Service Manual, LPCR2 - Stryker Corporation · Title Service Manual, LPCR2 Page 1 of 104 Doc Type...

Title Service Manual, LPCR2 of 104

Doc Type Service Product Drawing Doc

ID 3323299 Doc Rev B

Doc State Released State Date 11/14/2017

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This document is electronically signed in the Physio-Control, Inc. Product Lifecycle Management (PLM) System. Approvals can be obtained from the PLM system which displays the selected approvers, their approval roles, and approval dates.

PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR PHYSIO-CONTROL, INC. USE ONLY. This document is property of Physio-Control and may not be used, reproduced, published or disclosed to others without authorization from Physio-Control.

Owner Corporate

Attachments (Optional): Qty Pages Page Sequencing

Change Description 1. Added supported Wi-Fi frequency, 2.4 GHz and noted 5 GHz is not a supported frequency. 2. Added Warranty Void Letter template PNs for Tire 2 countries.





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Table of Contents Table of Contents ............................................................................................................................................................... 2

Preface ............................................................................................................................................................................... 5

Disclaimer ....................................................................................................................................................................... 5

Trademarks .................................................................................................................................................................... 5

Definitions, Acronyms, and Abbreviations..................................................................................................................... 5

Contacting Physic-Control .............................................................................................................................................. 7

Service Personnel Qualifications .................................................................................................................................... 8

Service Information ........................................................................................................................................................ 8

Recycling information .................................................................................................................................................... 9

Configuration Information ............................................................................................................................................. 9

Warranty ........................................................................................................................................................................ 9

Tamper Proof Label ........................................................................................................................................................ 9

Safety - Technical Description .......................................................................................................................................... 10

Serial Label Information ............................................................................................................................................... 10

Symbols ........................................................................................................................................................................ 10

General Danger and Warnings Statements ................................................................................................................. 12

LIFEPAK CR2 Defibrillator Description.......................................................................................................................... 15

LIFEPAK CR2 Defibrillator Specifications ...................................................................................................................... 15

CR2 Device Description .................................................................................................................................................... 20

Physical Description and Features ............................................................................................................................... 20

Functional Descriptions................................................................................................................................................ 21

Modes of Operation ..................................................................................................................................................... 22

Battery and Time .......................................................................................................................................................... 23

Electrodes .................................................................................................................................................................... 23

Connectivity Module .................................................................................................................................................... 24

Device Communication ................................................................................................................................................ 25

Initial Device Setup Overview ...................................................................................................................................... 30

CR2 Trainer Device Description ........................................................................................................................................ 31

CR2 Trainer Device Overview ....................................................................................................................................... 31





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CR2 Trainer Service ...................................................................................................................................................... 32

CR2 Trainer Parts ......................................................................................................................................................... 32

Data Management Solution ............................................................................................................................................. 33

LIFELINK and LIFENET account creation ....................................................................................................................... 33

LIFELINK or LIFENET Password Reset ........................................................................................................................... 33

Connectivity ..................................................................................................................................................................... 34

Download and Install Wi-Fi Configuration Tool ........................................................................................................... 34

Store Wi-Fi Settings on CR2 ......................................................................................................................................... 35

Confirm Connection to LIFELINK or LIFENET ................................................................................................................ 43

Check CR2 Device Readiness Status ............................................................................................................................. 44

Monthly Auto-Check-In ................................................................................................................................................ 46

Change or Remove Wi-Fi Settings on the CR2 ............................................................................................................. 47

Change Setup Options or Update Software ..................................................................................................................... 50

Update Setup Options or Software from LIFENET or LIFELINK .................................................................................... 50

Applying Updates with Wi-Fi or Cellular Connection ................................................................................................... 54

Applying Updates with USB connection ...................................................................................................................... 54

Monitor Update Status ................................................................................................................................................ 59

View Software Version ................................................................................................................................................. 61

Viewing LIFEPAK CR2 Log Files ......................................................................................................................................... 63

View Log from LIFENET System .................................................................................................................................... 63

View Log from LIFELINK ............................................................................................................................................... 65

View WCT Log .............................................................................................................................................................. 68

Post AED Event Services ................................................................................................................................................... 71

LIFELINK AED Event Service.......................................................................................................................................... 71

LIFENET AED Event Service for EMS customers ........................................................................................................... 74

Using DT EXPRESS Data Transfer Software to download an AED Event ...................................................................... 75

Preventive Maintenance .................................................................................................................................................. 81

Device self-test ............................................................................................................................................................. 81

Device Daily, Weekly, and Monthly Tests .................................................................................................................... 82

Battery Maintenance ................................................................................................................................................... 83

Performance Inspection Procedure (PIP) ..................................................................................................................... 85





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Replacement Procedure .................................................................................................................................................. 85

Supply and Replacement Parts .................................................................................................................................... 85

Lid Replacement ........................................................................................................................................................... 86

Handle or Carrying Case Replacement......................................................................................................................... 87

USB Cover Replacement .............................................................................................................................................. 88

Battery Replacement ................................................................................................................................................... 88

Electrode Replacement ................................................................................................................................................ 88

Troubleshooting ............................................................................................................................................................... 89

Readiness indicator ...................................................................................................................................................... 89

No Voice Prompt .......................................................................................................................................................... 90

Unable to establish USB connection to a computer .................................................................................................... 91

Unable to establish Wi-Fi network connection............................................................................................................ 91

Connection Failed ........................................................................................................................................................ 92

Unable to change/update the device setup options ................................................................................................... 92

Using Voice Prompts for Troubleshooting ................................................................................................................... 92

Error Codes .................................................................................................................................................................. 94

Tables of useful information ............................................................................................................................................ 97

LIFENET System URL ..................................................................................................................................................... 97

List of Declaration of Conformity Documents ............................................................................................................. 98

List of Reference Document and Tool .......................................................................................................................... 98

Wi-Fi Signal Noise Ratio (SNR) ..................................................................................................................................... 99

System Context Diagram ............................................................................................................................................ 100

System Component View ........................................................................................................................................... 101

Sample Warranty Void Letter .................................................................................................................................... 103





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Preface This Service manual describes how to support the following tasks for the LIFEPAK CR2 defibrillator:

• Connecting to LIFELINK or LIFENET System • Confirming connectivity • Checking self-test results • Changing device setup options • Updating device software • Post AED event support • Replacement Procedure • Troubleshooting common issues • Preventive Maintenance

Another publication, the LIFEPAK CR2 Defibrillator Operating Instructions, is for use by physicians, clinicians, and emergency care providers. The operating instructions provide step-by-step instructions for use, as well as operator-level testing and maintenance.

Disclaimer All the screenshots or pictures in this document are for the example only; they are subject to change without matching the latest versions of software.

Trademarks LIFEPAK, LIFENET, QUIK-STEP, LIFELINKcentral, cprCOACH, cprINSIGHT, Shock Advisory System, SAS, and ClearVoice are trademarks of Physio-Control, Inc. CODE SUMMARY, CODE-STAT, and DT EXPRESS are Trademarks of Physio-Control, Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation in the US and/or other countries. Specifications are subject to change without notice.

Definitions, Acronyms, and Abbreviations

802.11 Commonly known as "Wi-Fi," the IEEE 802.11 standards provide the wireless counterpart to Ethernet, and the Wi-Fi Alliance certifies products. The versions have the suffixes 11a, 11b, 11g, 11n and 11ac; the latest being 802.11ac. The original 20 MHz channel was increased to 40 MHz in 11n and to 80 and 160 MHz in 11ac.

AED Automated External Defibrillator

ASR Account Support Representative - a Physio-Control support team member dedicated to supporting customers with a full AED support service contract.

CR2 LIFEPAK CR2 Defibrillator

DTx DT Express™ Data Transfer Software

FSR Field Service Representative (services products in the Field)





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LIFELINK LIFELINKcentral AED Program Manager, a user interface on the LIFENET system designed for Workplace and Community Customers to view and manage their AED programs including devices, maintenance, and training.

LIFENET LIFENET System including website

LDA LIFENET Device Agent,

OI Operating Instructions

PCO file Physio Case Object file, a data format for a combination of device data and user-entered data. Data in this format can be imported and exported by Physio-Control data management applications.

SmartDesk Data Solutions Technical Support

WCT Wireless Configuration Tool is a software Application to configure Wi-Fi connection in the LIFEPAK CR2® Defibrillator.

Workplace and Community

A Physio-control customer segment that represents public access locations for Automated External Defibrillators such as schools, government agencies, airports, health clubs, and workplaces.





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Contacting Physic-Control Physio-Control, Inc. 11811 Willows Road NE Redmond, WA 98052-2003 USA Telephone: 425.867.4000 Toll Free (USA only): 800.442.1142 Fax: 1.425.867.4861 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

Regional Phone Number and LIFELINKcentral URLs: Region Phone Number LIFELINKcentral™ AED Program Manager

website Australia 1800 987 982 https://lifelink-au.lifenetsystems.com Austria / Österreich 01 74040 2866 https://lifelink-at.lifenetsystems.com Belgium / België / Belgique 0800 263 77 https://lifelink-be.lifenetsystems.com Bulgaria / България 0800 450 0013 https://lifelink-bg.lifenetsystems.com Canada 800 895 5896 https://lifelink-ca.lifenetsystems.com Cyprus / Κύπρος 0800 450 0013 https://lifelink-cy.lifenetsystems.com Czech Republic / Ceská republika 420 602 565 977 https://lifelink-cz.lifenetsystems.com Denmark / Danmark 69 60 70 58 https://lifelink-dk.lifenetsystems.com Estonia / Viro 0800 450 0013 https://lifelink-ee.lifenetsystems.com Faroe Islands / Färsaaret 358 98764630 https://lifelink-fo.lifenetsystems.com Finland / Suomi 09 876 4630 https://lifelink-fi.lifenetsystems.com France 01 70 36 86 98 https://lifelink-fr.lifenetsystems.com Germany / Deutschland 02131 6617 000 https://lifelink-de.lifenetsystems.com Greece / Ελλάδα 0800 450 0013 https://lifelink-gr.lifenetsystems.com Greenland / Grønland 0800 450 0013 https://lifelink-gl.lifenetsystems.com Guam 61 9415 5900 https://lifelink.lifenetsystems.com Hong Kong / 香港 65 6718 2080 Not applicable Hungary / Magyarország 1 882 3565 https://lifelink-hu.lifenetsystems.com Iceland 0800 450 0013 https://lifelink-is.lifenetsystems.com Ireland 44 808 258 0094 https://lifelink-ie.lifenetsystems.com Israel 0800 450 0013 https://lifelink-il.lifenetsystems.com Italy / Italia 02 6602 6100 https://lifelink-it.lifenetsystems.com Japan / 日本 0120 715 545 https://lifelink-jp.lifenetsystems.com Korea /대한민국 65 6718 2080 Not applicable Latvia / Latvija 0800 450 0013 https://lifelink-lv.lifenetsystems.com Liechtenstein 0800 450 0013 https://lifelink-li.lifenetsystems.com

http://www.physio-control.com/





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Region Phone Number LIFELINKcentral™ AED Program Manager website

Lithuania / Lietuva 0800 450 0013 https://lifelink-lt.lifenetsystems.com Luxembourg / Luxemburg 800 8 8075 https://lifelink-lu.lifenetsystems.com Malta 0800 450 0013 https://lifelink-mt.lifenetsystems.com Middle East and Africa 961 4 718 414 Not applicable Netherlands / Nederland 0800 450 0013 https://lifelink-nl.lifenetsystems.com New Zealand 0800 937 346 https://lifelink-nz.lifenetsystems.com Norway / Norge 22 83 88 00 https://lifelink-no.lifenetsystems.com Poland / Polska 22 56 91 210 https://lifelink-pl.lifenetsystems.com Portugal / República Portuguesa 351 210 415 920 https://lifelink-pt.lifenetsystems.com Puerto Rico 800 442 1142 https://lifelink.lifenetsystems.com Qatar 31 433 68 66 70 https://qa.lifenetsystems.com / قطرRomania / România 0800 450 0013 https://lifelink-ro.lifenetsystems.com Singapore / 新加坡 65-6718 2080 https://sg.lifenetsystems.com Slovak Republic / Slovenská Republika 420 602 565 977 https://lifelink-sk.lifenetsystems.com

Slovenia / Slovenija 0800 450 0013 https://lifelink-si.lifenetsystems.com Spain / España 091 843 1509 https://lifelink-es.lifenetsystems.com Sweden / Sverige 0770 870 120 https://lifelink-se.lifenetsystems.com Switzerland / Schweiz / Suisse 0800 00 66 33 https://lifelink-ch.lifenetsystems.com United Arab Emirates 31 433 68 66 70 https://ae.lifenetsystems.com United Kingdom 0808 258 0094 https://lifelink-gb.lifenetsystems.com United States 800 442 1142 https://lifelink.lifenetsystems.com US Virgin Islands 800 442 1142 https://lifelink.lifenetsystems.com

Service Personnel Qualifications Service technicians must be properly qualified and thoroughly familiar with the operation of the LIFEPAK CR2 defibrillator. They must meet at least one of the following requirements (or the equivalent):

• Physio-Control Service Depot technicians • Physio-Control Field Service Representatives • 3rd Party Service Providers that have service agreements with Physio-Control

Service Information The CR2 will not be opened for repair activities. Parts replacement is limited to the supply and replacement parts listed in Supply and Replacement Parts Before attempting to clean or service the device, the service technician should be familiar with the information provided in Preventive Maintenance. A qualified service technician (see Service Personnel Qualifications) should inspect any device that has been dropped, damaged, tampered, or abused to verify that the device is operating within performance standards listed in the Performance Inspection Procedures (PIP), and that the leakage current values are acceptable. To obtain service and maintenance for your device, contact your local Physio-Control service or sales representative. In the USA, call Physio-Control Technical Support at 1.800.442.1142. Outside the USA, contact your local Physio-Control representative. When you call Physio-Control to request service, provide the following information:

• Model number and part number • Serial number • Observation of the problem that led to the call





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Recycling information Recycle the device and its accessories at the end of their useful life. Do not dispose of this product or its batteries in the unsorted municipal waste stream. Any batteries must be removed from the device and disposed of separately before disposing of the device. At all times dispose of this product and its accessories, including batteries, according to local regulations. Contact your local Physio-Control representative for assistance, or refer to www.physio-control.com/recycling for instructions on disposing of this product.

• The device should be clean and contaminant-free prior to being recycled. • After using disposable electrodes, follow your local clinical procedures for recycling. • Packaging should be recycled according to national and local regulations.

Configuration Information This service manual is relevant for the following device and options: Unless otherwise noted, functions and features are consistent as specified throughout this manual. Differences are noted as appropriate.

Item Number (QAD) PN (on Serial Label)

Catalog Number (QAD) REF (on Serial Label)

CR2-2-0000XX* 99512-0000XX*

NOTE: * XX in the PN and REF can be different on each unit depending on the order configuration of the device.

Warranty To obtain a detailed warranty statement, contact your local Physio-Control representative or go to www.physio-control.com

Tamper Proof Label If the tamper-proof label shown below is broken or missing, the warranty may be void.

A customer facing warranty void letter template in different languages is available for service to use to inform customer. See here Sample Warranty Void Letter for detail.







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Safety - Technical Description The following information is provided to comply with Clause 7.9.3 in IEC 60601-1 (3rd Edition) for information that is “essential for safe operation, transport and storage, and measures or conditions necessary for installing the ME EQUIPMENT, and preparing it for use”. This information includes:

a) Explanation of information on the serial label b) Explanation of symbols used on the device including Cl. 6 (IEC 60601-1) applicable classifications (Type BF,

IP55) and an explanation of safety signs and other symbols.

c) For reference, the general danger and warning statements from the LIFEPAK CR2 Defibrillator Operating Instructions, 3321515.

d) A brief description of the LIFEPAK CR2 Defibrillator and its functions, and the device’s significant physical and performance characteristics.

e) Information concerning circuit diagrams, component lists available for authorized service representatives

Serial Label Information

Symbols The symbols in the following table may be found on the defibrillator, its accessories, or packaging.

SYMBOL DESCRIPTION

ON/OFF button

LANGUAGE button

CHILD MODE button

SHOCK button (on semi-automatic devices) SHOCK indicator (on fully automatic devices)





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SYMBOL DESCRIPTION

Consult instructions for use

Warning, high voltage

General warning

Single use only

Not made with natural rubber latex

Use By date shown: YYYY-MM-DD (on electrodes) Expiration date: YYYY-MM-DD (on battery)

Do not recharge battery

Lithium manganese dioxide battery

Defibrillation protected, type BF patient connection

Recommended storage temperature 15° to 35°C (59° to 95°F)

Keep away from sunlight

Do not place near an open flame, heat above 100°C (212°F), or incinerate

Do not crush, puncture, or disassemble

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See www.physio-control.com/recycling for instructions on disposing of this product.

Enclosure ingress protection code per IEC 60529

DC voltage

Device includes RF transmitter

Indicates device is certified to applicable Japanese wireless requirements

Complies with (USA) Federal Communications Commission regulations

China Compulsory Certification required for medical devices imported into China

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.





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SYMBOL DESCRIPTION

Indicates that a product complies with applicable Australian ACMA standards

Intertek certification for Canada and the United States

Recognized component mark for Canada and the United States

Mark of conformity to applicable European Directives

Manufacturer

Date of manufacture: YYYY-MM-DD

Authorized EC representative

For USA audiences only

By prescription only

Reference number

Lot number (batch code)

Serial number

Part number

General Danger and Warnings Statements For reference, the following are the general danger and warning statements found in the LIFEPAK CR2 Defibrillator Operating Instructions, 3321515.

Explosion Hazard

Do not use this defibrillator in the presence of flammable gases or anesthetics.

Possible Fire

Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

Shock Hazard

The defibrillator delivers up to 360 joules of electrical energy. Unless used properly by following the defibrillator's visual and audio prompts, this electrical energy may cause serious injury or death.





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Shock or Fire Hazard

Do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on defibrillator or accessories. Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified.

Possible Device Failure

Do not modify the device.

Possible Electrical Interference

This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects of defibrillator discharge on other equipment prior to using the defibrillator in an emergency situation, if possible.

Possible Electrical Interference With Device Performance

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which could affect the performance of this device. RFI may result in failure to detect a shockable rhythm. If use of equipment in close proximity is necessary, observe the device to verify normal operation in the configuration in which the device will be used. Avoid operating the device near cauterizers, diathermy equipment, or other portable and mobile RF communications equipment. Do not rapidly key EMS radios on and off. Refer to Separation Distances (on page Error! Bookmark not defined.) for recommended distances of equipment. Contact Physio-Control Technical Support if assistance is required.


This defibrillator should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the defibrillator should be observed to verify normal operation in the configuration in which it will be used.





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Using cables, electrodes, or accessories not specified for use with this defibrillator may result in increased emissions or immunity from electromagnetic or radio frequency interference (RFI) which could affect the performance of this defibrillator or of equipment in close proximity. Use only parts and accessories specified in these operating instructions.

Possible Improper Device Performance

Using other manufacturers’ cables, electrodes, power adapters, or batteries may cause the device to perform improperly and may invalidate the safety agency certifications. Use only the accessories that are specified in these operating instructions.

Safety Risk And Possible Equipment Damage

MR unsafe: Keep the defibrillator away from magnetic resonance imaging (MRI) equipment.

Shock Hazard

When instructed EVERYONE CLEAR, do not touch the defibrillator, patient, electrode pads, or any material or fluids in contact with the patient. Make sure no one is touching the patient when the defibrillator shocks the patient.

Possible Fire, Burns, and Ineffective Energy Delivery

During defibrillation, material in contact with the electrode pads can cause electrical sparks, skin burns, and divert important defibrillating energy away from the heart. Place electrode pads so that they adhere to the skin completely. Do not allow the electrode pads to touch each other, medication patches, dressings, metal objects, other electrodes, or any other material on the patient's chest.

Shock hazard

Do not touch the patient and the USB connector on the back of the device simultaneously.





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Possible Skin Burns

During defibrillation, air pockets between the skin and electrode pads can cause skin burns. To help prevent air pockets, make sure electrode pads completely adhere to the skin. Do not use damaged, expired, or dried-out electrode pads.

Possible Skin Burns and Ineffective Energy Delivery

Electrode pads that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not pull the red handle to open the electrodes until immediately before use.

Possible Equipment Damage

Prior to using this defibrillator, disconnect from the patient all equipment that is not defibrillator-protected.

LIFEPAK CR2 Defibrillator Description The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. Fully automatic and semi-automatic models are available. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The semi-automatic model evaluates the heart rhythm but requires the responder to press the shock button if a shockable rhythm is detected. Both models have voice instructions that guide the responder through the event.

The LIFEPAK CR2 defibrillator is also able to connect to the LIFELINKcentral™ AED Program Manager or LIFENET® System account using an internet connection. The device uses either Wi-Fi, cellular, or USB to connect.

NOTE: LIFELINKcentral AED Program Manager and LIFENET System are not available in all countries.

LIFEPAK CR2 Defibrillator Specifications All specifications are at 20°C (68°F) unless otherwise stated.

CHARACTERISTIC DESCRIPTION General

Classification Internally powered equipment per IEC 60601-1. Electrical Protection Applied parts - Electrodes are defibrillation-protected, type BF patient

connection per IEC 60601-1. Self-test When powered on, the device performs a self-test to check internal

electrical components and circuitry. The Readiness indicator stops flashing if an error is detected. The device also performs automatic self-tests daily, weekly, and monthly.





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Defibrillator Waveform Biphasic Truncated Exponential with voltage and duration

compensation for patient impedance. Patient Impedance Range

10 to 300 ohms. If the detected impedance is outside this range, the user is prompted to check the electrode pads and connector. The device will not deliver a shock if impedance is outside this range.

Output Energy Configurable energy levels for Shock 1, Shock 2, and Shock 3 or greater. Adult mode: 150, 200, 300, or 360 joules. Child mode: 35, 50, 75, or 90 joules.

Output Energy Accuracy

10% of the energy setting into 50 ohms. 15% of the rated energy output into 25–175 ohms.

Rated Energy Output

Rated energy output is the nominal delivered energy based on the energy setting and patient impedance, as defined in the following chart.

Waveform Shape and Measured Parameters





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Biphasic waveform at 200 joules, nominal

PATIENT IMPEDANCE (Ω) I1 (A) I2 (A) I3 (A) I4 (A) T1

(MS) T2

(MS) 25 58.1 21.0 20.9 10.6 5.0 3.3

50 30.0 14.8 14.8 9.2 6.9 4.7 75 20.7 11.8 11.8 8.1 8.3 5.5 100 16.0 9.9 9.9 7.3 9.3 6.2 125 13.2 8.7 8.7 6.6 10.1 6.7 150 11.3 7.8 7.8 6.1 10.8 7.2 175 9.9 7.1 7.1 5.7 11.4 7.6

Biphasic waveform at 90 joules, nominal

PATIENT IMPEDANCE (Ω) I1 (A) I2 (A) I3 (A) I4 (A) T1

(MS) T2

(MS) 25 33.1 12.0 11.9 6.1 5.0 3.3

50 20.1 9.9 9.9 6.2 6.9 4.6 75 13.9 7.9 7.9 5.4 8.3 5.5 100 10.7 6.7 6.7 4.9 9.3 6.2 125 8.8 5.8 5.8 4.4 10.1 6.7 150 7.6 5.2 5.2 4.1 10.8 7.2 175 6.7 4.8 4.8 3.8 11.4 7.6

Shock Advisory System

ECG analysis system used by this device. The Shock Advisory System determines whether a shock is appropriate. Note: The fully automatic device cannot cancel delivery of a shock after the Shock Advisory System determines a shock is advised. The semi-automatic device cancels the shock if the SHOCK button is not pressed within 15 seconds.

cprINSIGHT Analysis Technology

Additional ECG analysis system that is designed to analyze the ECG rhythm while CPR is being performed. The cprINSIGHT Analysis Technology can be set to be ON or OFF. When this feature is turned on, the voice prompts change so the user is instructed to continue CPR during analysis.

Device Capacity With new battery: Provides 166 200-joule shocks (with 1 minute of CPR between shocks), 103 360-joule shocks (with 1 minute of CPR between shocks), or 900 minutes of operating time.

When device has just reached a low battery state (Readiness indicator has stopped flashing):

Provides 39 200-joule shocks (with 1 minute of CPR between shocks), 24 360-joule shocks (with 1 minute of CPR between shocks), or 210 minutes of operating time.





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Shock Ready Time Note: These times apply for a device that has just reached a low battery state (Readiness indicator has stopped flashing). Fully automatic device:

The time to charge to 360 joules after electrode pads are applied is 35 seconds or less. The time to charge to 360 joules after power is turned on is 45 seconds or less, if electrode pads are on the patient when device is turned on.

Semi-automatic device: The time to charge to 360 joules after electrode pads are applied is 35 seconds or less. The time to charge to 360 joules after power is turned on is 45 seconds or less, if electrode pads are on the patient when device is turned on.

cprCOACH Feedback Technology Metronome rate 104 beats per minute Setup options Two options are available for CPR coaching:

• Hands-Only (no rescue breaths) • 30:2 compression to breath ratio

Communications USB, Wireless 802.11 b/g/n, or Cellular data transfer to LIFELINKcentral AED Program Manager or LIFENET System. USB cable type 2.0 A Male to Micro-B is required for USB communications.

Environmental Note: All performance specifications defined assume that the device has been stored (two hours minimum) at the operating temperature prior to operation.

Operating Temperature

0° to 50°C (32° to 122°F)

Long-term Storage Temperature

15° to 35°C (59° to 95°F)

Short-term Storage Temperature

-30° to 60°C (-22° to 140°F) for a maximum of 1 week

Altitude -382 to 4572 meters (-1253 to 15,000 feet) above sea level Relative Humidity 5 to 95% (non-condensing) Liquid and Solid Ingress

IP55 per IEC 60529

Physical (with handle) Height 9.7 cm (3.8 in) Width 22.6 cm (8.9 in) Depth 27.4 cm (10.8 in) Weight 2.0 kg (4.5 lb) including electrodes and battery

Battery Type Lithium Manganese Dioxide (Li/MnO2), 12.0 V, 4.7 Ah, 55.8 Wh Standby Life 4 years if installed in device that is not used Weight 0.3 kg (0.7 lb)





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Battery Operating Temperature

0° to 50°C (32° to 122°F)

Long-term Storage Temperature

0° to 25°C (32° to 77°F)

Short-term Storage Temperature

-30° to 60°C (-22° to 140°F) for up to 1 week

Relative Humidity 5 to 95% non-condensing

QUIK-STEP Electrodes

Pads Pacing/ECG/defibrillation electrodes Packaging Pre-connected tray with rapid-release cover Shelf Life 4 years1 Electrode Shape Oval-rectangular Electrode Size 13.34 x 8.89 cm (5.25 x 3.50 in) Lead Wire 1.1 m (42 in) Conductive Gel Contact Area

82 cm2 (32 in2)

Maximum Adhesion Time

4 hours

Maximum ECG Monitoring Time

4 hours

Maximum Number of Defibrillation Shocks

20 at 360 joules

Maximum Pacing Duration

1 hour

Operating Temperature

0° to 50°C (32° to 122°F)

Long-Term Storage Temperature

15° to 35°C (59° to 95°F)

Short-Term Storage Temperature

-30° to 60°C (-22° to 140°F) for up to 1 week

Altitude -382 to 4572 meters (-1253 to 15,000 feet) above sea level 1 Based on historical storage temperature data, the 4-year shelf life assumes a storage temperature of 25°C (77°F). Average storage temperatures

above 25°C (77°F) may decrease shelf life.





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CR2 Device Description Physical Description and Features

Four Control





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Functional Descriptions The LIFEPAK CR2 defibrillator is a portable, battery-powered therapeutic device. It consists of the following components:

• One PCB – the printed circuit board controls defibrillator functions, including ECG signal processing, mode control, rhythm and motion analysis, energy storage capacitor charging, impedance sensing, voice prompting, generation of biphasic defibrillation waveform, and patient event recording.

• Protective Lid – protects user interface and electrode tray during standby; controls defibrillator On/Off when lid is opened or closed.

• Wi-Fi Module – handles wireless connection to LIFENET System. • Cellular Module – handles cellular connection to LIFENET System. • USB connector – provides connection between defibrillator and computer to handle communication from

defibrillator to the LIFENET System. • Tray and Electrodes – electrodes are connected to the tray and the tray is plugged into the tray connector in

the defibrillator.





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Modes of Operation

Operation Description Open the Lid AED turns on and starts talking. LANGUAGE Button

Allows user to change the voice prompts to different language if a dual-language is installed on the device. A voice prompt will confirm language selection. At the next use, the device will power on in the language designated as primary.

CHILD Button Child mode/Adult mode button is a toggle switch to change between Child and Adult. Child mode: When pressed it once, a voice prompt will announce “Child Mode”. Defibrillation shocks will be delivered at reduced energy levels, and CPR coaching prompts will change. Adult mode: Press this button again to switch back to “Adult Mode”, if needed. Defibrillation shocks will be delivered at adult energy levels.

SHOCK Button

After the electrode pads are applied, when a shockable rhythm is detected, Fully automatic mode: AED delivers a shock automatically. Semi-automatic mode: requires the responder to press the shock button. Both modes have voice instructions that guide the responder through the event.

LANGUAGE Button + CHILD mode Button +

Device Data mode: Open the Lid. When the voice prompts start, press and hold LANGUAGE and CHILD buttons simultaneously for at least 2 seconds. The device will enter Data mode for device readiness troubleshooting, wireless status, LIFELINK/LIFENET check-in, or to apply software updates.

ON/OFF Button

The defibrillator turns on automatically when the lid is opened. Press and hold the ON/OFF button for 3 seconds to turn the defibrillator off. Press again to turn the defibrillator back on. The green LED is illuminated when the defibrillator is on.





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Battery and Time

Overview: CR2 battery is:

1. Non-rechargeable lithium manganese dioxide battery 2. 4 years battery (from installation time) 3. No (internal) coin cell battery on CR2. 4. Each battery maintains a real-time clock in UTC-0 time. All real time events on the CR2 will be converted to

local time from LIFENET System webpages, log file, event file and reports based on the device’s location. 5. There is no battery status indicator on the LIFEPAK CR2 device. See Battery Maintenance for more

information.

Electrodes

Expiration Date





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Overview: 1. One time use, 4 years shelf life 2. Pads function: Pacing/ECG/Defibrillation 3. Analyzes heart rhythm and delivers a shock 4. Pads can be used on both adults and children 5. If patient care is transferred to emergency medical personnel, electrode pads can be transferred to another

LIFEPAK defibrillator (except LIFEPAK 500).

Connectivity Module The LIFEPAK CR2 defibrillator has a built-in connectivity module that can connect to LIFELINK or LIFENET System using Wi-Fi, or Cellular, or USB connection.

• USB port on the device is a standard option • Wi-Fi configuration is optional, it has a built-in modem • Cellular configuration is optional, it has a built-in active SIM card plus Wi-Fi modem

To determine whether the CR2 has Wi-Fi or cellular capability, check the serial number label (located in the battery compartment). NOTE: All LIFEPAK CR2 devices with cellular capability also have Wi-Fi capability.





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Device Communication

If this additional pair of ID and IC numbers is present, the device has cellular capability and the SIM card is activated.

If this number is present, the device has Wi-Fi





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The LIFENET® System is a cloud-based platform designed by Physio-Control for Pre-Hospital and Hospital. It provides a complete software infrastructure that supports all LIFEPAK devices and 3rd party products to:

• Share critical patient data and reduce time-to-treatment for STEMI patients. • Request a remote cardiology consult through the dedicated LIFENET Consult app. • Rapidly distribute post-event review data to crews immediately after a code. • Enable organizations to manage their material assets. • Provide tools for remote physician consultation through the use of the LIFENET Consult application. • Manage software and configuration for LIFEPAK devices fleet-wide from a single website.

LIFELINKcentral AED Program Manager is a user interface on the LIFENET system designed for Workplace and Community Customers to view and manage their AED programs including devices, maintenance, and training.

To use the LIFELINKcentral web application, customers or service will need to have a proper LIFELINKcentral account to login to the website.

Both LIFELINKcentral AED Program Manager and LIFENET System are Data Management solutions that Physio-Control offers to customers and Service. LIFELINKcentral Functions

• Check device Readiness • Change device setup options • Update device software • View Logs • Manage AED Readiness activity • Manage AED supply replenishment • Manage AED/CPR training activity • Manage AED location • Manage AED records

LIFENET Functions

• OnePush: Automatically activate protocols for many emergent care needs, alert care teams to incoming patients, and timestamp specified events. All of this can be initiated by prehospital EMS transmission.

• Consult: Allow remote consultations and decision support via mobile devices, accelerating response to emergent patient data and increasing clinical efficiency.

• Alert: Receive pre-arrival notifications and urgent patient information to facilitate transfer to definitive care. • Asset: Review device readiness and get alerts for changes in device status. • Archive: Store 12-lead ECG data on a local computer, and automatically backup and restore to customer’s

database. • Adapter: Receive 12-lead ECG alerts from other brand monitor/defibrillators. • Export: Transfer all LIFENET System patient information into customer record management system.

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Wireless Configuration Tool The Wireless Configuration Tool is a computer application created by Physio-Control to help customers store Wi-Fi settings on the CR2 device so that the device can communicate with either LIFENET or LIFELINK.

LIFENET Device Agent LIFENET® Device Agent is computer-based software created by Physio-Control to help customers and service manage setup options and update software within LIFEPAK devices when the device has no Wi-Fi or Cellular capability. LIFENET Device Agent transfers the updates from LIFENET to the devices.

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DT EXPRESS™ Data Transfer Software DT Express Data Transfer Software is used to download patients’ cases from LIFEPAK devices to PCO data format.

CODE-STAT™ Data Review Software CODE-STAT Data Review Software is used to review patients’ cases in PCO data format.

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AED Event Viewer AED Event Viewer is a Mobile/PC Application to view AED event data from a specific incident, route data to CODE-STAT, and trigger LIFENET Alert Client Software. LIFENET Alert is a software program that runs in a hospital environment (for example, an emergency room or cardiac catheterization lab) and receives 12-lead ECG reports and AED event summary reports. The program alerts users to received reports so that they can view, print, and otherwise use the reports for diagnosis and treatment. From AED Event Viewer, data can be routed to CODE-STAT and also trigger LIFENET Alert, so hospital personnel can receive pre-arrival notifications and urgent patient information to facilitate transfer to definitive care.

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LIFENET Alert Client Software 9





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Initial Device Setup Overview The following diagram describes the initial device setup steps performing by the customers upon receiving the CR2. The printed literatures within the shipping box are designed to help the customers to perform device setup to bring the device to Ready state. A list of regional service contact phone numbers is included in the shipping box, Contacting Physic-Control.

1. Unpack the box. 2. Find printed literature: Operating Instructions, Getting Started Guide, and Wireless Setup Guide 3. Follow the Getting Started Guide to bring the device to Ready state. 4. For Cellular or Wi-Fi capable device, follow the Wireless Setup Guide to set up the wireless connection. 5. Test the device Wi-Fi or Cellular connection at the device installation location. 6. Check device readiness status from LIFELINK or LIFENET website.





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CR2 Trainer Device Description CR2 Trainer Device Overview

The LIFEPAK CR2 Trainer, AED Training System, provides realistic training in the use of the LIFEPAK CR2 defibrillator without the actual charge and discharge of electrical energy. The trainer is recommended so users can practice using the LIFEPAK CR2 defibrillator in simulated cardiac arrest situations. The LIFEPAK CR2 Trainer also simulates the LIFEPAK CR2 defibrillator features and functionality for sales demonstrations and customer evaluation. The Trainer device will function and provide learners with the following educational values:

• Simulates the LIFEPAK CR2 AED in appearance, features and operation • Provides a cost-effective CPR/AED training solution • Provides the same intuitive and simple operation as the LIFEPAK CR2 Defibrillator • Consumes 4 standard D-cell batteries • Displays Setup and configuration in LCD Display screen • Utilizes a reusable electrode tray • Localizes in text and voice prompts • Software flexibility covers scenarios that reflect certified global CPR/AED training courses, LIFEPAK CR2

defibrillator operation, and specific sales demonstrations.





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• Bluetooth USB device enables wireless communication to a mobile smart device, allowing sales demonstrations of the LIEPAK CR2 wireless notification technology.

CR2 Trainer Service • There will be no service manual for CR2 Trainer Device. For CR2 Trainer device operation details, refer to

CR2 Trainer Operating Instructions. • The Trainer is not field serviceable or repairable. There will be no service contract offering for the Trainer. The

customers can order trainer replacement parts (such as a lid, electrodes, carry bag, etc.) via Physio web-site or local authorized distribution partners.

• LIFEPAK CR2 Trainer will have a one year limited warranty. • Future software updates will be orderable from Physio-Control pre-loaded on a USB device. The customer can

use the USB device to reprogram trainers. Each new software update will have a unique part number for order. Software update instruction is in the Operating Instructions.

CR2 Trainer Parts PN Catalog Number Description

3324171-000 11250-000144 MANIKIN, TRAINER, LPCR2 3323897-000 11250-000140 PADS, REPLACEMENT, TRAINER, LPCR2 3323893-000 11250-000145 TRAY, ELECTRODE, TRAINER, LPCR2 3323894-000 11250-000146 TRAY, ELECTRODE, TRAINER, LPCR2, ISRAEL 3323896-000 11250-000139 ASSY, TRAY COVER WITH HANDLE, TRAINER, LPCR2 3323895-000 21250-000003 DOOR, BATTERY, 3 PACK, TRAINER, LPCR2 3323898-000 11250-000141 USB, BLUETOOTH, TRAINER, LPCR2 3323899-001 11250-000142 USB, REPROGRAMMING, TRAINER, LPCR2, CR2T-1.0S 3329256-000 11250-000178 Replacement Handle Kit 3324058-000 11141-000166 BATTERY, D-CELL, TRAINER, LPCR2 3324455-000 11260-000048 ASSY, CARRY TOTE, TRAINER, LPCR2, ENGLISH 3324455-040 11260-000049 ASSY, CARRY TOTE, TRAINER, LPCR2, GERMAN 3324455-060 11260-000050 ASSY, CARRY TOTE, TRAINER, LPCR2, ITALIAN 3324455-080 11260-000051 ASSY, CARRY TOTE, TRAINER, LPCR2, FRENCH 3324455-100 11260-000052 ASSY, CARRY TOTE, TRAINER, LPCR2, DUTCH 3324455-120 11260-000053 ASSY,CARRY TOTE, TRAINER,LPCR2, ES-SPAIN-LATAM 3324455-180 11260-000054 ASSY, CARRY TOTE, TRAINER, LPCR2, SWEDISH 3324455-200 11260-000055 ASSY, CARRY TOTE, TRAINER, LPCR2, DANISH 3324455-220 11260-000056 ASSY, CARRY TOTE, TRAINER, LPCR2, FINNISH 3324455-240 11260-000057 ASSY, CARRY TOTE, TRAINER, LPCR2, NORWEGIAN 3324455-260 11260-000058 ASSY, CARRY TOTE, TRAINER, LPCR2, POLISH 3324455-360 11260-000059 ASSY,CARRY TOTE, TRAINER,LPCR2, ZH TRADITIONAL 3324455-380 11260-000060 ASSY, CARRY TOTE, TRAINER, LPCR2, KOREAN 3324455-400 11260-000061 ASSY, CARRY TOTE, TRAINER, LPCR2, JAPANESE 3323900-000 21250-000004 ASSY, LID, LOCALIZED, TRAINER, LPCR2, ENGLISH 3323900-040 21250-000005 ASSY, LID, LOCALIZED, TRAINER, LPCR2, GERMAN 3323900-060 21250-000006 ASSY, LID, LOCALIZED, TRAINER, LPCR2, ITALIAN





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3323900-080 21250-000007 ASSY, LID, LOCALIZED, TRAINER, LPCR2, FRENCH 3323900-100 21250-000008 ASSY, LID, LOCALIZED, TRAINER, LPCR2, DUTCH 3323900-120 21250-000009 ASSY,LID,LOCALIZED,TRAINER,LPCR2,ES-SPAIN-LATAM 3323900-180 21250-000010 ASSY, LID, LOCALIZED, TRAINER, LPCR2, SWEDISH 3323900-200 21250-000011 ASSY, LID, LOCALIZED, TRAINER, LPCR2, DANISH 3323900-220 21250-000012 ASSY, LID, LOCALIZED, TRAINER, LPCR2, FINNSIH 3323900-240 21250-000013 ASSY, LID, LOCALIZED, TRAINER, LPCR2, NORWEGIAN 3323900-260 21250-000014 ASSY, LID, LOCALIZED, TRAINER, LPCR2, POLISH 3323900-360 21250-000015 ASSY,LID,LOCALIZED,TRAINER,LPCR2,ZH-TRADITIONAL 3323900-380 21250-000016 ASSY, LID, LOCALIZED, TRAINER, LPCR2, KOREAN 3323900-400 21250-000017 ASSY, LID, LOCALIZED, TRAINER, LPCR2, JAPANESE

Data Management Solution

LIFELINK and LIFENET account creation All CR2 devices shipped to customers will be added to LIFELINK or LIFENET System from manufacturing. For customers who already have a LIFENET account, the CR2 will be added to the customer’s LIFENET account. For customers who do not have an existing LIFENET account, the CR2 will be added to the customer’s LIFELINK account.

LIFELINK or LIFENET Password Reset

1. Click on “Forgot your password?” from LIFELINK or LIFENET website

2. Follow the onscreen steps to request a new password. A new password will be sent to the primary email

address listed in the user profile.

3. From the email, click on the link to reset the password.





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4. If a wrong password has been entered three times, the login account will be disable. The customer will need to call customer service to unlock the login account.

Connectivity Overview: There are four main steps to connect the CR2 to LIFELINK or LIFENET System:

1. Download and install Wi-Fi Configuration Tool from LIFELINK or LIFENET to the computer. 2. Use Wi-Fi Configuration Tool to set up and store CR2 Wi-Fi settings. 3. Check in CR2 to LIFELINK or LIFENET 4. Check device readiness status from LIFELINK or LIFENET website

NOTE: CR2 supports 2.4 GHz Wi-Fi frequency. It does not support 5 GHz frequency.

Download and Install Wi-Fi Configuration Tool Overview: Wi-Fi Configuration Tool is a PC application made by Physio-Control to help customers connect Physio-Control devices to the Wi-Fi network so that the devices can communicate with LIFENET system. This procedure describes how to download and install Wi-Fi Configuration Tool. Prerequisites:

• LIFENET or LIFELINK user account. • Windows Computer • Internet access available from Computer

Required Time: • Less than 10 minutes is required to download and install Wi-Fi Configuration Tool.

Steps: 1. Login to LIFELINK or LIFENET website. 2. Download the Wi-Fi Configuration Tool.

• In LIFELINK, select Resource Center, and then select Wi-Fi Configuration Tool, and click on

to download.

• In LIFENET, select Assets > Wi-Fi Configuration Tool Applications. Click on Add or Update Wi-Fi Configuration Tool. Under Description, click on Wi-Fi Configuration Tool (32 or 64-bit) to download.

3. When download completes, right click on “WCT.#.#.#.###_Setup.exe” from your download folder, and select “Run as administrator”.

4. Wait for the following screen to appear, select language, and then click Next.





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5. Follow the onscreen instructions to finish installing Wi-Fi Configuration Tool. 6. If an older version is detected during the installation, remove the previous version and repeat from step 3.

Store Wi-Fi Settings on CR2 Overview: The CR2 has no screen and keyboard, to setup Wi-Fi configuration on CR2, the Wi-Fi Configuration Tool software application is used from a computer, and a USB cable is used to transfer the Wi-Fi settings to the CR2. This procedure describes how to store Wi-Fi settings in the CR2. Prerequisites:

• LIFENET or LIFELINK account. • Wi-Fi hotspot available at the intended location of the CR2

Required Tools:

• USB cable type 2.0 A Male to Micro-B (PN 3321551-000, Cat # 11512-000003) • Computer with Windows® 7 or above operating system • Internet access available from computer • Wi-Fi network ID and password

Required Time:

• Less than 10 minutes is required for storing Wi-Fi settings on the CR2.

Steps: 1. Launch the Wi-Fi Configuration Tool, Click the Start button, type “Wi-Fi” in the search bar, and select Wi-Fi

Configuration Tool

2. Select your country (only required the first time using the Wi-Fi Configuration Tool), and enter your LIFENET or LIFELINK credentials: NOTE:





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This Wi-Fi Configuration Tool is intended to reach LIFENET product servers. When using this tool to test connectivity in LIFELINK or LIFENET test server, you must enter the test server URL in the tool. To do so, in the country field, select United States and then press Ctrl + F10. This should pop-up an input box where you can type in the test server URL.

Example of test servers: https://demo1.lifenetsystems.com/

https://physio-dev2.lifenetsystems.com/

3. If a Proxy service is in place for the computer Wi-Fi network, click Proxy Settings. Otherwise, click Next and continue on step 5.

https://demo1.lifenetsystems.com/






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4. Get your Proxy Server information from IT and enter into the following page so that the Wi-Fi Configuration Tool can reach the LIFELINK or LIFENET website.

NOTE: The Wi-Fi Configuration Tool will only store Proxy Server information on the computer; it will not store Proxy Server information on the CR2. If the CR2 Wi-Fi access point has another Proxy, customers will need to exempt the LIFENET or LIFELINK domain from their Proxy servers in order for the CR2 to reach LIFENET or LIFELINK server. See Table, LIFENET System URLs for regional addresses to put into the customer’s Proxy Server Whitelist.





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5. Connect the USB cable between the CR2 and computer.





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6. Open the CR2 lid. 7. Follow the onscreen instructions from the Wi-Fi Configuration Tool. 8. After selecting a Wi-Fi network name and entering Security key, click Test Connection to test if the CR2 can

communicate with the Wi-Fi network hotspot and reach LIFENET System. NOTE: If the intended CR2 Wi-Fi location is not in the range, skip the connection test and go to step 10.





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9. If the Connection Test Failed screen appears, follow the 5 common solutions on the screen to resolve the issue.

Note: If customer’s IT needs to know the MAC address of CR2, use a wrong password for the Wi-Fi network and let Test Connection failed, the CR2 MAC address will be displayed in Connection Test Failed window.

10. When the connection test is complete, click Next to apply the Wi-Fi settings to the CR2.

CR2 MAC address





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11. Click Next when Update successful screen appears.

12. For a site has multiple CR2s that need to connect to LIFENET, select Configure Another Device. Otherwise, select Close the Lid, disconnect the USB cable, and Close Wi-Fi Configuration Tool.





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Note: A multiple Wi-Fi networks can be stored in CR2 by repeating above procedure. The CR2 will be automatically detect and connect to whichever Wi-Fi network is in the range.

Confirm Connection to LIFELINK or LIFENET Overview: After the Wi-Fi settings have been stored in the CR2, perform this procedure at the intended CR2 location to make the CR2 check in to LIFELINK or LIFENET. If the intended location only has cellular signal and the CR2 has cellular capability, this procedure will perform the CR2 Check-In to LIFELINK or LIFENET via cellular network. Device data from the CR2 will be transferred to LIFELINK or LIFENET during this procedure. Prerequisites:

• The CR2 must be in its intended location, with access to the Wi-Fi or cellular network. • Wi-Fi settings must have been stored in the CR2, or • CR2 must have cellular capability.

Required Time: • Less than 5 minutes if Wi-Fi signal strength is optimal, or cellular network signal is available at the location.

Steps:

1. Take the CR2 to its intended location.





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2. Open the lid. 3. Wait until the voice prompts start and then press and hold the LANGUAGE and CHILD MODE buttons

simultaneously. 4. Release the buttons when you hear “Device ready” or “Device not ready.” (NOTE: This voice prompt indicates

whether the AED is ready for a cardiac emergency. It does not indicate whether wireless is ready.)

5. Close the lid and place the CR2 in its permanent storage location. 6. CR2 will attempt a Wi-Fi connection to LIFELINK or LIFENET immediately after the “Device ready” or “Device

not ready” voice prompt. 7. Listen for following voice prompts

• Wi-Fi Connection Initiated • Connection in progress • Connection established

If you hear “Unable to establish Wi-Fi network connection,” this may mean that the signal strength at the location is not strong enough to connect the CR2 to the Wi-Fi network. If possible, move the CR2 installation closer to the Wi-Fi access point and try again.

8. If the CR2 has cellular capability, it will attempt a cellular connection immediately after the Wi-Fi connection, whether or not the Wi-Fi connection was successful.

9. Listen for following voice prompts • Mobile connection initiated • Connection in progress • Connection established

10. If you hear “Unable to establish mobile network connection,” this may mean that the cellular signal strength at the location is not strong enough. If possible, move the CR2 installation and try again.

11. Once a Wi-Fi and/or cellular connection are established, the CR2 will update the LIFELINK or LIFENET account with its current status. The CR2 will also download any updates available from the account. The CR2 beeps every few seconds during the update process. When all updates are complete, “Communication complete” will be heard. Then the CR2 will terminate the Wi-Fi and/or cellular connection.

12. If “Connection Failed” is heard, refer to Unable to establish Wi-Fi network connection

Check CR2 Device Readiness Status Overview: For connected CR2 devices, after the initial connection is done, device data is transferred from the CR2 to LIFELINK or LIFENET System. From the LIFELINK or LIFENET website, customers or service can remotely monitor device readiness status including battery status, expiration dates, device self-test results, and test log. The CR2 will automatically check in to LIFELINK or LIFENET and update the status once a month.

To Check CR2 Device Readiness Status: 1. Log in to LIFELINK or LIFENET account. 2. Verify CR2 readiness from LIFELINK or LIFENET website.





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• From LIFELINK login: Go to the Equipment page and verify that the CR2 status is “Ready” in green.

• From LIFENET login: Go to the Devices page and verify that the CR2 status is “Ready” in green.





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Monthly Auto-Check-In Overview: This session explains how often and when the CR2 will send device data to LIFELINK or LIFENET System to update device status. The CR2 will send data when any of the following events occur:

1. Monthly Auto Check-In (initiated by the CR2) - The CR2 automatically runs the monthly self-test and checks in to LIFELINK or LIFENET to update device status

2. Manual check-in (initiated by a user) – replace the battery with a new battery 3. AED in use (lid opened) 4. AED event complete and lid closed 5. Self-Test failed (daily, weekly, monthly)

NOTE:

1. Device status on LIFELINK or LIFENET is not a real time status. To conserve device battery, the communication between device to LIFELINK or LIFENET will only happen in above five cases.

2. The Monthly Auto-Check-In date is set in each CR2 during manufacturing. It cannot be changed. To view the monthly Check-In date on the CR2, log in to LIFELINK and go to Equipment view.

3. In LIFENET, Next Expected Check-In Date/Time can be viewed from Devices View > View Device Details





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4. If the CR2 loses connectivity and misses the monthly Auto-Check-In to LIFELINK or LIFENET System, the Device Readiness status will be set to Outdated. To fix the Outdated status, refer to Confirm Connection to LIFELINK or LIFENET to perform manual check-in.

NOTE: Connection from the CR2 to the LIFELINK or LIFENET server is initiated from the CR2 (outbound connection). The LIFELINK or LIFENET server does not initiate connection with the CR2 (inbound connection).

Change or Remove Wi-Fi Settings on the CR2 Overview: Sometimes a customer’s Wi-Fi network will change. This procedure shows how to change or remove Wi-Fi settings on the CR2. Prerequisites:

• Have a LIFELINK or LIFENET login account. • New Wi-Fi hotspot available at the CR2 intended location

Required Tools:

• USB cable type 2.0 A Male to Micro-B (Cat # 11512-000003) • Windows computer • Internet access available from computer • Wi-Fi network ID and password

Required Time:

• ~10 minutes is required for changing Wi-Fi settings on a CR2.

Steps: 1. Launch Wi-Fi Configuration Tool. (Click Start -> type “Wi-Fi” in the search bar -> select Wi-Fi Configuration

Tool.) 2. Connect USB cable from the CR2 to your computer. 3. Open the lid on the CR2, and wait for the computer to establish a connection with the CR2. 4. When the Connect to Wi-Fi Network screen appears, select a new available network or Add Custom

Network. Then follow the on-screen instructions to finish the Wi-Fi Network setup.





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5. To remove Wi-Fi settings from the CR2, select More Options > Erase all Wi-Fi settings from the device > Next. The Wi-Fi settings on the CR2 will be erased and the Update Successful screen will appear.

6. Click Cancel to exit the Wi-Fi Configuration Tool.





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Change Setup Options or Update Software Overview: All LIFEPAK CR2 devices are shipped with customer-defined settings, e.g., language, therapy energy level, CPR Settings, and other options. If a customer wants to change the factory default settings or update the software, the changes must be made through LIFELINK or LIFENET System. Only customers can make changes on Setup Options and accept software updates for the CR2 device via LIFELINK. NOTE: Setup options and software version is site specific. For LIFELINK customers, all CR2 devices in one site share one setup option and software profile. Basic Steps to Change CR2 Setup Options or Update Software: (Details provided in the following sections.) For Wi-Fi device:

1. Make changes to CR2 Setup Options or accept software update in LIFELINK or LIFENET System. 2. Apply changes or update to CR2 via Wi-Fi network.

For Cellular device:

1. Make changes to CR2 Setup Options or accept software update in LIFELINK or LIFENET System. 2. Apply changes or update to CR2 via cellular network.

For non-connected device:

1. Make changes to CR2 Setup Options or accept software update from LIFELINK or LIFENET System. 2. Download and install LIFENET Device Agent from LIFELINK or LIFENET System to the computer. 3. Apply changes or update from LIFENET Device Agent to CR2 via USB cable

Update Setup Options or Software from LIFENET or LIFELINK Overview: This procedure describes how to change CR2 setup options or accept software update from LIFENET or LIFELINK. Prerequisites:

• LIFENET account or LIFELINK customer’s account • Internet connection on Computer • Browser: Internet Explorer version 10 or above; Google Chrome version 44 or below; any version of Mozilla

Firefox

Required Tools: • Computer

Required Time:

• ~ 10 minutes

Steps (using LIFELINK as an example) NOTE: For LIFELINK, only customer’s login can make changes on Setup Options or accept Software Update. ASR cannot perform this function. Follow steps are for supporting customers remotely or on-site with customer’s login credential.

1. login to LIFELINK 2. Click Sites from left, 3. Select a site from the list of sites





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4. Click on icon to open Software and Setup Options page 5. Select a profile (settings and software version are site-specific)

6. In the profile page, click on Edit Setup Options





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7. Then make changes to the setup options, and click on Save

8. To print or keep a record of site setup options, click on 9. The complete list of setup options will be showed in the print window as following picture





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10. To see which devices are linked to this profile, click the 'View Devices' icon, Steps (using LIFENET login as an example)

1. Login to LIFENET (both customers’ accounts or service accounts can perform this function) 2. Click on Asset, and select Device Software and Setup Options 3. Click Create Setup Options to make a new profile, and name the profile properly 4. After the new profile is created, from the row of Setup Option profile, under the Action Column, select Assign

Setup Options To Device(s) icon, to appy the profile to the device(s)

5. Select the Serial Number checkbox and click Save to apply the Setup Option Profile to the device. For example, in following Setup Option Profile “Upgrade CR2 1_0_3”, select three Assign Checkboxes for Serial Numbers, 43936666, 43936688, 43936841, and click Save.

6. Once the new Setup Option Profile has been assigned to the Serial Number, the update will apply to the CR2 device when device check-in to LIFENET system.





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Applying Updates with Wi-Fi or Cellular Connection Updates are not applied to CR2 until CR2 check-in to LIFELINK or LIFENET Systems. CR2 with access to a wireless connection or cellular network will check-in to LIFELINK or LIFENET automatically once a month. You can wait until the next CR2 check-in to apply updates automatically, or manually switch the device to Data mode and apply the updates immediately. See session Modes of Operation for how to enter to the Data mode. For non-connected CR2, use LIFENET Device Agent to apply updates to CR2. NOTE:

• During remote software updates to CR2 device via LIFENET connection, there are many steps behind the scenes. The remote update involves: 1. software package transfer; 2. verify transferred package file integrity; 3. persist hardware calibration; 4. commit (switch over to the new software) the update on device 5. perform monthly self-test

• Before the commit step, the software update process can be interrupted to respond to a patient event and the software update will exist gracefully.

• Only in the commit step during software update process, the CR2 device will be in unresponsive mode (no lid action, button action and data communication) for less than 40 seconds.

• If commit step fails, the software will be rolled back to the previous software version and setup options. • After monthly auto self-test is complete, the CR2 will perform check-in to LIFELINK or LIFENET System to

update device status.

Here is the list of voice prompts can be heard during a successful update for Wi-Fi only device: 1. Device Ready 2. Wi-Fi connection Initiated 3. Connection in progress – 2 beeping tones in sequence can be heard 4. Connection established 5. This may take several minutes - 2 beeping tones in sequence can be heard 6. Update in progress – during this time, 2 beeping tones in sequence can be heard 7. Rebooting – from this voice prompt to next one, there is a wait time. Relay clicking sound can be heard. Do

not touch the device and just wait for next voice prompt to start 8. Wi-Fi connection initiated 9. Connection established 10. This may take several minutes 11. Communication complete 12. Powering off – this means update is complete

Applying Updates with USB connection Overview: This procedure describes how to use LIFENET Device Agent (LDA) to apply setup option changes or software update on a CR2 when the CR2 has no Wi-Fi or Cellular capability. Prerequisites:

• LIFELINK or LIFENET login account • Computer with internet connection

Required Tools:

• USB cable (Cat # 11512-000003) • LIFENET Device Agent software

Required Time:

• ~30 minutes is required to install LIFENET Device Agent and perform CR2 updates.





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Steps:

1. If LIFENET Device Agent has been download to the computer before, skip to Step 4 2. To download LIFENET Device Agent, login to LIFELINK -> Resource Center -> Connection Tools -> LIFENET

Device Agent -> and click on 3. Launch LIFENET Device Agent installation software, LDA.#.#.#.###_Setup.exe, and follow the steps

onscreen to finish installing LIFENET Device Agent

4. To apply Setup Options or software update to CR2, Start LIFENET Device Agent from your computer.

5. Select the country at first time using LDA and login to LIFELINK or LIFENET to register LDA version.





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NOTE: When using this tool to test LDA in LIFELINK or LIFENET test server, you must enter the test server URL in the tool. To do so, in the country field, select United States and then press Ctrl + F10. This should pop-up an input box where you can type in the test server URL.

Example of test servers: https://demo1.lifenetsystems.com/

https://physio-dev2.lifenetsystems.com/ ,

https://demo1.lifenetsystems.com/






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6. Click Next in the Device List window

7. Select LIFEPAK CR2® Defibrillator and click Next,

8. Connect the USB cable from the CR2 to the computer, then open device lid





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9. If it is first time using LDA with CR2 USB cable, the USB driver software will be automatically installed to the

computer. Then trying to establish the connection between LDA and CR2 via USB cable. During this time, following screen appears.

10. When the connection between LDA and CR2 is established, the voice prompts will be stopped, and the

following screen appears. Downloading updates will be in progress from LIFENET System to the device





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11. When download is complete, the following screen appears.

Monitor Update Status Overview: All CR2 devices of the same model will have the same profile (software version and setup options) to ensure consistent device behavior across one site (the settings are site-specific; if you have access to multiple sites, you will need to configure each site's settings separately).





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Monitor Update Status from LIFELINK:

1. Login to LIFELINK website 2. Click on Sites from left menu 3. Highlight a site and click to open the Site view

4. Click icon Software and Setup Options to open available profile view

5. If all devices in the site have been updated to one profile, the status will be shown CURRENT.

6. The status of the profile will be one of the following:

Current All devices at this site have been updated to this profile Update Available A new version of software is available for devices at this site. Click

this profile to authorize the update. Update in Progress N/M A software update has been authorized for this site or setup options

have changed, and at least one of the devices still needs to be updated. N indicates the number of devices that have already been updated and M indicates the total number of devices assigned to the profile.

Profile





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Monitor Update Status from LIFENET: To check if update has been applied to the device, from Assets -> from View Assets by dropdown menu -> select Device software configuration -> look at Synchronization State for update status.

• Synchronization Failed – means update has been perfrom with error. Try again or call SmartDesk for

support; • Synchronized – means update has been performed and it is sucessful; • Synchronization Required – means update has not been performed. waiting for LIFENET check-in to

apply update to the device;

View Software Version Overview: Because all CR2 devices are registered either in LIFELINK or LIFENET, and the only way to update software is from LIFELINK or LIFENET, therefore, the software version on CR2 device can be viewed from LIFELINK or LIFENET. View device software version from LIFELINK

1. login to LIFELINK 2. On the main menu, click Equipment. 3. Point to highlight a device, and then click to open the Equipment view. 4. Scroll down to view the software version for the SN





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.

View device software version from LIFENET System

1. login to LIFELINK System 2. click Assets 3. Select View Assets by Device software configuration 4. View software version for each SN under Software version column





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Viewing LIFEPAK CR2 Log Files Overview: To view CR2 device log files, service personnel will need to have LIFENET or LIFELINK accounts.

View Log from LIFENET System From My Network menu, click Devices. In the Actions column, select the device row and click to open the View Device Log page.

On the View Device Log page, you can view logs available for the selected device, depending on the device type.





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There are four types of Device Logs for viewing, depending on the LIFENET System user role. Not all logs are available for viewing in all roles. For the LIFENET Account Support User role, all logs are available for viewing.

1. Device Test Log - Test log extracted from data transmitted by the device to show each test with timestamp, result,

device readiness, temperature, Fault Codes, Diagnostic Code (see Test Log example in the previous page). 2. Device Shock Log – Shock records

3. Device Battery Log – Battery Serial Number, Status, operating temperature, estimated remaining capacity (mAh),

and battery test timestamp.





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4. Device Event Log - Details of various device events (such as results of data transmissions, transmission errors, and warnings).

View Log from LIFELINK View Device Log:

For connected LIFEPAK CR2 devices, the Device Log can be viewed from the LIFELINK website.

1. Test Log – provides information about internal tests that are automatically run on the device including test type, test results, and fault codes. This information is primarily used by Physio-Control Technical Support for troubleshooting. However, it can also be viewed by Program Coordinators, Site Coordinators, and AED Inspectors.

2. Battery Log – Battery status, only Physio-Control ASR can view this log 3. Shock Log – device shock history, only Physio-Control ASR can view this log

To view a Device Log: 1. On the main menu, click Equipment. 2. Point and highlight a device, and then click to open the Equipment view.

3. Click on to view Device Log.





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Device Log





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View AED Usage Log:

The AED Usage Log shows data such as the device model and serial number, event date, and the date post event reports were sent to the Post Event Report Recipient (if applicable).

To view the AED Usage Log:

1. On the main menu, click Equipment. 2. Point to Manage Equipment and click AED Usage Log.

3. Select one event from the list and click to view AED Usage Log information.





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4. The AED Event Log Item window shows the Event detail for date, time, SN, and Site Name.

View WCT Log Overview: When the CR2 cannot connect to LIFELINK of LIFENET, there is a communication log in the WCT which will provide service more information for troubleshooting connection errors. To View a device communication log from WCT:

1. Launch Wi-Fi Configuration Tool. (Click Start -> type “Wi-Fi” in the search bar -> select Wi-Fi Configuration Tool.)

2. Use LIFELINK or LIFENET login credential to login 3. When following screen appears, following the onscreen steps





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4. When the Connect to Wi-Fi Network screen appears, select Advanced Setup, and Next





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5. Select Read LIFEPAK CR2 diagnostic data, and Next to see Communication Details





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6. If customer needs support with connection issues, instruct the customer to copy the log entries into a text file:

• selecting the first line in the log window, • scroll down to the last line in the log window, • hold Shift key and select the last line • Ctrl + C to copy the lines • Open Notepad, and Ctrl + V to paste the log entries. Save the file and attach it to an email to SmartDesk

for troubleshooting.

Post AED Event Services Overview: When the CR2 is used in a patient event, customers may need various types of support. The following cases describe how to support the customer for post AED Event data services. NOTE:

• The CR2 can store up to twenty 30 minute patient episodes in memory. When patient data storage is full is full, first-in first-out is used in memory management.

• The CR2 is capable of storing a 60 minutes episode with continuous ECG and impedance waveforms. • Each time the lid is opened, an AED-in-use event is recorded.

LIFELINK AED Event Service Case 1 (connected CR2): For LIFELINK customers in the United States who purchase the AED Post-Event Service and Medical Direction feature, real-time data flow to the customer and Medical Director works as shown in the following diagram.





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NOTE:

1. The “AED in Use” notification email will only be sent to Program Coordinator who is assigned in LIFELINK. 2. The “AED Post Event” email will be sent to the Medical Direcor with two reports attached in the email: CPR

report and Event Log Report.





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3. CPR Report Example:





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4. Event Log Example:

5. If the customer wants to see continuous wave form summary (ECG data), follow Case 3 below to download

Post Event data from the CR2 to the computer.

LIFENET AED Event Service for EMS customers Case 2 (Connected CR2): LIFENET customers (Hospital and pre-hospital) typically do not have Medical Directors that need to be informed of AED events. An EMS agency that has AED Event viewer can see and capture AED patient event data from devices in their community if they are the agency that treated the patient. This data will be sent to the EMS’s Code-Stat account.





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NOTE:

1. AED Event Viewer will keep the AED events for 7 days. 2. This Data flow method requires LIFENET implementation.

Using DT EXPRESS Data Transfer Software to download an AED Event Case 3 (non-connected CR2 or USB-only CR2): For non-connected LIFEPAK CR2 devices, including USB-only, if customers purchase AED Post-Event Service, an FSR will be sent on-site to use DT EXPRESS to manually download the AED Event from the CR2. The DT EXPRESS version which supports the CR2 is 6.1 or greater.





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Prerequisites:

• Computer with internet connection • DT EXPRESS 6.1 or greater installed on computer • CR2 that has been used in a patient event

Required Tools:

• USB cable (Cat # 11512-000003)

Required Time: • ~10 minutes is required for downloading event data.

Steps:

1. Launch DT EXPRESS from computer.





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2. Click QUIK-STEP.





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3. Select LIFEPAK™ CR2 AED from Download Wizard.

4. Connect USB cable from CR2 to computer.





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5. Open CR2 lid and wait for download to complete.





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6. Select desired files to download, and click Next>.

NOTE: The default setting of DT EXPRESS is set to only show unsent cases. To see the cases that have been sent to LIFENET system from the computer, contact Smartdesk to get a batch file, LPCR2DownloadUnsentFilesOnlyUI_Disable.bat, to modify the registry key.





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7. The Downloaded PCO files will be stored in this location: C:\ProgramData\Physio-Control\Resuscitation Suite\10\Download\. The PCO files can be manually imported to CODE-STAT for viewing.

8. If a viewer prefers to have the case in PDF format, select Export to export the case to PDF files. The export

folder is pre-configured in Configuration Properties. For details on how to use DT EXPRESS, use the Help system in DT EXPRESS.

Preventive Maintenance Periodic maintenance, inspection, and testing of the device helps prevent and detect possible electrical and mechanical problems.

Device self-test The purpose of a device self-test is to test the device hardware, mainly electrical components, for issues that may result in a critical failure. The self-test consists of a variety of tests that can be performed by the software. Each test is grouped into three periodic categories: Daily, Weekly, and Monthly. To conserve battery power, the Daily test focuses on electrode expiration, battery expiration, and battery capacity. The Weekly test includes all daily tests, plus additional tests that are not required to be tested on a daily basis. The Monthly test includes all daily and weekly tests, plus additional tests to check critical behavior and wireless functionality. See the table below for a list of tests performed. Following the Monthly test the device is provided an opportunity to contact LIFELINK or LIFENET to update status, and perform any data transfer and remote maintenance activities. The device self-test is meant to be run when the device is not being used. If the device is turned on during a self-test, the self-test is aborted and the device turns on for AED use. If you remove the battery and insert a new battery (that has not been used before), the defibrillator will automatically begin a Monthly self-test. The self-test may take up to 2 minutes.





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NOTE:

• Self-test pass: 3 audible tones sound and the green Readiness indicator is flashing every 6 seconds through a small hole located on top of the lid, the self-test has been completed and passed.

• Self-test fail: If there are no audible tones or the Readiness indicator is not flashing, the self-test has failed. Refer to Troubleshooting for possible solutions.

Device Daily, Weekly, and Monthly Tests Self-test to run based on Temperature ranges (as marked by X) Freq. Temperature Affect for …

[using T for temperature in degrees Celsius]

Operating 0<=T<=50

Out of Range -45<=T<0 or 50<T<=100

Broken Sensor T<-45 or T>100

Daily ELECTRODES EXPIRATION test X X X Daily BATTERY EXPIRATION test X X X Daily HIGH LIMIT OCV (open-circuit

voltage) test X

Daily BATTERY OCV (open-circuit voltage) test - OCV Voltage Drop test - OCV Voltage Level test

X

Daily TEMPERATURE test - Sensor Test - Operating Test

X X X

Weekly RAM CONNECTION test X X (unless triggered through Monthly test)

X

Weekly INTERPROCESSOR COMMUNICATION test

X X (unless triggered through Monthly test)

X

Monthly BATTERY LOAD test - Voltage Level test

X

Monthly PREAMP ECG test - pacer pulse detection test - ECG Single-Step test

X X

Monthly PREAMP IMPEDANCE test X X Monthly ISOLATION RELAY test

- Relay Close test - Relay Open test

X X

Monthly H-BRIDGE test - Phase 1 (NW to SE) Conduction test - Phase 2 (NE to SW) Conduction test

X X

Monthly CHARGE RATE test X X Monthly VCAP MEASUREMENT test X X Monthly SPEAKER test X X





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Monthly SWITCHES test - LID switch test - ON/OFF switch test - SHOCK switch test - LANGUAGE switch test - PEDIATRIC switch test

X X

Monthly WI-FI HARDWARE test - Interface Communication test

X X

Monthly WI-FI COMMUNICATION test - Wi-Fi scan test - Access Point test

X X

Monthly CELLULAR HARDWARE test - Interface Communication test

X X

Monthly CELLULAR COMMUNICATION test - Signal Strength test

X X

Monthly POWER SUPPLIES test - ANALOG (5 v) VOLTAGE test - GATE DRIVE (19 v) VOLTAGE test - VDDIO (3.3 v) VOLTAGE test - VDDA (1.8 v) VOLTAGE test - VDDD (1.2 v) VOLTAGE test - SYS (3.3 v) VOLTAGE test

X X

Monthly LED test - Shock test - Ped test

X X

Battery Maintenance Overview: There is no battery status indicator on the LIFEPAK CR2 device. The battery status is monitored through a combination of self-tests, automatic email notifications to the owner with battery status for connected devices, and voice prompt diagnostics. The Operating Instructions provide customers with information about battery maintenance and troubleshooting tips. NOTE:

• There is not coin cell battery on CR2. Each battery maintains a real-time clock in UTC-0 time. All real time events on CR2 will be converted in local time from LIFENET System in webpages, log file, event file, and reports based on CR2 location.

• Battery Specifications: See LIFEPAK CR2 Defibrillator Specifications • Battery Status: For devices that are connected to LIFELINK, the battery status can be viewed on the LIFELINK

website in the Equipment view with ASR role.





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• Battery Status: For devices that are connected to LIFENET System, the battery status can be viewed on the

LIFENET website in the Device view with LIFENET service role.

• Example of battery log for a good battery:

• Following Example shows that battery needs to replace:





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• Battery Status: To check battery status for non-connected devices, refer to Using Voice Prompts for

Troubleshooting.

• 90 days from Battery Expiration: Device readiness status changes to Needs Attention - Battery expiring which will trigger an email notification being sent to customer with email title: Needs Attention - Battery expiring. The email will be resent monthly if device status does not change.

• After Battery Expiration: Device readiness status changes to Not Ready (Battery expired) and an email notification is sent. Email notification will be resent weekly if device status does not change (Monday at 12:01am local time).

Performance Inspection Procedure (PIP) Overview: The Performance Inspection Procedure (PIP) is a set of manual and computer assist test procedures. The PIP is used for an operational, closed-case evaluation of the LIFEPAK CR2 defibrillator to determine if the defibrillator is operating within the required specifications. The PIP will be performed in a regularly scheduled preventive maintenance routine. NOTE:

1. Always use the latest version of the PIP document, PN 3323342, to perform PIP. 2. PIP document, PN 3323342, can be downloaded from SmartSolve. 3. Fillable PDF format PIP checklist, 3323342_F_PIP_Checklist_LPCR2.pdf, can be downloaded from

SmartSolve.

Replacement Procedure Supply and Replacement Parts The following table is the list of supplies and accessories that are available for replacement.





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PN Catalog Number Description

3323374-000 11141-000165 Kit, Replacement Battery LPCR2 3323372 11101-000021 Replacement Electrode Kit (Leonhard Lang) 3323375-000 11512-000001 Kit, Replacement, Lid, LPCR2 3323376-000 11512-000002 Kit, Replacement, Handle, LPCR2 3323377-000 11260-000047 Kit, Replacement, Case, Carry, LPCR2 3318171-001 21300-008152 Cover, USB Port, LPCR2 3321551-000 21300-008143 Cable, USB 2.0 A Male to Micro-B, L 5.5FT 3322310-000 26500-003645 TAG,LOCAL EMERGENCY CONTACT NUMBER,911,MULTI

Lid Replacement To replace the Lid:

1. Remove the battery from the device 2. Open the lid. 3. Push in one end of lid hinge to release the lid from the case. 4. Insert one end of the new lid into the small hole and push in the other end of the lid and snap into the place 5. Close the lid. 6. Insert the battery. 7. Open the lid (voice prompts will begin) 8. Close the lid to verify the readiness light is flashing in green every six seconds.





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Handle or Carrying Case Replacement To replace the Handle or Carrying Case:

1. Remove three screws from the handle. 2. Replace the handle with a new handle or with a carrying case. 3. Torque the three screws to fasten Handle or Carrying Case to device, using the 4.0 in-lb torque.





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USB Cover Replacement Install USB Cover onto Rear Case by inserting prong into small hole and push it all the way in.

Battery Replacement To replace the Battery:

1. Remove the old battery. 2. Insert the new battery. 3. Open the lid and wait for voice prompt to start (important to do this step because when lid is open, device will

start a self-test to register the new battery). 4. After hearing the voice prompt, close the lid. 5. Check device readiness light is flashing in green every six seconds.

Note: It is important to open the lid after insert a new battery because when the lid is opened, the device will perform a self-test and recognize that a new full battery has been installed and reset the device readiness status. If this step is not performed, device readiness will not be updated and the readiness light will not be flashing in green every six seconds until next self-test is run.

Electrode Replacement The electrode tray must be replaced if any of the following occur:

• The seal on the tray is broken • The electrodes are used • The Use By date (shown next to the hourglass symbol) has passed





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Refer to OI, “Replacing the Electrodes” for the proper steps to replace the electrode tray. NOTE: When the electrodes are used or expired, the Readiness indicator will not flash until the electrode tray is replaced. When a new electrode tray is installed, and after closing the lid, the Readiness indicator will flashes every 6 seconds. The AED status will be updated in LIFELINK or LIFENET after closing the lid.

Troubleshooting Overview: This section describes troubleshooting tips and methods for most common failure modes.

Readiness indicator 1. If readiness indicator is not flashing, the possible causes will be:

• Low battery power or expired electrodes • Depleted battery • Electrode tray not connected • Operating temperature is too low or too high • Defibrillator self-test failed

Follow the flowchart for the recommended corrective actions.





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Start

CR2 Readiness light is not flashing

Open the Lid

Can you hear voice prompt?

Press Two buttonsLanguage + Child

Yes

Replace Battery

No

Open the Lid

Can you hear voice prompt?

Close the Lid

Yes

Replace the Unit

End

No

Follow the voice prompt direction

Is Readiness light flashing

Yes

No

2. If flashing, but email notification indicates that CR2 needs attention, use Using Voice Prompts for Troubleshooting for troubleshooting.

No Voice Prompt The possible causes:

• Depleted battery – replace the battery • Speaker system failure or device failure – after replacing the battery, still has no voice prompt, replace the unit





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Unable to establish USB connection to a computer Overview: When running WCT, LDA, and PIP software, it will require using a USB cable to connect CR2 to the computer. If all these software cannot establish the connection between computer to the device, the possible causes are:

• Incorrect cable type – use the USB cable shipped with the device, PN 3321551-000. • COM port not assigned on Computer – following direction below to fix COM port assignment.

When connecting the CR2 to a computer using the USB cable, if Wi-Fi Configuration Tool or LIFENET Device Agent cannot connect to the CR2, use Computer Management to check which COM Port is assigned to USB cable.

Steps:

1. Click Start, and type Computer Management from Search programs and files. 2. Click Computer Management.

3. Select Device Manager and then expand Ports (COM & LPT) 4. Connect USB cable from CR2 to computer. 5. Open the CR2 lid. 6. Check if a COM port is automatically assigned to the CR2

7. If no COM port is assigned to the CR2, reboot the computer and repeat the steps. When LIFEPAK CR2 USB Port is visible, proceed to Wi-Fi Configuration ToolWi-Fi Configuration Tool or LIFENET Device Agent tasks.

Unable to establish Wi-Fi network connection Overview: “Unable to establish Wi-Fi network connection” may be heard if Wi-Fi settings are stored on the CR2 and the user has used the two-button press to attempt a Wi-Fi connection, but the CR2 is too far from the Wi-Fi access point. To Fix:

1. Use a smart phone to test the Wi-Fi signal strength and connection.





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2. If Wi-Fi connection from the smart phone is working, check that the Wi-Fi settings on the CR2 are correctly entered. Refer to Store Wi-Fi Settings on CR2 or Change or Remove Wi-Fi Settings on the CR2 for details.

Connection Failed Overview: “Connection Failed” may be heard if Wi-Fi settings are stored on the CR2 and the user has used the two-button press to attempt a Wi-Fi connection. This voice prompt means the CR2 can reach the Wi-Fi access point, but it cannot connect to LIFELINK or LIFENET System. To Fix: Have LIFENET Support check the CR2 device registration record on the LIFENET server.

Unable to change/update the device setup options • Browser version issue – Internet Explorer version 10 or above; Google Chrome version 44 or below; any

version of Mozilla Firefox are the supported browser versions to run setup options. If the browser version is not in the specified version, setup option window will not work.

• Account specific issue – ASR or SmartDesk will assist with account issues.

Using Voice Prompts for Troubleshooting Overview: The following table contains a list of voice prompts that may be heard during troubleshooting. Steps: To enter device troubleshooting mode (Data Mode),

1. Open the lid 2. After hearing the voice prompts start, press and hold LANGUAGE and CHILD buttons simultaneously for at

least 2 seconds to enter data mode. NOTE: There is a limited time window during which the CR2 will accept the two-button press. Only press the two buttons after the voice prompts start and within 20 seconds after the voice prompts start. If “Device Ready” or “Device Not Ready” is not heard, that means the time window to accept the two-button press has been missed. Close the lid and try again. Device Troubleshooting:

Voice Prompt What/When this prompt can be heard

Device Ready Readiness Status is OK. The device is ready for use.

Device Not Ready Readiness Status is not OK. The device is not ready for use.

Call Service Device has detected an issue that requires assistance from authorized service personnel.

Replace Battery Replaced as soon as possible.

Replace Electrode tray The electrodes have been used or expired and should be replaced as soon as possible.

Wi-Fi Troubleshooting:


Wi-Fi not Configured Wi-Fi configuration has not been done for Wi-Fi capable device. Use Wi-Fi Configuration Tool to store Wi-Fi settings on CR2.

Wi-Fi Connection Initiated If Wi-Fi is configured and the device has entered Data Mode, the device will start LIFENET initial Check-In.





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Connection In Progress After completion of "Wi-Fi Connection Initiated", and attempt to establish a Wi-Fi connection to LIFENET. During connection attempt, device beeps every 5 seconds.

Unable to Establish Wi-Fi Network

If Wi-Fi connection cannot be established from CR2 to Wi-Fi access point. See “Unable to establish Wi-Fi network connection” for detail.

Connection Failed

Connection between Wi-Fi access point to LIFENET timeout. This voice prompt means the CR2 can reach the Wi-Fi access point, but it cannot connect to LIFELINK or LIFENET System. See “Connection Failed” for detail.

LIFENET Connection Error An error has occurred while attempting to connect to LIFELINK or LIFENET System. Contact SmartDesk for support.

Connection Established Once LIFENET connection has been established. First HTTP response is an OK. Start LIFENET Check-In after the completion of "Connection Established"

This May Take Several Minutes

After the completion of "Connection Established" and before performing LIFENET Check-In. During LIFENET Check-In, device will beep every 5 seconds.

Update In Progress When software update is initiated with LIFNET

Rebooting Once software update is complete and ready for reboot. Software shall reboot after this prompt. When reboot is done, "Wi-Fi connection Initiated" prompt plays again.

Communication Complete After LIFENET Check-In completes.

Connection Lost If current LIFENET Check-In session aborts after a successful LIFENET connection has been established. Try again, if the same voice prompt occurs, contact SmartDesk for support.

Powering Off After completion of Wi-Fi Troubleshooting, if no Cell configured on the device.(If cell is configured, this prompt is heard after cellular connection. See cellular troubleshooting.)

Cellular Troubleshooting:


Mobile Connection Initiated After Wi-Fi "Communication Complete" or "Wi-Fi not Configured" prompt and if Cell configured on the device. The software will perform Cellular Troubleshooting when entering Data Mode.

Connection In Progress After completion of "Mobile Connection Initiated", and attempt to establish a cellular network connection to LIFENET. During connection attempt, device beeps every 5 seconds.

Unable to Establish Mobile Network

If a cellular network connection cannot be established. Check cellular signal from a smart phone and try again.

Connection Failed If transmission timeout occurs before a successful connection to LIFENET. Check cellular signal from a smart phone and try again.





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LIFENET Connection Error An error has occurred while attempting to connect to LIFELINK or LIFENET System. Contact SmartDesk for support.

Connection Established Once LIFENET connection has been established. First HTTP response is an OK. Start LIFENET Check-In after the completion of "Connection Established"

This May Take Several Minutes

After the completion of "Connection Established" and before performing LIFENET Check-In. During LIFENET Check-In, device will beep every 5 seconds.

Update In Progress When software update is initiated with LIFNET

Rebooting Once software update is complete and ready for reboot. Software shall reboot after this prompt. When reboot is done, "Mobile Connection Initiated" prompt plays again.

Communication Complete After LIFENET Check-In completes.

Connection Lost If current LIFENET Check-In session aborts after a successful LIFENET connection has been established. Check cellular signal from a smart phone and try again.

Powering Off Upon termination of Cellular Troubleshooting. There are additional voice prompts that are used during a cardiac arrest event. See Operator Instruction for the complete list of voice prompts.

Error Codes Overview: If any of following error codes occurs on the device, the device status will change to “Not Ready”. Follow recommended corrective action code to handle the errors.

Corrective Action Code Key Code Description

1 Replace Unit

Error Code Hex Id Event Name

Service Corrective

Action

0x40012 AOKLOGGEREVENT_HighChrgRate 1 0x40013 AOKLOGGEREVENT_LowChrgRate 1 0x40014 AOKLOGGEREVENT_OverVolt 1 0x40017 AOKLOGGEREVENT_MajorDiff 1 0x40020 AOKLOGGEREVENT_AokReset 1 0x40021 AOKLOGGEREVENT_SysReset 1





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0x40040 AOKLOGGEREVENT_AdcCalibrationFail

1

0x40041 AOKLOGGEREVENT_WakeUpAlarm7DayTimeout 1

0x41700 SHOCKEVENT_OverVolt

1

0x41701 SHOCKEVENT_DumpTmrExp 1 0x41705 SHOCKEVENT_ChargeCmpltVcapChkFail 1 0x41706 SHOCKEVENT_EnergyCalibrationCrcFailed 1 0x41707 SHOCKEVENT_EnergyCalibCalculationFailed 1 0x41708 SHOCKEVENT_ChargeTimedOut 1 0x42108 PREPROCEVENT_EcgCalibrationCrcFailed 1 0x42109 PREPROCEVENT_DeltaZCalibrationCrcFailed 1 0x4210A PREPROCEVENT_ImpedanceCalibrationCrcFailed 1 0x4210B PREPROCEVENT_EcgCalibCalculationFailed 1 0x4210C PREPROCEVENT_DeltaZCalibCalculationFailed 1 0x4210D PREPROCEVENT_ImpedanceCalibCalculationFailed 1 0x42200 CONFIGEVENT_ReadFail 1 0x42201 CONFIGEVENT_WriteFail 1

0x42202 CONFIGEVENT_CrcFail 1

0x42506 STEVENT_SelfTestTimedOut 1 0x4250C STEVENT_PreampEcgFreqFail 1 0x4250E STEVENT_PreampEcgAmpFail 1

0x42510 STEVENT_PreampEcgBaselineFail 1

0x42512 STEVENT_PreampEcgRiseTmFail 1

0x42514 STEVENT_PreampEcgStepVoltFail 1 0x42516 STEVENT_PreampImpedInPhaseDcFail 1

0x42518 STEVENT_PreampImpedQuadratureDcFail 1

0x4251A STEVENT_PreampImpedBaseln1Fail 1

0x4251C STEVENT_PreampImpedPeakTm1Fail 1

0x4251E STEVENT_PreampImpedPeakVt1Fail 1 0x42520 STEVENT_PreampImpedDecyTm1Fail 1 0x42522 STEVENT_PreampImpedBaseln2Fail 1 0x42524 STEVENT_PreampImpedPeakTm2Fail 1 0x42526 STEVENT_PreampImpedPeakVt2Fail 1 0x42528 STEVENT_PreampImpedDecyTm2Fail 1





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0x4252A STEVENT_IsoRelayCloseFail 1 0x4252C STEVENT_IsoRelayOpenFail 1 0x42536 STEVENT_HBridgePhs1CondFail 1 0x42538 STEVENT_HBridgePhs2CondFail 1 0x4253A STEVENT_ChargeRateFail 1 0x4253C STEVENT_VCapSysAokMeasureFail 1 0x4253E STEVENT_VCapFlbckAokMeasureFail 1 0x42540 STEVENT_RamCompleteFail 1 0x42542 STEVENT_SpeakerFail 1 0x42544 STEVENT_SwLidFail 1 0x42546 STEVENT_SwOnOffFail 1 0x42548 STEVENT_SwShockFail 1 0x4254A STEVENT_SwLangFail 1 0x4254C STEVENT_SwPedFail 1 0x4254E STEVENT_ProgramCrcFail 1 0x42550 STEVENT_TempertrSensFail 1 0x42554 STEVENT_WifiInterfaceCommFail 1 0x42556 STEVENT_CellIntfCommFail 1 0x42558 STEVENT_PwrSuppliesAnalogFail 1 0x4255A STEVENT_PwrSuppliesGatedriveFail 1 0x4255C STEVENT_PwrSuppliesVddioFail 1 0x4255E STEVENT_PwrSuppliesVddaFail 1 0x42560 STEVENT_PwrSuppliesVdddFail 1 0x42562 STEVENT_PwrSuppliesSysFail 1 0x42564 STEVENT_LedsShockFail 1 0x42566 STEVENT_LedsPedFail 1 0x42568 STEVENT_RamConnectnFail 1 0x4256A STEVENT_WatchdogPetFail 1 0x4256C STEVENT_WatchdogResetFail 1 0x4256E STEVENT_InterprcCommFail 1 0x4257D STEVENT_HBridgeNeSwLegShrtdFail 1 0x4257F STEVENT_HBridgeNwSeLegShrtdFail 1 0x4311B AOKSTEVENT_TempRsnblTestFail 1 0x4311D AOKSTEVENT_WatchDogCktTestFail 1 0x43120 AOKSTEVENT_OcvHiLimitTestFail 1 0x44500 SYSPLOGGEREVENT_SysReset 1





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Tables of useful information LIFENET System URL This is LIFENET System URL in each country. Use this list for customer’s Proxy server whitelist exemption.

Country Country

Code LIFENET URL United State US https://www.lifenetsystems.com Australia AU https://au.lifenetsystems.com New Zealand NZ https://nz.lifenetsystems.com United Kingdom GB https://uk.lifenetsystems.com France FR https://fr.lifenetsystems.com Germany DE https://de.lifenetsystems.com Spain ES https://es.lifenetsystems.com Switzerland CH https://ch.lifenetsystems.com Netherlands NL https://nl.lifenetsystems.com Denmark DK https://dk.lifenetsystems.com Poland PL https://pl.lifenetsystems.com Belgium BE https://be.lifenetsystems.com Czech CZ https://cz.lifenetsystems.com Italy IT https://it.lifenetsystems.com Portugal PT https://pt.lifenetsystems.com Sweden SE https://se.lifenetsystems.com Norway NO https://no.lifenetsystems.com Finland FI https://fi.lifenetsystems.com Austria AT https://at.lifenetsystems.com Israel IL https://il.lifenetsystems.com Slovenia SI https://si.lifenetsystems.com Hungary HU https://hu.lifenetsystems.com Canada CA https://ca.lifenetsystems.com Bulgaria BG https://bg.lifenetsystems.com Cyprus CY https://cy.lifenetsystems.com Estonia EE https://ee.lifenetsystems.com Greece GR https://gr.lifenetsystems.com Iceland IS https://is.lifenetsystems.com Ireland IE https://ie.lifenetsystems.com Latvia LV https://lv.lifenetsystems.com Liechtenstein LI https://li.lifenetsystems.com Lithuania LT https://lt.lifenetsystems.com Luxembourg LU https://lu.lifenetsystems.com Malta MT https://mt.lifenetsystems.com

https://www.lifenetsystems.com/

https://au.lifenetsystems.com/

https://nz.lifenetsystems.com/

https://uk.lifenetsystems.com/

https://fr.lifenetsystems.com/

https://de.lifenetsystems.com/

https://es.lifenetsystems.com/

https://ch.lifenetsystems.com/

https://nl.lifenetsystems.com/

https://dk.lifenetsystems.com/

https://pl.lifenetsystems.com/

https://be.lifenetsystems.com/

https://cz.lifenetsystems.com/

https://it.lifenetsystems.com/

https://pt.lifenetsystems.com/

https://se.lifenetsystems.com/

https://no.lifenetsystems.com/

https://fi.lifenetsystems.com/

https://at.lifenetsystems.com/

https://il.lifenetsystems.com/

https://si.lifenetsystems.com/

https://hu.lifenetsystems.com/

https://ca.lifenetsystems.com/

https://bg.lifenetsystems.com/

https://cy.lifenetsystems.com/

https://ee.lifenetsystems.com/

https://gr.lifenetsystems.com/

https://is.lifenetsystems.com/

https://ie.lifenetsystems.com/

https://lv.lifenetsystems.com/

https://li.lifenetsystems.com/

https://lt.lifenetsystems.com/

https://lu.lifenetsystems.com/

https://mt.lifenetsystems.com/





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Romania RO https://ro.lifenetsystems.com Slovakia SK https://sk.lifenetsystems.com South Africa ZA https://za.lifenetsystems.com

List of Declaration of Conformity Documents Doc PN in eCentral

Rev Title

3320908 A Technical Documentation File, LPCR2 AED Defibrillator 3320903 A MDD Essential Requirements Checklist, LPCR2 AED Defibrillator 3320901 A Declaration of Conformity, LPCR2 AED Defibrillator 3320899 A Agency Certification and Report, LPCR2 AED Defibrillator 3320906 A WEEE Directive, LPCR2 AED Defibrillator 3322223 A Technical Documentation File, LPCR2 Battery 3322224 A MDD Essential Requirements Checklist, LPCR2 Battery 3322225 A Declaration of Conformity, LPCR2 Battery 3320897 A Agency Certification and Report, LPCR2 AED Defibrillator Battery 3322226 A UN-DOT Hazardous Goods Transportation Report, LPCR2 Battery 3327300 A ISO 13485 Certification, LPCR2 Battery Pack 3327547 A Battery Directive and WEEE Directive, LPCR2 Battery 3320909 A Technical Documentation File, LPCR2 Electrode Pack 3320904 A MDD Essential Requirements Checklist, LPCR2 Electrode Pack 3320902 A Declaration of Conformity, LPCR2 Electrode Pack 3322046 H Intertek Test Reports, LPCR2 Quik-Step Electrode 3320905 A WEEE Directive and RoHS Directive, LPCR2 Quik-Step Electrode 3319338 A FCC and IC License Grant - LPCR2 AED Defibrillator 3327514 A Radio and Telecommunications Terminal Equipment Directive

Declaration of Conformity, LPCR2 AED Defibrillator 3319338 A Australian ACMA Declaration of Conformity, LPCR2 AED Defibrillator 3319338 A Cellular Licensing Certification, LPCR2 AED Defibrillator 3320900 A Wi-Fi Licensing Status, LPCR2 AED Defibrillator 3302935 E HIPAA Security Information for the LIFENET® System

List of Reference Document and Tool Name Location LIFEPAK CR2 Defibrillator Operating Instructions, 3321515

eCentral or http://www.physio-control.com/

LIFEPAK CR2 Getting Started Guide, 3321528


LIFEPAK CR2 Wireless Setup Guide, 3322174


LIFENET System Help File (PDF) From website, Click Help > LIFENET System Overview > >

LIFENET System Help (PDF), then save it to your computer.

https://ro.lifenetsystems.com/

https://sk.lifenetsystems.com/

https://za.lifenetsystems.com/





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LIFELINKcentral Help (PDF)

From website, Click > Contents > LIFELINKcentral Help (PDF), then save it to your computer.

Wi-Fi Configuration Tool • Download Wi-Fi Configuration Tool from LIFELINK account, select Resource Center, and then select Wi-Fi Configuration

Tool, and click on to download. • Download Wi-Fi Configuration Tool from LIFENET account,

select Assets > Wi-Fi Configuration Tool Applications, click on Add or Update Wi-Fi Configuration Tool, under Description, click on Wi-Fi Configuration Tool (32 or 64-bit) to download.

LIFENET® Device Agent • To download LIFENET Device Agent software from LIFELINK, >

Resource Center > Connection Tools > LIFENET Device

Agent, and click on to download.

• To download LIFENET Device Agent from LIFENET, > Assets > Device Agent Applications > Add or Update Device Agent > click on LIFENET Device Agent (32 or 64-bit)

LIFENET Alert Help To download, from LIFENET Alert application, Click Help > Help

Topics, then click PDF version of Help DT EXPRESS Help To download, from DTx application, Click Help > PDF version of

Help CODE-STAT Help To download, from CODE-STAT application, Click Help > PDF

version of Help

Wi-Fi Signal Noise Ratio (SNR) SNR

40dB Excellent signal, 5 bars 25dB ~ 40dB Very good signal, 3~4 bars 15dB ~ 25dB Low signal, 2 bars 10dB ~ 15dB Very low signal, 1 bar 5dB ~ 10dB No signal





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System Context Diagram





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System Component View





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Sample Warranty Void Letter The list of languages for this letter template can be found in eCentral:

Tier Warranty Void Letter 1 3330024_A: Cust Ltr Warranty Void, LPCR2, Intl Eng 1 3330025_A: Cust Ltr Warranty Void, LPCR2, Swedish 1 3330026_A: Cust Ltr Warranty Void, CR2, Spanish 1 3330027_A: Cust Ltr Warranty Void, CR2, Polish 1 3332137_A: Cust Ltr Warranty Void, LPCR2, Norwegian 1 3330029_A: Cust Ltr Warranty Void, CR2, Italian 1 3330030_A: Cust Ltr Warranty Void, CR2, German 1 3330031_A: Cust Ltr Warranty Void, CR2, Finnish 1 3330032_A: Cust Ltr Warranty Void, CR2, Dutch

[Date] [Name] [Business Name] [Street Address] [City, State, Zip]

Re: Device Type: _______

Serial Number: ______ Customer Number: ______

Dear [Name]: On [Date], Physio-Control, Inc. has confirmed that this device was not used in accordance with

applicable operating instructions or was not used in the intended environment or setting; specifically the device was [enter specific failure circumstance]. As such, Physio-Control is unable to certify the long-term reliability of a device subjected to this condition. Furthermore, the warranty is now void. Therefore, it is our recommendation that you replace this device; we cannot service the device.

We recommend that you do not use this device clinically. Physio-Control will not accept responsibility

if the device fails to function properly in the future. Please feel free to contact [Field Service Rep; or Technical Service Rep], or me if you have any further questions or concerns regarding this matter.

Sincerely, PHYSIO-CONTROL, INC. Jeffrey Laub VP, Global Operations and Services





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1 3330033_A: Cust Ltr Warranty Void, CR2, Danish 1 3330034_A: Customer Letter, Warranty Void, CR2, Chinese 1 3331868_A: Customer Letter, Warranty Void, LPCR2, Simplified Chinese 2 3332134_A: Cust Ltr Warranty Void, LPCR2, Arabic 2 3332135_A: Cust Ltr Warranty Void, LPCR2, Greek 2 3332136_A: Cust Ltr Warranty Void, LPCR2, Hebrew 2 3333060_A: Cust Ltr Warranty Void, LPCR2, Hungarian 2 3333062_A: Cust Ltr Warranty Void, LPCR2, Turkish

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