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LIFEPAK CR

®

 Plus 

LIFEPAK EXPRESS

®

Defibrillators

with ADAPTIV

™

 Biphasic Technology

1

Service Manual

 

Summary of Contents for LIFEPAK CR PLus

Page 1: ...Click Here for Table of Contents Click Here for Navigation Help LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology 1 Service Manual ...

Page 2: ...fibrillator Table of Contents Title Page Back Index Next Page Click a Topic 1 Preface 2 Safety 3 Device Description 4 Operating Instructions 5 Modes of Operation 6 Performance Inspection Procedure 7 Preventive Maintenance Index ...

Page 3: ...K CR Plus and LIFEPAK EXPRESS Defibrillators Operating Instructions intended for use by physicians clinicians and emergency care providers provides step by step instructions for operating the device as well as operator level testing and maintenance Click any of the links below to jump to a topic in this section Trademarks Adobe Reader Navigating Through the Manual Contacting Physio Control Respons...

Page 4: ...E STAT Partner Plus CHARGE PAK and PARTSLINE are trademarks of Physio Control Inc Physio Control is a registered trademark of Physio Control Inc Microsoft and Windows are registered trademarks of Microsoft Corporation Pentium is a trademark of Intel Corporation QED is a trademark and Dale and Fluke are registered trademarks of Fluke Corporation Adobe is a trademark of Adobe Systems Incorporated Sp...

Page 5: ...olumn on the left side of the screen They enable you to easily navigate to main sections of the manual similar to a table of contents To view or hide the bookmarks column click the BOOKMARKS tab located along the left side of the screen To jump to a bookmark topic click the desired topic Note A plus sign to the left of a bookmark topic indicates additional topics exist under that bookmark level Cl...

Page 6: ...a link A navigation bar at the bottom of each page also provides helpful links The navigation bar includes Click to jump to the main table of contents for the manual Click to jump to the table of contents for the section you are currently viewing Click to jump to the manual s index Click to retrace your steps in a document returning to each page in the reverse order visited Click to jump to the ne...

Page 7: ...rol Inc 11811 Willows Road Northeast Redmond WA 98052 2003 USA Telephone 1 425 867 4000 Toll Free USA only 1 800 442 1142 Fax 1 425 867 4121 Internet www physio control com Physio Control Operations Netherlands B V Galjoenweg 68 6222 NV Maastricht The Netherlands Physio Control Australia Pty Ltd Suite 4 01 15 Orion Road Lane Cove NSW 2066 Australia 1 5 ...

Page 8: ...o obtain a complete understanding of the use and maintenance of the defibrillator Failures that may occur during product introduction are addressed under the warranty and the need to disassemble or repair replace internal components is not necessary Contact Physio Control for additional information In the USA contact Technical Support Services at 1 800 442 1142 Outside the USA contact your local P...

Page 9: ...mber Internal asset or tracking numbers may also be useful in maintaining adequate control of defibrillators Device Tracking The U S Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators The address to which this particular device was shipped is now listed as the current tracking location If the device is located somewhere ...

Page 10: ...hould be recycled according to national and local regulations Contact your local Physio Control representative for assistance or go to www physio control com recycling Preparation The device should be clean and contaminant free prior to being recycled Recycling of disposable electrodes After using disposable electrodes follow your local clinical procedures for recycling Packaging Save or recycle p...

Page 11: ...instructions to ensure that your device is set up properly and that you are operating the device correctly If you determine that service or technical support is necessary please record the device s serial number and part number and have them available when you contact Physio Control To obtain a detailed warranty statement contact your local Physio Control representative or go to www physio control...

Page 12: ...h rapid technological changes and the availability of older replacement parts limit the useful life of all modern medical devices The American Hospital Association suggests a five year useful life expectancy for defibrillators Estimated Useful Lives of Depreciable Hospital Assets Revised 1998 Edition Similarly the U S Army lists an eight year life expectancy for defibrillators technical bulletin M...

Page 13: ...f it detects a shockable or nonshockable rhythm Refer to Appendix B of the operating instructions for additional information ADAPTIV biphasic technology Property of the shock waveform generated by the device The biphasic waveform is characterized by a positive current phase followed by a reverse current phase of shorter duration and decreased magnitude The waveform pulse characteristic is biphasic...

Page 14: ...t Page Safety 2 This section describes the safety conventions terms and symbols used in this service manual or on the defibrillator This information is intended to alert service personnel to recommended precautions in the care use and handling of this device Terms General Warnings and Cautions Symbols ...

Page 15: ... their definitions and significance Danger Immediate hazards that will result in serious personal injury or death Warning Hazards or unsafe practices that could result in serious personal injury or death Caution Hazards or unsafe practices that could result in device or property damage Note Points of particular interest for more efficient or convenient device operation additional information or ex...

Page 16: ...device close to oxygen sources such as bag valve mask devices or ventilator tubing Shock or fire hazard Do not immerse any portion of this device in water or other fluids Avoid spilling any fluids on the device or accessories If the device is ever immersed in water or other fluids remove the battery until the unit can be serviced Patient hazard Do not mount the device directly above the patient Pl...

Page 17: ...hen off CAUTIONS Possible device damage This defibrillator may be damaged by mechanical physical abuse for example immersion in water drop exceeding 18 inches Possible component damage Do not mount the device near vibration sources Possible device damage Broken or frayed wires or loose snap fittings may cause interference or loss of signal Pay particular attention to the point at which the wires e...

Page 18: ...evant to your device or used in every country OK indicator The defibrillator is ready for use Attention On the readiness display the internal battery is low Attention on the CHARGE PAK battery charger Consult accompanying documents Attention on the back of the defibrillator Consult accompanying documents Attention on the electrode pads Consult accompanying documents Warning high voltage CHARGE PAK...

Page 19: ...indicator There is a condition that prevents or could prevent normal defibrillator operation This end up Fragile breakable Handle with care Protect from water Power On Off button Type BF patient connection Not intended for use on children who are less than eight years of age or who weigh less than 25 kg 55 pounds Continued on next page 2 6 ...

Page 20: ...UIK COMBO defibrillation and therapy cables To use Infant Child Electrodes connect Infant Child Electrodes directly to the AED Not intended for use on adults Physio Control electrodes are not made with natural rubber latex Arrow indicates On Off button location Symbol denotes a defibrillator and identifies the SHOCK button Lot code Do not reuse single use only Continued on next page LOT YYWW 2 7 ...

Page 21: ...product in the unsorted municipal waste stream Dispose of this product according to local regulations See www physio control com recycling for instructions on the proper disposal of this product Symbol for China RoHS indicating the Environmentally Friendly Use Period EFUP denoting the number of years before any substance is likely to leak out into the environment Mark of conformity according to th...

Page 22: ... Atmospheric pressure limitation Relative humidity range 5 to 95 Store in a cool dry location 0 to 50 C or 32 to 122 F Recommended storage temperature 15 to 35 C 59 to 95 F Storage at extreme temperatures of 40 or 70 C 40 or 158 F is limited to seven days If storage at these temperatures exceeds one week the electrode shelf life will be reduced USA 35 C 15 C 95 F 59 F 50 C 0 C 122 F 32 F 2 9 Conti...

Page 23: ...afety Symbols continued Date of manufacture Do not place near an open flame Do not crush puncture or disassemble battery Rx Only Federal U S law restricts this device to sale by or on the order of a physician MIN Manufacturer s Item Number CAT Catalog number used for placing orders Reorder number YYYY REF 2 10 ...

Page 24: ...lator Section Contents Previous Page Table of Contents Back Index Next Page Device Description 3 This section includes the following topics Introduction Physical Description and Features Functional Description Supplies and Accessories ...

Page 25: ...the heart of the patient or it prompts the user to press the SHOCK button depending on your model The defibrillator delivers energy through self adhesive disposable defibrillation electrodes Internal circuitry continuously measures the impedance between the electrodes and allows defibrillation only when the defibrillation electrodes are attached to the patient Advanced arrhythmia analysis controls...

Page 26: ...us EXPRESS Defibrillator Physical Description and Features For information on any of the numbered defibrillator controls indicators and connectors shown below select the appropriate link at the bottom of the page 9 1 2 3 7 8 4 6 5 10 11 Continued on next page Parts 1 7 Parts 8 11 3 3 ...

Page 27: ...de pads 4 IrDA port Infrared data port provides wireless communication for transferring data from the defibrillator to a computer 5 SHOCK button Press to discharge the defibrillator Available only on the semiautomatic defibrillator model 6 LID RELEASE ON OFF button Opens the defibrillator lid and turns on the device Pressing and holding the button for approximately two seconds after the lid is ope...

Page 28: ...to the patient s exposed chest and then turn solid green when the pads have been applied 9 Speaker Provides audio prompts and alert tones 10 Readiness Display Four indicators OK indicator BATTERY indicator ATTENTION indicator WRENCH indicator These indicators are visible when the defibrillator is turned off and enable you to determine the state of the defibrillator 11 Lid The top of the defibrilla...

Page 29: ...ck Index Next Page LIFEPAK CR Plus EXPRESS Defibrillator Physical Description and Features continued For information on any of the components shown below select the appropriate button at the bottom of the page 1 2 3 Continued on next page Parts 1 3 3 6 ...

Page 30: ...tor Physical Description and Features continued Number Description 1 Safety Warnings Provide important information concerning the defibrillator s use and service 2 Serial Number Label Displays the defibrillator identification number 3 Carrying Handle Used to transport the defibrillator Back to Device 3 7 ...

Page 31: ...g voice prompting generate biphasic defibrillation waveform and record patient events Inductive Resistor A resistor that conditions the energy storage capacitor output Energy Storage Capacitor A metallized film capacitor used for energy storage Patient Connector A connection used for connecting patient electrodes and unit testing Function keys LID RELEASE ON OFF button and SHOCK button semiautomat...

Page 32: ...EXPRESS Owner s Manual 3205285 26500 001999 LIFEPAK CR Plus and LIFEPAK EXPRESS Reference Manual 3206089 26500 002069 Warranty 3202474 26500 001274 Implementation Kit 3202563 26500 001319 Accessory Catalog 3201619 26500 001314 Replacement Kit 3201616 11403 000002 Carrying Case 3201918 010 21300 004576 Replacement Shoulder Strap for Carrying Case 3201918 003 21300 004579 Hard Shell Carrying Case 32...

Page 33: ...ur local Physio Control representative Provide the part number and serial number located on the bottom of the device Specify all assembly numbers part numbers reference designations and descriptions Accessories may be substituted to reflect device modifications and improvements Serial Number The serial number of the device identifies the manufacturing conditions and elements used in producing your...

Page 34: ...nnel must consult the operating instructions and this service manual for a complete understanding of the use and maintenance of the defibrillator The operating instructions include the following topics Introduction About Automated External Defibrillators Safety Information Symbols About the LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillators Getting Started Unpacking and Inspecting the LIFEPAK CR P...

Page 35: ...Cardiac Arrest Emergency Voice Instructions and Tones Troubleshooting Data Storage Overview of Data Storage Caring for Your Defibrillator Maintaining a State of Readiness Cleaning Your Defibrillator Replacing the CHARGE PAK Battery Charger and the QUIK PAK Electrode Packet Obtaining Authorized Service Recycling Information Supplies Accessories and Training Tools Warranty Information Continued on n...

Page 36: ... Index Next Page Operating Instructions continued Defibrillator Operating Settings Operating Settings and Setup Configuration Appendix A Specifications Appendix B Shock Advisory System Appendix C User s Checklist Appendix D Declaration of Conformity Electromagnetic Compatibility Guidance 4 3 ...

Page 37: ...R Plus EXPRESS Defibrillator Section Contents Previous Page Table of Contents Back Index Next Page Modes of Operation 5 This section explains the operating modes of the defibrillator Normal Mode Auto Test Modes ...

Page 38: ...r Modes of Operation Normal Mode The defibrillator operates in normal mode for emergency patient care when the following conditions are met The lid is opened and the defibrillator is turned on The QUIK PAK electrodes are properly connected to the patient the electrode indicators change from red to green 5 2 ...

Page 39: ... Weekly test Monthly test Low power test Initialization Test The initialization test is performed each time the defibrillator is turned on all the defibrillator indicators will light momentarily indicating that the test is in process The initialization test includes the following memory tests RAM test Processor test Watchdog timer test If the initialization test completes successfully and verifies...

Page 40: ...first Monday of each month at 03 00 A M if the defibrillator is in use the test will be performed at 03 00 A M the following month If a weekly test and a monthly test are scheduled to occur at the same time the monthly test will occur WARNING Shock Hazard During the monthly auto test the defibrillator will automatically charge the main capacitor Do not attempt to disassemble the defibrillator In a...

Page 41: ...r 42 minutes of operation before shutting down Install a new CHARGE PAK battery charger at this time After the new CHARGE PAK is installed the defibrillator periodically completes a low power test to check the internal battery When the internal battery has sufficiently charged the OK indicator appears in the Readiness Display and the defibrillator will stop performing low power tests Failing an Au...

Page 42: ...fications Investigate and correct any malfunctions or out of tolerance conditions detected during the PIP The PIP comprises safety and performance tests recommended by AHA ASHE American Hospital Association American Society for Hospital Engineering Maintenance Management for Medical Equipment and International Electrotechnical Commission IEC Technical Report 1288 2 Maintenance of Cardiac Defibrill...

Page 43: ...ontrol for inspecting maintaining and cleaning the defibrillator and accessories Maintenance and Inspection Schedule CHARGE PAK Battery Charger Maintenance Replacing the QUIK PAK Electrodes Replacing the CHARGE PAK Battery Charger Battery Charger Troubleshooting Defibrillator Cleaning Product Support Policy WARNING Shock or fire hazard Servicing this defibrillator must be performed by qualified pe...

Page 44: ...rms various automatic self tests to ensure readiness The results of these tests are displayed in the Readiness Display If the defibrillator passes the test the OK indicator appears indicating that the device is ready for use If the defibrillator fails a test the BATTERY indicator appears indicating that the CHARGE PAK battery charger needs to be replaced If the defibrillator fails a test because i...

Page 45: ... that is required If the defibrillator is located in a high use area more frequent inspections may be required The inspection should include the following Check to ensure that the OK indicator is visible in the Readiness Display Check the Use By date on the QUIK PAK electrodes The date is visible through the clear plastic lid If the Use By date has passed replace the QUIK PAK electrodes and the CH...

Page 46: ...ached to a patient during an event and the battery charger has not been replaced The device has been on for more than 30 cumulative minutes without a patient connected to it the battery charger has not been replaced and the device is turned off The battery charger has been in the device two years or more and the device is turned off The BATTERY indicator appears in the Readiness Display Note It is...

Page 47: ...r having previously been installed in another device and the device is turned off The Use By date on the electrode packet has expired Use the Physio Control replacement kit to replace both the battery charger and the QUIK PAK electrodes at this time The ATTENTION indicator may remain lit for a period of time after you replace the battery charger This is normal because the internal battery requires...

Page 48: ... same Discard used electrode pads and any unused spare electrode pads according to recycling instructions To replace the QUIK PAK electrodes 1 Open the lid voice prompts will begin 2 Press and hold the LID RELEASE ON OFF button for approximately two seconds to turn off the defibrillator 3 Unplug the electrode connector 4 Remove the electrode packet anchor pin from the slot in the defibrillator 5 I...

Page 49: ...tor Preventive Maintenance Replacing the QUIK PAK Electrodes continued 8 Ensure that the new electrode packet is centered on the defibrillator and tucked behind the lip before closing the lid 9 Close the lid and confirm that the packet Use By date is visible in the upper right corner 7 6 8 yyyy mm dd 7 7 ...

Page 50: ...odes and the CHARGE PAK battery charger must be replaced at the same time To replace the battery charger 1 Remove the used battery charger by pressing down on the battery charger latch The battery charger will spring outward from the defibrillator Refer to the illustration below for the battery charger location 2 Slide the used battery charger out of the defibrillator Continued on next page 7 8 ...

Page 51: ...t is supplied with the replacement kit 4 Insert the new battery charger into the defibrillator until you hear it click into position If the battery charger is not completely inserted it will spring back out 5 Confirm that the BATTERY indicator disappears and that the OK indicator appears on the Readiness Display before returning the defibrillator to service The internal battery must charge for a p...

Page 52: ...and then reinserted With the device turned off for at least 60 seconds pull the battery charger out of the defibrillator and then reinsert it Refer to the following table for the meaning of the tones Number of Tones Indication Action 1 Internal error Call Physio Control Technical Support 2 Patient load previously connected Replace battery charger 3 Cumulative ON time 30 minutes Replace battery cha...

Page 53: ...nt use Do not clean any part of the defibrillator or accessories with bleach bleach dilution or phenolic compounds Do not use abrasive or flammable cleaning agents Do not steam autoclave or gas sterilize the defibrillator or its accessories Follow the cleaning guidelines provided below Item Cleaning Method Cleaning Agent Defibrillator exterior case readiness display and crevices Clean with damp sp...

Page 54: ...entive Maintenance Defibrillator Cleaning continued Item Cleaning Method Cleaning Agent Electrode pads None do not remove electrode pads from the packet until use None dispose of or recycle after use Carrying case Wipe with damp cloth or sponge Water Quick Reference Guide Wipe with damp cloth or sponge Water 7 12 ...

Page 55: ...enance Product Support Policy Physio Control provides full technical subassembly level support and subassembly replacement parts for a period of eight years beyond the device s production retirement date After this eight year period Physio Control provides technical support and subassembly replacement parts as available 7 13 ...

Page 56: ...ons and Features Routine Inspection Storage Temperature Device Description Device Tracking Document Navigation Instructions E Electrodes Replacing F Functional Description G General Warnings and Cautions Glossary I Initialization Test Inspection Procedures See PIP L Low Power Test M Maintenance and Inspection Schedule Modes of Operation Monthly Auto Test N Navigation Using Hyperlinks Normal Mode O...

Page 57: ...x Q QUIK PAK Electrodes Replacing R Recycling Information Responsibility for Information S Safety Storing the Defibrillator Supplies and Accessories Symbols T Terms Tests Failing an Auto Test Initialization Low Power Auto Monthly Auto Weekly Auto Trademarks W Warranty Weekly Auto Test ...

Page 58: ...est 2 Computer Assisted Tests Record the result of computer assisted test 3 Electrode Impedance Record the result of electrode impedance test 4 Automatic Advisory Operation a a Confirm unit completes automatic advisory operation tests Shock 1 Observed J _________________ 2 _________________ 3 _________________ b Confirm energy sequence is correct per device setup c Confirm the device used the corr...

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