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HeartStart XL+ Defibrillator/Monitor Manual

1. NOTES The presence of multiple alarm conditions at the same time is quite possible To avoid confusion and to make sure a less serious condition does not hide a more serious condition the HeartStart XL prioritizes and categorizes alarms so the highest priority alarm condition is announced If multiple same parameter same priority alarms occur all alarms are displayed one at a time Physiological alarms are not detected or displayed in a non clinical mode Only technical alarms are displayed in non clinical modes 33 3 Working with the HeartStart XL Alarms Clinical Mode Alarm Notification When in a Clinical Mode the HeartStart XL can be configured to react differently when an alarm condition occurs See Table 3 Table 3 Alarm Notification Types Notification Indication on Display Indication Status Alarms On None Both visual and audio indications are on Pause Audio Pause timeframe which is configurable When the pause timeframe is complete both audio and visual indications are on Alarm Audio icy Only visual indications are on for the duration of the EN Audio Pause Alarm Audio Off Only visual indications are on DX Audio Off Alarms Off VAN Alarms Off Both audio and visual indications are off for a set period of time All alarm conditions are cleared when you switch from a clinical mode to a non clinical mode Ifyou intentionally disconnect a sensor an alarm sounds Press the M
2. 6 Check your ECG and then re confirm your energy dose and waveform Press and hold the Shock button on the HeartStart XL or if using external paddles press and hold the orange buttons on both paddles It is important to continue to hold the Shock button or the paddle buttons until the shock is delivered The defibrillator shocks with the next detected R Wave Once the shock is delivered release the shock button The Shock counter increases by one WARNINGS Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation Do not change the energy level while holding the Shock button down NOTE Ifan ECG or pads technical alarm occurs while performing synchronized cardioversion the HeartStart XL does not charge and if charged disarms automatically With External Paddles Carefully review the waveform immediately prior to administering synchronized cardioversion and confirm that you have a non paddles wave label WARNING When performing synchronized cardioversion through external paddles you should not use paddles as your monitoring lead in Wave Sector 1 Artifact introduced by paddle movement may resemble an R Wave arrow and trigger a defibrillation shock Use external paddles as a monitoring lead for Synchronized Cardioversion only if no other lead source is available and you are in an emergency situation loc an 7 Cardiov
3. Overview Intended Use Indications for Use Safety Considerations Getting Started Documentation and Training Chapter 2 Device Basics Introduction Basic Orientation Front of the Device Right Therapy Side Connecting the Therapy Cable Left Monitor Side Top Panel Back Panel Accessory Storage System Installing Paper Test Plug amp Test Load Chapter 3 Working with the HeartStart XL Operating Modes Controls 2 e 4 Therapy Knob and Controls General Function Buttons Soft Keys Ready For Use Indicator Power ea Lithium Ion Battery Power Indicators w amp Turning the HeartStart XL On Turning the HeartStart XL Off Device Shutdown The Display Status Area Parameter Area Message Area 21 21 22 22 23 23 24 24 25 25 26 26 26 27 27 28 29 Ill Table of Contents Waveform and Display Soft Keys Area Adjusting Volumes Alarms Clinical Mode Nee Notation f Responding to Alarms Entering Patient Information Continued Use Passwords Safety Considerations Chapter 4 ECG Monitoring Overview Preparing to Monitor ECG Skin Preparation Monitoring ECG with Pads Monitoring ECG with Electrodes Monitor View Selecting the Warton Displaying an Annotated ECG Arrhythmia Monitoring Aberrantly Conducted Beats Intermittent Bundle Branch Block Arrhythmia Learning Relearning Heart Rate and Arrhythmia Alarms S
4. 2 Palpate and count down the chest until you locate the fourth intercostal space Lead Selection It is important to select a suitable lead for monitoring so that a QRS complex can be accurately detected For non paced patients e QRS complex should be tall and narrow recommended amplitude gt 0 5mV e R Wave should be above or below the baseline but not biphasic e P Wave should be smaller than 1 5 R wave height e T Wave should be smaller than 1 3 R wave height NOTE To prevent detection of P Waves or baseline noises as QRS complexes the minimum detection level for QRS complexes is set at 0 15 mV according to AAMI EC 13 specifications If the ECG signal is too weak you may get false alarms for asystole For paced patients with internal transvenous pacemakers e Confirm paced status is set correctly on the HeartStart XL see Entering Patient Information on page 38 e All four criteria for non paced patients listed above e Large enough to be detected half the height of the QRS complex with no re polarization artifact Some unipolar pacemakers display pace pulses with re polarization tails which may be counted as QRSs in the event of cardiac arrest or other arrhythmias Choose a lead to minimize the size of re polarization tails NOTE Adjusting the ECG wave size on the display does not affect the ECG signal which is used for arrhythmia analysis Lead Choices Available monitoring leads vary depending on w
5. e Select a sensor appropriate for the patient s weight e Select a sensor site with adequate perfusion e Improve perfusion at the site by rubbing or warming the site e Avoid application to sites with edematous tissue SpO sensors are either reusable or disposable Reusable sensors can be reused on different patients after they have been cleaned and disinfected see the manufacturer s instructions supplied with the sensor Disposable sensors should only be used once and then discarded They may be relocated to another appropriate site on the same patient but not reused on different patients See SpO Sensors and Cables on page 193 for a list of SpO sensors and accessories that can be used with the HeartStart XL CAUTIONS Do not use disposable sensors in high humidity environments or in the presence of fluids which may contaminate sensor and electrical connections causing unreliable or intermittent measurements Do not use disposable sensors on patients who have allergic reactions to adhesive Do not use more than one extension cable M19414A Do not use the ear transducer on patients with small ear lobes as incorrect measurements may result Applying the Sensor Follow the manufacturer s directions for applying and using the sensor making sure to observe any warnings or cautions For best results e Make sure the sensor is dry e Ifthe patient is moving secure the sensor cable loosely to the patient e M
6. 4 wo On BW Select the pacer rate by pressing the Rate soft key Use the upper portion of the soft key to increase the rate and the lower portion of the soft key to decrease the rate If needed adjust the initial pacer output Press the Output soft key Use the upper portion of the soft key to increase the output and the lower portion of the soft key to decrease the output Press Start Pacing Pacing appears in the Pacing Bar If you have an ECG waveform verify white pacing markers appear Verify the presence of a peripheral pulse and increase output if required Press the Output soft key a Use the upper portion of the soft key to increase the output until cardiac capture occurs If the ECG is on the display capture is indicated by the appearance of a QRS complex after each pacing marker b Use the lower portion of the soft key to decrease the output to the lowest level that still maintains capture 10 Assess the patient for a peripheral pulse Pulse alarms are automatically turned on 8 Pacing Defibrillating During Pacing To stop pacing e Press the Pause Pacing soft key A prompt message asks you to confirm your action Using the Navigation buttons select Yes to pause pacing select NO to continue pacing Once paused press the flashing Start Pacing soft key to resume pacing OR e Move the Therapy knob away from the Pacer position e a ee ee ee WARNINGS Use care when handling the multifunction e
7. A Documentation and Training Philips Healthcare provides several additional options for HeartStart XL documentation and training besides these Instructions for Use including e Quick Reference Card e Battery Application Note e ECG Quality Application Note e Algorithm Application Notes e Shift Checklist e User Training DVD e Service Manual and Training program e Web based Training NOTE Other application notes can be found on the Philips website at www philips com ProductDocs 2 Device Basics Introduction Combining Philips experience in resuscitation with the current wants and needs of today s medical environment the HeartStart XL has been designed with the clinician in mind Philips pioneered 1 2 3 defibrillation for you to defibrillate a patient and save a life quickly and easily HeartStart XL controls indicators menus and icons were carefully designed and organized to facilitate ease of use Display information is designed to present key information for the current task This chapter provides a basic orientation on the HeartStart XL s external features including the various color coded cable ports installing the battery and printer paper and optional external paddles See Working with the HeartStart XL on page 21 for instructions on how to operate the device NOTES If your HeartStart XL does not have some of the optional functionality listed in this chapter disregard these control
8. Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring electrodes lead wires dressings etc Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart During defibrillation air pockets between the skin and multifunction electrode pads may cause patient skin burns To help prevent air pockets make sure the pads completely adhere to the skin Do not use dried out pads Do not open pads package until just prior to use Never touch the patient or any equipment connected to the patient including the bed or gurney during defibrillation Avoid contact between the patient and conductive fluids and or metal objects such as the gurney Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation CAUTION Do not discharge the defibrillator with the paddles shorted together NOTES The neonatal patient category is not supported for monitoring For these patients use a separate monitor for monitoring Successful resuscitation depends on many variables specific to the patient s physiological state and the circumstances surrounding the patient event Failure to have a successful patient outcome is not a reliable indicator of defibrillator monitor performance The presence or absence of muscular response to the transfer of energy during electrical therap
9. Light E Emitting Diodes lt _____ Photodetector A photodetector positioned opposite the light emitting diodes compares the light absorbtion before and after pulsation The amount of light getting through reflects the blood flow in the aterioles This measurement of light absorbtion during pulsation is translated into an oxygen saturation percentage The SpO value and wave are displayed WARNING SpO readings can be inaccurate in patients that e Are hypothermic e Are acidotic e Are receiving a photosensitive drug e Are receiving vasoconstrictor medications e Have poor circulation NOTE For accurate SpO measurements the following conditions must apply e The patient must have perfusion in that extremity e The light emitter and photodetector must be directly opposite each other e All of the light from the emitter must pass through the patient s tissue e The sensor site should be free of vibration and excessive motion e The sensor cable and connector should be positioned away from power cables to avoid electrical interference 100 Understanding Pulse Oximetry 9 Pulse Oximetry Selecting a Sensor The most important factor when selecting a sensor is the position of the light emitting diodes in relation to the photodetector When the sensor is applied the diodes and the photodetector must be opposite each other Sensors are designed for patients with a specific weight range and for specific sites Be sure to
10. ful Operational S Baer acai Ch ck 2 Turn knob to 170 Required xit Proceed NOTE tis important to complete all instructions listed on the Setup screen in order to successfully complete an Operational Check Approximately 10 seconds after entering Operational Check a Proceed As Is prompt appears in the lower right corner of the display This prompt allows you to continue with the Operational Check if the device is not responding to actions you have taken during Setup Selecting Proceed As Is while there are still required items listed in the setup instructions causes Operational Check failures 153 14 Operational and Shift Checks Operational Check Operational Check Results Each test that makes up the Operational Check either passes or fails see Figure 73 for an example Figure 73 Operational Check In Process Screen Operational Check Reference Number Device Reference Number Serial Number Device Serial Number Last Operational Check 23Jan2011 04 32PM Pass General System Test Pass Therapy Knob Pass Charge Button Pass Shock Button Pass Audio Test Pass Sync Button Fail Therapy Delivery Test Fail arames o OOl Pads Paddles ECG Test Battery Test Sp0 Test NBP Test Printer Test NOTE Text Data appearing in parenthesis in Figures 72 and 73 are replaced by device information in an actual screen For example Device Serial Number is replaced with the device s serial number Once th
11. 0123 mark accordingly Manufacturer Philips Medical Systems 3000 Minuteman Road Andover MA USA 01810 1099 978 687 1501 Authorized EU representative Philips Medizin Systeme B blingen GmbH Hewlett Packard Str 2 71034 Boblingen Germany Canada EMC ICES 001 For the Declaration of Conformity Statement please see the Philips Healthcare web site at http incenter medical philips com PMSPublic Scroll over the Quality and Regulatory tab located in the upper left corner of the window Click to see the regulatory by Modality Then click to select Defibrillators and select the entry for Declaration of Conformity DoC Chemical Content REACH requires Philips Healthcare to provide chemical content information for Substances of Very High Concern SVHC if they are present above 0 1 of the product weight Components of within electric and electronic equipment may contain phthalates above the threshold e g bis 2 ethyl hexyl phthalate CAS nr 117 81 7 the REACH SVHC list is updated on a regular basis Therefore please refer to the following Philips REACH website for the most up to date information on products containing SVHC above the threshold http www philips com about sustainability reach page Warning Radio frequency RF interference coming from devices other than the HeartStart XL may degrade the performance of the device Electromagnetic compatibility with surrounding devices should be assessed pr
12. 3 Open the package and connect the pads connector to the end of the Therapy cable see Figure 5 NOTE Ifyou are using Philips HeartStart Preconnect Pads 989803166021 there is no need to open the pads package to connect the pads connector to the Therapy cable Figure5 Connecting Multifunctional Pads SEA T 4 Apply the pads to the patient as directed on the pads packaging or according to your organization s protocol Basic Orientation 2 Device Basics Left Monitor Side The left side of the HeartStart XL is dedicated to monitoring key vital signs see Figure 6 It has ports for ECG SpO and NBP Figure6 Left Monitor Side View Cable Wrap Snap a lt q White ECG port 6 4 Blue SpO port d TE Red NBP port Storage Pouch Connectors Connecting the ECG cable To connect a 3 or 5 Lead cable 1 Align the ECG cable with the white ECG port see Figure 7 The white key marker on the ECG cable faces the top of the device 2 Push the ECG cable firmly into the ECG port Figure7 Connecting the ECG Cable 2 Device Basics Basic Orientation 10 Connecting the SpO Cable To connect the SpO cable 1 Hold the cable connector with the flat side and blue marking facing the front of the HeartStart XL see Figure 8 2 Insert the cable into the blue SpO port and push the blue portion of the connector into the device until it is no longe
13. Table 28 Date Time Format Parameter Description Setting Choices Time Format Defines the time format 12 Hour 24 Hour Date Format Defines the date format DD Mon YYYY YYYY MM DD D Day M Month Y Year Auto Daylight Defines whether or not your Yes No Savings Time DST device auto corrects for Daylight Savings Time DST offset Defines the hour and minute 2 hours 1 hour time shift during DST adjusted in 30 minutes increments Month Defines the month DST DST Start Settings DST End Settings begins ends Any of the 12 months Any of the 12 months March November Week of Month Defines the week DST First Second Third First Second Third begins ends Fourth Last Fourth Last Day of Week Defines the day DST Any day of the week Sunday begins ends Hour Defines the hour DST 00 23 if 24 hour format 01 12 if 12 hour begins end format 2 Minute Defines the minute DST 00 59 00 begins end am pm Defines the 12 hour segment am pm DST begins end NOTE Daylight Saving Time changes occur when the next event is started The time does not change in the middle of an event that crosses over the DST change Table 29 General Settings Parameter Description Setting Choices Patient Category Selects the default patient category Adult Infant Child Alarm Tone Defines either traditional Philips or IEC standard alarm tones Philips IEC Alarm Pause Time Defines the interval o
14. The USB flash drive is full Delete or remove files from the flash drive to free up space or use a different flash drive You can t import a configuration file from the USB flash drive The flash drive does not contain a configuration file Save a new configuration file to the flash drive and re try USB Flash Drive Error message on display The USB flash drive was removed during data transfer Re insert the USB flash drive and re try Error Reading Configuration Data message on display The configuration file has become corrupted Save a new configuration file to the flash drive and re try USB Power Overload technical alarm A USB power overload has been detected at the USB port Turn the device off for 15 seconds Replace the USB device If the problem also occurs with a second USB device call for service 186 Calling For Service 16 Troubleshooting Calling For Service For telephone assistance call the Response Center nearest to you or visit Philips website at www healthcare philips com In the United States call 1 800 722 9377 For other telephone numbers worldwide 1 Visit www healthcare philips com 2 Click on the appropriate region of the world where you are located 3 Click on the Healthcare dropdown menu 4 Click on the Contact Us side menu 187 NOTES 17 Supplies amp Accessories This chapt
15. Cancelled audio message seea passed and the energy delivered is150J 15J 135J to the energy delivered is150J Shock Aborted alarm on the 165J If not confirm you did the test properly before 15 135J to 165J If not display and the printed strip taking the device out of use and calling for service confirm you did the test indicates Test Passed If not properly before taking the confirm you did the test properly device out of use and calling before taking the device out of for service use and calling for service 7 Detach test load plug from the Therapy cable so your device is Test complete reattach them Test complete ready for use when needed Do not leave the test load plug attached to the Therapy cable If you use preconnected pads NOTES For more information on the differences between a test load and test plug see Test Plug amp Test Load on page 19 If you perform a Weekly Shock Test with internal paddles and corresponding test equipment the HeartStart XL must be set to 50J Refer to the test equipment manufacturer s instructions for information on interpreting results of the test If you use external paddles and have the Pacing option you should confirm pads functionality by performing an Operational Check 148 Shift Check HeartStart XL Shift Checklist 14 Operational and Shift Checks Inspect the HeartStart XL accessories and supplies at the change of every
16. a learning process is initiated The goal is to learn the patient s normal complexes and or paced complexes if the patient with an internal transvenous pacemaker is in paced rhythm The learning process involves the first 15 valid non noisy beats encountered during the learning phase The QRS selected to represent the normal complex includes the beat that is the most frequently seen narrowest on time beat For this reason learning should not be initiated when the patient s rhythm is primarily ventricular Arrhythmia Monitoring 4 ECG Monitoring Arrhythmia learning relearning automatically occurs when e The Therapy knob is turned to Monitor Pacer AED or Manual Defib e Any time there is a change in the lead selection for Wave Sector 1 e After the correction of a leads or pads off condition that has been active longer than 60 seconds Initiate manual relearning if the beat detection is not occurring or if beat classification is incorrect and results in a false alarm Remember if the same signal condition which caused the algorithm to perform poorly still exists relearning does not correct the problem The problem can only be corrected by improving the signal quality e g selecting a different lead To initiate relearning manually 1 Press the Menu Select button 2 Using the Navigation buttons select Measurements Alarms and press the Menu Select button 3 Select HR Arrhythmia and press the Menu Select button 4 Sele
17. and NBP are available Measurements and waves are presented on the display and alarms are available to alert you to a change in the patient s condition You can also display the Vital Signs Trending Report to view all key monitoring parameters and their measurements at a glance Manual Defibrillation Mode provides simple 1 2 3 defibrillation You analyze the patient s ECG and if appropriate 1 select an energy setting 2 charge and 3 deliver the shock Defibrillation is performed using paddles internal or external or multifunction electrode pads You can also perform synchronized cardioversion in Manual Defibrillation Mode In AED Mode the HeartStart XL analyzes the patient s ECG and determines whether a shock is advised Voice prompts guide you through the 2 step defibrillation process while easy to follow instruction and patient information including Adult and Infant Child patient categories appear on the display Voice prompts are reinforced by messages on the display Optional Pacing Mode offers non invasive transcutaneous pacing therapy Pace pulses are delivered through multifunction electrode pads in Demand or Fixed modes The HeartStart XL incorporates Philips low energy SMART Biphasic waveform for defibrillation 1 Introduction Overview The HeartStart XL automatically stores critical event data such as Event Summaries and Vital Signs Trending You can also transfer the data to a USB drive and download it to a compat
18. arrows appear when the device is in Sync Mode Monitor Mode or Demand Mode Pacing Figure 32 Wave Sector 1 Markings i A A R VVave Arrows Lead Label gt Calibration Bar Auto Gain Indicator gj Rhythm Label After the ECG analysis algorithm analyzes the waveform in Wave Sector 1 it labels the rhythm Possible labels include Learning ECG V Tach Sinus Tachy SV Tachy Learning Rhythm Paced Rhythm e SV Brady Unknown ECG Rhythm Asystole Sinus Brady SV Rhythm Cannot Analyze ECG e V Fib Tach Sinus Rhythm 29 3 Working with the HeartStart XL The Display NOTES In synchronized cardioversion mode the R Wave arrows indicate which R Waves would trigger a shock if the shock button is pressed In Demand Mode Pacing the time until the next delivered external pace pulse is from the previous pace pulse or the R Wave arrow whichever is the most recent R Waves immediately after the an external pace pulse are not marked because they are likely caused by the pace pulse The displayed heart rate is determined by the arrhythmia analysis which is independent from R Wave arrows for synchronized cardioversion or for Demand Mode pacing 30 Wave Sectors 2 amp 3 Wave Sectors 2 and 3 are automatically populated when the parameter source s cable is connected to the HeartStart XL If the parameter source is the configured choice of a particular wave sector it is displayed in that wave sector wh
19. connecting 7 therapy knob 22 three steps 78 time to auto disarm 143 troubleshooting 180 with pads 76 Manual NBP measurements 112 Marginal impedance messages 68 Mark Event 119 134 button 6 23 configuration options 144 event markers 132 Event Summary 120 events stored in Event Summary 127 pacing 89 print options 145 Markers in Pacer Mode 90 Mean NBP 113 Measuring NBP 110 Menu Select button 23 31 location 6 Menus 31 grayed out options 31 Mercury 171 Message area 29 Modifying configuration settings 137 Monitor SpO 102 Monitor Mode 1 Alarms button 23 Mark Event button 23 trending 115 Monitor View 49 dashed lines 50 Monitoring ECG with electrodes 45 with pads 44 Mounting solutions 194 MRI 99 Multifunction electrode pads 8 accessories 189 Operational Check results 157 preconnected 63 76 troubleshooting 178 181 Weekly Shock Test 148 N Navigating Trends Reports 116 Navigation button 23 31 location 6 NBP 109 accessories 192 adjusting numeric values 32 AED 109 alarm limits 109 114 alarms 113 Alarms button 23 automatic measurements 112 calibration 114 changing automatic schedule 112 cleaning cuff 114 171 configuration options 141 connecting NBP cable 10 connecting the cuff 110 cuff deflation 110 cuff pressure 109 diastolic 113 enabling alarms 114 Event Summary 112 120 events stored in Event Summary 123 124 indications for use 3 initial cuff pressure 110 NBP 109 manual
20. examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the blood pressure measurements immediately Blood pressure readings may be affected by the position of the patient their physiologic condition the presence of arrhythmia and other factors To obtain accurate blood pressure readings the cuff must be the correct size and also be correctly fitted to the patient Incorrect size or incorrect fitting may result in incorrect readings a a a T E CAUTIONS Do not compress or restrict pressure tubes during an NBP measurement If a spill occurs and liquid appears inside the tubing contact your service personnel NOTE When utilizing NBP use your clinical judgment on appropriate application for patient s clinical status 111 10 Blood Pressure Monitoring Measuring NBP NOTE NBP Schedule NBP measurements can be taken on a manual or predetermined automatic basis depending on how the device is configured and the patient s needs Manual There is no schedule for additional measurements One measurement is taken each time you press the Start NBP soft key Take additional measurements by pressing the Start NBP soft key Automatic A measurement is attempted at configured intervals every 1 2 5 5 10 15 30 60 or 120 minutes In order for a measurement to successfully begin any previous measurement has to have ended the cuff must be deflated and 3
21. set the knob back to 150J when prompted to do so Operational Check runs automatically If you choose to proceed without setting up properly the Operational Check may fail 9 During the Operational Check when a response is required use the Navigation buttons to select your answer and the Menu Select button to confirm your choice As each test runs the name of the test appears highlighted on the display with the message In Progress See Figure 73 Operational Check 14 Operational and Shift Checks NOTE Once you have pressed the Sync button you can leave the HeartStart XL unattended as Operational Check completes its process If you cancel the Operational Check before it completes all tasks there is no record of the check in the Operational Check Summary 10 After the automated part of Operational Check concludes an Operational Check Report is printed see Printing Operational Check Results on page 158 WARNING When the shock button is pressed during Operational Check energy is delivered through the pads paddles into the defibrillator test plug test load or paddles pockets Make sure that the test plug or test load is connected or that the paddles are seated in the holders properly Figure 72 Operational Check Setup Screen 25 Jan 2011 11 10pm Operational Check Reference Number Device Reference Number Serial Number Device Serial Number Last Operational Check 23Jan2011 04 32PM Pass Prompts for
22. 1 Hold the Navigation buttons down to accelerate through the numeric values Release the Navigation button to stop scrolling To exit press the Menu Select button Figure 35 Setting Numeric Values Title HR High Limit Increase Arrow gt A 1 5 0 Decrease Arrow gt V The Increase Decrease arrow icons are not shown if the displayed value is at the upper lower limit of bpm Current Value Unit of Measure the range NOTE Accelerated scrolling is not available when selecting a low energy 1 10 Joule setting Adjusting Volumes The volume levels for alarms voice prompts and the QRS indicator are adjustable To adjust the volume for the current event 1 Press the Menu Select button 2 Using the Navigation buttons select Volume and press the Menu Select button 3 Select the volume type Alarm Voice QRS you wish to adjust and press the Menu Select button NOTE You can adjust one volume type without affecting the other volume types For example adjusting the QRS volume does not affect the volumes for alarms and voice 4 Select the new volume level and press the Menu Select button The new volume level remains in place for the duration of the current event Use Configuration Mode to adjust the default volume levels See Configurable Parameters on page 139 Alarms 3 Working with the HeartStart XL Alarms The HeartStart XL provides various types of alarms indicating changes in patient con
23. 2500 2000 1500 1000 Voltage V 1000 1500 0 5 10 15 20 25 e075 00 e125 50 175 Time ms Manual Defibrillation Mode Manual Output Energy Selected 1 10 15 20 30 50 70 100 120 150 170 200 Joules maximum energy limited to 50J with internal paddles Controls On Off Therapy knob Charge Shock Sync ECG Lead Select Patient Selection Print Mark Events Reports Alarms Menu Select Navigation Energy Selection Front panel Therapy knob Charge Control Front panel button button on external paddles Shock Control Front panel button buttons on external or switched internal paddles Synchronized Control Front panel Sync button Synchronized Shock Timing Maximum time from R Wave detected to shock delivered is 25ms as measured with oscilloscope from peak of input QRS wave to leading edge of defibrillation discharge into a 50 ohm test load Indicators Text prompts audio alerts QRS beeper battery status Ready For Use RFU External Power Sync Mode Armed Indicators Charging charged tones flashing shock button on front of panel and on external paddles energy level indicated on the display 197 18 Specifications Specifications 198 AED Mode ECG AED Energy Profile 150 Joules for Adult 50 J for Infant Child factory default nominal into a 50 ohm test load AED Controls On Off shock Text and Voice Prompts Extensive text audib
24. 4 At 80 MHz and 800 MHz the higher frequency range applies These guidelines might not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 and 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the 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 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 HeartStart XL is used exceeds the applicable RF compliance level above the HeartStart XL should be observed to verify normal operation If abnormal performance is observed additional measures may be necessar
25. Adult 30 295 50 bpm the HR derived from the ECG and the Infant Child 30 295 80 bpm pulse derived from SpO3 adjusted in increments of 5 VTach HR Limit Selects the VTach heart rate limit Adult 95 150 100 bpm Infant Child 95 150 120 bpm adjusted in increments of 5 VTach Run Limit Selects the VTach run limit Adult 3 20 5 Infant Child 3 20 5 PVC Rate Limit Selects the PVC limit Adult 1 99 10 Infant Child 1 99 5 Table 31 NBP Settings Parameter Description Setting Choices Color Selects the NBP color Red Yellow Blue Green Cyan Magenta White Unit Selects the measurements units mmHg kPa NBP Frequency Selects the frequency for NBP Manual q1 q2 5 q5 q10 q15 q30 measurement manual or automatic on a q60 q120 selected schedule NBP Alarm Source Selects the alarm source Systolic Diastolic Mean Systolic High Limit Selects the high limit alarm value when Adult 45 260 160 mmHg systolic is the selected alarm source 6 35 21 kPa Infant Child 45 160 120 mmHg 6 22 16 kPa Systolic Low Limit Selects the low limit alarm value when systolic is the selected alarm source Adult 40 255 90 mmHg 5 34 12 kPa Infant Child 40 155 70 mmHg 5 21 9 kPa 141 13 Configuration 142 Overview Table 31 NBP Settings Continued Parameter Description Setting Choices Diastolic High Limit Selects the high li
26. ECG set with snaps ICU M1674A 3 lead ECG set with snaps IEC ICU M1675A 3 lead ECG set with grabbers OR M1678A 3 lead ECG set grabber IEC OR M3526A 3 wire lead set and plug snap AAMI M3528A 3 wire lead set and plug snap IEC Ordering Replacement Supplies and Accessories Table 51 Supplies and Accessories Continued 17 Supplies amp Accessories Part Number Description 5 Lead ECG Cable Sets M1520A M1530A M1625A M1635A M1644A M1645A M1668A M1949A M1968A M1971A M1973A M1974A 5 lead ECG Trunk Cable AAMI 5 lead ECG Trunk Cable IEC 5 lead ECG set with snaps AAMI 5 lead ECG set with snaps IEC 5 lead ICU snaps AAMI 5 lead ICU snaps IEC 5 lead ECG Trunk Cable AAMI IEC 5 plus 5 ECG Trunk Cable AAMI IEC 5 lead ICU grabber AAMI 5 lead ICU grabber IEC 5 lead OR grabber AAMI 5 lead OR grabber IEC 6 Lead ECG Cable Sets M1667A M1680A M1681A M1682A M1683A M1684A M1685A 6 lead Trunk Cable AAMI IEC G lead ICU grabber limb AAMI 6 lead ICU grabber limb IEC 6 lead ICU snap limb AAMI G lead ICU snap limb IEC 6 lead OR grabber limb AAMI 6 lead OR grabber limb IEC 10 Lead ECG Cable Sets M1663A M1665A M1682A M1683A M3525A 10 lead Trunk Cable AAMI IEC 10 lead Trunk Cable AAMI IEC 6 lead ICU snap limb AAMI 6 lead ICU snap limb IEC 10 lead ECG patient Trunk Cable 12 pin ECG Monitoring Electrodes
27. Follow the voice and screen prompts Press the orange Shock button if prompted See the following sections for more information NOTE While operating in AED Mode the capabilities of the device are limited to those essential to the performance of semi automated external defibrillation Only the ECG acquired through pads is displayed If you have the SpO option and it is configured to display the numeric in AED Mode the Pleth waveform is also displayed Previously set alarms and scheduled NBP measurements are indefinitely paused and entry of patient information with the exception of patient category is disabled Additionally the Sync Lead Select and Alarm Pause buttons are inactive 6 OQ 5 AED Mode Using AED Mode to Defibrillate Step 1 Turn the Therapy Knob to AED When the HeartStart XL is turned to AED it announces and displays the patient category Confirm you have the correct category active for the patient If not use the Patient Category button at to select the correct category The device also checks to see if the Therapy cable and multifunction electrode pads are properly connected If the e Therapy cable is not properly attached you are prompted to Plug in Connector with a Connect Pads Cable prompt and graphic illustration on the screen e Multifunction electrode pads are not connected to the Therapy cable pads are not applied to the patient or pads are not making proper contact with the patient s s
28. NBP On frequency value Logged when an automatic NBP measurement is requested including the frequency value NBP Frequency Manual Logged when an automatic NBP measurement is changed to manual including the frequency value NBP Frequency frequency value Logged when the NBP frequency is changed 124 Event Summary 12 Data Management Table 26 Event Information Continued Logged Event Frequency NBP Alarms Off On Logged when NBP alarms are turned on or off and any subsequent change NBP Limits Systolic low value high value Logged when the Systolic NBP alarm limit is changed NBP Limits Diastolic low value high value Logged when the Diastolic NBP alarm limit is changed NBP Limits Mean low value high value Logged when the Mean NBP alarm limit is changed NBPs High value gt limit Logged when the patient s Systolic NBP is higher than the configured limit NBPs Low value lt limit Logged when the patient s Systolic NBP is lower than the configured limit NBPd High value gt limit Logged when the patient s Diastolic NBP is higher than the configured limit NBPd Low value lt limit Logged when the patient s Diastolic NBP is lower than the configured limit NBPm High value gt limit Logged when the patient s Mean NBP is higher than the configured limit NBPm Low value lt limi
29. NOTE Once the reason for the Pacing Stopped alarm has been resolved that part of the alarm message is removed from the display The audio alarm continues You must press the Start Pacing soft key to resume pacing remove the remainder of the alarm from the display and silence the audio alarm 8 Pacing Troubleshooting TEES WARNING Observe the patient closely while pacing Heart rate displays and alarms function during pacing but can be unreliable Do not rely on the indicated heart rate or heart rate alarms as a measure of the patient s perfusion status Troubleshooting If your HeartStart XL does not operate as expected during pacing see Defibrillation and Pacing Problems on page 180 9 Pulse Oximetry Pulse Oximetry SpO gt is one of the tools available to assist in assessing a patient s cardiac and respiratory systems This chapter explains how Pulse Oximetry works and how to use the HeartStart XL to monitor SpOo Overview Pulse oximetry is a non invasive method of continuously measuring functional oxygen saturation SpO gt in arterial blood SpO readings indicate the percentage of hemoglobin molecules in arterial blood which are saturated with oxygen You can monitor SpO in all HeartStart XL clinical modes and on both adult and infant child patients Use the Patient Category button to switch categories When pressing the Patient Category button all parameter alarm limits change to the new patie
30. Patient Category button to switch between patient categories When pressing the Patient Category button all parameter alarm limits and initial inflation pressures change to the new patient category These changes are retained when you switch modes e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category The neonatal patient category is not supported While an NBP measurement is in progress the current cuff pressure is displayed in the Parameter area Once the measurement is complete the values for systolic diastolic and mean pressure are displayed along with the measurement schedule manual or automatic intervals and a time stamp see Figure 59 Figure 59 NBP Values NBP q5 10 20am mmHg 1110 70 80 Alarm Limits If NBP alarms are NBP q5 10 20am mmHg turned on the alarm limits are 1 1 0 T 0 150 displayed If alarm limits are turned off 80 the alarms off symbol X is displayed WARNING Do not perform NBP monitoring on patients whose upper arm circumference is less than 13cm Doing so may result in inaccurate measurements NOTE For more information on NBP monitoring refer to the Application Note About Noninvasive Blood Pressure available on the Philips website at www philips com ProductDocs 109 10 Blood Pressure Monitoring Measuring NBP Measuring NBP The first time an NBP
31. SpO passed test Call for service to repair the internal SpO Fail SpO failed test SpO2 module If SpO2 functionality monitoring is essential to cable is not tested patient care take the device out of use NBP tests None None Pass NBP passed test Calibrate NBP module if internal NBP Fail NBP failed test calibration is overdue Ifa functionality o failure is detected call for Calibration Overdue service If NBP monitoring is essential to patient care take the device out of use Printer runs a None None Pass Printer passed its Call for service 157 14 Operational and Shift Checks Operational Check Printing Operational Check Results NOTES If configured to do so see Printing Settings on page 145 the Operational Check Report see Sample Operational Check Report on page 159 automatically prints out after an Operational Check is completed To manually print press the Menu Select button and select Print The first part of printed Operational Check lists test results The second part lists checks performed by the user User Checks Once the Operational Check Report prints perform the following manual checks to complete the Operational Check e Defibrillator Inspection Make sure the HeartStart XL is clean including the surfaces of the paddles and paddle trays clear of objects and has no visible signs of damage ECG Cables Connectors Paddles Pads Monitoring Electrodes Make sure t
32. Tachy Extreme Tachy 20 bpm above HR High limit up to 200 bpm adult 240 bpm infant child For higher rates the limit is equal to the HR High limit Pacer Not Capture No QRS following internal pacer pulse Medium Priority Pacer Not Pace No QRS or pacer internal pulse Latching Alarm detected PVC xx gt limit min The number of detected PVCs in Yellow Alarm message with detected rate gt limit a minute exceed the limit alarm tone Medium Priori HR High The HR exceeds the configured o oe HR Hish limi on Latching gh limit Alarm HR Low The HR is below the configured HR Low limit NOTE The high HR alarm condition is not detected when the HR High limit is configured greater than the maximum Extreme Tachy threshold You get the Extreme Tachy alarm The low HR alarm condition is not detected when the HR Low limit is configured less than or equal to the minimum Extreme Brady threshold Heart Rate and Arrhythmia Alarms 4 ECG Monitoring Table 8 HR Arrhythmia Technical Alarms Alarm Message Condition Type of Alarm Indication Lead The multifunction electrode Pads pad paddles or leads used as the Paddles Off source for Wave Sector 1 during Synchronized Cardioversion may be disconnected or not attached securely Cannot Analyze ECG data in Wave Sector 1 ECG cannot be analyzed an electrode used is disconnected not attached High Priority securely The an
33. They also increase or decrease numbers or values in a sequence If you hold either button down it scrolls When pressed the Alarms button pauses all audible physiological and technical alarms for the configured time interval At the end of the pause interval each alarm returns to its previous setting Pressing the Alarms button during the pause interval returns the alarms to their previous setting When in AED Mode pressing the Alarms button activates alarms See Alarms on page 33 The Mark Event button allows you to insert a time stamped annotation in the Event Summary Report to note events as they occur including the administration of certain drugs See Mark Events on page 134 When pressed the Reports button will bring up the Reports Menu From the Reports Menu you can print an Event Summary or Trends Report See Printing Data on page 132 The Print button begins a continuous printout of the primary ECG and other selected waveforms either real time or with a 10 second delay depending upon your configuration Pressing the Print button while printing is in progress stops the printing See Printing Data on page 132 The soft keys perform the function displayed as a label appearing directly above on the display The display and function change for the various modes of operation You can hit either the top or bottom of the soft key with the same result except during pacing therapy See Pacing on page 89 fo
34. XL CAUTIONS Be aware of patient cables including ECG monitoring equipment when used with high frequency surgical equipment Accessory equipment connected to the HeartStart XL s data interface must be certified according to IEC Standard 60950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible to ensure that the system complies with the requirements of system standard IEC Standard 60601 1 1 If in doubt contact your local Philips Customer Care Center or local Philips representative This device is suitable for use in the presence of high frequency surgical equipment Following electrosurgery interference the equipment returns to the previous operating mode within 10 seconds without loss of stored data Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation This does not affect patient or equipment safety See the electrosurgery device s Instructions for Use for information on reducing hazards of burns in the event of a defect in its equipment Do not expose the HeartStart XL to x ray or strong magnetic fields MRI NOTES This device and its accessories are not intended for home use If you use sterilizable paddles
35. XL charges If a rhythm change is detected before the shock is delivered and a shock is no longer appropriate the defibrillator disarms itself NOTE When fully charged you can disarm the device at any time by turning the Therapy knob off the AED position Resume AED monitoring by turning the Therapy knob back to AED e No Shock Advised NSA If a shockable rhythm is not detected the HeartStart XL tells you No shock advised Follow your institution s protocol for a No Shock Adviced alert The device s next steps are determined by the No Shock Advised Action configuration choice If the configuration is set to Monitor The HeartStart XL monitors the ECG and automatically resumes analysis if a potentially shockable rhythm is detected You are periodically prompted to press CPR and to begin CPR if CPR is indicated The frequency of these prompts is defined in the Monitor Prompt Interval configuration choice You may press CPR to suspend monitoring and administer CPR The pause period is defined by the CPR Timer configuration choice See Defib Sync AED Settings on page 143 an 4 Using AED Mode to Defibrillate 5 AED Mode Pause Time Analysis is suspended for the specific period which is defined by the NSA Action configuration choice You may attend to the patient and administer CPR if indicated The Pause Status Bar is displayed see AED View Layout on page 61 At the end of the pause period the Heart
36. and enters the configured CPR Timer period Prompts may be brief or detailed as defined by the Voice Prompt configuration choice Analysis begins again at the end of the pause period or when you press the Resume Analyzing soft key NOTES Once prompted to administer the shock if you do not do so within the configured Auto Disarm time interval the HeartStart XL disarms itself and enters a pause period for CPR The device resumes analyzing at the end of the pause period or when you press the Resume Analyzing soft key Rhythm monitoring is intended to provide a backup or secondary measure of potentially shockable rhythms in various environments but is not a substitute for being attentive to the patient s state 65 5 AED Mode AED Mode User Messages AED Mode guides you through the defibrillation process Depending upon the given situation voice prompts and display messages are presented to assist you in using the mode See Tables 9 16 Table 9 AED Mode Connect Pads Messages Using AED Mode to Defibrillate This message may appear when the Therapy cable is not connected properly to the HeartStart XL Audio Message Display Text Condition User Action Plug in Connector Connect Pads Cable The Therapy cable is not Securely connect the connected to the Therapy cable to the HeartStart XL device Table 10 AED Mode Messages These messages may appear during normal AED Mode
37. confirm that they have not reached the end of their sterility before using in an event See the sterilizable paddles Instructions for Use Keep your HeartStart XL Lithium Ion battery charged and a spare battery nearby The HeartStart XL does not require the practice of any special ElectroStatic Discharge ESD precautionary procedures 41 NOTES 4 ECG Monitoring Overview This chapter describes the HeartStart XL s basic ECG and arrhythmia monitoring functions The device uses Philips ST AR Algorithm for ECG analysis You can use the HeartStart XL to monitor your patient s ECG through e multifunction electrode pads e 3 or 5 lead ECG monitoring electrode sets e external paddles for quick assessment only not continuous monitoring If both pads and monitoring electrodes are connected the HeartStart XL allows you to select a lead to monitor from either source Configurable heart rate and arrhythmia alarms clearly communicate patient status both audibly and visually You can use the HeartStart XL to monitor both adult and infant child ECGs Use the Patient Category button to switch categories When pressing the Patient Category button all parameter alarm limits change to the new patient category These changes are retained when you switch modes e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use
38. from the display You must press the Start Pacing soft key to resume pacing and remove the remainder of the alarm from the display Table 47 SpO Monitoring Problems Symptom Possible Cause Possible Solution The SpO waveform is not displayed The sensor is not properly connected or the sensor cable is damaged Check the sensor connection and cable Try another sensor The SpO waveform is not configured to be displayed and there is not an unused wave sector Use the Displayed Waves menu to select a wave sector to display the SpO waveform You are in AED Mode and SpO waveform is not configured to be displayed or SpO is non pulsatile Configure AED Mode to use SpO3 Symptoms Table 47 SpO Monitoring Problems Continued 16 Troubleshooting Symptom Possible Cause Possible Solution Sp0O Non Pulsatile technical alarm The patient s pulse is absent or too weak to be detected or the sensor has come off Check perfusion at the measurement site Check that the sensor is applied properly Make sure the sensor site has a pulse Relocate the sensor to another site with improved circulation If the message occurs during an NBP measurement on the same limb wait until the NBP measurement is finished Try another sensor S pO Erratic technical alarm The SpO numeric value is replaced with a SpO measurements are erratic Check
39. in the device itself If you do not wish to rerun Operational Check press the Menu Select button to proceed without rerunning the test Operational Check Table 39 Operational Check Tests and Results 14 Operational and Shift Checks If the device does not detect a pressed Charge button within 10 seconds you are prompted to use the Menu Select button to charge Test Device eg eee Results What to do if test doesn t Prompts pass General System None None Pass All tested systems are Take the device out of use tests internal clock functioning properly and call for service sealed P a Fail One or more of the ie ae aaa tested systems is not internal memory finetoni unctioning properly Therapy Knob None None Pass The Therapy knob is set Confirm that the Therapy tests if the to 170J and functioning knob is set to 170J and Therapy knob is properly repeat Operational Check set to 170 and Fail The Therapy knob is hot If the test continues to fail functioning take the device out of use set to 170 properly and call for service Fail The Therapy knob is not functioning properly NOTE When the Therapy knob fails you restart and remain in Monitor Mode regardless of the knob s position on the dial Charge button Depending on the cable connected Pass Charge button passed Repeat the test and make tests the Charge Therapy cable Move Therapy knob Fail Charge button is n
40. includes ancillary functions such as ECG which affect the ability to deliver defibrillation or pacing therapy All other functions are considered nonessential performance but were monitored for EMC 209 18 Specifications Electromagnetic Compatibility Restrictions for Use Artifact on the ECG and parameter waveforms caused by electromagnetic disturbances should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment Emissions and Immunity The HeartStart XL is designed and tested to comply with the radiated and conducted emissions requirements of international and national standards IEC 60601 1 2 and EN 60601 1 2 See Tables 57 through 60 for detailed information regarding declaration and guidance WARNING The use of accessories transducers and cables other than those specified might result in increased emissions or decreased immunity of the HeartStart XL SSeS SS SS The list of cables transducers and other accessories with which Philips claims compliance with the emissions and immunity requirements of IEC standard 60601 1 2 are listed in Supplies amp Accessories on page 189 The EMC standards state that manufacturers of patient coupled equipment must specify immunity levels for their systems See Tables 58 and 59 for this detailed immunity information See Table 60 for recommended minimum separation distances between portable and mobile commu
41. measurements 112 mean 113 measuring 110 message area 29 Operational Check results 157 parameter area 28 patient category 110 port 9 precautions 111 qx in menu 112 specifications 203 start 111 systolic 113 time intervals 112 trending 115 troubleshooting 184 user checks 158 No capture 54 No Power 175 No shock advised in AED Mode 64 No shock delivered 60 Non latching alarms 33 O Operating modes 21 Operational Check 21 151 battery 157 entering 151 external paddles 157 leads rerun 154 NBP 157 pads 157 performing 152 print options 145 printer 157 printing a report 158 reports 159 results 154 155 setup screen 154 SpO 157 summaries 160 summary 151 tests performed 151 user checks 158 Options configuration 139 Ordering supplies 189 D Pace pulse duration 92 Paced Status location 27 Pacer Not Capture 54 Pacer Not Pace 54 Pacer Output 93 144 Pacer Rate 93 144 Pacing 54 89 93 adjusting numeric values 32 alarms 97 Alarms button 23 changing modes 95 charge button 22 configuration options 144 connecting multifunction electrode pads 8 connecting therapy cable 7 defibrillation 96 Demand Mode 93 179 device shutdown 26 Event Summary 120 events stored in Event Summary 126 fixed mode 95 indications for use 3 Lead Select button 93 lead sets 89 Mark Event button 23 markers 90 mode indication 90 NBP 109 not pacing 54 output 90 93 pace pulse duration 92 Pacer Mode 1 21 pacing stat
42. of an AED When operating in Monitor Manual Defibrillation or Pacing modes the HeartStart XL is suitable for use by healthcare professionals trained in advance life support Indications for Use The HeartStart XL is a defibrillator monitor The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support advanced life support or defibrillation It must be used by or on the order of a physician AED Therapy AED Mode is used in the presence of suspected cardiac arrest on patients that are unresponsive not breathing and pulseless Manual Defibrillation Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive Synchronous defibrillation cardioversion is indicated for termination of atrial fibrillation Overview 1 Introduction Non Invasive External Pacing The pacing option is indicated for treating patients with symptomatic bradycardia Pulse Oximetry The SpO option is indicated for use when it is beneficial to assess the patient s oxygen saturation level Non Invasive Blood Pressure Monitoring The NBP option is indicated for non invasive measurement of a patient s arterial blood pressure ECG Monitoring ECG monitoring is indicated to be used for monitoring alarming and recording of the patients heart rate and morphology Safety Co
43. paddles for a Quick Look to assess the patient s ECG rhythm and then if necessary deliver therapy Use this process only when multifunction pads and monitoring electrodes are not immediately available To view a patient s ECG using external paddles 1 Make sure the device is turned on to Monitor 2 Apply external paddles to the patient s chest minimizing any unnecessary movement 3 After the HeartStart XL detects the ECG view the waveform on the display NOTE Viewing the patients ECG through paddles is not recommended for long term monitoring Using Infant Paddles The HeartStart XL external paddle set comes with infant paddles included The American Heart Association recommends using the smaller paddles on children weighing less than 10 kg Larger paddles may be used as long as contact between the paddles is avoided To set up for defibrillating using infant paddles 1 2 3 4 Expose the infant paddle surfaces see Accessing Infant Paddles on page 12 Store the adult paddle surfaces in the paddle tray pockets Follow the steps for using external paddles see Using External Paddles on page 76 Follow the defibrillation steps in Defibrillation on page 78 Using Internal Paddles To set up for defibrillating using internal paddles 1 2 3 Select the appropriate paddle electrode size If using switchless internal paddles connect the paddles to the M4740A Paddle Adapter Cable Conne
44. page 189 Timely calibration for those modules which require calibration See Calibrating Batteries on page 167 and the HeartStart XL Service Manual for NBP Calibration WARNINGS HeartStart XL service should only be performed by qualified service personnel in accordance with the HeartStart XL Service Manual Electric shock hazards exist internally Do not open device NOTE Refer to the HeartStart XL Service Manual for information on the expected life of the device and components 163 15 Maintenance Automated Tests The HeartStart XL performs many maintenance activities including three tests that run automatically at regularly scheduled intervals when power is supplied and the device is off The tests assess operational performance and alert you if a problem exists 164 Automated Tests Results of tests associated with critical device functionality are reported through the RFU indicator and the Automated Test Summary Report Results are also reported through statements on the HeartStart XL s display when the device is turned on Table 40 provides a brief explanation of the tests and lists each test s frequency Table 40 Automated Tests Test Frequency Description Hourly Every hour Tests power supply charge level of the battery internal communication across all critical modules and components and also the device s internal temperature Daily Daily after midnight Tests all h
45. page 23 or through the Displayed Waves menu The waves for Wave Sectors 2 and 3 are selected through the Displayed Waves menu only To select a waveform using the Displayed Waves menu 1 Press the Menu Select button 2 Using the Navigation buttons select Displayed Waves and press the Menu Select button see Figure 43 3 Select the wave sector you want to modify and press the Menu Select button 4 Select the new wave type you want and press the Menu Select button 49 4 ECG Monitoring Monitor View 5 If needed select the appropriate ECG wave size and press the Menu Select button NOTE When you select the ECG wave size for a certain lead all instances of that lead adjust to the selected size For example if you have Lead II selected for both Wave Sectors 1 and 2 and you change the size in Wave Sector 1 Wave Sector 2 s size changes automatically Figure 43 Wave Menus Displayed Waves Wave 1 II Size Wave 1 Pads x4 Wave 2 I x2 Tae a Exit II x1 2 aVR x1 4 aVL Auto aVF V NOTES Selecting the Auto size automatically adjusts the ECG size to the maximum size allowed without clipping the wave sector Adjusting the ECG wave size on the display only affects the wave size on the display for viewing It does not affect the ECG signal used for arrhythmia analysis Detected R Waves for Synchronized Cardioversion and Demand Pacing are also unaffected by the ECG w
46. patient or anything connected to the patient Call out loudly and clearly Stay Clear If using e Pads or switchless internal paddles Press the flashing Shock button on the front of the HeartStart XL to deliver a shock B e External paddles Simultaneously press the flashing Shock buttons located on the paddles to deliver a shock e Switched internal paddles Press the orange Shock button located on the paddle to deliver a shock LESSEE WARNINGS Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation Alarm audio is turned off when an energy setting is selected for defibrillation and the Alarm Audio Off message is displayed Audio remains off until turned back on by pressing the Alarm button Sync Mode is turned on or the Therapy knob is turned to Monitor or Pacer T _ xT_ _ _ _ _ gt _ ___ E _ 7 L L L 79 6 Manual Defibrillation Manual Defibrillation Alarms Manual Defibrillation Alarms Defibrillation alarms can be generated for the conditions shown in Table 18 There are both audio and visual alerts when activated by the Alarms button When you switch patient categories all parameter alarm limits change to the new patient category These changes are retained when you switch modes e For patients that are gt 25kg or 8 years old use Adult patient category e
47. recommended separation distance between RF communications equipment and the HeartStart XL Reducing Electromagnetic Interference The HeartStart XL and associated accessories might be susceptible to interference from other RF energy sources and continuous repetitive power line bursts Examples of other equipment that can cause RF interference are medical devices cellular products information technology equipment and radio television transmission Should interference be encountered as demonstrated by artifact on the ECG or dramatic variations in parameter measurement values attempt to locate the source Assess e Is the interference intermittent or constant e Does the interference occur only in certain locations e Does the interference occur only when in close proximity to certain medical devices e Do parameter measurement values change dramatically when the AC line cord is unplugged Once the source is located attempt to attenuate the EMC coupling path by distancing the monitor defibrillator from the source as much as possible If assistance is needed call your local service representative Essential Performance Determinations per 60601 1 2 Ed 2 Essential performance of the HeartStart XL defibrillator monitor derived from the product s risk Management Summary e The ability to deliver defibrillation therapy manual AED and Synchronized Cardioversion e The ability to deliver pacing therapy fixed and demand This
48. replaced with the patient s name if available Table 27 Event Markers Event Symbol Mark Event P Physiological Alarm N Shock Delivered z The HeartStart XL can also be configured to print a strip when an alarm charge shock or mark event occurs See Printing Settings on page 138 To print an Event Summary for the current event 1 Press the Report button 2 Using the Navigation buttons select Event Summary and press the Menu Select button 132 Printing Data 12 Data Management Printing While in Data Management Mode To print a Event Summary contained in Internal Memory 1 Select the Event Summary you wish to print 2 Press the Menu Select button and select Print OR Press the Report button E select Event Summary from the listing and press the Menu Select button to print To print a Trends Report related to an Event Summary contained in Internal Memory 1 Select the Event Summary that contains the Trends Report you wish to print 2 Press the Report button E select Trends from the listing and press the Menu Select button 3 Using the Navigation buttons select the Trend Interval you want Press the Menu Select button to begin printing NOTES To see how to install printer paper rolls see Installing Paper on page 18 If you change from a clinical to non clinical mode during printing the HeartStart XL ask if you want to to stop printing Select Yes to stop printing and NO to cont
49. to low impedance Confirm proper skin prep and reapply pads Confirm that paddles are not touching each other when placed on the patient s chest Remove paste moisture or any other conductive material between the pads and patient Press Pads Firmly message on display Press Paddles Firmly for Next Shock message on display A shock was delivered but there was marginal impedance Check pads connection with the patient Check paddles connection with the patient Select Therapy Cable Type message on display The device can t detect the type of Therapy cable attached Select the proper Therapy cable from the list presented Therapy Not Available Due to Disabled Equipment message is displayed A device failure has occurred Run an Operational Check to diagnose the problem If the device is in use at the time of the message begin CPR if indicated Press LII Button to Select Another ECG Lead message on display The waveform in Wave Sector 1 is no longer valid and another ECG source is available Check that the monitoring electrodes pads are properly applied Use the Lead Select button to select another lead to monitor Pacing Stopped Power Interrupted technical alarm Appears after power is restored to indicate there was a loss of power during pacing Pacing does not restart automatically If indicated resume pacing 181 16 Troubleshoo
50. 0 seconds of rest time elapsed All criteria must be met in order for an automatic NBP to be taken For example if you have the automatic measurement setting set to every 1 minute the device attempts to take an NBP every 60 seconds However for the measurement to successfully begin the previous measurement must have ended cuff must be deflated and 30 seconds must have elapsed after cuff deflation If these criteria are not met the device waits the 60 seconds to attempt another measurement Additional manual measurements can be taken without affecting the automatic measurement schedule by pressing the Start NBP soft key The configured NBP measurements schedule may be changed during an event To change the NBP schedule and or the interval of automatic measurements for the current patient 1 Press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button 2 3 Select NBP and press the Menu Select button 4 Select NBP Frequency and press the Menu Select button 5 Select the desired interval and press the Menu Select button NOTES Interval choices are listed in the format qx indicating measurements are taken every x minutes from q 8 y the time you first press the Start NBP soft key When cuff measurements are set to be taken at an automatic interval there is a forced 30 second minimum period in between measurements even if a measurement is due to be take
51. 10 9 8 10J 8 7 10 10 11 11 11 11 15J 13 15 16 16 h7 h7 h16 20J 17 20 21 22 22 22 22 30J 26 30 31 32 33 33 33 50J 43 50 52 54 55 56 54 70J 61 70 173 76 78 78 76 100 J 87 100 105 108 111 111 108 120 J 104 120 126 130 133 134 130 150J 130 150 157 162 166 167 163 170 J 147 170 178 184 188 189 184 200J 173 200 209 216 222 223 217 The delivered energy accuracy is 10 or 1J whichever is greater for all energy settings Charge time Specifications 3 seconds to the recommended adult energy level 150 Joules with a new fully charged battery installed Less than 5 seconds to the selected energy level up to 200 Joules with a new fully charged battery installed Less than 15 seconds to the selected energy level while connected to AC power only The device powers on in manual defibrillation mode ready to deliver shock in less than 8 seconds plus applicable charge time assuming an immediate selection of an energy and initiation of a charge even at 90V AC and after 15 maximum energy discharges The device powers on in AED mode ready to deliver shock in less than 17 seconds plus applicable charge time Specifications 18 Specifications Patient Impedance Range Minimum 25 ohm external defibrillation 15 ohm internal defibrillation Maximum 250 ohm Actual functional range may exceed these values Figure 79 Smart Biphasic Waveform Philips Smart Biphasic Waveform at 200J into 25 175 Ohms
52. 132 132 133 134 135 135 135 135 136 137 Table of Contents Exporting Settings 6 ee 187 Importing Settings 0 a a 17 Printing Settings 0 a a a 188 Restoring Default Settings 000a a a aaa 188 Configurable Parameters 3 a a a aaa 39 Chapter 14 Operational and Shift Checks 147 Slum Check s 2 e wo eo wo amp ooe amp e ooo amp a Fe e amp amp aa TF Weekly Shock Test 00a a a aaa 8 Operational Check S a ew wo S E Performing an Operational Check So oe oe od we Om a OE te a e oe a S2 Printing Operational Check Results 0 wee 158 Operational Check Summaries we a aaa 160 Auto Test Summaries 4 ge Ok ee Oe ROO we Ow RO we OC Chapter 15 Maintenance 163 OUEIVIEW 4 0 4 x 4 po eo amp amp amp ww amp amp amp SS amp amp amp wm amp we amp TS Automated Tests 4 Gg 2 Se B amp amp ws amp Fh amp amp amp mw gy TO Auto Test Summaries 2 eee 164 Battery Maintenance 5 amp 2 amp amp amp BF F amp w 166 Battery Life 3 oe amp amp amp a amp amp amp mm amp amp a amp amp woe amp 166 Initializing Batteries ok ee ae OU a ae ee we OR Ow ee 166 Charging Batteries 2 2 4 amp x 4 amp amp amp amp amp ws we a 166 Calibrating Batteries 2 4 2 4 amp amp amp 8 amp Ge amp 167 Storing Batteries s wo w Toos a e e E
53. 155 cancelled 181 print options 145 synchronized cardioversion 85 the battery 166 time 196 Cleaning 170 cables 170 disinfecting 170 NBP cuff 114 171 printer 171 side pouches 171 SpO sensors 107 171 Clinical performance summaries 209 Color ECG options 140 NBP options 141 SpO options 142 Configuration 21 135 AED 143 CPR 144 ECG options 140 exporting 137 general settings 139 heart rate options 140 importing 137 manual defibrillation 143 Mark Events 144 modifying settings 137 NBP 141 options 139 pacing 144 password 135 print 138 printing 145 restoring defaults 138 saving changes 135 saving settings 137 setting date and time 136 SpO 142 synchronized cardioversion 143 waveforms 142 Connect Therapy cable message in AED Mode 66 Connecting ECG cable 9 multifunction electrode pads 8 NBP cable 10 NBP cuff 110 SpO2 cable 10 therapy cable 7 USB flash drive 12 Continued use 39 Copyright I CPR configuration options 144 in AED Mode 62 Cuff deflation 110 Cuff pressure 109 D Dashed line 178 Data management 119 128 accessories 194 available space 128 cleaning printhead 171 Data Management Mode 21 entering 128 event markers 132 Event Summary initiating 120 events stored in event summary 121 exporting configuration 137 importing configuration 137 internal memory data captured 129 deleting data 131 menus 129 viewing USB drive 129 Mark Events 134 patient name 27 print 133 Print butto
54. 18 Specifications Table 58 Electromagnetic Immunity General Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic IEC 61000 4 5 differential mode 2 kV common mode 2 kV common 8kVai 8 kV ai IEC 61000 4 2 a material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power transient burst supply lines supply lines IEC 61000 4 4 1 kV for 1 kV for input output input output lines lines Surge 1kv 1 kV differential 50 60 Hz magnetic field IEC 61000 4 8 mode mode Voltage dips short lt 5 Ur lt 5 Ur lesan e and gt 95 dip in gt 95 dip in Mains power quality should be that of a voltage variations on Ur for 0 5 cycle Uy for 0 5 cycle typical commercial or hospital environment power supply input lines 40 Ur 40 Ur IEC 61000 4 11 60 dip in Ur 60 dip in Ur for 5 cycles for 5 cycles 70 Ur 70 Ur 30 dip in Ur 30 dip in Ur for 25 cycles for 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in gt 95 dip in Ur for 5 sec Ur for 5 sec Power frequency 3 Alm 3 Alm Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or ho
55. 23 lead selection 47 lead size arrhythmia analysis 50 leads rerun in Operational Check 154 learning 52 manual relearning 53 Mark Event button 23 Mark Events 134 monitor view 49 ECG monitor view 49 monitoring electrode accessories 191 monitoring with electrodes 45 monitoring with pads 44 normal complex 52 paced status 27 parameter limits 141 Patient Category button 23 port 9 preparing to monitor 44 Print button 23 quick look 77 Rhythm label 29 R Wave arrow 29 selecting a waveform 49 setting alarm limits 56 skin prep 44 specifications 198 trending 115 troubleshooting 178 y fib v tach 54 Wave Sector 1 29 49 Wave Sector 2 30 Wave Sector 3 30 waveforms 43 ECG port 9 Ectopic Event 54 Electrode labels 141 Electrode placement 45 Electrodes monitoring 45 Electromagnetic compatibility 209 Energy doses in AED Mode 144 Entering patient ID 38 Entering patient information 38 Entering patient sex 38 Environmental specifications 204 Event markers 132 Event Summary 119 alarm identification 121 alarms 37 120 charge button 120 data collected 120 data limit 120 device shutdown 26 ECG 120 events stored 121 exporting de identified data 130 initiating 120 Mark Events 120 134 memory full 119 NBP 112 120 pacing 89 120 patient name 27 Print button 23 print options 145 printing a saved event 133 printing current event 132 reports 121 Reports button 23 217 Event Summary 119 SpO 120 stored events 121 Exiting Co
56. 5 pm Data Management Internal Memory ID Date and Time Elapsed Paced EventID Shocks N 2011 02 03 09 59pm 0 44 08 10 37 345432567 4 Y 2011 02 04 11 11am 0 20 09 12 09 345634261 2 N 2011 02 05 07 59pm 0 26 54 0 00 345634274 3 lt gj Scroll Bars Event Storage Used Free 128MB 200MB Number of Events Stored 3 Exit Data Mgmt um 128 Data Management Mode 12 Data Management NOTES The following information is listed on the display e ID Indicates if the event data record contains any patient information which could uniquely identify the individual Y indicates there is N indicates there isn t e Date and Time Date and time the event began e Elapsed Duration of the event e Paced Total paced time for the event e Event ID The unique ID for the event Shocks Total number of shocks delivered during the event e Event Storage Used Free The amount of space used available in internal memory e Number of Events Stored The number of events that are currently stored in internal memory Internal Memory Menu From the Internal Memory Menu you can print export remove all patient identification data and view data on your USB drive To use the Internal Memory Menu 1 Confirm you are in Data Management Mode 2 Press the Menu Select button 3 Using the Navigation buttons select your desired operation See Figure 65 Figure 65 Internal Mem
57. 59 S N Device Serial Number Software revision NOTE Text Data appearing in parenthesis in Figure 62 are replaced by patient information in an actual Trends Printed Report For example Patient Name is replaced with the patient s name if available Trends Reports can also be printed from Data Management Mode See Printing While in Data Management Mode on page 133 NOTE Do note enter Data Management Mode while monitoring a patient Troubleshooting If your HeartStart XL does not operate as expected during trending see Troubleshooting on page 173 117 NOTES 12 Data Management This chapter describes the data management features of the HeartStart XL including Data Management Mode Event Summary printing functionality and Mark Events Overview The HeartStart XL automatically generates an Event Summary for each patient event Each Event Summary is assigned a unique event identification number is date time stamped and stored in the device s internal memory Data related to the current event is available for viewing reporting and printing Vital sign parameters are part of the Event Summary but are also available in the Trends Report see Trending on page 115 The current Event Summary or Trends Report may be printed by pressing the Reports button on the front of the HeartStart XL When the internal memory is full each additiona
58. 77 LAN port 13 Latching alarms 33 Lead choices 47 Lead Select button 23 49 93 location 6 troubleshooting 179 synchronized cardioversion 83 wave sector 1 29 Lead selection 47 Leads configuration options 142 events stored in Event Summary 122 pacing 89 Learning ECG 52 Low battery condition 25 Low impedance messages 68 M Maintenance 163 Auto Test hourglass 165 results 165 summary 151 164 battery calibration 167 battery safety 168 battery storage 167 calling for service 187 caring for NBP cuffs 114 cleaning SpO sensors 107 Maintenance 163 cleaning SpO sensors 107 discarding battery 167 leads rerun 154 NBP calibration 114 Operational Check 151 155 power alarms 169 RFU 164 Shift Check 147 test loads 194 user checks 158 Weekly Shock Test 148 Making a selection 31 Manual defibrillation 73 1 10 energy settings 78 adjusting volume 32 alarms 80 Alarms button 23 charge 78 charge button 22 code view 75 configuration options 143 connecting multifunction electrode pads 8 defibrillating asystole 74 energy selected 75 events stored in Event Summary 125 external paddles 76 indications for use 2 infant paddles 77 internal paddles 77 Manual Defib Mode 1 21 Mark Event button 23 message area 29 NBP 109 paced status 27 Patient Category button 23 precautions 74 preparation 76 quick look 77 shock 79 shock button 22 shock counter 75 shock series 143 skin prep 44 specifications 197 Therapy cable
59. 9 appears 2 Select Yes and press the Menu Select button NOTE If the sensor cable is disconnected accidentally the message SpO2 Unplugged Turn Off Sp05 appears Select NO and press the Menu Select button Secure the sensor connection to begin SpO monitoring again Caring for Sensors Refer to the manufacturer s instructions for care and cleaning of your sensors To get the best results from your reusable sensors always handle the sensors and cable with care and protect them from sharp objects The sensor houses a sensitive electronic device that can be damaged Harsh treatment of the sensor reduces their useful life Troubleshooting If your HeartStart XL does not operate as expected during SPO Monitoring see Table 47 SpO Monitoring Problems on page 182 107 NOTES 10 Blood Pressure Monitoring This chapter explains how to monitor blood pressure NBP using the HeartStart XL Overview The HeartStart XL measures blood pressure for both adult and infant child patients using the oscillometric method Systolic diastolic and mean measurements are provided Alarms are available to alert you to changes in the patient s condition NBP measurements can be taken in Monitor Manual Defibrillation including Synchronized Cardioversion and Pacing modes NBP is not available in AED Mode NBP measurements can be taken automatically on a pre set schedule or manually on demand Use the
60. 989803171281 One therapy and one monitoring accessory system 989803171291 Three cable wraps one each for ECG hands free therapy cable external paddles Mounting Solutions 989803171701 Bed Rail Roll Stand Hook PH 0050 60 GCX Roll Stand with basket orderable through GCX PH 0050 03 GCX Flush Wall Mount orderable through GCX Test Loads and Test Plug MI1781A Test Load for use with M3507A Pad Cable M3725A Test Load for use with M3508A Pad Cable 989803171271 Defibrillator Test Plug for M3508A Cable 18 Specifications This chapter includes e HeartStart XL specifications See below e Symbol and abbreviation definitions see Symbol Definition on page 206 and Abbreviation Definitions on page 208 e Electromagnetic Compatibility see Electromagnetic Compatibility on page 209 Specifications General Dimensions 29 6 cm W x 23 cm H x 27 9 cm D 11 6 in W x 9 in H x 10 9 in D Weight 14 7 lbs 6 6 kg includes one battery one new roll of paper one Therapy cable Incremental weight of external standard paddles and paddle tray is less than 3 lbs 1 3 kg Standard Operator Position Within one meter 3 feet of the device Power Rechargeable Lithium Ion battery AC power using a protectively grounded outlet Alarm Tone and Voice Message Volume Range Maximum 85 dB A Minimum 45 dB A Alarm Tone Volumes Imminent Shutdown Continuous tone alternating between 1000 and 2100 Hz
61. Code View Layout 25 Jan 2011 10 44 AM 04 A G Patient z lt Category q5 10 40am mmHg 2112 71 80 Enlarged Wave N peels Shocks 0 Selected Energy 150 Joules Wave Selected Sector 2 gt Energy Cancel Charge Shock Counter 75 6 Manual Defibrillation Preparing for Defibrillation Preparing for Defibrillation To prepare for defibrillation 1 Prepare the patient s skin to improve skin contact See Skin Preparation on page 44 2 Connect the appropriate therapy cable See Connecting the Therapy Cable on page 7 3 Apply paddles or pads as described in the following sections Using Multifunction Electrode Pads To set up for defibrillating using multifunction electrode pads 1 Check the expiration date on the pads package and inspect the package for any damage 2 If not preconnected connect the Therapy cable to the HeartStart XL see Connecting the Therapy Cable on page 7 3 Ifthe pads are not expired and package is undamaged open the package and connect the pads connector to the end of the Therapy cable see Connecting Multifunctional Pads on page 8 NOTE Ifyou are using Philips HeartStart Preconnect Pads 989803166021 the pads may already be connected to the end of the Therapy cable Open the package to apply the pads to the patient 4 Apply the pads to the patient as directed on the pads packaging or according to your institution s protocol 5 Follow the defibrillati
62. Device Information Speed 25 mm s with an accuracy of 5 Amplitude Accuracy 5 for offset voltages of 300 mV at 5Hz Paper Size 50 mm W x 30 m L Noninvasive Pacing Waveform Monophasic Current Pulse Amplitude 10 mA to 200 mA if the pulse width is set to 20 ms 5 mA increments accuracy 10 or 5 mA whichever is greater For a 40 ms setting the maximum pacing current is 140 mA Pulse Duration 20 or 40 msec with 10 accuracy Rate 30 ppm to 180 ppm 10 ppm increments accuracy 1 5 Mode Demand or Fixed Refractory Period 340 msec 30 to 80ppm 240 msec 90 to 180 ppm 10 201 18 Specifications Specifications 202 SpO Pulse Oximetry SpO Measurement Range 0 100 SpO Resolution 1 SpO Update Period 1 2 sec typical maximum of lt 30 sec Table 53 SpO Accuracy with 1 standard deviation 70 100 Sensor Accuracy Sensor Accuracy Sensor Accuracy M1131A 3 M1191BL 2 M1196A 3 M1132A 2 M1191T 3 M1196S 3 M1133A 2 M1192A 2 M1196T 3 M1191A 2 M1192T 3 M1902B 3 M1191B 2 M1194A 3 M1903B 3 M1191AL 2 M1195A 3 M1904B 3 NOTES Accuracy outside the range specified for each sensor is not indicated The above referenced sensors were validated for use with the HeartStart XL using the Philips picoSAT II SpO module with Fourier Artifact Suppression Technology FAST While the SpO module is able to report values below 70 and alarm limit
63. Device Shutdown When no AC power is connected and the battery charge level drops to a critically low level the HeartStart XL can no longer guarantee correct operation The defibrillator generates an Imminent Shutdown alarm You have approximately one minute to connect the device to AC power before it shuts down If power is returned within 30 seconds and the Therapy knob is not in the Off position the HeartStart XL automatically turns back on user settings are restored to their values prior to the shutdown the HeartStart XL continues to use the current Event Summary and the duration of the shutdown is recorded in the Event Summary WARNING Pacing is not automatically restarted after the HeartStart XL recovers from a power loss You must restart pacing manually If the HeartStart XL restarts after 30 seconds and the Therapy knob is not in the Off position all settings are returned to their configured values a new Event Summary starts and you are notified that the previous Event Summary was closed The Display 3 Working with the HeartStart XL The Display The HeartStart XL s display layout is easily configurable There are four basic segments of the display See Figure 27 Figure 27 General Display Layout 25 Jan 2011 10 25 AM 0 2 2 Fi Non Paced Status area m Parameter Jus pm 1 NBP q5 10 20am mmHg me 70 95 10 110 70 eos Dotted box Waveform indicates Di location of isplay and k Soft Keys menu when ar
64. Enabling Disabling NBP Alarms To enable disable NBP alarms 1 2 3 4 Press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button Select NBP and press the Menu Select button Select Alarms On Alarms Off and press the Menu Select button a ee WARNING Turning alarms off prevents all alarms associated with the NBP measurement from being annunciated If an alarm condition occurs no alarm indication is announced Caring for Cuffs Refer to the manufacturer s instructions for care and cleaning of your NBP cuffs To get the best results from your cuffs handle them with care and protect them from sharp objects NBP Calibration NBP should be calibrated yearly To calibrate the NBP module call for service or refer to the HeartStart XL Service Manual Troubleshooting If your HeartStart XL does not operate as expected during NBP Monitoring see Table 48 NBP Monitoring Problems on page 184 11 Trending This chapter describes how to review patient data using HeartStart XL Trending Overview In Monitor Mode your HeartStart XL provides the ability to view and print numeric vital signs trending data for the current incident Trending data are automatically acquired if parameters are on When viewing trending data the Trending Report is displayed in the HeartStart XL s lower two wave sectors and takes over the soft key functions Tre
65. English HeartStart XL Model No 861290 About This Edition Publication number 453564090581 Edition 2 Printed in the USA To determine the product level version to which these Instructions for Use are applicable refer to the version level appearing on the back cover of this book or on the label of the User Documentation CD ROM that accompanied this device This information is subject to change without notice The information in this document applies to the HeartStart XL versions indicated below Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Edition History Pub Number Ed S W Version Print Date 453564090581 11 JA July 2011 453564090581 2 A 01 Dec 2011 Copyright Copyright 2011 Koninklijke Philips Electronics N V All rights are reserved Permission is granted to copy and distribute this document for your organization s internal educational use Reproduction and or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder SMART Biphasic is a registered trademark of Philips Other trademarks and trade names are those of their respective owners Medical Device Directive The HeartStart XL complies with the requirements of the Medical Device Directive 93 42 EEC and carries the C
66. For patients lt 25kg or lt 8 years old use Infant Child patient category For more information on alarms see Alarms on page 33 Table 18 Defibrillation Alarms aborted Abnormal Shock Dose Delivered Abnormal shock dose delivered due to marginal patient Alarm Message Condition Type of Alarm Indication Pads Off With pads in use the connection High Priority between the device and patient Non Latching has been lost Alarm Shock Aborted A shock has been automatically Red Alarm message with impedance alarm tone High Priority Pads Paddle Type The device detected a change in Latching Alarm Unknown paddles or pads type or the therapy cable identification is invalid Equipment Therapy is disabled due to an Disabled Therapy equipment failure Paddles Power A power overload has been Medium Priority Yellow Alarm message with Overload detected in the paddles Latching Alarm alarm tone Troubleshooting 80 If your HeartStart XL does not operate as expected during Manual Defibrillation see Table 46 Defibrillation and Pacing Problems on page 180 If there is a delay in delivering therapy start CPR if indicated 7 Cardioversion This chapter explains how to prepare for and perform synchronous cardioversion on the HeartStart XL See Chapter 6 Manual Defibrillation on page 73 for information on asynchronized cardioversion Overview The HeartStart X
67. Frequency Internal Paddles On Logged when internal paddles make contact with the patient Internal Paddles Off Logged after Internal Paddles On if paddles lose contact with the patient Leads On Logged when monitoring electrodes for primary ECG are attached to the patient Leads Off Logged after Leads On if a monitoring electrode for the primary wave loses contact with the patient Vitals HR value SpO value Pulse value NBP value Values logged when measurement is taken a minimum of every 5 minutes HR ECG Asystole V Fib V Tach V Tach Extreme Brady value lt limit Extreme Tachy value gt limit Logged when a high priority latching physiological alarm is generated Pacer Not Capture Pacer Not Pace Logged when a medium priority latching physiological alarm is generated and Pacer Mode is selected PVC xx gt Limit Min HR High value gt limit HR Low value lt limit Logged when a medium priority non latching physiological alarm is generated Cannot Analyze ECG Logged when there is ECG data that cannot be analyzed ECG Equipment Logged when there has been an ECG equipment malfunction Malfunction Pads ECG Equipment Logged when there has been a ECG pads or paddles equipment malfunction Malfunction ECG Alarms On Off Logged when ECG alarms are turned off or on and any subsequent change HR Limits low high Logged when H
68. High Priority Tone of 960 Hz lasting 0 5 sec repeated every second Medium Priority Tone of 480 Hz lasting 1 sec repeated every two seconds Low Priority Tone of 960 Hz lasting 0 25 sec repeated every two seconds Visual Alarm Characteristics High Priority Flashing at 2 Hz with 50 duty cycle a 25 sec flash twice every second Medium Priority Flashing at 0 5 Hz with 50 duty cycle a 1 sec flash every other second Low Priority Constant on See Figure 36 on page 35 for the relative size of the alarms on the display Defibrillator Waveform Biphasic Truncated Exponential Waveform parameters adjusted as a function of patient impedance Shock Delivery Via multifunction electrode pads or paddles Shock Series Configurable energy escalation in a series Leads Off Sensing and PCI Sensing for Pads Paddles Apply 500nA rms 571Hz 200uA rms 32KHz 195 18 Specifications 196 Table 52 Delivered Energy Accuracy Nominal Delivered Energy vs Load Impedance S lecced Load Impedance ohms 2 Energy 25 50 75 100 125 150 175 1J 1 2 1 3 11 3 1 2 1 1 1 0 10 9 2J 1 7 2 0 2 1 2 0 1 9 1 7 1 6 3J 2 6 3 0 3 1 3 2 3 2 3 1 2 9 4J 3 55 4 0 4 2 43 44 4 5 43 5J 4 3 15 0 5 2 5 4 5 5 15 6 15 4 6J 5 2 6 0 16 3 16 5 6 6 6 7 16 5 7J 6 1 7 0 17 3 7 6 7 8 7 8 7 6 8J 6 9 8 0 8 4 8 6 8 9 8 9 8 7 9j 7 8 9 0 9 4 9 7 10
69. If you use preconnected pads reattach them Test complete Operational Check 14 Operational and Shift Checks Operational Check Operational Checks supplement automated tests by verifying therapy cables the ECG cable paddles audio charge and shock buttons and the ability to deliver defibrillation and pacing therapy Operational Check also notifies you if the battery needs calibration checks the SpO and NBP modules and printer Operational Checks should be performed at regularly scheduled intervals to supplement the hourly daily and weekly tests the HeartStart XL performs automatically From Operational Check you can also print Automated Test and Operational Check results EE SSE eee ee ee WARNING When performing an Operational Check or Weekly Shock Test be sure to disconnect the ECG leads set from the cable and confirm the HeartStart XL is not connected to a patient NOTES Do not run Operational Check with internal paddles attached Perform a Weekly Shock Test to test internal paddles To confirm the ECG cable used during an event is functioning properly use that same cable during Operational Check If the HeartStart XL is equipped with multifunction electrode pads only and does not have a paddle tray you cannot test paddles during an Operational Check To test paddles you must have a simulator to deliver the shock into Run the Weekly Shock Test delivering the shock into the simulator To enter Operation
70. Infant Child patient category The neonatal patient category is not supported ECG waveforms can be acquired through the Therapy port for pads paddles or the ECG Monitoring port for 3 or 5 lead sets When you are using 3 lead ECG monitoring only one ECG lead vector is available If you are using 5 lead ECG monitoring up to three ECG lead vectors are available at the same time for display WARNINGS Do not use the HeartStart XL to monitor neonatal ECGs Doing so could result in inaccurate measurements and alarms When an external pacemaker is being used on a patient arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse This may result in the arrhythmia algorithm s failure to detect pacemaker non capture or asystole During complete heart block or pacemaker failure to pace or capture tall P Waves greater than 1 5 of the average R Wave height may be erroneously counted by the arrhythmia algorithm resulting in missed detection of cardiac arrest Algorithms in the HeartStart XL use the currently set internal Paced Status during rhythm analysis Confirm that the patient s paced status is correct EEE 43 4 ECG Monitoring Preparing to Monitor ECG Preparing to Monitor ECG 44 You can monitor ECG through multifunction electrode pads or ECG electrodes and do a quick look with external paddles NOTE If monitoring for an extended period of time monitoring electrodes and mul
71. J Se Remote Charge button T Brapar anes Proper sternum j Release buttons for paddle paddle placemen Infant Paddles Ecements icon icon 11 2 Device Basics Basic Orientation Accessing Infant Paddles To access the M3543A infant Figure 12 Infant Paddles paddles 1 Press down on the release buttons located on the front of the external paddles 2 Slide the adult electrode clip off and away from the paddle exposing the infant sized surface underneath 4 Infant Paddles _f WARNING Make sure the defibrillator is not charged before accessing the infant paddles USB Data Port The HeartStart XL allows you to save data to and import configurations and new software revisions from a USB drive which is inserted into a USB port on the top of the device To insert a USB drive Figure 13 Data Port 1 Locate the USB data port on the top right of the HeartStart XL just to the right of the RFU indicator 2 Lift the plastic door to expose USB port 3 Insert your USB drive USB symbol facing forward into the port 12 Basic Orientation 2 Device Basics Back Panel The back panel of the HeartStart XL has a compartment for the Lithium Ion battery It also contains the AC power connection the ECG Out jack to connect to an external monitor and the LAN port See Figure 14 For more information on ECG Out see the ECG Out Cable Application Note which can be found on the Philips webs
72. L provides synchronized cardioversion therapy by delivering a biphasic pulse of current to the heart immediately following an R Wave detected in the ECG waveform The waveform utilized in the HeartStart XL has undergone clinical testing demonstrating its effectiveness for cardioversion of atrial fibrillation You can perform synchronized cardioversion with e Multifunction electrode pads or external paddles and 3 or 5 Lead set monitoring electrodes directly connected to the HeartStart XL e Only the multifunction electrode pads directly connected to the HeartStart XL e Multifunction electrode pads directly connected to the HeartStart XL and an ECG signal coming from a Philips bedside monitor into the HeartStart XL NOTE The best quality source for cardioversion is a 3 or 5 Lead set connected to the HeartStart XL No matter what your monitoring source is cardioversion is still delivered through pads or paddles 7 Cardioversion Precautions for Cardioversion Precautions for Cardioversion WARNINGS Cardioversion should only be delivered by trained healthcare professionals When performing synchronized cardioversion through external paddles you should not use paddles as your monitoring lead in Wave Sector 1 Artifact introduced by paddle movement may resemble an R Wave arrow and trigger a defibrillation shock Use external paddles as a monitoring lead for Synchronized Cardioversion only if no other lead source is available and y
73. M2202A High Tack Foam ECG Electrodes 5 electrodes pack 60 packs case ECG Sync Out Cables M1783A M5526A 12 pin Sync Cable 8 feet 12 pin Sync Cable 25 feet 191 17 Supplies amp Accessories 192 Ordering Replacement Supplies and Accessories Table 51 Supplies and Accessories Continued Part Number Description NBP Interconnect Tubing M1598B Adult Pressure Interconnect Cable 1 5m M1599B Adult Pressure Interconnect Cable 3m Reusable Blood Pressure Cuffs 40400A Reusable Cuff Kit 3 sizes Pediatric Adult Large Adult 40400B Reusable Cuff Kit 5 sizes Infant Pediatric Adult Large Adult Thigh 40401A Traditional Reusable Cuff Infant 40401B Traditional Reusable Cuff Pediatric 40401C Traditional Reusable Cuff Adult 40401D Traditional Reusable Cuff Large Adult 40401E Traditional Reusable Cuff Thigh M4552B Easy Care Reusable Cuff Infant M4553B Easy Care Reusable Cuff Pediatric M4554B Easy Care Reusable Cuff Small Adult M4555B Easy Care Reusable Cuff Adult M4556B Easy Care Reusable Cuff Adult Long M4557B Easy Care Reusable Cuff Large Adult M4558B Easy Care Reusable Cuff Large Adult X Long M4559B Easy Care Reusable Cuff Thigh MI1571A Multi Patient Comfort Cuffs Infant M1572A Multi Patient Comfort Cuffs Pediatric M1573A Multi Patient Comfort Cuffs Small Adult M1574A Multi Patient Comfort Cuffs Adult M1575A Mu
74. Meets AAMI standard for ventricular bigeminy HR 80 bpm slow alternating ventricular bigeminy HR 60 bpm rapid alternating ventricular bigeminy HR 120 bpm bidirectional systoles HR 90 bpm as measured after a 20 sec stabilization time Heart rate averaging For heart rates gt 50 bpm heart rate is determined by averaging the 12 most recent R R intervals Beats N P and V are included When heart rate drops below 50 bpm the four most recent R R intervals are used in the average Note For ventricular tachycardia alarms which have a user definable PVC run length limit the heart rate is based on the user selected PVC length up to 9 PVCs maximum Pace Pulse Detection Sensitivity 1 mV for a width of 100 ps 200 pV for a 500 us width and 200 pV for widths of 500 pis to 2 ms ECG Analog Output Bandwidth 0 5 to 70 Hz ECG Analog Output Gain 1v output per 1mV input 10 ECG Analog Output Delay Propagation delay time is lt 35ms from ECG input to ECG analog output Pacemaker Pulse Rejection Capability Amplitude from 2 mV to 700 mV width from 0 1 ms to 2 0 ms as per ANSI AAMI EC 13 2002 4 1 4 1 Pacer Pulse Detector rejection of Fast ECG Signals Slew Rate of 1 1 V s Heart Rate Response Time 7 sec 80 120 bpm 6 sec 80 to 40 bpm Time to Alarm for Tachycardia 4 sec for 206 bpm 1 mV halved amplitude and double amplitude and 195 bpm 2 mV halved amplitude and double amplitude as measured following a normal 80 bpm rate wit
75. Mode below For more information on alarms see Alarms on page 33 Table 17 AED Defibrillation Alarms Alarm Message Condition Type of Alarm Indication Pads Off With pads in use the connection High Priority between the device and patient Non Latching has been lost Alarm Shock Aborted A shock has been automatically aborted Abnormal Shock Abnormal shock dose delivered Dose Delivered due to marginal patient Red Alarm message with impedance alarm tone High Priority Pads Paddle Type The device detected a change in Latching Alarm Unknown paddles or pads type or the therapy cable identification is invalid Equipment Therapy is disabled due to an Disabled Therapy equipment failure 71 5 AED Mode Troubleshooting Other Alarms in AED Mode ECG If ECG alarms are turned on in AED Mode all Technical Alarms listed in HR Arrhythmia Technical Alarms on page 55 and the following Physiological Alarms from HR Arrhythmia Physiological Alarms on page 54 are generated when the condition exists e Asystole e Extreme Tachy e HR High e V Fib Tach e Extreme Brady e HR Low Once generated all alarms appear as messages in the HR alarm status area above the HR numeric There are both audio and visual alerts For more information on ECG alarms see Arrhythmia Monitoring on page 52 SpO and Pulse If SpO and Pulse alarms are turned on once generated the alarm messages appea
76. Noisy Signal Logged when SpO is on and a noisy signal is detected SpO Interference Logged when SpO is on and light interference is detected at the SpO sensor SpO Non Pulsatile Logged when SpO is on and a non pulsatile SpO sensor signal is detected SpO Equipment Logged when SpO is on and an SpO equipment malfunction is detected Malfunction SpO Erratic Logged when SpO is on and an erratic measurement condition occurs SpO Extended Update Logged when SpO is on and the SpO measurement update period exceeds 30 seconds SpO Low Perfusion Logged when SpO is on and low perfusion occurs SpO Error Logged when a non critical SpO error is detected SpO Alarms On Off Logged when SpO alarms are turned on or off and any subsequent change SpO Limits low high Desat limit Logged when SpO alarms are turned on and when there is a change in alarm limits Pulse Pulse High value gt limit Logged when the patient s pulse is higher than the configured limit Pulse Low value lt limit Logged when the patient s pulse is lower than the configured limit Pulse Alarms On Off Logged when pulse alarms are turned on or off and any subsequent change Pulse Limits low limit high limit Logged when pulse alarms are turned on and when there is a change in alarm limits NBP NBP On Manual Logged when a manual NBP measurement is requested
77. R alarms are turned on and when there is a change in alarm limits VTACH Limits HR limit Run limit Logged when VTACH alarms are turned on and when there is a change in alarm limits PVC min Limit limit Logged when PVC rate alarms are turned on and when there is a change in alarm limits Learning ECG Logged when the HeartStart XL is evaluating the ECG signal Learning Rhythm Logged when the HeartStart XL is evaluating the ECG rhythm ECG bandwidth for Display setting for Printing setting Initial ECG bandwidth for display printing and storage are logged 123 12 Data Management Event Summary Table 26 Event Information Continued Logged Event Frequency Equipment Disabled Logged when the device detects a therapy equipment failure Therapy SpO2 SpO On Off Logged when SpO monitoring is connected and any subsequent disconnect connect SpO High value gt limit Logged when the patient s SpO value is higher than the configured limit SpO gt Low value lt limit Logged when the patient s SpO value is lower than the configured limit Desat value lt limit Logged when the patient s Desat value is lower than the configured limit SpO Sensor Malfunction Logged when the device is on and unable to acquire a Pleth waveform SpO Unplugged Logged when SpO monitoring is on and the sensor is disconnected SpO
78. Range Operating and Storage 1014 mbar to 572 mbar 0 to 15 000 ft 0 to 4 500 m Shock Operating Half sine waveform duration lt 11ms acceleration 15 3 G 3 shocks per face Non operating Trapezoidal waveform acceleration 30G velocity change 7 42 m s 10 1 shock per face Vibration Operating Random Nene ae SED Non Operating Random Frequency Slope PSD Frequency Amplitude Frequency PSD Acceleration Hz dB octave m s Hz Hz Hz 10 100 1 0 1057 aasma ssw O22 Sai Gs g Hz 100 200 3 0 57 150 2g 200 2000 0 5 Specifications 18 Specifications Water Solids Ingress Resistance Meets Ingress Protection level IP21 EMC Complies with the requirements of standard EN 60601 1 2 2002 Safety Meets UL 60601 1 1st edition EN 60601 2 4 2003 EN 60601 1 1990 Other considerations e The HeartStart XL is not suitable for use in the presence of concentrated oxygen or a flammable anesthetic mixture with air oxygen or nitrous oxide e Hazards arising from software errors were minimized by the products compliance with the software requirements contained in EN 60601 1 4 1996 Mode of Operation Continuous AC Line Powered 100 240 VAC 50 or 60 Hz 1 0 46 A Class I Equipment Battery Powered Minimum 14 4 V Rechargeable Lithium Ion USB Device Correct Drive Use the USB Drive that accompanied your device If it is not available use a USB device that i
79. Start XL resumes analyzing e ECG cannot be analyzed If artifact interferes with analysis the HeartStart XL alerts you and attempts to continue analyzing If artifact persists and device announces that the ECG can t be analyzed it enters a pause period While paused analysis is suspended Check that the pads are making proper contact with the patient s skin and minimize movement Analysis resumes automatically in 30 seconds or when you press the Resume Analyzing soft key You should always use the analyze function to determine if a rhythm is shockable For more information on AED messages see AED Mode User Messages on page 66 Step 3 Press Shock Button if Prompted Once charging is complete the HeartStart XL prompts you with Deliver shock now Make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stay Clear Then press the flashing orange Shock button to deliver a shock to the patient WARNINGS The Shock button must be pressed to deliver a shock The HeartStart XL does not automatically deliver a shock Defibrillation current can cause operator or bystander injury Do not touch the patient or equipment connected to the patient during defibrillation Delivery of the shock is confirmed by an Attend to Patient Shock Delivered visual message and the shock counter is updated to reflect the number of shocks given The defibrillator then announces Begin CPR
80. The SpO numeric value is replaced with a An NBP measurement or an excessively noisy signal is delaying display update of the SpO measurement for more than 30 seconds Wait until the NBP measurement is complete Try another sensor site Move sensor to a different limb than the NBP cuff SpO Low Perfusion technical alarm The SpO numeric value is replaced with a The SpO signal is too low to give an accurate reading Check that the sensor is applied properly Make sure the sensor site has a pulse Relocate the sensor to another site with improved circulation Try another sensor SpO Error technical alarm A non critical device failure has occurred Restart device when it is appropriate to do so If the alarm continues call for service of the SpO module If SpO monitoring is essential to patient care take the device out of use Table 48 NBP Monitoring Problems Symptom Possible Cause Possible Solution Measurement cycle doesn t automatically start NBP is not configured for automatic measurements Check modify the configuration as needed Automatic measurements are not scheduled for the current patient Use the Measurements Alarms menu to define an automatic schedule of measurements for the current patient The Start NBP soft key has not been pressed Press the Start NBP soft key The pump operates but the cuff does not inflat
81. There are both audio and visual alerts For more information on alarms see Alarms on page 33 Table 23 Pulse Rate Alarms Alarm Message Condition Type of Alarm Indication Pulse High Pulse value is greater that the Medium Pulse high alarm limit Priority Yellow alarm message with Pulse Low Pulse value is less that the Pulse Non Latching audio tone low alarm limit Alarm NOTE Pulse alarms are off by default except when the HeartStart XL enters Pacing Mode Changing Pulse Rate Alarm Limits To change the Pulse high and low alarm limits 1 Press the Menu Select button Select Pulse and press the Menu Select button Select Pulse Limits and press the Menu Select button Select the new high limit value and press the Menu Select button au bh WN Select the new low limit and press the Menu Select button Enabling Disabling Pulse Rate Alarms To enable disable Pulse alarms 1 Press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button 2 3 Select Pulse and press the Menu Select button 4 Select Alarms On Alarms Off and press the Menu Select button Disabling SpO Monitoring 9 Pulse Oximetry Disabling SpO Monitoring To disable SpO monitoring 1 Disconnect the sensor cable from the SpO port The message p02 Unplugged Turn Off Sp0
82. a e 167 Discarding Batteries gt lt amp a amp aaa 17 General Battery Safety ge i ow aa aaa 168 Power Related Alarms 2 a aaa 169 Cleaning Instructions oe ee O e a Boe aa AO Defibrillator Monitor Paddles Cables wi Bues aooe ao a o w o o amp O Printer Printhead 4 aaa TI Side Pouches 5 4 so amp oca oo amp 4 a oOo oa o amp o oao amp amp A SpO Sensor and Cable 2 w 4 2 aaa T7 NBP Cuff s ye oe Se ee amp he a we we Be Be amp boe a a amp a amp amp D7 HeartStart XL Disposal 2 amp amp S amp amp BY amp amp amp Ho amp e 2 17 Chapter 16 Troubleshooting 173 QOyerview 3 2 4 e 2 Gl amp 4 oA ow a amp amp FY 2 we TB Resolving Issues oE amp amp amp toa a a Boao amp Se a ke so a TF Responding to Test nee sE mopo oam amp Ge se S Me we wy amp amp we we a Symptoms es bee Se ee 2 es Be ee amp Ge oe ae ee Calling For Sanie So a oe Ae e Oe a Ge Be amp we e Be a e VII Table of Contents Chapter 17 Supplies amp Accessories Ordering Replacement Supplies and Accessories Chapter 18 Specifications Specifications General Defibrillator Manual Defibrillation Mode AED Mode ECG and Arrhythmia Monaro Display Battery Thermal dass ee Noninvasive Pacing SpO Pulse Oximetry NBP 2 Patient Data Storage Environmental USB Device Symbol Definition l Shipper Carton Symbol Deno Abb
83. able type connected removed from service If it continues to fail take the device out of use and call for service Leads ECG tests None None Pass Tested system is Rerun the Leads ECG test leads ECG functioning properly when prompted at the end acquisition and Pail esed system is 10t of Operational Check Ifit the ECG cable continues to fail take the device out of use and call for service 156 Operational Check 14 Operational and Shift Checks Table 39 Operational Check Tests and Results Continued printer self test self test Fail Printer failed its self test Test Device see Acdons Results What to do if test doesn t Prompts pass Pads Paddles ECG None None Pass cable type ECG If Operational Check fails Checks ECG acquisition and the cable are with a cable connected acquisition with both functioning replace the cable and run pads paddles Pass No Cable ECG the test again If it path eae continues to fail take the acquisition is functioning device out of use and call cable not tested for service Fail Cable type ECG acquisition and or the cable specified are not functioning Battery tests None None None there is no battery in battery capacity the slot and calibration RO Pass Battery is functioning status properly and charged Pass Low Battery Charge battery Fail Calibration is required Calibrate battery SpO tests None None Pass
84. acing 8 Press the Output soft key a Use the upper portion of the soft key to increase the output until cardiac capture occurs Capture is indicated by the appearance of a QRS complex after each pacing marker b Use the lower portion of the soft key to decrease the output to the lowest level that still maintains capture 9 Assess the patient for a peripheral pulse Pulse alarms are automatically turned on To stop pacing e Press the Pause Pacing soft key A prompt message asks you to confirm your action Using the Navigation buttons select Yes to pause pacing select NO to continue pacing Once paused press the flashing Start Pacing soft key to resume pacing OR e Move the Therapy knob away from the Pacer position A WARNINGS Use care when handling the multifunction electrode pads on the patient to avoid shock hazard during pacing Use multifunction electrode pads prior to their expiration date Discard pads after use Do not reuse pads Do not use for more than 8 hours of continuous pacing If pacing is interrupted for any reason you must press the Start Pacing soft key to resume pacing When pacing in Demand Mode the ECG cable from the patient must be directly connected to the HeartStart XL Ifyou are using the pacing function with battery and the Low Battery alarm sounds connect the device to external power to avoid interrupted pacing therapy U NOTES Pacing does not start if there is a problem with the mul
85. ake sure the sensor is not too tight Too much pressure can cause venous pulsation or can impede blood flow resulting in low readings e Keep power cables away from the sensor cable and connection e Avoid placing the sensor in an environment with bright lights If necessary cover the sensor with opaque material e Avoid placing the sensor on an extremity with an arterial catheter blood pressure cuff or intravenous infusion line 101 9 Pulse Oximetry Monitoring SpO gt WARNINGS Failure to apply the sensor properly may reduce the accuracy of the SpO measurement Inspect the sensor application site at least every two hours for changes in skin quality correct optical alignment and proper sensor application If skin quality is compromised change the sensor site Change the application site at least every four hours More frequent checking may be required due to an individual patient s condition Do not use a damaged sensor or one with exposed electrical circuits Monitoring SpO To monitor SpO 1 Connect the appropriate sensor cable to the HeartStart XL see Connecting the SpO Cable on page 10 Apply the sensor to the patient If the HeartStart XL is not turned on turn the Therapy knob to a clinical mode SpO needs to be configured to appear in AED Mode and does not display unless it is pulsatile Check that the patient category is appropriate for the patient If necessary change the Patient Cat
86. al Check 1 Turn the Therapy knob to Monitor 2 Press the Menu Select button 3 Using the Navigation buttons select Other and press the Menu Select button 4 Select Operational Check and press the Menu Select button See Figure 71 for Operational Check menu options Figure 71 Operational Check Operational Check Peg Select Run Op Check to run an Operational Check Run Op Check Select Op Check Summary to review a summary of Op Check Summary lt Operational Checks see Operational Check Auto Test Summary Summaries on page 160 Exit Select Auto Test Summary to review a summary of hat Auto Tests see Auto Test Summaries on page 161 Select Exit to exit the menu 5 Confirm your exit from a clinical mode Select Yes and press the Menu Select button The following tests are performed during an Operational Check see Operational Check Tests and Results on page 155 e General System Sync button e SpO e Printer e Therapy Knob Therapy e NBP e Battery e Charge button Leads ECG e Shock button e Audio e Leads ECG rerun if necessary e Pads Paddles ECG 151 14 Operational and Shift Checks Operational Check Performing an Operational Check Prior to performing an Operational Check If you use external paddles Make sure the paddles are connected to the device paddles and the paddle tray are thoroughly clean and there is no debris or residue including all conductive material on
87. al Number including field Auto Correct for Daylight Alarm Pause Time setting upgrade kits and Savings Time setting factory installed Software revision options DST Start setting Alarm Volume setting DST End setting Minimum Alarm Volume setting DST Offset setting Voice Volume setting QRS Volume setting Units Display setting Export Without Patient Info setting Following the General Settings listing the Configuration Report continues to list the configured device settings in the order they are listed in Configuration Mode See Configurable Parameters on page 139 NOTE Configuration setting information appearing in parenthesis in Figure 70 are replaced by the current setting when an actual Configuration Report is printed For example Current Date is replaced with the date the report is printed Restoring Default Settings To return all configuration settings to those originally set during manufacturing 1 Press the Change Config soft key 2 Enter the Configuration Password 3 Press the Factory Defaults soft key 4 Once you are prompted to save changes select YeS and press the Menu Select button Overview Configurable Parameters 13 Configuration The following tables list configurable parameters for the HeartStart XL Default settings are in bold type Values are adjusted in increments of 1 unless otherwise stated
88. alarms 37 Results from Operational Check 154 Resume analyzing in AED Mode 62 RFU 2 6 24 164 Rhythm label 29 R Wave aberrantly conducted beats 52 arrows 29 pacing 90 synchronized cardioversion 81 84 85 WwW Safety accessory precautions 189 AED precautions 60 alarm warnings 34 battery precautions 168 general considerations 3 40 manual defibrillation precautions 74 NBP precautions 111 pacing with a second defibrillator 96 radio frequency warning I SpO precautions 99 synchronized cardioversion precautions 82 Saving configuration changes 135 137 Screen prompts AED 64 Select energy 78 Select energy menu 78 Selecting an SpO sensor 101 Separation distances 213 Serial number 174 Service 21 163 173 Setting date and time 136 Shift Check 147 Shift Checklist 149 Weekly Shock Test 148 Shock administering in AED Mode 65 advised in AED Mode 64 button 6 22 external paddles 11 Operational Check results 156 counter 75 counter AED 61 energy dose in AED 144 event markers 132 print options 145 rhythms 198 series 143 synchronized cardioversion 85 timeout 143 Shutdown countdown 26 Silencing alarms 37 Skin preparation 44 SMART Analysis Algorithm 59 Soft keys 23 30 62 AED Mode 62 location 6 pacing 93 Software revision 174 Solid red X 24 Specifications AED 198 alarms 195 battery 200 charge time 196 data storage 204 defibrillator 195 display 200 ECG 198 environmental 204 general 195 manual defibrillatio
89. alyzing algorithm cannot Disabled Therapy analyze the ECG signal ECG Equipment A malfunction has occurred in Malfunction the ECG hardware Pads ECG A malfunction has occurred in Equipment the Pads ECG hardware Malfunction Equipment Therapy is disabled due to an equipment failure Non Latching Alarm Red Alarm message with alarm tone Figure 44 Basic Mode Arrhythmia Alarm Priority Chain For Monitor Manual Defibrillation Synchronized Cardioversion and Pacing RED ALARMS High Priority Asystole V Fib VTach VTach irate Tachy ache Brady YELLOW ARRHYTHMIA ALARMS Medium Priority PVC Alarms Beat Detection Alarms Rate Alarms Pacer Not Capture High Low HR PVCs gt x Min Pacer Not Pacing 55 4 ECG Monitoring Heart Rate and Arrhythmia Alarms 56 Figure 45 Cardiotach Mode Arrhythmia Alarm Priority Chain For AED Mode Only RED ALARMS High Priority Asystole V Fib VTach nk Tachy Bane Brady YELLOW ARRHYTHMIA ALARMS Medium Priority High Low HR Setting Alarms Alarm settings for Heart Rate HR VTach and PVC Rate Limit for the current patient event can be changed via the Menu Select button during the event Settings for other HR and arrhythmia alarms may not be changed Changing Alarm Limits To change HR VTach or PVC Rate Limits 1 Press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select butto
90. anagement Erase Drive View Internal Memory Exit Select Erase Drive to erase all data on the USB a drive lt _ Select View Internal Memory to view all Event Summaries in the device s internal memory oe Select Exit to exit the menu 131 12 Data Management Printing Data Printing Data The HeartStart XL can print multiple pieces of information in both clinical and non clinical modes The device can be configured to print automatically when certain events occur or you can initiate a print request at any time during an event Printing During a Patient Event The HeartStart XL allows you to print various data reports in a clinical mode during a patient event To print a strip during an event 1 Press the Print button EJ The printed strip see Figure 67 contains the header information configured waveforms wave markings R Wave Arrows Pacing Markers and events including event markers See Table 27 Figure 67 Sample Printed Strip HeartStart XL 861290 date and time Alarm status Patient Category HR value bpm Sp0O value Pulse value bpm Patient Name Patient ID current mode selected energy J Pacing information Primary ECG Waveform 1 information Optional Printed Waveform 2 information Listing of ongoing events NOTE Text Data appearing in parenthesis in Figure 67 are replaced by patient information in an actual Printed Strip For example Patient Name is
91. and or metal objects such as the gurney Medical electrical equipment which does not incorporate defibrillator protection should be disconnected before defibrillation NOTES Successful resuscitation depends on many variables specific to the patient s physiological state and the circumstances surrounding the patient event Failure to have a successful patient outcome is not a reliable indicator of defibrillator monitor performance The presence or absence of muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance Impedance is the resistance found between the defibrillator s pads when applied to the patient s body the device must overcome to deliver an effective discharge of energy The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair moisture and lotions or powders on the skin The low energy SMART biphasic waveform is an impedance compensating waveform that is designed to be effective across a wide range of patients However if you receive a Shock Aborted message on the display check that the patient s skin has been washed and dried and that any chest hair has been clipped If the message persists change the pads and or Therapy cable The HeartStart XL s SMART Analysis algorithm detects internal pacemaker pulses that are 2 5 ms or less in duration and removes these pulses so t
92. arge QRS complex Use external paddles as the monitoring lead only if no other lead source is available See With External Paddles on page 85 NOTES When a patient is already connected to Philips bedside monitoring equipment an external Sync cable can plug into the bedside s ECG Output jack and into the HeartStart XL s ECG port This connects the ECG signal from the monitor into the HeartStart XL where it is displayed and synchronization occurs The signal from the bedside monitor is displayed as Lead II on the HeartStart XL even though it may not necessarily be Lead II coming from the bedside monitor Do not use a Philips SureSigns monitor connected to the HeartStart XL The devices are not compatible WARNING If you use an external monitor as the ECG source a biomedical technician MUST verify that the combination of the external monitor and HeartStart XL can deliver a synchronized shock within 60ms of the peak of the R Wave Use a 1 mV QRS complex with a QRS width of 40 ms This performance cannot be guaranteed with all commercially available monitors 83 7 Cardioversion Code View and Cardioversion Code View and Cardioversion When Synchronized Cardioversion is active Code View adds R Wave arrows and a Sync notification to the display The Sync button is also backlit See Figure 51 Figure 51 Code View With Sync Layout 25 Jan 2010 10 44 AM 04 4 8 non paced a NBP q5 10 40am mmHg 112 71 80 2 ie S
93. ave size Dashed Lines A dashed line on your ECG display indicates that you have an invalid ECG signal in the wave sector You can either troubleshoot the currently selected lead to solve the problem Table 45 ECG Monitoring Problems on page 178 or select a different lead To replace a dashed line with a different lead In Wave Sector 1 use the Lead Select button to cycle through available leads and select an appropriate lead OR Use the Displayed Wave menu see above to select an appropriate lead NOTE When using a 3 Lead cable dashed lines will briefly occur with a change of the selected lead wa Monitor View Displaying an Annotated ECG 4 ECG Monitoring You may choose to display an annotated ECG with arrhythmia beat labels in Wave Sector 2 The same ECG source appearing in Wave Sector 1 is displayed in Wave Sector 2 with a six second delay Delayed appears near the waveform White arrhythmia beat labels also appear See Table 6 for beat label classifications Table6 Arrhythmia Beat Labels Label Description Where Displayed N Normal V Ventricular Ectopic P Paced Above QRS L Learning Patients ECG Insufficient information to classify beats Pacer Spike Above waveform where pacer spike was detected If the patient is both atrially and ventricularly paced the display shows two marks above the waveform aligned with the atrial and ventricular pacing Biventricu
94. battery Battery charge indicators seem inaccurate The battery may need calibration Calibrate the battery When turning the device on it starts up in Service Mode and displays a Therapy Not Available Due to Disabled Equipment message If you turned the device to AED or Manual Defibrillation Mode Begin CPR is added to the message Clinical Mode is not available because of a device failure Begin CPR if needed Run an Operational Check If it fails or the problem continues take the device out of use and call for service Audio is too low or absent The QRS Voice or Alarm volume is configured to a Very Soft or Off setting Use the Volume menu to adjust the volume of the prompt There is a problem with the device s speaker Run an Operational Check to confirm the speaker is operating All Setting Reset to Default Values message on display A power failure or critical software failure has occurred Reset alarms waveforms volumes and other settings previously defined for the current patient Critical Device Failure Detected Service Required message on display Equipment Disabled System Failure message on display A critical device failure has been detected at startup or during RFU testing Clinical modes are disabled Equipment Disabled Therapy message on display A device failure has been detected at startup or during RFU testing The device is unab
95. c event is logged and the Event menu screen remains on the display for 5 seconds Figure 68 Events Menu Events IV Access Epinephrine Atropine Morphine WwW 13 Configuration This chapter describes the configurable parameters of the HeartStart XL and procedures for modifying configuration Overview Configuration settings allow you to customize the HeartStart XL to meet your needs Configuration is viewed and changed through the Configuration Menu A password is required to change your device s configuration NOTES As you are making configuration choices consider all the clinical environments the HeartStart XL may be used in Choices for one department might not be suitable for another department The change configuration password is printed on the front of the HeartStart XL User Documentation CD ROM Entering Configuration Mode Once you enter Configuration Mode without a password you can view print or export configuration settings and you can also change the date and time Once you enter the password you can view change print save and export configuration settings New configuration settings are not saved until you press the Save Changes soft key WARNING Do not perform configuration activities while the HeartStart XL is connected to a patient Accessing Configuration Mode To access Configuration Mode 1 Turn the Therapy knob to Monitor Manual Defibrillation or Pacer Press t
96. c value has fallen below the low alarm limit NBPm Low The NBP mean value has fallen below the low alarm limit Table 25 NBP Technical Alarms Alarm Message Condition Type of Alarm Indication NBP Cuff The cuff pressure exceeded 300 Overpressure mmHg 40 kPa NBP Cuff Not The cuff has failed to deflate Deflated NBP The device is unable to complete Measurement a measurement Low Priority Failed NorTatckiog Cyan alarm message with NBP Calibration NBP module calibration is due Alarm Oe Overdue NBP Equipment A problem with the NBP Malfunction module has been detected NBP Error A non critical failure has been detected 113 10 Blood Pressure Monitoring Caring for Cuffs NOTE NBP alarms are on unless you specifically turn them off or alarms for the entire device are off Once disabled alarms remain off until they are turned back on Changing NBP Alarm and Source Limits To change the NBP alarm source and or limits 1 2 3 4 5 Press the Menu Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button Select NBP and press the Menu Select button Select NBP Limits and press the Menu Select button Select the desired source for the alarm Systolic Diastolic or Mean and press the Menu Select button Select the new high limit value and press the Menu Select button Select the new low limit and press the Menu Select button
97. cessful cardioversion depends on many variables specific to the patient s physiological state and the circumstances surrounding the patient event Failure to have a successful patient outcome is not a reliable indicator of defibrillator monitor performance The presence or absence of muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance The neonatal patient category is not supported for Cardioversion Synchronized Cardioversion should be turned off unless you specifically intend to perform synchronized cardioversion Sync Mode can prevent the delivery of defibrillation in situations involving cardiac arrest If you enter Pacing Mode Sync settings are turned off Use only approved lead sets with the HeartStart XL Failure to do so may introduce noise and result in intermittent Cannot Analyze ECG messages Preparing for Synchronized Cardioversion 7 Cardioversion Preparing for Synchronized Cardioversion To prepare for synchronized cardioversion 1 Perform tasks as described in Preparing for Defibrillation on page 76 2 If monitoring through a 3 or 5 Lead ECG cable plug the ECG cable into the ECG port on the HeartStart XL and apply monitoring electrodes to the patient see Lead Selection on page 47 3 Use the Lead Select button B to select the waveform you want in Wave Sector 1 The selected ECG source should have a clear signal and a l
98. ch as low battery and 1000 Hz device failure Tone synchronized with QRS Single beeps aligned with the QRS The volume of 667 Hz each heart beat this tone can be set in Configuration See Table 29 General Settings on page 139 Continuous tone with Imminent shutdown The device will shut down in one Alternating alternating pitch minute between 1000 and 2100 Hz Philips high priority alarm tone 960 Hz Tone lasting 0 5 second repeated every second IEC s high priority alarm tone Meets IEC 60601 1 8 Philip medium priority alarm tone 480 Hz Tone lasting 1 second repeated every 2 seconds IEC s medium priority alarm tone Meets IEC 60601 1 8 Philips low priority alarm tone 480 Hz Tone lasting 0 25 second repeated every 2 seconds IEC s low priority alarm tone Meets IEC 60601 1 8 Alarms 3 Working with the HeartStart XL Responding to Alarms Alarm limits are displayed with each parameter if alarms for the parameter are on When an alarm condition occurs there are several ways to respond Initially 1 2 3 Attend to the patient Identify the alarm s indicated Silence pause the alarm s Press the Menu Select button on the front panel of the HeartStart XL to acknowledge the alarm and press it again to pause the alarm for the configured pause period while you attend to the patient If the alarming condition continues to exist it re alarms after the configured pause period ends Silencing a specif
99. ckage until immediately prior to use Radio Frequency Interference RFI is causing artifact Relocate or turn off equipment that may be causing RFI Try repositioning the Therapy cable The Therapy cable may be faulty Run an Operational Check with the Therapy cable and check pads ECG results If the test fails replace the Therapy cable When monitoring with pads there is a dashed line on the display instead of an ECG ECG data is not being acquired Confirm that the desired lead is selected Check the pads paddles or ECG cable connection Check that the pads paddles or monitoring electrodes are properly applied NOTE Viewing a patient s ECG through paddles is not recommended for long term monitoring See Quick Look on page 77 178 Symptoms Table 45 ECG Monitoring Problems Continued 16 Troubleshooting Symptom Possible Cause Possible Solution The Lead Select button does not respond as expected Device is in AED Mode The Lead Select button is disabled in AED Mode To select a lead exit AED Mode and enter Monitor or Manual Defibrillation Mode Pads paddles cannot be used for the primary ECG in Demand Mode pacing Exit pacing or choose Fixed Mode pacing If a 3 Lead cable is in use or some wires in a 5 Lead cable are disconnected augmented and V leads may not be selectable Confirm all leads are connected Solid flat line n
100. cluding Power on off Technical alarms Initial mode and mode changes Initial battery status and subsequent changes Print Strip Research data including waves AED Mode only and shock no shock decisions You can configure the HeartStart XL to save short or long Event Summaries Short Event Summaries include all the above information except waveforms Long Event Summaries contain everything Printing an Event Summary You can print an Event Summary Report see Figure 63 during a patient event or from Data Management Mode after the event has concluded See Printing While in Data Management Mode on page 133 Event Summary 12 Data Management Figure 63 Sample Printed Event Summary Report Event ID 12232000K 05 33 53 Device On Patient Name 05 33 53 Monitor Mode Patient ID CGP03061998 05 34 10 Pads On ee Patient Sex M or F High priority physiological alarms are preceded by Medium priority physiological alarms are preceded by First Event Date and Time Last Event Date and Time Elapsed Time Time High priority technical alarms Total Shocks Number are preceded by Medium Total Pacer Time Time priority alarms are preceded by il ine HeartStart XL 861290 S N II Low priority alarms are not Device Serial Number preceded by any marks Software revision NOTE Text Data appearing in parenthesis in Figure 63 is replaced by patient information in an ac
101. ct Relearn Rhythm and press the Menu Select button Learning ECG and Learning Rhythm messages appear in the bottom portion of Wave Sector 1 eee ee ee ee eee WARNINGS If arrhythmia relearning takes place during a ventricular rhythm or during a period of poor ECG signal quality ectopic beats may be incorrectly learned as the normal QRS complex This may result in missed detection of subsequent events of V tach and high PVC rates For this reason you should e Take care to initiate arrhythmia relearning only when the ECG signal is noise free e Be aware that arrhythmia relearning can happen automatically e Respond to any messages e g if you are prompted to reconnect electrodes e Display an annotated wave to ensure the beat labels are correct Pacemaker Pulse Rejection When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm the monitor may erroneously count paced pulses as QRS complexes when the algorithm first encounters them resulting in missed detection of cardiac arrest Be sure that the paced status is set correctly on the device Some pace pulses can be difficult to reject When this happens the pulses are counted as a QRS complex and could result in incorrect HR and failure to detect cardiac arrest or some arrhythmias Keep pacemaker patients under close observation See Specifications Chapter 18 on page 195 for details on Pacemaker Pulse Rejection Capability NOTES It is important to set the patient
102. ct the paddles cable or the paddle adapter cable to the HeartStart XL See Connecting the Therapy Cable on page 7 Follow the defibrillation steps in Defibrillation on page 78 77 6 Manual Defibrillation Defibrillation Defibrillation After performing the necessary preparation defibrillation with HeartStart XL is a simple 1 2 3 process 1 Select an energy 2 Charge the device 3 Administer the shock See the following sections for more information Step 1 Select Energy Rotate the Therapy knob to the desired energy level The current energy selection is displayed on the device in the Select Energy section The recommended energy dose for adult patients is 150J Follow your institution s guidelines for Infant Child patients Energy choices range from 1 to 200J with 150J highlighted as the recommended level for adult patients Selecting the 1 10 energy setting brings up the Select Energy menu See Figure 50 Use the Navigation buttons to increase or decrease the desired setting The HeartStart XL automatically knows your energy setting To re adjust a low energy setting 1 Press the Menu Select button 2 Use the Navigation buttons to select Energy 1 10 Joules and press the Menu Select button 3 Use the Navigation buttons to increase or decrease the energy level and press the Menu Select button Figure 50 Select Energy Select Energy Joules See ee SS SS SS SS Se WARNINGS For manual defibrillati
103. d to the patient Recheck pads Confirm they are securely connected to the patient If they are remove them and replace with new pads Good pads contact cannot be established If CPR is indicated begin CPR Table 14 AED Mode Low Impedance Messages These messages may appear when the HeartStart XL detects a lower pad impedance than expected in the average patient The cause could be that the pads are touching or there is too much moisture on the patient Audio Message Display Text Condition User Action Poor pads contact Apply pads as shown on screen Reapply Pads to Dry Chest Poor pads contact Replace pads Poor Pads Contact Begin CPR None When the device is not in a pause period the pads are detecting a low impedance Confirm there is a good pads contact with the skin Recheck pads Confirm they are securely connected to the patient If they are remove them and replace with new pads Good pads contact cannot be established If CPR is indicated begin CPR 68 Using AED Mode to Defibrillate Table 15 AED Mode Shock Related Messages 5 AED Mode These messages may appear when a shock is advised or immediately after a shock is delivered in AED Mode Audio Message Display Text Condition User Action Deliver shock now Deliver Shock Now Press the flashing orange button now Press Ora
104. d delete from the USB drive Additional USB drive operations can be performed with a USB compatible computer Saving Data to the USB Drive You can save data to a USB drive from Data Management Mode Configuration Mode and after an Operational Check To save data to a USB Drive 1 Confirm you have a USB drive inserted into the USB port 2 Press the Export soft key or press the Menu Select button and select Export from the menu The HeartStart XL copies your data to the USB drive NOTE If data exporting is in process and you change from a non clinical mode to a clinical mode or vice versa the HeartStart XL asks you if you wish to continue exporting Select Yes to stop NO to continue with the export 130 Data Management Mode 12 Data Management Deleting Event Summaries from the USB Drive To delete Event Summaries from the USB drive Press the Menu Select button OO N AU A WN Confirm you are in Data Management Mode Using the Navigation buttons select View USB Drive and press the Menu Select button Once in the USB Drive Screen press the Menu Select button The USB Drive Menu appears See Figure 66 Using the Navigation buttons select Erase Drive Press the Menu Select button to erase all event summaries from the USB drive HeartStart XL prompts you to confirm your selection Select Yes to erase all data on the drive Select NO to leave all data on the drive Figure 66 USB Drive Menu Data M
105. ddles external or internal or a therapy cable with multifunction electrode pads Figure 2 Right Therapy Side View USB Data Port l fa jai Cable Wrap Snap Therapy Port _ gt Storage Pouch Connectors i Connecting the Therapy Cable To connect the Therapy Cable 1 Align the white pointer on the cable with the white arrow on the green Therapy port see Figure 3 2 Insert the cable into the green Therapy port and push until you hear it click into place Confirm the connection by gently tugging on the cable to make sure it does not come loose Figure 3 Connecting the Therapy Cable To detach the Therapy Cable m 1 Rotate the green knob in a clockwise direction as indicated by the lock unlock symbol next to the Therapy port a 2 Pull the cable away from the device SS 2 Device Basics Basic Orientation Multifunction Electrode Pads You can use multifunction electrode pads to monitor and administer therapy to patients with the HeartStart XL Figure 4 Multifunctional Pads Q 3 K H Anterior Apex Anterior Posterior Placement Placement Connecting Multifunction Electrode Pads To connect multifunction electrode pads 1 Check the expiration date on the pads package and inspect the package for any damage Discard expired or damaged pads 2 Connect the Therapy cable to the HeartStart XL see Connecting the Therapy Cable on page 7
106. de 1 Confirm the patient is e Unresponsive e Not breathing e Pulseless Expose patients bare chest Wipe moisture from the patient s chest and if necessary clip or shave excessive chest hair Check the expiration date on the pads package and inspect the package for any damage Connect the Therapy cable to the HeartStart XL see Connecting the Therapy Cable on page 7 If the pads are not expired and package is undamaged open the package and connect the pads connector to the end of the Therapy cable see Connecting Multifunctional Pads on page 8 Apply the pads to the patient as directed on the pads packaging or according to your organization s protocol NOTE Ifyou are using Philips HeartStart Preconnect Pads 989803166021 the pads may already be connected to the end of the Therapy cable Open the package to apply the pads to the patient CAUTION Aggressive handling of multifunction electrode pads in storage or prior to use can damage the pads Discard the pads if they become damaged Operation To operate the HeartStart XL in AED Mode 1 2 3 Turn the Therapy knob to AED The HeartStart XL announces and displays the current patient category If not correct use the Patient Category button to select the appropriate patient category e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category
107. de Make sure your device is in Monitor Mode before attempting to display trending information You receive a Event Record Limit Reached technical alarm You have reached the eight hour duration limit for the current event To continue event recording you need to start a new event by powering the device off for 10 seconds and then turning it back on Do not perform this function if patient safety is an issue You receive a Event Storage Error technical alarm You receive a USB Error technical alarm A non critical device failure has occurred Recording of events and waves has stopped Restart device when it is appropriate to do so If the alarm continues call for service Restart device when it is appropriate to do so If the alarm continues call for service You receive a Device Temp High technical alarm The device s internal temperature is above 65 C 149 F Turn the device off and allow to cool If the problem persists remove the device from use and call for service You receive a Device Restarted Due to Error technical alarm The previous shutdown was caused by an internal device error You receive a Power Equipment Malfunction technical alarm A power supply failure has occurred but no critical functions are affected Run an Operational Check to diagnose the problem If the problem persists remove the device from use and call for service You receive an A
108. dge of the bag with the bottom of the pouch see Figure 19 Step 3 4 Secure the bottom edges of the bag by snapping them together through the holes along the bottom edge of the pouch see Figure 19 Step 4 Figure 19 Attaching the Pouches Ed NOTE Figure 19 illustrates attaching the Accessory Storage System pouch on the right therapy side of the device Use the same procedure to install the pouch on the left monitoring side Basic Orientation 2 Device Basics Filling the Accessory Pouches The HeartStart XL Accessory Pouches are designed to hold your essential monitoring and defibrillation accessories Recommended accessory placement includes e Monitor side see Figure 20 e Connect the NBP tubing to the NBP port Coil the remaining tubing with the NBP cuff Place them in the outside slot of the double sided black bag e Connect the SpO cable to the SpO port Coil the remaining cable and finger sensor and place them in the inside slot of the double sided bag Connect the ECG cable to the ECG port Coil the remaining cable and leads and place it in the large pouch e Therapy side see Figure 21 e Connect the Therapy cable to the Therapy port Coil the remaining cable and place it in the large pouch e Ifyou are using pads place pads in the inside slot of the double sided bag If you use paddles place gel pads or conductive material in the ins
109. dition or device cable conditions that may require attention Alarms conditions are based on comparisons against preset limits and algorithm results The HeartStart XL breaks alarms into two categories Physiological Alarm An alarm detected while in a clinical mode resulting from a patient related parameter being monitored SPO Low is an example of a physiological alarm These alarms are not detected in non clinical modes Technical Alarm An alarm resulting from a equipment related issue All alarms are either latching or non latching and fall into one of three priority categories See Table 2 Table 2 Alarm Types Alarm Type Condition High Priority An immediate response is required A life threatening wei alarm condition is present A red alarm message is displayed and an alarm tone sounds Medium Priority Prompt response is required A non life threatening spo2 Low _ alarm condition exists A yellow alarm message is displayed and an alarm tone sounds Low Priority Awareness is required A non life threatening alarm condition exists A cyan alarm message is displayed and an alarm tone sounds Latching The alarm remains active regardless if the alarm condition continues to exist or not A latching alarm is not removed until it is either acknowledged or a higher priority alarm condition occurs Non Latching The HeartStart XL automatically removes the alarm when the alarm condition no longer exists
110. dition to the periodic checks performed by your facility s biomedical or clinical engineering team The activities on this checklist include verifying that the appropriate supplies and accessories are present the device is plugged in and has sufficient battery power and the device is ready for use Philips Healthcare supports the AHA checklist recommendations and has provided a Shift Checklist document with the device and published a copy in this book See HeartStart XL Shift Checklist on page 149 As part of the Shift Check you must verify the device s ability to deliver defibrillation therapy once a week by performing a shock test You can complete this important requirement by performing one of the following e Weekly Shock Test see Weekly Shock Test on page 148 e Operational Check see Operational Check on page 151 TE WARNING When performing an Operational Check or Weekly Shock Test be sure to disconnect the ECG leads set from the cable and confirm the HeartStart XL is not connected to a patient Oo Oa a a SSS 147 14 Operational and Shift Checks Weekly Shock Test A Weekly Shock Test is performed using either a test plug a test load or paddles The Weekly Shock Test process and results differ depending which way you choose to perform the test See chart below To perform the Weekly Shock Test Shift Check If you are If you are using If you are using paddles usi
111. djusting volume 32 AED 64 Volume 178 configuration options 139 V Tach 54 W Wave Sector 1 29 lead behavior 49 pacing 91 Rhythm label options 29 Wave Sector 2 30 51 Wave Sector 3 30 Wave Sector configuration options 142 Waveforms 43 Weekly Shock Test 148 221 NOTES PHILIPS Philips Healthcare is part of Royal Philips Electronics On the web www philips com heartstart By e mail healthcare philips com By postal service Philips Healthcare 3000 Minuteman Road Andover MA 01810 1085 Asia Tel 49 7031 463 2254 Europe Middle East and Africa Tel 49 7031 463 2254 Latin America Tel 55 11 2125 0744 North America Tel 425 487 7000 1 800 285 5585 USA only A 2011 Koninklijke Philips Electronics N V All rights are reserved Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder Philips Healthcare reserves the right to make changes in specifications or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication Published December 2011 Edition 2 Printed in the USA 453564090581 OA A OT N T T Mi
112. e Operational Check is completed a summary note appears in the middle of the display To remove the message from the screen press the Hide Messages soft key To bring the messages back hit the Show Messages soft key If you fail an Operational Check for a therapy related problem for example a failed Therapy knob or button therapy is disabled You receive messages on the display and the RFU indicator is a solid Red X After exiting Operational Check the HeartStart XL restarts with therapy disabled NOTE When exiting Operational Check if the failure is related to the Therapy knob you restart and remain in Monitor Mode regardless of the knob s position on the dial If the device does not turn off with the knob in the Off position take it out of use and call for service The failure may have been caused by an improperly performed Operational Check To clear the failed Operational Check successfully perform a proper Operational Check If the device continues to fail the Operational Check and you have confirmed you are performing the Operational Check properly take the device out of use and call for service Leads ECG Test Rerun If the Leads ECG test fails upon the completion of Operational Check the HeartStart XL prompts you with the message Leads ECG Test Failed With Cable Disconnect the ECG Cable to rerun test without the cable As soon as you remove the ECG cable the device reruns Operational Check to check if the problem is
113. e amplitude of the inserted pulse is gt 40 and lt 70 of the detected pacemaker pulse amplitude for pulses widths of 0 5 ms to 2 0 ms Monitor View 4 ECG Monitoring Monitor View You primarily monitor your patients ECG waveform in Monitor View by turning the Therapy knob to Monitor In Monitor View you can review three waves simultaneously while monitoring all current vital sign parameters See Figure 42 Figure 42 Monitor View Layout 25 Aug 2011 10 44 AM 0 Fi 4 8 Non Paced Status Area m Parameter HR bpm Sp02 Pulse bpm NBP q5 10 40am mmHg 70 95 702110 70 soy Message Area Wave Sector 1 Wave Sector 2 Wave Sector 3 Selecting the Waveform The HeartStart XL allows you to configure the lead displayed as the primary ECG lead in Wave Sector 1 when the device is turned on The factory default is Lead II See Table 33 Wave Settings on page 142 When you first turn the HeartStart XL on in Manual Defibrillation Synchronized Cardioversion or Monitor modes or switch into one of those modes the default lead is displayed in Wave Sector 1 If the default lead is not available or is of poor quality the device automatically searches for the ECG lead with the best quality and displays that new lead in Wave Sector 1 You can also change the waveform for each sector during a patient event A The ECG wave for Wave Sector 1 is selected through the Lead Select button see General Function Buttons on
114. e frequency and duration of use When properly cared for and used in its intended environment the HeartStart XL Lithium Ion battery has a useful life of approximately 3 years Use outside those conditions could significantly reduce battery life To optimize performance a battery that is in the low battery condition less than 40 remaining should be charged as soon as possible Initializing Batteries When opening a new battery for the first time it needs to first be charged before the fuel gauge lights activate Charging Batteries The HeartStart XL Lithium Ion battery needs to be charged in the HeartStart XL Insert the battery to be charged in the battery compartment and then plug the device into an AC power outlet Once AC power is supplied the Battery Charging Indicator flashes green to indicate the battery is charging and the battery is lt 90 percent of capacity The indicator turns solid green when the battery charge is gt 90 percent of capacity and AC power is present If no battery is installed or the installed battery is not functioning properly the light remains off With the HeartStart XL turned off and the temperature between 0 35 C 32 95 F a fully discharged battery typically charges to 80 capacity in 2 hours and to 100 capacity in 3 hours The battery charges at a slower rate with the device turned on Battery Maintenance 15 Maintenance Charge Status You can check the current charge status of a Hear
115. e in Demand Mode pacing if you change the lead in Wave Sector 1 the HeartStart XL waits a second before notifying you with a Cannot Analyze ECG alarm 2 Press the Lead Select button to select the best lead with an easily detectable R Wave See Lead Selection on page 47 3 Verify white R Wave arrows appear above or on the ECG waveform A single arrow should be associated with each R Wave If the R Wave arrows do not appear are incorrectly labeling beats or do not coincide with the R Wave select another lead NOTE Ifyou are using anterior anterior pad placement while pacing and are experiencing difficulty with Lead II select another lead 4 Select the pacer rate by pressing the Rate soft key Use the upper portion of the soft key to increase the rate and the lower portion of the soft key to decrease the rate See Figure 53 5 Ifneeded adjust the initial pacer output Press the Output soft key Use the upper portion of the soft key to increase the output and the lower portion of the soft key to decrease the output See Figure 53 Figure 53 Pacer Keys Pacing Paused Demand Pacing 70 ppm 30 mA Rate ppm Output mA Start A Pacing Vv Press top part of soft key to increase value Press bottom part of soft key to decrease value 6 Press Start Pacing Pacing appears in the Pacing Bar 7 Verify white pacing markers or white R Wave arrows appear on the ECG waveform 93 8 Pacing Demand Mode P
116. e or fails to inflate fully Defective cuff Replace the cuff Poor connection between the cuff and the HeartStart XL Check connections and replace tubing if needed NBP measurements appear high low The cuff size is too small large for the patient Use the correct cuff size and take another measurement NBP Cuff Not Deflated technical alarm The NBP numeric value is replaced with a The cuff has not fully deflated after 3 minutes Remove the cuff from the patient Release pressure in the cuff disconnect cuff from tubing Replace the cuff If the problem persists call for service NBP Cuff Overpressure technical alarm The NBP numeric value is replaced with a The NBP cuff pressure has exceeded the overpressure safety limit of 300 mmHg 40 kPa The cuff should deflate automatically If not remove cuff from patient and deflate Turn device off to reset the alarm and restart NBP 184 Symptoms Table 48 NBP Monitoring Problems Continued 16 Troubleshooting Symptom Possible Cause Possible Solution NBP Measurement Failed technical alarm The NBP numeric value is replaced with a A measurement value could not be obtained Check cuff size and placement NBP Calibration Overdue technical alarm The NBP module needs calibration Calibration should be performed once a year NBP Equipment Malfunction
117. ea displayed See Menus on page 31 Status Area The Status Area contains key device and patient information see Figure 28 Figure 28 Status Area Event Ti Paced Status Patient Name Date and Patient Te EEEREN ean Weight rn EE a r j I lt Range Technical Alarm Area Multiple Technical Clinical Alarm Area Alarms Indicator Patient information includes e Name The patients name for the current event if entered e Date and Time The current date and time e Paced Status Internally paced or non paced The area remains blank if paced status has not been selected This information is not displayed in Pacing Mode e Event Timer The elapsed time for the current event displayed in hours minutes seconds e Patient Category and Weight Range Adult defined as 25kg or Infant Child defined as lt 25kg The neonatal patient category is not supported for AED Mode and all monitoring functions 27 3 Working with the HeartStart XL The Display Device information includes e Clinical Alarm Indicator Indicates the state of global alarms If alarms are on the indicator is blank If they are off the indicator says Alarms Off and uses the Alarms Off icon AN e Technical Alarms Technical alarms not related to the battery or pacing are displayed in the Technical Alarms area A triangle amp indicates there are multiple alarms present alternating on the display e Battery Status Ifa battery is ins
118. ea displays key messages during an event The type of message shown varies according to the current mode Figure 31 Message Area Check Pads Connection from Patient to Device Waveform and Display Soft Keys Area The HeartStart XL is configured to populate each of its three wave sectors with a preconfigured waveform when powered on in Monitor Manual Defibrillation Pacing Mode two wave sectors only and AED one wave sector A dashed line in an ECG wave sector indicates that the waveform source is invalid Wave sectors may contain a variety of information as appropriate to the parameter view and task currently being performed You can display one two or three waveforms at one time on the display depending on which mode the HeartStart XL is currently in and how you have your device configured The area also displays other key information including the number of shocks delivered and the selected energy Wave Sector 1 Wave Sector 1 contains only an ECG waveform This waveform is used by the arrhythmia heart rate derivation and AED analysis algorithms Available waveforms include Paddles unavailable in AED Mode Pads I II III aVR aVL aVF and V Wave Sector 1 also contains the ECG Calibration Bar the Auto Gain Indicator Rhythm Label and R Wave arrows The Calibration Bar is used as a reference point to compare the actual ECG wave displayed to the selected size The Auto Gain Indicator is displayed when auto scaling is active R Wave
119. egory to select the appropriate category See General Function Buttons on page 23 Once the sensor cable is connected and the device is turned on an SpO measurement begins A is displayed for the SpO value in the Parameter Area while the oxygen saturation is initially measured and value calculated In a few seconds a value replaces the See Figure 56 Figure 56 SpO Value Alarm Limits If SpO alarms are turned on the alarm limits are displayed If alarm limits are turned off the alarms off symbol X is displayed Pulse Rate The patient s pulse rate as derived from pulse oximetry is displayed in the Parameter Area See Figure 57 102 SpO Alarms 9 Pulse Oximetry Figure 57 Pulse Rate Value i Alarm Limits If pulse rate alarms are P turned on the alarm limits are displayed If alarm limits are turned off the alarms off symbol X is displayed Pulse alarms are off by default Pleth Wave When the sensor is connected to the HeartStart XL the pleth wave is displayed in the configured Wave Sector Grid lines are displayed to indicate signal quality When the signal quality is good the pleth wave is auto scaled to the grid lines When the signal is poor the size of the wave is proportionally decreased and appears not to reach the grid lines Figure 58 Pleth Waves Good Pleth Signal Quality Poor Pleth Signal Quality SpO Alarms Alarms are annunciated if measurements fall outside the co
120. en available Available waveforms include Paddles Pads I II HI aVR aVL aVF V Pleth and a Cascade Wave from Wave Sector 1 You can also select an annotated ECG for Wave Sector 2 See Displaying an Annotated ECG on page 51 Changing Displayed Waveforms Wave Sector 1 has a dedicated Lead Select button see General Function Buttons on page 23 to change the displayed lead source Waveforms displayed in the other sectors are changed for the current event using the Menu Select button See Menus on page 31 Soft Key Labels The four soft key labels correspond to the soft key buttons located immediately below See Figure 33 These labels change as appropriate according to the current display view and function Soft key labels appearing as gray text indicate the soft key is inactive Figure 33 Waveform and Display Soft Keys Area Waveforms Soft Keys The Display 3 Working with the HeartStart XL Menus Menus with controls and options specific to each HeartStart XL function are easily accessible using the Menu Select and Navigation buttons located on the front panel Menus are used to adjust volume select waveforms select waves for printing set alarms enter patient information generate reports and complete a variety of other tasks To display a menu press the Menu Select button iV and then use the up or down g Navigation buttons to scroll up or down through the available choices until the desired se
121. en mode or selected energy changes Exit Clinical Mode Logged when exiting a clinical mode Patient Info Adult or Infant Child Logged when patient category is set or changed Paced Non Paced Pacing Status Unknown Logged when internal paced status is set or changed Battery Status Low Battery Logged when battery is low Pacing on Low Battery Logged when you are pacing and the battery is low Shutting Down in 1 min Logged when imminent shutdown warning is issued Shutting Down Now Logged when shutdown warning is issued Battery Calibration Logged when Op Check detects that the battery needs calibration Required Battery Charge Good Logged when the battery charge level is good Battery Not Present Logged when the battery is not present Pads Paddles Leads Pads On Logged when pads are applied to the patient Pads Off Logged after a Pads On event if the multifunction electrode pads are removed from the patient or the Therapy cable is disconnected Pads Shorted Logged when a pad impedance is low Pads Marginal Logged when pad impedance is minimal External Paddles On Logged when external paddles make contact with the patient External Paddles Off Logged after External Paddles On if paddles lose contact with the patient 122 Event Summary 12 Data Management Table 26 Event Information Continued Logged Event
122. enough to encircle 50 80 of the limb NOTE Selecting the right cuff size for the patient is important The wrong cuff size may give false and misleading results If you do not have the correct cuff size use a larger one to minimize error 2 Attach the cuff to the NBP tubing making sure that air can pass through the tubing and the tubing is not squeezed or kinked See Figure 60 Figure 60 Connecting the NBP Cuff Tubing NOTE Securely attach the cuff and tubing to prevent accidental disconnections 3 Insert the NBP tubing into the NBP port as described in Connecting the NBP Cable on page 10 4 Apply the blood pressure cuff to the patient s arm or leg as follows a Ensure that the cuff is completely deflated b Wrap the cuff around the arm making sure that the artery marker is aligned over the brachial artery Ensure that e The cuffis not placed on the same extremity as an SpO sensor e The cuffis not wrapped too tightly around the limb Excessive tightness may cause discoloration and eventual ischemia of the extremities e The NBP tubing from the defibrillator to the cuff is not compressed crimped or damaged Measuring NBP 10 Blood Pressure Monitoring c Check that the edge of the cuff falls within the range identified by the lt gt markings If it does not use a cuff that fits better Place the limb used for taking the measurement at the same level as the patient s heart 6 Press the Start NBP sof
123. ently stored in the HeartStart XL see Figure 75 Using the Navigation buttons select the Operational Check report you want Press the Menu Select button see Figure 76 to print out or export the summary Figure 75 Operational Check Summary 25Jan2011 11 11am P Operational Check Summary Date and Time Result Date and Time Result 16Jan2011 12 37PM Pass 18Jan2011 11 11AM _ Fail DX 20Jan2011 01 11PM Pass 25Jan2011 03 18AM Pass Figure 76 Operational Check Summary Menu Operational Check Summary Pea Select Print to print the current Operational Check Print Select Export to export the current Operational Check Export to the USB drive see Saving Data to the USB Drive Exit on page 130 Select Exit to exit the menu 160 Operational Check Auto Test Summaries 14 Operational and Shift Checks Selecting Auto Test Summary from the Operational Check menu see Figure 71 displays a summary of automated test results currently stored in the HeartStart XL Using the Navigation buttons select the summary you want and press the Menu Select button to print out or export the summary Figure 77 Auto Test Summary Menu Auto Test Summary Export Summary Export Detail Exit a n Select Print to print the Auto Test Summary Select Export Summary to export the selected Auto Test Summary to the USB drive See Saving Data to the USB Drive on page 130 Select Export Detail to
124. enu Select button to stop the alarm The HeartStart XL prompts you to confirm your selection Press the Menu Select button again WARNINGS Silencing either audio or audio and visual indications of active alarms can result in missed alarm conditions and also inhibit indications of new alarm conditions Confirm alarm limits are appropriate for the patient each time there is a new patient event Do not set alarm limits to such extreme values that render the alarm system useless A potential hazard exists if different alarm limits are used for the same or similar equipment in any single area C 34 Alarms NOTE 3 Working with the HeartStart XL Alarm Notification Display Locations Depending on the alarm type the HeartStart XL displays notifications in various locations See Figure 36 Figure 36 Alarm Notification Locations Battery related alarms are displayed here Technical alarms are displayed here Teda 25 Jan 2010 10 25 AM TA 0 y y 7 NancPaced E general alarm status is B X Alarms Off displayed here HR Alarm mmHg L Alarms A U 50 110 70 80 ito to parameter Check Pads Connection from Patient to Deyi Multiple Alarm Indicator limits appear above the parameter Messages in the Message Area help with technical alarms and provide clinical suggestions Pacing alarms appear in the Pacing Bar See Pacing Alarms on page 97 Adjusting Alarm Limits Alarm limit
125. er provides information on the various supplies and accessories for the HeartStart XL Ordering Replacement Supplies and Accessories To order accessories and supplies e Visit our Healthcare web site at http www medical philips com main products resuscitation products supplies e Inthe US call 800 225 0230 for pads electrodes cables paper etc e Outside the US contact your local Philips Healthcare Sales Office or your authorized Philips Healthcare Dealer or Distributor WARNINGS Use only multifunction electrode pads battery and accessories listed in this Instructions for Use Substitutions may cause the HeartStart XL to function improperly For example some electrodes may be subject to large offset potentials due to polarization Use single use supplies and accessories only once Use multifunction electrode pads prior to their expiration date Discard pads after use Do not reuse pads Do not use for more than 8 hours of continuous pacing Approved Supplies and Accessories Table 51 Supplies and Accessories Part Number Description Multifunction Electrode Pads M3501A M3504A M3713A M3716A M3717A M3718A M3719A 989803166021 989803158211 989803158221 989803139261 Adult Child Pads barrel connector AAMI Infant Pads barrel connector AAMI HeartStart Adult Child Plus Pads HeartStart Adult Child Radiolucent Pads HeartStart Infant Plus Pads HeartStart Adult Child Radiotran
126. erning ventricular fibrillation Because ventricular tachycardia rhythms may have an associated pulse SMART Analysis is more conservative when making shock decisions with these rhythms Besides resuscitating a patient in AED Mode you can also monitor the patients ECG SpO and pulse Certain ECG alarms can also be displayed in AED Mode Even though ECG alarms which are obtained through the ST AR Algorithm can be viewed in AED Mode the SMART Analysis algorithm is used as the only basis for determining a shock See Other Alarms in AED Mode on page 72 The HeartStart XL AED Mode can be used on both adult and infant child patients Use the Patient Category button to switch categories When pressing the Patient Category button all parameter alarm limits change to the new patient category These changes are retained when you switch modes e For patients that are 25kg or 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category The neonatal patient category is not supported in AED Mode For information on annotating storing exporting and printing event information acquired in AED Mode see Data Management on page 119 For information on setting AED configuration choices see Defib Sync AED Settings on page 143 Optional SpO and Pulse monitoring are also available in AED Mode For more information see SpO and Pulse on page 72 and Chapter 9 Pulse O
127. ersion Delivering a Synchronized Shock To perform synchronized cardioversion using external paddles 1 Prepare your patient for synchronized cardioversion as stated above 2 Place paddles on the patient s chest prior to charging the defibrillator 3 Look at the wave label appearing in Wave Sector 1 If the label is Paddles e Change the monitoring lead in Wave Sector 1 by pressing the Lead Select button multiple times to cycle through available leads Select the waveform you wish to use e Confirm a non paddles monitoring leads appears in Wave Sector 1 Check for R Wave arrows e Proceed with the normal protocol for synchronized cardioversion If the label is not Paddles e Proceed with the normal protocol for synchronized cardioversion Delivering Additional Shocks There are times when additional synchronized shocks are clinically indicated To deliver additional synchronized shocks 1 Confirm the Sync function is still enabled the Sync button is lit the Sync indicator is present and the R Wave arrows are still visible 2 Repeat steps 3 5 under Delivering a Synchronized Shock on page 85 NOTE The HeartStart XL s Sync function can be configured to either be enabled or disabled after each synchronized shock is delivered Turning Sync Off To turn the Sync function off press the Sync button again The button light turns off and Sync indications are removed from the display Cardioversion Alarms Cardioversi
128. ert the plug or load into the Therapy cable see Figure 23 The Test Plug and Test Load behave differently during the Weekly Shock Test The Test Plug creates an electrical short while the Test Load applies an impedence at the end of the Therapy cable Therefore similar successful Weekly Shock Test results appear differently on the device For more on the Weekly Shock Test see Weekly Shock Test on page 148 Figure 23 Connecting Defibrillator Test Plug Load Test Plug _ Na Test Load N _ e CAUTION The defibrillator test plug is not compatible for use with the HeartStart MRx or HeartStart XL NOTE Using the tie provided tie the test plug about 18 inches 46 cm from the end of the therapy cable tight enough to prevent the plug from sliding along the cable The plug should be oriented such that it can easily be inserted into the cable while you have the the cable stowed 19 NOTES 3 Working with the HeartStart XL The HeartStart XL was designed and built with clinical use in mind Philips designers and engineers building on our experience as a market leader worked with clinicians around the globe to confirm the HeartStart XL meets clinicians needs Operating Modes The HeartStart XL has four Clinical Modes and four non clinical modes of operation each with a customized display see Table 1 Table1 Operating Modes Mode Description For
129. etting Alarms Responding to Alarms HR Arrhythmia Alarms in AED Mode Troubleshooting Chapter 5 AED Mode Precautions for AED pare AED View AED Soft Keys Using AED Mode to Debbiillate Preparation Operation Using AED Mode to Menor Configurable Resuscitation Protocols AED Alarms Other Alarms in AED Made Troubleshooting Chapter 6 Manual Defibrillation Overview IV 29 32 33 34 37 38 39 39 40 43 43 44 44 44 45 49 49 51 52 52 52 52 54 56 57 57 57 59 60 61 62 63 63 63 70 71 71 72 72 73 73 Precautions for Manual Defibrillation Code View Preparing for Debain Using Multifunction Electrode Pads Using External Paddles Using Infant Paddles Using Internal Paddles Defibrillation Step 1 Select Wag Step 2 Charge Step 3 Shock Manual Defibrillation Alarms Troubleshooting Chapter 7 Cardioversion Overview Precautions for Camliovesian Preparing for Synchronized Cidivenion Code View and Cardioversion Delivering a Synchronized Shock With External Paddles Delivering Additional Shocks Turning Sync Off Cardioversion Alarms Troubleshooting Chapter 8 Pacing Overview Pacing View Demand Mode Versus fixed Mode Preparing for Pacing Demand Mode Pacing Fixed Mode Pacing Defibrillating During Pdi Pacing Alarms Troubleshooting Chapter 9 Pulse Oximetry Overview Understanding Pulse ir mietin Selecting a Sen
130. export all Auto Test details to the USB drive see Saving Data to the USB Drive on page 130 Select Exit to exit the menu For more information see Automated Tests on page 164 NOTE Ifyou try to print a summary or report while the printer is printing another report or summary the HeartStart XL asks you if you want to stop the current printing and begin the second one Using the Navigation buttons select your answer and press the Menu Select button NOTES 15 Maintenance This chapter describes how to care for your HeartStart XL and its accessories Overview Proper maintenance of the HeartStart XL is a simple yet important factor in dependability Attending to routine maintenance is vital to keeping the HeartStart XL ready to respond in an emergency Routine maintenance involves Providing power so automated tests can run see Automated Tests on page 164 Observing the Ready For Use RFU indicator to confirm the device s readiness see Ready For Use Indicator on page 24 Performing Operational Checks and Shift Checks see Chapter 14 Operational and Shift Checks on page 147 Caring for batteries see Battery Maintenance on page 166 Cleaning the device and accessories see Cleaning Instructions on page 170 Checking expiration dates on supplies and accessories and ordering replacements see Chapter 17 Supplies amp Accessories on
131. f time during which alarms are paused after the Alarm button is pressed 1 min 2 min 3 min 5 min 10 min indefinite Alarm Volume Defines alarm volume level Very Soft Soft Medium Loud Very Loud 139 13 Configuration Table 29 General Settings Continued Overview Parameter Description Setting Choices Minimum Alarm Volume Defines the minimum audible alarm level available within use Very Soft Soft Medium Loud Very Loud Voice Volume Defines voice prompt levels Very Soft Soft Medium Loud Very Loud Patient Info prompt is displayed asking if you want to de identify the data QRS Volume Defines the volume level of audible beeps Off Very Soft Soft Medium with each QRS complex detected Loud Very Loud Units Display Defines if parameter values are displayed On Off with or without the corresponding measurement units Export Without Defines if when exporting clinical dataa Prompt Disabled NOTE The list of available alarm volumes is limited so that no choice less that the current setting for Minimum Alarm Volume is presented If the Minimum Alarm Volume is changed and the current alarm volume is quieter than the new Minimum Alarm Volume the current alarm volume is changed to match the setting for the Minimum Alarm Volume Table 30 Heart Rate ECG Settings Parameter Description Setting Choices Color Selec
132. ge 103 Pulse alarms see Pulse Rate Alarms on page 106 NBP alarms see NBP Alarms on page 113 Power alarms see Power Related Alarms on page 169 3 Working with the HeartStart XL Entering Patient Information Entering Patient Information Patient information can be entered except when in AED Mode for the following categories e Name eID e Sex e Paced Status To enter patient information on the HeartStart XL 1 Press the Menu Select button to activate the Main Menu 2 Using the Navigation buttons select Patient Info and press the Menu Select button 3 Select the category you want to enter information for and press the Menu Select button 4 If you are entering the patient s name the Last Name screen appears with a menu of letters to enter the patient s last name See Figure 38 Using the Navigation buttons select the first letter of the patient s last name a Press the Menu Select button to select the letter b Repeat the process with the remaining letters of the last name c Once you have completed spelling the patient s last name select Done The HeartStart XL stores the last name and prompts you to enter a first name 5 Repeat Step 4 to insert the patient s first name Selecting Done saves the first name and prompts you to enter a Patient ID NOTES Ifyou had previously entered the last name first name or patient ID the HeartStart XL remembers the information and populates the screen for
133. h multifunction electrode pads is displayed in AED Mode 5 AED Mode AED View AED Soft Keys AED Mode has four soft keys available see Figure 47 e CPR Pressing the CPR soft key initiates the configured pause period to perform CPR e Resume Analyzing Pressing the Resume Analyzing soft key initiates the AED analysis algorithm to resume or restart analysis e SpO On Off Available if you have the SpO option installed and AED SpO monitoring enabled Pressing the SPQ soft key turns SpO monitoring on or off e Background Analysis This key is available if your device is configured for No Shock Advised NSA Monitoring and you have activated NSA Pause Press it to begin NSA monitoring Pressing the Menu Select button brings up the main menu for AED Mode See Figure 48 Figure 48 AED Main Menu Select Voice Volume to adjust the volume of AED Mode voice prompts Main Menu Select Alarm Volume to adjust the volume of ALAA OIIINE a AED Mode alarms ECG Wave Size q Select ECG Wave Size to modify the ECG wave Measurements Alarms size See page 50 Exit Select Measurements Alarms to modify alarm limits Select Exit to exit the menu For more information on menus see Menus on page 31 NOTE In loud environments use the display prompts in addition to the voice prompts Using AED Mode to Defibrillate 5 AED Mode Using AED Mode to Defibrillate Preparation To prepare for defibrillation in AED Mo
134. h the display facing away from the body or other surfaces If not the Therapy knob may be bumped and inadvertently moved from its desired position Never operate the HeartStart XL in standing water Do not immerse or pour fluids on any portion of the HeartStart XL If the device does get wet dry it with a towel Do not use the HeartStart XL in the presence of a flammable anesthetic mixture or oxygen concentrations greater than 25 or partial pressures greater than 27 5 kPa 206 27 mmHg This can cause an explosion hazard Avoid connecting the patient to several devices at once Leakage current limits may be exceeded Do not use a second defibrillator on the patient while pacing with the HeartStart XL Operating the HeartStart XL or its accessories in conditions outside the environmental specifications can result in device or accessory malfunction The HeartStart XL should be allowed to stabilize within the operating temperature range for 30 minutes prior to operation The HeartStart XL should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the HeartStart XL should be observed to verify normal operation in the configured use Use only 3 wire AC power cords with 3 pronged grounded plugs For operations in the U S the cord must have the proper NEMA type plug Do not touch the communication ports and a patient simultaneously 40 Safety Considerations 3 Working with the HeartStart
135. h upper alarm limit set at 100 and lower alarm limit set at 60 bpm Patient Isolation Defibrillation Proof e Lead ECG Type CF SpO Type CF e NBP Type CF e Pads Paddles Type BF e Internal Paddles Type CF Other consideration The HeartStart XL is suitable for use in the presence of electrosurgery Burn hazard protection is provided via a 1K current limiting resistor contained in each ECG lead wire Proper lead placement see Electrode Placement on page 45 is important to reduce burn hazards in the event of a defect in the electrosurgical equipment 199 18 Specifications Specifications 200 Display Size Approximately 6 5 in 16 5 cm diagonal viewing area Type Color TFT LCD Resolution 640 x 480 pixels VGA with 32 brightness levels per color Sweep Speed 20 mm s nominal stationary trace sweeping erase bar for ECG and SpO Wave Viewing Time 5 2 sec Battery Type Rechargeable Lithium Ion See battery label for capacity information Dimensions 23 6mm H x 116mm W x 146 mm L 1 in H x 4 5 in W x 5 7 in L Weight Approximately 68kg 1 5 lbs Charge Time with Device Turned Off and AC Power Connected With the temperature between 0 35 C 32 95 F less than 3 hours to 100 capacity less than 2 hours to 80 capacity Charge Time with Device On and AC Power Connected Charge time is less than 10 hours Capacity With a new fully charged battery at 20 C 68 F one of
136. hat they are not counted by the algorithm Perform all routine diagnostic tests to verify that voice prompts are operational during Operational Check and according to your organization s protocol AED View 5 AED Mode AED View When the Therapy knob is moved to AED AED View is displayed see Figure 47 AED Mode related information includes AED Message Area Displays important messages for the user while in AED Mode Shock Counter Displays the number of shocks for the current event including shocks delivered in Manual Defibrillation Mode Configured Energy Displays the configured energy for the current patient category Wave Sector 2 Displays the SpO waveform if your device has the option and is configured to do so or the AED Pause CPR Progress Bar AED Pause CPR Progress Bar When in use replaces the wave in Wave Sector 2 and tracks the progress of the analysis pause and CPR periods Patient Category Displays the current Patient Category The patient category triggers specific alarm limits and AED energy settings for defibrillation Figure 47 AED View Layout 25 Jan 2011 10 44 AM 0 0 4 8 Patient m lt Category AED Message No Shock Advised Attend to Patient Area Shock Counter Enlarged Energy Wave N LA Setting SA Shocks 0 Selected Energy 150 Joules AED 5 Pause CPR i Length of Resume Sp02 Off Pause Analyzing Period w Soft Keys Current Duration NOTE Only the ECG acquired throug
137. hat type of ECG cable is connected to the HeartStart XL and its configuration See Table 5 Table 5 Lead Choices If you are using These leads are available a 3 Lead ECG set I I Il a 5 Lead ECG set I II III aVR aVL aVE V To select leads to display on the HeartStart XL see Selecting the Waveform on page 49 n WARNING Avoid touching monitoring electrodes and other measuring devices when they are applied to the patient Doing so can degrade safety and may affect results 4 N 4 ECG Monitoring Preparing to Monitor ECG CAUTIONS Beware of patient cables including ECG monitoring equipment when used with high frequency surgical equipment Conductive parts of electrodes and associated connectors for applied parts including the neutral electrode should not contact other conductive parts including earth NOTES Signals from TENS or ESU units can cause artifact For patients who exhibit intrinsic rhythm only the risk of missing cardiac arrest may be reduced by monitoring these patients with low heart rate limit at or slightly above the basic demand pacemaker rate A low heart rate alarm alerts you when the patient begins pacing Proper detection and classification of the paced rhythm can then be determined When using the ECG Analog Output detected internal pacemaker pulses are inserted into the output as pulses of less than 3 5 ms in width when measured at 50 of the peak of the pulse Th
138. he Device Info Report provides that information To print a Device Info Report 1 Press the Menu Select button 2 Using the Navigation buttons select Other and press the Menu Select button 3 Select Print Device Info and press the Menu Select button to print the report The Device Info Report contains information on e Serial Number e Installed Options e Software Revision e Therapy Board e Main Processor PCA e Printer e Processor Module If there is a device failure and the HeartStart XL cannot determine a version number a is displayed in its place Symptoms Symptoms 16 Troubleshooting The following tables list symptoms statements and messages that you may encounter while using the HeartStart XL The tables also provide possible causes and potential solutions Symptoms are categorized by functionality NOTE When troubleshooting issues related to connecting the patient to the HeartStart XL it is recommended that one single person follow the connection path from the patient to the device to assure a proper end to end connection Table 44 General Problems Symptom Possible Cause Possible Solution The HeartStart XL does not turn on There is no power Check the battery pack Insert a fully charged battery Connect the device to AC power Short battery life battery appears to lose its charge quickly Battery may be nearing its end of life Calibrate the battery Replace the
139. he Menu Select button 2 3 Using the Navigation buttons select Other and press the Menu Select button 4 Select Configuration and press the Menu Select button 5 To confirm your selection select Yes and press the Menu Select button If you select NO you are returned to the mode you started from Once in Configuration Mode press the Exit Config soft key to return to clinical operation 135 13 Configuration Overview Setting Date and Time To modify the date and time from Configuration 1 Once in Configuration Mode press the Menu Select button 2 Select Date Time and press the Menu Select button The Configuration Date Time screen appears See Figure 69 Figure 69 Configuring Date and Time 3 Using the Navigation buttons select the entry you want to change and press the Menu Select button 4 Adjust the value see Adjusting Numeric Values on page 32 Press the Menu Select button to accept your change 5 Select another value for modification or press the Main Config soft key to save changes and return to the main Configuration screen NOTE To adjust the format of the date and time you need to enter the Configuration Mode password See Changing Settings on page 137 Overview 13 Configuration Changing Settings To change default settings in Configuration Mode 1 2 Press the Change Config soft key Enter the configuration password a Using the Navigation buttons select the fi
140. he device does aftera No NSA Monitor NSA CPR Shock Advised decision NSA Monitor allows you to initiate background shock advisory analysis NSA CPR prompts you to initiate a CPR Pause period if needed NSA Monitor Defines the interval for patient care 1 2 3 Infinite no prompts at all min SpO Monitoring Defines whether SpO monitoring is available in AED Mode Enabled Disabled 143 13 Configuration 144 Table 34 Defib Sync AED Settings Continued Overview Parameter Description Setting Choices Adult 1st Shock Defines the energy dose for the first shock All energy settings gt 100J 150 Energy Dose in a series in AED Mode Adult 2nd Shock Defines the energy dose for the second All energy settings gt the first Energy Dose shock in a series in AED Mode configured shock in the series 150 Adult 3rd Shock Defines the energy dose for the third and All energy settings gt the second Energy Dose subsequent shocks in a series in AED configured shock in the series 150 Mode Table 35 CPR Settings Parameter Description Setting Choices CPR Time Defines the length of the CPR 1 1 5 2 2 5 3 min administration interval Table 36 Pacer Settings Parameter Description Setting Choices Default Pacer Rate Defines the delivery rate of paced pulses 30 180 70 pulses per minute Adjusted in increments of 10 Pace Pulse Duration Defi
141. heck Alarms Alarms On Off Logged when alarms are enabled disabled All Alarm Audio Pause Logged when alarm audio is paused All Alarm Audio Off Logged when alarm audio is turned off Active Alarms Audio Paused Logged when an active alarm s audio is paused Active Alarms Audio Off Logged when an active alarm s audio is turned off 127 12 Data Management Data Management Mode Data Management Mode Data Management Mode is a non clinical mode used to manage event data records You can print or export an individual Event Summary or export all Event Summaries You can also configure the HeartStart XL to remove patient information from Event Summaries prior to exporting them And you can also manage Event Summary data on the external USB drive NOTE Do not enter Data Management Mode while monitoring a patient To enter Data Management Mode 1 Turn the Therapy knob to either Monitor Pacer or Manual Defib Press the Menu Select button 2 3 Using the Navigation buttons select Other and press the Menu Select button 4 Select Data Management and press the Menu Select button 5 Confirm your selection Use the Navigation buttons to select Yes and press the Menu Select button If you select NO you are returned to the mode you started from Internal Memory When first entering Data Management Mode the Internal Memory Screen is displayed See Figure 64 Figure 64 Data Management Internal Memory 25 Jan 2011 10 2
142. heck pads connection Attend to patient begin CPR if indicated 66 Using AED Mode to Defibrillate Table 12 AED Mode Pads Off Messages 5 AED Mode These messages may appear when the multifunction electrode pads are not secured to the patient Audio Message L long prompts S short prompts Not noted Both Display Text Condition User Action L Insert connector firmly Apply pads to patient s bare chest S Insert connector firmly Apply pads Apply Pads is repeated four times or until the connection is made Insert connector firmly Look carefully at the screen for Infant Child pad placement Apply pads as shown on screen Apply first pad to child s chest Apply second pad to child s back Apply pads as shown on screen Insert Connector Apply Pads With Adult patient category selected there is no connection between the pads and the Therapy cable With Infant Child patient category selected there is no connection between the pads and the Therapy cable With Infant Child patient category selected if pads remain disconnected more audio prompts follow Securely connect the Therapy cable and the pads connector See ce bi Connecting Multifunction Electrode Pads on page 8 Press pads firmly to patient s bare skin Pads must not be touching clothing or each other If needed remove hair from patient s c
143. hen the Pacer Rate is changed Pacer Output value mA Logged when the Pacer Output is changed Pacing Paused Logged when pacing is paused 126 Event Summary 12 Data Management Table 26 Event Information Continued Logged Event Frequency Pacer Started rate ppm current mA width ms Logged when pacing starts Pacing Stopped Power Interrupted Logged when power is restored if pacing is interrupted or stopped due to a power loss and the Therapy knob remains in the Pacer position Pacer Output Low Logged when the Pacer Output is less than the selected setting by 20 percent or 10mA whichever is greater Pacing Stopped reason Logged when the device stops pacing Reasons include Pads Off Logged when a pads off condition is detected Device Error Logged when a device error that prevents delivery of pacing therapy is detected Pads Cable Off Logged when the Therapy cable is disconnected from the device Leads Off Logged when there is a leads off condition with the primary ECG lead for pacing Mark Event Mark Event Logged when the Mark Event button is pressed Configured Event Text Logged when you select an entry from the Mark Event menu Printing Print Strip Logged when you hit the Print button on the front of the device Printer Test Failure Logged when there is a printer failure during an Operational C
144. here are no visible cracks broken wires or other visible signs of damage Make sure all the connections are secure Check expiration date and quantity of pads and monitoring electrodes e Charged Battery Make sure a charged battery is installed in the HeartStart XL Another charged battery should be available or charging Confirm the battery has no visible signs of damage e AC Power Cord Check the AC power source by connecting the AC power cord to the HeartStart XL and plug it into a power outlet Then verify that the external power indicator on the front panel is lit e Printer Paper Make sure the printer has sufficient paper and is printing properly SpO Sensor Inspect the sensor and cable for visible signs of damage e NBP Cuffs and Tubing Inspect the pressure cuffs and tubing for visible signs of damage e USB Connector Inspect the port for visible signs of debris or damage Upon completing the Operational Check and returning to a clinical mode all settings are reset to the device s configured values If your institution s protocol requires periodic alarm verification and you wish to perform an alarm verification test in a non clinical environment outside of Operational Check testing you can connect the HeartStart XL to a simulator then manually change the alarm limits to a setting which should cause the device to alarm Look at the display and listen for the alarm Be sure to reset the alarm limits to
145. hest Be sure pads connector is completely inserted Press Pads Firmly Poor pads contact Replace pads Poor Pads Contact Begin CPR Press The CPR Button And Begin CPR The Therapy cable is connected A pads off condition still exists Securely connect the Therapy cable and the pads connector See cC a Connecting Multifunction Electrode Pads on page 8 Confirm there is a good pads contact with the skin Replace the pads Begin CPR if indicated 67 5 AED Mode Using AED Mode to Defibrillate Table 13 AED Mode Marginal Impedance Messages These messages may appear when the HeartStart XL detects a higher pad impedance than expected in the average patient The cause could be a hairy chest you are using old pads or the pads may not be fully on the patient Audio Message Display Text Condition User Action Press pads firmly to patient s bare skin Press pads firmly to patient s bare skin Pads must not be touching clothing or each other If needed remove hair from patient s chest Press Pads Firmly Poor pads contact Replace pads Poor Pads Contact Begin CPR Press The CPR Button And Begin CPR When the device is not charged charging or delivering a shock or in a pause period pads impedance condition is marginal Recheck pads Confirm they are securely connecte
146. hock Test Do one of the following checks at least once a week to verify the ability to deliver defibrillation therapy L Operational Check See the HeartStart XL Instructions for Use for details Ll Deliver a 150J shock into a test plug load if using multifunction electrode pads or the paddle tray if using paddles LI Weekly Shock test is not applicable for this Shift Check Check off which option you selected and sign date below Signature Date NOTE Test reusable sterilizable paddles internal or external prior to each use See the Sterilizable Defibrillator Paddles Instructions for Use To perform the Weekly Shock Test If you are using If you are using If you are using paddles pads with a test pads with a test load plug 1 Connect the Therapy cable to Connect the Therapy cable to Make sure the paddles and the paddle tray are the defibrillator and test load the defibrillator and test plug to thoroughly clean and there is no debris or residue to the end of the Therapy the end of the Therapy cable including all conductive material on the electrode cable surfaces of the paddles and tray Secure paddles in tray and confirm Patient Contact Indicator PCI LEDs are not lit If the LEDs are lit adjust paddles in tray If the LEDs continue to light clean both the adult and infant paddle electrode surfaces 2 Turn the device on by turning the Therapy kn
147. horizontal scroll soft keys to scroll left and right backward and forward in time in the Trending Report The soft key is inactive grayed out if there is no more data to be viewed in that direction If there are more lines of data than can be shown on the screen use the Navigation buttons next to the Menu Select button to scroll up and down the display NOTE Make sure there are no active menus before using the Navigation buttons to scroll up and down the Trends Report If you do have an active menu exit the menu before trying to scroll up or down in the Trends Report Overview 11 Trending Printing the Trends Report You can print a Trends Report with or without a Trending report on the HeartStart XL s display To print a Trends Report from Monitor Mode 1 Press the Report button 2 Using the Navigation buttons select Trends and then the appropriate interval A report for the entire event period is printed See Figure 62 Figure 62 Sample Trends Printed Report Trends Header Page Trends Data Page Trend Report date 9 45 9 40 9 35 9 30 9 25 9 20 9 15 9 10 9 05 9 00 Event ID XXXXXXXX HR bpm 107 105 99 103 100 99 103 105 110 99 Patient Name Sp02 100 100 99 98 100 99 100 100 99 97 Patient ID XXXXXXXX Pulse bpm 107 105 99 103 100 99 103 105 110 99 Patient Sex M or F NBPs mmHg 120 120 117 120 118 Incident Date NBPd mmHg 70 60 64 70 65 NBPm mmHg 82 80 81 82 81 HeartStart XL 9 39 9 29 9 19 9 09 8
148. hourglass symbol the device is ready for use The HeartStart XL is powered by a Lithium Ion battery or AC power The battery should always be installed so the device is ready for use whether or not AC power is available at the point of care When pacing AC power should be connected if possible to prevent the battery from eventually becoming depleted and interrupting the pacing operation Keep your battery charged at all times For more information on your battery see The Display on page 27 and Battery Maintenance on page 166 If AC power is used as the only power source during defibrillation for instance when no battery is installed or when the battery is fully discharged the HeartStart XL may take longer to charge to the desired energy level and in the event of power loss all settings reset to configured settings and a new event is created when power is returned However all saved data remains intact up to the device s memory capacity and can be found by retrieving the previous event Keep your battery installed and charged To ensure proper grounding reliability the HeartStart XL must be plugged into a hospital grade outlet To remove AC power disconnect the power cord from the outlet If you question the AC power cord s functionality disconnect it from the device and operate on battery power Replace the cord before reconnecting to AC power For information on power related alarms see Power Re
149. hout the cable connected If the Pads Paddles ECG Test passes without the cable connected replace the Therapy cable If the test fails remove the device from use and call for service Equipment Disabled Therapy technical alarm A device failure has been detected The device is unable to deliver therapy Run an Operational Check If it fails or the problem occurs repeatedly take the device out of use and call for service 179 16 Troubleshooting Table 45 ECG Monitoring Problems Continued Symptoms Symptom Possible Cause Possible Solution Press LIT Button to Select Another ECG Lead message on display The waveform in Wave Sector 1 is no longer valid and another ECG source is available Check that the monitoring electrodes pads are properly applied Use the Lead Select button to select another lead to monitor Lead Wire Off message on the display The specified monitoring electrode is off or not making proper contact with the patient Check that the monitoring electrodes are properly applied If necessary prepare the patient s skin and apply new electrodes Check Limb Leads message on the display Two or more limb lead electrodes are off or not making proper contact with the patient Check that the limb lead electrodes are properly applied Table 46 Defibrillation and Pacing Problems Symptom Possible Cause Possible Solutio
150. ible version of Philips data management solution HeartStart Event Review Pro The HeartStart XL is powered by a rechargeable Lithium Ion battery Available battery power is determined by viewing the battery power indicators located on the front of the device the icons on the display or by checking the gauge on the battery itself Additionally AC Power may be applied as a secondary power source and for continual battery charging The Ready For Use RFU indicator provides a constant status update indicating the HeartStart XL is ready for use needs attention or is unable to deliver therapy The device performs automated tests on a regular basis and displays results on the RFU indicator In addition performing specified Operational Checks ensures the HeartStart XL is functioning properly The HeartStart XL is highly configurable to better meet the needs of diverse users Be sure to familiarize yourself with your device s configuration before using the HeartStart XL See Configuration on page 135 for more details Intended Use The HeartStart XL is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support advanced life support or defibrillation When operating as a semi automated external defibrillator in AED Mode the HeartStart XL is suitable for use by medical personnel trained in basic life support that includes the use
151. ic alarm does not prevent another alarm from sounding If you silence the second alarm it resets the pause period for all active alarms If you press the Alarms button you are silencing all parameter alarms for the configured pause period Address the alarm condition on the HeartStart XL by using the Alarm Response Menu see Figure 37 Figure 37 Sample Alarm Response Menu For latching alarms Sp02 High Acknowledge clears the Acknowledge alarm condition when the j condition no longer exists Turns the parameter s alarms off and prevents _ Sp02 Alarms Off future alarms from alarming 2P Select this entry to change the parameter s alarm limits NOTE Alarm history can be accessed in the patients Event Summary This information is maintained after powering the device down and in the unlikely event of a power loss To access this information see Event Summary on page 120 For more information on alarms and messages as they pertain to a particular functionality see the specific alarm section in the HeartStart XL Instructions for Use Heart rate and arrhythmia alarms see Heart Rate and Arrhythmia Alarms on page 54 AED alarms see AED Alarms on page 71 Defibrillation alarms see Manual Defibrillation Alarms on page 80 Cardioversion alarms see Cardioversion Alarms on page 87 Pacing alarms see Pacing Alarms on page 97 SpO alarms see SpO Alarms on pa
152. id in rhythm analysis and alarm detection e Examines the ECG signal for ventricular arrhythmias and asystole NOTE Because the ST AR Algorithm is the HeartStart XL s cardiotach source and is needed to generate heart rate and heart rate alarms the algorithm can never be disabled However if desired arrhythmia and heart rate alarms can be turned off See Setting Alarms on page 56 ST AR cardiotach and alarms when activated also work in AED mode for ECG monitoring Aberrantly Conducted Beats As P Waves are not analyzed it is difficult and sometimes impossible for the algorithm to distinguish between an aberrantly conducted supraventricular beat and a ventricular beat If the aberrant beat resembles a ventricular beat it is classified as a ventricular beat You should always select a lead where the aberrantly conducted beats have an R Wave that is as narrow as possible to minimize incorrect classifications Intermittent Bundle Branch Block Bundle branch and other fascicular blocks create a challenge for the arrhythmia algorithm If the QRS complex changes considerably from the learned normal due to bundle branch block the blocked beat may be incorrectly identified as ventricular and may cause false PVC alarms You should always select a lead where bundle branch block beats have an R Wave that is as narrow as possible to minimize incorrect classifications Arrhythmia Learning Relearning When arrhythmia monitoring starts
153. ide slot Figure 20 Monitor Side Accessories Figure 21 Therapy Side Accessories 17 2 Device Basics Basic Orientation Installing Paper The HeartStart XL uses 50 mm graphed paper for printing To install printer paper 1 2 3 4 5 6 7 Open the printer door by pushing on the printer door latch see Figure 22 If there is an empty or almost empty paper roll in the printer pull up on the roll to remove it Examine the new roll of printer paper and remove any remaining adhesive residue from the outer layer of paper Place the new roll of paper in the paper well positioning the roll so that the end of the roll is on the bottom and the grid faces up as indicated by the symbol inside the printer 8 p y the sy eQ p Pull the end of the paper out past the roller Close the printer door Test the printer before putting the defibrillator back into service See Printing Data on page 132 Figure 22 Installing Printer Paper 18 Sy M W M m M y Uy W A D Ui Ty Q SS SSRIs Fao RAY SSS SSN ORR SERRE SSNS l bys l Ka Uh Basic Orientation 2 Device Basics Test Plug amp Test Load Your HeartStart XL comes with a defibrillator Test Plug to assist in performing a Weekly Shock Test You can also use the M3725A Test Load ordered seperately to perform a Weekly Shock Test To use either the Test Plug or Test Load during a Weekly Shock Test ins
154. iew Layout 25 Jan 2011 10 44 AM 0 0 A 8 m Pacing Markers R Wave Arrows Pacing Pacing Bar Pacing BEM omnanc Pacin Status Alarms ee 1 0 pei 3 0 na Pacing Migas Start Pause Pacing Pacing Rate Pacing Pacing Control soft key Press Pause Pacing Value Output Value to pause pacing press Start Pacing to start or resume pacing WARNING If pacing is interrupted for any reason you must press the Start Pacing soft key to resume pacing 90 Demand Mode Versus Fixed Mode 8 Pacing Demand Mode Versus Fixed Mode The HeartStart XL can deliver paced pulses in either Demand Mode or Fixed Mode e In Demand Mode the pacer only delivers synchronous paced pulses when the patient s heart rate is lower than the selected pacing rate e In Fixed Mode the pacer delivers asynchronous paced pulses at the selected rate ETT WARNING Use Demand Mode pacing whenever possible Use Fixed Mode pacing when artifact or other ECG noise makes R Wave detection unreliable when monitoring electrodes are not available or at your clinical discretion The HeartStart XL requires a 3 or 5 Lead ECG cable and monitoring electrodes as the source of the ECG during Demand Mode pacing Pace pulses are delivered through multifunction electrode pads However during Demand Mode pacing the pads cannot be used to monitor ECG and deliver paced pulses simultaneously NOTES The ECG derived from pads does not need to be displayed in a wa
155. indicators 6 imminent shutdown tone 36 indicators 25 specifications 195 user checks 158 Preconnected pads 63 76 Preparing for manual defibrillation 76 Press pads firmly message in AED Mode 67 68 Print 132 Auto Test results 161 button 6 23 cleaning printhead 171 configuration options 145 configuration settings 138 current Event Summary 132 during an event 132 ECG bandwidth 140 event markers 132 events stored in Event Summary 127 Operational Check 157 158 paper accessories 194 printer specifications 201 220 Print 132 saved event summary 133 Trends report 117 troubleshooting 185 user checks 158 Printer location 6 Printing astrip 132 configuration settings 138 installing paper 18 Pulse adjusting numeric values 32 alarm limits 103 alarms 106 changing alarm limits 106 enabling alarms 106 events stored in Event Summary 123 124 parameter area 28 rate 102 QRS 175 178 adjusting volume 32 configuration options 140 Quick look 77 AJ Radio frequency warning I Reapply pads to dry chest message in AED Mode 68 Red X Auto Test results 165 blinking 24 solid 24 Relearning ECG 52 Remote Charge button 11 Removing patient data 130 Removing the battery 14 Reports button 6 23 device info 174 Event Summary 121 events stored in Event Summary 121 Operational Check 159 printed strip 132 printing configuration settings 138 printing Operational Check results 158 trending 115 117 Responding to
156. inter door latch to open the door 2 Remove the roll of paper 3 Clean the printhead surface top front of the compartment with a cotton swap dipped in isopropyl alcohol 4 Replace roll of paper and close door Side Pouches After removing from the device the side pouches may be cleaned by hand with mild soap and water and air dried Do not wash or dry by machine SpO Sensor and Cable Follow the manufacturer s instructions to clean the SpO sensor and cable NBP Cuff Follow the manufacturer s instructions to clean the cuff HeartStart XL Disposal Prior to disposal remove the battery Then dispose the device and accessories in accordance with your country s regulations for equipment containing electronic parts WARNINGS Disposing the device with the battery inserted presents an potential shock hazard To avoid contaminating or infecting personnel the environment or other equipment make sure you disinfect and decontaminate the device and any appropriate accessories prior to disposal NOTE This product consists of devices that may contain mercury which must be recycled or disposed of in accordance with local state or federal laws Within this system lamps in the display contain mercury 171 NOTES 16 Troubleshooting Overview If the HeartStart XL detects an error or potential problem during use it displays a textual message to guide you These messages are
157. inue printing If you have manually started printing a strip and the HeartStart XL tries to automatically initiate a strip the automated print strip is ignored If the HeartStart XL automatically initiates a print strip and then automatically initiates another print strip the first strip is extended to include data through the end time of the second strip If a request to print a data report is made while the printer is currently printing another report the HeartStart XL prompts you with questions Your answers determine which report takes precedence for printing 133 12 Data Management Mark Events Mark Events The Mark Events button allows you to annotate the Event Summary and ECG strip when the button is pressed If configured pressing the Mark Event button prints a 10 second ECG strip leading up to the event the event itself and the 5 seconds after the event To mark an event 1 Press the Mark Event button The Event Menu see Figure 68 is displayed 2 Using the Navigation buttons select the desired event 3 Press the Menu Select button to mark the event If configured an ECG strip prints including the mark event symbol and the selected event label NOTE Ifthe Mark Event button is pressed and no event is selected from the Event Menu within 5 seconds the Event Menu is removed from the screen and a generic event is logged If the Mark Event button is pressed a second time within 5 seconds of the first one a generi
158. inute min minutes cm centimeter mmHg millimeters of mercury dB Decibel ms millisecond dB A A weighted decibels mW milliwatt Hz hertz nM nanometer in inches NSA No Shock Advised J Joules PSD Power Spectral Density kg kilograms RFU Ready For Use kPa kilo Pascal sec seconds Lbs Pounds V Volt m meter Electromagnetic Compatibility 18 Specifications Electromagnetic Compatibility When using the HeartStart XL electromagnetic compatibility with surrounding devices should be assessed A medical device can either generate or receive electromagnetic disturbances Testing for electromagnetic compatibility EMC with the appropriate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC standard has been adopted in Europe as the European Norm EN 60601 1 2 The EMC standards describe tests for both emitted and received interference Emission tests deal with electromagnetic disturbances generated by the device being tested SSS SSS SSS SSS SE SSE EE ea ee WARNINGS Radio frequency RF disturbances or emissions from devices other than the HeartStart XL might degrade performance of the HeartStart XL Electromagnetic compatibility with surrounding devices should be assessed prior to using the defibrillator Fixed portable and mobile radio frequency communications equipment could affect the performance of medical equipment See Table 60 on page 213 for the minimum
159. ion available with the HeartStart XL and describes how to perform pacing Overview Noninvasive transcutaneous pacing therapy is used to deliver monophasic pace pulses to the heart Pace pulses are delivered through multifunction electrode pads that are applied to the patient s bare chest Pacing with paddles is not supported While in Pacing Mode the ECG strip and Event Summary are easily annotated using the Mark Event button See Mark Events on page 134 The HeartStart XL Pacing Mode can be used on both adult and infant child patients Use the Patient Category button to switch categories WARNING Pacing therapy should only be delivered by trained healthcare professionals CAUTION Pacing must be turned off before defibrillating with a second defibrillator Failure to do so could damage the HeartStart XL NOTES Use only approved lead sets when pacing with the HeartStart XL Failure to do so may introduce noise and result in intermittent Cannot Analyze ECG messages For treatment of patients with implantable devices such as permanent pacemarkers or cardioverter defibrillators consult a physician and the instructions for use provided by the device s manufacturer The neonatal patient category is not supported for Demand Mode pacing Waveforms ECG monitoring measurements and most alarms remain active and retain their settings when you transition from Monitor or Manual Defibrillation Mode to Pacing Mode Ho
160. ior to using the defibrillator monitor Use of supplies or accessories other than those recommended by Philips may compromise product performance THIS PRODUCT IS NOT INTENDED FOR HOME USE U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Notice Conventions Used in This Manual This book contains the following conventions WARNING Warning statements alert you to a potential serious outcome adverse event or safety hazard Failure to observe a warning may result in death or serious injury to the user or patient CAUTION Caution statements alert you to where special care is necessary for the safe and effective use of the product Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property loss of data and possibly in a remote risk of more serious injury and or cause environmental pollution NOTE Notes contain additional information on usage The bull s eye icon indicates a process or a procedure a set of steps to achieve a certain goal Text represents text that appears on the device screen Soft key text represents text that appears as a soft key label on the device screen Voice represent voice prompt messages On line viewing only Hypertext represents hypertext links which display as blue click on the blue link to jump to that destination Table of Content Chapter 1 Introduction
161. it 40 255 90 40 155 70 5 34 12 5 21 9 Diastolic high limit 25 200 90 25 120 70 3 27 12 3 16 9 Diastolic low limit 20 195 50 20 115 40 2 26 7 2 15 5 Mean high limit 30 220 110 30 135 90 4 30 15 4 18 12 Mean low limit 25 215 60 25 130 50 3 29 8 3 17 7 203 18 Specifications Specifications 204 Auto Mode Repetition Time 1 2 5 5 10 15 30 60 or 120 min Maximum Measurement Time 120 sec Interconnect Tube Length M1598B Connect tubing 1 5 m 4 92 ft M1599B Connect tubing 3 0 m 9 24 ft Recommended Frequency of Pressure Transducer Calibration Yearly Patient Data Storage Internal Event Summary The HeartStart XL can store up to 8 hours of 2 continuous ECG waves 1 pleth wave research waves AED Mode only events and trending data per Event Summary There is a maximum capacity of approximately 50 Event Summaries of approximately 30 minutes in length Environmental Temperature 0 C to 45 C 32 F to 113 F operating 20 C to 70 C 4 F to 158 F storage e Charging the battery at temperatures above 45 C 113 F may degrade battery life e Storing the battery for extended periods at temperatures above 40 C 104 F reduces battery capacity and degrades battery life Humidity Up to 95 relative humidity e Printer paper may jam if the paper is wet e Thermal printer may be damaged if wet paper is allowed to dry while in contact with printer elements Atmospheric Pressure
162. ite at www philips com ProductDocs Figure 14 Back Side View Cable Wrap Snap AC Connection LAN Port yo aes Sets S Ey Battery Latch Battery Compartment TE WARNING Do not connect a LAN cable to the HeartStart XL while in a clinical mode Incorrect ECG diagnosis may result due to excessive noise Installing the Battery To install the HeartStart XL Lithium Ion battery 1 Align the battery in the battery compartment Confirm the arrow on the Battery Tab is pointed up 2 Insert the battery into the battery compartment until you hear the Battery Latch lock into place Figure 15 Installing the Battery 13 2 Device Basics Basic Orientation Removing the Battery To remove the HeartStart XL Lithium Ion battery 1 Push the Battery Latch to the left to eject the battery 2 Pull on the Battery Tab and battery to completely remove the battery Figure 16 Removing the Battery Battery Fuel Gauge When you want to check the power remaining in your Lithium Ion battery when it is not installed in the HeartStart XL press the Battery Power Gauge see Figure 17 located on the end of the battery opposite the battery tab Each solid green light indicates approximately 20 percent charge A flashing green light closest to the button indicates the battery is too weak and must be recharged before use Figure17 Battery Gauge Press here _ lt 000o To check the battery power remaining when
163. ized Cardioversion Mode when a leads off condition is detected in the synchronizing lead Pads Paddle Type Unknown Logged when with the therapy cable connected the device detects a change in the paddles or pads type or if the therapy cable type identification is not valid Shock number energy J impedance peak current A Logged when a shock is delivered Shock Aborted impedance Logged when a shock is initiated but aborted before a full shock dose is delivered Sync On Off Logged when Sync is turned on or off and any subsequent change Abnormal Shock Dose Logged when a shock is initiated and completed but the full dose is not delivered AED Mode Analyzing Logged when the algorithm begins analysis Artifact Detected Logged when artifact has been detected Shock Advised Logged when the algorithm detects a shockable rhythm No Shock Advised Logged when the algorithm detects a non shockable rhythm Cannot Analyze ECG Logged when the algorithm is unable to make a shock no shock decision Forced Pause Logged when the device enters or exits a forced pause NSA Pause Logged when the device enters or exits a NSA pause NSA Monitoring Logged when the device enters or exits NSA monitoring CPR Pause Logged when the device enters or exits CPR pause Pacing Pacer Mode Demand Fixed Logged when pacing starts and when the mode is changed Pacer Rate value ppm Logged w
164. kin you are prompted to Insert connector firmly Apply pads Follow the audio and visual prompts to correct the issues When properly connected AED Mode automatically begins Step 2 Follow Screen and Voice Prompts Once an ECG is detected through the multifunction electrode pads the HeartStart XL warns you not to touch the patient and automatically analyzes the patient s heart rhythm NOTE The AED algorithm only looks at the ECG for analysis It does not use SpO data even if the option is active in AED Mode WARNING Handling or transporting the patient during ECG rhythm analysis can cause an incorrect or delayed diagnosis Under these circumstances if the HeartStart XL issues a Shock Advised command keep the patient as still as possible for at least 10 seconds so the device can reconfirm the rhythm analysis before pressing the orange Shock button to deliver a shock The AED Mode algorithm can return one of the following results e Shock Advised If a shockable rhythm is detected the HeartStart XL automatically charges to the preconfigured Joule setting default is 150J if the Adult patient category is selected see Defib Sync AED Settings on page 143 or 50J if in the Infant Child category Charging is accompanied by voice and screen prompts When the device is fully charged a steady high pitched tone sounds and the orange Shock button flashes Heart rhythm analysis continues while the HeartStart
165. l Generation Delay 10 seconds SpO Response Time 90 to 80 average 18 9 seconds standard deviation 0 88 seconds Specifications NBP SpO and Pulse Averaging Time 10 sec Emitted Light Energy lt 15 mW Wavelength Range 500 1000 nm Information about wavelength range can be useful to clinicians especially those performing photodynamic therapy Desat Alarm Signal Generation Delay 20 sec Pulse Rate Measurement Range 30 300 bpm Pulse Rate Resolution 5 bpm Pulse Rate Accuracy 2 or 1 bpm whichever is greater Pulse Response Time 90 to 120 bpm average 18 0 seconds standard deviation 0 86 seconds Pulse Alarm Range Low Limit 30 295 Adult and Infant Child High Limit 35 300 Adult and Infant Child 18 Specifications Pressure Range mmHg kPa Measurement Adult Infant Child Adult Infant Child Systolic 40 260 40 160 5 35 5 21 Diastolic 20 200 20 120 2 27 2 16 Mean 26 220 26 133 3 30 3 18 Pulse Rate Range 30 to 220 bpm Initial Pressure 160 mmHg 21 kPa adult 120 mmHg 16 kPa Infant Child Maximum Pressure 300 mmHg 40 kPa Overpressure Safety Limits 300 mmHg 40 kPa Cuff Inflation Time 75 sec maximum Pressure Transducer Accuracy 3 mmHg over the range 1 300 mmHg 1 40 kPa Alarm Range mmHg kPa Measurement Adult Infant Child Adult Infant Child Systolic high limit 45 260 160 45 160 120 6 35 21 6 22 16 Systolic low lim
166. l summary causes one or more of the oldest event summaries to be overwritten Event Summaries stored in internal memory can be e Printed e Copied to a USB flash drive in Data Management Mode for transfer to a data management application 119 12 Data Management Event Summary Event Summary A new Event Summary is initiated the first time one of the following occurs after the device is powered on The arrival of a valid ECG signal either through electrodes or pads paddles The arrival of valid SpO data The arrival of valid NBP data The Charge button is pressed The Mark Event button is pressed NOTE There is an 8 hour data limit per incident for an Event Summary When the 8 hour limit is reached the HeartStart XL stops recording and a message is displayed on the HeartStart XL The number of Event Summaries that can be stored is related to the duration of each individual Event Summary For example the HeartStart XL can store approximately 50 Event Summaries of approximately 30 minutes in length or 5 Event Summaries of approximately 8 hours in length Event Summary Data Collected Patient data collected if available includes Two ECG waveforms with beat labels One pleth waveform Patient event information including Patient name sex category ID Parameter information Trends data Physiological alarms and alarm limits Defibrillation and pacing events Mark events Technical device event information in
167. lacement on the right lower abdomen LA L black yellow placement directly N below the clavicle and near the left shoulder Il LL F red green placement on the r left lower abdomen The single V C lead may be placed in any of the precordial electrode positions as shown in Figure 41 V1 C1 through V6 C6 VIC Electrode Placement 4 l sr l J 6 Figure 41 V C 1 placement fourth intercostal space at right sternal margin V C 2 placement fourth intercostal space at left sternal margin V C 3 placement midway between V C 2 and V C 4 VIC 4 placement fifth intercostal space at left midclavicular line V C 5 placement same level as V C 4 on anterior axillary line V C 6 placement same level as V C 4 at left mid axillary line NOTES No matter which V C electrode placement you select it appears as V on the HeartStart XL If using a V electrode it can act as a reference electrode if the RL electrode is unavailable Preparing to Monitor ECG 4 ECG Monitoring For accurate V C lead placement and measurement it is important to locate the fourth intercostal space To locate the fourth intercostal space 1 Locate the second intercostal space by first palpitating the Angle of Lewis small bony protuberance where the body of the sternum joins the manubrium This rise in the sternum is where the second rib is attached and the space just below this is the second intercostal space
168. lar Pace Pulse Above waveform where the biventricular pace pulse was detected A Artifact noisy episode Above waveform where noise was detected I Inoperative condition e g there is a lead_ Above waveform at start of a technical alarm off every second of the alarm and at the end M _ Pause Missed Beat No QRS Above waveform where condition detected To display an annotated ECG 2 3 4 Press the Menu Select button Using the Navigation buttons select Displayed Waves and press the Menu Select button Select Wave 2 and press the Menu Select button Select Annotated ECG and press the Menu Select button 51 4 ECG Monitoring Arrhythmia Monitoring Arrhythmia Monitoring The HeartStart XL uses the ST AR Algorithm Arrhythmia analysis provides information on your patient s condition including heart rate and arrhythmia alarms The HeartStart XL uses the ECG lead appearing in Wave Sector 1 for single lead arrhythmia analysis During arrhythmia analysis the monitoring function continuously e Optimizes ECG signal quality to facilitate arrhythmia analysis The ECG signal is continuously filtered to remove baseline wander muscle artifact and signal irregularities Also if the patients paced status is set to yes pace pulses are filtered out to avoid processing them as QRS beats e Measures signal features such as R Wave height width and timing e Creates beat templates and classifies beats to a
169. lated Alarms on page 169 Power 3 Working with the HeartStart XL Lithium lon Battery The HeartStart XL uses a Lithium Ion battery for power Battery Life Battery life depends on the frequency and duration of use When properly cared for and used in its intended environment the HeartStart XL Lithium Ion battery has a useful life of approximately 3 years Use outside those conditions could significantly reduce battery life To optimize performance a battery that is in the low battery condition less than 40 remaining should be charged as soon as possible Battery Capacity A new fully charged battery at 20 C 68 F provides power for at least e 175 full energy charge shock cycles or e Three hours of monitoring ECG and SpO continuously monitored and NBP sampled every 15 minutes followed by 20 full energy charge shock cycles or e Two hours of pacing 180ppm at 140mA with 40msec pulse and monitoring followed by 20 full energy charge shock cycles Low Battery Conditions The HeartStart XL enters a low battery condition when e The battery charge is low but contains sufficient power to provide at least six full energy charge shock cycles and at least 10 minutes of monitoring e The HeartStart XL cannot determine the battery s charge level NOTE The longer the battery stays in the Low Battery condition without charging the ability to deliver six full energy shocks and perform 10 minutes of monitoring dimini
170. le 33 Wave Settings Continued 13 Configuration Parameter Description Setting Choices NOTE The default for Wave Sector 1 cannot be set to Paddles Sector 3 Wave 2 Selects the waveform displayed in Wave Pads Paddles I II HI aVR aVL Sector 2 aVF V Cascade Annotated ECG Pleth None Wave 3 Selects the waveform displayed in Wave Pads Paddles I II HI aVR aVL aVF V Pleth None Default Pleth if you have the SpO option installed None if you do not Table 34 Defib Sync AED Settings Parameter Description Setting Choices 1 10 Joules Default Defines the device s low energy setting 1 2 3 4 5 6 7 8 9 10J Remain in Sync Defines if the device remains in Sync Yes No part of a shock series Mode after shock Mode after a delivered shock Time to Auto Disarm Defines the amount of time the device 30 60 90 sec remains charged if a shock has not been delivered Applies to Manual Defibrillation and Sync modes only Shock Series Defines the number of shocks in a shock 1 2 3 4 series Shock Protocol Defines the time interval used to 1 min 2 min Indefinite Timeout determine if a shock should be counted as AED Only Voice Prompts Defines the level of detail in AED Mode voice prompts Long Short Prompt Interval prompts in NSA Monitor following a No Shock Advised decision NSA Action Defines what t
171. le messages guide user through a user configured protocol Indicators Monitor display messages and prompts voice prompts battery status RFU external power Armed Indicators Charging charged tones flashing shock button energy level indicated on the display ECG analysis Evaluates patient ECG and signal quality to determine if a shock is appropriate and evaluates connection impedance for proper defibrillation pad contact Shockable Rhythms SMART Analysis is designed to shock ventricular fibrillation ventricular flutter and polymorphic ventricular tachycardia It is designed to avoid delivering a shock for rhythms that are commonly accompanied by a pulse or rhythms that would not benefit from an electrical shock Shock Advisory Algorithm Sensitivity Meets AAMI DF39 requirements and AHA recommendations Adult Ventricular Fibrillation 90 with lower confidence limit LCL of 87 Polymorphic Ventricular Tachycardia and Ventricular Flutter 75 with LCL of 67 Infant Child Ventricular Fibrillation 90 with LCL of 87 Shock Advisory Algorithm Specificity Meets AAMI DF39 requirements and AHA recommendations Normal Sinus Rhythm 99 with LCL of 97 Asystole 95 with LCL of 92 Other non shockable Rhythms 95 with LCL of 88 and Arrhythmia Monitoring Inputs Up to 3 ECG waves may be viewed on the display and up to 2 waves printed simultaneously Lead I II or HI is obtained through the 3 wire ECG cable and separate monitori
172. le to deliver therapy Run an Operational Check If it fails or the problem occurs repeatedly take the device out of use and call for service 175 16 Troubleshooting Table 44 General Problems Continued Symptoms Symptom Possible Cause Possible Solution Non critical Device Failure Detected Service Required message on display A non critical device failure has been detected at startup or during RFU testing Review error and alarm messages on screen Call for service Pads Paddles Type Unknown message on display There is a problem with the Therapy cable and or the device s Therapy port When prompted pick the correct cable type from the menu and press the Menu Select button Ifyou select the wrong cable type in error unplug and re plug in the cable Replace the Therapy cable If problems persist take the device out of use and call for service Replace Battery message on display The battery has reached its end of life Replace the battery Low Battery message on display The battery may not have enough remaining charge to provide six 200J shocks and 10 minutes of monitoring Shutting Down in 1 min message on display Very low battery and the device is not connected to AC power Connect to AC power Insert a fully charged battery Shutting Down Now message on display Battery charge is depleted and the device is not connected to AC
173. lection is highlighted The menus have a wrap around scrolling feature once you hit the bottom of a menu it automatically wraps around to the top of the menu and continues scrolling Holding either end of the Navigation button down accelerates scrolling through the menu choices in that direction To make a selection highlight the menu entry you want and press the Menu Select button Select Exit to close the menu without making a selection Arrows at each end of the menu indicate additional list options are available in that direction on the menu Use the Navigation button to scroll up or down to reveal the remaining options Depending upon your given situation there are times when some options are unavailable for use Menu choices are grayed out when they are unavailable They cannot be highlighted or selected See Figure 34 Figure 34 Sample Menu Menu a lt q _ Scroll Up Arrow Volume Selected Item Measurements Alarms Patient Info Trends lt qj __ Disabled Item Other wv lt g Scroll Down Arrow NOTE Menus are removed from the display when the Charge button is pressed 3 Working with the HeartStart XL The Display Adjusting Numeric Values Using the HeartStart XL Navigation buttons you can enter numeric values for several parameters including high and low alarm limits See Figure 35 The value initially displayed is the default value Some values are adjustable in increments greater than
174. lectrode pads on the patient to avoid shock hazard during pacing Use multifunction electrode pads prior to their expiration date Discard pads after use Do not reuse pads Do not use for more than 8 hours of continuous pacing If pacing is interrupted for any reason you must press the Start Pacing soft key to resume pacing If you are using the pacing function with battery and the Low Battery alarm sounds connect the device to external power to avoid interrupted pacing therapy Defibrillating During Pacing If you need to defibrillate the patient during pacing refer to the procedure for defibrillation in Manual Defibrillation Mode see Chapter 6 Manual Defibrillation on page 73 or AED Mode Chapter 5 AED Mode on page 59 Once the Therapy knob is moved from the Pacer position to a Manual Defibrillation Mode energy setting or AED pacing is stopped To resume pacing after defibrillation repeat the pacing procedure as described in Demand Mode Pacing on page 93 or Fixed Mode Pacing on page 95 When pacing is resumed pacing settings selected prior to defibrillation mode rate and output are retained Be sure to confirm cardiac capture has been retained CAUTION Pacing must be turned off before defibrillating with a second defibrillator Failure to do so could damage the HeartStart XL Pacing Alarms Pacing Alarms 8 Pacing Pacing alarms can be generated for the conditions shown in Table 20 Once ge
175. lti Patient Comfort Cuffs Large Adult M1576A Multi Patient Comfort Cuffs Thigh Ordering Replacement Supplies and Accessories 17 Supplies amp Accessories Table 51 Supplies and Accessories Continued Part Number Description Disposable Blood Pressure Cuffs M1874A M1875A M1876A M1877A M1878A M1879A M4572B M4573B M4574B M4575B M4576B M4577B M4578B M4579B Disposable Cuff Infant Disposable Cuff Pediatric Disposable Cuff Small Adult Disposable Cuff Adult Disposable Cuff Large Adult Disposable Cuff Thigh Soft Single Patient Disposable Cuff Infant Soft Single Patient Disposable Cuff Pediatric Soft Single Patient Disposable Cuff Small Adult Soft Single Patient Disposable Cuff Adult Soft Single Patient Disposable Cuff Adult X Long Soft Single Patient Disposable Cuff Large Adult Soft Single Patient Disposable Cuff Large Adult X Long Soft Single Patient Disposable Cuff Thigh SpO Sensors and Cables M1131A M1132A M1133A M1191A M1191B M1191AL M1191BL M1191T M1192A M1192T M1194A M1195A M1196A M1196S M1196T M1902B M1903B M1904B Disposable SpOy Sensor Adult Pediatric Finger Disposable SpOy Sensor Pediatric Disposable SpO Sensor Neonatal Adult for adults only any finger except thumb Reusable SpO Sensor Adult finger Reusable SpO Sensor Adult finger Reusable SpO Sensor Adul
176. m analysis if the rhythm is not shockable the HeartStart XL begins to monitor the patient 3 To activate ECG alarms in AED Mode press the Alarms button on the front of the HeartStart XL 70 Configurable Resuscitation Protocols 5 AED Mode To monitor optional SpO and pulse in AED Mode and activate alarms 1 Once in AED Mode attach an SpO sensor to the patient see Applying the Sensor on page 101 2 If you have the device configured to monitor SpO in AED Mode SpO monitoring begins once a pulsatile reading is obtained For more information on SpO see Chapter 9 Pulse Oximetry on page 99 3 To activate SpO and Pulse alarms in AED Mode press the Alarms button on the front of the HeartStart XL Configurable Resuscitation Protocols In AED Mode you have the flexibility to configure the HeartStart XL to match your institution s resuscitation protocols You can e Customize the device for the number of shocks 1 4 in a series e Select the energy setting within a given shock series e Set the CPR Pause interval from 1 3 minutes For more information see Tables 34 and 35 in the Configuration chapter AED Alarms The SMART Analysis algorithm generates AED Defibrillation alarms for the conditions shown in Table 17 There are both audio and visual alerts when turned on When monitoring a patient the ST AR ECG Monitoring Algorithm generates ECG alarms in AED Mode if turned on See Other Alarms in AED
177. measurement is taken the cuff s initial inflation pressure is 160 mmHg 21 kPa adult and 120 mmHg 16 kPa infant child If the measurement is successful the next inflation pressure is 30 mmHg 4 kPa above the systolic pressure measurement with a minimum inflation pressure of 120 mmHg 16 kPa If the patient s initial systolic pressure measurement is higher than the inflation pressure the inflation pressure is automatically increased by 30 mmHg 4 kPa and another measurement is attempted The device aborts a measurement deflates the cuff and generates an alarm when the inflation pressure exceeds 300 mmHg 40 kPa NOTES Initial cuff inflation pressure is based on the configured patient type adult or infant child If necessary select the correct patient type during use by changing the Patient Category selection using the Patient Category button on the front of the HeartStart XL For pediatric and adult patient populations blood pressure measurements made with the Advantage OEM BP Module Series are equivalent to those obtained by trained observers using the cuff stethoscope auscultatory method within limits prescribed by ANSI AAMI SP10 1992 amp 2002 mean error difference of 5 mmHg or less standard deviation of 8mmHg or less To measure NBP 1 Select the appropriately sized cuff for the patient The cuff width should be either 40 of the limb circumference or 2 3 of the upper arm length The inflatable part of the cuff should be long
178. mit alarm value when Adult 25 200 90 mmHg diastolic is the selected alarm source 3 27 12 kPa Infant Child 25 120 70 mmHg 3 16 9 kPa Diastolic Low Limit Selects the low limit alarm value when diastolic is the selected alarm source Adult 20 195 50 mmHg 2 26 7 kPa Infant Child 20 115 40 mmHg 2 15 5 kPa Mean High Limit Selects the high limit alarm value when mean is the selected alarm source Adult 30 220 110 mmHg 4 30 15 kPa Infant Child 30 135 90 mmHg 4 18 12 kPa Mean Low Limit Selects the low limit alarm value when mean is the selected alarm source Adult 25 215 60 mmHg 3 29 8 kPa Infant Child 25 130 50 mmHg 3 17 7 kPa Table 32 SpO Settings Parameter Description Setting Choices Color Selects the SpO color Red Yellow Blue Green Cyan Magenta White SpO High limit Selects the high alarm limit value Adult 51 100 100 Infant Child 51 100 100 SpO Low Limit Selects the low alarm limit value Adult 50 99 90 Infant Child 50 99 90 SpO Desat Limit Selects the extreme low limit alarm value Adult 50 SpO Low Limit 80 Infant Child 30 SpO Low Limit 80 Table 33 Wave Settings Parameter Description Setting Choices Wave 1 Selects the waveform displayed in Wave Sector 1 Pads I II III aVR aVL aVE V Overview Tab
179. more information see Monitor This mode is used to monitor ECG optional ECG Monitoring on NBP and SpO parameters and for viewing Vital page 43 Signs Trending data 6 AED This mode is used to analyze ECG and if AED Mode on page 59 E necessary administer semi automated external g defibrillation You can also monitor HR and 5 SpO 2 E Manual This mode is used to perform asynchronous and Manual Defibrillation on Defibrillation synchronous cardioversion defibrillation page 73 and Cardioversion on page 81 Pacer This optional mode is used to perform demand or Pacing on page 89 fixed pacing Operational This mode is used to perform routine Operational and Shift 2 Check maintenance activities related to Operational Checks on page 147 E Check E Data This mode is used to review Event Summaries and Data Management on S Management other device data after clinical use page 119 Configuration This mode is used to display and change the Configuration on HeartStart XL s configuration page 135 Z Service This mode is used when servicing the device The HeartStart XL Service including software upgrades Manual 21 3 Working with the HeartStart XL Controls Controls 22 Operating controls are organized by function with the defibrillation controls to the right of the display soft keys under the display general function buttons under the soft ke
180. n Cannot Analyze ECG technical alarm ECG data cannot be analyzed An electrode may be disconnected or the analyzing algorithm cannot analyze the ECG signal Check ECG signal quality If necessary improve lead position or reduce patient movement Equipment Disabled Therapy technical alarm A device failure has been detected at startup or during RFU testing The device is unable to deliver therapy Take the device out of use and call for service Connect Therapy Cable message is displayed Pads Paddles are not connected when attempting to charge the device Connect the pads paddles to the device The Therapy cable is not connected to the device Connect the Therapy cable to the device Insert Connector Apply Pads message is displayed Pads are not applied to the patient Properly apply pads to patient Pads connector is not securely connected to the Therapy cable Check that pads connector and Therapy cable are securely connected Check ECG Lead message on display during Synchronized Cardioversion There is a leads off condition for the synchronizing lead Check the synchronizing lead and improve the connection Energy Limited to 50J message is displayed An attempt to deliver greater than 50J using internal paddles Select a lower energy Only energies up to 50J are allowed using internal paddles 180 Symptoms 16 Trouble
181. n Select HR Arrhythmia and press the Menu Select button Select the limit you want to adjust and press the Menu Select button uu fh WwW N Select the new value and press the Menu Select button Enabling Disabling Alarms To enable disable the HR and Arrhythmia alarms 1 Press the Menu Select button 2 Using the Navigation buttons select Measurements Alarms and press the Menu Select button 3 Select HR Arrhythmia and press the Menu Select button 4 Select Alarms On Alarms Off and press the Menu Select button Troubleshooting 4 ECG Monitoring Responding to Alarms When an alarm occurs the audio pause label appears above the Navigation and Menu Select buttons Press either button to silence the alarm audio while you attend to the patient The alarm reannunciates if the condition continues to exist beyond the configured alarm pause period or another alarm condition occurs After pausing the audio on the HeartStart XL attend to the patient and press the Menu Select button to acknowledge the alarm condition If required adjust the alarm limits using the Menu Select and Navigation buttons Figure 46 Sample Alarm Response Menu PVC 13 gt 10 min Certain lethal arrhythmias Acknowledge a only have Acknowledge as a menu option HR Arrhythmia Alarms in AED Mode If alarms are turned on in AED Mode all Technical Alarms listed in Table 8 and the following Physiological Alarms from Table 7 are generated when the condition exis
182. n The HeartStart XL display shows the last NBP if obtained in the last 60 minutes time obtained and frequency If no subsequent measurements are taken NBP values are removed from the display after 60 minutes but can still be obtained through Vital Signs Trending and the Event Summary NBP Alarms NBP Alarms 10 Blood Pressure Monitoring Alarms are annunciated when a measurement for the configured source systolic diastolic or mean falls outside the configured high or low limits NBP alarms are non latching alarms meaning they are automatically removed when their alarm condition no longer exists Both the source of the alarm and the limits may be changed during an ongoing patient event NBP alarms can be generated for the conditions shown in Tables 24 and 25 Once generated they appear as alarm messages in the NBP alarm status area above the NBP numeric There are both audio and visual alerts For more information on alarms see Alarms on page 33 Table 24 NBP Physiological Alarms Alarm Message Condition Type of Alarm Indication NBPs High The NBP systolic value exceeds the high alarm limit NBPd High The NBP diastolic value exceeds the high alarm limit NBPm High The NBP mean value exceeds the Medium high alarm limit Priority Yellow alarm message with NBPs Low The NBP systolic value has fallen Non Latching audio tone below the low alarm limit Alarm NBPd Low The NBP diastoli
183. n 197 NBP 203 pacing 201 printer 201 SpO 202 synchronized cardioversion 197 USB 205 accessories 193 100 32 AED configuration 143 alarm limits 102 103 Alarms button 23 and MRI 99 caring for sensors 107 105 171 142 10 desat alarm 105 103 edematous tissue 101 105 Event Summary 120 events in Event Summary 123 124 how it works 100 in AED Mode 62 3 message area 29 102 Operational Check results 157 parameter area 28 101 103 142 99 102 sensor 100 101 202 SpO port 9 trending 115 182 user checks 158 values 102 ST AR Algorithm 43 52 Starting an NBP measurement 111 Storing accessories 16 Storing the battery 167 Supplies ordering 189 Symbols defined 206 Synchronized Cardioversion button 84 R Wave arrows 84 Synchronized cardioversion 81 84 additional shocks 86 adjusting volume 32 alarms 87 Alarms button 23 and a bedside monitor 83 button 6 22 84 Operational Check results 156 charge 85 charge button 22 code view 84 configuration options 143 Synchronized cardioversion 81 84 events stored in Event Summary 125 layout 84 lead select 83 Mark Event button 23 message area 29 NBP 109 non paddles lead 85 paced status 27 Patient Category button 23 precautions 82 preparation 83 R Wave 81 R Wave arrows 85 shock 85 shock button 22 shock delivery 85 skin prep 44 specifications 197 time to auto disarm 143 troubleshooting 180 with external paddles 85 Systolic NBP 113 T Technical alarm
184. n 23 printing configuration 138 removing patient data 130 Reports button 23 storage 204 trending 115 USB data port 12 Date and time configuration options 139 Daylight Savings Time 139 location 27 Default configuration 138 Defib Disarmed 156 Defibrillating in AED Mode 63 Defibrillation during pacing 96 therapy 73 De identifying patient data 140 Deleting data from internal memory 131 Delivered energy accuracy 196 Demand Mode pacing 91 93 Desat alarm 105 Desat limit 103 Device Info report 174 Diastolic NBP 113 Discarding the Battery 167 Disinfecting 170 Display 200 alarm locations 35 alarm state 27 annotated ECG 51 battery status 27 dashed lines 50 date and time 27 ECG bandwidth 140 general layout 27 paced status 27 patient category 27 status area 27 trending 115 Wave Sector 2 30 Wave Sector 3 30 Disposing the unit 171 E ECG aberrantly conducted beats 52 accessories 190 191 alarm chain 55 56 alarms 54 Alarms button 23 alarms in AED Mode 57 annotated ECG 51 arrhythmia beat labels 51 asystole alarm 54 Auto Gain indicator 29 bandwidth 140 bundle branch block 52 Calibration bar 29 cannot analyze 55 changing waveforms 30 configuration options 140 connecting ECG cable 9 dashed line 50 178 ECG out 13 ECG port 9 ectopic event 54 electrode placement 45 Event Summary 120 events stored in Event Summary 123 extreme brady 54 extreme tachy 54 indications for use 3 lead choices 47 Lead Select button
185. nal Check Shock Select button to shock continues to fail take the Buttons on Fail Device disarmed device out of use and call Paddles for service functioning properly Audio tests the The device Using the Pass You responded that you Repeat Operational Check speaker system announces Navigation buttons heard the audio test prompt _ If it continues to fail take Shock select Yes or No the device out of use and Fail You responded that you Delivered or Press the Menu f call for service did not hear the audio test No Shock Select button prompt Delivered Sync button tests The device Press and release the Pass Sync button passed Repeat Operational Check the Syne buttons prompts you to Sync button Fail Sync button is not and make sure you press functionality Press and ee the Sync button If it nctioning Release Sync continues to fail take the Button device out of use and call If the device does not detect a pressed fasennce Sync button within 10 seconds you are prompted to use the Menu Select button to select OK Therapy Delivery None None Pass Therapy Delivery test Repeat Operational Check tests defibrillation passed with the specified cable using a different cable and pacing type connected Passing a second time circuitry and Fail Therapy Delivery test indicates the previous cable delivers a shock is defective and should be failed with the specified c
186. nd data can be displayed at selected intervals for up to 8 hours of monitoring You can set your trend interval to 1 5 10 15 30 or 60 minutes Trending data displayed for parameters continuously measured heart rate SpO3 and pulse are the average of multiple measurements over the trend time period Trending data for NBP appear with the timestamp of the measurement Viewing Trend Data To view trending data 1 Confirm your HeartStart XL is in Monitor Mode 2 Press the Menu Select button 3 Using the Navigation buttons select Trends and press the Menu Select button The Trending Report takes over the bottom two wave sectors See Figure 61 To close the Trends Report press the Close Trends soft key Figure 61 Trending Report 7 20 9 25 9 30 9 35 9 40 9 Time Date p gt 9 15 9 20 9 25 9 30 9 35 9 40 9 45 x Intervals 107 Parameter j 100 Trend Data 120 Scroll Bars 80 gt Close lt q gt Trends Multiple Measurements A after a x measurement indicates multiple measurements were taken during the interval Horizontal Scroll Soft Keys 115 11 Trending Overview About the Data Displayed e When trending is initially displayed the most recent trending data appear in the far right column e The display automatically updates as new data become available with the newest data appearing in the far right column of the display and older data moving over to the left If
187. nerated they appear as alarm messages in the Pacer Bar There are both audio and visual alerts When you switch patient categories all parameter alarm limits change to the new patient category These changes are retained when you switch modes e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category For more information on alarms see Alarms on page 33 Table 20 Pacing Alarms Pads Cable Off cable is disconnected from the device Equipment Disabled Therapy Therapy is disabled due to an equipment failure Pacing Stopped Leads Off Pacing has stopped The primary ECG lead has become invalid in Demand Mode pacing Pacer Output Low The actual delivered pace pulse current is less than the selected output Battery Low The battery s charge level is low Alarm Message Condition Type of Alarm Indication Pacing Stopped Pacing has stopped There has Power been a power failure during Interrupted pacing Pacing Stopped Pacing has stopped A pads off Pads Off condition has been detected during pacing Pacing Stopped Pacing has stopped The Device Error HeartStart XL has detected an error which prevents delivery of pacing therapy Pacing Stopped Pacing has stopped The Therapy High Priority Non Latching Alarm Red Alarm message with alarm tone
188. nes the paced pulse duration 20 40 msec Default Pacer Output Defines the pacer output default setting at which paced pulses are delivered If Paced Pulse duration is 20 msec 10 200 30 mA If Paced Pulse duration is 40 msec 10 140 30 mA Table 37 Mark Event Settings Parameter Description Setting Choices Mark Event 1 Defines the first mark event menu choice IV Access Mark Event 2 Defines the second mark event menu choice Epinephrine Mark Event 3 Defines the third mark event menu choice Amiodarone Mark Event 4 Defines the fourth mark event menu choice Atropine Mark Event 5 Defines the fifth mark event menu choice Morphine Mark Event 6 Defines the sixth mark event menu choice Nitroglycerin Overview Table 37 Mark Event Settings Continued 13 Configuration Parameter Description Setting Choices Mark Event 7 Defines the seventh mark event menu Aspirin choice Mark Event 8 Defines the eighth mark event menu choice Other NOTE There is a 20 character limit when defining Mark Events See Mark Events on page 134 Table 38 Printing Settings Parameter Description Setting Choices Print On Alarm Defines the type of alarms that automatically High High Medium print a strip Print On Charge Defines if a continuous strip is printed when Yes No the device is charged Pri
189. nfiguration Mode 135 Exporting configuration settings 137 data 130 External Paddles manual defibrillation 76 Patient Contact Indicators 11 External paddles accessing infant paddles 12 accessories 190 cleaning 170 infant paddles 11 Operational Check results 157 pressure 11 quick look 77 remote charge button 11 Shock buttons 11 synchronized cardioversion 85 troubleshooting 178 181 Weekly Shock Test 148 Extreme brady 54 Extreme tachy 54 E Factory default settings 138 Fixed Mode pacing 95 demand vs fixed 91 Flash drive location 6 Flat line 179 Forced pause messages 70 Fourth intercostal space locating 47 Frequency of NBP 141 General settings 139 Heart rate accuracy 199 configuration options 140 events stored in Event Summary 123 Hourglass 165 l Imminent shutdown tone 36 Impedance 60 Importing configuration settings 137 Indications for use 2 AED 2 ECG 3 manual defibrillation 2 NBP 3 218 Indications for use 2 pacing 3 SpO 3 Infant paddles release button 11 12 using 77 Initial NBP cuff pressure 110 Initiating an Event Summary 120 Insert connector apply pads message in AED Mode 67 Installed options 174 Installing battery 13 Installing paper 18 Intended Use Statement 2 Internal memory data captured 129 menus 129 removing patient data 130 viewing USB drive 129 Internal paddles accessories 190 internal switchless paddles 190 Joule limit 78 using
190. nfigured limits for high or low SpO or if the measurement falls below the configured SpO Desat Limit SpO alarms except Desat are non latching alarms meaning they are automatically removed when their alarm condition no longer exists Desat alarms are latching meaning they remain present even if the alarm condition no longer exists SpO alarms can be generated for the conditions shown in Tables 21 and 22 Once generated they appear as alarm messages in the SpO alarm status area above the SpO numeric There are both audio and visual alarms For more information on alarms see Alarms on page 33 103 9 Pulse Oximetry SpO Alarms Table 21 SpO Physiological Alarms Alarm Message Condition Type of Alarm Indication Desat The SpO value has fallen below High Priority Red alarm message with the Desat low limit Latching Alarm audio tone SpO2 High The SpO value exceeds the high Medium alarm limit Priority Yellow alarm message with Sp0 Low The SpO value has dropped Non Latching audio tone below the low alarm limit Alarm Table 22 SpO Technical Alarms Pleth waveform due to a SpO4 sensor malfunction Sp0 Unplugged The SpO sensor is disconnected SpO Noisy Signal A noisy SpO sensor signal has been detected Non Pulsatile Sp02 Light interference has been Interference detected at the SpO sensor Sp0 A non pulsatile SpO signal has been detected Low P
191. ng electrodes With a 5 Lead ECG cable leads aVR aVL aVF and V can also be obtained Pads ECG is obtained through two multifunction electrode pads Lead Fault Messages and dashed lines appear on the display if an electrode or lead becomes disconnected Pad Fault Dashed line appears on the display if a pad becomes disconnected Heart Rate Display Digital readout on the display from 16 to 300 bpm Adult Patient Category or 16 to 350 bpm Infant Child with an accuracy of 10 or 5 bpm whichever is greater Heart Rate Arrhythmia Alarms HR high low Asystole VFIB V TACH VTACH Extreme Tachy Extreme Brady PVC rate Pacer Not Capture Pacer Not Pacing Common Mode Rejection 105 dB for Leads ECG 96 dB for pads ECG ECG Size 1 4x 1 2x 1x 2x 4x auto gain 1x gain is 1Omm mV on the printed strip ECG waveforms Displayed at a fixed timebase of 25 mm sec printer 5 20 mm sec display 10 ECG Leads Off Sensing 3 and 5 Lead wires apply a 30nA DC current Maximum T Wave amplitude Device rejects up to 80 of R Wave amplitude for synchronized cardioversion up to 55 of R Wave amplitude for demand pacing up to 34 of R Wave amplitude for arrhythmia analysis Specifications 18 Specifications Frequency Response e ECG AC Line Filter 50 Hz or 60 Hz e ECG for Display 0 15 40 Hz 0 05 40 Hz e ECG for Printer 0 05 150 Hz Diagnostic 0 15 40 Hz 0 05 40 Hz Heart rate accuracy and response to irregular rhythm
192. ng pads E pads with a test with a test plug Ca load 1 Connect the Therapy cable Connect the Therapy cable to Make sure the paddles and the paddle tray are to defibrillator and test load defibrillator and test plug to the thoroughly clean and there is no debris or residue to the end of the Therapy end of the Therapy cable including all conductive material on the electrode cable surfaces of the paddles and tray Secure the paddles in the tray and confirm the Patient Contact Indicator PCI LEDs are not lit If the LEDs are lit adjust the paddles in the tray If the LEDs continue to light clean both the adult and infant paddle electrode surfaces 2 Turn the device on by turning the Therapy knob to 150J 3 Press the Charge button on the front panel If it becomes Press the Charge button on the paddles sitting in the necessary to disarm the defibrillator press Cancel tray If it becomes necessary to disarm the defibrillator Charge press Cancel Charge 4 A strip prints if configured to do so If the strip does not print A strip prints if configured to do so If the strip does not immediately press the Print button print immediately press the Print button 5 Press the Shock button on the HeartStart XL Simultaneously press the Shock buttons located on the paddles 6 Confirm the printed strip Confirm that you hear a Shock Confirm the printed strip indicates the defibrillator test indicates Test Passed and
193. nge Button The defibrillator is charged and waiting for you to press the Shock button Press the flashing orange Shock button Shock cancelled Shock cancelled No shock advised Shock cancelled Pads must not be touching clothing or each other Shock cancelled Press pads firmly to patient s bare skin Shock delivered Press pads firmly to patient s bare skin None After charging the device detected a non shockable rhythm and automatically disarmed Attend to the patient A shock was aborted due to low impedance A shock was aborted due to high impedance Confirm pad placement is correct and pressed firmly against the chest then try shocking again A shock has been delivered to the patient Attend to the patient Shock delivered abnormal energy due to marginal impedance Confirm pad placement is correct and pressed firmly against the chest Attend to Patient Shock The final shock in a series Shock Delivered has been delivered None Delivered has been delivered Attend to the patient F A shock in a None atay Clear or Patient yet to be completed series Stay clear of patient 69 5 AED Mode Table 16 AED Mode Forced Pause Related Messages Using AED Mode to Monitor These messages may appear during a forced pause time period when analysis is not taking place and you can attend
194. nications equipment and the HeartStart XL Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance Degradation in ECG quality is a qualitative assessment which could be subjective Caution should therefore be taken in comparing immunity levels of different devices The criteria used for degradation is not specified by the standard and might vary with the manufacturer Guidance and Manufacturer s Declaration The HeartStart XL is intended for use in the electromagnetic environment specified in the tables below The customer or the user of the HeartStart XL should assure that it is used in such an environment Table 57 Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The HeartStart XL uses RF energy only for its internal function Therefore its RF emissions are very low and CISPR 11 not likely to cause interference in nearby electronic equipment RF emissions Class B CISPR 11 The HeartStart XL is suitable for use in all Harmonic emissions Class A f i establishments including domestic establishments or IEC 61000 3 2 those directly connected to the public low voltage power Voltage Complies supply network that supplies buildings used for domestic fluctuations flicker purposes emissions IEC 61000 3 3 Electromagnetic Compatibility
195. nnotated ECG 51 Applying an SpO sensor 101 Arrhythmia monitoring 43 52 Asystole 54 Audio Operational Check results 156 tones 36 Auto Gain 140 Auto Test hourglass 165 print options 145 results 165 RFU 164 summaries 161 summary 151 164 Auto Gain 29 215 Automatic NBP measurements 112 B Basic orientation 5 adjusting numeric values 32 adjusting volume 32 AED View 61 Alarms Pause button 6 attaching pouches 16 audio tones 36 Auto Gain indicator 29 automatic NBP measurements 112 back panel 13 battery compartment 13 battery indicator 6 beat labels 51 calibration bar 29 changing configuration settings 137 changing waveforms 30 Charge button 6 cleaning 170 code view layout 75 Device Info report 174 device shutdown 26 display 27 ECG out jack 13 ECG port 9 entering patient ID 38 entering patient info 38 entering patient sex 38 external paddles 11 external power indicators 6 Flash drive 6 front view 6 hourglass 165 infant paddles 11 12 installing paper 18 Lead Select button 6 23 making a selection 31 manual NBP measurements 112 Mark Event button 6 Mark Events 134 Menu Select button 6 23 menus 31 monitor side 9 Navigation button 6 23 NBP port 9 Operational Check 151 pacing view 90 Patient Category button 6 print button 6 Printer 6 printing a strip 132 pulse rate 102 red X 165 reports button 6 restoring default settings 138 RFU indicator 6 Rhythm label 29 R Wave arrows 29 selecting an SpO se
196. nsiderations General warnings and cautions that apply to the use of the HeartStart XL are provided in Safety Considerations on page 40 Additional warnings and cautions specific to a particular feature are provided in the appropriate sections of these instructions WARNINGS The HeartStart XL is not intended to be deployed in settings or situations that promote use by untrained personnel Operation by untrained personnel can result in injury or death Electric shock hazards exist internally Do not attempt to open the device Refer servicing to qualified personnel Use only supplies and accessories approved for use with your HeartStart XL Use of non approved supplies and accessories could affect performance and results Use the HeartStart XL on one patient at a time Use single use supplies and accessories only once NOTE The HeartStart XL has not been tested for use outside a hospital s clinical environment See Environmental on page 204 for use environment specifications Getting Started The HeartStart XL comes from the factory ready to use However before putting the device into clinical use for the first time it is recommended you e Read these Instructions for Use in their entirety e Fully charge the battery See Power on page 24 e Run an Operational Check See Operational Check on page 151 e Perform a Shift Check See Shift Check on page 147 Qe 1 Introduction Overview
197. nsor 101 setting date and time 136 Shift Check 147 216 Basic orientation Shift Check 147 Shock button 6 soft keys 6 23 SpO port 9 symbols defined 206 Sync button 6 therapy knob 6 22 Therapy port 6 therapy side 7 trending 115 trending report 115 turning device on 26 turning the device off 26 USB data port 12 Battery 171 accessories 194 alarms 169 application note 166 calibration 167 capacity 25 charge levels 28 charge status 167 charging 166 cleaning 170 discarding 167 events stored in Event Summary 122 fuel gauge 14 indicator 6 installing 13 latch 14 life 25 166 167 location 13 27 low battery condition 25 maintenance 166 Operational Check results 157 power 24 removing the battery 14 safety 168 specifications 200 status 27 storing 167 tab 13 troubleshooting 175 user checks 158 Bedside monitor and synchronized cardioversion 83 Blinking hourglass 24 Blinking red X 24 Bundle branch block 52 p Cable management accessories 194 attaching pouches 16 cleaning side pouches 171 connector 13 filling pouches 17 installing 15 user checks 158 Calibrating NBP 114 Calibrating the battery 167 Calibration bar 29 Calling for service 187 Cannot analyze ECG 55 179 180 Cascading leads 142 Changing configuration settings 137 Changing leads with Lead Select button 23 Changing NBP schedule 112 Changing waveforms 30 Charge button 22 Event Summary 120 location 6 Operational Check results
198. nt category These changes are retained when you switch modes e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category The neonatal patient category is not supported WARNINGS Do not leave an SpO sensor on a patient undergoing an MRI For patients with an intra aortic balloon pump access peripheral pulses according to your institution s protocol Do not rely solely on SpO readings assess the patient at all times Inaccurate measurements may be caused by e Incorrect sensor application or use e Significant levels of intravascular dyshemoglobins such as carboxyhemoglobin or methemoglobin in patient e Patients with other disorders of hemoglobin e Patients with restricted blood flow to the extremities such as those in severe shock or hypothermia e Injected dyes such as methylene blue e Exposure to excessive illumination such as surgical lamps especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight eee ee 99 9 Pulse Oximetry Understanding Pulse Oximetry Understanding Pulse Oximetry A pulse oximetry sensor sends light through patient tissue to a receiver on the other side of the sensor Light emitting diodes transmit red and infrared light through the peripheral areas of the body such as a finger See Figure 55 Figure 55 Pulse Oximetry Sensor
199. nt On Shock Defines if a continuous strip is printed when Yes No a shock is delivered or when a shock is attempted but not delivered Print On Mark Defines if a continuous strip is printed when Yes No the Mark Event button is pressed Printer Delay Defines whether printed strips include an 0 Sec 10 sec additional 10 seconds of information which occurred just prior to initiating the print Event Summary Defines the information contained in an Short Long Report Event Summary Short includes a log of events and vitals Long adds waveforms Auto Print Defines ifa OpCheck report is automatically Yes No OpCheck printed upon the completion of an Report Operational Check Weekly Tests in Provides a numerical value indicating the No default Auto Test number of weekly tests in the auto text Summary summary 145 NOTES 14 Operational and Shift Checks The HeartStart XL performs several automated tests to make sure it is ready for use see Automated Tests on page 164 Two important checks you perform to supplement the automated tests are Operational Check and Shift Check This chapter details both of these important tasks Shift Check In order to ensure defibrillators are ready when needed the American Heart Association AHA recommends that users complete a checklist often referred to as a Shift Check at the beginning of each change in personnel These checks are performed in ad
200. nt frequency e Event Summary NOTES The Sync feature remains active if the HeartStart XL is turned off for less than 10 seconds However Sync is disabled when AED Mode is activated and must be turned back on upon returning to Manual Defibrillation Mode The Continued Use feature does not function if both battery and external AC power are removed from the device even briefly Passwords The HeartStart XL requires passwords to enter Service Mode and to make certain changes in Configuration Mode See the HeartStart XL Service Manual for the Service Mode password The Configuration Mode password is printed on the front of your HeartStart XL User Documentation CD ROM 3 Working with the HeartStart XL Safety Considerations Safety Considerations The following general warnings and cautions apply to the use of the HeartStart XL Additional warnings and cautions specific to a particular feature are provided in the appropriate sections WARNINGS The HeartStart XL is not intended to be deployed in settings or situations that promote use by untrained personnel Operation by untrained personnel can result in injury or death Use of the HeartStart XL is restricted to a single patient at a time Algorithms in the HeartStart XL use the currently set Paced Status during rhythm analysis Confirm that the patient s paced status is correct When transporting a patient or carrying the HeartStart XL it is important to position it wit
201. o a USB drive 1 2 3 Confirm you have a USB drive inserted into the USB port and you are in Configuration Mode Press the Export soft key The HeartStart XL copies your current configuration to the USB drive NOTE If you already have a configuration stored on the USB drive exporting another to the USB drive overwrites the one already on the drive Importing Settings To import configuration settings from a USB drive 1 2 3 Once in Configuration Mode insert the USB drive with the saved settings into the USB port Press the Change Config soft key and enter the Configuration password Press the Import soft key The HeartStart XL copies the current configuration from the USB drive Make any device specific configuration changes Press the Save Changes soft key 137 13 Configuration Overview Printing Settings To print the configuration settings 1 In Configuration Mode press the Menu Select button 2 Using the Navigation buttons select Print Configuration 3 Press the Menu Select button to print the report See Figure 70 NOTE To stop printing press the Print button Figure 70 Sample Configuration Report Configuration Report Options Date Time format Settings General Settings Current Date All installed Date Format setting Patient Category setting options on your HeartStart XL HeartStart XL are Time Format setting Alarm tone setting listed here S N Device Seri
202. o waveform no leads Cannot Analyze ECG alarm Short in the patient cable or leads Run an Operational Check with the ECG cable If the test fails run it without the ECG cable If the test passes replace the cable If not remove the device from use and call for service Pads Paddles Off technical alarm The multifunction electrode pads or paddles may be disconnected or not attached securely Check that the pads paddles are properly applied If necessary replace the pads Change the ECG in Wave Sector 1 to a lead derived from monitoring electrodes Cannot Analyze ECG technical alarm ECG data cannot be analyzed An electrode may be disconnected or the analyzing algorithm cannot analyze the ECG signal Check ECG signal quality If necessary improve lead position or reduce patient movement ECG Equipment Malfunction technical alarm A device hardware failure was detected Disconnect the ECG cable and perform an Operational Check If the Leads ECG test fails remove the device from use and call for service If the Leads ECG test passes replace the ECG cable and perform another Operational Check Pads ECG Equipment Malfunction technical alarm A device hardware failure was detected Perform an Operational Check If the Pads Paddles ECG test fails with Therapy cable disconnect the Therapy Cable from the device when prompted in order for the the Pads Paddles ECG Test to run wit
203. ob to 150J 3 Press the Charge button on the front panel If it becomes Press the Charge button on the paddles sitting in the necessary to disarm the defibrillator press Cancel Charge tray If it becomes necessary to disarm the defibrillator press Cancel Charge 4 A strip prints if configured to do so If the strip does not print A strip prints if configured to do so If the strip does immediately press the Print button not print immediately press the Print button 5 Press the Shock button on the HeartStart XL Simultaneously press the Shock buttons located on the paddles 6 Confirm the printed strip Confirm that you hear a Shock Confirm the printed strip indicates the defibrillator indicates Test Passed and Cancelled audio message see a test passed and the energy delivered is150J 15J 135 the energy delivered is150J Shock Aborted alarm on the to 165J If not confirm you did the test properly 15J 135J to 165J If not display and the printed strip before taking the device out of use and calling for confirm you did the test indicates Test Passed If not service properly before taking the confirm you did the test device out of use and calling properly before taking the for service device out of use and calling for service 7 Detach test load plug from the Therapy cable so your device is Test complete ready for use when needed Do not leave the test load plug attached to the Therapy cable
204. of paper Reload with new fresh dry roll of paper Printer Door Open technical alarm The printer door is not fully closed Open the printer door and reclose such that it snaps into place 185 16 Troubleshooting Table 49 Printing Problems Continued Symptoms Symptom Possible Cause Possible Solution Printer Font Unavailable technical alarm The required font is unavailable for the currently installed language If printing is essential to patient care take the device out of use and call for service Printer Malfunction technical alarm The printer is faulty or there is a problem communicating with the printer Turn the HeartStart XL off for 15 seconds and then turn it back on If the problem persists call for service If printing is essential to patient care take the device out of use Printer Error technical alarm A non critical device failure has occurred Restart device If the error continues and printing is essential to patient care take the device out of use and call for service Table 50 USB Drive Problems Symptom Possible Cause Possible Solution Insert Compatible USB Device message on display A non compatible USB device has been inserted in the USB port Use only a compatible USB device to store data from the HeartStart XL See USB Device on page 205 You can t save data to the USB flash drive
205. often accompanied by a voice prompt or audible beeping tone This chapter describes these statements that you see along with other symptoms and provides suggestions for what to do and resources for you to contact for further information Resolving Issues If you are unable to resolve a problem using the suggestions in this chapter run an Operational Check to determine if there is a malfunction requiring service If a malfunction is identified call for service and e Ifthe malfunction is related to ECG monitoring defibrillation or pacing take the HeartStart XL out of service e Ifthe malfunction is related to SpO or NBP take the device out of service if the function is essential to patient care in your institution Responding to Test Results Results of Automated Tests associated with critical functionality are reported through the Ready For Use Indicator and the Automated Test Summary report see Automated Tests on page 164 To respond to errors reported through Operational Check see Operational Check Tests and Results on page 155 For further technical and repair information refer to the HeartStart XL Service Manual WARNING Product servicing and repair should only be performed by qualified service personnel SSS SSS 173 16 Troubleshooting Resolving Issues 174 Device Info Report While troubleshooting it is often beneficial to know what versions of software and hardware your HeartStart XL contains T
206. on Alarms 7 Cardioversion Alarms can be generated for the conditions shown in Table 19 There are both audio and visual alerts When you switch patient categories all parameter alarm limits change to the new patient category These changes are retained when you switch modes e For patients that are 25kg or 2 8 years old use Adult patient category e For patients lt 25kg or lt 8 years old use Infant Child patient category For more information on alarms see Alarms on page 33 Table 19 Defibrillation Alarms aborted Abnormal Shock Dose Delivered Abnormal shock dose delivered due to marginal patient impedance Disabled Therapy Pads Paddle Type The device detected a change in Unknown paddles or pads type or the therapy cable identification is invalid Equipment Therapy is disabled due to an equipment failure High Priority Latching Alarm Alarm Message Condition Type of Alarm Indication Pads Off With pads in use the connection High Priority between the device and patient has Non Latching been lost Alarm Shock Aborted A shock has been automatically Red Alarm message with alarm tone Troubleshooting If your HeartStart XL does not operate as expected during Cardioversion see Table 46 Defibrillation and Pacing Problems on page 180 87 NOTES 8 Pacing This chapter explains the noninvasive transcutaneous pacing opt
207. on of infant child patients follow your institution s policy guidelines are 2 to 4 J kg first shock and 4 J kg per subsequent shocks The HeartStart XL has a built in limitation of 50 Joules when using internal paddles Do not leave patients unattended when the HeartStart XL is in Manual Defibrillation Mode with pads applied to the patient Step 2 Charge Press the Charge button on the front panel See Therapy Knob and Controls on page 22 If using external paddles the charge button on the side of the apex paddle may be used instead As the defibrillator charges the energy selection shown on the display changes to show the current charge state A continuous low pitch charging tone sounds until the desired energy level is reached at which point a continuous high pitch charged tone sounds You may increase or decrease the selected energy at any time during or after charging Move the Therapy knob to the desired energy level The HeartStart XL charges to the selected energy level automatically Defibrillation 6 Manual Defibrillation If you need to disarm the defibrillator press the Cancel Charge soft key Also the defibrillator disarms automatically when the Shock button has not been pressed within the time period specified in the Time to Auto Disarm configuration setting Step 3 Shock Confirm that a shock is still indicated and the defibrillator is charged to the selected energy level Make sure no one is touching the
208. on steps in Defibrillation on page 78 Using External Paddles To set up for defibrillating using external paddles 1 After connecting the paddles cable to the HeartStart XL remove the paddle set from the paddle tray by pulling the paddles straight up and out of the paddle tray Confirm you are using the correct size paddles for the patient and verify there is no debris or residue including dried electrode gel on the surface of the paddles Clean if necessary 2 Apply conductive matter as per your organization s protocol CAUTION Do not distribute conductive matter by rubbing the paddle electrode surfaces together Surfaces could get scratched or damaged if you do 3 Apply the paddles to the patient s bare chest using the anterior anterior placement or in accordance with your organization s protocol 4 Use the Patient Contact Indicator PCI lights on the sternum paddle handle to adjust paddle pressure and placement to optimize patient contact Once proper contact is made the PCI turns green See External Paddles on page 11 NOTE Reasonable effort should be made to obtain at least one green PCI light Due to size of the patient or other physical factors this might not be possible for some patients Orange lights may be the best that can be achieved 5 Follow the defibrillation steps in Defibrillation on page 78 Preparing for Defibrillation 6 Manual Defibrillation Quick Look You can use external
209. onnect the battery to any other batteries CAUTIONS Use caution when handling using and testing batteries Do not short circuit crush drop mutilate puncture apply reverse polarity expose to high temperatures or disassemble Misuse or abuse could cause physical injury Avoid extreme shock and vibration to the battery Do not expose batteries to temperatures greater than 60 C 140 F Excess temperatures may result in battery damage Wash skin with large amounts of water in the event of electrolyte leakage to prevent skin irritation and inflammation Battery Maintenance Power Related Alarms Power related alarms are generated for the conditions shown in Table Figure 43 Once generated they appear as alarm messages on the HeartStart XL display There are both audio and visual alerts For more information on alarms see Alarms on page 33 15 Maintenance Table 43 Power Related Alarms Alarm Message Condition Type of Alarm Indication and Location Low Battery Battery power is low High Priority if Red alarm message if pacing otherwise low priority non latching alarm pacing cyan if not with audio tone in Battery Status area Shutting downin 1 min Battery power is critically low The device will shut down in 1 minute High Priority if pacing otherwise medium priority non latching alarm Red alarm message if pacing yellow if not with audio tone in Technical Alarm area Shut
210. operation Audio Message Display Text Condition User Action 9s Adult The current AED Mode pee oc gt 25 Kg patient category is Adult None Infant Child The current AED Mode Infant Child Mode lt 25K patient category is None g Infant Child si See battery icon in upper left The HeartStart XL battery Chong We patei 2 Low battery replace it with a charged of the display charge level is low battery Table 11 AED Mode Analysis Related Messages These messages may appear during AED analysis No shock advised Attend to Patient No Shock Advised determined the rhythm is not shockable Audio Message Display Text Condition User Action Stay clear of patient Stay Clear of Patient ee Analyzing Stay dear Analyzing ECG analysis is underway Do not touch the patient ECG analysis has Attend to the patient Begin CPR if indicated clear of patient Stop all motion Stay Clear of Patient Analyzing Interrupted interrupted because of a bad ECG signal Shock advised F ECG analysis has Once the device is charged Stay Clear of Patient 7 Shock Advised determined the rhythm is _ press the flashing orange Stay clear shock advised shockable Shock button Analyzing Interrupted Stay ECG analysis was Stop patient movement and reanalyze Cannot analyze Cannot Analyze ECG analysis cannot determine if the rhythm is shockable or not C
211. ory Menu Select Print to print the currently selected Event Summary Data Management Select Export to export the currently selected Event Print Summary to the USB drive Export Select Export All to export all Event Summaries Export All currently in Internal Memory to the USB drive Remove Al Garen Info a Select Remove All Patient Info to de identify all vew USB Dike Event Summaries in Internal Memory See Removing Exit All Patient Data on page 130 Select View USB Drive to view all Event Summaries on an external USB drive See Accessing Data on the USB Drive on page 130 Select Exit to exit the menu 4 Press the Menu Select button to perform the task Select Cancel Export from the Data Management Menu to cancel an export once it begins The option appears in the menu after you have begun to print export To cancel printing hit the Print button If you change from Data Management Mode to a clinical mode while data is exporting you are alerted that data export is in process and asked to Stop Exporting Select Yes to stop data export and continue to the new mode Select NO to continue exporting data If you turn the device off while exporting data the export is stopped and the exported data might be incomplete 129 12 Data Management Data Management Mode Removing All Patient Data In Data Management Mode you can de identify patient Event Summaries two ways Patient related da
212. ot sure you press the Charge button s arc button If Operational Stack You are to 150 functioning functionality d Check continues to fail eee ath Confirm test Fail You used the Menu take the device out of use L ai load defibrillator test Select button to charge and call for service oar s plug is attached and Attached press the Charge Press the button Charge l Button External Move Therapy knob Paddles You are to 150 aes ted to Confirm the paddles Verify are seated in their Paddles Are k 3 pockets and press the Mik otder Charge button Press the Charge Button 155 14 Operational and Shift Checks Table 39 Operational Check Tests and Results Continued Operational Check Device What to do if test doesn t If the device does not detect a pressed Shock button within 10 seconds you are prompted to use the Menu Select button to shock NOTE The device auto disarms when reaching the time specified in Configuration A Defib Disarmed message is displayed automatically Test User Actions Results Prompts pass Shock button Once charged Press the Shock Pass Shock button passed Repeat Operational Check tests the Shock the device button on the device ai _ Shock button is not and make sure you press button s prompts you to or paddles functioning the Shock button before functionality Press Shock the defibrillator disarms If or Press Both Fail You used the Menu Operatio
213. ou are in an emergency situation Incorrect timing of Synchronized Cardioversion could occur if the patient has an internal pacemaker with pacemaker tails large enough to be detected as an R Wave Use only pads that are approved for use with the HeartStart XL Use of non approved pads could affect performance and results See Table 51 for a list of supported pads Remain attentive to the patient during the delivery of therapy Keep hands and feet clear of the paddle electrode edges Use your thumbs to depress the shock buttons on the paddle handles Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring electrodes lead wires dressings etc Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart During defibrillation air pockets between the skin and multifunction electrode pads may cause patient skin burns To help prevent air pockets make sure the pads completely adhere to the skin Do not use dried out pads Do not open pads package until just prior to use Never touch the patient or any equipment connected to the patient including the bed or gurney during defibrillation Avoid contact between the patient and conductive fluids and or metal objects such as the gurney Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation NOTES Suc
214. ourly components as well as defibrillation ECG according to the pacing SpO gt NBP and the printer device s internal clock Weekly Weekly after midnight Tests all daily components as well as various electrical circuit Sunday morning tests and administers a 150J shock internally to test the according to the defibrillation circuitry device s internal clock Auto Test Summaries You can review print and export all Auto Test Summaries the HeartStart XL performs To view a summary of Automated Tests 1 Turn the Therapy knob to Monitor u fk WwW N Press the Menu Select button Using the Navigation buttons select Other and press the Menu Select button Select Operational Check and press the Menu Select button Select Auto Test Summary and press the Menu Select button The message Leaving clinical mode Patient monitoring will be turned off appears 6 Select Yes if you wish to continue Select NO to return to Monitor Mode Press the Menu Select button to confirm your choice 7 Ifyou selected Yes the HeartStart XL displays the Automated Test Summary screen see Figure 78 Automated Tests Figure 78 Automated Test Summary 16Jan2011 1 10am 15 Maintenance n Automated Test Summary Result Pass Date and Time Period 16Jan2011 12 11AM Hourly 15Jan2011 01 11AM Daily Pass 13Jan2011 01 11AM Daily Pass 11Jan2011 01 11AM Daily Pass Auto Test Summary Results Date andTime Period Result The A
215. out the process Be attentive to these messages when displayed The ECG strip and Event Summary are easily annotated with information using the Mark Event button See Mark Events on page 134 Monitoring alarms are available in Manual Defibrillation Mode but they are turned off by default To activate alarms press the Alarm button rs Alarms are reactivated once the Therapy knob is moved to Monitor an energy setting or Pacer or the Sync button is pressed The HeartStart XL Manual Defibrillation Mode can be used on both adult and infant child patients Use the Patient Category button to switch categories 73 6 Manual Defibrillation Precautions for Manual Defibrillation Precautions for Manual Defibrillation WARNINGS Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely eliminate any chance of recovery Asystole should not be routinely shocked Begin CPR Remain attentive to the patient during the delivery of therapy Delay in delivering a shock may result in a rhythm that was identified as shockable converting spontaneously to non shockable and could result in inappropriate shock delivery Keep hands and feet clear of the paddle electrode edges Use your thumbs to depress the shock buttons on the paddle handles Use only pads that are approved for use with the HeartStart XL Use of non approved pads could affect performance and results See Table 51 for a list of supported pads
216. per volume The QRS volume was turned off or set too low through the Volume menu Adjust the volume through the Volume menu The amplitude of the QRS complex is too small to detect Select a different lead Poor ECG signal quality noisy trace wandering baselines etc from signal acquired through monitoring electrodes The monitoring electrodes are not making proper contact with the patient Check that the monitoring electrodes are properly applied If necessary prepare the patients skin and apply new electrodes The monitoring electrodes are out of date or dried out Check the date code on the electrodes Do not open the electrode package until immediately prior to use Radio frequency interference RFI is causing artifact Relocate or turn off equipment that may be causing REI Try repositioning the cables leads The ECG cable may be faulty Run an Operational Check with the ECG cable and check Leads ECG results If the test fails replace the ECG leadset and trunk cable Poor ECG signal quality noisy trace wandering baselines etc from signal acquired through pads The pads are not making proper contact with the patient Ensure proper skin preparation and correct application If necessary apply new pads Paddles are only for a quick look not long term monitoring The pads are outdated or dried out Check the date code on the pads Do not open the pads pa
217. power Connect to AC power to restart the device Battery Calibration Required message on display The battery needs to be calibrated Connect to AC power Insert a fully charged battery Calibrate battery before returning to service Battery Communication Failure technical alarm The HeartStart XL is not able to communicate with the battery Connect to AC power Insert a fully charged battery If problems persist call for service If battery power is essential to patient care take the device out of use The power gauge on the side of the battery does not work when you first receive the battery Battery was shutdown to prolong its life during shipping Insert the battery in a HeartStart XL for about 1 minute to awaken it One or more controls do not respond as expected e g Lead Select button does not function soft keys do not work There is a faulty control or connection problem Remove the device from use and call for service Arching or sparking during paddles in pocket test therapy discharge Weekly Shock Test Debris or residue such as electrolytic gel on the surfaces of the paddles and or paddles tray Clean paddles and paddles tray 176 Symptoms Table 44 General Problems Continued 16 Troubleshooting Symptom Possible Cause Possible Solution Trending data is not appearing on the display You might not be in Monitor Mo
218. r 61 precautions 60 prompts 64 resume analyzing 62 shock advised 64 shock analysis 59 shock button 22 shock counter 61 shock related messages 69 skin prep 44 specifications 198 SpO 62 70 successful resuscitation 60 user messages 66 Alarms 175 adjusting numeric values 32 adjusting volume 32 alarm area 27 asystole 54 audio tones 36 button 23 cannot analyze ECG 55 changing pulse limits 106 changing SpO limits 105 configuration options 139 continuous tone 36 ECG 54 ECG alarm chain 55 56 ECG in AED Mode 57 72 enabling NBP 114 enabling pulse 106 enabling SPO 105 event markers 132 Event Summary 37 120 extreme brady 54 extreme tachy 54 general warnings 34 high priority 33 in AED Mode 71 indications 34 latching 33 location 27 35 low priority 33 manual defibrillation 80 Index medium priority 33 multiple alerts indicator 27 multiple conditions 33 NBP 113 NBP limits 109 114 non latching 33 notification 34 pacing 97 pacing stopped 97 parameter area 28 Pause button 6 pausing 37 periodic chirp 36 periodic verification 158 physiological 33 power related 169 print options 145 pulse 106 pulse limits 103 responding 37 setting ECG limits 56 silencing 37 single beep 36 specifications 195 SpO limits 102 stored in Event Summary 127 synchronized cardioversion 87 technical 33 location 27 types 33 Algorithm SMART Analysis 59 ST AR 43 52 71 American Heart Association 147 Analysis messages 66 A
219. r in the SpO or Pulse status area above their respective numeric For more information on these alarms see SpO Alarms on page 103 and Pulse Rate Alarms on page 106 Troubleshooting If your HeartStart XL does not operate as expected during AED Mode see Table 46 Defibrillation and Pacing Problems on page 180 If there is a delay in delivering therapy start CPR if indicated 72 6 Manual Defibrillation This chapter explains how to prepare for and perform defibrillation or asynchronous cardioversion on the HeartStart XL using multifunction electrode pads external paddles and internal paddles See Chapter 7 Cardioversion on page 81 for information on synchronized cardioversion Overview Defibrillation therapy is the definitive method for termination of lethal arrhythmias The HeartStart XL provides this therapy through the application of a biphasic pulse of current to the heart This electrical energy is transferred through attached paddles or disposable multifunction electrode pads applied to the patient s bare chest Internal paddles for open chest intrathorasic defibrillation can also be used In Manual Defibrillation Mode the entire defibrillation process is under your control You must assess the ECG decide if defibrillation or cardioversion is indicated select the appropriate energy charge the HeartStart XL and deliver the shock Text messages on the display provide relevant information through
220. r more information Functionality of the soft keys are described in their appropriate chapters throughout these Instructions for Use See Soft Key Labels on page 30 23 3 Working with the HeartStart XL Ready For Use Indicator Ready For Use Indicator Power NOTES 24 The Ready For Use RFU Indicator is located on the right side base of the device handle It indicates the status of the therapy delivery functions using the following conventions are ready for use Sufficient battery power is available for device operation Blinking red X with Indicates either periodic audio chirp X e A low battery condition exists and the battery is not charging Blinking Hourglass x Indicates the shock pacing and ECG functions of the device e There is no battery installed and the device is running on AC power only Blinking red X Indicates a low battery power condition but the battery is without periodic X currently charging The device can be used but its audio chirp J battery only operation time is limited Solid red X with Indicates a critical failure has been detected that may prevent periodic audio chirp X the delivery of defibrillation therapy pacing or ECG S acquisition Solid red X without Indicates no power available or the device cannot power on periodic audio chirp X If after power is returned the indicator reverts to the J blinking black
221. r visible Figure8 Connecting the SpO Cable AN Connecting the NBP Cable To connect the NBP cable 1 Insert the NBP cable into the red NBP port see Figure 9 and push completely in 2 Attach the NBP cable to the NBP cuff Figure9 Connecting the NBP Cable Basic Orientation 2 Device Basics Top Panel The top of the HeartStart XL has a handle for easy transport and also the USB data port If optional external paddles are present they reside in the paddle tray on the top of the device as shown in Figure 10 Figure 10 Top View with optional paddles installed Back of device External Z y Paddles _ Th C 1e Handle HeartStart XL Front of device External Paddles The M3543A External Paddles can be used on both adult child 2 10kg and infant lt 10kg patients The apex paddle has a yellow button to remotely charge the defibrillator Both paddles have orange shock buttons that flash when the defibrillator is charged Press both buttons simultaneously to administer a shock The sternum paddle contains a Patient Contact Indicator PCI with PCI icons x Orange or red lights on the PCI indicate poor patient contact Adjust paddle pressure and placement to optimize patient contact Green lights on the PCI indicate good contact is established Figure 11 External Paddle Features Flashing Shock buttons gt Patient Contact Indicator p N
222. reviation Definitions Electromagnetic Compatibility VIII Reducing Electromagnetic Interference 189 189 195 195 195 195 197 198 198 200 200 201 201 202 203 204 204 205 206 207 208 209 209 Introduction Thank you for choosing the HeartStart XL defibrillator monitor Whether the HeartStart XL is your first Philips product or another in a long list of Philips devices we welcome you to the Philips family of defibrillators The HeartStart XL has been developed and designed around you to meet the advanced requirements of hospital code teams nurses physicians and biomedical engineers The device is easy to use in all modes You can monitor ECG and optional pulse oximetry SpO4 and non invasive blood pressure NBP And you can administer therapy using 1 2 3 defibrillation in Manual Mode 2 step AED Mode synchronized cardioversion and optional Pacing Mode Overview The HeartStart XL is a lightweight portable defibrillator monitor It provides four clinical modes of operation Monitor Manual Defibrillation Synchronized Cardioversion AED and Pacing In Monitor Mode depending on the ECG cable used you can view 2 different ECG waveforms at one time on the display Using a 3 lead ECG cable you can view either Lead I II or II With a 5 Lead ECG cable you can view two leads from Leads I II II aVR aVL aVF or V Optional monitoring of SpO numeric and pleth wave
223. rint or export the Auto Test Summaries from Operational Check See Operational Check on page 151 165 15 Maintenance Battery Maintenance Battery Maintenance 166 Battery maintenance is essential to ensure that the battery s charge state is accurately reported there is sufficient charge and capacity to operate your HeartStart XL and battery life is optimized Remove faulty batteries from service immediately Battery maintenance begins when you first receive your device and continues throughout the life of the battery Detailed information on battery care is available in the Lithium Ion Battery Application Note which was provided with your HeartStart XL and can also be found on the Philips website at www philips com ProductDocs Table 42 lists battery maintenance activities and when they should be performed Table 42 Battery Maintenance Activities Activity When to perform Visual inspection As part of a standard Operational Check Charge the battery Upon receipt after use if the Low Battery message is displayed Calibrate the battery When the Operational Check results state Calibration Required or every 6 months whichever comes first Store the battery When not in use for an extended period of time store the battery at a 20 40 charge Discard the battery When there are visual signs of damage or you receive a message to replace the battery Battery Life Battery life depends on th
224. riority SpOz Equipment Malfunction A problem with the SpO module has been detected Non Latching Alarm SpO Erratic An erratic measurement has been detected SpO Extended The SpO measurement has not Update been updated within the last 30 seconds Sp0 Low The device has detected low Perfusion perfusion SpO Error A non critical failure has been detected Alarm Message Condition Type of Alarm Indication SpO Sensor The device is unable to detect a Malfunction Cyan alarm message with audio tone NOTES SpO alarms are on in all clinical modes except AED and Manual unless you specifically turn them off or alarms for the entire device are off Once disabled alarms remain off until they are turned back on While an NBP measurement is in progress SpO alarms are suppressed SpO Alarms 9 Pulse Oximetry SpO Desat Alarm The SpO Desat alarm provides an additional limit setting below the low limit setting to notify you of potentially life threatening decreases in oxygen saturation This additional limit is preset through Configuration Mode NOTE If the SpO Low Limit alarm value is set below the configured SpO Desat Limit the Desat Limit is automatically adjusted to the SpO Low Limit value Should the SpO reading fall below this value the SpO Desat Limit Alarm is announced Changing SpO Alarm Limits To change the SpO high and low alarm limits 1 Press the Men
225. round the entire edge of each electrode to ensure they are secure Make sure the lead wires do not pull on the electrodes See Electrode Placement for proper electrode locations 4 Ifnot preconnected connect the ECG cable as described in Connecting the ECG cable on page 9 EO WARNING Be sure the electrodes do not come in contact with other conductive material especially when connecting or disconnecting the electrodes to from the patient Le L l l ll eee eee eee eee eee ea sss NOTE Use only approved lead sets with the HeartStart XL Failure to do so may introduce noise and result in intermittent Cannot Analyze ECG messages Electrode Placement Figure 39 shows the typical electrode placement for a 3 lead ECG set Figure 39 3 Lead Placement LA L black yellow RA R white red I placement directly placement directly below the clavicle below the clavicle D and near the left and near the right shoulder id LL F red green placement on the n left lower abdomen o Ed N shoulder 45 4 ECG Monitoring Preparing to Monitor ECG Figure 40 shows the typical electrode placement for a 5 lead ECG set Figure 40 5 Lead Placement RA R white red placement directly below the clavicle and d J near the right shoulder V C brown white placement on the chest So position depends on e your required lead a selection see Figure 41 RL N green black p
226. rst number and press the Menu Select button b Use the Navigation and Menu Select buttons to enter the remaining numbers in the password c When finished select Done and press the Menu Select button Press the Menu Select button and use the Navigation buttons to select the parameter to be changed Then press the Menu Select button Select the sub menu you want to change then press the Menu Select button Select the new default option Press the Menu Select button to select the highlighted choice Use the Next Screen soft key to advance to the next parameter and repeat steps 4 6 to make additional changes Once the desired changes have been made press the Main Config soft key to return to the Configuration Main screen Press the Save Changes soft key to save the new configuration e Pressing the Cancel Changes soft key returns you to the previous settings e Pressing the Factory Defaults soft key resets all settings to factory defaults Press the Exit Config soft key to return to normal operating mode If you press Exit Config before saving changes you are asked if you want to exit without saving the changes e Ifyou want to save the changes select NO press the Menu Select button press the Save Changes soft key and then exit Configuration Mode e Ifyou do not want to save the configuration select Yes and press the Menu Select button to exit Configuration Mode Exporting Settings To export configuration settings t
227. s 33 TENS unit pacing 92 Test loads 194 Testing the defibrillator 148 Therapy cable 190 connecting 7 disconnecting 7 Therapy knob 22 location 6 select energy 78 Therapy port 7 location 6 Time intervals for NBP measurements 112 Time to Auto Disarm 143 Training available tools 4 Trending 115 adjusting report 116 data 116 display 115 duration 116 intervals 116 multiple measurements indication 115 Print button 23 print from internal memory 133 printing reports 117 report 115 Reports button 23 Trends report 119 Troubleshooting 173 AED Mode user messages 66 blinking red X 24 calling for service 187 clinical alarm area 27 Device Info report 174 Troubleshooting 173 ECG 178 external paddles 178 181 flat line 179 Lead Select button 179 manual defibrillation 180 message area 29 multiple alerts indicator 27 NBP 184 NBP calibration 114 no shock delivered 60 pacing 180 181 pads 178 181 printing 185 solid red X 24 SpO 182 symptoms 175 synchronized cardioversion 180 technical alarms location 27 USB 186 Turning the device off 26 Turning the device on 26 U USB accessing the drive 130 accessories 194 data port 12 exporting Auto Test results 161 exporting configuration settings 137 specifications 205 troubleshooting 186 user checks 158 viewing the drive 129 User checks during Operational Check 158 User messages in AED Mode 66 Vi V V Fib 54 Viewing USB drive 129 Voice prompts a
228. s USB 2 0 compatible and is lt 32 gigabytes 205 18 Specifications Symbol Definition Symbol Definition Table 54 lists the meaning of each symbol appearing on the HeartStart XL and the Lithium Ion battery Table 54 HeartStart XL Symbol Definitions Symbol Definition Symbol Definition Dangerous voltage Input Y Meets IEC type CF leakage current requirements and is defibrillator protected Patient Applied part is isolated and defib proof suitable for direct patient contact including the heart or major arteries O TAN D c This product has passed relevant safety tests by the CSA a nationally recognized test lab AA 0123 Device complies with the requirements of the Medical Device Directive 93 42 EEC SpO port AC Current Output Data In Caution See operating instructions in Instructions For Use Electrostatic sensitive device This device can run off a battery Manufacture date Dispose of in accordance to your country s requirements RoHS exempt Environmentally friendly for a use period of 50 years Consult Instructions For Use DC Current UL Recognized Component for Canada and the United States Lii OE pla Rechargeable battery Le eral gt 9 USB Port B Meets IEC type BF leakage current requirements and is defibrillator protected Patient Applied Part i
229. s affected by absorption and reflection from structures objects and people 213 NOTES A Abbreviations 207 208 Aberrantly conducted beats 52 AC Connection 13 AC Line Filter 140 Accessing USB drive 130 Accessories 189 adapters 194 battery 194 ECG cable sets 190 191 ECG monitoring electrodes 191 external paddles 190 internal paddles 190 mounting solutions 194 multifunction electrode pads 189 NBP 192 paper 194 pouches 194 SpO 193 storage 16 test loads 194 therapy cables 190 USB 194 Adapters 194 Adjusting numeric values 32 AED 62 adjusting volume 32 administer a shock 65 adult patients 70 AED Mode 1 21 59 AED View 61 alarms 71 Alarms button 23 analysis messages 66 configuration options 143 connecting multifunction electrode pads 8 connecting therapy cable 7 CPR 62 defibrillating 63 ECG alarms in AED Mode 57 ECG cannot be analyzed 65 ECG monitoring 70 energy dose settings 144 events stored in Event Summary 126 forced pause messages 70 handling patient during ECG analysis 64 impedance 60 indications for use 2 infant child 70 low impedance messages 68 marginal impedance messages 68 menus 62 message area 29 mode messages 66 monitoring parameters 70 monitoring pulse 70 multifunction electrode pads 61 no shock advised 64 pads connect messages 66 pads off messages 67 Patient Category button 23 63 pause time 65 pause progress ba
230. s and the related information described throughout this manual Pictures of the HeartStart XL display appearing throughout this manual are for illustration purposes only The content of these areas varies with the display view the options on your device and the function being performed a 2 Device Basics Basic Orientation Basic Orientation This section provides an overview of the HeartStart XL options and accessories Front of the Device The front of the device contains operational controls and indicators as shown in Figure 1 Figure1 Front View Patient Category button Ready For Use RFU Indicator Flash Drive USB Data aa oN Port Therapy Knob Lead ii Select o MEN Select Charge a button ae Therapy Port Display Shock button Sync button Soft v Printer Keys 4 door and E P latch Mark Event Reports Print Battery indicator n Menu Select Oo button Mark Event Print button External Power Indicator Alarm Pause button button Reports button Navigation buttons Additional controls and indicators are located on the external paddles see External Paddle Features on page 11 and the Lithium Ion battery see Battery Fuel Gauge on page 14 Basic Orientation 2 Device Basics Right Therapy Side The right side of the HeartStart XL is dedicated to administering therapy It contains a therapy port for pa
231. s are preset on the HeartStart XL based on its configuration and the patient type When alarms are on alarm limits are visible next to the parameter s numeric value At times you might want to adjust an alarm limit for the current event To adjust an alarm limit 1 Press the Menu Select button 2 Select Measurements Alarms and press the Menu Select button 3 Select the desired parameter and press the Menu Select button 4 Select the parameter Limits and press the Menu Select button 5 Press the top Navigation button to increase the limit Press the bottom Navigation button to decrease the limit 3 Working with the HeartStart XL 36 Audio Tones and Alarm Indications Alarms The HeartStart XL uses a mixture of audio tones and alarm indications to communicate device and patient status Table 4 describes the device s audio tones and alarm indications Table 4 Tones and Alarms Tone Indication Description Tone level Single beep Message Accompanies a new message on the display 2000 Hz generally informational Continuous tone Charged Generated when the the selected defibrillation 2042 Hz energy is reached and continues until the Shock button is pressed or the device is disarmed Continuous tone lower Charging Generated when the Charge button is pressed 1333 Hz pitch than charged tone and continues until the device is fully charged Periodic chirp Attention Generated in instances su
232. s can be set below 70 the accuracy of measurements less than 70 has not been validated SpO accuracy was validated in human studies against arterial blood sample references measured with a CO oximeter In a controlled desaturation study healthy adult volunteers with saturation levels between 70 100 SaO were studied The population characteristics for those studies were approximately 50 male and 50 female ranging in age from 19 39 with skin tone from light to dark Pulse oximetry equipment measurements are statistically distributed therefore only two thirds of pulse oximeter equipment measurements can be expected to fall within Arms of the value measured by a CO oximeter Functional test equipment designed for SpO testing cannot be used to assess the accuracy of the SpOy readings See the sensor s instructions for use for the maximum temperature possible at the sensor skin interface and other information such as intended patient population sensor application sites and use criteria The HeartStart XL is calibrated to display functional oxygen saturation Ambient Light Sensitivity Interference from fluorescent light is lt 2 SpO2 under the following conditions 0 3 and 1 perfusion 50 nA mA transmission 10 to 1000 lx light intensity 50 60Hz power line frequency 0 5 Hz line frequency SpO Alarm Range Low Limit 50 99 Adult and Infant Child High Limit 51 100 Adult and Infant Child SpO and Pulse High Low Alarm Signa
233. s correct paced status in order to optimize ECG analysis For more information on arrhythmia analysis refer to the Application Note Arrhythmia Monitoring Algorithm for HeartStart XL available on the Philips website at www philips com ProductDocs 53 4 ECG Monitoring Heart Rate and Arrhythmia Alarms Heart Rate and Arrhythmia Alarms The HeartStart XL detects HR and arrhythmia alarm conditions by comparing ECG data to a set of pre defined criteria An alarm can be triggered by a rate exceeding a threshold e g HR gt configured limit an abnormal rhythm e g Ventricular Tachycardia or an ectopic event e g PVC gt configured limit HR Arrhythmia alarms can be generated for the conditions shown in Tables 7 and 8 Once generated they appear as alarm messages in the HR alarm status area above the HR numeric When ECG alarms are off an ECG Alarms Off message appears above the HR numeric There are both audio and visual alerts For more information on alarms see Alarms on page 33 Table 7 HR Arrhythmia Physiological Alarms Alarm Message Condition Type of Alarm Indication Asystole No detectable beats for four seconds in the absence of V Fib VFib VTach A fibrillatory wave detected for four seconds VTach Consecutive PVCs and HR exoeed ommigured limits High Priority Red Alarm message with Extreme Brady Extreme Brady 10 bpm below Latching Alarm alarm tone HR low limit capped at 30 bpm Extreme
234. s is selected for display in Wave Sector 2 and the device enters Pacer Mode the Wave Sector 2 waveform automatically switches to None If Pads is selected for the display in Wave Sector 2 and the device enters Demand Mode pacing the Wave Sector 2 waveform automatically switches to None If monitoring for an extended period of time monitoring electrodes and multifunction electrode pads may need to be changed periodically Refer to the manufacturers documentation for replacement frequency Signals from TENS or ESU units can cause interference with the ECG which may impact pacing 92 Pace Pulse Duration You can configure the duration of the paced pulse in Configuration Mode to either 20 or 40 msec Confirm with your organization which setting best meets your clinical needs If you select 20 msec you can select a current setting between 10 200 mA If you select 40 msec you can select a current setting between 10 140 mA See Pacer Settings on page 144 Demand Mode Pacing 8 Pacing Demand Mode Pacing To pace in Demand Mode 1 Turn the Therapy knob to the Pacer position The message Pacing Paused appears in the Pacing Bar indicating the pacing function is enabled but pace pulses are not being delivered Pacing is enabled in Demand Mode with the configured lead in Wave Sector 1 used for R Wave detection NOTES If the configured lead is Pads Lead I or the first available monitoring lead is displayed automatically Whil
235. s isolated and defib proof suitable for direct patient contact except the heart or major arteries NOTE For definitions of symbols which appear on the HeartStart XL s front panel see Front of the Device on page 6 and General Function Buttons on page 23 For definitions of symbols which appear on the external paddles see External Paddles on page 11 For RF transmission symbol definition see page 212 Shipper Carton Symbol Definitions Shipper Carton Symbol Definitions 18 Specifications Table 55 lists the meaning of each symbol appearing on the HeartStart XL shipping carton Table 55 Carton Symbol Definitions Symbol Definition Definition Fragile Temperature Range Do not get wet Atmospheric pressure range tht Stack only three high Relative humidity range CE Device complies with the requirements of the Medical Device Directive 93 42 EEC eA i Recyclable paper product 207 18 Specifications Abbreviation Definitions 208 Abbreviation Definitions Table 56 lists various abbreviations used with the HeartStart XL and in these Instructions for Use Table 56 Abbreviations Abbreviation Definition Abbreviation Definition percent us microseconds C degrees Celsius pV microVolt F degrees Fahrenheit mA milliAmpere AC alternating current mV milliVolt bpm beats per m
236. shes Battery Maintenance For information on battery maintenance see Battery Maintenance on page 166 Power Indicators The Power Indicators are located in the lower left corner of the HeartStart XL s front panel see Figure 25 The green AC Power Indicator is lit whenever AC power is connected to the HeartStart XL even if the device is turned off The green Battery Charging Indicator flashes when the battery is charging The indicator is solid green when the battery is fully charged and AC power is present The light is off if no battery is installed the battery is installed but not functioning properly or there is no AC power present 3 Working with the HeartStart XL Power Figure 25 Power Indicators AC Power KF ae Indicator Battery Charge Indicator gt Turning the HeartStart XL On To turn the HeartStart XL on turn the Therapy knob to the desired mode of operation Turning the HeartStart XL Off To turn the HeartStart XL off turn the Therapy knob to the Off position If you turn the device off while in a clinical mode the HeartStart XL enters the Continued Use Period see Continued Use on page 39 The screen displays a 10 second countdown see Figure 26 before turning off Figure 26 Shut Down Countdown Shutting Down in 8 seconds NOTE You should leave the device plugged in to keep the battery charged and allow automated diagnostic tests to run periodically
237. shift per AHA Guidelines Place a checkmark in the box as you check each item in the list below Place a dash mark or other symbol if the entry is not applicable Initial the list to indicate the check was performed for that shift Device Name or Serial Number Unit or Department RFU Indicator Hourglass If blinking red X Plug into AC power or insert charged battery If solid red X Insert charged battery or plug in AC power If condition persists call for service Case clean free from spills and objects Cable connectors present and inspected Paddles Therapy Cable present inspected and paddles release from tray Multifunction pads present sufficient supply check expiration date Monitoring electrodes present sufficient supply check expiration date Charged batteries one in device spares Check battery gauge AC power cord plugged in green light on Printer paper present sufficient supply USB drive present SpO sensors if option is installed present sufficient supply NBP cuffs tubing if option is installed present sufficient supply Other ancillary supplies test plug test load gel scissors razor present sufficient supply Initials 149 14 Operational and Shift Checks Shift Check Shift Checklist Page 2 HeartStart XL Weekly S
238. shooting Table 46 Defibrillation and Pacing Problems Continued Symptom Possible Cause Possible Solution Check Pads Connection From Patient to Device message on display A test load or defibrillator test plug is attached to the end of the Therapy Cable Remove the test load or defibrillator test plug and attach multifunction electrode pads Pads impedance is less than 10 ohms Check pads connection with the patient Charge Cancelled message is displayed Therapy cable is not attached Pads paddles connection compromised Make sure the Therapy cable is connected and the pads paddles are making proper contact with the patient The Shock button was not pressed within the configured time period No action required If desired charge the device and press the Shock button Press Paddles Firmly message is displayed Press Pads Firmly message is displayed A shock has been aborted due to high impedance Check paddles connection with the patient Remove paste moisture or any other conductive material between the pads and patient Check pads connection with the patient Replace Pads message is displayed A shock has been aborted due to high impedance second notice Replace the pads and check connection with patient Reapply Pads to Dry Chest message on display Paddles Must Not Be Touching Each Other message on display A shock has been aborted due
239. sor Applying the Sensor Monitoring SpO SpO Alarms Table of Contents 74 75 76 76 76 _77 77 78 78 78 79 80 80 81 81 82 83 84 85 85 86 86 87 87 89 89 90 91 91 93 95 96 97 98 99 99 100 101 102 103 Table of Contents SpO Desat Alarm Changing SpO Alarm Huit Enabling Disabling SpO Alarms Pulse Rate Alarms Changing Pulse Rate Kees isis Enabling Disabling Pulse Rate Alarms Disabling SpO Monitoring Caring for Sensors Troubleshooting Chapter 10 Blood Pressure Monitoring Overview Measuring NBP NBP Alarms Changing NBP Alarm sa e Lini Enabling Disabling NBP Alarms Caring for Cuffs NBP Calibration Troubleshooting Chapter 11 Trending Overview Viewing Ted Ds Printing the Trends Report Troubleshooting Chapter 12 Data Management Overview Event Summary Data Management Node Internal Memory Accessing Data on the USB Dive Printing Data Gs a y Printing During a Patient Event Printing While in Data Management Mode Mark Events Chapter 13 Configuration Overview Entering Cofradia T Accessing Configuration Mode Setting Date and Time Changing Settings 105 105 105 106 106 106 107 107 107 109 109 110 113 114 114 114 114 114 115 115 115 117 117 119 119 120 128 128 130
240. sparent Reduced Skin Irritation Pads HeartStart Infant Radiotransparent Reduced Skin Irritation Pads HeartStart Adult Child Preconnect Pads HeartStart Adult 1 set HeartStart Adult 5 sets SMART Pads II Adult Child Infant for handoff only 189 17 Supplies amp Accessories 190 Ordering Replacement Supplies and Accessories Table 51 Supplies and Accessories Continued Part Number Description Hands Free Pads Therapy Cables M3507A Defibrillator Pads Hands Free Cable barrel style 2 2 m 7 ft M3508A Defibrillator Pads Hands Free Cable plug style 2 2 m 7 ft 05 10200 Pads Adapter use with M3507A External Paddles M3543A External Paddles M4745A Sterilizable External Paddles M4759A Paddle Electrode Replacement Internal Switched Paddles M4741A 7 5cm Switched Internal Paddles M4742A 6 0cm Switched Internal Paddles M4743A 4 5cm Switched Internal Paddles M4744A 2 8cm Switched Internal Paddles Internal Switchless Paddles M1741A 7 5cm Switchless Internal Paddles M1742A 6 0cm Switchless Internal Paddles M1743A 4 5cm Switchless Internal Paddles M1744A 2 8cm Switchless Internal Paddles 3 Lead ECG Cable Sets M1500A 3 lead ECG Trunk Cable AAMI M1510A 3 lead ECG Trunk Cable IEC M1605A 3 lead ECG Set with Snaps AAMI MI1615A 3 lead ECG Set with Snaps IEC M1669A 3 lead ECG Trunk Cable AAMI IEC M1671A 3 lead ECG grabber AAMI ICU M1672A 3 lead ECG set ICU grabber IEC M1673A 3 lead
241. spital environment Ur is the AC mains voltage prior to application of the test level 211 18 Specifications Electromagnetic Compatibility Table 59 Electromagnetic Immunity Life Supporting Systems Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment Guidance Level Portable and mobile RF communications equipment should be used no closer to any part of the HeartStart XL including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 3 Vrms Conducted RF 150 kHz to 80 MHz 3 Vrms Recommended Separation Distance ene outside ISM bands d 24 P IEC 61000 4 6 10 Vrms 10 Vrms 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the 3 V m 3 V m transmitter in watts W according to the transmitter s Radiated RF z specified output power and d is the recommended IEC 61000 4 3 10 V m 20 V m 10 V m separation distance in meters m gt 80 MHz to 2 5 GHz 20 V 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 might occur in the vicinity of equipment marked with the following symbol K Applies to functions that are not considered life supporting No inadvertent energy delivery per IEC 60601 2
242. t Logged when the patient s Mean NBP is lower than the configured limit NBP Calibration Overdue Logged when NBP module calibration is due NBP Cuff Not Deflated Logged when the NBP cuff fails to deflate after 3 minutes NBP Cuff Overpressure Logged when the NBP cuff pressure reaches 300 mmHg 40 kPa NBP Measurement Failed Logged when an NBP measurement fails to complete NBP Error Logged when the device detects a non critical NBP failure NBP Equipment Logged when the NBP module detects a malfunction Malfunction Defibrillation Charging to value J Logged when charging is initiated Disarm Manual Logged when the device is disarmed manually 125 12 Data Management Event Summary Table 26 Event Information Continued Logged Event Frequency Disarm Auto reason Logged when the device disarms automatically Reasons include Pads Off Logged when the automatic disarm is caused by a bad connection between the device and the patient Shock Equipment Malfunction Logged when the device is unable to reach the selected energy during charging Timeout Logged when the device reaches its configured auto disarm period Shock Aborted Logged when the shock is aborted No Shock Advised Logged when in AED Mode the algorithm determines the rhythm is not shockable Device Off Logged when the device is turned off while charged Leads Off Logged in Synchron
243. t finger 3m cable Reusable SpO Sensor Adult finger 3m cable Reusable SpO Sensor Adult finger 9 pin connector Reusable SpO Sensor Pediatric Small Adult Reusable SpO Sensor Pediatric Finger 9 pin connector Reusable SpO Sensor Adult Pediatric ear clip Reusable SpO Sensor Infant Reusable SpO Sensor Adult clip Reusable SpO Sensor Adult clip 2m Reusable SpO Sensor Adult clip 9 pin connector Disposable SpO Sensor Infant digit available outside the U S only Disposable SpOy Sensor Pediatric Finger available outside the U S only Disposable SpO Sensor Adult Finger available outside the U S only 193 17 Supplies amp Accessories 194 Ordering Replacement Supplies and Accessories Table 51 Supplies and Accessories Continued Part Number Description M1941A SpO Extension Cable 2m M1943A Reusable SpO Sensor Adapter Cable Im Use with M1903B M1904B M1943AL Reusable SpO Sensor Adapter Cable Paper 40457C 50 mm Chemical Thermal Paper gray grid 10 rolls 40457D 50 mm Chemical Thermal Paper gray grid 80 rolls Adapters M4740A Adapter for use with internal switchless paddles 05 10200 Adapter for M3507A Changes barrel cable to flat removable or permanent for M37xxA pads Power 989803167281 HeartStart XL Lithium Ion Battery Data Management 989803171261 USB Data Drive Accessory Pouches
244. t key As the cuff begins to inflate and then deflate the pressure is displayed 7 When the measurement is complete the NBP values are displayed To stop an NBP measurement in progress press the Stop NBP soft key WARNINGS Do not perform noninvasive blood pressure measurements on patients with sickle cell disease or any condition where skin damage has occurred or is expected Do not use in a hyperbaric chamber Care should be taken when using an oscillometric NBP device on patients with decreased consciousness neuropathy irregular cardiac rhythm labile high blood pressure increased arm activity or arterial insufficiency especially if the unit is utilized for a prolonged period Use clinical judgement to decide whether or not to perform automatic blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb wearing the cuff Do not apply the cuff to a limb that has an intravenous infusion or arterial catheter in place This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation Use only approved cuffs and tubing in order to prevent inaccurate data injury or damage All specified cuffs are protected against the effects of the discharge of a defibrillator Prolonged series of NBP measurements in automatic mode may be associated with purpura ischemia and neuropathy in the limb wearing the cuff When monitoring a patient
245. tStart XL Lithium Ion battery by e Pushing the fuel gauge button on the battery to illuminate the fuel gauge see Battery Fuel Gauge on page 14 Each light represents approximately 20 of capacity e Turning the Therapy knob to any position and observing the battery power indicators displayed in the Status Area see Status Area on page 27 Calibrating Batteries Battery capacity diminishes with use and age Battery calibration ensures the fuel gauge provides accurate estimates of the charge remaining and it also checks to see if the battery is nearing the end of its useful life and should be discarded Calibrate your battery when the Calibration Required message is displayed or every 6 months whichever comes first NOTE Battery calibration can only be done while the battery is installed in the HeartStart XL and while in Service Mode See the HeartStart XL Service Manual for more details After successfully calibrating your battery perform an Operational Check Storing Batteries Batteries should be rotated regularly to ensure even usage When storing batteries make sure the battery terminals do not come in contact with metallic objects If storing batteries for an extended period of time it is recommended they are stored between 15 C 35 C 59 95 F Storing batteries at a higher temperature significantly reduces the battery s life expectancy Stored batteries should be charged every 2 months to 20 40 of
246. ta include name medical record number dates related to the individual patient age if over 89 and any other information that could uniquely identify an individual e When exporting Event Summaries the HeartStart XL can be configured to prompt you to remove all patient related data prior to exporting If this function is enabled you are prompted to Export Without Patient Info Select Yes to remove the patient related data prior to exporting and NO to export with patient related data in the Event Summary e When the Internal Memory Menu is displayed Figure 65 selecting Remove All Patient Info prompts the HeartStart XL to ask you Remove Patient Info from All Internal Event Data Select Yes to remove the patient related data and NO to keep the patient related data in the Event Summary Accessing Data on the USB Drive When you select the View USB Drive option from the Internal Memory Menu the HeartStart XL first checks that there is a compatible USB drive inserted into the USB port on top of the device see USB Data Port on page 12 Ifa compatible USB drive is not found the Internal Memory Screen remains on the display If a compatible drive is found then the USB Drive Screen is displayed NOTE The USB Drive Screen s layout is similar to the Internal Memory Screen see Figure 64 except Internal Memory is replaced with USB Drive in the screen s title Using the HeartStart XL you are only able to save Event Summaries to an
247. talled the battery icon indicates the level of charge remaining See Figure 29 Figure 29 Battery Charge Level S A Ga ff 6 gt Low lt 40 gt 40 lt 65 65 lt 90 gt 90 ah Battery remaining remaining remaining remaining Condition See Low Battery Conditions on page 25 Parameter Area The Parameter Area displays the key physiological parameters currently being monitored see Figure 30 Displayed values for each parameter include e Parameter Label e Current value Display e Number a valid value was obtained e an invalid value was obtained e with a number the value obtained is questionable e blank the parameter is unavailable or off e Currently configured upper and lower alarm limits with the units label Figure 30 Parameter Area Heart Rate SpO Pulse Rate NBP Parameter Time ot Units Parameter Units Label Parameter P t last NBP Label nits Labe Label ae og HSR Er pa Label Label Frequency Pia abel NBP q5 10 20am mmHg SA lt 110 70 80 3 5s EL lt A Mma HR Value SpO Value Pulse Value itis vests er alue Upper and Lower Upper and Lower Upper and Lower o pel T Alarm Limits prea Limits a Limits Upper and Lower Alarm Limits Alarm Source Pulse Limits are configured off by default but when they are on they appear in this location 28 The Display 3 Working with the HeartStart XL Message Area The message ar
248. technical alarm Faulty NBP hardware NBP Error technical alarm A non critical device failure has occurred Call for service and perform NBP calibration within two weeks After two weeks do not use the NBP monitoring capabilities until calibration has been performed If NBP monitoring is essential to patient care take the device out of use Table 49 Printing Problems Symptom Possible Cause Possible Solution Paper wont move Paper improperly loaded jammed or wet Reload paper or clear jam If paper is wet replace with a fresh dry roll Paper moves and then stops Door improperly latched Check door latch Paper improperly loaded or jammed Reload paper or clear jam Paper moves but printing is faint or absent Paper roll improperly installed Check that the paper is installed correctly Incorrect paper type Use only recommended paper type Printhead temperature approaching maximum recommended operating temperature Wait until the printer cools down to restart printing If there is a lot of black printed on the paper check ECG for excessive noise Paper moves but print quality is poor or some dots are missing Dirty printhead Clean the printhead White line running along paper Loud buzzing or grinding noise Print door improperly latched Check door latch Printer Out Of Paper technical alarm The printer has run out
249. that the sensor is applied properly Make sure the sensor site has a pulse Relocate the sensor to another site with improved circulation Try another sensor Sp0O Noisy Signal technical alarm Excessive patient movement or electrical interference Minimize patient movement Make sure the sensor cable is not positioned too close to power cables SpO Interference technical alarm Ambient light is too high Cover the sensor with an opaque material to minimize ambient light Make sure the sensor cable is not positioned too close to power cables Make sure that the sensor cable is not damaged SpO Unplugged technical alarm The sensor is not connected There is too much interference The sensor is damaged Check the SpO connection Try another sensor SpO Sensor Malfunction technical alarm The SpO sensor or cable is faulty Try another sensor If the problem persists call for service of the SpO module If SPO monitoring is essential to patient care take the device out of use SpO Equipment Malfunction technical alarm Faulty SpO hardware Call for service of the SpO module If SpO monitoring is essential to patient care take the device out of use 183 16 Troubleshooting Table 47 SpO Monitoring Problems Continued Symptoms Symptom Possible Cause Possible Solution SpO Extended Update technical alarm
250. the appropriate settings before returning the device to a clinical environment 158 Operational Check 14 Operational and Shift Checks Figure 74 Sample Operational Check Report Operational Check Report HeartStart XL S N Device Serial Number SW Rev Software revision Current Operational Check Date Time Result Last Operational Check Date Time Result Current Test Results General System Test Pass Therapy Knob Pass Charge Button Pass Shock Button Pass Audio Test Pass Sync Button Pass Therapy Delivery Test Pass Leads ECG Test Pass Pads Paddles ECG Test Battery Test Sp02 Test NBP Test Printer Test Pass Pass Pass Pass Pass Qty Check List _ Defibrillator Inspection _ ECG Cable Connectors _ Paddles Pads _ Monitoring Electrodes _ Charged Battery _ AC Power Cord _ Printer Paper _ Sp02 Sensor _ NBP Cuff s amp tubing _ USB Connector Comments Inspected by NOTE Information appearing in parenthesis in Figure 74 is replaced by the current setting when an actual Operational Check Report is printed For example Device Serial Number is replaced with the device s actual serial number when the report is printed 159 14 Operational and Shift Checks Operational Check Operational Check Summaries Selecting Op Check Summary from the Operational Check menu see Figure 71 displays a summary of Operational Checks curr
251. the electrode surfaces of the paddles and tray Secure the paddles in the tray and confirm the Patient Contact Indicator PCI LEDs are not lit If the LEDs are lit adjust the paddles in the tray If the LEDs remain lit clean both the adult and infant child paddle electrode surfaces If you use multifunction electrode pads Make sure the pads therapy cable is plugged into the defibrillator test plug or test load To begin an Operational Check 1 Confirm your device has a charged battery and an ECG cable connected but not connected to a patient or lead sets Turn the Therapy knob to Monitor Press the Menu Select button Using the Navigation buttons select Other and press the Menu Select button Select Operational Check and press the Menu Select button ow bh WN Select Run Op Check and press the Menu Select button The message Leaving clinical mode Patient monitoring will be turned off appears u Select Yes if you wish to continue with an Operational Check Select NO to return to Monitor Mode Press the Menu Select button to confirm your choice 8 Ifyou selected Yes the HeartStart XL displays the Operational Check Screen see Figure 72 and starts the Operational Check automatically NOTE Ifthe HeartStart XL is not set up correctly the display prompts you to make the required changes for a successful Operational Check see Figure 72 The Therapy knob must be set to 170J to begin Operational Check Once the check begins
252. the battery is inserted in the device look at the battery gauge on the display see Figure 29 Battery Charge Level on page 28 a SEES WARNING Use only approved batteries to power the HeartStart XL Use of non approved batteries could affect performance and results Basic Orientation 2 Device Basics Installing the Cable Wraps The HeartStart XL comes with cable wraps to assist in cable management To attach the cable wraps to the HeartStart XL 1 Snap the cable wrap into the Cable Management Connector snap on the back of the device 2 Loop your cable around the cable wrap and snap into place 3 To remove the cable tug on the loose end of the cable wrap to unsnap Figure 18 Cable Wrap 15 2 Device Basics Basic Orientation Accessory Storage System The HeartStart XL can be ordered with an optional Accessory Storage System to assist in cable and accessory management NOTE You need a Phillips head screwdriver to install the Accessory Storage System pouches Attaching the Pouches To attach your HeartStart XL Accessory Storage System to your defibrillator 1 Insert the hook on the bottom of the storage system s side pouch into the groove along the side of the HeartStart XL see Figure 19 Step 1 Lift the pouch up into place and secure in two locations with Phillips screws see Figure 19 Step 2 Drape the double sided black pocket over the outside end of the pouch aligning the tapered e
253. the display is full the oldest displayed data is removed e Ifyou scroll horizontally to view older data the HeartStart XL updates the newest data when you scroll back e Ifa parameter data point has invalid information a is displayed Questionable data are indicated by a question mark just before the numeric value Unavailable data are indicated by a blank space e Ifa parameter has not been measured during the display period it is not listed in the far left column e The Heart Rate parameter is always the top entry in the Trends Report If your device has the SpO Option and values for SpO and Pulse are available they are listed second and third in the Trend Report If your device has the NBP option and values for NBP are available they are listed fourth in the Trends Report e The units of measure for trend data are not displayed in the Trend table and report Setting Trend Intervals Trending data can be shown at selected intervals for up to the last 8 hours of monitoring You can adjust the display s time interval for the current incident to 1 5 10 15 30 or 60 minutes The default is 5 minutes To adjust the Trend Interval 1 Confirm there is a Trends Report on the HeartStart XL screen 2 Press the Menu Select button 3 Using the Navigation buttons select Trend Interval and press the Menu Select button 4 Select the interval you want and press the Menu Select button Navigating Around the Trending Report Use the
254. the following At least 3 hours of monitoring ECG and SpO monitored continuously and NBP sampled every 15 minutes followed by 20 full energy charge shocks At least two hours of pacing 180ppm at 140mA with 40 msec pulse width while monitoring ECG and SpO monitored continuously and NBP sampled every 15 minutes followed by 20 full energy charge shocks At least 175 full energy charge shocks Battery Indicators Battery gauge on battery capacity indicator on display power indicators on front of device flashing RFU indicator chirp and Low Battery messages on the display for low battery condition When a low battery message first appears there is still enough energy for at least 10 minutes of monitoring and 6 maximum energy discharges Battery Storage Storing the battery for extended periods at temperatures above 40 C 104 F reduces battery capacity and degrades battery life Specifications 18 Specifications Thermal Array Printer Continuous ECG Strip The Print key starts and stops the strip The printer can be configured to be run real time or with a 10 second delay The strip prints the primary ECG lead and a second wave with event annotations and measurements Auto Printing The printer can be configured to automatically print on Mark Events Charge Shock and Alarm Reports The following can be printed e Event Summary Long or Short e Vital Signs Trends e Operational Check e Configuration e Status Log e
255. their full capacity They should be charged to full capacity before being put into use CAUTION Do not store batteries in the HeartStart XL if the device is out of service for an extended period of time Discarding Batteries Batteries should be discarded if there are visual signs of damage or if they fail calibration They should be discarded in an environmentally safe manner WARNINGS Properly dispose of or recycle batteries according to local regulations Do not puncture disassemble or incinerate batteries Be careful not to short the battery terminals because this could result in a fire hazard 16 N 15 Maintenance Battery Maintenance General Battery Safety The following general warnings and cautions apply to the HeartStart XL battery Additional warnings and cautions specific to a particular battery feature are provided in the appropriate sections WARNINGS Built in safety circuits cannot protect against handling abuse Adhere to all warnings and cautions in handling and using Lithium Ion batteries Keep batteries away from flame and other heat sources Do not short circuit the battery Avoid placing batteries around metal objects that may short circuit the battery Avoid getting batteries wet or using batteries in high humidity environments Do not crush dent or allow any deformation of the batteries Do not disassemble or open batteries Do not attempt to alter or bypass the safety circuit Do not c
256. tifunction electrode pads may need to be changed periodically Refer to the manufacturer s documentation for how often to replace the monitoring electrodes or pads Skin Preparation Skin is a poor conductor of electricity so proper skin preparation is important to achieving good electrode pad to skin contact To prepare the skin 1 4 Identify the appropriate locations For pads see the pads package For electrodes see Electrode Placement on page 45 If necessary clip hair at the site or shave if needed Clean and abrade skin at the site Dry the site briskly to increase capillary blood flow in the tissues and to remove oil and skin cells Monitoring ECG with Pads To monitor ECG through multifunction electrode pads 1 If not preconnected connect the Therapy cable to the HeartStart XL as described in Connecting the Therapy Cable on page 7 Connect the pads to the Therapy cable as described in Connecting Multifunction Electrode Pads on page 8 Prepare the skin as directed above Apply the pads to the patient as described on the pads package Preparing to Monitor ECG 4 ECG Monitoring Monitoring ECG with Electrodes To monitor ECG through electrodes 1 Prepare the skin 2 Attach the snaps or grabbers to the electrodes before placing them on the patient 3 Apply electrodes by peeling them one at a time from the protective backing and sticking them firmly to the patient s skin Press a
257. tifunction electrode pads connection or patient contact Pace pulses are not delivered if there is a problem with the ECG monitoring electrode connections If either situation occurs a system message is displayed The Start Pacing soft key is grayed out for Demand Mode pacing until a leads on condition is detected for the ECG lead used for R Wave detection and the pads on condition is detected In Fixed Mode the soft ley is grayed out until pads are detected Fixed Mode Pacing 8 Pacing Fixed Mode Pacing To pace in Fixed Mode 1 Turn the Therapy knob to the Pacer position The message Pacing Paused appears in the Pacing Bar and indicates the pacing function is enabled but pace pulses are not being delivered Demand pacing is the default pacer mode Change to Fixed Mode pacing a Press the Menu Select button b Using the Navigation buttons select Pacer Mode and press the Menu Select button c Select Fixed and press the Menu Select button See Figure 54 Figure 54 Changing Pacing Modes 3 Main Menu Pacer Mode Cae Volume Displayed Waves Measurements Alarms Patient Info Use the Lead Select button to select the desired lead for viewing if one is available NOTE Ifyou want to see the ECG waveform and related parameters while pacing you must have ECG electrodes on the patient with pads Viewing Pads in Wave Sector 1 while pacing may give you an incorrect heart rate and inappropriate alarms
258. ting Symptoms Table 46 Defibrillation and Pacing Problems Continued Symptom Possible Cause Possible Solution Pacing Stopped Pads Off technical alarm Proper pads contact has been lost with the patient Check pads connection with patient Confirm proper skin prep Replace pads if necessary Resume pacing Pacing Stopped Device Error technical alarm The HeartStart XL has detected an error which prevents pacing therapy delivery Replace the defibrillator Remove the device from use and call for service Pacing Stopped Pads Cable Off technical alarm The Therapy cable is disconnected from the device Check all Therapy cable connections Replace pads if necessary Resume pacing Pacing Stopped Leads Off technical alarm The primary ECG lead has become invalid Check that the monitoring electrodes are applied properly to the patient Check cable connections Resume pacing Shock Aborted prompt but you see a physiological response from the patient and the Shock Counter remains unchanged Poor skin contact pads are not properly connected to the patient Minimal patient movement is possible in this situation as the defibrillator may deliver a small amount of energy Make sure the pads are applied properly Replace pads if necessary NOTE Once the reason for the Pacing Stopped alarm has been resolved that part of the alarm message is removed
259. ting Down Battery power is critically low failed Replace Battery The battery has reached its end of life Now icei i The device is shutting down l _ PE now High Priority Non Latchi audio tone in Technical Equipment A low voltage has been ons Oe Alarm area Disabled System detected Failure Battery The battery needs to be Calibration calibrated Required Cyan alarm message with Battery Communications between the 28 ailcio tone a Seals Communication device and the battery have Low Priority ni Failure Non Latching Cyan alarm message with audio tone in Technical Alarm area 169 15 Maintenance Cleaning Instructions Cleaning Instructions CAUTIONS Listed below are the recommended cleaning instructions for the HeartStart XL and its associated accessories The HeartStart XL along with its accessories and supplies may not be autoclaved steam sterilized ultrasonically cleaned or immersed unless otherwise indicated in the Jnstructions for Use that accompany the accessory or supply Do not use abrasive cleaners or strong solvents such as acetone or acetone based compounds Do not clean electrical contacts or connectors with bleach A soft cloth is recommended for cleaning the display window to prevent scratching Quaternary ammonium compounds such as Steris Coverage Plus NPD are not recommended for routine cleaning Disinfect the HeartStart XL as determined by your institu
260. tion s policy to avoid damage to the device Defibrillator Monitor Paddles Cables and Battery CAUTIONS NOTE You can clean the exterior of the HeartStart XL external paddles therapy cables ECG cables and battery by hand wiping with a clean cloth Remove all soil tissue fluid etc and wipe thoroughly with a water dampened cloth before applying one of the following cleaning products e Isopropyl alcohol 70 solution in water e Mild soap and water e Chlorine bleach containing 6 sodium hypochlorite 3 solution in water e Cleaning solutions wipes with milder Isopropyl alcohol and chlorine bleach concentrations When cleaning do not immerse Wring any excess moisture from the cloth before cleaning and be sure to avoid pouring fluids on the device Do not allow fluids to penetrate the exterior surfaces of the device No parts of the device except sterilizable internal and external paddles may not be ultrasonically cleaned immersed autoclaved or ETO sterilized The ECG cables may not be ultrasonically cleaned immersed autoclaved or steam sterilized For information about cleaning and sterilizing internal and external sterilizable paddles see the Sterilizable Defibrillator Paddles Instructions For Use HeartStart XL Disposal 15 Maintenance Printer Printhead If the printout has light or varying print density clean the printhead to remove any buildup of paper residue To clean the printhead 1 Push the pr
261. to the patient Audio Message Display Text Condition User Action Begin CPR Attend to Patient A shock series has ended and the device has entered a pause period for CPR A no shock decision has been made and the device has entered a pause period for CPR Attend to Patient Monitoring A no shock decision has been made and during monitoring artifact has been detected Attend to patient Attend to Patient You have paused the device No shock advised Attend to Patient no Shock Advised A no shock decision has been made and the device has entered a pause period Attend to the patient Begin CPR if indicated Begin CPR Check patient None for CPR Stop CPR None The CPR pause period has Attend to patient Resume ended analysis if indicated Using AED Mode to Monitor You can use AED Mode to monitor your patients ECG SpO and pulse Related alarms can also be activated for the parameters To monitor ECG in AED Mode and activate alarms 1 Turn the Therapy knob to AED The HeartStart XL announces the patient category currently set If not correct use the Patient Category button to select the appropriate patient category e For patients that are gt 25 kg or 2 8 years old use Adult patient category e For patients lt 25 kg or lt 8 years old use Infant Child patient category 2 After performing an initial ECG rhyth
262. ts e Asystole e Extreme Tachy e HR High e V Fib Tach e Extreme Brady e HR Low For more information on AED Mode see AED Mode on page 59 For more information on Alarms see Alarms on page 33 Troubleshooting If your HeartStart XL does not operate as expected during ECG and Arrhythmia monitoring see Table 45 ECG Monitoring Problems on page 178 57 NOTES 5 AED Mode Defibrillation therapy is the definitive method for termination of lethal arrhythmias The HeartStart XL s Semi Automated External Defibrillation AED Mode is designed to guide you through standard treatment algorithms for cardiac arrest The HeartStart XL provides therapy through the application of a brief biphasic pulse of current to the heart This energy is transferred through disposable multifunctional pads applied to the patient s bare chest This chapter describes how to use AED Mode It explains the voice and visual prompts that guide you through the defibrillation process and describes how prompts vary depending upon the condition of the patient and the configuration of your device Configuration choices allow you to customize AED Mode to better meet the unique needs of your institution or resuscitation team The HeartStart XL uses Philips SMART Analysis algorithm as the basis for making a shock decision in AED Mode The SMART Analysis algorithm was designed to make aggressive shock decisions conc
263. ts the HR ECG color Red Yellow Blue Green Cyan Magenta White Auto Gain Determines whether ECG size is On Off automatically adjusted to the maximum wave size without clipping the wave sector If auto gain is off the gain is set to x1 10mm mYV NOTE Adjusting the ECG wave size on the display does not affect the ECG signal which is used for arrhythmia analysis AC Line Filter Selects the setting used to filter out AC 50 Hz 60 Hz line noise from ECG data Adjust setting to the power frequency of your country ECG Bandwidth For Selects the display filter frequency for 0 15 40 Hz 0 05 40 Hz Display 3 5 Lead ECG cable ECG Bandwidth For Selects the display filter frequency for the 0 05 150 Hz Diagnostic 0 15 40 Printer attached therapy cable or 3 5 Lead ECG Hz 0 05 40 Hz cable Table 30 Heart Rate ECG Settings Continued 13 Configuration Parameter Description Setting Choices NOTE Ifthe ECG source is pads or paddles 0 15 40 Hz is used regardless of the configuration settings ECG Electrode Selects the electrode label format AAMI AAMI IEC Labels RA LA LL RL V IEC R L EN C HR Pulse High Selects the default High Alarm Limit for Adult 35 300 120 bpm Limit the HR derived from the ECG and the Infant Child 35 300 160 bpm pulse derived from SpO3 adjusted in increments of 5 HR Pulse Low Limit Selects the default Low Alarm Limit for
264. tual Event Summary For example Patient Name is replaced with the patient s name if it has been logged Events Stored in an Event Summary Events and wave segments can be stored in an Event Summary Table 26 lists events and related information stored in an Event Summary Not all events listed are possible based on your device s configuration Text in parenthesis are replaced by an appropriate value To have waves stored in the Event Summary you must have the HeartStart XL configured for long Event Summaries See Table 38 on page 145 Segments include a header waveform and events NOTES Ifan Event Summary stops printing because the paper runs out the report resumes printing if a new roll of paper is installed within 3 5 minutes Values listed on a printed Event Summary also include the parameter s unit of measurement 121 12 Data Management Event Summary Table 26 Event Information Logged Event Frequency Power related events Device On Logged when device first turns on Continued Use Logged when device is turned on after being turned off for less than 10 seconds Device Off Logged when the Therapy knob is turned to the Off position RFU Failure Logged when a critical device failure has been reported Mode and Energy Positions AED Mode Monitor Mode Pacer Mode Manual Defib Mode Sync Mode value J Logged at the start of an event and wh
265. u Select button Using the Navigation buttons select Measurements Alarms and press the Menu Select button Select pOg and press the Menu Select button Select pO Limits and press the Menu Select button Select the new high limit value and press the Menu Select button au A WN Select the new low limit and press the Menu Select button Enabling Disabling SpO Alarms To enable disable SpO alarms 1 Press the Menu Select button 2 Using the Navigation buttons select Measurements Alarms and press the Menu Select button 3 Select SpOg and press the Menu Select button 4 Select Alarms On Alarms Off and press the Menu Select button EEE WARNING Turning alarms off prevents all alarms associated with the SpO measurement from being annunciated If an alarm condition occurs no alarm indication is announced 105 9 Pulse Oximetry Pulse Rate Alarms 106 You can turn on off Pulse Rate alarms in all clinical modes where SpO is available Pulse Rate Alarms The configured alarm limits may be changed during use Alarms are annunciated if measurements fall outside the configured limits for high or low pulse rate All Pulse Rate alarms are categorized as non latching alarms meaning they are automatically removed when their alarm condition no longer exists Pulse Rate alarms can be generated for the conditions shown in Table 23 Once generated they appear as alarm messages in the Pulse status area right above the Pulse numeric
266. us 90 pacing status bar 89 pacing stopped 97 Patient Category button 23 pause 90 pulses delivered 91 rate 90 93 R Wave arrows 90 93 shock button 22 skin prep 44 soft keys 93 specifications 201 start 90 status bar 89 stopped 97 182 stopping 94 TENS unit affects 92 therapy knob 22 troubleshooting 180 181 view layout 90 with a second defibrillator 96 Paddles events stored in Event Summary 122 Operational Check 151 Pads 8 events stored in Event Summary 122 manual defibrillation 76 monitoring 44 Paper 194 Paper installing 18 Parameter area 28 Passwords 39 configuration 135 219 Patient category adult 59 70 button 23 59 63 button location 6 configuration options 139 infant child 59 70 location on display 27 NBP 110 weight range on display 27 Patient Contact Indicators 11 Patient Data Event Summary 120 Patient Information events stored in Event Summary 122 Patient information entering name 38 entering patient ID 38 entering sex 38 location 27 Pause time in AED Mode 65 Pausing alarms 37 Physiological alarms 33 Pleth wave 103 Poor pads contact in AED Mode 67 68 Power 24 alarms 169 battery calibration 167 battery charge levels 28 battery fuel gauge 14 battery life 166 battery safety 168 battery status 27 167 battery storage 167 battery Operational Check results 157 charging the battery 166 device shutdown 26 discarding the battery 167 Event Summary events 122 external power
267. utomated Test Summary reports results for the hourly daily and weekly tests that have been performed See Table 41 The AutoTest Summary lists the result of the most recent hourly test the six most recent daily tests and the last 53 weekly tests The table below describes each result and the corresponding RFU Indicator display For more on the RFU Indicator see Ready For Use Indicator on page 24 Table 41 Auto Test Summary Results Result RFU Indicator Definition Required Action Pass Hourglass All tests passed None Fail DX Solid red X chirp Service required A Turn the Therapy knob to Monitor A critical device failure message indicating the problem is displayed has been detected Refer to Chapter 16 Troubleshooting on page 173 for further action Fail BW Blinking red X Service is not required Charge the battery as soon as possible or but the battery is low replace it with a charged battery You can or malfunctioning charge the battery in the HeartStart XL by connecting the device to AC power Fail CX Solid red X chirp An ECG cable failure Replace the ECG cable and rerun has been detected Operational Check Fail D Hourglass A non critical failure Turn the Therapy knob to Monitor A has been detected message indicating the problem is displayed Refer to Chapter 16 Troubleshooting on page 173 for further action Printing Exporting Auto Test Summaries You can p
268. utotest Failure technical alarm One of the Ready For Use tests failed to run to completion at its scheduled interval Take the device out of use and call for service The device has been without power for more than one week Run an Operational Check to diagnose the problem If the problem persists remove the device from use and call for service You receive a Power Test Failure technical alarm The installed battery is unable to charge the device for defibrillation Insert a fully charged battery Run an Operational Check to diagnose the problem If the problem persists remove the device from use and call for service You receive a Non Critical Device Error technical alarm A non critical software error has occurred Restart device when it is appropriate to do so If the alarm continues call for service Your device s display remains in Monitor Mode even when you switch to a different mode Therapy is disabled The Therapy knob has failed an Operational Check Run a proper Operational Check to diagnose the problem If the problem persists remove the device from use and call for service 177 16 Troubleshooting Table 45 ECG Monitoring Problems Symptoms Symptom Possible Cause Possible Solution QRS beeper inaudible or beeps do not occur with each QRS complex The QRS volume is configured to Off or the setting is too low Configure the QRS bee
269. ve sector in order to deliver pacing therapy When using the HeartStart XL for pacing in the Operating Room in the presence of cautery tools use Fixed Mode only When using Demand Mode pads are not an available choice for display in Wave Sector 1 through either the Lead Select button or the Displayed Waves menu Preparing for Pacing To prepare for pacing 1 If not already connected connect the Therapy cable to the HeartStart XL See Connecting the Therapy Cable on page 7 2 Prepare the patient s skin to achieve good contact See Skin Preparation on page 44 3 Connect the multifunction electrode pads See Connecting Multifunction Electrode Pads on page 8 4 If pacing in Demand Mode apply monitoring electrodes see Electrode Placement on page 45 and connect the ECG cable to the HeartStart XL see Connecting the ECG cable on page 9 SS eS SE EE ea ee ee WARNING Do not reverse pad position on the patient Reversing the pads positions increases the pacing threshold which means more current is needed to capture the heart resulting in greater patient discomfort 9 8 Pacing Preparing for Pacing NOTES Pacing Therapy should be administered while connected to AC power with a battery installed for backup so that pacing will not be interrupted in the event of either an AC power failure or the battery losing its charge If you enter Pacing Mode Sync settings are turned off If Paddle
270. wever the waveform displayed in Wave Sector 3 is replaced by the Pacing Status Bar 89 8 Pacing Pacing View Pacing View Pacing View appears when the Therapy knob is turned to the Pacer position Pacing View includes a status block which appears in Wave Sector 3 of the display see Figure 52 Pacing related information in Pacing View includes e Pacing Markers Markers indicating a pace pulse was delivered appear in Wave Sector 1 and in Wave Sector 2 if the wave is cascading each time a pacer pulse is delivered e R Wave Arrows R Wave arrows appear in Wave Sector 1 and in Wave Sector 2 if the wave is cascading when in Demand Mode pacing R Wave arrows do not appear on paced beats e Pacing Status Indicates the current pacing status e When pacing is active Pacing is displayed when the device is on AC power e If the device is running on battery Pacing on Battery is displayed e If pacing is not active Pacing Paused is displayed e Pacing Alarm If there is a pacing related alarm during pacing the current pacing status is replaced with an alarm message See Pacing Alarms on page 97 e Pacing Mode Indicates if the device is in Demand or Fixed Mode Pacing e Pacing Rate Indicates the current pacing rate including unit of measure e Pacing Output Indicates the current output including unit of measure e Start Pause Pacing soft key Starts or pauses pacing e Alarms Are on automatically Figure 52 Pacing V
271. ximetry on page 99 59 5 AED Mode Precautions for AED Therapy Precautions for AED Therapy WARNINGS The AED algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker In patients with cardiac pacemakers the HeartStart XL may have reduced sensitivity and not detect all shockable rhythms Use only pads that are approved for use with the HeartStart XL Use of non approved pads could affect performance and results See Table 51 for a list of supported pads For adults in AED Mode the multifunction electrode pads must be in the anterior apex position shown on the packaging For Infant Child patients the pads can be in the anterior posterior position Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring electrodes lead wires dressings etc Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart During defibrillation air pockets between the skin and multifunction electrode pads may cause patient skin burns To help prevent air pockets make sure the pads completely adhere to the skin Do not use dried out pads Do not open pads package until just prior to use Never touch the patient or any equipment connected to the patient including the bed or gurney during analysis and defibrillation Avoid contact between the patient and conductive fluids
272. y such as re orienting or relocating the HeartStart XL d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 212 Electromagnetic Compatibility 18 Specifications Recommended Separation Distances The HeartStart XL is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HeartStart XL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HeartStart XL as recommended below according to the maximum output power of the communications equipment Table 60 Recommended Separation Distances Separation Distances According to Frequency of Transmitter m Rated Maximum 150 kHZ to 800 MHz 800 MHz to 2 5 GHz Output Power of Transmitter W a 1 2J P d INP 0 01 0 1 m 0 2 m 0 1 0 4 m 0 7 m 1 1 2 m 2 3 m 10 m 7m 100 12 m 23m 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 s manufacturer At 80 MHz and 800 MHz the higher frequency range applies These guidelines might not apply in all situations Electromagnetic propagation i
273. y is not a reliable indicator of energy delivery or device performance Defibrillation is always performed through paddles or pads However during defibrillation you may choose to monitor the ECG using an alternate ECG source 3 or 5 Lead monitoring electrodes If an alternate ECG source is connected any available lead may be displayed Do not use medical gels or pastes of poor electrical conductivity Use only approved lead sets and monitoring electrodes with the HeartStart XL Failure to do so may introduce noise and result in intermittent Cannot Analyze ECG messages Code View 6 Manual Defibrillation Code View In Manual Defibrillation Mode when an energy is selected Code View is displayed Code View is optimized to clearly communicate data associated with a resuscitation event see Figure 49 Code related information in Code View includes Enlarged Wave Sector 1 The waveform in Wave Sector 1 is larger for easier viewing Shock Counter Displays the number of shocks for the current event including shocks delivered in AED Mode Selected Energy Displays the currently selected energy Wave Sector 2 Displays the currently configured waveform If Cascade is selected depending on the ECG size parts of the wave may be clipped due to the smaller sector size Patient Category Displays the current Patient Category The patient category triggers specific alarm limits and AED energy settings for defibrillation Figure 49
274. ync Shocks 0 Selected Energy 50 Joules Lit Syne button Cancel Charge 84 Delivering a Synchronized Shock 7 Cardioversion Delivering a Synchronized Shock To perform synchronized cardioversion 1 Turn the Therapy knob to the desired energy setting 2 Press the Sync button see Figure 1 on page 6 3 Confirm that the Sync button lights up the Sync indicator is present and R Wave arrows appear only with each R Wave R Wave arrows do not always appear at the peak of the R Wave but always appear on the R Wave Use the Lead Select button to change leads if the R Wave arrows do not appear correctly 4 Press the yellow Charge button on the HeartStart XL or if using paddles the yellow charge button located on the apex paddle You may increase or decrease the selected energy at any time during charging or after charging Move the Therapy knob to the desired energy level The HeartStart XL charges to the selected energy level automatically Wait until the charge reaches the selected energy level before proceeding If you need to disarm the defibrillator press the Cancel Charge soft key Also the defibrillator disarms automatically when the Shock button has not been pressed within the time period specified in the Time to Auto Disarm configuration setting 5 When the defibrillator has reached its charge level make sure no one is touching the patient or anything connected to the patient Call out clearly and loudly Stay Clear
275. ynchronized energy delivery used during cardioversion and asynchronous energy delivery used during defibrillation The Sync button lights blue when Sync is active Figure 24 Therapy Knob and Controls Energy 120 Therapy knob cma Charge button 4 ff Shock button Sync button pa Lights blue 7 when active Controls 3 Working with the HeartStart XL General Function Buttons The General Function buttons control monitoring or non critical resuscitation activity See Basic Orientation on page 6 for the location of the buttons and below for their definitions Lead Select Patient Category Menu Select Navigation Alarms Mark Event Reports Print Soft Keys LI Changes the ECG lead in Wave Sector 1 Pressing this button cycles through the available ECG waves changing the displayed wave and label The list of available ECG waves is based on the connected lead set and your device configuration including pads if the corresponding cable is connected See Lead Selection on page 47 Allows you to quickly change the patient category from adult 2 25kg or 2 8 years old to infant child lt 25kg or lt 8 years old and back again Pressing the Menu Select button displays the current menu or confirms a menu selection Pressing either Navigation button displays the current menu While within a menu or list pressing the buttons move the selection to the next or previous item on the list
276. you There are 18 letter limits for a first name and a last names 16 character limit for Patient ID 6 Ifyou are entering the Patient ID the Patient ID screen appears with a menu of letters and numbers to enter the patient s ID If you are entering the patient s sex the sex menu appears with Male and Female options to select If you are entering the patient s internal paced status the Paced Menu appears with Yes and No options Select Yes if the patient is paced and No if they are not paced NOTE It is important to set the patient s correct paced status in order to optimize ECG analysis Figure 38 Entering Patient Name Last Name Wa i Continued Use 3 Working with the HeartStart XL Continued Use Once in a clinical mode the Continued Use feature is activated This feature facilitates continued treatment of the same patient by retaining the current settings and patient record when the HeartStart XL is turned off for less than 10 seconds This could occur when turning the knob from Monitor Mode to AED Mode or when the Therapy knob is accidentally moved to the Off position If you turn the HeartStart XL back on within 10 seconds it retains the most recent e Alarm settings and conditions e Wave sector settings e Event timing e Volume settings e Vital Signs Trending data e Pacing settings e Synchronized Cardioversion settings e SpO value e NBP value and measureme
277. ys and to the left and right of the display Therapy Knob and Controls The HeartStart XL Therapy knob is customized for the options included in your device If you have the Pacing Option a Pacer knob position is included The knob enables AED Mode Pacing Mode Monitor Mode or selects an energy for Manual Defibrillation Mode defibrillation or cardioversion Regardless of the options the knob and controls function the same Turning the HeartStart XL on Grasp the Therapy knob and turn to the right for Monitor Mode Manual Defibrillation or Pacing turn to the left for AED Mode Charge button Charges the defibrillator to the selected Manual Defibrillation energy setting It is used only in Manual Defibrillation Mode The defibrillator charges automatically in AED Mode Shock button Delivers a shock through multifunction electrode pads or switchless internal paddles In Manual Defibrillation Mode the shock is delivered at the selected energy In AED Mode a 150J shock is delivered if the patient category is set to Adult 50J if set to Infant Child The button flashes when charged NOTE When external paddles or switched internal paddles internal paddles that have Shock buttons as opposed to switchless internal paddles where you administer the shock by pressing the Shock button on the device are used the HeartStart XL delivers a shock by pressing the Shock button s located on the paddles Sync button Toggles between s

HeartStart XL+ Defibrillator/Monitor Manual

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