Home

CU Medical Systems, Inc.

1. eene 78 7 Asynchronous Defibrillation in Manual Mode eene 80 7A OVERVIEW c ite s See D OE UEM MD ES 80 7 2 Patient Preparation cccceceeeee eee ee eee scene eee nemen 82 7 3 Analysis essct ee E V DUE DE ia Sail 83 7 4 Chargitig eus ee tree texere eda ta eles deret 83 725 SHOCK T 84 8 Synchronized Cardioversion esses nennen nnn 85 8 1 OVE SW varri diora de ode ex Rocco nde ex ende ee onde x odit A ond 85 8 2 Patient Preparation esses enm 85 8 3 Synchronization 5 5 eee eee e dre de xe ees 85 SAA Analysis io eeu dyes vx e xx eO Aon nt A X a ui Rd 85 8 5 Charging ien IRE RRQREXIDDRAR RE IRTM RI p NP A XI NY ERI 85 8 6 Shock sce reve Rx ven DR Vw ERR E E E ROI neu 86 9 ECG Monitoring In Manual Mode seseeeee nnnm 87 9 1 ECG Monitoring Mode sirieni a enemies 87 9 2 Patient Preparation is eie eise et eor epe RR ER EI RP ED ERE ents 87 9 3 ECG Monitoring err rexit eere tentes 87 CU ER3 Operator s Manual _ver 2 00 TO SPO2 Monitoring reor hh er nh t Rhe IR x dei ores 889 10 1 OVerVIGW ziii id da er qox Ex a y E XN SRA NERIS RAN AE AIRAN 889 10 2 Pulse Oximetry Sensors eesseeseeeenn nnns 90 10 3 Application and Connection of the Sensor 91 104 SPO2 MOhIEOFITIg enc eser errore mE Tee p Rn eRRF RT ERNES 91 10 5 Setting the Alarm e entr ere nee xa der ene d er
2. 25 CU ER3 Operator s Manual ver 2 00 Optional Accessories ECG Monitoring Cable and Connector Assembly The cable and connector assembly that must be used if it is desired to run the Paramedic CU ER3 in ECG monitoring mode ECG Monitoring Electrodes Used for the ECG Monitoring Cable and Connector Assembly Pa AS Y N Bs P Reduced energy Pediatric Defibrillator Electrode Pads The defibrillator electrode pads that must be used when the patient appears to be less than 8 years old or 25kg 55 Ib and the Paramedic CU ER3 is run in AED Mode Pediatric Defibrillator Electrode Pads Connector Adapter An adapter that enables you to connect the Reduced energy Pediatric Defibrillator Pads to the ECG DEFIB port of the Paramedic CU ER3 S NA SmartMedia Card Used for storage of rescue data ECG Rescue Event Highlights and Voice Only SMCs supplied by the manufacturer are compatible with the Paramedic CU ER3 Do not use any other kind of flash memory card 26 CU ER3 Operator s Manual ver 2 00 Optional Accessories continued A stand alone thermal printer that enables you to print the ECG and rescue data stored in the internal and removable flash memories of the Paramedic CU ER3 Cord Used to connect the device to a car cigar lighter jack for recharging the batteries In the emergency vehicle The batteries can be charged by connect
3. Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 4 Down Button REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW amp fo X Ho RETURN 5 Menu Button ECG REVIEW A N j A f A N N Aw NL 1113 gt PRESS THE MENU KEY TO RETURN 44 4 5 5 VOICE REVIEW VOICE REVIEW CU ER3 Operator s Manual _ver 2 00 e Plays back the voice recorded during a rescue operation e Works only if the SmartMedia Card is inserted Voice record can be stored only in the SmartMedia Card To access Voice Review turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 1 ON OFF Button DEVICE INFORMATION DEVICE HISTORY BATTERY HISTORY g x A g RETURN 2 Down Button REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW amp lh X E e RETURN 3 Menu Button REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW amp fo X Ho RETURN 45 Voice Review continued CU ER3 Operator s Manual _ver 2 00 Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 4 Down Button
4. a d REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 5 Down Button in X HO REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN Menu Button 6a SmartMedia Card is inserted amp fo X Eje VOICE REVIEW PRESS THE MENU KEY TO RETURN Menu Button 6b No SmartMedia card is inserted in X BO VOICE REVIEW NO DATA PRESS THE MENU KEY TO RETURN 46 4 5 6 GENERAL DEVICE SETUP GENERAL DEVICE SETUP CU ER3 Operator s Manual _ver 2 00 e enables you to change or adjust operating parameters such as date time and voice recording To access General Device Setup turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence ON OFF Button Menu DEVICE INFORMATION DEVICE HISTORY BATTERY HISTORY amp la X G el RETURN 2 Down Button REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW amp fa X EC e RETURN 3 Down Button DEVICE SETUP GENERAL ADMINISTRATION MONITOR RETURN amp lan XR e 47 General Device Setup continued CU ER3 Operator s Manual _ver 2 00 Press the following button s
5. Inspected by Signature of operator doing the inspection 107 CU ER3 Operator s Manual ver 2 00 12 3 Cleaning the Paramedic CU ER3 After each use clean the Paramedic CU ER3 using a soft damp cloth moistened with any of the following solvents Soap and water 70 solution isopropyl alcohol Chlorine bleach and water mixture 30 ml bleach liter of water Ammonia based cleaners Hydrogen peroxide Do not immerse any part of the Paramedic CU ER3 in fluids Do not let any fluid enter the case of the device Do not spill liquids on the case of the device Do not use strong acetone based cleaners in cleaning the device Do not use abrasive materials in cleaning the unit especially on the LCD display and the infrared filter on the IrDA port Do not sterilize the Paramedic CU ER3 108 CU ER3 Operator s Manual _ver 2 00 13 Troubleshooting 13 1 Self Tests The Paramedic CU ER3 executes automated and manual self tests to verify the functionality of its major subsystems The Paramedic CU ER3 raises alarms if it detects a fault during those self tests It raises more alarms when it is turned ON after a fault is detected Alarms Alarms raised after a failure is detected during Power On or Run Time Test 1 The Paramedic CU ER3 displays the error name and code on the LCD screen 2 The ERROR indicator light turns ON 3 The beeper emits short beeps at regular intervals Alarms raised after a fault is detected
6. 3 Introduction 3 1 Product Description The Paramedic CU ER3 is a portable external defibrillator with the following modes e Automated External Defibrillation AED Mode e Manual Mode In AED Mode the Paramedic CU ER3 analyzes the ECG of the patient to determine whether the patient has a shockable or nonshockable ECG rhythm In this mode the Paramedic CU ER3 provides you with voice and text prompts throughout a rescue operation In Manual Mode the Paramedic CU ER3 lets you control the defibrillation process You assess the ECG of the patient and set the energy of the shock to be delivered You may also perform synchronous cardioversion for the treatment of atrial fibrillation in this mode In synchronous cardioversion the defibrillating shock is delivered within 60 milliseconds of the occurrence of a QRS peak in the patient s ECG The Paramedic CU ER3 may also be used to do ECG monitoring only when it is in Manual mode ECG monitoring only is done by connecting the custom designed ECG monitoring cable assembly from CU Medical Systems Inc No shocks may be delivered when the ECG monitoring cable assembly is connected to the Paramedic CU ER3 The Paramedic CU ER3 uses two kinds of electrodes These are e Multifunction defibrillator electrode pads used for ECG acquisition and shock delivery These pads are used during rescue operations e ECG electrode pads used for ECG acquisition only together with the ECG monitoring cable and conn
7. Daily might have been generated For any other error messages during the Daily Periodic Self please call the manufacturer or its Test designated service center Check supplies accessories f p If any supplies have expired and spare parts for damage AE replace them immediately and expiration Initiate complete self test by If the self test detects any problem doing a Manual Self Test see the chapter on Troubleshooting Monthly and after each use Check the case of the Paramedic CU ER3 and the accessories for any sign of apparent damage Check for dirt contamination If there is any apparent damage to the case of the device consult the manufacturer If there is dirt contamination clean the case as suggested in the section on Cleaning After each use Ensure that the connector of the defibrillator pad assembly is disconnected from the ECG DEFIB port of the Paramedic CU ER3 Disconnect the pad assembly from the ECG DEFIB port 106 CU ER3 Operator s Manual _ver 2 00 MAINTENANCE CHECKLIST Paramedic CU ER3 Serial Number Location Vehicle ID Date Scheduled Frequency Paramedic CU ER3 Clean no signs of damage free of excessive wear Supplies Available 2 sets of defibrillator electrode pads undamaged sealed within expiration date supplementary supplies razor scissors gloves gauze Remarks Problems Corrective Actions
8. Heart Rate Both ECG and SPO2 ECG signal ECG only ECG signal SPO2 only SPO2 signal Indicates the basis of heart rate calculation Heart rate Icon Displayed Indication Calculation LI The heart rate is calculated from the ECG Source F signal Indicator Q The heart rate is calculated from the SPO2 Sensor signal Alarm Status Indicates the Alarm System status of the Paramedic CU ER3 Icon Displayed Indication CA Indicator Heart Rate and SPO2 Alarms are ON Ped Heart Rate and SPO2 Alarms are OFF Indicates the status of the alarm beeper Icon Displayed Indication The alarm beeper is OFF Alarm Beep NE When this is displayed the alarm function is Icon PN still ON but the beeper will not emit the alarm s sound Alarm indication is given through flashing text prompts d The alarm beeper is ON ECG Display Displays the ECG waveform of the patient Pleth Wave Display Displays the plethysmographic wave of the patient 31 CU ER3 Operator s Manual _ver 2 00 4 3 2 Screen Display Rescue Operation Ongoing AED Mode Heart Rate Shock Count Alarm Status Indicator Energy EE SPO2 Value ENERGY 150J Heart Rate Calculation Source Indicator ECG Display Chest Compression Breath ratio indicator Analyzing heart rhythm Battery Level l cPR30 2 00 00 15 4 Elapsed Indicator Time Text Prompt Manual Mode Heart Rate Calculation Source I
9. NOTICE Make sure that the SmartMedia Card is loaded before turning ON the device Do not pull out the SmartMedia Card before turning OFF the device Loading or pulling out the SmartMedia Card while the power is ON will cause data error and may damage the SmartMedia card 113 CU ER3 Operator s Manual _ver 2 00 Reviewing Data Using a SmartMedia Card After installing the SmartMedia Card turn ON the Paramedic CU ER3 Activate the menu by pressing the MENU button Go to REVIEW INCIDENT The following screen is displayed REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW fo X Eje RETURN 3 submenu listings Usage Review ECG Review Voice Review of the recorded incident data are then shown Scroll the highlighter bar through the choices Usage Review ECG Review Voice Review Press the MENU key to enter the chosen sublevel The data Usage ECG waveform voice will be displayed on the LCD or played back on the speaker You may scroll through the ECG and Event data by pressing the UP A or DOWN Y key 114 CU ER3 Operator s Manual ver 2 00 NOTICE When the SmartMedia Card is inserted into the Paramedic CU ER3 for recording of rescue data all the data present in the SmartMedia Card are overwritten with data from the current rescue operation The previous data are no longer retrievable To preserve data through a series of rescue operations the data must be transferred to a personal
10. 30 kg Index finger MAX AL disposable Adult gt 30 kg Index finger MAX P disposable Pediatric 10 50 kg Index finger MAX I disposable Infant 3 20 kg Great toe MAX N disposable Neonatal 3 kg Neonatal ball of the foot Adult Or gt 40 kg Adult index finger MAX R disposable adult gt 50 kg nose Adult gt 40kg index finger Neonate ae Pediatric 15 40kg index finger DURA Y Reusable Pediatric gt 1kg Infant 3 15kg great toe Adult Neonate 1 3kg ball of the foot DYSE EAR Reusable adult gt 30 kg Ear lobe and pinna CLIP DYSPD PED Reusable Pediatric 3 to 40 kg Index finger CLIP DS100A Reusable adult gt 40 kg Index finger Reusable sensors may be reused on different patients after cleaning and disinfecting Disposable sensors may be used only once NOTICE Only Nellcor SPO2 sensors Oximax are compatible with the Nellcor SPO2 module of the Paramedic CU ER3 Do not use any other sensors aside from the ones recommended Before using carefully read the OxiMax sensor directions for use including all warnings cautions and instructions 90 CU ER3 Operator s Manual ver 2 00 10 3 Application and Connection of the Sensor Apply the sensor to the site specified in the table in section 10 2 Connect the sensor cable to the SPO2 Sensor Port as shown in the following figure SPO2 Sensor Port As soon as the SPO2 Cable is connected the Paramedic CU ER3 acquires the SPO2 signal of t
11. fully charged NiMH internal battery pack depleted by 15 discharges at 150 Joules per discharge Less than 27 seconds Using new LiMnO battery pack depleted by 15 discharges at 150 Joules per discharge Less than 27 seconds Using AC power at 90 of rated mains voltage Less than 27 seconds Time from initially switching power ON to charge ready at 150 Joules using AC power at 90 of the rated mains voltage Less than 27 seconds Using AC power at 90 of the rated mains voltage 137 CU ER3 Operator s Manual _ver 2 00 AED Mode continued AED Energy Profile Fixed energy at 150 Joules Text and Voice Prompts Provided to user in every step of a rescue operation AED Controls Power On Off Pause Disarm Analyze Stop Analysis Pause Resume SHOCK Volume control Electroluminescent back lit Liquid Crystal Display for ECG waveform and Indicators Plethysmographic wave text prompts and Alarm indicators Charging complete text prompt Armed Continuous tone on beeper Indicators p Flashing red backlight of the SHOCK button Patient Analysis Detects and evaluates connection defibrillator electrode pads contact e Analyzes patient s ECG to determine if a shock is necessary impedance for proper Shockable rhythms Ventricular fibrillation and ventricular tachycardia with rates gt 150 bpm Sensitivity and Specificity Meets AAMI guide
12. Enter Menu Operation by selecting MENU in the MODE SELECTOR KNOB before turning the device ON Upon entering Menu Operation the Paramedic CU ER3 displays the following screen DEVICE INFORMATION DEVICE HISTORY E BATTERY HISTORY x A eg RETURN To navigate through the menu use the UP MENU and DOWN buttons on the keypad of the device The UP A key and DOWN V key are used for scrolling the menu highlight bar and the MENU key is used for selecting the highlighted option in the MENU There are 4 top level menus DEVICE INFORMATION REVIEW INCIDENT DEVICE SETUP COMMUNICATION 35 CU ER3 Operator s Manual _ver 2 00 4 5 1 Device History Device History contains the history of the device during its lifetime The following data are displayed on the LCD a number and total elapsed time of device usage b number of shocks delivered CG number and total elapsed time of trainings conducted using the device d number and total elapsed time of the different tests daily weekly monthly and manual tests To access Device History turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence DEVICE INFORMATION DEVICE HISTORY 1 ON OFF Button 58 BATTERY HISTORY o E e RETURN DEVICE INFOR
13. SETUP of the section on MENU OPERATION Proceed with data transmission as enumerated in the data transmission steps of section 14 3 1 IrDA port 117 CU ER3 Operator s Manual ver 2 00 14 4 Printing Using a Stand alone Serial Printer The UART port may also be used to transmit data to a stand alone serial printer Stand alone Serial Thermal Printer The optional stand alone printer is a serial printer configured to receive data using RS232 protocol Zz 4 Printer Paper bd Feed Button gt 4 Power Switch UART Port connector Stand alone Thermal Printer Power Switch Used to turn the printer ON or OFF Feed Button Used to advance the printer paper UART Port Used to connect the printer to the UART Port of the Paramedic Connector CU ER3 The printer is powered by the Paramedic CU ER3 through the UART Port Connector 118 CU ER3 Operator s Manual ver 2 00 Loading Paper into the Printer a Open the paper compartment of the printer by pushing the locks inward simultaneously When the locks are disengaged pull the paper compartment lid upward This is shown in the following figure Push b Place a roll of printer paper into the compartment The printing surface must face the paper cutter of the printer C Close down the lid of the printer paper compartment Allow around 1 4 inch of printer paper to go past the paper cutt
14. Semi automatic Waveform Manual and e cube biphasic Truncated exponential type impedance AED Modes compensated Shock Delivery Via multi function defibrillator electrode pads Patient Impedance Range Manual and AED 25Q to 175Q Modes Delivered Energy Joules VS Load Impedance 9 Selected Load Impedance Ohms Energy Accuracy Q 25 50 75 100 125 150 175 2 2 2 2 2 2 2 2 x1 J 3 3 3 3 3 3 3 3 1 5 5 5 5 5 5 5 5 2 J 7 7 7 7 7 7 7 7 2 J 10 10 10 10 10 10 10 10 2 J 20 20 20 20 20 20 20 20 4 30 30 30 30 30 30 30 30 15 50 50 50 50 50 50 50 50 15 96 70 70 70 70 70 70 70 70 15 96 100 100 100 100 100 100 100 100 15 96 150 150 150 150 150 150 150 150 15 96 200 200 200 200 200 200 200 200 X15 96 135 Manual Mode CU ER3 Operator s Manual _ver 2 00 Charging Time 200 Joules Less than 11 seconds Using new fully charged NiMH internal battery pack Less than 10 seconds Using new disposable external LiMnO2 battery pack Less than 11 seconds Using AC power at 100 of rated mains voltage Less than 11 seconds Using new fully charged NiMH internal battery pack depleted by 15 discharges at 200 Joules per discharge Less than 10 seconds Using new LiMnO battery pack depleted by 15 discharges at 200 Joules per discharge Less than 11 seconds Using AC power at 90 of rated mains v
15. Text Do compression by pushing the chest down fast two inches GIVE TWO BREATHS Voice and Text Indicates that you must give respiration to the patient BREATH BREATH Voice Guides you with on the correct respiration delivery rhythm NO SHOCK ADVISED Indicates that the patient has a non shockable ECG rhythm CHECK PULSE Voice and Text You must check the pulse of the patient IF NO PULSE BEGIN CPR Voice and Text If there is no pulse you must begin CPR THE SHOCK BUTTON WAS NOT PRESSED Voice and Text Indicates that a shockable rhythm has been detected and a prompt to press the SHOCK button has been given but the SHOCK button is not pressed within 15 seconds The device will discharge through internal circuit Then re analyze and defibrillate if indicated CHECK PATIENT IF NO PULSE PRESS ANALYZE Text The Paramedic CU ER3 uses this prompt when it is set to NO AUTOMATIC REANALYSIS MODE in AED Mode You must press the ANALYZE CHARGE button to initiate an analysis of the patient s ECG ECG MONITORING MODE Text This indicates that the custom designed ECG MONITORING CABLE AND CONNECTOR ASSEMBLY is attached to the ECG DEFIB port In this mode the Paramedic CU ER3 can do only acquisition and display of ECG It does not analyze the ECG for a shockable rhythm and it can not deliver a defibrillating shock 34 CU ER3 Operator s Manual _ver 2 00 4 5 Menu Operation
16. The voice and text prompt PUSH THE CHEST DOWN FAST TWO INCHES A CYCLE NO and COMPRESSION NO indicator keeps track of the progress of the CPR This is shown in the figure above 6 Beat guide from the beeper accompanies the CYCLE NO and COMPRESSION NO indicator 7 The Paramedic CU ER3 lets you perform 5 cycles of CPR After the administration of CPR the Paramedic CU ER3 goes into another cycle of ECG acquisition and analysis OT Ne 77 CU ER3 Operator s Manual _ver 2 00 6 3 AED NO Automatic Reanalysis Mode The Paramedic CU ER3 is in NO Automatic Reanalysis Mode if it has been set for NO automatic reanalysis see section 4 5 7 1 Insert the SmartMedia Card into port optional Select AED ON on the mode selector knob Turn the Paramedic CU ER3 ON If patient is e Not responsive e Not breathing e Pulseless Attach pads Press ANALYZE SHOCK advised NO YES Press SHOCK button Administer CPR Administer CPR 78 CU ER3 Operator s Manual ver 2 00 Rescue Operation in NO Automatic Reanalysis Mode The Rescue Protocol in NO Automatic Reanalysis Mode is similar to the Rescue Protocol in Automatic Reanalysis Mode except for the following differences e You must press the ANALYZE button in order for the Paramedic CU ER3 to begin analysis of the patient s ECG Pressing the ANALYZE button initiates a single round of analysis and shock delivery Also in this mode you are afforded
17. This time is accumulated from the time the Paramedic CU ER3 is first used Only the elapsed time when the Paramedic CU ER3 is powered ON is counted STATUS Battery power state Indicates the power level of the internal battery pack If the Status indicates LOW recharge the internal battery pack 39 4 5 3 USAGE REVIEW CU ER3 Operator s Manual _ver 2 00 USAGE REVIEW displays the list of Rescue Events recorded together with their time stamp The list of Rescue Events is given in the following table Name of Event Event Power ON Indicates the time when the Paramedic CU ER3 is turned ON Power OFF Indicates the time when the Paramedic CU ER3 is turned OFF Pads ON Indicates the time when the defibrillator electrode pads are connected to the Paramedic CU ER3 Pads OFF Indicates the time when the defibrillator electrode pads are disconnected from the Paramedic CU ER3 Aired Indicates the time when the defibrillating capacitor of the Paramedic CU ER3 is fully charged Indicates the time when the charge in the defibrillating capacitor is dumped to the internal dump resistance of the Diarmgd Paramedic CU ER3 The charge in the defibrillating capacitor is automatically dumped when the SHOCK button is not pressed within 15 seconds after the prompt to press the SHOCK button is given Shock X Indicates the time when the Xth shock is delivered by the Paramedic CU ER3 Indicates the time when the Paramedic C
18. USING THE PARAMEDIC CU ER3 14 2 1 Internal Flash Memory Data from the latest rescue operation is stored in the internal flash memory of the Paramedic CU ERS3 if the SmartMedia Card is not present in its port The data stored in the internal flash memory may be displayed and reviewed on the LCD screen of the device To review the stored data perform the following steps a Turn the Paramedic CU ER3 ON without inserting the SmartMedia Card b Activate the menu by turning the Paramedic CU ER3 with the selector knob set to MENU and go to REVIEW INCIDENT USAGE REVIEW or REVIEW INCIDENT ECG REVIEW 14 2 2 SmartMedia Card Optional Accessory Data from the latest rescue operation is stored in the SmartMedia flash memory card if it is installed in its port before the Paramedic CU ER3 is turned ON Installation of a SmartMedia Card a Ensure that the SmartMedia Card is clean and dry b Turn the Paramedic CU ER3 OFF C Load the SmartMedia Card with the metallic strip facing down and the notched end going in first Push the card all the way in until the card hits a stop The SmartMedia Card is ready to record data when the Paramedic CU ERS is turned ON for use d Only SmartMedia Cards supplied by CU Medical Systems Inc are compatible with the Paramedic CU ER3 Do not use any other kind of flash memory card Removal of a SmartMedia Card a Turn the Paramedic CU ERS3 OFF b Pull out the SmartMedia Card from the SmartMedia Card port
19. battery condition is detected it does the following a Display the text prompt LOW BATTERY CODE 0001 b Turn the ERROR indicator light ON c Emit short beeps at a regular interval When the Paramedic CU ER3 displays the flashing empty battery icon have its internal battery pack recharged immediately Do not wait for the voltage level to fall below the minimum tolerable voltage level because the Paramedic CU ER3 will be inoperative 11 2 2 Recharging of the Internal Battery Pack There are two ways to recharge the internal battery pack a Using the AC DC adapter b Using the Car Cigar Lighter Jack Power Cord Recharging Using the AC DC adapter The internal battery pack is recharged by connecting the AC DC adapter output to the AC DC adapter port of the Paramedic CU ER3 The AC DC adapter is powered through the AC mains with the following specifications a Frequency 50Hz to 60Hz b Voltage 100V to 240V Minimum recharging time is 4 hours When the battery is fully charged the Paramedic CU ER3 automatically shuts down the recharging system thus you do not have to worry about overcharging the battery pack However the AC DC adapter must be pulled off the mains when recharging is over Recharging Using the Car Cigar Lighter Jack Power Cord a Turn the engine of the vehicle ON b Connect the appropriate end of the cigar lighter jack power cord to the cigar lighter jack of the vehicle c Connect the other end of the p
20. detect and display measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream Each time the Paramedic CU ER3 is used to monitor SPO2 check alarm limits to ensure that they are appropriate for the patient being monitored Do not attach any cable that is intended for computer use to the SPO2 sensor port of the Paramedic CU ER3 Tissue damage can be caused by incorrect application or duration of use of an SPO2 OxiMax sensor Inspect the OxiMax sensor site periodically as directed in the OxiMax sensor directions for use Do not immerse or wet the OxiMax sensor If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the pulse oximeter is functioning properly To get an accurate reading see to it that there is no excessive motion from the patient and that the sensor is applied properly Do not place the sensor on an extremity that has a blood pressure cuff arterial catheter or intravascular line 95 CU ER3 Operator s Manual ver 2 00 11 Power Supply 11 1 Power Sources The Paramedic CU ER3 may be powered by the following power sources Internal Battery Pack External Battery Pack AC DC Adapter mains powered Car Cigar Lighter Jack anov 11 2 Internal Battery Pack The default power supply of the Paramedic CU ER3 is its internal batt
21. device 12 CU ER3 Operator s Manual _ver 2 00 2 Device Operation Guidelines 2 1 General Guidelines Do not operate or store the device in conditions that are beyond the following specified limits Operating Conditions Temperature 32 F to 104 F 0 C to 40 C Humidity 5 to 95 non condensing Standby conditions Stored with defibrillator electrode pads ready for rescue Temperature Humidity 32 F to 109 F 0 C to 43 C 5 to 95 non condensing Storage Conditions Device only no defibrillator electrode pads Temperature Humidity 4 F to 140 F 20 C to 60 C 5 to 95 non condensing Do not store the device in areas that are directly exposed to sunlight y Do not store the device in areas with highly fluctuating temperatures Do not store the device near heating equipment or appliances Do not store the device in areas where there is high vibration in excess of Category 10 of MIL STD 810F Method 514 5 Do not operate or store the device in environments with high concentration of flammable gas anesthetics or other flammable chemicals 4 Do not operate or store the device in areas with high concentration of dust L Only personnel authorized by the manufacturer may open the device for servicing There are no user serviceable components inside the device 13 CU ER3 Operator s Manual ver 2 00 There is a possibility
22. e There are no known contraindications to ECG Monitoring In AED Mode The Paramedic CU ER3 may be used on children from 1 to 8 years old or under 25kg 55 Ib in weight If the patient appears to be from 1 to 8 years old or less than 25kg 55 Ib use the reduced energy defibrillator pads For children older than 8 years old the American Heart Association recommends using the adult Chain of Survival and resuscitation sequence Part 3 Overview of CPR 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation CPR and Emergency Cardiovascular Care ECC In Manual Mode Clinicians must select an appropriate level for patients under 8 years old 17 CU ER3 Operator s Manual _ver 2 00 3 3 Intended Users The Paramedic CU ER3 is intended for use by emergency rescue organizations 3 3 1 AED Mode In AED Mode the Paramedic CU ER3 is intended for use by emergency rescue personnel who have been trained in basic life support that includes the use of AEDs 3 3 2 Manual Mode In Manual Mode the Paramedic CU ER3 is intended for use by health care professionals and emergency rescue personnel who have been trained in advanced cardiac life support In this mode the user must know how to interpret ECGs 18 CU ER3 Operator s Manual ver 2 00 4 Operating Controls Indicators and Accessories 4 1 Device Parts Illustration ON OFF Switch Quick Reference Guide LCD Screen ECG DEFIB ANALYZE CHARGE Bu
23. eN cube Biphasic Technology Pup gt 1 What is Defibrillation Sudden cardiac arrest SCA associated with ventricular fibrillation VF remains a leading cause of unexpected death in the Western world It has been estimated that chances for survival from SCA decrease approximately 7 to 10 with each passing minute and that survival rates after 12 minutes are only 2 to 5 The most common cause of SCA is ventricular fibrillation VF a lethal heart rhythm and survival depends on the rapid treatment called de fibrillation an electrical shock sent to the heart to resume normal and healthy heart rhythm So early defibrillation is the sole definitive determinant of survival and is the key factor in cardiopulmonary resuscitation Currently fewer than 5 of the 250 000 persons who experience out of hospital cardiac arrest each year survive to hospital discharge 2 How does cube Biphasic waveform Defibrillate For defibrillation to be successful a sufficient amount of electrical current must be delivered to the heart muscle How to deliver the electrical current to the heart muscle is the core technique to defibrillate the heart Successful defibrillation would be done when the cell membranes of the heart are coated with positive ions on one side and negative ions on the other side enough to depolarize nearly 100 percent of the cardiac cells at the same instant Optimal current is determined with the pressure this means electric V
24. input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ur 29596 dip in Ur for 0 5 cycles 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Uy for 25 cycles 5 Ur gt 95 dip in Ur for 0 5 cycles 5 96 Ur 29596 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Uy for 25 cycles 5 Ur gt 95 dip in Ur for 0 5 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the Paramedic CU ER3 requires continued operation during power mains interruptions it is recommended that the Paramedic CU ER3 be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 144 CU ER3 Operator s Manual _ver 2 00 Guidance and manufacturer s declaration electromagnetic immunity for LIFE SUPPORTING EQUIPMENT and SY
25. is monitored by the Paramedic CU ER3 The status of the external battery pack is indicated by the battery status icon which is displayed on the LCD screen during operation See section 4 3 for the explanation of the battery status icon Connecting the External Battery Pack to the Paramedic CU ER3 a Turn the Paramedic CU ER3 OFF b Connect the connector of the battery pack to the AC DC Adapter and UART ports of the Paramedic CU ER3 c Turn the Paramedic CU ER3 ON If the external battery pack is connected while the Paramedic CU ER3 is ON the Paramedic CU ER3 automatically switches its power supply circuit to use the external battery pack The external battery pack is non rechargeable Recharging poses risks of fire heat generation leakage or bursting Read the instructions on the installation usage and storage of the external disposable battery pack on this User s Manual before the said battery pack Do not open the case of the battery pack Do not saw or break apart the case of the battery pack Do not let the battery pack come into contact with open flames and other hot objects Do not dispose of in fire Do not short circuit the terminals of the battery pack Do not subject the battery pack to serious physical impact Do not hit it with a hammer In case of leakage or strange smell keep away from fire to prevent ignition of any leaked electrolyte Keep the battery pack out of children s reach If the battery pack leaks
26. little current to the myocardial tissue cells will not depolarize the cells and result in an unsuccessful defibrillation Impedance distribution 60 50 40 30 eo eo 6 8 amp Impedance v 2 amp vu g 125 CU ER3 Operator s Manual _ver 2 00 cube Biphasic technology 1 makes it easy to compensate the shock waveform to match the patient s impedance 2 is more efficient than monophasic technology 3 delivers enough energy for restoring heart rhythm 1 Gase in compensation of patient impedance variance 50 40 4 Through e cube Biphasic technology defibrillation shock delivery is controlled while taking into consideration the patient s impedance The patient s impedance is measured through the defibrillator electrodes According to the measured patient s impedance e cube Biphasic technology 10 adjusts the duration of current flow to optimize the 20 4 effectiveness of the shock delivery E cube Biphasic technology is based on 3 core technologies 9 4 8 12 Time msec 30 4 20 4 Current amps 150 Joules at 50 Ohms Time msec 1 The technology for measuring the patient s impedance 2 The technology for controlling the voltage level to be delivered 3 The technology for controlling the duration of current flow These technologies can adjust the parameters of the shock waveform to match the transthoracic impedance of the patient E cube Biph
27. n et 93 10 6 Responding to an Alarm n sssssssssssrsssrnssrrrrsrrrrsrnnnnrrnnernnnernn 93 10 7 SPO2 Monitoring Notes and Warnings seesseeese 94 LI iPower SUPPIY Aas TEE er ex x RE ERR E REA 96 T11 1 Power SOURCES oue regne nexu nre xit Y xix i a eT 96 11 2 Internal Battery Pack sssessesseeeeenen nnns 96 11 3 External Battery Pack eseessesseeseeee nennen nnns 99 11 4 AC DC Adapter ssssssessseeseee se enne ana 101 11 5 Car Cigar Lighter Jack sessssesene 102 12 Testing Maintenance And Troubleshooting ueeseeees 103 LD MED EE 103 12 1 1 Automatic Self Tests ccccccceceeeeeeeeeeeeeeeeeaeeneeas 103 12 1 2 Power On Self Test ssesssseeeeeen nnns 103 12 1 3 Periodic Self Tests s ssssssrrsessrrrrrrssrerrsrrressns 104 12 1 4 Run Time Self Test eessesseseeeeenen nnn 104 12 1 5 Manual Self Test cessessesseeseeeeeneen nennen nnn 105 12 2 Maintenance leid den eiie ep na EEEIEE ERRIERTA eR YR IR EREI 105 12 3 Cleaning the Paramedic CU ER3 cecceceeeeeee teens eee es 108 13 Troubleshootilig oorr ptc epe bite t pa rere eda 109 13 1 Self Tests uc uei RR 109 13 2 Prompts During Rescue Operation eeeeeeeeees 111 14 Data Management and Review sessessesseenen nnnm 112 14 1 OVerVIeW E E E rk Rr re vex vere indices vede edis 112 14 2 Data Review Usin
28. s in sequence COMMUNICATION DATA TRANSMISSION 7 DOWN Button DATA RECEPTION PRINT e RETURN The data transmission and printing processes are discussed thoroughly in Chapter 14 Data Management and Review 4 5 10 RETURN To return to a higher level in the MENU system during menu operation highlight the RETURN option or icon then press the MENU button You will then be taken to the next higher level in the system If you are in the highest sublevel highlighting the RETURN icon and then pressing the MENU button turns the Paramedic CU ER3 OFF 4 5 11 Speaker Volume Adjustment In AED Mode the volume of the speaker of the Paramedic CU ER3 may be adjusted by pressing the UP or DOWN Menu button while it is in operation Pressing the UP button increases the volume while pressing the DOWN button decreases the volume The volume level is shown by an icon on the screen display This is shown in the following figure BO oo Peer AMAN PINSIH e PII esr Analyzing heart rhythm Volume level icon dH CPR 30 2 nnnilill 00 00 15 65 CU ER3 Operator s Manual ver 2 00 5 Device Setup and Storage 5 1 Unpacking e Carefully inspect the packing container and the device for any damage that might have been sustained during shipping e Check the shipping list to ensure that the unit comes with the complete accessories It is important to have all the necessary accessories all t
29. the SHOCK button 136 Manual Mode continued CU ER3 Operator s Manual _ver 2 00 Energy Selection Mode Energy Selector Knob Charge Control ANALYZE CHARGE Button Shock Control SHOCK button Synchronizer SYNC message appears on the LCD Audible beep when R wave is detected Tick mark R wave marker on the LCD screen Shock is delivered within 60 ms of an R wave occurrence AED Mode Less than 9 Seconds Using new fully charged NiMH internal battery pack Time from activation of ae 9 Using new disposable external LiMnO2 battery pack RHYTHM RECOGNITION Less than 3 Using AC power at 100 of rated mains voltage DETECTOR to seconds the Less than 9 Using new fully charged NiMH internal battery pack DEFIBRILLATOR seconds depleted by 15 discharges at 150 Joules per discharge being ready for discharge at Less than 9 Using new LiMnO battery pack depleted by 15 150 Joules seconds discharges at 150 Joules per discharge Less than 9 Using AC power at 90 of rated mains voltage seconds Less than 27 Seconds Using new fully charged NiMH internal battery pack bess tham Using new disposable external LiMnO2 battery pack seconds Time from initially mi zi Using AC power at 100 of rated mains voltage switching power ON or from within any OPERATOR programming mode to the DEFIBRILLATOR being ready at 150 Joules Less than 27 seconds Using new
30. this icon is shown a progress bar is also shown underneath the Paramedic CU ER3 icon The attempt to make a connection has failed When this is shown the Communication icon also stops moving the a um arrow tips Attempts to establish a connection is stopped if no connection is made in 1 minute This icon is also shown if data transfer is cancelled due to interference The progress of the data transmission is tracked by a progress bar in the LCD display of the Paramedic CU ER3 5 The order of device activation may also be reversed It is possible to set the Paramedic CU ER3 first to transmit data and then set the CU Expert to receive data 6 When the data transmission is completed the CU Expert ECG Data Management Software prompts you about the completion of the transmission The completion of the data transmission is also shown by a full progress bar in the LCD display of the Paramedic CU ER3 7 When the transmission is finished the Paramedic CU ER3 may be turned OFF 14 3 2 UART Port The UART port may be used to transmit data to a PC running the CU Expert ECG Data Management Software Connect the Paramedic CU ER3 to the PC as specified in the User s Manual of the CU Expert Data Management Software Insert the SmartMedia Card if the data to be transferred is in the SmartMedia Card The Paramedic CU ER3 must be set to communicate through its UART port by setting the COM PORT to UART as outlined in the GENERAL DEVICE
31. 0 of full level DI icm Battery level 1096 of full level When this is displayed the battery pack must be replaced Do not wait for the battery pack to be drained below the level where the Paramedic CU ER3 could not operate anymore The time that elapsed since the Paramedic CU ER3 was turned ON Elapsed time during the current rescue operation Chest This is the indicator on the screen that tells you the current setting of Compression the chest compression breath ratio Breath ratio indicator Energy indicates the amount of energy to be delivered to the patient indicates the number of shocks that have been delivered during the Shock Count rescue session SPO2 Value Indicates the Oxygen saturation of the patient s arterial hemoglobin Designate which among the following keys is are currently active e CHARGE ANALYZE e SYNC e PAUSE DISARM Key Labels 30 CU ER3 Operator s Manual _ver 2 00 Initial Screen Display Legend continued Text Prompt Indicates actions that state of the sensors in you need to do in AED Mode or indicates the Manual Mode SYNC Indicates that the shock delivery will be synchronized with the R wave Indicator of the patient indicates the heart rate of the patient in beats per minute BPM Derived from either the ECG signal or the SPO2 sensor signal Signals present Heart rate calculation is based on
32. 00 12 1 3 Periodic Self Tests When the Paramedic CU ER3 is stored with a charged battery pack connected to it it performs periodic self tests to ensure that it is ready for use in emergencies Three types of periodic self tests are done These are a Daily Periodic Self Test this is done daily The following are checked during this test i Battery capacity This test is the same as the one done during power on self test When the device is turned ON if the LOW BATTERY CODE 0001 message is displayed on the LCD screen recharge the battery ii RAM same test as the one done during Power On Test iii RTC same test as the one done during Power On Test b Weekly Periodic Self Test This is done weekly i All the subsystems tested under the Daily Periodic Self Test ii Read Only Memory test verifies the functionality of the read only flash memories iii High Voltage Subsystem test tests the critical components of the high voltage subsystem These are the SCR silicon controlled rectifier and IGBT insulated gate bipolar transistor switches in the H bridge circuit that controls the discharging of the defibrillating capacitor the comparator that checks the voltage level of the defibrillating capacitor the internal load dumping components and the relay that connects the front end amplifier high voltage circuit and the patient iv Impedance Calibration Test same test as the one done during Power On Test v RTC same tes
33. 1 Mechanical Strength Vibration Meets MIL STD 810E Method 514 4 Category 10 Meets IEC 60601 1 clause 44 Overflow spillage Sealing leakage humidity ingress of liquids cleaning sterilization and disinfection ESD Meets IEC 61000 4 2 2001 EMI Radiated Meets IEC 60601 1 2 limits method EN 55011 1998 A1 1999 A2 2002 Group 1 Class B EMI Immunity Meets IEC 60601 1 2 limits method EN 61000 4 3 2001 Level 3 10V m 80MHz to 2500MHz 133 Arrhythmia Detector Performance CU ER3 Operator s Manual _ver 2 00 ECG Analysis System ECG Database Test ECG m Test 90 One Rhythm Rhythms Minimum test Performance sample Shock No Shock Observed Sided Lower y sample size goal 3 Decision Decision Performance Confidence Class size Limit 97 26 pees 200 Bais 219 213 6 213 219 95 m y sensitivity O 75 81 02 5 Fast VT 50 amp ensitivi 137 111 26 111 137 76 y sensitivity Normal 100 gt 99 100 Sinus minimum E ecificit 100 0 100 100 100 97 Rhythm arbitrary p y specificity AESBS S VT heart 99 54 o 30 9596 e block poe 219 1 218 218 219 98 i idioven arbitrary specificity specificity 5 tricular gt PVC s gt 95 96 21 Asystole 100 ms ficit 132 5 127 127 132 93 P y specificity 134 CU ER3 Operator s Manual _ver 2 00 Defibrillator Category Nominal Specifications Operating Modes Manual
34. 3 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 145 CU ER3 Operator s Manual _ver 2 00 Recommended separation distances between portable and mobile RF communications equipment and the Paramedic CU ER3 LIFE SUPPORTING FUNCTIONS Recommended separation distances between portable and mobile RF communications equipment and the Paramedic CU ER3 The Paramedic CU ER3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Paramedic CU ER3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Paramedic CU ER3 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated m Mis 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2 5 of transmitter outside ISM bands in ISM bands MHz GHz Ww d 1 16JP d 12JP d 12JP d 2 3VP 0 01 0 116 m 0 12 m 0 12 m 0 23 m 0 1 0 37 m 0 38 m 0 38 m 0 73 m 1 1 16 m 1 2 m 1 2 m 2 3m 10 3 67 m 3 79 m 3 79 m 7 27 m 100 11 6m 12m 12m 23m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of th
35. 5729 email address sales cu911 com Service Request and Technical Support Customer Service Team CU Medical Systems Inc Medical Industry Complex Bldg No 2 1720 26 Taejang dong Wonju si Gangwon do 220 120 Republic of Korea Tel 82 33 747 7690 Fax 82 33 747 7659 email address service cu911 com Our website http www cu911 com EU Authorized Representative of CU Medical Systems Inc A M I Italia s r l Via Cupa Reginella N 17A 80010 Quarto Napoli Italy Tel No 0039 0 81 806 34 75 0039 0 81 806 34 75 Fax No 0039 0 81 876 47 69 Email info amitaliasrl it Website www amitaliasrl it 11 CU ER3 Operator s Manual ver 2 00 1 How to Use This Manual 1 1 Contents of This Manual This Operator s Manual contains all the information a user needs to operate the Paramedic CU ER3 properly In case you have any problems regarding the operation of the device please don t hesitate to contact the manufacturer 1 2 Manual Conventions This Operator s Manual uses the following conventions Conditions hazards or unsafe practices that can result in serious personal injury or loss of life Conditions hazards or unsafe practices that can result in minor or moderate personal injury damage to the device or loss of data stored in the device particularly if precautionary steps are not taken NOTICE Used to denote items that are important during installation operation or maintenance of the
36. AIN or Volume setting by pressing the Menu button while ECG GAIN or Volume is highlighted respectively When the parameter variable is highlighted change its value by pressing the UP or DOWN button The possible ECG GAIN values are a 5 mm mV b 10 mm mV c 20 mm mV d AUTO AUTO displays the ECG autoscaled 0 3 to 1 mV signals are displayed with 10mm mvV gain outside of that range the peak to peak value is displayed as 10 mm on the LCD display Volume Setting Values Highest Volume 32 Lowest Volume 0 55 CU ER3 Operator s Manual _ver 2 00 4 5 7 3 Password The Password Menu enables you to change the password for the Manual Mode and to set the Manual Mode Security ON or OFF Setting the Manual Mode Security ON makes the device ask for the Password before you can operate it in Manual Mode Enter a new password by entering any combination of the UP MENU and DOWN keys Four characters are necessary for a single password 1 character 1 key press To access the Password Menu access the Device Setup Administration Menu by pressing the keypad keys as shown in 4 5 7 Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence ADMINISTRATION k AED SETTINGS O GENERAL SETTINGS 1to10 Key sequence in 4 5 7 plus A PASSWORD assword ads g RETURN Upon entering the correct password this screen is displayed ADMINISTRATION AED SETTINGS 2
37. CU s Emergency Responder 3 CU ERS Operator s Manual 9 CU Medical Systems Inc Medical Systems Inc CU ER3 Operator s Manual ver 2 00 Paramedic CU ER3 Quick Reference Card Patient is Unconscious Not Breathing Without a Pulse CU ER3 Operator s Manual _ver 2 00 Notice Paramedic CU ER3 Operator s Manual CU Medical Systems Inc reserves the right to make changes on the device specifications contained in this manual at any time without prior notice or obligation to customers Printed in the Republic of Korea Publication Date April 2006 Operator s Manual Part No CU ER3 version 2 00 2006 CU Medical Systems Inc No part of this manual may be reproduced without the permission of CU Medical Systems Inc CU ER3 Operator s Manual _ver 2 00 TABLE OF CONTENTS Table Of Contents 5 irte xt x AE AREE ANE enr cde TER UE EE 4 ied T A E E ATTE TAA A PI E A A A 8 Warranty ees anran eraan ceed dediak xU aE ATEENA NAANA NETE E NANNE SENE 9 Warranty Disclaimer esses 9 SORVIGCE is EE 10 Contact rs EE 11 1 How to Use This Manual esssessseeee meme me menm 12 1 1 Contents of This Manual cesses nmn nnns 12 1 2 Manual Conventos reari aee er EE oct ta ee eame oud dx ee eu aie eeu 12 2 Device Operation Guidelines eese 13 2 1 General GuldelineS 5 2 e iiie eee ERI IE ARR CSRRDE Gees ben 13 2 2 Electrical Safety Guidelines sssss
38. Class B CISPR 11 Harmonic Class A The Paramedic CU ER3 is suitable for use in all Emissions establishments including domestic establishments and those directly connected to IEC 61000 3 2 the public low voltage power supply network that i supplies buildings used for domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 The Paramedic CU ER3 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Paramedic CU ER3 should be observed to verify normal operation in the configuration in which it will be used 143 CU ER3 Operator s Manual _ver 2 00 Guidance and manufacturer s declaration electromagnetic immunity The Paramedic CU ER3 is intended for use in the electromagnetic environment specified below The customer or the user of the Paramedic CU ERS should assure that it is used in such an environment Immunity Test IEC 60601 1 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact X8 kV air 6 kV contact X8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 95 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for
39. Down Button WER PASSWORD RETURN amp fh FJ e 56 CU ER3 Operator s Manual _ver 2 00 Password Menu continued Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence ADMINISTRATION Os AED SETTINGS 3 Down Button M GENERAL SETTINGS a g RETURN PASSWORD Enter New Password C A 4 M Butt ee Manual Mode Security ON oa e PASSWORD want Enter New Password A sequence of four EEE 5 keys to implement the i d that denas BETA Manual Mode Security EN JH J When the new password is keyed in the field of the Manual Mode Security variable is highlighted Cycle through the choices by pressing the UP or DOWN key button The possible values are Manual Mode Security ON When the Paramedic CU ER3 is turned ON in Manual Mode it prompts for the password before you can proceed with the rescue operation Manual Mode Security OFF When the Paramedic CU ER3 is turned ON in Manual Mode it does not prompt you for the password and it enters Manual Rescue Mode immediately 57 Password Menu continued CU ER3 Operator s Manual _ver 2 00 Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence Either UP button or DOWN button to set the Manual Mode Security OFF or ON am
40. EFIB port of the Paramedic assembly connector is connected to the ECG this prompt is CU ER3 DEFIB port of the Paramedic CU ER3 given if the Paramedic CU Remedial Action Attach the defibrillator ER3 is in electrode pads firmly to the patient s skin The sticky side should be in contact with the patient s skin Remedial Action Make sure that the defibrillator electrode pads are not touching each other DISCONNECTED PROBE PROBE OFF The SPO2 sensor is disconnected from the SPO2 Sensor Port The SPO2 sensor is connected to the SPO2 Sensor Port but it is not connected to the patient Remedial Action Connect the SPO2 sensor to the SPO2 Sensor Port Remedial Action Connect the SPO2 sensor to the patient 111 CU ER3 Operator s Manual ver 2 00 14 Data Management and Review 14 1 Overview The Paramedic CU ER3 stores the following rescue operation data 1 ECG data the ECG signal acquired from the patient during an entire rescue operation 2 Rescue Events Data the significant events during a rescue operation These include events such as POWER ON PADS ON etc These events are recommended for recording by the AAMI DF39 Standard 3 Audio Signal Data this is a recording of the audio signals in the vicinity of the rescue operation These include the voice prompts given by the device and the audio signals generated by sources close to the rescue operation e g voice of the rescue administrator The
41. ER3 displays the following screen s in sequence 4 Menu Button amp fo X Hho USAGE REVIEW 22 00 00 03 22 7 Sep 2003 ELAPSED TIME TOTAL SHOCKS 3 DETAILED REVIEW RETURN 5 Menu Button amp fh X EJ e gt ANALYZING USAGE REVIEW POWER ON 00 00 00 PADS ON 00 00 02 00 00 05 00 00 08 00 00 17 1 2 SHOCK ADVISED ARMED RETURN 42 4 5 4 ECG REVIEW ECG REVIEW CU ER3 Operator s Manual _ver 2 00 e Displays the ECG record stored in the internal memory or the SmartMedia Card memory e ECG data from the latest rescue operation can be scrolled to the right or to the left earlier or later part of the recording respectively e Scroll the data by pushing the UP or DOWN arrow button To access ECG Review turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence DEVICE INFORMATION DEVICE HISTORY 1 ON OFF Button BATTERY HISTORY H rA RETURN REVIEW INCIDENT USAGE REVIEW 0 2 Down Button ECG REVIEW B VOICE REVIEW e RETURN 3 Menu Button in X No REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 43 ECG Review continued CU ER3 Operator s Manual _ver 2 00
42. G rhythm such as VF or VT with rates greater than 150 bpm STAND CLEAR Voice and Text Indicates that everybody in the vicinity of the patient must stand clear and not touch the patient CHARGING Text Indicates that the Paramedic CU ER3 capacitor to prepare for a shock delivery is charging its CHARGING COMPLETE Text Indicates that the Paramedic CU ER3 has finished charging its capacitor This prompt is in text form only PRESS THE FLASHING RED BUTTON NOW SHOCK DELIVERED Voice and Text Indicates that you have to press the SHOCK button for the delivery of a defibrillation shock At this time the SHOCK button is flashing and the beeper is beeping Voice and Text Indicates that the Paramedic CU ER3 has delivered a defibrillation shock 33 CU ER3 Operator s Manual _ver 2 00 Voice and Text Prompts continued for the following These voice and text prompts are given when the device is operated in AED mode except e The ECG MONITORING MODE text prompt is given only when the device is in Manual Mode and the ECG monitoring cable assembly is connected to the ECG DEFIB port of the device e The CHARGING text prompt is given when the defibrillating capacitor is being charged in both AED and Manual Modes Prompt Indication BEGIN CPR NOW Voice and Text You must administer cardiopulmonary resuscitation CPR PUSH THE CHEST DOWN FAST TWO INCHES Voice and
43. II I Aia a a fi Sal A 7 i j J Fs Stork Shocks Shocks hompits Derm in 1 De tin T2 Defbin is Ouid Pre BBa 8 Menohasic Pwhcepital diToriliation and mewciistion efficacy for 115 patene who presented wih 7F Scheider et al Circulation 2000 102 1 80 1787 127 CU ER3 Operator s Manual ver 2 00 Extensive animal and human data with implanted devices demonstrate that biphasic waveforms offer substantial reductions in defibrillation thresholds and produce less myocardial dysfunction than monophasic waveforms 1 2 3 4 The defibrillation efficacy of the 150 J biphasic waveform was superior to that of the 200 J to 360 J conventional escalating energy monophasic waveforms for 115 patients who presented with VF 5 40 20 Les S i 8 i 3 DF E E 2 i EN I 3 d 27 20 o i 8 40 i a j E Bud E z A 80 t A E M 100 0 100 200 300 400 500 600 700 Time ms Transme rrbrane potential for a single Beeler Reuter cell subject to monophasic and biphasic Each stimulus amplitude 4 is 17 0 mV duration is 10 ms and is applied 360 res after the initial action potential Notice that for a stimulus of the same amplitude duration and tir ng the biphasic stimulus is successful at activating the cell whereas the monophasic stimulus fails to activate the cell Morophasic biphasic Keener et al J theor Biol 1999 200 1 17 J Th
44. ING If the patient needs a defibrillation shock press the CHARGE button when it is active as shown in the following figure EHERGY 150J CHARGE C SYNC OFF The CHARGE button is active when the key label indicates CHARGE as shown in the figure above A charging beep sounds when the Paramedic CU ER3 charges Aside from the charging beep the text prompt CHARGING also flashes on the screen The beep changes into a continuous tone when charging is finished The Paramedic CU ER3 is ready for a shock delivery The shock energy level may be changed while the Paramedic CU ER3 is charging or when it has finished the charging process If the energy level is changed the CHARGE button will have to be pressed again to recharge the defibrillator 83 CU ER3 Operator s Manual ver 2 00 7 5 SHOCK Confirm that the patient still needs a defibrillation shock Confirm that the Paramedic CU ER3 has finished charging The beeper must emit a continuous tone and the SHOCK button must be flashing its red backlight Make sure that nobody is touching the patient and shout out loudly STAND CLEAR Press the SHOCK button to deliver the shock EHERGY 150J 00 00 15 SYNC OFF DISARM The Paramedic CU ER3 may be disarmed when it is charged To disarm press the PAUSE DISARM button If the SHOCK button is not pressed within 15 seconds after it is charged the Paramedic CU ER3 will automatically disarm itself After
45. MATION DEVICE HISTORY 2 Menu Button BATTERY HISTORY t bx Of RETURN DEVICE HISTORY p USES 15 135 SHOCKS 32 7 TRAINING 0 0 3 Menu Button DPST 30 2 west 4 2 MPST 1 1 sf ust 1 2 d PRESS THE MENU KEY TO RETURN 36 CU ER3 Operator s Manual _ver 2 00 In this example the Device History indicates the following Uses Middle Number of times the Paramedic CU ER3 was used in RESCUE column operations In this example the Paramedic CU ERS3 was used 15 times in rescue operations A rescue operation is counted when the following conditions occur 1 The Paramedic CU ER3 is turned ON 2 The Paramedic CU ERS is able to acquire an ECG signal 3 The Paramedic CU ERS is turned OFF Right Total elapsed time minutes that the device was used in RESCUE column operations In this example the device was used for a total of 135 minutes in 15 rescue operations Shocks Middle Total number of shocks delivered since the device was put into use column Training this option is not implemented in this version of the Paramedic CU ER3 Middle Number of training uses For future versions Not implemented in this column version of the Paramedic CU ER3 Right Total elapsed time of training sessions minutes For future versions column Not implemented in this version of the Paramedic CU ER3 Self Tests DPST Daily WPST Weekly MPST Monthly MST
46. O PULSE BEGIN CPR Y At the end of charging Text prompt CHARGING COMPLETE Beeper A burst of two beeps i Voice and text prompts PRESS THE FLASHING RED BUTTON NOW While the Paramedic CU ER3 is waiting for the SHOCK button to be pressed Beeper Continuous tone Shock button backlight Flashing red light _ Paramedic _ CU ER3 detects decides Within 15 seconds SHOCK PRESSED button was NOT PRESSED Y v Voice and text prompts Voice and text prompts THE SHOCK BUTTON WAS SHOCK DELIVERED NOT PRESSED gt Y Voice and text prompts BEGIN CPR NOW e v Voice and text prompts PUSH THE CHEST DOWN FAST TWO INCHES Text prompt CYCLE NO COMPRESSION NO Beeper Beat Sound at 100 beats per minute Voice and text prompts GIVE TWO BREATHS BREATH BREATH This CPR sequence is done for 5 cycles 131 APPENDIX C Parts and Accessories Number CU ER3 Operator s Manual _ver 1 00 To order replacement parts and accessories please cite the part numbers given in the table below Standard Parts Name Part Number Paramedic CU ER3 2 sets of Multifunction Defibrillator Electrode Pads CUA05080 Power Cord AC DC Adapter ER3 SP1 Operator s Manual Quick Reference Card Nic
47. PO2 module in the Paramedic CU ER3 measures functional oxygen saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen e The range of the peak wavelengths and maximum optical power are stated in the Specifications found in the Appendices of this Operator s Manual This is useful to clinicians performing therapies that are using light emissions e g photodynamic therapy Do not rely solely on SPO2 readings The SPO2 module of the Paramedic CU ER3 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Failure to cover the SPO2 sensor site with opaque material in high ambient light conditions may result in inaccurate measurements As with all medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation Disconnect the Paramedic CU ER3 and the SPO2 sensor from the patient during magnetic resonance imaging MRI scanning Induced current could potentially cause burns Do not use SPO2 sensor or cable that appear damaged The SPO2 sensor may remain attached to the patient during defibrillation or while an electrosurgical unit is in use but the SPO2 readings may be inaccurate during defibrillation and shortly thereafter 94 CU ER3 Operator s Manual ver 2 00 Physiological conditions medical procedures or external agents that may interfere with the monitor s ability to
48. Paramedic CU ER3 stores the rescue operation data in the following locations 1 Internal Data Flash Memory this is the nonvolatile default data storage location of the Paramedic CU ER3 Audio signal data can not be recorded here It is nonvolatile thus the stored data is not erased when the device is turned OFF The Internal Data Flash Memory has a capacity of 12 hours of ECG and Event data recording The whole memory location is erased at the beginning of a rescue operation thus data stored from a previous rescue operation is overwritten To keep previously recorded data from being lost these must be transferred to a personal computer using the CU Expert ECG Data Management software 2 SmartMedia Flash Memory Card this is the optional removable nonvolatile memory card available from CU Medical Systems Inc Audio signals may be stored here This card is also erased during the start of a rescue operation if it is inserted in its port before the Paramedic CU ER3 is turned ON The data has to be transferred to a PC the same way as described above The SmartMedia card has a recording capacity of 42 hours of ECG and Events data or 1 hour of ECG Event data and Audio Signal Data When used the SmartMedia card has to be installed in its port before the Paramedic CU ER3 is turned ON The Paramedic CU ER3 has to be turned OFF before removing the SmartMedia card from its port 112 CU ER3 Operator s Manual ver 2 00 14 2 DATA REVIEW
49. R3 Operator s Manual ver 2 00 4 2 Accessories Only parts and accessories approved by CU Medical Systems Inc must be used with the Paramedic CU ER3 Using parts and accessories that are not approved by CU Medical Systems Inc may degrade performance Using accessories and cables other than the ones specified in this manual may result in increased ELECTROMAGNETIC EMISSIONS or may decrease the ELECTROMAGNETIC IMMUNITY of the Paramedic CU ER3 Replacement accessories and consumables must be sourced only from CU Medical Systems Inc or its authorized representatives 24 CU ER3 Operator s Manual ver 2 00 Standard Accessories Defibrillator Electrode Pads and Connector Assembly Self adhesive pre gelled defibrillator electrode pads used to acquire the ECG signal from the patient and to deliver the defibrillation shock to the patient Quick Reference Card A reference card that enumerates the steps to be done during a rescue operation Nickel Metal Hydride Battery Pack Power source of the Paramedic CU ER3 This battery is inside the case of the device RETURN the Paramedic CU ER3 to an authorized service representative in case the battery pack needs to be replaced AC DC Adapter Used to connect the AC DC adapter unit to the mains power supply Used for charging the rechargeable Nickel Metal Hydride battery pack May also be used to power the Paramedic CU ER3 during rescue operation
50. STEMS Guidance and manufacturer s declaration electromagnetic immunity The Paramedic CU ER3 is intended for use in the electromagnetic environment specified below The customer or the user of the Paramedic CU ER3 should assure that it is used in such an environment Immunity IEC 606011 Compliance Electromagnetic environment guidance Test test level level 9 9 Portable and mobile RF communications equipment should be used no closer to any part of the Paramedic CU ER3 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 Vrms 3 Vrms 150 kHz to 80 d 1 16VP MHz outside ISM Conducted RF bands IEC 61000 4 6 ON 5s rms rms 150 kHz to 80 d 1 24P MHz in ISM bands Radiated RF 10 V m 10 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 124 P 80 MHz to 800 MHz d A5 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2
51. These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHZ 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 Paramedic CU ER3 is used exceeds the applicable RF compliance level above the Paramedic CU ER3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Paramedic CU ER
52. U ER3 is analyzing Analyzing No Shock Advised the ECG of the patient Indicates the time when the Paramedic CU ER3 issues the NO SHOCK ADVISED prompt Shock Advised Indicates the time when the Paramedic CU ER3 issues the SHOCK ADVISED prompt Paused for CPR Indicates the time when the Paramedic CU ER3 pauses to give way to CPR administration ECG Pads On Indicates the time when the ECG monitoring cable and connector assembly is connected to the Paramedic CU ER3 ECG Pads Off Indicates the time when the ECG monitoring cable and connector assembly is disconnected from the Paramedic CU ER3 40 CU ER3 Operator s Manual ver 2 00 To access Usage Review turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence DEVICE INFORMATION DEVICE HISTORY 1 ON OFF Button BATTERY HISTORY n E e RETURN REVIEW INCIDENT USAGE REVIEW 2 Down Button ECG REVIEW VOICE REVIEW amp lh X EC RETURN REVIEW INCIDENT USAGE REVIEW 3 Menu Button ECG REVIEW VOICE REVIEW fo X HO RETURN 41 Usage Review continued CU ER3 Operator s Manual _ver 2 00 Press the following button s in sequence The Paramedic CU
53. ULT DEFIBRILLATION 1 Remove clothing from the patient s upper body 2 Remove excess hair and wipe moisture off the skin of the patient on the area where the defibrillator electrode pads are to be attached 3 Open the defibrillator electrode pads package 4 Peel off the protective backing of the defibrillator electrode pads Check that the conductive gel has not dried out 5 Place the defibrillator electrode pads on the patient a The pads must be placed with the sticky side on the skin of the patient b The pads must be placed in an EA anterior anterior position as shown in the figure at the right c The reverse side of each pad indicates its position on the patient dak 6 Plug the connector of the defibrillator electrode pads into the ECG DEFIB port of the Paramedic CU ER3 71 CU ER3 Operator s Manual _ver 2 00 CHILD DEFIBRILLATION If you are going to use the Pediatric Electrode Pads you must set the Paramedic CU ER3 to output 150 Joules by selecting AED ON or Manual ON with energy set to 150 Joules Do not use the Reduced energy Pediatric Electrode Pads with an output setting other than 150 Joules 1 Ensure that the Paramedic CU ER3 is set for a 150 Joule output 2 Remove clothing from the patient s upper body 3 Wipe moisture off the skin of the patient on the area where the defibrillator electrode pads are to be attached Pediatric Pads Device Patient connection Connector guides 4 Use t
54. al _ver 2 00 6 2 AED Automatic Reanalysis Mode The Paramedic CU ER3 will be operating in Automatic Reanalysis Mode if it has been set for automatic reanalysis see section 4 5 7 1 Insert the SmartMedia Card into port optional Select AED ON on the mode selector knob Turn the Paramedic CU ER3 ON If patient is e Not responsive e Not breathing e Pulseless Attach pads SHOCK advised No YES Press SHOCK button Administer CPR Administer CPR AED Operation Flowchart 70 CU ER3 Operator s Manual _ver 2 00 6 2 1 Preparation 1 Insert SmartMedia Card if desired 2 Turn the MODE ENERGY Selector Knob to AED ON 3 Turn ON the Paramedic CU ER3 4 Evaluate the condition of the patient The patient must exhibit the symptoms indicated for AED defibrillation These symptoms are a Unresponsiveness b Absence of normal breathing and c Lack of detectable pulse If the patient is exhibiting the said symptoms do the following 5 Assess the age and weight of the patient e If the patient is an adult proceed to instructions on ADULT DEFIBRILLATION e If the patient appears to be younger than 8 years old or weighs less than 25 kg 55 Ib proceed to instructions on CHILD DEFIBRILLATION e Do not delay the rescue operation when you determine the age and weight of the patient If the child appears to be older than 8 years old or heavier than 25 kg proceed to instructions on ADULT DEFIBRILLATION AD
55. and the leaked liquid gets in the eyes wash them with clean water and consult a physician immediately Do not leave the battery pack in direct sunlight or in high temperature areas Do not have the battery pack in contact with water Keep the battery pack away from direct sunlight high temperature and humidity Follow local regulations when disposing of the battery pack Do not subject the battery pack to conditions beyond the safe environmental conditions for the Paramedic CU ER3 100 CU ER3 Operator s Manual ver 2 00 11 4 AC DC Adapter The AC DC Adapter is primarily used for recharging the internal battery pack However it may also be used to power the Paramedic CU ER3 during rescue operations It has medical device grade isolation properties passes the requirements of EN 60601 1 The AC DC Adapter and the power cord are shown in the following figures Output Jack Power Cord Receptacle Power Cord 9 The AC DC Adapter power supply derives power from the AC mains with the following specifications a Frequency 50Hz to 60Hz b Voltage 100V to 240V 101 CU ER3 Operator s Manual ver 2 00 Connecting the AC DC Adapter a Connect the power cord to the adapter b Plug the power cord to the power mains c Connect the output jack of the adapter to the AC DC port of the Paramedic CU ER3 Do not connect or disconnect the AC adapter plug while the device is being
56. ary resuscitation CPR in accordance with the 2005 American Heart Association Guidelines on CPR and ECC emergency cardiovascular care 75 CU ER3 Operator s Manual ver 2 00 The patient should be kept motionless during signal acquisition and analysis If the patient is being transported in an emergency vehicle the vehicle should be stopped during ECG signal acquisition and analysis Attach the pad as described on the reverse side of the defibrillator pads Make sure that there is good contact between the defibrillator pads and the patient s skin Ensure that there are no air pockets between the skin and the pads Air pockets increases skin resistance to current flow and may cause burns due to the heating up of the skin electrode interface Do not short circuit the defibrillator pads Do not place them very close to each other during operation Do not let them touch lead wires transdermal patches or other electrodes connected to the patient If it becomes necessary to use another defibrillator on the patient do not leave the Paramedic CU ER3 connected to the patient Disconnect the Paramedic CU ER3 from the patient before using any other defibrillator When using the Paramedic CU ER3 disconnect from the patient any MEDICAL ELECTRICAL EQUIPMENT that has no DEFIBRILLATION PROOF applied parts During defibrillation you and other rescue personnel and bystanders on the scene must avoid contact between parts of the patient s
57. asic technology increases the duration of current flow for patients with high impedance When escalating energy for example 150J to 180 it delivers the electrical energy with higher voltage level if the patient s impedance does not vary 50 ohms 100 ohms 126 2 more Gfficient than monophasic waveform The electrical therapy delivered by transthoracic cardiac defibrillators has changed little since the introduction of direct current defibrillation more than 30 years ago Throughout this time the industry standard shock waveform for external defibrillators has been a monophasic damped sine MDS waveform in which current flows in one direction throughout the shock Many well organized emergency medical systems using monophasic devices for early defibrillation have documented better than 2096 survival to hospital discharge for cardiac arrest patients found in ventricular fibrillation VF Attempts to improve this survival rate CU ER3 Operator s Manual _ver 2 00 biphasic E monophasic have adapted proposals to change the waveform and energy level of defibrillation shocks 6 Biphasic waveform defibrillators incorporate two way current flow in which electrical current first flows in one direction then reverses direction approximately midway through the shock delivery A oo 29990 P 0090 000 4 7 LE iy Ley a d Percent of VF Patients A 17 P
58. athing c Lack of detectable pulse Do not use the Paramedic CU ER3 on patients who show either of the following signs a Responsiveness b Presence of normal breathing c Presence of detectable pulse 3 2 2 Manual Mode Indications Asynchronous defibrillation the shock delivery is not synchronized with the QRS peak In asynchronous manual defibrillation the Paramedic CU ER3 is indicated for use on patients with the following symptoms a Unresponsiveness b Absence of normal breathing and c Lack of detectable pulse These are the same symptoms indicated for AED defibrillation Synchronous defibrillation the shock delivery is synchronized with the QRS peak of the patient s ECG In synchronous manual defibrillation the Paramedic CU ER3 is indicated for use on patients with ECGs that show the presence of Atrial Fibrillation Contraindications The Paramedic CU ER3 must not be used in Asynchronous Manual Mode on patients who show any of the following symptoms a Responsiveness b Normal breathing c Detectable pulse 16 CU ER3 Operator s Manual ver 2 00 3 2 3 SPO2 Monitoring Indications e SPO2 Monitoring is indicated when it is beneficial to assess a patient s oxygen saturation level Contraindications e There are no known contraindications for SPO2 Monitoring 3 2 4 ECG Monitoring Indications e ECG Monitoring is indicated when it is desired to monitor the heart rate of a patient Contraindications
59. body such as exposed skin of head or limbs with conductive fluids such as gel blood or saline solutions with metal objects connected with the patient such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current 76 CU ER3 Operator s Manual ver 2 00 6 2 4 Cardiopulmonary Resuscitation CPR After delivery of a shock the Paramedic CU ER3 pauses to enable you to administer CPR to the patient Check the patient for signs of circulation after delivering a shock In the absence of circulation administer 5 cycles of cardiopulmonary resuscitation CPR The Paramedic CU ERS3 gives the following signals for CPR administration If a shock is delivered 1 The voice and text prompt BEGIN CPR NOW 2 The voice and text prompt PUSH THE CHEST DOWN FAST TWO INCHES immediately after the prompt in no 1 above is given 3 A CYCLE NO and COMPRESSION NO indicator keeps track of the progress of the CPR This is shown in the figure below 4 Beat guide from the beeper accompanies the CYCLE NO and COMPRESSION NO indicator EHERGY 150 1 9 i Aaa 1 Cycle 15 dall CPR30 2 00 00 42 5 The Paramedic CU ER3 lets you perform 5 cycles of CPR If a shock is not delivered decision is NO SHOCK ADVISED The voice and text prompt CHECK PULSE The Paramedic CU ER3 gives you 10 seconds to check the pulse of the patient The voice and text prompt IF NO PULSE BEGIN CPR
60. ce prompts In Manual Mode May be used to toggle the UP Button plethysmographic wave display ON and OFF MENU May be used to access the Monitor Alarm Button Menu DOWN M e used to silence the alarm beeps Button ay be used to si alarm beep The Menu Keypad buttons are also used to input the password in Manual Mode 21 CU ER3 Operator s Manual _ver 2 00 Device Parts Explanation continued Operating Controls continued ANALYZE Used to initiate charging of the defibrillating capacitor or to CHARGE make the Paramedic CU ER3 begin analysis of the patient s ECG CHARGE ANALYZE SYNC Used to synchronize the delivery of the shock with the R Wave of the patient s ECG SYNC PAUSE DISARM In Manual mode used to discharge the energy of the defibrillating capacitor into the internal charge dumping load In AED mode used to pause the device to give way to CPR MODE ENERGY SELECTOR Used to select the operation mode AED MANUAL or MENU In Manual Mode used to select the energy to be delivered to the patient Indicator Lamps POWER oO POWER Oo BATTERY BATTERY 0 ERROR Indicates that the source of power is external to the device either the AC DC adapter or the external battery pack Indicates that the source of power is a battery pack either the internal battery pack or the external battery pack This lamp indicator also flashes
61. computer before using the SmartMedia card again The same is true with the internal flash memory Previously recorded data are overwritten every time new data are recorded in the internal flash memory during a rescue operation Stored data in the internal flash memory are not overwritten if the data in a current rescue operation are stored in a SmartMedia Card Thus the data in the internal flash memory are still available for review when the Paramedic CU ER3 is turned ON without the SmartMedia Card inserted 14 3 DATA TRANSFER TO PERSONAL COMPUTER The data from the previous rescue operation stored in the internal flash memory or the SmartMedia card are overwritten every time the Paramedic CU ER3 is used in a rescue operation To keep data permanently it must be transferred to a computer that is running the CU Expert ECG Data Management Software The CU Expert is an optional data management software available from CU Medical Systems Inc Data transfer can be done through the IrDA port or the UART port of the Paramedic CU ER3 14 3 1 IrDA Connect the IrDA transceiver to the COM1 or COM2 serial port of the PC hosting the CU Expert ECG Data Management Software Align the IrDA transceiver with the IrDA port of the Paramedic CU ER3 Insert the SmartMedia Card if the data to be transferred is in the SmartMedia Card See the illustrations on the CU Expert User s Manual The Paramedic CU ER3 must be set to communicate through its IrDA
62. d reliability In this regard Only persons authorized by CU Medical Systems Inc may service this device There are no user serviceable parts in this device You must operate this device in accordance with the instructions specified in this manual To ensure safety and reliability use only parts and accessories recommended by CU Medical Systems Inc If you intend to use this device in conjunction with other devices not specified in this manual please notify the manufacturer CU ER3 Operator s Manual ver 2 00 WARRANTY This device is warranted by CU Medical Systems Inc against defects in materials and workmanship for two full years from the date of original purchase During the warranty period we will repair or at our option replace at no charge a product that proves to be defective provided you return the product shipping prepaid to us or to our authorized representative This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by an entity other than CU Medical Systems Inc or its authorized representatives IN NO EVENT SHALL CU MEDICAL SYSTEMS INC BE LIABLE FOR CONSEQUENTIAL DAMAGES Only products with serial numbers and their accessories are covered under this warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and modules without serial numbers are not covered under this war
63. de the Paramedic CU ER3 does not do any arrhythmia analysis Only the ECG and the calculated heart rate of the patient are shown on the screen display No defibrillation shock may be delivered when the device is in ECG MONITORING MODE 9 2 Patient Preparation a Remove clothing from the patient s chest Wipe moisture and clip or shave excessive chest hair b Open the package of the disposable ECG MONITORING electrodes and peel off their protective sheets C Attach the ECG MONITORING 4 electrodes to the patient The sticky side must be in contact with the 2797 patient s skin The placement is shown in the figure at the right d Connect the snap connector of the ECG Monitoring Cable and Connector Assembly to the corresponding snap connector at the back of the electrodes 9 3 ECG Monitoring When the Paramedic CU ER3 detects the ECG of the patient it computes the heart rate and displays both the ECG trace and the heart rate value on the screen display The display is shown in the figure below Spor mo Ok 65 98 eM ECG Monitoring mode amm q 00 00 15 87 CU ER3 Operator s Manual ver 2 00 The ECG MONITORING MODE is available only in Manual Mode If the device has been turned ON in Manual Defibrillating Mode it can be switched to ECG MONITORING MODE by replacing the defibrillator electrode pads with the ECG MONITORING electrodes When in ECG Monitoring Mode it can be switched back to Defibril
64. delivering the shock attend to the patient in accordance with the International Guidelines for CPR cardiopulmonary resuscitation and ECC emergency cardiovascular care Determine whether more shocks are needed or not 84 CU ER3 Operator s Manual _ver 2 00 8 Synchronized Cardioversion 8 1 OVERVIEW The Paramedic CU ER3 may be used to treat patients with Atrial Fibrillation through synchronized cardioversion Synchronized cardioversion enables you to deliver the shock synchronized with the R wave of the patient The ECG monitored during Synchronized Cardioversion is acquired using the same defibrillator electrode pads that are used to deliver the synchronized shock 8 2 PATIENT PREPARATION Do the same patient preparation done in Asynchronous Defibrillation in Manual Mode as detailed in section 7 2 8 3 SYNCHRONIZATION Press the SYNC Button to begin synchronization with the R wave of the patient R wave markers will mark the occurrences of the patient s R wave These are shown in the following figure ENERGY SYNC 150J Indicator QRS Marker The beeper emits a beep that is synchronized with the occurrence of the R wave of the patient 8 4 ANALYSIS Analyze the ECG of the patient and decide whether the patient needs a synchronized cardioversion shock or not 8 5 CHARGING Charge the Paramedic CU ER3 as in the asynchronous defibrillation in Manual Mode see section 7 4 85 CU ER3 Operator
65. ds to CPR guidance THE SHOCK gave the prompt to PRESS THE BUTTON WAS FEASHING RED BUTTON FOR Remedial action Be sure to press the SHOCK NOT DELIVERING A SHOCK TO button within 15 seconds when the Paramedic PRESSED PATIENT SDUE youdid nat press CU ER3 issues the prompt PRESS THE ME oR siat eo EY ts FLASHING RED BUTTON FOR DELIVERING A SHOCK TO PATIENT if it is your intention to prompt was given deliver a shock Remedial action Attach the defibrillator electrode pads to the bare chest of the patient ATTACH The defibrillator electrode pads PADS are not attached to the patient s Follow the graphic direction provided at the back this prompt is bare chest of each defibrillator electrode pad given if the Patients with excessive chest hair must be Paramedic CU shaved ER3 is in AED mode The defibrillator electrode pads Remedial Action Confirm that the connector of assembly is not connected to the the defibrillator electrode pads assembly is ECG DEFIB port of the Paramedic firmly connected to the ECG DEFIB port of the CU ER3 Paramedic CU ER3 The defibrillator electrode pads Remedial Action Make sure that the area are not attached well to the where the defibrillator electrode pads are to be patient s chest or the defibrillator attached is clean and free of moisture electrode pads assembly Shave excessive hair and wipe off moisture connector is not connected to the Make sure that the defibrillator electrode pads CHECK PADS ECF D
66. during self tests automatic and manual 1 The ERROR indicator light turns ON then OFF 2 The beeper emits a single beep 3 The alarms stated in 1 and 2 are repeated every minute while the Paramedic is OFF Alarms raised when the Paramedic CU ER3 is turned ON after a fault is detected during automatic or manual self test 1 The Paramedic CU ER3 displays the error name and code on the LCD screen 2 The ERROR indicator light turns ON 3 The beeper emits short beeps at regular intervals Self Test Errors Error Name Code Fault Remedial Action LOW BATTERY 0001 Low battery charge Recharge Wieibabtety Return to an authorized SYSTEM ERROR 0002 NAND Flash memory failure i service center for repair Random Access Mem Return t n thorize SYSTEM ERROR 0004 innate Sy aran onan Secs RAM Failure service center for repair Real Time Clock RTC Return t n thorized SYSTEM ERROR 0008 A POE A E Failure service center for repair Complex P mmable Return t n thorize SYSTEM ERROR 0016 o p x Progra ab ur o an au one d Logic Device service center for repair 109 CU ER3 Operator s Manual _ver 2 00 Self Test Errors continued Error Name Code Fault Remedial Action SYSTEM ERROR 0032 Capacitor charge comparator failure Return to an authorized service center for repair SYSTEM ERROR 0064 ECG relay failure Return to an authorized service center for repair SYSTEM ERROR 0128 Imp
67. e difference between monophasic and biphasic waveform is qualitatively similar but varies quantitatively for different parameter values The fundamental difference is that first phase of the biphasic pulse acts as a pre pulse to remove inactivation from the heart cell accelerating its recovery and thereby lowering the activation threshold for defibrillation prior to second phase of biphasic pulse which is reversed current flow This means that Biphasic shock is more effective than a monophasic shock at eliminating reentrant electrical activity in an ionic model of cardiac ventricular electrical activity 7 128 CU ER3 Operator s Manual _ver 2 00 3 nough energy for restoring heart rhythm The Biphasic Truncated Exponential waveform uses lower energy than the Monophasic waveform But the lower energy of biphasic shock is more efficient than high energy of the monophasic shock for defibrillation to restore heart rhythm 1 Monophasic at 200 Joules Biphasic Truncated Exponential at 150 Joules 150 Current 4 2007 x 0 10 20 30 40 50 Time Amps In a multicenter randomized controlled trial of 150J biphasic waveform compared with 200J and 360J monophasic waveforms done in humans Schneider et al 5 showed that the 150 J biphasic waveform defibrillated at higher rates resulting in more patients who achieved a return of spontaneous circulation Although survival rates to hospital admission and discharge did not differ disc
68. e internal battery is being recharged External Battery Pack Type 4200mAh 12V Non rechargeable LiMnO Dimensions 104mm X 67mm X 42mm LXWXH Weight Approximately 423 grams including connector Capacity 200 shocks at 150 Joules Battery Indicators Battery level indicator Battery Operating Temperature 40 C to 60 C 141 CU ER3 Operator s Manual _ver 2 00 Thermal Array Printer Printing method Direct thermal line printing Resolution 230dpi 8 dots mm Printing Speed 50mm s Dimensions 75mmXx95mmx35mm Weight 169g including roll paper Input power 12V DC Standby current 60mA maximum current 3A Operating Temperature 10 C to 40 C Storage Temperature 10 C to 70 C 142 CU ER3 Operator s Manual ver 2 00 Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic emissions The Paramedic CU ER3 is intended for use in the electromagnetic environment specified below The customer or the user of the Paramedic CU ER3 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF Emissions Group 1 The Paramedic CU ER3 uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions
69. e the MODE ENERGY SELECTOR is set to MANUAL ON Heart Rate Heart Rate Shock Count Calculation Alarm Status Source Indicator PEN N aes Value Spo2 ENERGY buat 1450 34 9 4 x Indicator Pleth Wave Display LA VIA 4 ECG Display Check Pads Text Prompt PROBE OFF Battery Level Elapsed Indicator gt am Time CHARGE SYNC ON a nati Alarm Beep CN Icon Key Labels Figure 4 4 Initial Screen Display Manual Mode 29 CU ER3 Operator s Manual ver 2 00 Initial Screen Display Legend Flashing pads Indicate the location where the defibrillator electrode pads must be icon placed Battery Level Indicator Power provided by the internal battery pack Shows the charge status of the battery pack of the Paramedic CU ER3 The battery is fully charged Battery level is 80 of full charge al Battery level is 65 of full charge Battery level is 50 of full Aci 1 Battery is almost empty Recharge the battery pack when this icon is displayed Do not wait for the battery pack to be totally drained E the device is powered by an AC adapter or a Car cigar lighter jack Battery Level Indicator Power provided by the external battery pack Shows the power level of the external battery pack of the Paramedic CU ER3 Battery level gt 90 of full level oz 90 gt Battery level gt 60 of full level E 60 gt Battery level gt 30 of full level E 30 gt Battery level gt 1
70. e transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 146 CU ER3 Operator s Manual ver 1 00 Paramedic CU ER3 Shock Waveform Plots 250 Impedance Load 150 Joules output Tek Stop E 50Q Impedance Load 150 Joules output dex Tok Stop rrt 147 CU ER3 Operator s Manual ver 2 00 7590 Impedance Load 150 Joules output Tek Stop 1002 Impedance Load 150 Joules output Tek Stop 148 CU ER3 Operator s Manual ver 2 00 1250 Impedance Load 150 Joules output Tek Stop 1502 Impedance Load 150 Joules outpu
71. ector assembly The Paramedic CU ER3 is capable of monitoring pulse oximetry SPO2 in manual and AED modes Pulse oximetry measurement is automatically done when the pulse oximetry sensor is connected to the appropriate port of the device The Paramedic CU ER3 automatically records ECG and events such as shock deliveries in nonvolatile memory during rescue operations These data may be printed directly using a portable printer or downloaded to a personal computer for printing and archiving The Paramedic CU ER3 is powered by an internal rechargeable Nickel Metal Hydride battery pack It may also be powered by an optional external disposable LiMnOz battery pack or its AC DC adapter While the internal battery is being recharged by the AC DC adapter the AC DC adapter also supplies power to the whole device which enables it to be fully functional The Paramedic CU ER3 runs automatically initiated self tests even during storage to test its readiness for rescue operations Faults during these tests are communicated to the user through prompts and alarms 15 CU ER3 Operator s Manual _ver 2 00 3 2 Indicated Use 3 2 1 AED Mode In AED Mode the Paramedic CU ER3 is indicated for use on patients that are exhibiting the symptoms of sudden cardiac arrest SCA The Paramedic CU ER3 is to be used on patients that are suspected of suffering from sudden cardiac arrest with all of the following signs a Unresponsiveness b Absence of normal bre
72. edance Measurement System Failure Return to an authorized service center for repair SYSTEM ERROR 0256 Shock Engine Failure Return to an authorized service center for repair SYSTEM ERROR 0512 Charge Failure Return to an authorized service center for repair SYSTEM ERROR 1024 Internal Discharge Failure Return to an authorized service center for repair SYSTEM ERROR 2048 Key Button Failure Make sure that the Key Button Failure is not caused by a failure of the operator to press the Key Button during Manual Self Testing Do this by running a Manual Self Test and press the buttons as prompted If the error is not due to a failure to press the buttons during Manual Self Test return the device to an authorized service center for repair 110 CU ER3 Operator s Manual _ver 2 00 13 2 Prompts During Rescue Operation If there are problems during a rescue operation that prevents the Paramedic CU ER3 from successfully operating the Paramedic CU ER3 gives voice and text prompts to inform you of the problems These prompts together with the remedial actions are shown in the following table Manual mode The defibrillator electrode pads are in contact with each other ERONAT POSSIBLE CAUSES REMEDIAL ACTION The Paramedic CU ER3 The Paramedic CU ER3 disarms dumps the charge in its internal disarm resistance load and detected a shockable rhythm n procee
73. eese 47 CU ER3 Operator s Manual _ver 2 00 4 5 7 Administration Device Setup een 50 4 5 7 AED Settings 7 eor e EDEN ERR 52 4 5 7 2 General Settings ccecceeeeeee ee eee eee e eee eee 54 4 5 73 PASSWOM ied pete enti Ere eh 56 4 5 8 Device Setup Monitor esee 59 4 5 9 Printing and Transferring Data ccseeeeeeeeeee ees 63 42 5 10 RECU ii eve cladveri end yu ER T DR Re gIOD E DR EARS LOU 65 4 5 11 Speaker Volume Adjustment eeeeeeneee 65 5 Device Setup and Storage sss 66 5 1 UNPACKING eee eaei pero erg ce peer pete p de xa E 66 He 2 Ii re 66 5 2 1 Manual Self Test sessesseeseeseenenen enn nnn 66 5 2 2 Battery Charge Check sesssessseeeee 67 5 2 3 Battery Charging csssessssesseemem 67 5 2 4 Configuration Settings ccceeeeeee eee ee teens eee eeeaeees 67 BS SlORAGS ad Rm 68 6 Defibrillating in AED Mode ccccceceee eect eee e eee teeta nena eee eaeeeeanaes 69 6 1 OVerVIGW iis oie eesti dian cate o TEER EREE RER RER RR 69 6 2 AED Automatic Reanalysis MOde cccceceeeeeeeeeeeeeeaeeneenenas 70 6 2 1 Preparation bove ede de x Yee aia 71 6 2 2 Step 3 ECG Acquisition and Analysis 73 6 2 3 Step 3 Shock Delivery eeseeeeeennn nnn 75 6 2 4 Cardiopulmonary Resuscitation CPR 77 6 3 AED NO Automatic Reanalysis Mode
74. eparation 1 Insert SmartMedia Card if desired 2 Turn the MODE ENERGY Selector Knob to MANUAL ON Select the energy setting that is appropriate for the patient 3 Turn ON the Paramedic CU ER3 4 Evaluate the condition of the patient The patient must exhibit the symptoms indicated for Asynchronous Manual Defibrillation These symptoms are a Unresponsiveness b Absence of normal breathing and c Lack of detectable pulse If the patient is exhibiting the said symptoms do the following 5 Remove clothing from the patient s upper body 6 Remove excess hair and wipe moisture off the skin of the patient on the area where the defibrillator electrode pads are to be attached 7 Open the defibrillator electrode pads package 8 Peel off the protective backing of the defibrillator electrode pads Check that the conductive gel has not dried out 9 Place the defibrillator electrode pads on the patient a The pads must be placed with the sticky side on the skin of the patient b The pads must be placed in an anterior anterior position as shown in the figure at the right EA c The reverse side of each pad indicates its position on the patient A 10 Plug the connector of the defibrillator electrode pads into the ECG DEFIB port of the Paramedic CU ER3 82 CU ER3 Operator s Manual ver 2 00 7 3 ANALYSIS Analyze the ECG of the patient and decide whether the patient needs a defibrillation shock or not 7 4 CHARG
75. er to ensure that the paper will feed properly during printing 119 CU ER3 Operator s Manual _ver 2 00 Printing Data From the Paramedic CU ER3 1 Connect the UART Port connector of the printer to the Paramedic CU ER3 s UART port 2 Do not connect any connector defibrillator electrode pads assembly or ECG monitoring electrodes assembly connector to the ECG DEFIB port of the Paramedic CU ER3 3 If it is desired to print data contained in the SmartMedia card insert the SmartMedia card into its port in the Paramedic CU ER3 otherwise do not insert the SmartMedia card and the data in the internal flash memory will be printed 4 Turn the Paramedic CU ER3 ON with the MODE ENERGY selector knob set to MENU Go to COMMUNICATION menu see section 4 5 9 Printing and Transferring Data highlight PRINT then press the MENU button The following screen is displayed 9 PRINT ALL 59 PRINT SEGMENT RETURN PRINT ALL prints all the data ECG and event stored in the active data memory internal data flash memory if no SmartMedia card is present SmartMedia card if it is in its port PRINT SEGMENT prints a selected range of the stored data 5 Press the MENU button while PRINT ALL is highlighted if it is desired to print all of the data 120 CU ER3 Operator s Manual ver 2 00 The Paramedic CU ER3 displays the following figure during printing PRINT ALL PRINT ALL PRESS THE MENU KEY TO RETURN If it i
76. erval 6 seconds Resolution 1 Nellcor Sensors DS100A Sensor Wavelength Near 660 nm and 890 nm Power Not exceeding 15 mW Event Storage Internal Flash Memory 12 hours of event and ECG recording SmartMedia Card 32MB 42 hours of event and ECG recording or 1 hour if voice recording is enabled ECG Record Printing May be printed directly from the Paramedic CU ER3 using a portable thermal printer May also be printed using a personal computer by downloading the data to the PC using the data management software from CU Medical Systems Inc CU Expert External Links UART Port IrDA Port 140 CU ER3 Operator s Manual _ver 2 00 Display Type Liquid Crystal Display with electroluminescent backlight Size 4 inches 10 16 cm diagonal Resolution 320X240 pixels Sweep speed 25 mm s nominal stationary trace sweeping erase bar Viewing Time 3 2 seconds Battery Internal Battery Pack Type 4500mAh 12V rechargeable Nickel Metal Hydride Dimensions 89mmx36mmXx69mm LXWXH Weight About 620grams Charge time 4 to 5 hours Capacity 200 shocks at 150 Joules Battery Indicators Battery level indicator Battery charging indicator Battery Storage Should not be stored beyond 40 C for extended periods more than 90 days Charger output Unit can be used while th
77. ery pack which is made of rechargeable Nickel Metal Hydride cells It has a capacity of 200 shocks 150 Joules into 509 when new and fully charged The internal battery pack is connected to the circuit boards of the Paramedic CU ER3 at the factory by default Do not disconnect the internal battery pack from the circuit board of the Paramedic CU ER3 The Paramedic CU ER3 is shipped with the internal battery pack connected The battery must be kept connected when the device is not in use so that it could perform all the programmed self tests regularly The battery powers the device during these self tests 11 2 1 Internal Battery Pack Charge Status The charge status of the internal battery pack is checked by the Paramedic CU ER3 everyday The status is indicated in the battery history in the device menu and on the LCD screen through the battery status icon See section 4 3 for the explanation of the battery status icon If the voltage level of the internal Battery pack falls below the minimum tolerable level the Paramedic CU ER3 is going to be inoperative When this is detected during the Daily Self test the Paramedic CU ER3 a Turns the ERROR indicator light ON then OFF b Emits a single beep 96 CU ER3 Operator s Manual ver 2 00 After the low battery condition is detected the Paramedic CU ER3 turns the ERROR indicator light ON then OFF and emits a single beep every minute When the Paramedic CU ER3 is turned ON after a low
78. eshooting 12 1 1 Automatic Self Tests The Paramedic CU ER3 performs automatic self tests These tests are automatic and these are done without your intervention When Automatic Self tests are performed the green lamp of the ON OFF button is turned ON but the LCD screen display is off 12 1 2 Power On Self Test Whenever the Paramedic CU ERS is turned on it initiates a self test to ensure that the whole system is ready for use in emergencies The following tests are performed a SHOCK Button functionality test verifies that the SHOCK button is in proper condition for operation b Charging and Discharging test verifies the proper functioning of the charging and discharging subsystems c Impedance Calibration Test verifies that the impedance measuring subsystem is working properly This is done by measuring the impedance of a reference load d Battery capacity test verifies that battery capacity is sufficient for proper operation If the battery level becomes too low the device prompts you of the low battery condition when you turn the Paramedic CU ER3 ON e Random Access Memory RAM test verifies that the RAM chip is in working condition f Real Time Clock RTC chip test verifies that the real time clock chip is in working condition The Paramedic CU ER3 displays the text prompt STARTING when the Power On Self Test is conducted This is shown in the following figure STARTING UP 103 CU ER3 Operator s Manual ver 2
79. g The Paramedic CU ER3 113 14 2 1 Internal Flash Memory cccccceeeeee eee eeeeeeeeaeenenas 113 14 2 2 SmartMedia Card Optional Accessory 113 14 3 Data Transfer To Personal Computer esee 115 14 3 THrDA iain esti ceed dudes epe ex ERAT ERN RT ER ER RE ERI Uere REE 115 14 3 2 UART Port erede nere ee n a de n eee 117 14 4 Printing Using a Stand alone Serial Printer 11818 APPENDIX Asoc d ect ete er onda hn oath tnt ode ctc ht ed 124 eecube Biphasic Technology eesseeeeenen nmn 124 APPENDIX Buliss EET 131 Rescue Protocol in AED Mode Automatic Reanalysis 131 APPENDIX Cass PE 132 Parts and Accessories Number sessesseeeeenen nennen 132 CU ER3 Operator s Manual _ver 2 00 APPENDIX Dis reinet ren ER 133 Technical Specifications cesses emen nnn 133 143 Electromagnetic Compatibility cesses CU ER3 Operator s Manual ver 2 00 General Thank you for choosing the Paramedic CU ER3 Please read this Operator s Manual carefully and thoroughly before using the Paramedic CU ER3 to be fully acquainted with its operating and maintenance instructions CU Medical Systems Inc designs and manufactures all of its products in accordance with international standards NS EN ISO9001 2000 ISO13485 2003 MDD 93 42 EEC This ensures that CU Medical Systems Inc provides products of high quality an
80. harged patients who had been resuscitated with biphasic shocks were more likely to have good cerebral performance Positive evidence for safety and clinical effectiveness of biphasic truncated exponential waveforms for internal and external use was ascertained by the AHA ECC committee 8 9 129 CU ER3 Operator s Manual ver 2 00 REFERENCES 1 Chapman PD Vetter JW Souza JJ Wetherbee JN Troup PJ Comparison of monophasic with single and dual capacitor biphasic waveforms for nonthoracotomy canine internal defibrillation J Am Coll Cardiol 1989 14 242 5 2 Kavanagh KM Tang ASL Rollins DL Smith WM Ideker RE Comparison of the internal defibrillation thresholds for monophasic and double and single capacitor biphasic waveforms J Am Coll Cardiol 1989 14 1343 9 3 Winkle RA Mead RH Ruder MA et al Improved low energy defibrillation efficacy in man with the use of a biphasic truncated exponential waveform Am Heart J 1989 117 122 7 4 Ruppel R Siebels J Schneider MA Kuck KH The single endocardial lead configuration for ICD implantation biphasic versus monophasic waveform abstract J Am Coll Cardiol 1993 21 128A 5 T Schneider et al Multicenter Randomized Controlled Trial of 150 J Biphasic Shocks Compared With 200 to 360 J Monophasic Shocks in the Resuscitation of Out of Hospital Cardiac Arrest Victims Circulation 2000 102 1780 1787 6 Steven L Higgins et al A comparison of biphasic and monophasic sh
81. he Reduced energy Pediatric Defibrillator Electrode Pads as shown in the figure at the right 5 Open the defibrillator electrode pads package 6 Peel off the protective backing of the defibrillator electrode pads Check that the conductive gel has not dried out 7 Place the defibrillator electrode pads on the patient S a The pads must be placed with the sticky 7 side on the skin of the patient C y b The pads must be placed in an anterior H posterior position as shown in the figure at the right c The reverse side of each pad indicates its position on the patient Q 8 Connect the device connector of the defibrillator x Connect with the Pediatric Pads Connector electrode pads to the Pediatric Electrode Pads Connector Adapter 9 Connect the appropriate end of the 4 Pediatric Electrode Pads Connector Adapter x A to the ECG DEFIB port of the Paramedic CU ER3 See figure at the right Connect with the Paramedic CU ER3 ECG DEFIB Port 72 CU ER3 Operator s Manual ver 2 00 Always make sure that the defibrillator electrode pads stored together with the Paramedic CU ER3 are in good condition and not yet past their expiration date See the reverse side of the defibrillator electrode pads for their placement guide NOTICE The Paramedic CU ER3 automatically turns OFF if its operating MODE is changed while it is ON 6 2 2 Step 2 ECG Acquisition and Analysis Follow the instruction
82. he patient 10 4 SPO2 Monitoring In AED Mode If the SPO2 sensor is connected to the patient during AED mode the SPO2 value is shown at the upper right hand corner of the LCD screen display The alarm may not be enabled in AED Mode 150 34 653 98 AA Analyzing heart rhythm 91 CU ER3 Operator s Manual _ver 2 00 In Manual Mode The SPO2 value is displayed on the screen at the upper right hand corner The plethysmographic wave of the patient may be displayed on the screen by pressing the UP button on the Menu keypad The UP button toggles the display of the plethysmographic wave ON and OFF The plethysmographic wave is positioned as shown in the following figure ENERGY 150J In ECG Monitoring Mode SPO2 Monitoring may also be done when the Paramedic CU ER3 is in ECG Monitoring Mode The plethysmographic wave and the SPO2 value may be displayed e The SPO2 Alarm may be enabled and the limits may be set The following figure shows the screen display during ECG Monitoring Mode with SPO2 monitoring Spo2 ww o e654 98 ee ECG Monitoring mode Emm X 00 00 15 L T 92 CU ER3 Operator s Manual ver 2 00 10 5 Setting the Alarm The SPO2 alarm may be set to warn you if the SPO2 value goes outside of the defined lower and upper limits The alarm may be set by accessing the Device Setup Monitor Menu See section 4 5 8 If the SPO2 value falls outside the specified limits a
83. he time Make sure that you have the complete accessories during unpacking If there are problems with the shipment contact the distributor that shipped the product to you 5 2 Setup The Paramedic CU ER3 is a self contained portable device Please follow the following setup procedures upon receiving your unit to ensure that the device is always ready for any emergency 5 2 1 Manual Self Test Conduct a Manual Self Test to verify that the device is in good order Initiate a Manual Self Test by performing the following steps Press the UP and DOWN keypad buttons simultaneously Press the ON OFF button without releasing the UP and DOWN buttons The Paramedic CU ER3 turns ON and displays the text prompt SYSTEM CHECK Follow the text prompts displayed by the device that tell you to press the Menu Keys and the Shock Button one by one e Verify that the Paramedic CU ER3 displays the text prompt SYSTEM OK The Paramedic CU ER3 shuts down automatically after the Manual Self Test f If the Paramedic CU ER3 detects any fault in its system it emits a beep and turns the error indicator light ON momentarily see section 12 1 Self Tests for more details g Ifa fault is detected turn the Paramedic CU ER3 ON to see the error code h Ifa battery failure is detected recharge the battery pack see section 11 2 Internal Battery Pack Recharging for details For any other failure contact CU Medical Systems Inc or an auth
84. id or heat generation The performance and life of the battery pack may also be impaired 98 CU ER3 Operator s Manual ver 2 00 11 3 External Battery Pack An optional disposable external LiMnO battery pack is available from CU Medical Systems Inc This battery pack has a capacity of 200 shocks 150J into 509 when used before the recommended usage date The battery pack is shown in the following figure Battery Pack Case UART Port Connector AC DC Adapter Port Connector The external battery pack is fitted with a circuitry that relays signals to the Paramedic CU ER3 indicating that an external battery pack is connected to its AC DC Adapter port The signal is transmitted through the UART port Do not attempt to use external battery packs from other sources External battery packs from other sources will not be able to indicate to the Paramedic CU ER3 that a battery pack is connected at the AC DC adapter port When an external battery pack from other sources is connected to the AC DC adapter port of the Paramedic CU ER3 the Paramedic CU ER3 treats the battery pack as if it is an output from either the AC DC adapter or the car cigar lighter jack cord When this happens the battery pack will not only be used to power the Paramedic CU ER3 it will also be used to charge the internal battery pack of the device 99 CU ER3 Operator s Manual ver 2 00 External Battery Pack Status The energy level of the external battery pack
85. in red when the internal battery is being charged ERROR Indicates that a system error occurred If error lamp is ON see Chapter 13 Troubleshooting for appropriate remedial action 22 CU ER3 Operator s Manual _ver 2 00 Device Parts Explanation continued Input Output Ports ECG DEFIB port Used to connect the Defibrillator Electrode Pads assembly to the Paramedic CU ER3 Also used to connect the custom made ECG MONITORING CABLE AND CONNECTOR ASSEMBLY to the Paramedic CU ER3 SmartMedia Receptacle for the SmartMedia card CARD port pta or artMedia cari IDA bort Used to transfer ECG monitoring and rescue data from the P Paramedic CU ER3 to a personal computer Used for e transfer of ECG monitoring and rescue data from the Paramedic CU ER3 to a personal computer UART port e connection to a stand alone printer for the printing of ECG monitoring and rescue data acquisition of identification data from an external disposable battery pack AC DC Adapter port receptacle for the 12V DC power supply from an AC DC Adapter unit or a car cigar lighter jack input connector for the external disposable battery pack SPO2 Sensor Port Used to connect the SPO2 sensor to the Paramedic CU ER3 Others Battery Pack Compartment Cover Access cover to the battery pack compartment Only authorized technicians must open this if the need arises 23 CU E
86. in sequence The Paramedic CU ER3 displays the following screen s in sequence 4 Menu Button 9l Cl 8 ADMINISTRATION H 8 MONITOR e RETURN DEVICE SETUP 5 Menu Button amp to EQ 6 GENERAL DATE 03 09 09 TIME 00 15 VOICE REC ON COM PORT UART RETURN 6 Menu Button amp bH coe GENERAL goo 00 TIME i15 VOICE REC ON COM PORT RETURN 48 CU ER3 Operator s Manual _ver 2 00 General Device Setup continued The parameter variables are highlighted one by one by pressing the MENU button while the parameter is highlighted For example when DATE is highlighted the day month or year can be highlighted by pressing the MENU button repeatedly until the desired variable is reached When a variable such as day for DATE is highlighted its value can be changed by pressing the UP or DOWN button on the MENU Keypad ECBISpOs z m UP will increase the value DOWN will decrease the value When the boundary of the value is reached the value will wrap around For example for the MONTH variable of DATE a When 12 is reached while pressing the UP button one more press of the UP button will wrap the value to 01 b When O1 is reached while pressing the DOWN button one more press of the DOWN button will wrap the value to 12 49 CU ER3 Operator s Manual _ver 2 00 4 5 7 ADMINISTRATION DEVICE SETUP In the DEVICE SETUP ADMINISTRATION o
87. ines Do not connect the defibrillator pad assembly to the Paramedic CU ER3 during storage Do not open the sealed container of the pads until ready for use to prevent them from drying out 68 CU ER3 Operator s Manual _ver 2 00 6 Defibrillating in AED Mode 6 1 Overview In AED mode the Paramedic CU ER3 determines whether the patient needs a defibrillation shock or not Defibrillation is achieved in three easy steps after the patient is connected to the Paramedic CU ER3 These are 1 Select AED ON mode and turn the Paramedic CU ER3 ON 2 Follow the voice and text prompts issued by the Paramedic CU ER3 3 If prompted press the SHOCK button There are two sub modes of operation when the Paramedic CU ER3 is operating in AED Mode These are 1 Automatic Reanalysis In this mode the Paramedic CU ER3 a Automatically conducts analyses of the ECG of the patient b Automatically reanalyzes the ECG of the patient after a defibrillating shock is delivered and CPR is administered 2 No Automatic Reanalysis In this mode the Paramedic CU ER3 a Starts ECG analysis only when you press the ANALYZE button ANALYZE button is active b Reanalyzes the ECG of the patient after a shock is delivered and CPR is administered only when you press the ANALYZE button ANALYZE button is active The detailed flowchart of the rescue protocol in AED Mode Automatic Reanalysis is shown in the Appendices 69 CU ER3 Operator s Manu
88. ing the device to the car cigar lighter jack 12V Only Disposable LiMnO Battery Pack An external disposable battery pack that may be used to provide power to the Paramedic CU ER3 UART Cable Used to connect the Paramedic CU ER3 to a personal computer for rescue and ECG monitoring data transfer IrDA COM Port Serial Adapter Used to connect the Paramedic CU ER3 to a personal computer for rescue and ECG monitoring data transfer 27 CU ER3 Operator s Manual ver 2 00 Optional Accessories continued Carrying Case Used to store the Paramedic CU ER3 and the accessories needed for a rescue operation 28 CU ER3 Operator s Manual _ver 2 00 4 3 Screen Display Views 4 3 1 Initial Screen Display AED Mode Turn on the Paramedic CU ER3 while the MODE ENERGY SELECTOR is set to AED ON and observe the initial screen display shown on Figure 4 3 This screen is shown right after the Paramedic CU ER3 is done with its Power On Self Test Power On Self Test is indicated by a text prompt STARTING UP Screen Display No Defibrillator Electrode Pads Attached ATTACHPADS q Text Flashing Prompt Pads Icon Chest Compression Breath Batt ratio indicator attery Level am ocv 00 00 19 4 Elapsed Indicator Time Figure 4 3 Initial Screen Display AED Mode Manual Mode The Paramedic CU ER3 displays the screen on Figure 4 4 when it is turned ON whil
89. kel Metal Hydride rechargeable battery pack DS100A SPO2 Sensor Optional Accessories Carrying Case ER3 OA01 SmartMedia Card 32M ER3 OA02 External Thermal Printer Wire ER3 OA03 Car Cigar Lighter Jack Power Cord ER3 OA04 1 Set of Multifunction Defibrillator Electrode Pads ER3 OA05 CUA05080 External Thermal Printer Paper 10 rolls ER3 OA06 ECG Cable 3 lead ER3 OA07 ECG Electrodes ER3 OA08 Disposable Battery Pack Li ion ER3 OA09 DS100A SPO2 Sensor ER3 OA10 Data management software with Key File UART ER3 OA11 Cable Included Reduced energy Pediatric Defibrillator Electrode ER3 PPO1 Pads Pediatric Pads Connector Adapter ER3 OA12 132 CU ER3 Operator s Manual _ver 2 00 APPENDIX D TECHNICAL SPECIFICATIONS Physical Category Nominal Specifications Size 305 mm X 250 mm X 95 mm LX W X H Weight Approximately 2 8 kg Environmental Category Nominal Specifications Operating Temperature 32 F to 104 F 0 C to 40 C Conditions Humidity 5 to 95 non condensing Standby Conditions Temperature 32 F to 109 F 0 C to 43 C Ready for rescue stored together with defibrillator Humidity 5 to 95 non condensing electrode pads Storage Temperature 4 F to 140 F 20 C to 60 C Conditions device only no defibrillator Humidity 5 to 95 non condensing electrode pads Shock Drop Abuse Tolerance Meets IEC 60601 1 clause 2
90. lating mode by replacing the ECG Monitoring Cable and Connector Assembly with the Defibrillator Electrode Pads Assembly When the Paramedic CU ER3 is switched between ECG MONITORING MODE and RESCUE MODE all the relevant events e g Pads On etc are recorded The ECG waveforms and the voice signals are recorded in sequence from one mode to the other During the operation of the Paramedic CU ER3 the device can be switched from one mode to the other as often and as many times as the operator wants The ECG waveform and the voice signal will also be recorded up to the recording capacity of the Paramedic CU ER3 It is also possible to monitor the SPO2 of the patient during ECG Monitoring Mode by connecting the SPO2 sensor as directed in the chapter on SPO2 Monitoring Chapter 10 NOTICE Use only the ECG MONITORING electrodes that are recommended by CU Medical Systems Inc Do not attempt to operate the Paramedic CU ER3 in ECG MONITORING MODE using cable and connector assemblies other than the proper cable and connector assembly supplied by CU Medical Systems Inc During ECG MONITORING MODE the Paramedic CU ER3 does not do any analysis of the ECG waveform Thus the Paramedic CU ER3 is not able to prompt you about the presence of a shockable rhythm During ECG MONITORING MODE the Paramedic CU ER3 is not able to deliver a defibrillating shock 88 CU ER3 Operator s Manual ver 2 00 10 SPO2 Monitoring 10 1 Overview The Para
91. lines 138 CU ER3 Operator s Manual _ver 2 00 ECG Monitoring Mode Single channel ECG may be viewed on LCD and printed Inputs Lead II ECG is acquired using a 3 wire ECG cable and connector assembly CHECK PADS prompt and dashed line on BPM value are Lead Fault displayed when the ECG cable and connector assembly is disconnected from the ECG DEFIB port Digital readout display from 30 to 300 bpm with an accuracy Heart Rate Display of 2 You may set the lower and upper limits with the following values Lower limit from 30 to 299 bpm Upper limit from 31 to 300 bpm Heart Rate Alarm ECG Cable Length 3 meters Common mode rejection Greater than 90 dB measured per AAMI EC 13 5 mm mV 10 mm mV 20 mm mV AUTO 0 3 to 1 mV signals are displayed with 10mm mvV gain outside of that range the peak to peak value is displayed as 10 mm on the LCD display ECG size ECG Monitoring Mode 0 3 to 40 Hz 3 dB rreguency Response AED and MANUAL modes EMS 1 Hz to 30 Hz Patient Isolation Defibrillation Proof BF for all modes 139 SPO2 Pulse Oximetry CU ER3 Operator s Manual _ver 2 00 Displayed Pulse Rate 20 to 250 bpm 3 bpm Displayed Saturation SPO2 value 70 to 100 3 Perfusion 0 2 SPO2 Alarm Limits Lower limit 85 to 1 less than the upper limit Upper limit 100 to 1 more than the lower limit Display Update Int
92. manual tests Middle column Number of self tests conducted Right column The total elapsed time minutes of the particular self test 37 CU ER3 Operator s Manual _ver 2 00 4 5 2 Battery History The battery history indicates the number of minutes that the battery has been in use and the current state of the battery GOOD or LOW To access Battery History turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence DEVICE INFORMATION DEVICE HISTORY 1 ON OFF Button BATTERY HISTORY n A e RETURN DEVICE INFORMATION DEVICE HISTORY 5 BATTERY HISTORY 2 Menu Button b X GB RETURN DEVICE INFORMATION DEVICE HISTORY 3 Down Button 5 BATTERY HISTORY amp n GB RETURN 38 CU ER3 Operator s Manual ver 2 00 Battery History continued Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence BATTERY HISTORY P USAGE TIME 43500 MIN O 5 Menu Button STATUS a NENNEN Y PRESS THE MENU KEY TO RETURN Battery History indicates the following USAGE TIME Total time that the internal battery pack is used as the power supply of the Paramedic CU ER3
93. medic CU ER3 is fitted with a Nellcor SPO2 Module The SPO2 Module measures functional oxygen saturation in the blood The measurement determines the oxygenated hemoglobin as a percentage of the hemoglobin that can transport oxygen Light Emitting Diodes ss Vv vv Vw i Pug Photodetector Pulse oximetry works by having light emitting diodes pass red and infra red light into arteriolar vascular beds such as a finger or a toe and having the light detected by a photo detector afterwards Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation SpO2 Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry OXIMAX sensor serve as light sources a photo diode serves as the photo detector Because oxyhemoglobin and deoxyhem
94. more control of the rescue operation through the following e You may stop Analysis while it is in progress This is possible when the CHARGE ANALYZE button is active and the button label indicates STOP ANALYSIS e You may stop CPR administration resume ECG analysis by pressing the PAUSE DISARM button while it is labeled RESUME e You may go back to CPR administration by pressing the PAUSE DISARM button while it is labeled PAUSE 79 CU ER3 Operator s Manual _ver 2 00 7 Asynchronous Defibrillation in Manual Mode 7 1 Overview In MANUAL mode you have to determine whether the patient needs defibrillation or not You will also have to set the energy level of the shock to be delivered Manual Mode Defibrillation is achieved in three steps after the patient is connected to the Paramedic CU ER3 These are a Select an energy setting and turn the Paramedic CU ER3 ON b Analyze the ECG of the patient and press the CHARGE button if the patient needs a defibrillation shock c Press the SHOCK button 80 CU ER3 Operator s Manual _ver 2 00 Insert the SmartMedia Card into port optional Select energy setting MANUAL ON Turn the Paramedic CU ER3 ON If patient is e Not responsive e Not breathing e Pulseless Attach pads ANALYZE ECG RE NO Administer CPR YES CHARGE SHOCK Administer CPR Asynchronous Manual Defibrillation Flowchart 81 CU ER3 Operator s Manual _ver 2 00 7 2 Patient Pr
95. n alarm tone alerts you of the said condition The text prompt SPO2 ALARM also flashes on the screen The alarm may also be set while SPO2 signal acquisition is ongoing Press the Menu button and a window with the alarm settings opens Set the alarm using the keypad buttons in the same way it is done in section 4 5 8 The window with alarm settings is shown in the following figure EHERGY 98 150 04 Von Ex s SpO2 95 ALARM cabe Tam X 00 00 15 CHARGE SYNC OFF 10 6 Responding to an Alarm The alarm sound may be disabled while you are attending to the patient To disable the alarm sound press the DOWN button on the keypad The DOWN button serves to toggle the alarm sound ON and OFF The alarm sound is automatically enabled when the SPO2 value of the patient changes from a value outside the alarm limits to a value inside the alarm limits The following sequence of events illustrates this feature a The limits of the SPO2 value alarm are set from 85 to 100 b The SPO2 value of the patient falls to 80 c The alarm sounds d The alarm sound is disabled At this point as long as the SPO2 value of the patient is beyond the limits and the DOWN button is not pressed again the alarm sound stays disabled e The SPO2 value of the patient rises to 90 At this point the alarm sound is automatically enabled 93 CU ER3 Operator s Manual ver 2 00 10 7 SPO2 Monitoring Notes and Warnings e The S
96. ndicator Heart Rate Shock Count Alarm Status Indicator iua N i SPO2 Value ENERGY SYNC 150J Indicator i Pleth Wave Display ECG Display Battery Level nn Elapsed Indicator anm 00 00 15 4 F aP CHARGE Time E Alarm Beep Mt aid Icon Key Labels Legend Same as Initial Screen Display Legend 32 CU ER3 Operator s Manual _ver 2 00 4 4 Voice and Text Prompts These voice and text prompts are given when the device is operated in AED mode except for the following e The ECG MONITORING MODE text prompt is given only when the device is in Manual Mode and the ECG monitoring cable assembly is connected to the ECG DEFIB port of the device e The CHARGING text prompt is given when the defibrillating capacitor is being charged in both AED and Manual Modes Prompt Type Meaning ATTACH PADS Voice and Text Indicates that you have to attach the defibrillator electrode pads to the bare chest wall of the patient DO NOT TOUCH THE PATIENT Voice and Text Indicates that the Paramedic CU ER3 is analyzing the ECG signal acquired from the patient You must not touch the patient to minimize artifacts Motion during ECG acquisition introduces artifacts ANALYZING HEART RHYTHM Voice and Text Indicates that the device is doing an analysis of the patient s ECG SHOCK ADVISED Voice and Text Indicates that the patient has a shockable EC
97. ocks for external defibrillation Prehospital Emergency Care 2000 4 305 313 7 J P KEENER T J LEWIS The Biphasic Mystery Why a Biphasic Shock is More Effective than a Monophasic Shock for De5brillation J theor Biol 1999 200 1 17 8 AHA Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care an international consensus on science Circulation 2000 102 Suppl 1 9 U Achleitner et al Waveform analysis of biphasic external defibrillators Resuscitation 50 2001 61 70 130 CU ER3 Operator s Manual _ver 1 00 APPENDIX B Rescue Protocol in AED Mode Automatic Reanalysis You pressed the ON OFF button to turn ON the Paramedic CU ER3 Paramedic _ CU ER3 detects decides AED electrode pads attached Voice and text prompts NO ATTACH PADS T YES Voice and text prompts DO NOT TOUCH THE PATIENT E Voice and text prompts ANALYZING HEART RHYTHM y Paramedic CU ER3 detects decides NO ECG Shockable Y YES Voice and text prompts NO SHOCK ADVISED Voice and text prompts SHOCK ADVISED v Voice and text prompts i CHECK PULSE Voice and text prompts Timer STAND CLEAR 10 second interval for checking pulse v Text prompt flashing CHARGING Speaker playback Voice and text prompts SIREN SOUND IF N
98. of explosion or fire if the Paramedic CU ER3 is used in the presence of flammable agents or in an OXYGEN enriched atmosphere Do not use the Paramedic CU ERS if it has been submerged in water Call immediately for service assistance To ensure safety and reliability use only parts and accessories approved by CU Medical Systems Inc 2 2 Electrical Safety Guidelines Usethe correct power supply during recharging See the Chapter on Power Supply for more details During recharging do not place the device where the environmental conditions exceed the operating conditions specified in the Device Operation Guidelines Electromagnetic interference may alter device performance During operation the device should be placed away from sources of electromagnetic interference such as motors generators X Ray equipment radio transmitters cellular mobile telephones and others as these might interfere with the signals being acquired and analyzed NOTICE The Paramedic CU ER3 is classified as follows It is a Class I BF equipment in terms of electrical shock prevention EN 60601 1 Therefore this device is not rated for use around combustible anesthetic or solvents The Electromagnetic emission level is Class B according to EN 60601 1 Safety of Electric Medical Equipment and the noise redemption is B level according to the EN 60601 1 2 Electromagnetic Compatibility Requirements 14 CU ER3 Operator s Manual ver 2 00
99. oglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The pulse oximeter bases its SpO2 measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood Texts in this section are excerpts from Oximax N 595 Pulse Oximeter Operator s Manual Nellcor Puritan Bennett Inc 89 10 2 Pulse Oximetry Sensors CU ER3 Operator s Manual ver 2 00 The Paramedic CU ER3 is equipped with a DS100A reusable Nellcor sensor that is designed to be used with a finger of the patient Other sensors from Nellcor may also be used with the Paramedic CU ER3 The following table shows all the Nellcor Oximetry sensors that may be used with the Paramedic CU ER3 Choose the sensors to suit the weight of the patient Sensor Type Patient Patient Size Ideal Site MAX FAST disposable Pediatric gt 10 kg forehead Adult MAX AG disposable Adult gt
100. oltage Time from initially switching power ON or from within any OPERATOR programming mode to the DEFIBRILLATOR being ready at 200 Joules Less than 20 seconds Using new fully charged NiMH internal battery pack Less than 20 seconds Using new disposable external LiMnO2 battery pack Less than 20 seconds Using AC power at 100 of rated mains voltage Less than 20 seconds Using new fully charged NiMH internal battery pack depleted by 15 discharges at 200 Joules per discharge Less than 20 seconds Using new LiMnO battery pack depleted by 15 discharges at 200 Joules per discharge Less than 20 seconds Using AC power at 90 of rated mains voltage Less than 20 seconds Time from initially switching power ON to charge ready at 200 Joules using AC power at 90 of the rated mains voltage Less than 20 seconds Using AC power at 90 of the rated mains voltage Output Energy 2 3 5 7 10 20 30 50 70 100 150 200 Joules Delivered Controls Power ON OFF SHOCK Mode Energy Select CHARGE DISARM SYNC Plethysmographic wave display ON OFF Monitor Alarm Menu Alarm Silence Electroluminescent back lit Liquid Crystal Display for ECG waveform and Indicators Plethysmographic wave text prompts Alarm indicators and Menu Operation Display Armed Charging complete text prompt Continuous tone on beeper Indicators Flashing red backlight of
101. oltage that controls what an amount of current can be pushed and the duration of time the current flows This defibrillation current is commonly described in joules of energy Energy is a measure of the amount of current voltage and duration of time the current flows Energ yGoules Current amps x Voltage volts x Time sec 124 CU ER3 Operator s Manual ver 2 00 When the Defibrillation shock is delivered current flow is affected by transthoracic impedance the body s resistance from electrode to heart Impedance is dependent on the anatomy of the chest skin surface air in the chest hair fat and bone as well as the size and location of the defibrillation electrodes Voltage vo Its Resistance ohms Current am ps Research has shown that chest resistance can vary significantly from patient to patient Patients with low impedance are generally easier to defibrillate because the flow of current meets little resistance Those with higher impedance may be more difficult to defibrillate According to the International Guidelines 2000 by the American Heart Association AHA in collaboration with the International Liaison Committee On Resuscitation ILCOR average adult impedance is 70 80 ohms Defibrillation energy should be designed to optimize the delivery of current over a wide range of patient impedances Too much current to the myocardial cells can cause damage to the cells and result in an unsuccessful defibrillation Too
102. or s Manual _ver 2 00 Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 4 Menu Button amp fa XR e DEVICE SETUP M ADMINISTRATION MONITOR RETURN 5 DOWN Button amp la G e DEVICE SETUP GENERAL ADMINISTRATION MONITOR RETURN 6 DOWN Button amp fa G e DEVICE SETUP GENERAL ADMINISTRATION MONITOR 7 MENU Button amp fh FJ o gt gt SpO2 Limits MONITOR on HR Limits 60 120 BPM RETURN 90 99 DISPLAY ECG RETURN 60 Device Setup Monitor continued CU ER3 Operator s Manual _ver 2 00 Cycle through the parameters by pressing the UP or DOWN button To change the value of a parameter highlight its variable by pressing the Menu button while the parameter is highlighted and then press the UP or DOWN button For example when HR Limits is highlighted the lower limit or the upper limit can be highlighted by pressing the MENU button repeatedly until the desired variable is reached The variable values can be changed by pressing the UP or DOWN button while the variable is highlighted The Paramedic CU ER3 sounds an alarm when the ALARM is ON and the heart rate or the SPO2 value falls beyond the limits Parameter Description Setting Choices ALARM Turns the alarm f
103. orized representative anow 66 CU ER3 Operator s Manual _ver 2 00 5 2 2 Battery Charge Check The internal battery pack of the Paramedic CU ER3 is fully charged before leaving the factory In the course of storage in the distribution system the battery pack may be depleted when the Paramedic CU ER3 reaches you The Manual Self Test in the previous section can detect a drained battery pack condition At this condition the Paramedic CU ER3 displays an error message when it is turned ON and it can not be used in a rescue operation If a low battery error occurs during the manual self test in the previous section recharge the battery pack When the battery pack is not fully drained check the battery level by activating the Menu and accessing Battery History see section 4 5 2 Battery History If the battery status is LOW recharge the battery pack 5 2 3 Battery Charging Charge the internal battery pack of the Paramedic CU ER3 if the Manual Self Test indicates a Battery Failure error or if the indicator in the Battery History Menu indicates LOW battery status To charge the battery pack see Section 11 2 Internal Battery Pack 5 2 4 Configuration Settings You must set the following parameters of the Paramedic CU ER3 before deploying it for use Time and Date Settings The Paramedic CU ER3 is equipped with a timer integrated circuit that continuously keeps track of time and date You must set the timer when you receive the Pa
104. ower cord to the AC DC adapter port of the Paramedic CU ER3 d Disconnect the power cord from the AC DC adapter port before turning the engine of the vehicle OFF 97 CU ER3 Operator s Manual ver 2 00 Internal Battery Charging Indicator The Paramedic CU ER3 indicates that charging is in progress through the Battery Indicator lamp When charging is in progress the Battery Indicator lamp is red and flashing When charging is finished the Battery Indicator lamp is green and non flashing NOTICE Do not remove or change the internal battery pack If the battery pack reaches the end of its lifecycle have it changed and disposed of by the manufacturer or any of its authorized representatives The internal battery pack is not to be disposed of in fire nor incinerated It is not to be shorted nor disassembled It is not to be taken off its compartment and recharged with a charger other than the built in charger of the Paramedic CU ER3 If the internal battery pack leaks call the manufacturer or any of its authorized representatives immediately When the operating time of the internal battery pack becomes much shorter than its initial operating time have it replaced by the manufacturer or any of its authorized representatives The battery pack is not to be subjected to sharp impacts or concussions The battery pack is to be recharged within the temperature range 0 to 40 Recharging beyond this range may cause leakage of battery flu
105. p fo FJ o gt Manual Mode Security ON PASSWORD Enter New Password EB HH EH EN 7 Menu Button Use the UP and DOWN buttons to cycle through YES and NO amp fh FJ o gt Manual Mode Security ON PASSWORD Enter New Password CE E E Save Changes to Password YES NO 8 Menu Button amp fh FJ e gt gt ADMINISTRATION AED SETTINGS GENERAL SETTINGS s RETURN 58 CU ER3 Operator s Manual _ver 2 00 4 5 8 Device Setup Monitor The Device Setup Monitor Menu enables you to set the Monitor Settings of the Paramedic CU ER3 You may set the alarm function together with its limits in this menu You may also set the display on the screen To access Device Setup Monitor turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence DEVICE INFORMATION DEVICE HISTORY 1 ON OFF Button BATTERY HISTORY n A e RETURN REVIEW INCIDENT USAGE REVIEW 2 Down Button ECG REVIEW VOICE REVIEW amp fo XO RETURN DEVICE SETUP GENERAL 3 Down Button 9 ADMINISTRATION MONITOR RETURN amp la G e 59 Device Setup Monitor continued CU ER3 Operat
106. perating parameters such as automatic reanalysis in AED mode ECG Gain and speaker volume can be set or adjusted by the operator To access Device Setup Administration turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 1 ON OFF Button DEVICE INFORMATION DEVICE HISTORY BATTERY HISTORY n A e RETURN 2 Down Button REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW amp fo XO RETURN 3 Down Button DEVICE SETUP GENERAL ADMINISTRATION MONITOR RETURN amp fa R G e 50 CU ER3 Operator s Manual _ver 2 00 Device Setup Administration continued Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 4 Menu Button DEVICE SETUP 5 DOWN Button 9 Cl 8 ADMINISTRATION B 8 MONITOR e RETURN DEVICE SETUP O as GENERAL Cl a H 9 MONITOR e RETURN 6 MENU Button PASSWORD Enter Password amp bH coe The DEVICE SETUP ADMINISTRATION menu is accessible only after the Password is entered The Password is entered through the MENU keys UP MENU DOWN It consists of 4 pre
107. port by setting the COM PORT to IrDA as outlined in the GENERAL DEVICE SETUP of the section on MENU OPERATION 115 CU ER3 Operator s Manual ver 2 00 Transmit the data from the Paramedic CU ER3 through the following steps 1 Open the CU Expert ECG Data Management Software in the host personal computer 2 Turn the Paramedic CU ER3 ON with the MODE ENERGY selector knob set to MENU 3 Go to the CU Expert and begin data reception by executing the instructions given in its User s Manual 4 Go back to the Paramedic CU ER3 Go to COMMUNICATION DATA TRANSMISSION The following screen should be displayed COMMUNICATION 0 DATA RECEPTION PRINT z m RETURN Push the MENU button The data transmission screen is displayed DATA TRANSMISSION Communication icon gt gt Connection icon t H gt coe PRESS THE MENU KEY TO RETURN When the Paramedic CU ER3 is communicating the Communication icon shows moving arrow tips 116 CU ER3 Operator s Manual ver 2 00 The Connection icon shows the status of the connection of the Paramedic CU ER3 with the PC during data transmission Icon Meaning Before the start of data transmission A connection has not been made yet os MAIL At the end of data transmission Data transfer has been finished A connection has been established and communication is ongoing When m s nmm
108. ramedic CU ER3 To set the time and date see section 4 5 6 General Device Setup Device Administration Settings Set the following Administration Settings a Password Automatic Reanalysis during AED Mode Operation ECG Gain Speaker Volume Password protection in Manual Mode Operation panog To set the Device Administration Settings see section 4 5 7 67 CU ER3 Operator s Manual ver 2 00 Monitor Settings The Paramedic CU ER3 enables you to set the following monitor settings a Alarm b HRLimits c SpO2Limits d DISPLAY To set the Monitor Settings see section 4 5 8 5 3 Storage Place the Paramedic CU ERS in an accessible place so that it can be used readily during emergencies Do not open the Battery Compartment Cover Do not disconnect the internal battery pack during storage The internal battery pack must be connected all the time so that e The Paramedic CU ER3 can be readily turned ON during emergencies e The Paramedic CU ERS can conduct automatic periodic self tests The battery pack powers the Paramedic CU ER3 during these tests Check the status of the Paramedic CU ERS daily by turning it ON Pay close attention to the power level of the battery pack see section 4 3 Screen Display Views on how to interpret the Battery Status Icon and Chapter 11 Power Supply on how to recharge the batteries Store the Paramedic CU ER3 within the environmental conditions specified in section 2 1 General Guidel
109. ranty Warranty Disclaimer Servicing by unauthorized personnel renders this warranty null and void If the factory seal is broken without proper authorization from CU Medical Systems Inc this warranty becomes null and void Service CU ER3 Operator s Manual _ver 2 00 The Paramedic CU ER3 must be serviced only by authorized personnel Unauthorized servicing during the warranty period renders the warranty null and void The Paramedic CU ER3 will be serviced free of charge during the warranty period After the warranty period the cost of material and service shall be shouldered by the user When the Paramedic CU ER3 is not operating properly immediately bring it for servicing to an authorized service center e Please fill up the following table with the necessary information when requesting for service Product Paramedic Model CU ER3 Serial No Date of Purchase Sales Representative Authorized Dealer Address Customer Information Name Contact No Brief Description of Problems 10 CU ER3 Operator s Manual _ver 2 00 CONTACT US You may contact us at the following address and telephone number for services and supplies Product and Order Inquiries International Marketing Team CU Medical Systems Inc Room No 534 DooSan Venture Digm 126 1 Pyeongchon dong Dongan gu Anyang si Gyeonggi do Republic of Korea Tel 82 31 478 5722 Fax 82 31 478
110. s Manual ver 2 00 8 6 SHOCK Confirm that the patient still needs a synchronized cardioversion shock Confirm that the Paramedic CU ER3 has finished charging The beeper must emit a continuous tone and the SHOCK button must be flashing its red backlight Make sure that nobody is touching the patient and shout out loudly STAND CLEAR Press the SHOCK button continuously to deliver the shock You must press the SHOCK button continuously until the shock is delivered The Paramedic CU ER3 synchronizes the delivery of the shock with an R wave of the patient The Paramedic CU ERS delivers the shock within 60 milliseconds of the first R wave detected after you press the SHOCK button The Paramedic CU ER3 may be disarmed after it is charged To disarm the Paramedic CU ER3 press the DISARM button If the SHOCK button is not pressed within 15 seconds after the Paramedic CU ER3 has been charged the Paramedic CU ER3 automatically disarms itself After delivering the shock attend to the patient in accordance with the International Guidelines for CPR cardiopulmonary resuscitation and ECC emergency cardiovascular care Determine whether more shocks are needed or not 86 CU ER3 Operator s Manual _ver 2 00 9 ECG Monitoring In Manual Mode 9 1 ECG Monitoring Mode You may activate the ECG Monitoring Mode by connecting the custom made ECG Monitoring Cable and Connector Assembly provided by CU Medical Systems Inc In this mo
111. s NO SHOCK ADVISED 1 The Paramedic CU ER3 gives the prompts CHECK PULSE and IF NO PULSE BEGIN CPR 2 Check the patient and do CPR if the patient has no pulse Attend to the patient according to CPR guidelines on AED Treatment 74 CU ER3 Operator s Manual ver 2 00 6 2 3 Step 3 Shock Delivery Press the SHOCK Button if instructed You must press the SHOCK button when the Paramedic CU ER3 gives the prompt to press the flashing red SHOCK button in order to deliver the shock The Paramedic CU ER3 gives the following indications to signify that you must press the SHOCK button 1 A voice prompt telling you to Press the flashing red button now A text prompt displayed on the LCD screen telling you to Press the flashing red button now 3 The red backlight of the SHOCK button is flashing and the beeper is emitting a continuous tone In AED Mode the Paramedic CU ERS3 does not automatically deliver the shock after charging It waits for you to press the SHOCK button Do not let anybody touch the patient when you press the SHOCK button Defibrillation shock can cause operator or bystander injury The Paramedic CU ER3 gives the prompt SHOCK DELIVERED voice and text after the shock is delivered to the patient The Paramedic CU ER3 also shows the cumulative number of shocks delivered during the rescue operation After a shock is delivered the Paramedic CU ERS guides you in the administration of cardiopulmon
112. s desired to print only a segment of the stored ECG data highlight PRINT SEGMENT then press the MENU button The Paramedic CU ER3 displays the following screen POWER ON 00 00 00 PADS ON 00 00 00 ANALYZING 00 00 05 SHOCK ADVISED 00 00 09 ARMED 00 00 18 gt g d PRESS THE MENU KEY TO RETURN The event highlights are displayed 6 Choose the starting point of the segment to be printed by pressing the UP or DOWN button A highlighter bar appears and scrolls UP or DOWN 7 Mark the starting Event point by highlighting it with the highlighter bar and pressing the MENU button 8 Choose the ending Event point by pressing the DOWN button As the DOWN button is pressed the Events included in the segment to be printed are highlighted The ending point will be the last highlighted event After choosing the range to be printed the screen display will look like this 121 CU ER3 Operator s Manual ver 2 00 PRINT SEGMENT POWER ON 00 00 00 PADS ON 00 00 00 ANALYZING 00 00 05 SHOCK ADVISED 00 00 09 ARMED 00 00 18 1 5 PRESS THE MENU KEY TO RETURN 9 Press the MENU button to print the chosen segment While the segment is being printed the Paramedic CU ER3 displays the PRINT SEGMENT screen PRINT SEGMENT Qs g d PRESS THE MENU KEY TO RETURN 122 CU ER3 Operator s Manual _ver 2 00 Notes 123 CU ER3 Operator s Manual _ver 2 00 APPENDIX A A
113. s provided by the voice and text prompts of the Paramedic CU ER3 The Paramedic CU ER3 automatically acquires and analyzes the ECG of the patient when 1 The defibrillator electrode pads are correctly attached to the patient 2 And the plug of the defibrillator electrode pads connector is connected to the ECG DEFIB port of the Paramedic CU ER3 Do not touch the patient during ECG acquisition and analysis The patient must be still during ECG signal acquisition and analysis to minimize motion artifacts in the signal Electronic devices that may interfere with the ECG signal should be turned off or moved to a safe distance during signal acquisition and analysis The Paramedic CU ER3 decides and gives the prompt SHOCK ADVISED or NO SHOCK ADVISED after ECG analysis 73 CU ER3 Operator s Manual ver 2 00 If the decision is SHOCK ADVISED 1 The Paramedic CU ERS charges itself in preparation for shock delivery The Paramedic CU ER3 emits a warning tone during charging The Paramedic CU ER3 gives the text prompt CHARGING COMPLETE at the end of the charging process 2 The Paramedic CU ER3 gives the prompt PRESS THE FLASHING RED BUTTON NOW after charging While the Paramedic CU ER3 is charging after a shockable rhythm is detected the ECG of the patient is continuously acquired and analyzed If the ECG rhythm changes to a non shockable rhythm the Paramedic CU ER3 disarms itself If the decision i
114. sses of the buttons on the MENU buttons group The Password set by default at the factory is UP UP UP UP UP is the UP arrow button 51 CU ER3 Operator s Manual _ver 2 00 4 5 7 1 AED SETTINGS The AED Settings Menu allows you to turn the Reanalysis option ON or OFF To access the AED Settings access the Device Setup Administration Menu by pressing the keypad keys as shown in 4 5 7 Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence ADMINISTRATION AED SETTINGS Key sequence in GENERAL SETTINGS 1 to 10 4 5 7 plus PassWord amp PASSWORD amp fb Eo 6 RETURN Upon entering the correct password this screen is displayed AED SETTINGS Automatic Reanalysis ON Compression Breath Ratio 30 2 2 Menu Button amp fo FJ e RETURN AED SETTINGS Automatic Reanalysis ES Compression Breath Ratio 30 2 3 Menu Button gt amp bce RETURN Automatic Reanalysis can be set ON or OFF by pressing the DOWN or UP button respectively 52 CU ER3 Operator s Manual ver 2 00 Setting the Automatic Reanalysis Option ON makes the Paramedic CU ER3 analyze and reanalyze the ECG signal from the patient during operation in AED mode without intervention from you When this option is turned OFF you have to press the ANALYZE CHARGE button to initiate ECG signal analysis Compre
115. ssion Breath Ratio setting allows you to change the ratio of the chest compression to respiration setting Two settings are available for Compression Breath Ratio 30 2 gt CPR guide allocates time and beat for 30 chest compressions and 2 respirations per CPR cycle 15 2 CPR guide allocates time and beat for 15 chest compressions and 2 respirations per CPR cycle To exit AED SETTINGS highlight RETURN then press the MENU button 53 CU ER3 Operator s Manual _ver 2 00 4 5 7 2 GENERAL SETTINGS The General Settings menu enables you to set the ECG gain and the volume of the speaker To access the General Settings Menu access the Device Setup Administration Menu by pressing the keypad keys as shown in 4 5 7 Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence ADMINISTRATION AED SETTINGS GENERAL SETTINGS 1to10 Key sequence in 4 5 7 plus password PASSWORD amp bce RETURN Upon entering the correct password this screen is displayed ADMINISTRATION AED SETTINGS 2 Down Button ECE PASSWORD RETURN GENERAL SETTINGS Volume 28 amp fh FJ o 3 Menu Button amp fh FJ o RETURN 54 CU ER3 Operator s Manual ver 2 00 You may scroll the highlighter between ECG GAIN and Volume by pressing the UP or DOWN key button You may change the ECG G
116. ssssssssrrrrrssrrrrrrrrsrrrrrrrrss 14 3 Introductio a Pes cae AR ie eae sea ede A aes 15 3 1 Product DeESCTIPtiON cciceccee eee eee eee eee e nnnm 15 3 2 Indicated S6 eee eae tena eee RETE E EH EYE 16 3 2 JOAED MOE ee ise deseen a tse tee 16 3 2 2 Manual Mode ssssssseesseese nennen ene ness 16 3 2 3 SPO2 Monitoring iix t eR ERR RUE EAR IER 17 3 2 4 ECG MonitOFlng re deer 17 3 3 Intended Users ciens ee necne e xe xn exu VER EXER S 18 CECI AED MOUE ei ae AEE a lates bende ta lets 18 3 3 2 Manual Mode era na e x ER EE ra e RR 18 4 Operating Controls Indicators and Accessories usus 19 4 1 Device Parts Illustration cssseseeenm mmm 19 4 2 ACCESS ONES ois ce pori xr tosee dv te Biv tre dee ier evo er eie dede qu 24 4 3 Screen Display Views sessesseeeee nnnm nnns 29 4 3 1 Initial Screen Display eeseeeeennnn nn 29 4 3 2 Screen Display Rescue Operation Ongoing 32 4 4 Voice and Text Prompts essessesseeeenne nennen nnn 33 4 5 Menu Operation cec xere aR ANANA eru Rr e Rx ERR XX Re eas 35 4 5 1 Device HIStory ccinn e i e exe de e teet d 36 4 5 2 Battery History csssssesssessse n mmm 38 4 5 3 Usage Review iere Rennen Re A er n x eds 40 4 5 4 ECG Review orritan teiaa nnnm rna nnn 43 4 5 5 Volce REVIEW oe i ER Rp E ADIPE REX ER EYTIRR OE aK Eein EE 45 4 5 6 General Device Setup
117. st To initiate a Manual Self Test 1 Press the UP A and DOWN keys in the MENU keypad simultaneously 2 Turn ON the Paramedic CU ER3 without releasing the UP and DOWN buttons 3 The Paramedic CU ER3 turns ON and displays the text prompt SYSTEM CHECK 4 The Paramedic CU ER3 prompts you to press the Menu Keys and the SHOCK button one by one You must press the particular key button under test within 10 seconds of the prompt If you do not press the key button within 10 seconds the Paramedic CU ER3 will interpret it as a button key failure The SYSTEM OK prompt will be displayed on the LCD if the Paramedic CU ER3 detects no failure during a Manual Self Test 12 2 Maintenance Although there are no user serviceable parts inside the Paramedic CU ER3 you can perform simple maintenance tasks to help prolong the life of the device and to help ensure that the device is in working condition The following are the activities together with frequency that you can perform Used consumables should be disposed of in accordance with local regulations Care should be taken in disposing of the used defibrillator electrode pads so as not to contribute to the pollution of the environment 105 CU ER3 Operator s Manual _ver 2 00 Maintenance Activities Frequency Activity Actions to be Taken Check the Paramedic CU ER3 If a message that the battery is low for any error messages that is displayed recharge the battery
118. t Tek Stop 149 CU ER3 Operator s Manual ver 2 00 1759 Impedance Load 150 Joules output TekStop E 150 CU ER3 Operator s Manual ver 2 00 250 Impedance Load 200 Joules Tek Stop 5090 Impedance Load 200 Joules Tek Stop 151 CU ER3 Operator s Manual ver 2 00 7590 Impedance Load 200 Joules Tek Stop 1002 Impedance Load 200 Joules Tek Stop 152 CU ER3 Operator s Manual ver 2 00 1250 Impedance Load 200 Joules Tek Stop 1502 Impedance Load 200 Joules Tek Stop 153 CU ER3 Operator s Manual ver 2 00 1759 Impedance Load 200 Joules TekStop 154 CU ER3 Operator s Manual _ver 2 00 CU Medical Systems Inc B Address Product and Order Inquiries International Marketing Team CU Medical Systems Inc Room No 534 DooSan Venture Digm 126 1 Pyeongchon dong Dongan gu Anyang si Gyeonggi do Republic of Korea Tel 82 31 478 5722 Fax 82 31 478 5729 email address sales cu911 com Service Request and Technical Support Customer Service Team CU Medical Systems Inc Medical Industry Complex Bldg No 2 1720 26 Taejang dong Wonju si Gangwon do 220 120 Republic of Korea Tel 82 33 747 7690 Fax 82 33 747 7659 email address service cu911 com E Homepage http www CU911 com Medical Systems Inc 155
119. t as the one done during Power On Test vi CPLD test tests the complex programmable logic device CPLD for functionality c Monthly Periodic Self Test this automatic self test is done once a month The following subsystems are tested i All the subsystems tested under the Weekly Periodic Self Test ii Capacitor charging test tests the charging function of the Paramedic CU ER3 s defibrillating capacitor 12 1 4 Run Time Self Test Aside from the Power On Self Test the Paramedic CU ER3 performs a Run Time Self Test continuously whenever it is operating after checking that the defibrillator electrode pads are properly attached to the patient The following are checked during a Run Time Self Test a Battery Capacity Check same as the one done during Power On Self Test b Capacitor charging and discharging charging and discharging are verified when these actions are carried out by the Paramedic CU ER3 during a rescue operation If charging or discharging fails the operator is prompted of the failure c CPLD the functionality of the CPLD is verified whenever any function using the said logic device is carried out 104 CU ER3 Operator s Manual _ver 2 00 12 1 5 Manual Self Test The Paramedic CU ER3 can also run a manual self test that requires your intervention The manual mode test evaluates all functions tested in all the automated test modes Power On Self Test Run Time Self Test Daily Weekly Monthly Periodic Self Te
120. transferred to a personal computer If the SmartMedia Card is not inserted the data stored in the internal flash memory is printed If the SmartMedia Card is inserted the ECG data stored in it is printed To access the Communication menu turn ON the device with the MODE SELECTOR set to MENU and press the sequence of keypad buttons shown in the following table Press the following button s The Paramedic CU ER3 displays the following in sequence screen s in sequence DEVICE INFORMATION rj DEVICE HISTORY 1 ON OFF Button BATTERY HISTORY sal g RETURN REVIEW INCIDENT io USAGE REVIEW f 2 DOWN Button x ECG REVIEW B VOICE REVIEW g RETURN 63 Communication Print continued CU ER3 Operator s Manual _ver 2 00 Press the following button s in sequence The Paramedic CU ER3 displays the following screen s in sequence 3 DOWN Button DEVICE SETUP GENERAL ADMINISTRATION MONITOR RETURN 4 DOWN Button 5 MENU Button 6 DOWN Button COMMUNICATION DATA TRANSMISSION Cl 8 DATA RECEPTION X PRINT ji e RETURN COMMUNICATION 8 DATA RECEPTION 8 PRINT RETURN COMMUNICATION DATA TRANSMISSION Cl x ES PRINT ji e RETURN 64 CU ER3 Operator s Manual _ver 2 00 Press the following button s The Paramedic CU ER3 displays the following in sequence screen
121. tton SYNC Button PAUSE DISARM Button Microphone Menu Keys Indicator Lamps MODE ENERGY Selector Knob SHOCK Button Figure 4 1 Top view of the Paramedic CU ER3 19 CU ER3 Operator s Manual ver 2 00 Battery Pack Compartment SmartMedia spo2 oo Card Port Sensor Port KONTOR UART Port AC DC Adapter Port Figure 4 2 Side view of the Paramedic CU ER3 20 CU ER3 Operator s Manual _ver 2 00 Device Parts Explanation Displays the ECG and plethysmographic waveform of the LCD Screen i Mn patient and the various prompts and indicators Microphone Captures audio signals during a rescue operation Plays voice prompts during rescue operation and recorded Speaker T P p audio signal during recording playback Quick Reference Guide Outlines the steps to be taken during a rescue operation Operating Controls Q ON OFF Switch Turns the power of the Paramedic CU ER3 ON or OFF N SHOCK button Flashes its red backlight when the Paramedic CU ER3 is ready to deliver a shock Delivers the shock when pressed while the backlight is flashing PE MENU keys Controls special functions such as device setup and data management and review In AED Mode M e used to increase the volume of the UP Button ay be used to i en volu o speaker for louder voice prompts DOWN May be used to decrease the volume of the Button speaker for softer voi
122. unction of the ON OFF Paramedic CU ER3 ON or OFF The alarm function is for ECG alarm or SPO2 alarm HR Limits Sets the lower and upper limits of the Lower limit 30 to 299 bpm ECG Heart Rate alarm Upper limit 31 to 300 bpm Upper and lower limits may be set 1 bpm apart SpO2 Limits Sets the lower and upper limits of the Lower limit 85 to 99 SpO2 alarm Upper limit 86 to 100 Upper and lower limits may be set 1 apart DISPLAY Sets the waveform that is displayed on ECG the screen display ECG SpO2 Setting this to ECG shows only the ECG wave on the screen display Setting this to ECG SpO2 shows the ECG and plethysmographic wave on the screen display 61 CU ER3 Operator s Manual ver 2 00 Shortcut Access to the Device Setup Monitor Menu In Manual Mode fast access to the Device Setup Monitor Menu is provided through the keys of the Menu Keypad ALARM and the rate limits can be set by pressing the Menu Button A window pops up on the screen when the Menu Button is pressed while the Paramedic CU ER3 is operating in Manual Mode The ALARM and rate limits settings can then be changed This is shown in the following figure EHERGY 150J CHARGE SYNC OFF 62 CU ER3 Operator s Manual _ver 2 00 4 5 9 Printing and Transferring Data The ECG and rescue data stored in the internal flash memory or the SmartMedia Card may be printed through the optional stand alone thermal printer or
123. used the transients during power changeover in the middle of a rescue operation may cause some problems in the operation of the device 11 5 Car Cigar Lighter Jack The Car Cigar Lighter Jack is another convenient power source for the Paramedic CU ER3 This is to be connected to the cigar lighter jack of a vehicle 12V DC The cigar lighter jack power cord is shown in the following figure Cigar Lighter Jack Connector Output Jack Connecting the Cigar Lighter Jack Connector a Turn the engine of the vehicle ON b Plug the appropriate end of the connector to the cigar lighter jack of the vehicle c Connect the output jack of the connector to the AC DC Adapter port of the Paramedic CU ER3 d If needed turn the Paramedic CU ER3 ON When using the car cigar lighter jack for recharging the vehicle must be started before the plug is connected and when the recharging is finished the plug must be pulled out before the vehicle engine is turned off When the Paramedic CU ER3 is powered using the AC DC Adapter Port the presence absence and the level of the internal battery pack does not affect the defibrillating capacitor charging time 102 CU ER3 Operator s Manual _ver 2 00 12 TESTING MAINTENANCE AND TROUBLESHOOTING 12 1 Testing To ensure that the Paramedic CU ER3 is always ready for any emergencies self tests and interactive tests are performed by the device If the ERROR LED is ON consult the chapter on Troubl

CU Medical Systems, Inc.

Contents

Download Pdf Manuals

Related Search

Related Contents