Physio Control TrueCPR 80596-000001, Instructions For Use Manual

Page 1: ...INSTRUCTIONSFORUSE ...

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Page 3: ...s Checklist 12 Data Management 13 Troubleshooting Tips for Data Management 14 Cleaning the Device 14 Storing the Device 14 Maintaining and Recycling the Device 15 Maintenance 15 Battery Replacement 15 Service and Repair 15 Service Life 15 Recycling the Device and Batteries 15 Symbols 16 Product Specifications 17 Safety Classifications 17 Electromagnetic Compatibility Guidance 18 Regulatory Complia...

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Page 5: ...e use 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 dev...

Page 6: ...ement 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 INTERFEREN...

Page 7: ...ecoil 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 25 minutes of operation 8 Compression Rate Meter Displays rate as compressions per minute Changes to Inactivity Timer when compressions stop 9 Elapsed Time Meter Displays elapsed time since beginning of event 10 Airway Indicat...

Page 8: ...ORTANT Do not press on the chest pad until calibration is complete and feedback screen appears approximately 3 seconds Back Pad Item Description 1 Battery Readiness Indicator Flashing LED on back pad handle indicates battery capacity is sufficient for at least 25 minutes of operation Note LED flashes approximately once every 4 seconds 2 USB Port Cover Provides access to USB port Use a coin or simi...

Page 9: ...ormation If the Reposition Back Pad alert persists perform CPR unaided If the device cannot be placed in the recommended position the alternative position shown in Figure 2 may be used When the back pad is placed in the side position the chest pad must be rotated 180 Keep the palm pad in the middle of the chest on the lower half of the sternum If the device cannot be positioned properly perform CP...

Page 10: ...mation 12 Continue CPR as long as indicated by your local protocols When compressions stop the inactivity timer appears in place of the compression rate meter If compressions resume within 10 minutes compression feedback resumes The device turns off automatically after 10 minutes with no activity 13 To turn the device off press and hold the POWER button for 2 seconds Using the TrueCPR Device on a ...

Page 11: ...action testing and known safety standards for implanted pacemaker and ICD systems Using the TrueCPR Device for Training The TrueCPR device may be used on a manikin for training purposes Some manikins may require updates to reach compression depths of 5 to 6 cm 2 to 2 4 in consistent with AHA and ERC guidelines You can use a manikin that does not allow these depths but the TrueCPR device will not r...

Page 12: ...ators Calibration in progress Do not apply pressure to chest pad Ensure chest pad and back pad are separated during calibration Calibration complete Begin chest compressions Compression in progress Gray fan representing compression depth moves across screen Sufficient depth Dark green wedge in compression target zone Sufficient recoil Dark green wedge in recoil target zone Compression too shallow ...

Page 13: ...Countdown to ventilation prompts Three short tones sound Ventilation prompts Two long tones indicate when ventilations should occur Resume chest compressions immediately after the two tones Electronic noise is interfering with device Locate and remove source of interference If indicator persists perform CPR unaided Device cannot provide feedback Turn device off and back on If indicator persists pe...

Page 14: ...and POWER buttons simultaneously to turn the device on in Event Review mode To switch between the screens press the MUTE button Progress bar appears during shut down Note Shut down may take several minutes Do not remove batteries while shut down is in progress Percent of compressions with depth 5 cm 2 in Percent of compressions with proper recoil Average compression rate compressions per minute To...

Page 15: ...uidance Device does not function Only use device within specified operating temperature range of 0 40 C 32 104 F Remove batteries wait 30 seconds and then re install batteries Perform CPR unaided Display is visible but does not provide compression feedback Turn device off and back on Do not apply pressure to chest pad until calibration is complete and feedback screen appears Perform CPR unaided Al...

Page 16: ...ate Initials Instruction and Recommended Corrective Action Check each box after completing Check that battery readiness indicator on back pad is flashing If not replace batteries with two new nonrechargeable Duracell DL123 batteries Check device and cable for wear or damage If present remove device from service and contact your Physio Control representative for assistance Operator s Checklist ...

Page 17: ...TrueCPR device If the software on the computer does not start automatically open the program manually 3 Follow the instructions in the software on the computer to select the TrueCPR device and initiate data transfer Data transfer may take up to 5 minutes if memory is full The following screens may appear on the TrueCPR device WARNINGS SHOCK HAZARD To avoid potential shock hazard any device connect...

Page 18: ...a clean damp cloth IMPORTANT Do not immerse or soak the chest pad or back pad Storing the Device Place chest pad onto back pad Store in carrying bag so that battery readiness indicator is visible OBSERVATION CORRECTIVE ACTION Feedback screen appears on TrueCPR device and metronome is heard Confirm USB cable is properly connected Confirm computer is on Replace USB cable Use recommended USB cable se...

Page 19: ...al support or your local Physio Control representative for assistance Service and Repair The TrueCPR device contains no serviceable parts If the device does not function correctly contact your local Physio Control representative for assistance Service Life During product development the TrueCPR coaching device is subjected to rigorous life testing However both rapid technological changes and the a...

Page 20: ...oduct in the unsorted municipal waste stream Dispose of this product according to local regulations For instructions on disposing of this product see www physio control com recycling Enclosure ingress protection code per IEC 60529 This rating provides for a specified degree of protection against the ingress of particles and the harmful ingress of water Device includes RF transmitter Mark of confor...

Page 21: ...condensing Altitude 382 to 4 572 m 1 253 to 15 000 ft Object and Water Resistance IP55 per IEC 60529 and EN 1789 Weight Less than 0 75 kg 1 65 lb with batteries installed Ventilation Prompts 2 ventilation prompts every 30 compressions in No Airway mode No ventilation prompts in Airway mode Compression Depth Target depth range of 5 to 6 cm 2 to 2 4 in Metronome Rate 104 4 1 compressions per minute ...

Page 22: ...ference in nearby electronic equipment RF emissions CISPR 11 Class B The TrueCPR device is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes The TrueCPR device is battery powered Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions...

Page 23: ...or use in the electromagnetic environment specified below The customer or user should ensure that the TrueCPR device is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the TrueCPR device including cables than the recommended separation distanc...

Page 24: ...dio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the TrueCPR device is used exceeds the applicable RF complia...

Page 25: ...ce by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TrueCPR device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 0...

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Page 28: ... Herbert Street St Leonards NSW 2065 Australia Physio Control Inc 11811 Willows Road NE Redmond WA 98052 USA Stryker European Operations B V Herikerbergweg 110 1101 CM Amsterdam The Netherlands 2018 Physio Control Inc TrueCPR DT EXPRESS and CODE STAT are trademarks of Physio Control Inc Duracell is a registered trademark of Procter Gamble Company Publication date 08 2018 3313585 024 ...