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Powerheart® G5 Automated External Defibrillator

70-00569-02 G

E-1

E

Waste Electrical and Electronic
Equipment (WEEE) Directive
Compliance

Contents

◆

Manufacturer’s WEEE compliance instructions

Manufacturer’s WEEE compliance instructions

Pursuant to European Community Directive 2002/96/EC (effective: February 2003), Cardiac Science
Corporation is committed to minimising the disposal of WEEE as unsorted municipal waste.

European Community-based Users of the WEEE medical device contained herein are instructed
to contact the following approved service provider for the complimentary / gratis collection and
disposal of the subject equipment at the end of its useful life:

WasteCare
Richmond House
Garforth, Leeds
LS25 1NB
Tel: 0800 800 2044
Fax: 01133 854 322
Email: [email protected]

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Summary of Contents for Powerheart G5

Page 1: ...User Guide 70 00569 02 G Cardiac Science Powerheart G5 Automated External Defibrillator...

Page 2: ......

Page 3: ...USER GUIDE POWERHEART G5 AUTOMATED EXTERNAL DEFIBRILLATOR 70 00569 02 G...

Page 4: ...nce Corporation All other product and company names are trademarks or registered trademarks of their respective companies Copyright 2014 Cardiac Science Corporation All Rights Reserved Patents U S and...

Page 5: ...evice 1 4 Intellisense battery 1 5 Chapter 2 Steps of a Rescue 1 Assess the patient 2 2 2 Prepare the patient 2 2 3 Place pads 2 3 4 Analyse the ECG 2 4 5 Deliver a shock 2 5 6 Give CPR 2 6 7 Prepare...

Page 6: ...hapter 5 Troubleshooting Self tests 5 2 Troubleshooting indicators 5 3 Maintenance and service messages 5 4 Diagnostic mode messages 5 6 Chapter 6 Product Care Periodical maintenance 6 2 Cleaning and...

Page 7: ...manufacturer s declaration electromagnetic emissions D 2 Guidance and manufacturer s declaration electromagnetic immunity D 3 Recommended separation distances between portable and mobile RF communicat...

Page 8: ...Contents 70 00569 02 G vi Contents...

Page 9: ...r fibrillation that cause Sudden Cardiac Arrest SCA There are two models available fully automatic and semi automatic After the defibrillation pads are applied to the patient the fully automatic model...

Page 10: ...Rescue Ready Rescue Ready technology assesses the AED battery and pads to ensure that they are ready to perform a rescue Rescue Ready status indicator Latch press to open Pad expiration window Lid Ba...

Page 11: ...m the patient during a rescue Smartgauge battery status indicator The green LEDs display the capacity of the battery With use the LEDs turn off as battery capacity decreases When the green LEDs turn o...

Page 12: ...anying paediatric pads to replace preinstalled pads with paediatric pads DO NOT delay therapy to determine the patient s exact age or weight Contact Cardiac Science Customer Services to order replacem...

Page 13: ...ng life The battery history can be reviewed using the AED Manager software Important See Warnings and cautions on page 3 4 for important safety information How to replace the battery Ensure that the b...

Page 14: ...70 00569 02 G Powerheart G5 Automated External Defibrillator 1 6 About the AED...

Page 15: ...he general steps involved in performing a rescue 1 Assess the patient page 2 2 2 Prepare the patient page 2 2 3 Place the defibrillation pads page 2 3 4 Analyse the patient s ECG page 2 4 5 Deliver a...

Page 16: ...VICES Note When the patient is 8 years of age or younger or weighs 25 kg 55 pounds or less use the AED with paediatric defibrillation pads if available See the directions for use that accompany the pa...

Page 17: ...n the package 2 Remove the pads from the package You can leave the package attached to the pad wires Peel one of the white pads completely from the blue plastic 3 With a firm steady pull peel one pad...

Page 18: ...Open lid to continue rescue The lid of the AED is closed Ensure that the lid is fully open Press pads firmly to patient s bare chest The pads are not properly placed or are loose Ensure that the pads...

Page 19: ...delivered in 3 2 1 The AED delivers the defibrillation shock automatically Semi automatic model When the AED is ready to deliver a defibrillation shock the Shock button flashes Press the red flashing...

Page 20: ...AED returns to the ECG analysis mode see 4 Analyse the ECG on page 2 4 If the patient is conscious and breathing normally leave the pads on the patient s chest and connected to the AED Make the patie...

Page 21: ...of the AED See the AED Manager User s Guide for details 3 Connect a new adult pads package to the AED See the Defibrillation Pads Instructions for Use for details 4 Verify that the pad connection ind...

Page 22: ...70 00569 02 G Powerheart G5 Automated External Defibrillator 2 8 Steps of a Rescue...

Page 23: ...alert descriptions 3 3 Warnings and cautions 3 4 Symbols and labels 3 8 Before operating the AED ensure that you have become familiar with the various safety alerts in this section Safety alerts iden...

Page 24: ...ing the AED should be left attached to allow for acquisition and detection of the ECG rhythm If a shockable ventricular tachyarrhythmia recurs the device will charge automatically and advise the opera...

Page 25: ...tential hazard categories The definition of each category is as follows DANGER This alert identifies hazards that will cause serious personal injury or death WARNING This alert identifies hazards that...

Page 26: ...is indicated Do not touch metal objects that are in contact with the patient Keep defibrillation pads clear of other pads or metal parts in contact with patient Disconnect all non defibrillator proof...

Page 27: ...nce with implanted pacemaker Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the patient is unconscious and not breathing or not bre...

Page 28: ...ion hazards do not burn or incinerate the battery CAUTION Use only Cardiac Science approved equipment Using batteries pads cables or optional equipment other than those approved by Cardiac Science may...

Page 29: ...pment to the signal input part or signal output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 606...

Page 30: ...hen connected to the patient s chest by the pads can withstand the effects of an externally applied defibrillation shock CE Mark This equipment conforms to the essential requirements of the Medical De...

Page 31: ...tor attention or maintenance and is not Rescue Ready Rescue Ready indicator A green indicator means that the AED is Rescue Ready Manufacturer Date of manufacture month and year Use the pads by the dat...

Page 32: ...ction for waste electrical and electronic equipment For more information see Manufacturer s WEEEcomplianceinstructions on page E 1 Waste Electronic Electrical Equipment WEEE containing lead Separate c...

Page 33: ...istance given to a rescuer to the CPR protocol used from the amount of assistance given to a rescuer to the CPR protocol used In addition each rescue is recorded Note All configuration is performed by...

Page 34: ...ferences in audio prompting provided for the levels of coaching See Appendix A RescueCoach voice and text prompts for a complete list of audio and visual prompts Table 4 1 Audio prompts for applying p...

Page 35: ...sessions or Advanced prompting and compressions only CPR sessions Rescue Coach prompts vary for all CPR styles depending on the prompting level chosen AED device history and rescue data recording The...

Page 36: ...70 00569 02 G Powerheart G5 Automated External Defibrillator 4 4 AED Features...

Page 37: ...g Contents Self tests 5 2 Troubleshooting indicators 5 3 Maintenance and service messages 5 4 Diagnostic mode messages 5 6 This section presents information about AED diagnostics self tests troublesho...

Page 38: ...ronics to full energy in addition to the items tested in the weekly self test Note If the AED s lid is opened during one of these periodic self tests testing stops A subset of the self tests is also r...

Page 39: ...Ready status indicator and the service indicator are red The AED requires service by authorised service personnel Enter Diagnostic mode for more information see Diagnostic mode messages on page 5 6 Co...

Page 40: ...the lid is opened to perform a rescue and the battery charge is low The battery charge is too low to support a rescue In addition the following events occur The Rescue Ready indicator turns red The AE...

Page 41: ...the lid After the lid is closed an alarm beep sounds until the battery is removed or is depleted Contact Cardiac Science Technical Support or your local representative immediately Maintenance require...

Page 42: ...ts appear when the AED is in Diagnostic mode Use the table to resolve the reported conditions Press Text display Voice prompt Line 1 Line 2 Situation Resolution Diagnostic mode DIAGNOSTIC MODE The AED...

Page 43: ...be remedied as soon as possible the AED may be used to perform a rescue Move the AED to a cooler location TEMP TOO COLD ADJUST STORAGE TEMP The AED is cooler than its permitted storage temperature Wh...

Page 44: ...ot adhere properly to the patient Improper pad adhesion may result in skin burns Improper pad adhesion may result in improper AED performance Used pads may cause patient to patient contamination Repla...

Page 45: ...s contact Customer Services For assistance with product installation or operation contact Technical Support Cardiac Science provides 24 hour support by telephone You can also contact Technical Support...

Page 46: ...prompts that correspond to the audio 4 Close the lid The voice prompts should stop 5 Verify that the Rescue Ready indicator returns to green If no prompts are heard or they continue after the lid is...

Page 47: ...e window of the lid 10 Make sure that the Rescue Ready indicator is green If the indicator is red make sure that the pads are installed properly If the indicator remains red contact Cardiac Science Te...

Page 48: ...se solutions to clean the case of the AED soapy water denatured ethanol or 91 isopropyl alcohol The AED and its accessories cannot be sterilised Authorised service The AED has no user serviceable inte...

Page 49: ...at the AED provides for rescues and maintenance RescueCoach voice prompts are activated when the AED lid is opened and help to guide the rescuer through a rescue The AED s information display provides...

Page 50: ...Table A 2 Pad placement Text display Prompt level Voice prompt Line 1 Line 2 Situation Adv Std Bas Begin by exposing the patient s bare chest BARE PATIENT S CHEST REMOVE ALL CLOTHING Prompts the rescu...

Page 51: ...epeats every 3 seconds until the pads are separated If a pad has been peeled before the prompt starts this prompt will be skipped This prompt will be interrupted when the pad is peeled X Firmly place...

Page 52: ...eats until second pad placement is sensed If the pad is placed before the prompt starts then this prompt will be skipped This prompt will be interrupted when the second pad is placed X Table A 2 Pad p...

Page 53: ...IENT ANALYSING RHYTHM Repeats until analysis of the patient s cardiac rhythm is completed This prompt will be interrupted if the AED is ready to shock X X Do not touch the patient Analysing rhythm DO...

Page 54: ...Table A 5 Delivering therapy G5 semi automatic Text display Prompt level Voice prompt Line 1 Line 2 Situation Adv Std Bas Press the red flashing button to deliver shock PRESS BUTTON TO DELIVER SHOCK...

Page 55: ...s the rescuer that it is safe to touch the patient After the AED delivers a shock After the AED detects a non shockable rhythm X X Table A 5 Delivering therapy G5 semi automatic continued Text display...

Page 56: ...rompts when the shock is delivered X X X Shock not delivered SHOCK NOT DELIVERED Plays if the AED is unable to deliver a shock because of a fault condition X X X It is now safe to touch the patient NO...

Page 57: ...S AND BREATHS Prompts the rescuer to prepare to provide compressions and breaths CPR X X Place the heel of one hand on the centre of the chest between nipples PLACE ONE HAND ON CENTRE OF CHEST Prompts...

Page 58: ...PR session The voice prompt or metronome paces the speed of the compressions given by the rescuer X X Stop compressions STOP COMPRESSIONS Prompts at the end of each CPR set X X X Give breath GIVE BREA...

Page 59: ...OF CHEST Prompts the rescuer to put the CPR device in the correct place for giving compressions X X Place the heel of one hand on the CPR device PLACE ONE HAND ON CPR DEVICE Prompts the rescuer to pl...

Page 60: ...EMOVE USB Prompts after the data transfer has completed Remove the flash drive X X X UPDATING LANGUAGE Updating the text and audio prompts as part of a software upgrade using the flash drive X X X VER...

Page 61: ...R A problem has occurred with the data transfer Check the connection with the flash drive and retry the transfer X X X DOWNLOADING DATA The data transfer to the flash drive is in progress X X X SOFTWA...

Page 62: ...on the display panel Press the button to switch the prompting language both audio and text to this language X X X DUTCH On multi lingual AED models only appears above a button on the display panel Pr...

Page 63: ...hnical Data Contents Powerheart G5 parameters B 2 Defibrillation pads B 7 Intellisense battery model XBTAED001 B 8 This section lists the physical operating standby and storage parameters of the AED a...

Page 64: ...Standby Short term 5 days temperature 0 C to 50 C 32 F to 122 F Long term temperature 20 C to 30 C 68 F to 86 F Humidity 10 to 95 non condensing Storage and transport up to 3 days Temperature 30 C to...

Page 65: ...seconds maximum With a fully charged battery Initiation of rhythm analysis to ready to shock used battery 15 seconds typical 45 seconds maximum With a battery that has been used for 15 shocks Lid ope...

Page 66: ...AEDs have been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC This AED and defibrillation pads conform to the appl...

Page 67: ...IEC 61000 4 8 ESD IEC 61000 4 2 IEC 60601 2 4 6 KV contact discharge 8 KV air gap discharge Free fall drop MIL STD 810G Method 516 5 Procedure IV Shock MIL STD 810G 516 5 Procedure 1 Vibration Random...

Page 68: ...601 2 4 requirement and AHA recommendation of Sensitivity of 75 Non shockable Rhythm NSR Meets IEC 60601 2 4 requirement 95 and AHA recommendation 99 of Specificity Non shockable Rhythm Asystole Meets...

Page 69: ...l XELAED002 Parameter Details Type Pre connected pre gelled self adhesive disposable non polarised identical pads which can be placed in either position defibrillation pads with CPR device Applicable...

Page 70: ...ock stack followed by 60 seconds of CPR using Basic prompt settings between each set of shocks Table 8 Intellisense battery Parameter Details Type Intellisense lithium battery non rechargeable Output...

Page 71: ...lator 70 00569 02 G C 1 C ECG Analysis Algorithm and Rescue Waveform Contents RHYTHMx AED ECG analysis algorithm C 2 Rescue protocol C 2 STAR biphasic waveform C 3 This section describes the ECG analy...

Page 72: ...er software Detection rate All ventricular tachycardia VT rhythms at or above this rate are classified as shockable All rhythms below this rate are classified as non shockable Non committed shock If t...

Page 73: ...le energy waveform with 50 ohm resistive load Patient impedance The Cardiac Science Biphasic Truncated Exponential BTE waveform uses variable energy The actual energy that is delivered varies with the...

Page 74: ...4 50 907 3 2 128 172 75 1 431 5 75 968 3 2 116 156 100 1 433 7 00 1 000 3 2 108 144 125 1 435 8 25 1 019 3 2 102 136 150 1 436 9 50 1 031 3 2 97 130 175 1 437 10 75 1 038 3 2 94 126 Table C 2 Low var...

Page 75: ...typical Phase 1 Phase 2 Patient sImpedance Ohms Voltage Volts Duration ms Voltage Volts Duration ms Energy Joules 25 1 895 3 25 997 3 2 263 355 50 1 914 4 50 1 216 3 2 230 310 75 1 920 5 75 1 299 3 2...

Page 76: ...25 682 3 25 359 3 2 35 46 50 689 4 50 438 3 2 30 40 75 691 5 75 468 3 2 27 36 100 692 7 00 483 3 2 25 33 125 693 8 25 493 3 2 24 31 150 694 9 50 498 3 2 23 30 175 694 10 75 802 3 2 22 29 Table C 5 Lo...

Page 77: ...eform all values are typical Phase 1 Phase 2 Patient sImpedance Ohms Voltage Volts Duration ms Voltage Volts Duration ms Energy Joules 25 915 3 25 481 3 2 62 82 50 924 4 50 588 3 2 54 72 75 927 5 75 6...

Page 78: ...70 00569 02 G Powerheart G5 Automated External Defibrillator C 8 ECG Analysis Algorithm and Rescue Waveform...

Page 79: ...Emissions Standards Compliance Contents Guidance and manufacturer s declaration electromagnetic emissions D 2 Guidance and manufacturer s declaration electromagnetic immunity D 3 Recommended separatio...

Page 80: ...etic environment guidance RF emissions CISPR 11 Group 1 The AED uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in n...

Page 81: ...s used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV...

Page 82: ...quency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 80 A m Power frequency magnetic fields should be at levels no higher than those characteristic of a typical location in typical heavy industrial and...

Page 83: ...transmitter Recommended separation distance d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manu...

Page 84: ...ference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ra...

Page 85: ...s and the AED as recommended below according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation di...

Page 86: ...27 283 MHz and 40 66 to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz...

Page 87: ...effective February 2003 Cardiac Science Corporation is committed to minimising the disposal of WEEE as unsorted municipal waste European Community based Users of the WEEE medical device contained her...

Page 88: ...70 00569 02 G Powerheart G5 Automated External Defibrillator E 2 Waste Electrical and Electronic Equipment WEEE Directive Compliance...

Page 89: ...eries and accessories are covered below Disposable defibrillation pads shall be warranted until the expiry date Lithium batteries part number XBTAED001 have a full operational replacement guarantee of...

Page 90: ...his Limited Warranty for either a 90 days or b the remainder of the original warranty period whichever is longer provided the warranty applies and the warranty period has not expired Obligations and w...

Page 91: ...ised product alterations unauthorised service unauthorised product case opening failure to follow instructions improper use abuse neglect fire flood war or acts of God Cardiac Science makes no warrant...

Page 92: ...ur Powerheart AED and for other repair information including charges Charges for non warranty repairs will be assessed and are your responsibility Upon completion of the repair the terms and condition...

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Page 96: ...Technical Support US Fax 262 798 5236 techsupport cardiacscience com internationalservice cardiacscience com International internationalsupport cardiacscience com Cardiac Science the Shielded Heart l...

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