ Sensitivity seeriviwoncrnssanccuesaseetenendsesmencsseanatavsadeswedeniaresanasameraleers 10 11 Selecting the Heart Rate Pulse Rate HR PR Tone ccceecccseeeeeeeeeeeeeeeeeees 10 11 SPO System WESSAGES siscrickeriteteeRecacutnnt ists woawutteen aactstudh aesvonietaerbeadankomepsanegems te 10 11 Functional Testers and Patient Simulators ceccccceececeecceeeeceeeeeeeeeesaeeeeeesseeseeesaaeeess 10 12 Chapter 11 Monitoring Invasive Pressures IBP INVASIVE Pressure Trans dUCerS asiriene a etait Oa 11 1 IBP SGUD eiea a E O E E 11 2 Attaching the Invasive Pressure Transducer c cccccccsseecceeeeecceeseeseeeseeseeeeeeseaeeeseeeenes 11 2 Zeroing the TransduCehsstnicdanensn ne ee o a a e bebe 11 3 Rezeroing a INANSOUCEN ties mucscetetctasseatetdentesavsdigsiuneivatesuasious e E TAO 11 4 Displaying IBP Measurements esinninin tides 11 5 Conditions Affecting IBP Measurements cccseecceceeeeec
249. pacing may cause discomfort ranging from mild to severe depending on the patient s tolerance level muscle contractions and electrode placement In certain cases discomfort may be decreased by slightly relocating the pacing pads It is important to monitor the patient closely to verify that both mechanical and electrical capture are occurring Electrical capture can be verified by observing the presence of a large ectopic beat after the pacing pulse is delivered The size and morphology of the beat are dependent on the patient In some instances the beat may appear as a relatively normal looking QRS pulse Mechanical capture can be verified by checking for signs of increased blood flow 1 e reddening of the skin palpable pulses increased blood pressure etc Continuously observe the patient during pacing administration to insure capture retention Do not leave the patient unattended when administering external pacing therapy This device can only be used for external pacing of patients and cannot be used for internal pacing Do not connect internal pacing lead wires to the X Series defibrillator The CPR monitoring function is not intended for use on patients under 8 years of age Place the patient on a firm surface before performing CPR The patient must be motionless during CPR for accurate CPR measurements Pulse Oximeter Keep the ZOLL finger probe clean and dry SpO measurements may be affected by certain patient conditions severe
250. packs regularly A battery that does not pass the ZOLL charger s capacity test might cause the X Series unit to shut down unexpectedly If the Low Battery indication occurs at any time during operation immediately replace the battery pack 9650 001355 01 Rev B X Series Operator s Guide 1 21 CHAPTER 1 GENERAL INFORMATION If the LOW BATTERY icon appears plug the X Series unit into a power source or install a fully charged battery pack When the warning low battery shutdown prompt appears immediately replace the battery pack with a fully charged pack or plug the X Series unit into a power source as unit shut down due to a low battery condition is imminent If mistreated a battery pack might explode Do not disassemble a battery pack or dispose of it in fire Operator Safety 1 22 A The X Series can deliver 200 joules of electrical energy If this electrical energy is not discharged properly as described in this manual the electrical energy could cause personal injury or death to the operator or bystanders Do not use the X Series in the presence of oxygen rich atmospheres flammable anesthetics or other flammable agents such as gasoline Using the unit in such environments might cause an explosion Do not use the unit near or within standing water Electrical safety might be compromised when the defibrillator is wet Never discharge the unit with the defibrillation electrodes or paddles shorted together or in open air
251. peed sets the respiratory sweep speed on the display www zoll com 9650 001355 01 Rev B Heart Rate Meter Warning Enabling Disabling Resp Monitoring Select the Resp Monitoring prompt to enable or disable Resp monitoring When Resp Monitoring is set to On the default the X Series unit displays the Respiration Rate Meter When set to off X Series removes the Respiration Rate meter from the display When using impedance pneumography the X Series unit automatically rejects cardiovascular artifact CVA This function requires the accurate ECG R wave detection Therefore always select the ECG lead with the most prominent QRS complex when using impedance pneumography to monitor respiration Heart Rate Meter The Heart Rate meter displays the heart rate that it derives from the ECG monitoring function by default or from a monitoring function that you specify If the ECG or user specified monitor function measurements are not available the Heart Rate meter derives the heart rate from the following monitoring functions if they are available in this order User selected default source ECG IBP channel 1 SpO gt IBP channel 2 IBP channel 3 and NIBP The Heart Rate meter is labeled HR as in the following example if the source is ECG and PR if any other source is used Configuring Heart Rate HR Meter Alarms The X Series unit allows you to enable and disable the Heart Rate HR alarm to set alarm limits and to select
252. per and lower limits can be ON or OFF default is OFF The following table lists the default respiration rate alarm limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type Respiration Rate Default Respiration Rate Range Lower 3 br min Lower 0 to 145 br min Upper 50 br min Upper 5 to 150 br min Lower 38 br min Lower 0 to 145 br min Upper 50 br min Upper 5 to 150 br min Lower 12 br min Lower 0 to 145 br min Upper 80 br min Upper 5 to 150 br min Using the Resp Parameter Control Panel 7 4 To configure alarms through the Resp Parameter Control Panel use the navigation keys to highlight and select the Respiration Rate meter and display the Resp Parameter Control Panel RR BR Alarm No Breath Alarm Resp Monitoring Resp Lead Lead lI RA LL CO2 Resp Sweep Speed 12 5 mm s Figure 7 1 Respiration Parameter Control Panel The Resp Parameter Control Panel allows you to set the following parameters RR BR Alarm enable disable the Resp alarm and set high low alarm limits No Breath Alarm sets the duration of the No Breath alarm or disables alarm by selecting Off Resp Monitoring enable disable respiration monitoring Resp Lead selects the Resp lead Lead I RA LA or Lead II RA LL from which the X Series unit calculates the respiration rate Resp Lead selection is independent of ECG Lead selection CO2 Resp Sweep S
253. pid succession If a need for repetitive testing arises allow a waiting period of at least 2 minutes after every third discharge In the SYNC mode the defibrillator does not discharge without a command signal R wave detection from the ECG monitor indicated by a SYNC marker on the trace and a flashing SYNC indicator If conductive gel forms a continuous path between the defibrillator electrodes delivered energy may be dramatically reduced to zero In this case reposition the electrodes to eliminate the shunting path before attempting additional shocks Improper defibrillation technique can cause skin burns To limit possible skin burns use only ZOLL defibrillation gel on paddles ensure the gel covers the entire paddle surface and press firmly against patient s chest If a new energy level is selected after the CHARGE button is pushed and while the defibrillator is charging or charged the defibrillator will disarm The CHARGE button will need to be pressed again to charge to the new energy level Prior to defibrillation disconnect from the patient any medical electronic device that is not labeled defibrillation protected 9650 001355 01 Rev B X Series Operator s Guide 1 17 CHAPTER 1 GENERAL INFORMATION Pacing Before charging the defibrillator verify that the energy selected on the display is the desired output Defibrillation takes priority over external pacing Should the defibrillator be charged during the administ
254. plays the default upper and lower systolic limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default NIBP Systolic limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type NIBP Systolic Limit Default NIBP Systolic Limit Range Lower 75 mmHg Lower 30 258 mmHg Upper 220 mmHg Upper 32 260 mmHg Pediatric Lower 75 mmHg Lower 30 158 mmHg Upper 145 mmHg Upper 32 160 mmHg Lower 50 mmHg Lower 20 118 mmHg Upper 100 mmHg Upper 22 120 mmHg Setting Upper and Lower Diastolic Alarm Limits Initially the NIBP Diastolic Alarm Settings menu specifies that the NIBP diastolic pressure alarms are enabled ON or disabled OFF and displays the default Upper and Lower diastolic limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default diastolic limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type Diastolic Limit Default Diastolic Limit Range Lower 35 mmHg Lower 20 218 mmHg Upper 110 mmHg Upper 22 220 mmHg Pediatric Lower 35 mmHg Lower 20 128 mmHg Upper 100 mmHg Upper 22 130 mmHg Lower 30 mmHg Lower 10 108 mmHg Upper 70 mmHg Upper 12 110 mmHg www zoll com 9650 001355 01 Rev B Configuring NIBP Alarms and Settings Setting Upper and Lower NIBP MAP Alarm Limits Initially
255. ple 06 appears for products manufactured in 2006 The last character of the date of manufacture code gives the month in which the product was manufactured The month appears in the form of a single alphanumeric character A for January B for February C for March and so on through L for December The product serial number is a unique set of alphanumeric characters that ZOLL assigns to each individual unit www zoll com 9650 001355 01 Rev B Chapter 2 Product Overview Defibrillator Controls and Indicators 9650 001355 01 Rev B X Series Operator s Guide 2 1 CHAPTER 2 PRODUCT OVERVIEW Table 2 1 X Series Unit Features Item Description 1 Handle Integrated carrying handle 2 Front panel Includes the display screen and primary controls 3 Speaker Emits R wave detection beeps and alarm tones 4 Paper Compartment Holds the paper for the printer 5 Patient connectors For details refer to Patient Cables and Connectors on page 2 7 6 USB device connector For connecting the X Series defibrillator to a USB device For details refer to Transferring Data to a USB Device on page 21 3 Battery compartment Holds a rechargeable lithium ion battery pack Auxiliary power connector For connecting the device to an auxiliary power adapter Dock connector For connecting the device to a docking station The Front Panel The front panel of the X Ser
256. population will range from newborn neonate to adult www zoll com 9650 001355 01 Rev B X Series Product Functions 12 Lead Analysis The 12 lead ECG Analysis is useful in the diagnosis and treatment of patients with acute myocardial infarction AMI 12 lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur When used in the prehospital setting the 12 lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department X Series Product Functions Defibrillator Function The X Series contains a direct current dc defibrillator capable of delivering up to 200 joules It may be used in synchronized mode to perform synchronized cardioversion using the patient s R wave as a timing reference The unit uses paddles or disposable pregelled electrodes for defibrillation Defibrillator Output Energy X Series defibrillators can deliver biphasic energy from 1 joule to 200 joules The energy delivered through the chest wall however is determined by the patient s transthoracic impedance An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms 22 to 26 4 pounds must be applied to each paddle in order to minimize this impedance If hands free therapy electrodes are used make sure that they are properly applied Refer to the instructions on the ele
257. r the Patient Age and Patient Gender parameters To change a default value highlight and select the parameter and then specify a new value as follows To change Patient Age use the navigation keys on the front panel to decrease or increase the default value 45 then press Select To change Patient Gender use the navigation keys on the front panel to toggle between the default value M male and F female then press Select 12 Lead ECG Monitoring Setup The proper application and placement of electrodes is essential for high quality 12 Lead ECG monitoring Good contact between the electrode and skin minimizes motion artifact and signal interference To set up 12 lead ECG monitoring perform the following steps Prepare the patient s skin for electrode application Apply the electrodes to the patient Connect each lead of the ECG cable to the appropriate electrode Connect the 12 Lead cable to the X Series unit oS a ee E Observe the patient s electrocardiogram on the display and adjust size of the 12 Lead ECG waveform traces as necessary Preparing the Patient for Electrode Application 14 4 The proper application of electrodes is essential for high quality ECG monitoring Good contact between the electrode and skin minimizes motion artifact and signal interference Before applying electrodes prepare the patient s skin as necessary e Shave or clip excess hair at electrode site e Clean oily skin with an alco
258. race highlight and select the trace label above the trace In the following example the unit is configured to cascade the ECG Lead trace 06 06 2011 12 34 56 a 00 4 7 43 Note The X Series unit automatically inserts a new waveform when you turn on a parameter CO2 or a new sensor signal is present SPO2 IBP The X Series unit automatically removes a waveform when you turn off a parameter or remove a sensor and the unit displays the resulting equipment alert 9650 001355 01 Rev B X Series Operator s Guide 3 7 CHAPTER 3 MONITORING OVERVIEW 3 8 When the unit cascades the ECG Lead II trace the Waveform Display window appears as follows 06 06 2011 12 34 56 Adult O 00 4 7 43 The following screens demonstrate how to insert two more waveform traces into the window A third trace is inserted for ECG lead aVR and fourth trace for EtCO2 a capnogram Notice that when the third trace is inserted the numeric displays move to the right side of the window to allow more room for the waveform traces www zoll com 9650 001355 01 Rev B Configuring the Waveform Display Inserting a third waveform trace for ECG lead aVR 06 06 2011 12 34 56 Adult 00 S 4 7 43 KFE e6 L A Bt bpm NIBP mmHg SpO2 180 121 Ja 98 6 9 06 06 2011 12 34 56 00 17 43 bpm 1 cm mV Bo ee gt 1 cm mV ana ene bens bane nee 7 T1 F 98 6 9650 001355 01 Rev B X Series Operators Guide 3 9 CH
259. rate display Verify patient s pulse rate against the ECG heart rate www zoll com 9650 001355 01 Rev B Warnings Warnings SpO s Oximeter Sensor SpOo Oximeter Sensor Use only ZOLL approved Masimo oximeter sensors Other manufacturers sensors might not perform properly with the X Series oximeter Tissue damage can result from incorrect application or use of a sensor for example wrapping the sensor too tightly applying supplemental tape failing to periodically inspect the sensor site To ensure skin integrity correct positioning and sensor adhesion inspect the sensor site as directed in the Directions for Use provided with the sensor Do not use damaged sensors or cables Do not use a sensor with exposed optical components Do not sterilize a sensor by irradiation steam or ethylene oxide Refer to the cleaning instructions in the Directions for Use for reusable Masimo sensors Do not allow the sensor to remain on the same site for a prolonged period especially when monitoring neonates Check the application site at regular intervals at least every 2 hours and change the site if any compromise in skin quality occurs Do not attach the oximeter sensor to a limb being monitored with a pressure cuff or with restricted blood flow A poorly applied sensor might give incorrect saturation readings A weak pulse signal on the display might indicate a poorly applied sensor or a poorly chosen monitoring site Choose
260. rated for functional saturation 1 The Masimo SET Technology with LNOP sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO oximeter and ECG monitor 2 The Masimo SET Technology with LNOP sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO oximeter and ECG monitor 1 has been added to the saturation accuracy to account for the effects of fetal hemoglobin This variation equals plus or minus one standard deviation which encompasses 68 of the population 3 The Masimo SET Technology with LNOP sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 100 SpO2 against a laboratory CO oximeter and ECG monitor 1 has been added to the saturation accuracy to account for the effects of fetal hemoglobin This variation equals plus or minus one standard deviation which encompasses 68 of the population 4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulat
261. ration of external pacing the pacer turns off and the defibrillator charges to the selected energy Ventricular fibrillation does not respond to pacing and requires immediate defibrillation Therefore the patient s dysrhythmia must be determined immediately so that you can employ appropriate therapy If the patient is in ventricular fibrillation and defibrillation is successful but cardiac standstill asystole ensues you should use the pacemaker Ventricular or supraventricular tachycardias can be interrupted with pacing but in an emergency or during circulatory collapse synchronized cardioversion is faster and more certain Pulseless electrical activity PEA can occur following prolonged cardiac arrest or in other disease states with myocardial depression Pacing might then produce ECG responses without effective mechanical contractions making other effective treatment necessary Pacing can evoke undesirable repetitive responses tachycardia or fibrillation in the presence of generalized hypoxia myocardial ischemia cardiac drug toxicity electrolyte imbalance or other cardiac diseases Pacing by any method tends to inhibit intrinsic rhythmicity Abrupt cessation of pacing particularly at rapid rates can cause ventricular standstill and should be avoided Noninvasive temporary pacing can cause discomfort of varying intensity which occasionally can be severe and preclude its continued use in conscious patients Similarly unav
262. requency of the transmitter Recommended Separation Distance Conducted RF 3 Vrms d 1 17 JP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10Vrms d 1 2 P 150 KHz to 80 MHz in ISM bands Radiated RF 10 V m d 1 20 JP IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 800 MHz d 2 30 JP 800 MHz to 2 5 GHz 3 V m 3 V m d 4 P 80 MHz to 2 5 CHz IBP only 80 MHz to 800 MHz IEC 60601 2 34 d 7 67 JP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol ke1 A 9650 001355 01 Rev B X Series Operator s Guide A 31 Specifications Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 KHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in th
263. rify that the pacer status bar indicates button again to close the Pacer Settings PACING SHORT DETECTED dialog box Verify that the green pace indicator continues to flash once each second Verify that no pacer related error messages display 15 Disconnect the test connector from the MFC Verify that the pacer status bar displays PACING CHECK THERAPY ELECTRODES Press the Pacer button on the front panel to Verify that the Pacer Settings dialog is closed display the Pacer Settings dialog Select Turn and that the pacer status bar is removed from Pacer Off to turn off the pacer the display 17 Reconnect the external AC Adapter to the X Verify that the green Auxiliary Power indicator Series rear panel light on the X Series front panel is illuminated www zoll com 9650 001355 01 Rev B Defibrillator Testing with External Paddles Defibrillator Testing with External Paddles Warning Prior to testing external defibrillator paddles with the X Series unit complete the testing described in Defibrillator Pacing Test with Hands Free Therapy Electrodes on page 24 3 Note If alow battery message appears during any of this testing the battery is close to depletion and should be replaced or recharged Keep hands fingers and other conductive materials away from paddle electrode plates when discharging the defibrillator or pacing Function Response Press the X ee ee power switch to turn the Verify
264. ring Setup The proper application and placement of electrodes is essential for high quality ECG monitoring Good contact between the electrode and skin minimizes motion artifact and signal interference The following procedure describes how to monitor a patient s ECG using 3 and 5 Lead ECG cables For information on the application and use on MultiFunction Pads and External Paddles which you can also use to monitor ECG see Chapter 14 Manual Defibrillation To monitor a patient s ECG using 3 and 5 Lead ECG cables perform the following steps Prepare the patient s skin for electrode application Apply the electrode pads to the patient Connect each lead of the ECG cable to the appropriate electrode Insert the patient cable plug into the ECG input connector on the X Series unit Select the ECG waveforms to be displayed on the waveform trace display screen Oy ge es a Observe the patient s electrocardiogram on the display and adjust size of the ECG waveform trace as necessary Preparing the Patient for Electrode Application 6 2 The proper application of electrodes is essential for high quality ECG monitoring Good contact between the electrode and skin minimizes motion artifact and signal interference Before applying electrodes prepare the patient s skin as necessary e Shave or clip excess hair at electrode site e Clean oily skin with an alcohol pad e Rub site briskly to dry www zoll com 9650 001355 01 R
265. riod of CPR the unit will issue a STOP CPR prompt while it restarts ECG analysis 9650 001355 01 Rev B X Series Operator s Guide 13 7 CHAPTER 13 AUTOMATED EXTERNAL DEFIBRILLATOR AED OPERATION Continue Patient Care Continue patient care according to medical protocols Operating Messages The unit uses both audio and visual prompts to present critical information to operators The following information describes the unit default configuration If your device has been custom configured some of the information may be different There are 10 voice prompts used in AED mode Most of these prompts are accompanied by a message displayed on the monitor The voice prompts are given only once but the monitor continues to display the message until new action is taken by the operator or the device status changes The unit will alternately display two different messages in the same field of the display when two conditions are detected at the same time For example a LOW BATTERY message may alternately display on the same line of the monitor as the CHECK PADS message Audio and Display Messages 13 8 The display messages and voice prompts that can occur during AED operation are described below ATTACH PADS If the unit is powered on without therapy pads connected to the patient the ATTACH PADS message is announced and displayed ANALYZING ECG STAND CLEAR The ANALYZING ECG message is displayed and the STAND CLEAR message is displayed
266. rs with a check mark selected cases begins printing www zoll com 9650 001355 01 Rev B Chapter 24 Maintenance Resuscitation equipment must be maintained to be ready for immediate use To ensure the readiness and optimum working condition of the X Series unit you should perform the following inspections and tests daily or at each shift change In addition to the daily check authorized personnel should complete performance and calibration testing at regularly scheduled intervals which should not exceed one year A maintenance log is an important part of a successful maintenance program in which you record information on a regular basis This allows for verification of necessary maintenance and for scheduling periodic requirements such as calibration and certification In accordance with the recommendations of the Defibrillator Working Group of the Food and Drug Administration an operator s shift check list is included in this chapter which you can copy for use as needed 9650 001355 01Rev B XSeriesOperatorsGuide i i i MA CHAPTER 24 MAINTENANCE Daily Shift Check Procedure Inspection 24 2 Equipment and Accessories Ensure that the X Series unit is clean with no fluid spills and free of visible damage Inspect all cables cords and connectors for signs of damage or excessive wear cuts in insulation fraying broken wires dirty or bent connector pins Replace if damaged Inspect the battery ECG pati
267. ry pack typically delivers more than 6 hours of ECG monitoring Use of other functions such as the defibrillator printer or pacemaker reduces this time When a LOW BATTERY icon appears on the display and the unit emits three beeps in conjunction with the displayed battery icon the battery must be replaced and recharged You can charge the battery by either of the following methods www zoll com 9650 001355 01 Rev B X Series Product Functions e Internal charging plug the X Series into an auxiliary power adapter to automatically begin charging the installed battery pack The front panel battery indicator operates as follows When the indicator is It means Steady yellow Battery is charging Steady green Battery is charged Alternating yellow and The charge state cannot be green determined or a battery charging fault has been detected Not lit No battery in device Note Upon power up it takes approximately 45 seconds for the LEDs on the battery to accurately display run time e External charging use the ZOLL SurePower Battery Charger with the X Series battery adapter to charge the battery pack and test the battery s capacity For details refer to the SurePower II Battery Pack Guide The Recalibration LED icon cB lights for approximately 10 seconds after you press and release the Display button if the battery needs to be calibrated If the Recalibration LED lights the runtime indicator w
268. s 98 6 Figure 4 1 Trends Status window The Trends status window displays the logged trend information and the time at which the trend measurements were logged While trend measurements are logged to memory at a user configurable interval the Trends status window can display the logged information at an interval that you specify with the exception of NIBP measurements which are logged and reported at the times they are taken The Trends status window reports the trends information at 5 minute intervals Displaying and Printing Trend Information To navigate in the Trends status window 1 Use the navigation keys to highlight the Navigate Here to Scroll Through Trends bar then press Select 2 Press the Up Down buttons s to scroll through the trend information 3 To print all trends for the current patient highlight the NIBP Trends field then press Select Press the Print Trend Summary button in the Trend Settings menu 4 To select which trends to print for the current patient press the Log quick access key 63 then press the Print Trends button E 42 wwwzolleom 9650 001355 01 Rev B Changing the Trends Status Window Display Changing the Trends Status Window Display By default the Trends status window displays all logged trend information It displays the numeric information for all monitoring functions which the unit logs at a user configurable interval and when you take NIBP measurements when a patient
269. s Print Speed 25 mm or 50 mm per second Print Number of Traces 1 2 0r3 Print Grid On or Off Print on Snapshot On or Off Print on Patient Alarm On or Off Print on NIBP On or Off Print on Trend On or Off Automatic Prints You can print any following events by setting the monitor to print automatically in the Setup gt Supervisor gt Printer window To do this press hey then press FE Using the navigation buttons select Supervisor and then Printer e Defib Pacer Events e Event e Treatment Snapshot e Treatment Summary Snapshots Printing Waveforms 23 2 You can print waveforms by pressing EJ The X Series unit will print the displayed waveforms as configured in the Number of Traces option The Print Number of Traces option can be set to 1 2 or 3 Patient vital sign numerics are printed above the waveforms Note Waveforms that have invalid data print a dashed line for that trace The ECG Waveform ECG waveforms are printed on a grid with major divisions dotted lines every 5mm and minor divisions single dots every 1 mm The ECG waveform is always printed if ECG is monitored The Invasive Pressure Waveform Pressure waveforms are printed on a grid with major divisions vertical dotted lines every 5 mm and the pressure scale grids are printed horizontally www zoll com 9650 001355 01 Rev B Printing Patient Data The SpO Plethysmograph The SpO plethysmograph is printed
270. s a different procedure follow that protocol This chapter also describes how to switch the AED unit to Manual mode see Switching to Manual Mode Operation on page 14 10 1 Circulation 2005 112 IU 19 IU 34 2 Resuscitation 2005 671S S7 S23 3 Circulation 2010 122 S640 S656 4 Resuscitation 2010 1219 1276 9650 001355 01 Rev B X Series Operator s Guide 13 1 CHAPTER 13 AUTOMATED EXTERNAL DEFIBRILLATOR AED OPERATION In AED operation there is an Analysis CPR Protocol mode guides you through a cardiac event by performing ECG analysis preparing the device for a shock if needed and leading you through a CPR interval This cycle is repeated as long as Analysis CPR Protocol is active and pads are attached to the patient If pads become detached from the patient or shorted during the Analysis CPR Protocol the protocol halts and waits for the pads to be reattached or continues through the CPR interval and then halts and waits for the pads to be reattached The X Series defibrillator is capable of analyzing a patient s ECG rhythm in two different ways The first mode of analyzing is automatic the other mode of analyzing is user activated analysis and is initiated by pressing the ANALYZE button Automatic and user activated analysis of a patient s ECG can be performed only when e Hands free therapy electrodes are connected and making good contact with the patient e The defibrillator is on This analysis n
271. s the required number of pacing pulses to maintain the patient s heart rate at approximately the rate selected in the pacing rate window See the procedure below Pacing in Demand Mode for more information In Fixed mode pacing pulses are not dependent on the patient s cardiac activity Fixed pacing should be performed only in an emergency when no alternative is available The pacer delivers pacing pulses at the selected pacing rate See Pacing in Fixed Mode on page 18 6 for more information Pacing in Demand Mode Determine Patient Condition and Provide Care Following Local Medical Protocols Prepare the Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip it to ensure proper adhesion of the electrodes 1 Turn On Unit 18 2 Press the green power switch located on the top of the unit The green yellow and red lights at the top of the unit flash on and off and the unit displays the message SELF TEST PASSED www zoll com 9650 001355 01 Rev B Pacing in Demand Mode 2 Apply ECG Electrodes Hands Free Therapy Electrodes Apply ECG electrodes attach lead wires and connect the ECG cable to the X Series side panel see Chapter 6 Monitoring ECG for instructions on attaching ECG electrodes to the patient Attach hands free therapy electrodes according to instructions on the electrode packaging Connect these therapy electrodes to the multifun
272. s voltage Rhythm Analysis and Charge Time in AED Mode e Less than 30 seconds with a new fully charged battery first 15 charges to 200 joules e For the sixteenth discharge at maximum energy the analysis and charge time is less than 30 seconds Depleted batteries result in a longer defibrillator charge time e Less than 30 seconds when operating without a battery using AC power alone at 90 of the rated mains voltage e Less than 40 seconds from the initial power on with a new fully charged battery pack depleted by up to fifteen 200 joule discharges or when operating without a battery using AC power alone at 90 of the rated mains voltage Patient Impedance Range 10 300 ohms Synchronized Mode Synchronizes defibrillator discharge to the patient s R wave SYNC is indicated on the display with R wave markers above the ECG waveform on the screen and stripchart When ECG is monitored by the device meets the DF 80 2003 requirement of 60ms maximum time delay between the peak of the R wave and the delivery of energy Table A 1 shows the characteristics of the X Series Rectilinear Biphasic waveform when discharged into 25 ohm 50 ohm 100 ohm 125 ohm 150 ohm and 175 ohm loads at the maximum energy setting of 200 joules Table A 1 X Series Rectilinear Biphasic Waveform Characteristics 200 J discharged into 250 500 1009 1250 1500 175Q Firs
273. security key Press SAVE to save changes and return to the Temporary Profile menu press Cancel to return to the Temporary Profile menu without saving changes Of f 26 11 17 46 26 Adult Security Key LetMelnit sMe When you are done editing the Temporary Profile menu press the back arrow Emm to exit the wireless menu Note The selected Temporary Profile remains as the default profile until configured otherwise 22 6 www zoll com 9650 001355 01 Rev B The Wireless Menu Setting up and Viewing Paired Devices In the wireless menu use the navigation keys to highlight and select View Configure Paired Devices You can now view paired Bluetooth devices To pair a new device use the navigation keys and select New rm 99 99 38 Log Full T P IBP NIBP mmHg a Wireless gt Configure Bluetooth Paired Devices Bluetooth Name Nickname No Paired Devices Resp imin Resp Off Provider Name New Ka The unit will then scan for nearby Bluetooth devices that are in discoverable mode Use the navigation keys to select the desired device a green check mark indicates which device has been selected rm 99 93 54 Some APA Limits Disabled a Wireless gt Configure Bluetooth gt Pair New Device NIBP mmHg Available Devices Bluetooth Name Resp min Resp Off Start Scan Pair Now Current PIN i e Change PIN Ka Select Pair Now to pair the device The unit then returns to th
274. so allows you to set all alarm limits relative to the patient s current vital signs measurements by performing the following actions 1 Press Ll 2 Press the Alarm quick access key Cy 3 Press the Stat Set quick access key ED The X Series unit sets all parameters to a new value based on the current values as follows Parameter Range Upper Limit Calculation Lower Limit Calculation units HR PR Limit is unchanged Limit 25 bpm 26 lt 26 lt Numeric lt 99 lt 99 Limit Numericx 1 2 Numeric x 1 2 Limit Numericx0 8 Numeric x 0 8 100 lt Numeric lt 250 Limit Numeric 20 Limit Numeric 20 Numeric gt 250 Limit 250 Limit is unchanged Numeric lt 26 Limit Numeric 5 Limit Numeric 5 EE lt 26 lt Numeric lt 99 lt 99 Limit Numericx 1 2 Numeric x 1 2 Limit Numericx0 8 Numeric x 0 8 Limit Numeric 20 Limit Numeric 20 st Numeric lt 26 Limit Numeric 5 Limit Numeric 5 i lt 26 lt Numeric lt 99 lt 99 Limit Numeric x 1 2 Limit Numeric x 0 8 Limit Numeric 20 Limit Numeric 20 m Numeric lt 26 Limit Numeric 5 Limit Numeric 5 ee ae lt 26 lt Numeric lt 99 lt 99 Limit Numeric x 1 2 Limit Numeric x 0 8 Numeric gt 99 Limit Numeric 20 Limit Numeric 20 5 8 www zoll com 9650 001355 01 Rev B Alarm Options SpO Entire range Limit 100 Adult and Limit Numeric 5 Pediatric
275. sponse Time Response time to tachycardia alarm is on average 3 4 seconds per AAMI EC 13 2002 section 4 1 2 1 g and IEC 60601 2 27 clause 6 8 2 bb 7 Response times include a 1 0 second display update interval Pacemaker Pulse Rejection In accordance with AAMI EC13 2002 section 4 1 4 and IEC 60601 2 27 2005 subclause 50 103 13 e Pulses without overshoot Rejects all pulses with amplitude of 2 mV to 700 mV and duration of 0 1 ms to 2 ms with no tail e Pulses with overshoot Rejects all pulses with amplitude of 2 mV to 700 mV and duration of 0 1 ms to 2 ms with overshoot up to 100 ms e A V sequential pulses A V sequential pacemaker pulses may not be rejected e Fast ECG signals Approximately 50 of ECG input pulses with a slew rate of 3 V s RTI may trigger the pacemaker pulse detector Electrosurgery Protection The X Series is suitable for use in the presence of electrosurgery Burn hazard protection via a 1K current limiting resistor contained in each ECG leadwire Impedance Pneumography Displayed Data Numeric breath rate Impedance waveform Breath rate range Adult Ped 2 to 150 breaths minute Neonates 3 to 150 breaths minute Breath rate accuracy 2 or 2 breaths minute whichever is greater Displayed Breath Rate Average of last 10 breath to breath rates Leads Lead I RA LA Lead II RA LL Sweep Speed 3 13 6 25 12 5 mm sec Alarm settings High low and no breath rate alarm 9650 00
276. steps each of which corresponds to a section in this chapter Read each section carefully before you perform NIBP measurements l Select the correct size cuff 2 Apply the cuff to the patient 3 4 Configure NIBP alarms and settings if the current NIBP alarms and settings are not Connect the inflation hose to the X Series unit and to the cuff appropriate Press the NIBP button on the X Series unit s front panel and take the blood pressure measurement 9650 001355 01 Rev B X Series Operators Guide 8 3 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP selecting the NIBP Cuff Caution Caution 8 4 To take accurate measurements you must use the proper sized cuff the cuff s bladder length should be at least 80 percent of the limb circumference while the cuff width should be equal to 40 percent of the limb circumference Use only hoses and cuffs that are approved by ZOLL Medical Corporation See Appendix B Accessories for a listing of the approved hoses and cuffs Use the following guidelines when selecting the appropriate hose and cuff Adult Mode Pediatric Mode Neonate Mode Cuffs typical cuff Adult Large Adult Child Small Child Neonate 1 to 5 labeling Small Adult Child Small Adult Infant disposable Thigh Newborn Newborn 6 Infant 7 reusable Recommended Limb 15 cm or greater 7 7 to 25 cm 15 cm or less Circumference Hoses Neonate Infant Disposable Cuff o
277. t alarms and technical alerts are stored in the Event Log and retained with normal power down or total loss of power Visual Alarm Indicators In addition to status messages that appear on the display the X Series unit lights the red or yellow LED on the front panel to indicate the priority level of the highest priority active alarm The X Series LEDs indicate the priority level of the highest priority active alarm as shown in the following table Active Alarm Priority Visual Alarm Indicator High Priority Patient Alarm Flashing Red LED Medium Priority Technical Alert Flashing Yellow LED Low Priority Technical Alert Continuous Yellow LED 9650 001355 01 Rev B X Series Operator s Guide 5 1 CHAPTER 5 ALARMS Audible Alarm Indicators The X Series unit sounds an audible alarm to indicate the priority level of highest priority active alarm The X Series indicates the priority level of the highest priority active alarm by sounding the audible alarm tones described in the following table Active Alarm Priority Audible Alarm Indicator Alarm Alert Volume High Priority Two sets of five short beep tones Volume is adjustable up to a Patient Alarm repeated at 15 second intervals maximum sound pressure of at least 70 dBA measured at 1m Medium Priority One set of three longer beep tones Volume is 3 to 12 dBA below high Technical Alert repeated at 30 second intervals priority alarm Low Priority A si
278. t phase Maximum initial current 31 4A 30 4A 19 7A 19 4A 16 7A 15 6A Average current 27 1A 24 9A 17 5A 16 2A 14 4A 13 2A Duration 6 ms 6 ms 6 ms 6 ms 6 ms 6 ms Interphase duration 200 us 200 us 200 us 200 us 200 us 200 us between first and second phases Second phase Initial current 29 2A 18 8A 15 1 A 13 2 A 12 1 A 11A Average current 14 7 A 13A 12 5 A 11 3 A 10 7 A 9 9 A Duration 4 ms 4 ms 4 ms 4 ms 4 ms 4 ms A 2 www zoll com 9650 001355 01 Rev B Defibrillator Table A 2 Delivered Energy at Every Defibrillator Setting into a Range of Loads Selected Load Energy 250 500 75Q 1000 1250 1500 1750 Accuracy 1J 1J 1J 1J 1J 1J 1J 1J 15 2J 1J 2J 2J 2J 2J 2J 2J 15 3J 2J 3J 3J 3J 3J 3J 3J 15 4J 3J 4J 4J 5J 5J 5J 4J 15 5J 3J 5J 6J 6J 6J 6J 6J 15 6J 4J 6J 7J 7J 7J 7J 7J 15 7J 5 J 7J 8 J 8 J 8 J 8 J 8 J 15 8 J 5 J 8 J 9J 9J 10J 9J 9J 15 9J 6J 9J 10J 11J 11J 11J 10 J 15 10 J Td 10J 12J 12J 12J 12J 12J 15 15J 10J 16J 17J 18J 18J 18J 17J 15 20 J 14 J 21J 23 J 24 J 24 J 24 J 23 J 15 30 J 21J 32 J 35 J 36 J 37 J 36 J 35 J 15 50 J 35 J 54 J 59 J 61 J 62 J 61 J 59 J 15 70 J 49 J 76 J 83 J 85 J 87 J 86 J 83 J 15 85 J 60 J 92 J 101 J 104 J 106 J 104 J 101 J 15 100 J 71J 109 J 119 J 122 J 125 J 123 J 119 J 15 120 J 85 J 131 J 143 J 147 J 150 J 147 J 143 J 15 150 J 107 J 164 J 180 J 183 J 188 J 184 J 179 J 15 200 J 142 J
279. temperature monitoring channels and if both are used displays the monitored temperatures in degrees F or C one after the other followed by the difference between those temperatures Invasive Pressures IBP The X Series unit provides three separate channels for monitoring arterial venous or intracranial pressure using internal probes The pressure measurements for each pressure channel appear in a labeled P1 P2 P3 numeric display Non Invasive Blood Pressure NIBP The X Series unit provides patented Smartcuf motion tolerant technology for NIBP monitoring NIBP monitoring measures the patient s systolic diastolic and mean blood pressure through an inflatable blood pressure cuff that the X Series unit inflates deflates NIBP measurements can be taken automatically or on demand by pressing the NIBP button e on the front panel of the X Series unit The blood pressure measurements appear in a labeled NIBP numeric display You can also specify that the X Series unit display non invasive pressure waveforms in the waveform trace area 3 2 www zoll com 9650 001355 01 Rev B Monitoring Display Options Capnography CO CO monitoring measures the CO concentration in a patient s exhaled breath End Tidal Carbon Dioxide EtCO CO monitoring can also measure a patient s breath rate and the CO concentration in the gasses supplied to intubated patients Fractional Inspired Carbon Dioxide FiCO Since FiCO represents th
280. that is not currently available the unit displays the message LEAD FAULT For more information on how to configure the display of waveforms on the X Series unit see Chapter 3 Monitoring Overview 9650 001355 01 Rev B X Series Operator s Guide 6 7 CHAPTER 6 MONITORING ECG Selecting the Waveform Trace Size The X Series unit allows you to select the waveform trace size to adjust the size of displayed the ECG waveform To select the waveform size use the navigation keys to highlight and select the trace size that appears to the right of the electrode label 06 06 2011 12 34 56 Adult 1 em 0 125 cm mV 0 25 cm mV 0 50 cm mV 1 0 cm mV 2 0 cm mV 4 0 cm mV Auto The default trace size is 1cm mV You can select a larger 2 0 4 0 cm mV or smaller 0 125 0 25 0 50 cm mV trace size You can also specify that the X Series unit select a best fit trace size AUTO 6 8 www zoll com 9650 001355 01 Rev B ECG Monitoring and Pacemakers ECG Monitoring and Pacemakers When the unit performs ECG monitoring on a patient with an implantable pacemaker the unit s Pacer indicator feature can indicate the occurrence of pacemaker signals If the Pacer Indicator setting is ON the X Series performs the following actions e detects the implantable pacemaker pulses e blanks the pacemaker pulses from the waveform preventing them from disturbing the ECG waveform and allowing for an accurate QRS detection e displays and
281. that the unit displays the Ii a TEST unit on PASSED message Connect the MFC to the defibrillator and Verify thata CHECK THERAPY disconnect the patient end of the MFC from ELECTRODES message displays in the any attached accessory paddles or test waveform window connector Select Pads as the waveform display source Connect the paddles set to the X Series MFC Verify that the CHECK THERAPY cable Do not place the paddles electrodes in ELECTRODES message changes to APPLY contact with each other PADDLES TO PATIENT 4 Press the RECORDER ON OFF button on Verify that the recorder begins printing the Sternum paddle Press the RECORDER ON OFF button again Verify that the recorder stops printing Press the Apex and Sternum paddle Verify that the APPLY PADDLES TO PATIENT electrodes together face to face maximizing message changes to SHORT DETECTED the contact area between the electrodes Press the ENERGY SELECT button on Verify that the defib window displays and the the Sternum paddle following message appears PADDLE SHORT DETECTED SELECT 30 J TO TEST Press the ENERGY SELECT button Verify that the selected energy increases to the in next highest level Repeatedly press the ENERGY SELECT Verify that the defibrillator window shows button on the Sternum paddle until 30 Joules 30 J as the selected energy is selected 10 Press the CHARGE button on the Apex Verify that a periodic tone sounds while the paddle
282. the IBP transducer for the corresponding channel P1 P2 or gt 0 oA Navigation Keys Use the navigation keys up clockwise arrow down counterclockwise arrow and select button to navigate through windows and make selections Using Up Clockwise and Down Counterclockwise Arrows Use the up clockwise down counterclockwise arrows to do the following e Move clockwise and counterclockwise through the main display windows e Move up and down in a window e Change parameter settings Using the Select Button Use the Select button to do the following e Display the settings window while a parameter is highlighted in the main window e Select options from a window Display Brightness The monitor can display in two different brightness modes e high contrast with white background for optimal display in bright sunlight e color with black background numerics and waveforms are easy to read Common Tasks The section contains procedures for the following tasks e Changing the Display Brightness on page 2 16 e Replacing a Battery Pack on the X Series on page 2 16 e Using Treatment Buttons on page 2 17 9650 001355 01 Rev B X Series Operators Guide 2 15 CHAPTER 2 PRODUCT OVERVIEW Changing the Display Brightness The following procedure shows how to select the different brightness options 1 Press the power switch to turn the unit on 2 Press the Brightness quick access key IDS repeatedly t
283. the NIBP MAP Alarm Settings menu specifies that NIBP MAP alarms are enabled ON or disabled OFF and displays the default Upper and Lower MAP limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default MAP alarm limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type MAP Default MAP Range Lower 50 mmHg Lower 25 230 mmHg Upper 120 mmHG Upper 23 228 mmHg Pediatric Lower 50 mmHg Lower 25 140 mmHg Upper 110 mmHg Upper 23 138 mmHg Neonate Lower 35 mmHg Lower 15 110 mmHg Upper 80 mmHg Upper 13 108 mmHg Using the NIBP Parameter Control Panel Use the navigation keys to highlight and select the NIBP numeric display to display the NIBP Parameter Control Panel NIBP Systolic Alarm NIBP Diastolic Alarm NIBP MAP Alarm 50 100 150 200 250 300 Lilith bette eee ad C Figure 8 4 NIBP Parameter Control Menu 9650 001355 01 Rev B X Series Operators Guide 8 11 CHAPTER 8 MONITORING NON INVASIVE BLOOD PRESSURE NIBP On the NIBP Parameter Control Panel you can select an alarm configuration option SYS DIA or MAP to enable disable alarms and set high and low alarm limits as described previously You can also configure these NIBP options e NIBP Mode Mode e NIBP Automatic Measurement Interval Auto Interval e Enable Disable Smartcuf motion artifact filter Smartcuf e Start Stop Turbocuf M
284. the X Series unit is within range of the wireless server 22 19 CHAPTER 22 WIRELESS COMMUNICATIONS 22 20 www zoll com 9650 001355 01 Rev B WARNING Chapter 23 Printing This chapter describes procedures for printing permanent records of pertinent patient care data and events To avoid risk of electrical shock do not touch the patient and internal parts of the printer simultaneously while the printer door is open Printing Patient Data The printing option allows you to print the following patient information e Waveforms e Reports e Trends Note A date that contains question marks indicates that the X Series was not able to determine the date and time on power up Power cycling the unit may correct the problem If the problem persists set the date and time by highlighting the Date and Time display field and pressing Select Note The Print quick access key 6 is highlighted with a blue background while the printer is printing Pressing Ej when it is highlighted stops the current printer activity 9650 001355 01 Rev B X Series Operators Guide 23 1 CHAPTER 23 PRINTING Printer Setup To configure the printer functions press the More quick access key hey press the Setup quick access key E highlight Printer and press Select Use the navigation keys to select the desired print configuration The Setup gt Printer window contains the following print configuration options Print configuration Option
285. the monophasic shocks was greater in patients with high transthoracic impedance greater than 90 ohms The first shock first induction efficacy of biphasic shocks was 100 versus 63 for monophasic shocks for patients with high impedance p 0 02 95 confidence interval of the difference of 0 0217 to 0 759 and 90 confidence interval of the difference of 0 037 to 0 706 Monophasic Biphasic First shock efficacy 63 100 high impedance patients p value 0 02 95 confidence interval 0 021 to 0 759 90 confidence interval 0 037 to 0 706 A single patient required a second biphasic shock at 150 joules to achieve 100 efficacy versus six patients for whom monophasic shocks of up to 360 joules were required for 100 total defibrillation efficacy Conclusion The data demonstrate the equivalent efficacy of low energy rectilinear biphasic shocks compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients at the 95 confidence level The data also demonstrate the superior efficacy of low energy rectilinear biphasic shocks compared to standard high energy monophasic shocks in patients with high transthoracic impedance at the 90 confidence level There were no unsafe outcomes or adverse events due to the use of rectilinear biphasic waveform Randomized Multi Center Clinical trial for Cardioversion of Atrial Fibrillation AF A 26 Overview The defibrillation efficac
286. the sensor from the patient cable if appropriate Wipe the entire sensor clean with a 70 isopropyl alcohol moistened pad Allow the sensor to air dry before returning it to use Connecting the SpO Sensor To connect the SpO sensor to the X Series unit 1 When using a sensor extension cable inspect the cable before use Replace the cable if it shows any signs of wear breakage or fraying Plug the sensor extension cable into the SpO receptacle on the side of the X Series unit Figure 10 3 Connecting the SpO Sensor to the X Series Unit Displaying SoO5 SoCO and SoMet Measurements When the connection is made between the SpO sensor and the unit the message INITIALIZING appears in the SpO display After a brief delay the unit displays the SpO measurement If SpCO and SpMet are installed the SpCO and SpMet measurements will alternate every two seconds underneath the SpO display SpO gt Blip bar Measurement Blip bar Alternating SoMet Measurement Alternating SoCO Measurement If the message SENSOR FAILURE appears the sensor is either incompatible with the X Series unit or it is not working and you will need to replace the sensor A blip bar appears on the right side of the SpO numeric display window The blip bar indicates the relative pulsatile strength and quality of the SpO data 10 8 www zoll com 9650 001355 01 Rev B Enabling Disabling SpO Alarms and Setting Alarm Limits Enabling Dis
287. thetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the X Series unit requires continued operation during power mains interruptions it is recommended that the X Series unit be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level www zoll com 9650 001355 01 Rev B Electromagnetic Compatibility Guidance and Manufacturer s Declaration Guidance and Manufacturer s Declaration Electromagnetic Immunity IEC 60601 1 2 Table 203 The X Series unit is intended for use in the electromagnetic environment specified below The customer or the user of the X Series should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment Guidance Level IEC 60601 1 2 Portable and mobile RF communications equipment should be used no closer to any part of the X Series unit including cables than the recommended separation distance calculated from the equation applicable to the f
288. three windows e Waveform Display window which initially displays an ECG waveform trace and numeric displays for each monitoring function e Trends Status window which displays a report listing vital signs measurements that the X Series unit logs automatically and the primary ECG waveform trace e Large Numerics Display window on which large numeric displays of all vital signs measurements appear The Waveform Display window appears when you power on the X Series unit Initially the Waveform Display window displays a single ECG waveform trace All other monitored values appear in numeric display areas at the bottom of the screen 9650 001355 01 Rev B X Series Operators Guide 3 3 CHAPTER 3 MONITORING OVERVIEW 06 06 2011 12 34 56 Adult You can display up to four waveform traces that you specify on the Waveform Display window You will determine how to add waveform traces to this window later in this chapter Press the Home Display button when viewing the Waveform Display window and the unit displays the Trends Status window The Trends Status window reports the patient s vital sign measurements which the X Series logs automatically at a configurable interval see the following chapter Trends for more detailed information about the Trends Status window The primary ECG waveform trace appears above the Trends report 3 4 www zoll com 9650 001355 01 Rev B 06 06 2011 CO SYNC E amp 9650 001355 01 Rev B 1
289. tient 3 Connect the sensor to the X Series unit 4 Configure SpO alarms and settings if the current SpO gt alarms and settings are not appropriate Pulse oximetry measurements begin as soon as the sensor is applied to the patient and connected to the X Series unit selecting the SpO Sensor When selecting the SpO sensor consider the patient s weight the adequacy of perfusion the available sensor sites and the anticipated duration of monitoring For more information refer to the Accessories section of this chapter which provides a list of ZOLL approved reusable and single use SpO gt sensors for adult pediatric and neonate patients Before applying the sensor always familiarize yourself with the Directions for Use that the manufacturer provides with the sensor Applying the SpO Sensor 10 4 Choose a site that is well perfused and restricts a conscious patient s movements the least The ring finger or middle finger of the nondominant hand is preferred Alternatively you can use the other digits on the nondominant hand Be sure the sensor s detector is fully covered by flesh You can use the great toe or long toe next to the great toe on restrained patients or patients whose hands are unavailable To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material if required Failure to take this precaution in high ambient light conditions may resu
290. tings menu specifies that the IBP systolic pressure alarms are enabled ON or disabled OFF and displays the default upper and lower systolic limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default IBP Systolic limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type IBP Systolic Limit Default IBP Systolic Limit Range Lower 75 mmHg Lower 30 to 298 mmHg Upper 220 mmHg Upper 28 to 300 mmHg Lower 75 mmHg Lower 30 to 298 mmHg Upper 145 mmHg Upper 28 to 300 mmHg Lower 50 mmHg Lower 30 to 298 mmHg Upper 100 mmHg Upper 28 to 300 mmHg Enabling Disabling IBP Alarms and Setting Alarm Limits Setting Upper and Lower Diastolic DIA Alarm Limits Initially the IBP Diastolic Alarm Settings menu specifies that the IBP diastolic pressure alarms are enabled ON or disabled OFF and displays the default Upper and Lower diastolic limits The upper and lower limits can be ON or OFF default is OFF The following table lists the default diastolic limits for adult pediatric and neonate patients and gives the range in which you can set these limits Patient Type IBP Diastolic Limit Default Lower 35 mmHg Upper 110 mmHg IBP Diastolic Limit Range Lower 30 to 298 mmHg Upper 28 to 300 mmHg Pediatric Lower 35 mmHg Upper 100 mmHg Lower 30 to 298 mmHg Upper 28 to 300 mmHg
291. tment Summary 9650 001355 01 Rev B X Series Operators Guide 23 3 CHAPTER 23 PRINTING Printing Trends 23 4 Printed trends are useful for reviewing the patient s vital signs over the last several minutes to the last five hours The X Series unit enables you to print vital signs data at one selected time or a trend summary showing vital signs values acquired during the current case up to the last 24 hours Printing Trend Summary Follow the steps below l 2 3 Use the navigation keys to highlight Trends and press Select Highlight Print Trend Summary and press Select The Trend Summary Report begins printing and Print Summary field changes to Cancel Report To cancel the report highlight Cancel Report and press Select Printing Individual Trend Snapshots Follow the steps below 1 Highlight Press the Select Button to Start Scrolling at the bottom of the Trends window then press Select 2 Using the navigation keys select the trend snapshot you want to print and press Select 3 Highlight Print this Trend and press Select The trend snapshot begins printing Printing Trend Data for Current or Older Cases You can print a trend summary for one or more cases by doing the following mele Press a l 2 Use the navigation keys to select the case or cases you want to print 3 4 Highlight the Print Trend Summary field and press Select The trend data for all the Press Select The case s appea
292. to AED operation When changing from AED mode to Manual mode the current selected energy level is maintained Note To transfer back to AED mode from Manual mode power down the unit for more than 30 seconds and less than two minutes then power it back up If you wait longer than two minutes the unit will reset the settings to the defaults and treat the case as a new patient 13 10 www zoll com 9650 001355 01 Rev B Warning Chapter 14 12 Lead ECG Interpretive Analysis The X Series 12 Lead input is Type CF defibrillator proof This chapter describes how to use the X Series unit to monitor 12 Lead ECG for adult and pediatric patients and how to display 12 Lead ECG Interpretive Analysis information for adult patients X Series 12 Lead ECG Monitoring provides simultaneous acquisition and storage of 12 Lead information for adult and pediatric patients and post acquisition Interpretive Analysis for adult patients 12 Lead ECG monitoring is intended for the recording 12 lead ECG signal acquisition and analysis from adult and pediatric patients in the supine resting position always ensure that the patient is kept motionless during 12 lead ECG signal acquisition and analysis Use of the device to acquire ECG signals from moving or shaking patients may produce noisy signals that are difficult to interpret 12 Lead Interpretive Analysis is for use with only adult patients Excessive body hair or wet sweaty skin may interfere
293. to come in contact with metal objects such as a bed frame as unwanted pathways for defibrillation current may result Press and hold the SHOCK button on the front panel until energy is delivered to the patient The delivered energy level is displayed at the bottom of the screen and the shock number 1 displays at the top of the screen and in the Defib Control panel at the bottom of the screen Note Ifat any time you want to cancel the defibrillation press the Disarm softkey If the defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself If additional countershocks are needed follow steps 1 through 3 of this procedure starting on page 16 3 to readjust the energy settings charge the unit and deliver shock Perform CPR Begin chest compressions and rescue breathing per local protocol 9650 001355 01 Rev B X Series Operators Guide 16 5 CHAPTER 16 ADVISORY DEFIBRILLATION Repeat Analysis Press the ANALYZE button to restart an ECG analysis and determine if additional shocks are required Note Reanalysis of the ECG rhythm is inhibited for 3 seconds after each shock Continue Patient Care Continue patient care according to medical protocols 16 6 www zoll com 9650 001355 01 Rev B Chapter 17 Advisory CPR Protocol Defibrillation ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection When the X S
294. tric patients can result in the delivery of excessive energy doses Advisory CPR Protocol Defibrillation Procedure Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse Begin CPR Following Local Medical Protocols Request additional assistance Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach hands free therapy electrodes according to instructions on the electrode packaging and as described in Therapy Electrode Application on page 15 6 Ensure that the electrodes are making good contact with the patient s skin and are not covering any part of the ECG electrodes If therapy electrodes are not making good contact with the patient s skin the unit issues the message CHECK PADS and does not allow delivery of energy 17 2 www zoll com 9650 001355 01 Rev B Advisory CPR Protocol Defibrillation Procedure 1 Turn on unit WARNING Press the green power switch located on the top of the unit The green yellow and red lights on the top of the unit flash on and off and the unit displays the message SELF TEST PASSED If the unit is in AED mode press the Manual Mode quick access key on the front panel of the unit to enter the Manual mode of operation Using the navigation keys sel
295. ts Pulse Rate bpm During Motion Conditions Adults Pediatrics Neonates 25 240 5 digits Resolution SpO 1 SpCO 1 SpMet 0 1 for range up to 9 9 1 for range 10 99 Pulse rate 1 bpm beats per minute Alarm Limits On Off displayed on monitor User selectable SpO High 72 100 saturation Low 70 98 saturation SpCO High 2 100 saturation Low 0 99 saturation SpMet High 1 100 saturation Low 0 99 saturation Pulse Rate High 60 235 beats per minute Low 20 100 beats per minute SpO Wavelength for LNCS Sensors Nominal Red LED Wavelength 660 nanometers Nominal Infrared LED Wavelength 905 nanometers Energies Radiant Power of light for LNCS Sensors at 50 mA pulsed lt 15 mW SpO Wavelength for Rainbow Sensors The Rainbow sensors use 8 different LEDs with wavelengths of 610 905 nanometers A 20 www zoll com 9650 001355 01 Rev B Pulse Oximeter Energies Radiant Power of light for Rainbow Sensors at 100 mA pulsed lt 25 mW Bio Compatibility Patient contacting material meets requirements of ISO 10993 1 Biological Evaluation of Medical Device Part I for external devices intact surfaces and short term exposure Environmental Operating Temperature 0 to 50 C 32 to 122 F Storage Temperature 40 to 70 C 40 to 158 F Electromagnetic Immunity SpO Option Only AAMI DF 80 EN61000 4 3 2002 to 10 V m Note The X Series Pulse Oximetry Option is calib
296. uidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people A 32 www zoll com 9650 001355 01 Rev B ECG Analysis Algorithm Accuracy Rhythms ECG Analysis Algorithm Accuracy Sensitivity and specificity are expressions of ECG analysis algorithm performance when compared to ECG interpretation by a clinician or expert Sensitivity refers to the algorithm s ability to correctly identify shockable rhythms as a percentage of the total number of shockable rhythms Specificity refers to the algorithm s ability to correctly identify non shockable rhythms as a percentage of the total number of non shockable rhythms The data in the following table summarizes the accuracy of the ECG analysis algorithm as tested against ZOLL s ECG Rhythm Database The algorithm sequence takes approximately 9 seconds and proceeds as follows e Divides the ECG rhythm into three second segments e Filters and measures noise artifact and baseline wander e Measures baseline content waviness at the correct frequencies frequency domain analysis of signal e Measures QRS rate width and variability e Measures amplitude and temporal regularity auto correlation of peaks and troughs e Determines if multiple 3 second segments are shockable then displays SHOCK ADVISED message Clinical Performance Results The performance of the incorporated analysis
297. ult values The X Series unit can monitor the following patient vital signs e ECG e Heart Rate e Respiration Rate e Temperature e Invasive Pressures IBP e Non invasive Blood Pressure NIBP e Capnography CO3 e Pulse Oximetry SpO gt 9650 001355 01 Rev B X Series Operator s Guide 3 1 CHAPTER 3 MONITORING OVERVIEW ECG An ECG waveform trace appears at the top of the display area You can specify that the unit display the waveform trace of any available ECG source such as Pads ECG Leads I Ill or IH and so on in this area You can configure the X Series unit to display up to four ECG waveform traces In addition to being able to specify the ECG source for each waveform trace you can adjust the display scale of those traces to make them easier to view Heart Rate A Heart Rate meter gives the patient s heart rate in Beats Per Minute bpm By default the X Series unit derives the heart rate from the patient s ECG but can be configured to use other monitoring functions to derive the patient s heart rate Respiration Rate A Respiration Rate meter gives the patient s respiration rate in Breaths Per Minute br min The X Series unit can be configured to derive the respiration rate from the patient s ECG or from the optional CO monitoring function Temperature The Temperature Temp meter can display temperature measurements from up to two temperature probes The X Series unit provides two separate
298. ure A 9 Rectilinear Biphasic Waveform at 20 Joules 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm e 150 Ohm 175 Ohm 200 Ohm Figure A 10 Rectilinear Biphasic Waveform at 15 Joules A 8 www zoll com 9650 001355 01 Rev B Defibrillator 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 11 Rectilinear Biphasic Waveform at 10 Joules 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 12 Rectilinear Biphasic Waveform at 9 Joules 9650 001355 01 Rev B X Series Operator s Guide Specifications 25 Ohm 50 Ohm 4 amp 75 Ohm 100 Ohm 125 Ohm 150 Ohm t 175 Ohm 200 Ohm ms Figure A 13 Rectilinear Biphasic Waveform at 8 Joules 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 14 Rectilinear Biphasic Waveform at 7 Joules A 10 www zoll com 9650 001355 01 Rev B Defibrillator 25 Ohm 50 Ohm A 75 Ohm 100 Ohm 125 Ohm 150 Ohm 175 Ohm 200 Ohm ms Figure A 15 Rectilinear Biphasic Waveform at 6 Joules 25 Ohm 50 Ohm 75 Ohm 10
299. ut their depth is consistently less than the target depth AHA ERC 2005 1 75 AHA ERC 2010 2 0 the device periodically issues the Push Harder voice prompt If the rescuer responds by increasing compression depth to more than the target depth on a consistent basis the unit issues a Good Compressions prompt 9650 001355 01 Rev B X Series Operator s Guide 19 3 CHAPTER 19 REAL CPR HELP CPR Idle Time Display This display indicates the elapsed time in minutes and seconds since the last detected chest compression Ten seconds following the cessation of compressions the idle time is displayed As soon as a new compression is detected the idle time is removed from the screen If no compressions have been detected for at least 20 minutes dashes are displayed in this time field CPR Idle CPR Countdown Timer The X Series unit displays a CPR Countdown Timer to indicate the time in minutes and seconds left in the current CPR interval It decrements the time until it reaches zero The CPR dashboard disappears if the CPR electrodes are disconnected CPR CPR Time 1 485 CPR Countdown Depth in Rate cpm PPI Timer CPR Compression Bar Graph The X Series unit can display a CPR compression bar graph computed from the CPR sensor signals This bar graph representing depth of compression is presented on a AHA ERC 2005 0 2 1 AHA ERC 2010 0 2 5 inch displacement scale with reference markers at AHA ER
300. utton instead of the paddle SHOCK buttons will produce an audible invalid operation tone The delivered energy level is displayed at the bottom of the screen and the shock number 1 displays at the top of the screen and in the Defib Control panel at the bottom of the screen Note Ifat any time you want to cancel the defibrillation press the Disarm quick access key If the defibrillator is not discharged within 60 seconds after reaching the selected energy level the unit automatically disarms itself If additional countershocks are needed follow steps 1 through 3 of this procedure starting on page 15 2 to readjust the energy settings charge the unit and deliver the shock 9650 001355 01 Rev B X Series Operators Guide 15 5 MANUAL DEFIBRILLATION Emergency Defibrillation Procedure with Hands Free Therapy Electrodes J ZOLL hands free therapy electrodes are a defibrillation protected Type BF patient connection 4 g L ECG leads are a defibrillation protected Type CF patient connection Determine the Patient s Condition Following Local Medical Protocols Verify e Unconsciousness e Absence of breathing e Absence of pulse Begin CPR Following Medical Protocols Request additional assistance Prepare Patient Remove all clothing covering the patient s chest Dry chest if necessary If the patient has excessive chest hair clip or shave it to ensure proper adhesion of the electrodes Attach hands free therapy
301. ve much but not all of the artifact from the ECG signal Under some conditions residual noise after filtering can obscure the ECG rhythm requiring the rescuer to stop CPR to assess the ECG For example in the case 9650 001355 01 Rev B ZOLL X Series Operator s Guide 20 1 CHAPTER 20 SEE THRU CPR OPTIONAL of asystole or low amplitude PEA the residual artifact seen after filtering may look like fine ventricular fibrillation Because the filtered ECG signal may contain residual chest compression and or filtering artifacts a rescuer should always follow the standard procedure of stopping CPR to assess the patient s ECG rhythm before determining treatment Using See Thru CPR To use See Thru CPR e The X Series unit must be monitoring CPR e ZOLL OneStep CPR pads OneStep Complete pads or CPR D padz must be attached to the unit When chest compressions begin the X Series unit automatically starts filtering the CPR artifact after detecting the first 3 to 6 compressions The filtered ECG with the label FIL may be displayed on the second or third trace by selecting FILT ECG in the Trace2 or Trace3 menu See Thru CPR filtering continues as long as the OneStep CPR OneStep Complete or CPR D padz detect compressions and patient impedance is valid When no compressions are detected or one of the conditions noted above occurs See Thru CPR filtering stops and unfiltered ECG signals are displayed When compressions resume filteri
302. with electrode adhesion Remove the hair and or moisture from the area where the electrode is to be attached Remove ECG electrodes from their sealed package immediately prior to use Using previously opened or out of date electrodes may degrade the ECG signal quality Monitoring electrodes may become polarized during defibrillator discharge causing the ECG waveform to briefly go off screen ZOLL Medical Corporation recommends the use of high quality silver silver chloride Ag AgCl electrodes to minimize this effect the circuitry in the instrument returns the trace to the monitor display within a few seconds 9650 001355 01Rev B X Series Operator s Guide i tti s s A CHAPTER 14 12 LEAD ECG INTERPRETIVE ANALYSIS Wait 15 seconds after defibrillator discharge before attempting a 12 lead acquisition Electrode polarization subsequent to defibrillator discharge may result in excessive noise on the 12 lead ECG printout When not in use cover the patient cable s V lead connector with the supplied plastic cap Failure to do so may result in a shock hazard during defibrillation attempts To assure protection against the effects of defibrillator discharge use only 12 lead cables supplied by ZOLL Medical Corporation Check the operation and integrity of the X Series unit and 12 lead cable regularly by performing the Daily Operational Verification Test When attempting to interpret subtle ECG changes such as ST segments use only the
303. word Once you have set up a wireless connection you can send 12 lead reports to an email or fax recipient Data can also be retrieved automatically using ZOLL RescueNet or ePCR software This chapter describes how to select different recipients and how to set up wireless communications in the X Series unit for different types of recipients Important Test all wireless connections after initial setup and prior to use 9650 001355 01 Rev B X Series Operator s Guide 22 1 CHAPTER 22 WIRELESS COMMUNICATIONS The Wireless Icon The wireless icon is located to the right of the patient mode in the display screen It has three possible states shown the table below If wireless connectivity is disabled no icon is displayed State Description Connected Wireless connectivity is available WiFi Bluetooth USB cellular Cp modem Not connected Wireless connectivity is not available due to incorrect configuration or Ea weak no signal strength Wireless communication hardware has failed Failed You can select this icon to access the Wireless menu and view preconfigured WiFi access points paired devices or distribution lists or set up a temporary WiFi access point or Bluetooth connection Use the navigation keys to select the wireless icon Wireless icon 16 50 19 22 2 www zoll com 9650 001355 01 Rev B The Wireless Menu The Wireless Menu The Wireless menu has the following options WiFi Access Poi
304. y of ZOLL s Rectilinear Biphasic Waveform was compared to a monophasic damped sine waveform in a prospective randomized multi center study of patients undergoing cardioversion of their atrial fibrillation A total of 173 patients entered the study Seven 7 patients who did not satisfy all protocol criteria were excluded from the analysis ZOLL disposable gel electrodes with surface areas of 78 cm anterior and 113 cm posterior were used exclusively for the study Objective The primary goal of the study was to compare the total efficacy of four consecutive rectilinear biphasic shocks 70J 120J 150J 170J with four consecutive monophasic shocks 100J 200J 300J 360J The significance of the multiple shocks efficacy was tested statistically via two procedures the Mantel Haenszel statistic and the log rank test significance level of p 0 05 or less was considered statistically significant The data are completely analogous to the comparison of two survival curves using a life table approach where shock number plays the role of time The secondary goal was to compare the first shock success of rectilinear biphasic and monophasic waveforms A significance level of p 0 05 or less was considered statistically significant using Fisher Exact tests Also differences between the two waveforms were considered statistically significant when the 95 confidence interval between the two waveforms was greater than 0 www zoll com 9650 001355 01 Rev B

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