CU Medical Systems Paramedic CU-ER1 Operator'S Manual Download Page 104

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CU-ER1 Operator’s Manual _ver 3.00

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, SHOCK button, Volume control

Indicators

Electroluminescent back lit Liquid Crystal Display for ECG waveform and text

prompts.

AC Power, Battery, and ERROR indicator lamps

Armed
Indicators

“Charging complete” text prompt
Continuous tone from the beeper
Flashing red backlight of the SHOCK button

Patient Analysis

•

Detects and evaluates connection impedance for proper
defibrillator electrode pads contact.

•

Analyzes patient’s ECG to determine if a shock is necessary.

Shockable
rhythms

•

Ventricular Fibrillation

•

Ventricular Tachycardia with rates > 220 bpm

Sensitivity and
Specificity

Meets AAMI guidelines

104

Summary of Contents for Paramedic CU-ER1

Page 1: ...CU S Emergency Responder 1 Operator s Manual 1 CU Medical Systems Inc Paramedic Series AED CU ER1 ...

Page 2: ...CU ER1 Operator s Manual _ver 3 00 Paramedic CU ER1 Quick Reference Card 2 ...

Page 3: ... 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 ER1 version 3 00 2006 CU Medical Systems Inc No part of this manual may be reproduced without the permission of CU Medical Systems Inc 3 ...

Page 4: ...ion 14 3 2 Indicated Use 15 3 3 Intended Users 15 4 Device Orientation 16 4 1 Device Parts Illustration 16 4 2 Accessories 19 4 3 Screen Display Views 24 4 3 1 Initial Screen Display 24 4 3 2 Screen Display Rescue Operation Ongoing 26 4 4 Voice and Text Prompts 28 4 5 Menu Operation 30 4 5 1 Device History 31 4 5 2 Battery History 33 4 5 3 Usage Review 35 4 5 4 ECG Review 38 4 5 5 Voice Review 40 ...

Page 5: ... 8 1 Power Sources 63 8 2 Internal Battery Pack 63 8 3 External Battery Pack 66 8 4 AC DC Adapter 68 8 5 Car Cigar Lighter Jack 69 9 Testing Maintenance And Troubleshooting 70 9 1 Testing 70 9 1 1 Automatic Self Tests 70 9 1 2 Power On Self Test 70 9 1 3 Periodic Self Tests 71 9 1 4 Run Time Self Test 71 9 1 5 Manual Self Test 72 9 2 Maintenance 72 9 3 Cleaning the Paramedic CU ER3 75 10 Troublesh...

Page 6: ...a Stand alone Serial Printer 85 APPENDIX A 91 e cube Biphasic Technology 91 APPENDIX B 98 Rescue Protocol 98 APPENDIX C 99 Parts and Accessories Number 99 APPENDIX D 100 Technical Specifications 100 Electromagnetic Compatibility 108 Paramedic CU ER1 Shock Waveform Plots 112 6 ...

Page 7: ...ISO13485 2003 MDD 93 42 EEC This ensures that CU Medical Systems Inc provides products of high quality and reliability In this regard z Only persons authorized by CU Medical Systems Inc may service this device There are no user serviceable parts in this device z You must operate this device in accordance with the instructions specified in this manual To ensure safety and reliability use only parts...

Page 8: ...e 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 an...

Page 9: ...After the warranty period the cost of material and service shall be shouldered by the user y When the Paramedic CU ER1 is not operating properly immediately bring it for servicing to an authorized service center y Please fill up the following table with the necessary information when requesting for service Product Paramedic Model CU ER1 Serial No Date of Purchase Sales Representative Authorized De...

Page 10: ... 478 5722 Fax 82 31 478 5729 email address admin 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 admin cu911 com Our website http www cu911 com EU Authorized Respresentative of CU Medical System Inc Br...

Page 11: ...act 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 Used...

Page 12: ...0 C to 60 C Humidity 5 to 95 non condensing Do not store the device in areas that are directly exposed to sunlight 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...

Page 13: ...rating 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 The Paramedic C...

Page 14: ...atient and critical events charging shock delivery etc are automatically recorded in the internal memory of the device Voice recording may also be done if the optional removable flash memory card is used The ECG data acquired by the Paramedic CU ER1 may be reviewed and printed directly using the device or may be transferred to a personal computer for archiving review and printing The Paramedic CU ...

Page 15: ...he Paramedic CU ER1 may be used on children under 8 years old or under 25kg 55 lb in weight If the patient appears to be less than 8 years old or under 25kg 55 lb use the reduced energy defibrillator pads The Paramedic CU ER1 may be used to monitor the ECG of a responsive and breathing patient Use the optional ECG monitoring cable and connector assembly 3 3 Intended Users The Paramedic CU ER1 is i...

Page 16: ...CU ER1 Operator s Manual _ver 3 00 4 Device Orientation 4 1 Device Parts Illustration Figure 4 1 The Paramedic CU ER1 Figure 4 2 Side view of the Paramedic CU ER1 16 ...

Page 17: ...hen pressed while the backlight is flashing Controls special functions such as device setup and data management and review UP Button May be used to increase the volume of the speaker for louder voice prompts MENU keys DOWN Button May be used to decrease the volume of the speaker for softer voice prompts Indicator Lamps POWER Indicates that the source of power is external to the device either the A...

Page 18: ...c CU ER1 to a personal computer UART port Used for transfer of ECG monitoring and rescue data from the Paramedic CU ER1 to a personal computer 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 ...

Page 19: ... 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 ER1 Replacement accessories and consumables must be sourced only from CU Medical Systems Inc or its authorized representatives 19 ...

Page 20: ...merates the steps to be done during a rescue operation Nickel Metal Hydride Battery Pack Power source of the Paramedic CU ER1 This battery is inside the case of the device RETURN the Paramedic CU ER1 to an authorized service representative if the battery pack needs to be replaced Power Cord Used to connect the AC DC adapter unit to the mains power supply AC DC Adapter Used for charging the recharg...

Page 21: ...lectrode Pads The defibrillator electrode pads that must be used when the patient appears to be less than 8 years old or 25kg 55 lb 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 ER1 SmartMedia Card Used for storage of rescue data ECG Rescue Event Highlights an...

Page 22: ...ting the device to the car cigar lighter jack 12V Only Use this accessory only for recharging the battery pack of the Paramedic CU ER1 Do not use the Paramedic CU ER1 in a rescue operation while being connected to a car cigar lighter power jack Disposable LiMnO2 Battery Pack An external disposable battery pack that may be used to provide power to the Paramedic CU ER1 UART Cable Used to connect the...

Page 23: ...CU ER1 Operator s Manual _ver 3 00 Optional Accessories continued Carrying Case Used to store the Paramedic CU ER1 and the accessories needed for a rescue operation 23 ...

Page 24: ... on Figure 4 3 This screen is shown right after the Paramedic CU ER1 is done with its Power On Self Test Power On Self Test is indicated by a text prompt STARTING UP ATTACH PADS 00 00 12 CPR 30 2 Text Prompt Flashing pads icon Figure 4 3 Initial Screen Display Battery Status Icon Elapsed Time SmartMedia Card Indicator Chest Compression Breath ratio indicator 24 ...

Page 25: ...igar 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 ER1 Battery level 90 of full level 90 Battery level 60 of full level 60 Battery level 30 of full level 30 Battery level 10 of full level Battery level 10 of full level When this is displayed the battery pack must be replaced Do not wait for th...

Page 26: ...the number of shocks that have been delivered during the current rescue session Heart Rate Indicates the heart rate of the acquired ECG in beats per minute bpm ECG Waveform Displays the ECG waveform acquired from the patient Battery Status Icon See explanation in Figure 4 3 Text Prompt Displays the action that you have to do Elapsed Time Indicates the time that elapsed since the device was turned ...

Page 27: ...waveform voice and event data is being done When is displayed the voice recording option is ON and audio signals in the vicinity of the rescue operation are being recorded When is displayed the voice recording option is OFF and the voice signals in the vicinity of the rescue operation are not recorded All the other rescue data are recorded 27 ...

Page 28: ...CK ADVISED Voice and Text Indicates that the patient has a shockable ECG rhythm 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 ER1 is charging its capacitor to prepare for a shock delivery CHARGING COMPLETE Text Indicates that the Paramedic CU ER1 has finished charging its c...

Page 29: ...CK 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 its internal circ...

Page 30: ...dic CU ER1 displays the following screen L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN To navigate through the menu use the UP MENU and DOWN buttons on the keypad of the device The UP S key and DOWN T 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 INCIDE...

Page 31: ...different tests daily weekly monthly and manual tests To access Device History turn ON the device and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 MENU Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Menu Button L DEVICE INFORMATION L RETURN DEVICE ...

Page 32: ...sed in RESCUE operations In this example the device was used for a total of 135 minutes in 15 rescue operations Shocks Middle column Total number of shocks delivered since the device was put into use Training this option is not implemented in this version of the Paramedic CU ER1 Middle column Number of training uses For future versions Not implemented in this version of the Paramedic CU ER1 Right ...

Page 33: ...rn ON the device and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 MENU Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Menu Button L DEVICE INFORMATION L RETURN DEVICE HISTORY BATTERY HISTORY 3 Down Button L DEVICE INFORMATION RETURN L DEVICE HISTOR...

Page 34: ...EY 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 ER1 This time is accumulated from the time the Paramedic CU ER1 is first used Only the elapsed time when the Paramedic CU ER1 is powered ON is counted STATUS Battery power state Indicates the power level of the internal battery pack If the Status...

Page 35: ...the defibrillating capacitor is dumped to the internal dump resistance of the Paramedic CU ER1 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 ER1 Analyzing Indicates the time when the Paramedic ...

Page 36: ... table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 Menu Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 3 Menu Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 36 ...

Page 37: ... Paramedic CU ER1 displays the following screen s in sequence 4 Menu Button L USAGE REVIEW RETURN ELAPSED TIME 7 Sep 2003 00 03 22 3 TOTAL SHOCKS 22 00 DETAILED REVIEW 5 Menu Button L USAGE REVIEW POWER ON RETURN PADS ON ANALYZING SHOCK ADVISED ARMED 1 2 00 00 00 00 00 02 00 00 05 00 00 08 00 00 17 X 37 ...

Page 38: ...the data by pushing the UP or DOWN arrow button To access ECG Review turn ON the device and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 Menu Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE...

Page 39: ...nued Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 4 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 5 Menu Button L PRESS THE MENU KEY TO RETURN X 1 13 ECG REVIEW 39 ...

Page 40: ...oice Review turn ON the device and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 Menu Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 3 Menu Button L REVIEW INCIDENT USAGE REVI...

Page 41: ...sequence 4 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 5 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 6a Menu Button SmartMedia Card is inserted L VOICE REVIEW 00 17 00 PRESS THE MENU KEY TO RETURN 6b Menu Button No SmartMedia card is inserted L VOICE REVIEW PRESS THE MENU KEY TO RETURN NO DATA 41 ...

Page 42: ...turn ON the device and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 Menu Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 3 Down Button L DEVICE SETUP RETURN GENERAL ADMINISTRA...

Page 43: ...equence The Paramedic CU ER1 displays the following screen s in sequence 4 Menu Button L DEVICE SETUP GENERAL ADMINISTRATION RETURN 5 Menu Button L GENERAL RETURN 03 09 09 00 15 ON UART DATE TIME VOICE REC COM PORT 6 Menu Button L GENERAL RETURN 03 ON UART DATE TIME VOICE REC 09 09 00 15 COM PORT 43 ...

Page 44: ...riable 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 UP increases the value DOWN decreases the value When the boundary of the value is reached the value wraps 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 wraps the valu...

Page 45: ...ce without connecting any connector into the ECG DEFIB port and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 Menu Button L DEVICE INFORMATION L DEVICE HISTORY BATTERY HISTORY RETURN 2 Down Button L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW RETURN 3 Down Button...

Page 46: ... button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 4 Menu Button L DEVICE SETUP GENERAL ADMINISTRATION RETURN 5 DOWN Button L DEVICE SETUP GENERAL ADMINISTRATION RETURN 6 MENU Button L ADMINISTRATION RETURN Compression Breath Ratio 30 2 ECG GAIN 10 mm mV 46 ...

Page 47: ... setting allows you to change the chest compression to respiration ratio setting Two settings are available for Compression Breath Ratio 30 2 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 ECG GAIN allows you to set the gain of the ECG display The possible...

Page 48: ...ash 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 without connecting any connector into the ECG DEFIB port and press the sequence of keypad buttons shown in the following table Press the following button s in sequence The Paramedic CU ER1 displays the following screen s in sequence 1 MENU Button L DEVIC...

Page 49: ...ys the following screen s in sequence 3 DOWN Button L DEVICE SETUP RETURN GENERAL ADMINISTRATION MONITOR 4 DOWN Button L COMMUNICATION RETURN DATA RECEPTION DATA TRANSMISSION PRINT 5 MENU Button L COMMUNICATION RETURN DATA RECEPTION DATA TRANSMISSION PRINT 6 DOWN Button L COMMUNICATION RETURN DATA RECEPTION DATA TRANSMISSION PRINT 49 ...

Page 50: ...URN 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 takes you to the Initial Screen Display 4 5 10 Speaker Volume Adjustment In the middle of a rescue operation the volume of the speaker of the Paramedic CU ER1 may be adjusted by pressing the UP ...

Page 51: ...good order Initiate a Manual Self Test by performing the following steps a Press the UP and DOWN keypad buttons simultaneously b Press the ON OFF button without releasing the UP and DOWN buttons c The Paramedic CU ER1 turns ON and displays the text prompt SYSTEM CHECK d 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 tha...

Page 52: ...lly 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 ER1 if the Manual Self Test indicates a Battery Failure error or if the indicator in the Battery History Menu indicates LOW battery status To char...

Page 53: ... self tests The battery pack powers the Paramedic CU ER1 during these tests Check the status of the Paramedic CU ER1 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 8 Power Supply on how to recharge the batteries Store the Paramedic CU ER1 within the environmental conditio...

Page 54: ...e complete step by step rescue protocol of the Paramedic CU ER1 is shown in this Appendix For quick reference refer to the laminated Quick Reference Guide which is a standard accessory of the Paramedic CU ER1 Do not place the patient on a wet surface during defibrillation If patient is Not responsive Not breathing Turn the Paramedic CU ER1 ON Insert the SmartMedia Card into port optional Attach pa...

Page 55: ...ct determination of age and weight If the child appears to be older than 8 years old or heavier than 25 kg proceed to instructions on ADULT DEFIBRILLATION ADULT 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 pads are to be attached 3 Open the defibrillator pads package 4 Peel off ...

Page 56: ...he skin of the patient b The pads must be placed in an anterior posterior position as shown in the figure at the right c The reverse side of each pad indicates its position on the patient 7 Connect the device connector of the pads to the Pediatric Pads Connector Adapter 8 Connect the appropriate end of the Pediatric Pads Connector Adapter to the ECG DEFIB port of the Paramedic CU ER1 See figure at...

Page 57: ...interfere with the ECG signal should be turned off or moved to a safe distance during signal acquisition and analysis The Paramedic CU ER1 decides and gives the prompt SHOCK ADVISED or NO SHOCK ADVISED after ECG analysis If the decision is SHOCK ADVISED 1 The Paramedic CU ER1 charges itself in preparation for shock delivery The Paramedic CU ER1 emits a warning tone during charging The Paramedic CU...

Page 58: ...ed button now 2 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 beeping The Paramedic CU ER1 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 may c...

Page 59: ...use burns If it is necessary to use another defibrillator on the patient do not leave the Paramedic CU ER1 connected to the patient Disconnect the Paramedic CU ER1 from the patient before using any other defibrillator Disconnect from the patient any MEDICAL ELECTRICAL EQUIPMENT which has no DEFIBRILLATION PROOF applied parts when using the Paramedic CU ER1 During defibrillation you and other rescu...

Page 60: ...ress of the CPR This is shown in the figure below 4 Beat guide from the beeper accompanies the CYCLE NO and COMPRESSION NO indicator 5 The Paramedic CU ER1 lets you perform 5 cycles of CPR If a shock is not delivered decision is NO SHOCK ADVISED 1 The voice and text prompt CHECK PULSE 2 The Paramedic CU ER1 gives you 10 seconds to check the pulse of the patient 3 The voice and text prompt IF NO PU...

Page 61: ...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 electrodes to the patient The sticky side must be in contact with the patient s skin The placement is shown in the figure at the right d Connect the snap connector of the ECG Monitoring Cable and Connect...

Page 62: ...he operation of the Paramedic CU ER1 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 ER1 Use only the ECG MONITORING electrodes that are recommended by CU Medical Systems Inc Do not attempt to operate the Paramedic CU ER1 in ECG MONITOR...

Page 63: ...ramedic CU ER1 The Paramedic CU ER1 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 8 2 1 Internal Battery Pack Charge Status The charge status of the internal battery pack is checked by the Paramedic CU ER1 ever...

Page 64: ...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 ER1 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 th...

Page 65: ...e 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 ER1 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 tim...

Page 66: ...ck 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 ER1 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 t...

Page 67: ... 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...

Page 68: ...CU ER1 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 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 68 ...

Page 69: ...gure 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 ER1 When using the car cigar lighter jack for recharging the vehicle must be started before the plug...

Page 70: ...owing 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 Batter...

Page 71: ...e 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 test as the one done during Power On Test vi CPLD test tests the complex programmable logic device CPLD for functionality c Monthly Period...

Page 72: ...e 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 ER1 will interpret it as a button key failure The SYSTEM OK prompt will be displayed on the LCD if the Paramedic CU ER1 detects no failure during a Manual Self Test 9 2 Maintenance Although there are no user serviceable parts inside the Paramed...

Page 73: ...e expired replace them immediately Initiate complete self test by doing a Manual Self Test If the self test detects any problem see the chapter on Troubleshooting Check the case of the Paramedic CU ER1 and the accessories for any sign of apparent damage If there is any apparent damage to the case of the device consult the manufacturer Monthly and after each use Check for dirt contamination If ther...

Page 74: ..._ Date Scheduled Frequency Paramedic CU ER1 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 Inspected by Signature of operator doing the inspection 74 ...

Page 75: ...ture 30 ml bleach liter of water Ammonia based cleaners Hydrogen peroxide Do not immerse any part of the Paramedic CU ER1 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...

Page 76: ... 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 ER1 is turned ON after a fault is detected during automatic or manual self test 1 The Paramedic CU ER1 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 Sel...

Page 77: ... 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 Te...

Page 78: ...umps the charge in its internal disarm resistance load and proceeds to CPR guidance Remedial action Be sure to press the SHOCK button within 15 seconds when the Paramedic CU ER1 issues the prompt PRESS THE FLASHING RED BUTTON FOR DELIVERING A SHOCK TO PATIENT if it is your intention to deliver a shock The defibrillator electrode pads are not attached to the patient s bare chest Remedial action Att...

Page 79: ... 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 s...

Page 80: ...dia 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 ER1 is turned ON Installation of a SmartMedia Card a Ensure that the SmartMedia Card is clean and dry b Turn the Paramedic CU ER1 OFF c Load the SmartMedia Card with the metallic strip facing down and the notched end going in first P...

Page 81: ...edia Card After installing the SmartMedia Card turn ON the Paramedic CU ER1 Activate the menu by pressing the MENU button Go to REVIEW INCIDENT The following screen is displayed L REVIEW INCIDENT USAGE REVIEW ECG REVIEW VOICE REVIEW 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...

Page 82: ...rtMedia Card inserted 11 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 ER1 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 ma...

Page 83: ...ER1 ON and press the Menu button 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 ER1 Go to COMMUNICATION DATA TRANSMISSION The following screen should be displayed L COMMUNICATION RETURN DATA RECEPTION DATA TRANSMISSION PRINT Push the MENU button The data transmission screen is displayed L DATA TRANSMISSION PRESS...

Page 84: ...smission 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 ER1 7 When the transmission is finished the Paramedic CU ER1 may be turned OFF 11 3 2 UART Port The UART port may be used to transmit data to a PC running the CU Expe...

Page 85: ...rinter is a serial printer configured to receive data using RS232 protocol Feed Button Power Switch UART Port connector Printer Paper Stand alone Thermal Printer Power Switch Used to turn the printer ON or OFF Feed Button Used to advance the printer paper UART Port Connector Used to connect the printer to the UART Port of the Paramedic CU ER1 The printer is powered by the Paramedic CU ER1 through ...

Page 86: ...ngaged pull the paper compartment lid upward This is shown in the following figure 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 inch of printer paper to go past the paper cutter to ensure that the paper will feed properly during printing 86 ...

Page 87: ... not insert the SmartMedia card and the data in the internal flash memory will be printed 4 Turn the Paramedic CU ER1 ON and press the MENU button Go to COMMUNICATION menu see section 4 5 8 Printing and Transferring Data highlight PRINT then press the MENU button The following screen is displayed L PRINT RETURN PRINT ALL PRINT SEGMENT PRINT ALL prints all the data ECG and event stored in the activ...

Page 88: ...SHOCK ADVISED 00 00 09 ARMED 00 00 18 1 5 X 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 butt...

Page 89: ... X ARMED 00 00 18 POWER ON 00 00 00 PADS ON ANALYZING SHOCK ADVISED 00 00 00 00 00 05 00 00 09 9 Press the MENU button to print the chosen segment While the segment is being printed the Paramedic CU ER1 displays the PRINT SEGMENT screen L PRINT SEGMENT PRESS THE MENU KEY TO RETURN 89 ...

Page 90: ...CU ER1 Operator s Manual _ver 3 00 Notes 90 ...

Page 91: ...fewer than 5 of the 250 000 persons who experience out of hospital cardiac arrest each year survive to hospital discharge 2 How does the e 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 Suc...

Page 92: ...rally 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 optim...

Page 93: ...s impedance e cube Biphasic technology adjusts the duration of current flow to optimize the effectiveness of the shock delivery E cube Biphasic technology is based on 3 core technologies 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...

Page 94: ...nt flows in one direction throughout the shock Many well organized emergency medical systems using monophasic devices for early defibrillation have documented better than 20 survival to hospital discharge for cardiac arrest patients found in ventricular fibrillation VF Attempts to improve this survival rate have adapted proposals to change the waveform and energy level of defibrillation shocks 6 B...

Page 95: ...presented with VF 5 The 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 pha...

Page 96: ... 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 discharged patients who had been resuscitated with biphasic shocks were more likely to have good cerebral...

Page 97: ...ial 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 mo...

Page 98: ...ext prompts PRESS THE FLASHING RED BUTTON NOW While the Paramedic CU ER1 is waiting for the SHOCK button to be pressed Beeper Continuous tone Shock button backlight Flashing red light Paramedic CU ER1 detects decides Within 15 seconds SHOCK button was Voice and text prompts THE SHOCK BUTTON WAS NOT PRESSED PRESSED Voice and text prompts BEGIN CPR NOW Voice and text prompts NO SHOCK ADVISED Voice a...

Page 99: ...chargeable battery pack ER1 NSP1 Optional Accessories Carrying Case ER1 OA01 SmartMedia Card 32M ER1 OA02 External Thermal Printer Wire ER1 OA03 Car Cigar Lighter Jack Power Cord ER1 OA04 1 Set of Multifunction Defibrillator Electrode Pads CUA0508O ER1 OA05 External Thermal Printer Paper 10 rolls ER1 OA06 ECG Cable 3 lead ER1 OA07 ECG Electrodes ER1 OA08 Disposable Battery Pack Li ion ER1 OA09 Dat...

Page 100: ...midity 5 to 95 non condensing Temperature 4 F to 140 F 20 C to 60 C Storage Conditions device only no defibrillator electrode pads Humidity 5 to 95 non condensing Shock Drop Abuse Tolerance Meets IEC 60601 1 clause 21 Mechanical Strength Vibration Meets MIL STD 810E Method 514 4 Category 10 Sealing Meets IEC 60601 1 clause 44 Overflow spillage leakage humidity ingress of liquids cleaning steriliza...

Page 101: ...Lower Confidence Limit Coarse VF 200 90 sensitivity 219 213 6 97 26 213 219 sensitivity 95 SHOCKABLE Fast VT 50 75 sensitivity 137 111 26 81 02 111 137 sensitivity 76 Normal Sinus Rhythm 100 minimum arbitrary 99 specificity 100 0 100 100 100 100 specificity 97 AF SB S VT heart block idioven tricular PVC s 30 arbitrary 95 specificity 219 1 218 99 54 218 219 specificity 98 NON SHOCKABLE Asystole 100...

Page 102: ...ED Modes e cube biphasic Truncated exponential type impedance compensated Shock Delivery Via multi function defibrillator electrode pads Patient Impedance Range 25Ω to 175Ω Delivered Energy Joules VS Load Impedance Ω Load Impedance Ohms Nominal Energy Setting J 25 50 75 100 125 150 175 Accuracy 150 150 150 150 150 150 150 150 15 102 ...

Page 103: ...ILLATOR being ready for discharge at 150 Joules Less than 9 seconds Using AC power at 90 of rated mains voltage Less than 27 seconds Using new fully charged NiMH internal battery pack Less than 27 seconds Using new disposable external LiMnO2 battery pack Less than 27 seconds Using AC power at 100 of rated mains voltage Less than 27 seconds Using new fully charged NiMH internal battery pack deplete...

Page 104: ... and text prompts AC Power Battery and ERROR indicator lamps Armed Indicators Charging complete text prompt Continuous tone from the beeper Flashing red backlight of the SHOCK button Patient Analysis Detects and evaluates connection impedance for proper defibrillator electrode pads contact Analyzes patient s ECG to determine if a shock is necessary Shockable rhythms Ventricular Fibrillation Ventri...

Page 105: ...0 mm mV AUTO 0 3 to 1 mV signals are displayed with 10mm mV gain outside of that range the peak to peak value is displayed as 10 mm on the LCD display Frequency Response ECG Monitoring Mode 0 3 to 40 Hz 3 dB AED Mode EMS 1 Hz to 30 Hz Patient Isolation AED Mode BF ECG Monitoring Mode BF Event Storage Internal Flash Memory 12 hours of event and ECG recording SmartMedia Card 32MB 42 hours of event a...

Page 106: ... 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 the internal battery is being recharged External Battery Pack Type 4200mAh 12V Non rechargeable LiMnO2 Dimensions 104mm X 67mm X 42mm L...

Page 107: ...method Direct thermal line printing Resolution 230dpi 8 dots mm Printing Speed 50mm s Dimensions 75mmX95mmX35mm 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 ...

Page 108: ... its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B Harmonic Emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The Paramedic CU ER1 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power su...

Page 109: ...nvironment 1 kV differential mode 1 kV differential mode Surge IEC 61000 4 5 2 kV common mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment 5 UT 95 dip in UT for 0 5 cycles 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 cycles Voltage di...

Page 110: ...e following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and...

Page 111: ...8 m 0 38 m 0 73 m 1 1 16 m 1 2 m 1 2 m 2 3 m 10 3 67 m 3 79 m 3 79 m 7 27 m 100 11 6 m 12 m 12 m 23 m 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 the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmit...

Page 112: ...CU ER1 Operator s Manual _ver 1 00 Paramedic CU ER1 Shock Waveform Plots 25Ω Impedance Load 150 Joules output 50Ω Impedance Load 150 Joules output 112 ...

Page 113: ...CU ER1 Operator s Manual _ver 3 00 75Ω Impedance Load 150 Joules output 100Ω Impedance Load 150 Joules output 113 ...

Page 114: ...CU ER1 Operator s Manual _ver 3 00 125Ω Impedance Load 150 Joules output 150Ω Impedance Load 150 Joules output 114 ...

Page 115: ...CU ER1 Operator s Manual _ver 3 00 175Ω Impedance Load 150 Joules output 115 ...

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