CZO-TRUCPREV152TrueCPR

Coaching-Gerät Dispositif d’assistance Dispositivo de orientación INSTRUCTIONS FOR USE Gebrauchsanweisung Instructions d’utilisation Instrucciones de uso English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 German/Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 French/Francais . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Spanish/Espanol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Electromagnetic Compatibility Guidance . . . . . . . . 73 CONTENTS ©2012 Physio-Control, Inc.1 Introduction The Physio-Control TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitation (CPR) in accordance with current CPR guidelines. IMPORTANT! Read these instructions carefully before use, and keep for future reference. These operating instructions provide the procedural steps for proper use of the TrueCPR device, and can be used for training purposes. Operators should read these instructions and be thoroughly familiar with the device before use. For information about electromagnetic compatibility, see “Electromagnetic Compatibility Guidance” on page 19. Intended Use The TrueCPR device is intended to provide feedback to assist rescuers to perform CPR. Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older. Indications The TrueCPR device is indicated for use on patients in cardiac arrest (unconscious, pulseless, not breathing normally). Operating Principle The TrueCPR device consists of a chest pad, which is placed on the sternum, and a back pad, which is placed beneath the patient. The device determines the depth of chest compressions during CPR by measuring the distance between the chest pad and back pad. The device measures distance by sending and receiving electromagnetic signals between the chest pad and back pad. Safety Information The following terms are used in these operating instructions: Warning: Hazards or unsafe practices that may result in serious personal injury or death. Caution: Hazards or unsafe practices that may result in minor personal injury, product damage, or property damage. English 2TrueCPR Device Instructions for Use Safety Information IMPORTANT! Check the battery readiness indicator regularly. If indicator is not flashing, replace batteries immediately. WARNINGS POSSIBLE PATIENT INJURY: • The TrueCPR device is not intended for use on children or infants. Only use the device on patients who are 8 years of age or older. POSSIBLE INEFFECTIVE CPR: • After use, inspect device and cable for wear or damage. Remove from service if damaged. • Do not use the TrueCPR device over very large metal surfaces. Perform CPR unaided instead.* • The TrueCPR device may provide incorrect feedback if not positioned properly. • Check back pad and chest pad position after patient movement and during transport. • If patient is on a mattress, place a backboard beneath the patient according to standard protocols. Then insert the device back pad between the patient and backboard. • If the device cannot be positioned correctly on the patient or fails to operate, remove the device and perform CPR unaided. POSSIBLE DEVICE FAILURE: Do not modify the TrueCPR device. 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. Avoid operating the device near cauterizers, diathermy equipment, or other portable and mobile RF communications equipment. See “Separation Distances” on page 22 for recommended distances of equipment. Contact Physio-Control Technical Support if assistance is required. POSSIBLE EXPLOSION HAZARD: Do not use this device in the presence of flammable gases or anesthetics. * The TrueCPR device has been designed for use on hospital beds, stretchers, gurneys, and in ambulances. The device is compatible with common patient-worn or implanted metal, such as jewelry, ICDs, or pacemakers. ©2012 Physio-Control, Inc.3 English Basic Orientation Chest PadScreen ItemDescription 1 Power Button: Press green button to turn device on. Press and hold for 2 seconds to turn device off. 2 Mute Button: Press to turn metronome on or off. In Event Review mode, press to switch between screens. 3Palm Pad: Hand placement area. 4 Airway Button: Press to switch metronome between Airway (continuous compressions) mode and No Airway mode. 5Screen: Displays compression feedback and other indicators. 6 Recoil Target Zone: Changes from light green to dark green when compression is completely released. 7 Low Battery Indicator: Appears when remaining battery capacity is less than 30 minutes of operation. 8 Compression Rate Meter: Displays rate as compressions per minute. Changes to Inactivity Timer when compressions stop. 9Elapsed Time Meter: Displays elapsed time since beginning of event. 10Airway Indicator: Appears when device is in Airway mode. 11 Compression Target Zone: Changes from light green to dark green when compression reaches target depth of 5–6 cm (2–2.5 in). 12 Compression Depth History: Dark green or gray segment in outer circle shows depth of previous compression. 5 1 2 4 3 11 6 7 8 10 12 9 4TrueCPR Device Instructions for Use Using the TrueCPR Device Using the TrueCPR Device Performing CPR To use the TrueCPR device: 1 Confirm patient is in cardiac arrest. 2 Remove the device from the carrying bag. 3 Separate the chest pad and back pad. Back Pad ItemDescription 1 Battery Readiness Indicator: Flashing LED on back pad handle indicates battery capacity is sufficient for at least 30 minutes of operation. 2 USB Port Cover: Provides access to USB port. Use a coin or similar tool to open. 3 Battery Compartment: Holds two nonrechargeable Duracell ® DL123 batteries. Use a coin or similar tool to open. 1 2 3 ©2012 Physio-Control, Inc.5 English 4…

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WTD 12.7.3 FCC Compliance Opinion MERS0489 Information about the Applicant Grantee (Company Name) Physio-Control, Inc. FCC Contact Person Matthew Hedlund Address 11811 Willows Road NE City, State, Zip Redmond, WA 98073-9706 Job Number MERS0489 Model TrueCPR FCC ID CZO-TRUCPREV152 Agent NA Approval Type Original Equipment Class DCD Part 15, low power Tx below 1.705 MHz Rule Part 15.209 Overview Physio-Contro's model TrueCPR is a device to aid rescuers in applying CPR to a patient. With one pad (coil) on the patients back and one on the sternum the distance between the two pads (coils) can be measured to determine the amount of compression applied during CPR. The coils are excited by a 12 kHz signal. Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 7/24/2012

Part# / description : Changes made in revision : Project # : REV Originally created by / date :Revised by / date : 76435-01 / backpad - label model Catron / Apr 14 2011 Update ETL symbol; Final Intertek number changed to 6pt size; Add R&TTE symbol. B358 - Physio TrueCPR C Kathy / July 20, 2012 artwork form COLORS Pantone 430 White Pantone 2728 Pantone 485 Black 4005216 SCALE : 100% FCC & IC numbers: Arial - Regular - 9 pt Intertek number: Arial - Bold - 6 pt SCALE REFERENCE: 1” square when form is printed at correct size 1” 1” 1449A-TRUCPREV152 CZO-TRUCPREV152

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. EMC Report for Plexus on the Model: TrueCPR Page 1 of 171 TEST REPORT- EMC Report Number: 100613810DEN-001 Project Number: G100613810 Report Issue Date: April 24, 2012 Product Designation: Model: TrueCPR Standards: EMC Directive 2004/108/EC Medical Device Directive 93/42/EEC IEC 60601-1-2, Edition 3: 2007 IEC/ CISPR 11: 2009+A1:2010 FCC 47CFR 15C IC RSS-210 Issue 7: 2007 ICES-003: 2004 Tested by: Client: Intertek Testing Services NA, Inc. 1795 Dogwood Street, Suite 200 Louisville, CO 80027 Plexus 285 Century Place Louisville, CO 80027 Report prepared by Report reviewed by Randy Thompson Senior EMC Project Engineer Richard Georgerian Senior Project Engineer Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 2 of 171 TABLE OF CONTENTS Section Page Number 1 Introduction and Conclusion .............................................................................................................. 3 2 Test Summary ...................................................................................................................................... 4 3 Description of Equipment Under Test................................................................................................ 6 4 System setup including cable interconnection details, support equipment and simplified block diagram ...................................................................................................................................................... 11 5 Performance Criterion of the Equipment when tested against the immunity requirements for the European CE Mark .............................................................................................................................. 13 6 Electrostatic Discharge Immunity Test – (SYSRS242.1) (SYSRS242.2) ....................................... 16 7 Radiated, Radio-Frequency, Electromagnetic Field Immunity Test – (SYSRS242.3) .................. 32 8 Electrical Fast Transient/Burst Immunity Test – (Test not Applicable) ........................................ 36 9 Immunity to Voltage Surge - (Test not Applicable)......................................................................... 37 10 Conducted, Radio-Frequency, Electromagnetic Field Immunity - (SYSRS242.4) .................... 39 11 Power Frequency Magnetic Field Immunity Test – (SYSRS242.5)............................................. 44 12 Voltage Dips / Interruptions Immunity Tests – (Test not Applicable)........................................ 50 13 Tx Spurious Radiated Electromagnetic Emissions – Product in Compression Mode – (SYSRS11) (SYSRS315) (SYSRS242.6) ................................................................................................... 51 14 Radiated Electromagnetic Emissions – Product in Receive/Idle Mode – (SYSRS11) (SYSRS315) (SYSRS242.6) ....................................................................................................................... 77 15 Unintentional Radiated Electromagnetic Emissions – Product Data Mode – (SYSRS242.6) 102 16 AC Mains Conducted Emissions – (Test not Applicable)......................................................... 123 17 Telecom Port Conducted Emissions – (Test not Applicable) .................................................. 124 18 Current Harmonic Emissions – (Test not Applicable) .............................................................. 125 19 Voltage Fluctuations and Flicker – (Test not Applicable)......................................................... 126 20 Intentional Radiated Emissions – Fundamental & Harmonics of Fundamental (SYSRS11) (SYSRS315).............................................................................................................................................. 127 21 Magnetic Field Emissions – Fundamental & Harmonics – (SYSRS130) (SYSRS131)............ 138 22 Tx Frequency Accuracy - (SYSRS331) ....................................................................................... 148 23 Measurement Uncertainty............................................................................................................ 155 24 Product Modifications Required to Pass – Radiated Immunity ............................................... 156 25 Identification, Marking and Documents – EN 60601-1-2, Edition 3.0 - Section 5.................... 157 26 Essential Performance – Supplied by Client ............................................................................. 160 27 FDA EMC Requirements .............................................................................................................. 161 28 Revision History ........................................................................................................................... 162 Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 3 of 171 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 3.0. The remaining test sections are the verbatim text fr…

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Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 52 of 171 13.4 Setup Photographs: Product in Compression Mode Radiated Emissions – Product 3-Axes Axis 1 – Product Flat on Table (worst-case axis) Axis 2 – Product Vertical Axis 3 – Product Vertical & Rotated 90 Degrees Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 53 of 171 Photo: Product in Compression Mode Radiated Emissions (Front View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 54 of 171 Photo: Product in Compression Mode Radiated Emissions (Rear View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 55 of 171 Photo: Product in Compression Mode Radiated Emissions (Antenna) Active Loop Antenna – 10kHz to 30MHz BiLog Antenna – 30MHz to 1000MHz Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 148 of 171 21.4 Setup Photographs: Tx Magnetic Field Radiated Emissions Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 149 of 171 Photo: Back Pad Loop Parallel to product Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 150 of 171 Photo: Back Pad Loop Perpendicular to product Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 151 of 171 Photo: Chest Pad Loop Parallel to product Loop Parallel to product Loop Perpendicular to product Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 132 of 171 20.4 Setup Photographs: Intentional Radiated Emissions – Fundamental & Harmonics Axis 1 – EUT Flat on Table Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 133 of 171 Photo: Axis 2 – EUT Vertical Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 134 of 171 Photo: Axis 3 – EUT Vertical & Rotated 90 degrees Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 107 of 171 15.4 Setup Photographs: Product in Data Mode Radiated Emissions – Product 3-Axes Axis 1 – Product Flat on Table (worst-case axis) Axis 2 – Product Vertical Axis 3 – Product Vertical & Rotated 90 Degrees Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 108 of 171 Photo: Product in Data Mode Radiated Emissions (Front View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 109 of 171 Photo: Product in Data Mode Radiated Emissions (Rear View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 110 of 171 Photo: Product in Data Mode Radiated Emissions (Antenna) BiLog Antenna – 30MHz to 1000MHz Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 81 of 171 14.4 Setup Photographs: Product in Idle Mode Radiated Emissions – Product 3-Axes Axis 1 – Product Flat on Table (worst-case axis) Axis 2 – Product Vertical Axis 3 – Product Vertical & Rotated 90 Degrees Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 82 of 171 Photo: Product in Idle Mode Radiated Emissions (Front View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 83 of 171 Photo: Product in Idle Mode Radiated Emissions (Rear View) Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 84 of 171 Photo: Product in Receive/ Idle Mode Radiated Emissions (Antenna) Active Loop Antenna – 10kHz to 30MHz BiLog Antenna – 30MHz to 1000MHz Intertek Report Number: 100613810DEN-001 Issued: 04/24/2012 EMC Report for Plexus on the Model: TrueCPR Page 158 of 171 22.4 Setup Photographs: Tx Frequency Accuracy