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Powerheart G5 AED Operator/Service Manual

1. Do not touch the patient Analyzing heart rhythm Please wait The AED begins analyzing the cardiac rhythm of the patient Do this 1 Do not touch the patient 2 Wait for the next prompt During the analysis phase you may hear one or more of these prompts If the AED prompts This is the problem Do this Open lid to continue rescue Press pads firmly to patient s bare chest Make sure pad connector is plugged into AED Analysis interrupted Stop patient motion The AED restarts the analysis 5 Deliver a shock When the AED prompts Shock advised Do not touch the patient Automatic model Shock will be delivered in 3 2 1 The AED delivers the defibrillation shock automatically Semi automatic model When the AED is ready to deliver a defibrilla tion shock the Shock button flashes Press red flashing button to deliver shock After the AED delivers the defibrillation shock Shock delivered It is now safe to touch the patient Give CPR as instructed The lid of the AED is closed The pads are not properly placed or are loose The pads are disconnected from the AED The patient is excessively jostled or there is strong electromagnetic emitting equipment nearby within 2 meters Do this Ensure that no one is touching the patient Automatic model Ensure that no one is touching the patient Semi au
2. Cardiac Science Powerheart Automated External Def bri CARDIAC SCIENCE USER S GUIDE POWERHEART G5 AUTOMATED EXTERNAL DEFIBRILLATOR 70 01704 01 B CARDIAC AT THE HEART OF SAVING SCIENCE LIVES Information in this document is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted Trademark Information Cardiac Science the Shielded Heart logo Powerheart STAR Intellisense Rescue Ready RescueCoach and RHYTHMx are trademarks or registered trademarks of Cardiac Science Corporation All other product and company names are trademarks or registered trademarks of their respective companies Copyright 2015 Cardiac Science Corporation All Rights Reserved Patents U S and foreign patents pending See www cardiacscience com patents for a complete list CARDIAC SCIENCE Cardiac Science Corporation N7 W22025 Johnson Drive Waukesha WI 53186 USA techsupport cardiacscience com www cardiacscience com 70 01704 01 B CE 0086 MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany Powerheart G5 Automated External Defibrillator Contents Chapter 1 About the AED PAE DOV ZAY OW Dr rr rr dD 1 1 AED e J GS PY N YEK SE oe DR YD e eo e e NNN 1 2 Tedis play Dan su sn Kew Pan nO wel rae K e n y 1 2 Defibrillation pdd S PY DD N N DD DD eV 1 3 CPR feedback dev ic A iA x l e lue keh A n MON Ka y WA D W 1 3 Mmte
3. Recycle or dispose of the lithium battery in accordance with all federal country state and local laws To avoid fire and explosion hazard do not burn or incinerate the battery Powerheart G5 Automated External Defibrillator Safety A A A CAUTION Use only Cardiac Science approved equipment Using batteries pads cables or optional equipment other than those approved by Cardiac Science may cause the AED to func tion improperly during a rescue therefore Cardiac Science does not endorse their use The use of non approved accessories if proved to contribute to a device malfunction shall void any and all support from Cardiac Science CAUTION Possible improper AED performance Using pads that are damaged or expired may result in improper AED performance CAUTION Moving the patient during a rescue During a rescue attempt excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient s cardiac rhythm Stop all motion or vibration before attempting a rescue Symbols and labels The following symbols can appear in this manual on the AED or on its accessories Some of the symbols represent standards and compli ances associated with the AED and its use Symbol Z N T EN CE AP C Authorized representative in the European Community Description Caution Consult accompanying documentation Additional information is provided in the accompanying documentation Da
4. 1 Place the AED next to the patient Note The normal use for the AED is with it lying horizontally 2 Open the AED lid 3 Remove clothing from the patient s chest 4 Ensure that the patient s skin is clean and dry 5 Dry the patient s chest and shave excessive hair if necessary Do this Tear open white package across dotted line and 1 remove pads Keeping the pads connected to the AED tear open 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 blue plastic 3 With a firm steady pull peel one pad away from the blue plastic liner You can use either pad Firmly place the pad without the blue plastic on patient s bare chest exactly as shown on pads Next peel second white pad from the blue plastic Firmly place the second pad on the other location exactly as shown on pads 4 Place the pad in either location on the chest 5 Pull the blue plastic from the second pad 6 Place the pad on the other location on the chest Note Cardiac Science s standard defibrillation pads are non polarized and can be placed in either position as shown on the pad package The package itself can be left attached to the defibrillation pads wires 70 01704 01 B Powerheart G5 Automated External Defibrillator Steps to a Rescue 4 Analyze the ECG When the AED prompts
5. Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Shock will be delivered in SHOCK IN Notifies the rescuer after the AED is fully charged and X X X ready to deliver the shock Three THREE Prompts approximately three seconds prior to X X X delivering shock Two TWO Prompts approximately two seconds prior to X X X delivering shock One ONE Prompts approximately one second prior to X X X delivering shock Shock delivered SHOCK DELIVERED Prompts 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 X X X of a fault condition It is now safe to touch NOW SAFE Advises the rescuer that it is safe to touch the patient X X the patient TO TOUCH PATIENT After the AED delivers a shock e After the AED detects a nonshockable rhythm 70 01704 01 B Powerheart G5 Automated External Defibrillator RescueCoach Voice and Text Prompts Table A 7 CPR Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas If needed perform IF NEEDED If the AED detects a nonshockable rhythm prompts X X compressions as instructed GIVE COMPRESSIONS rescuer to prepare to provide compressions only CPR Give compressions as GIVE COMPRESSIONS Prompts rescuer to prepare to provide compressions X X instructed only CPR If needed perform CPR IF NEEDED Prompts rescuer to prepare to provide compressions X X as instructed PERFORM CPR and breath
6. Obligations and warranty limits Limited Warranty Obligation Exclusive Remedy THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESSED OR IMPLIED WAR RANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Some states do not allow limitations on how long an implied warranty lasts so this limitation may not apply to you NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF CARDIAC SCIENCE IS AUTHORIZED TO MAKE ANY REPRESENTA TION OR WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY 70 01704 01 B Limited Warranty YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSQEVER SHALL BE AS SPECIFIED ABOVE CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY SPECIAL PUNITIVE INDIRECT CONSEQUENTIAL OR INCI DENTAL DAMAGES OF ANY KIND INCLUDING BUT NOT LIMITED TO EXEMPLARY DAMAGES COMMERCIAL LOSS FROM ANY CAUSE BUSI NESS INTERRUPTION OF ANY NATURE LOSS OF PROFITS OR PERSON AL INJURY OR DEATH EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES HOWEVER OCCASIONED WHETHER BY NEGLIGENCE OR OTHERWISE Some states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you What this warranty does not cover This L
7. 01704 01 B Table 3 Functionality Continued Parameter Detail Internal data 90 minutes storage Table 4 Applicable standards Type Detail Cardiac Science AEDs have been designed and manufactured to conform to the highest standards of safety and performance includ ing electromagnetic compatibility EMC This AED and defibrillation pads conform to the applicable requirements of the following CE General CE Marked by BSI 0086 per the Medical Device Directive 93 42 EEC 0086 Classified by CSA with respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 No 60601 1 08 EN60601 1 and G C US EN60601 2 4 e Certified to CAN CSA Standard C22 2 No 60601 1 08 and 60601 2 4 IEC 60601 1 e IEC 60601 1 2 IEC 60601 2 4 e RTCA DO 160G 2010 Section 5 Category C Section 4 Category A4 EN 1789 Safety and performance Emissions EM EN 55011 A1 CISPR 11 Group 1 Class B Immunity EM e IEC 61000 4 3 Level X 20V m e IEC 60601 2 4 20V m e Magnetic e IEC 61000 4 8 IEC 61000 4 8 e ESD e 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 MIL STD 810G Method 514 5 Procedure 1 Random Category 24 RTCA DO 160G Section 8 Category S Zone 2 curve B and Category U Zone 2 curves F and F1 Vibration Sine
8. 2 Maintenance and Service messages s ssssssssessssssessssesecsssesscsesecsssesscassecseeeees 5 3 Diagnostic mode MESSAGES cscsscsssssssscsssesscsssecsssecscsssecscsessesssecscssseceeseessaees 5 4 Chapter 6 Product Care Periodic MAINTENANCE ceccescscessssceccsccsscsccescecsscsecsssseccecssssecssssccecsecsecsecseccecs 6 1 cleaning GMC Gale aerian cen e GAR K i e aera 6 2 A thorized Sef VCC LA alla need l n rae ade la sere r la Ak 6 2 Powerheart G5 Automated External Defibrillator Appendix A RescueCoach Voice and Text Prompts san jun T o QESD N AE N E DD DD T MD ET A 1 Pads placement oeren aE E A A R A 2 PAS DIO S unen N n NE YE nk AN e KENE A A 3 PRIVY SUS cess kann n we hn ne e en we De O vaste au re SON r aden A 3 Delivering therapy G5 semi automatic sesessseesssessseesssessseeosseesseosseeossee A 3 Delivering therapy G5 AUTOMATIC ou sessesesssesscsssecscsesecsssesscssseeseseeesees A 4 CPR O way Seke ENO EN AE N AA esas tacts A 5 CPR feedback device optional 4 ere eeereeeeeekeeeee A 6 Data tranisiel si sayan AA Kek ai AAy TAA A 7 Langaage selection iy su maye ke ney ae in di yin l l edin k l N A 8 Appendix B Technical Data Powerheart G5 parameters su waya wayan Wu d KAR ke i Ware WA k k A B 1 D ellDl TIST O FN dO S Se ay ye kokan Na B 3 Intellisense battery model XBTAEDOO1 emeerreeereeee B 3 Appendi
9. 8 in Weight with 2 6 kg 5 7 Ib battery and pads Table 2 Environmental information Parameter Detail Operating Temperature 0 C to 50 C 32 F to 122 F e Humidity 10 to 95 non condensing Standby Short term 5 days temperature 0 C to 50 C 32 F to 122 F e Long term temperature 20 C to 30 C 68 F to 86 F e Humidity 10 to 95 non condensing Storage and e Temperature 30 C to 65 C 22 F to 149 F transport e Humidity 10 to 95 non condensing up to 3 days Altitude CSA evaluated 382 m to 3000 m Minimum 382 m approximate calculated from pressure e Maximum 4594 m approximate calculated from pressure Powerheart G5 Automated External Defibrillator Table 2 Environmental information continued Parameter Detail e CSA evaluated 700 hPa to 1060 hPa e Minimum 570 hPa e Maximum 1060 hPa Pressure Operating AED with pads and battery installed and lid open Standby AED with pads and battery installed and lid closed Storage and transport AED with pads optionally connected and battery not installed The defibrillator and its accessories have been tested for long term standby for 24 months in the temperature range from 20 to 30 C only For operation namely when the defibrillator lid is open the operating temperature range is from 0 to 50 C Hence after each rescue attempt please close the lid thus bringing the defibrillator
10. Customer Care to order the preinstalled pads with CPR feedback device DO NOT use the CPR feedback device on children under 8 years old or under 55 Ibs SF SS Ensure Rescue Ready is green Press down to hear click ay www cardiacscience com batteryrecycle Caw 70 01704 01 B About the AED ta 70 01704 01 B Powerheart G5 Automated External Defibrillator 2 Steps to a Rescue These are the general steps 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 2 4 Analyze the patient s ECG page 2 3 5 Deliver a defibrillation shock page 2 3 6 Give CPR page 2 4 7 Prepare the AED for the next rescue page 2 4 Powerheart G5 Automated External Defibrillator 70 01704 01 B Steps to a Rescue 1 Assess the patient Determine that the patient is more than 8 years of age or weighs more than 25 kg 55 Ibs and is both Unresponsive Not breathing or not breathing normally DO NOT delay therapy to determine the patient s exact age or weight CALL EMERGENCY MEDICAL SERVICES Note When the patient is 8 years of age or younger or weighs 25 kg 55 Ibs or less use the AED with pediatric defibrillation pads if available See the directions for use accompanying pediatric pads to replace preinstalled pads with pediatric pads 3 Place pads When the AED prompts 2 Prepare the patient
11. X Contact Technical Support or your local representa tive for help CLOSE THE LID After a data transfer is complete and the flash drive X X X is removed from the AED re connect the pads and close the lid of the AED USB DATA ERROR A problem occurred with the data transfer Check the X X X connection with the flash drive and retry the transfer DOWNLOADING DATA The data transfer to the flash drive is in progress X X X SOFTWARE ERROR There is a problem with the data transfer to the X X X flash drive Contact Technical Support or your local representative for help REMOVE USB The data transfer is complete It is safe to remove the X X X CLOSE THE LID flash drive reconnect the defibrillation pads and close the lid of the AED RESETTING DEVICE After a software upgrade the AED restarts itself X X X CONTROL CODE UPDATE Updating the control software X X X Powerheart G5 Automated External Defibrillator 70 01704 01 B RescueCoach Voice and Text Prompts Table A 10 Language selection Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas ENGLISH On multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language FRENCH On multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language DUTCH O
12. back to the standby state with the associated standby requirement of 20 to 30 C only The defibrillator has not been qualified for long term standby in an environment between 30 to 50 C The AED can be stored in long term standby at temperatures between 0 to 50 C However continuous storage at temperature extremes may reduce the life of the electrodes and or battery Rescue Ready technology assesses the AED battery and pads to ensure they are ready to perform a rescue When the Rescue Ready status is green the AED is ready for a rescue Audible and visual indicators will notify when the device requires attention Deployments in the conditions described above are covered under the Cardiac Science AED warranty battery performance replacement guarantee electrode warranty through expiration date and Cardiac Science indemni fication agreement Refer to Section F for complete warranty information 70 01704 01 B Technical Data Table 3 Functionality Parameter Detail RHYTHMx The AED RHYTHMx ECG Analysis system analyzes ECG analysis the patient s ECG and advises you when the AED performance detects a shockable or non shockable rhythm This system makes it possible for a person with no training in the interpretation of ECG rhythms to offer defibrillation therapy to victims of sudden cardiac arrest Waveform STAR Biphasic Impedance 25 to 175 0Q Energy Escalating energy from 95 J to 354 J preinstalled pads model
13. patient to patient contamination The AED detects an issue with the defibrillation pads The AED detects more than one error The AED displays a TEMP TOO HOT or TEMP TOO COLD error Replace the defibrillation pads Replace the defibrillation pads Ensure the connector is securely plugged into the AED Replace the pads if necessary Press the lighted button to view the next error Press the lighted button to remove the error message from the AED Powerheart G5 Automated External Defibrillator 6 Product Care Contents lt Periodic MAINTENANCE ssssseseseseseseesesesesesessssssesesesessesesosesesessses 6 1 Cleaning and CA eienen nN WAA Ka da kalk 6 2 lt Authorized service sssesesesesesessesssesesosessseesesosesenossesssesesososossesesese 6 2 This section presents information about AED product care and cleaning Cardiac Science Corporation provides customer service and technical support To order additional product or accessories contact Customer Care For assistance with product installation or operation contact Technical Support Cardiac Science provides 24 hour support by telephone You can also contact Technical Support through fax or email Customer Care 800 426 0337 USA 262 953 3500 USA and Canada care cardiacscience com Technical Support 800 426 0337 USA 262 953 3500 USA and Canada Fax 262 798 5236 USA and Canada techsupport cardiacscie
14. product Inside the US call us toll free at 800 426 0337 seven days a week 24 hours a day Our technical support representative will try to resolve your issue over the phone If necessary and at our sole discretion we will arrange for service or a replacement of our product Outside the US contact your local Cardiac Science representative Powerheart G5 Automated External Defibrillator What we will do If your Cardiac Science product is returned within 30 days of the date it was purchased at the direction of a technical support representa tive we will repair or replace it with a new product of equal value at no charge to you or offer a full refund of the purchase price provided the warranty applies Cardiac Science retains the exclusive right to repair or replace the product or offer a full refund of the purchase price at its sole discretion SUCH REMEDY SHALL BE YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF WARRANTY If your Cardiac Science product is returned at the direction of a tech nical support representative after 30 days but within the warranty period Cardiac Science at its sole discretion will repair your product or replace it The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either a 90 days or b the remainder of the original warranty period which ever is longer provided the warranty applies and the warranty period has not expired
15. to arrive Note If the AED does not provide expected CPR coaching the rescuer must conduct CPR as appropriate After transferring the patient to emergency medical personnel close the lid of the AED to end the rescue session Prepare the AED for the next rescue 7 Prepare the AED for the next rescue 1 Open the lid 2 Optional Retrieve the rescue 3 Connect a new preinstalled 4 Verify that the pad connec data stored in the internal pads package Model tion indicator is off If the indi memory of the number XELAEDO01 cator is on make sure that the AED See the AED to the AED See the pad connector is Manager User s Defibrillation Pads properly attached Guide for details Instructions for to the AED Use for details 5 Verify that there is adequate 6 Verify that the service 7 Close the lid 8 Verify that the Rescue Ready charge 1 remaining in the indicator is off indicator is green battery If the battery charge is low 2 replace the battery QES CU e YA 70 01704 01 B Powerheart G5 Automated External Defibrillator 3 Safety Contents indications for USE sonsonen 3 1 Safety alert descriptions sessssessssessseessseessseesssesssseosserosseeosseesssesss 3 1 lt Warnings AN cautions ssessesseessesseessesseessesssesseossesseesscsseeseeoseessess 3 1 Symbols and labels yunan nun n na NA na WNN NA 3 3 Before operating the AED become familiar with the various safety alerts in this
16. 3 High variable energy waveform all values are typical Phase 2 Patient s Voltage Duration Voltage Duration Energy Impedance Volts Volts Joules Ohms V1 V2 70 01704 01 B Waveform and energy levels for pediatric defibrillation pads Table C 4 Ultra low variable energy waveform all values are typical Patient s Voltage Duration Voltage Impedance Volts Ohms 25 682 so 7 100 175 694 Table C 5 Low variable energy waveform all values are typical Phase 2 Patient s Voltage Duration Voltage Duration Energy Impedance Volts Volts Joules Ohms T2 sa2 75 542 37 48 125 32 42 150 31 40 Table C 6 High variable energy waveform all values are typical Phase 2 Patient s Voltage Duration Voltage Duration Energy Impedance Volts Volts Joules Ohms V1 V2 Powerheart G5 Automated External Defibrillator D Electromagnetic Emissions Standards Compliance Contents lt Guidance and manufacturer s declaration electromagnetic emissione D 1 Guidance and manufacturer s declaration electromagnetic immunity j D 1 Recommended separation distances between portable and mobile RF communications equipment ANC the AED ou ssssesesesssscsesesesscsescscsescssssesesesesessssesesesesescseseeseseseseeees D 3 Guidance and manufacturer s declaration e
17. Delivering therapy G5 semi automatic A 3 Delivering therapy G5 AUTOMATIC sssesssessseesseesseesseesseesseessees A 4 CPR assessed evinces n N i a a KN r re O oceania A 5 CPR feedback device optional A 6 Data TASS asics minin n k R NERE A 7 Language SELECTION 4 45 y45444y 405 451554555 a A 8 This section describes the prompts the AED provides for rescues and maintenance RescueCoach voice prompts activate when the AED lid is opened and help guide the rescuer through a rescue The AED information display provides equivalent text to the voice prompts These tables list the voice and text prompts descriptions of when the prompts are used and with what prompt level they are used advanced Adv standard Std or basic Bas For maintenance and service messages see Maintenance and service messages on page 5 3 For diagnostic messages see Diagnostic mode messages on page 5 4 Table A 1 Start up Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Stay calm Follow these STAY CALM Plays when the lid is opened X instructions FOLLOW INSTRUCTIONS Make sure 911 is called now CALL 911 Plays when the lid is opened X X NOW Make sure emergency services CALL EMERGENCY Plays when the lid is opened X X are called now SERVICES NOW Alternative start up prompt Powerheart G5 Automated External De
18. ECG noise artifacts stop moving X X X or touching the patient Remove other electronic devices from the vicinity Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Press red flashing button to PRESS BUTTON Prompts after the AED is fully charged and ready X X X deliver shock TO DELIVER SHOCK to deliver the defibrillation shock The red SHOCK button flashes and the phrase repeats for 30 seconds or until the SHOCK button is pressed Shock delivered SHOCK DELIVERED Prompts when the shock is delivered X X X Rhythm Changed Shock RHYTHM CHANGED Notifies the rescuer when the AED detects a rhythm X X X Cancelled SHOCK CANCELLED change and cancels the shock Powerheart G5 Automated External Defibrillator 70 01704 01 B RescueCoach Voice and Text Prompts Table A 5 Delivering therapy G5 semi automatic continued Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Shock not delivered SHOCK NOT DELIVERED Plays for either of these situations X X X The SHOCK button is not pressed within 30 seconds of the AED giving the Press red flashing button prompt The AED is unable to deliver a shock because of a fault condition It is now safe to touch the NOW SAFE Advises the rescuer that it is safe to touch the patient X X patient TO TOUCH PATIENT After the AED delivers a shock After the AED detects a nonshockable rhythm Table A 6 Delivering therapy G5 automatic
19. ED Manager software s sssesssesssessseessessseesseesseesseesseesseesseesseessses 4 2 The Powerheart AED provides customization for aspects of a rescue from the amount of assistance given to a rescuer to the CPR protocol used Additionally each rescue is recorded Note All configuration is performed by a medical director through the AED Manager software supplied with the AED Dual languages The Powerheart G5 provides the option to choose between two languages in selected models This allows for the user at any point during the rescue to change between the two languages The AED provides all prompts in the chosen language The prompt language resets to the default when the lid closes Prompting levels The AED provides three selectable levels of prompts Advanced The AED provides detailed prompts for performing a rescue Standard The AED provides some guiding prompts Basic The AED provides minimal prompting for the various stages of a rescue Note The names and descriptions of these prompting levels are provided as suggestions only Table 4 1 Audio prompts for applying pads to a patient Advanced Standard Do not construe them as medical guidance Medical directors must use their professional judgment to determine the proper configura tion of the AEDs for which they are responsible The following table gives an example of the differences in audio prompting provided for the levels of coaching See Appen
20. Electronic Equipment WEEE Directive Compliance Contents Manufacturer s WEEE compliance instructione E 1 Manufacturer s WEEE compliance instructions Pursuant to European Community Directive 2002 96 EC effective February 2003 Cardiac Science Corporation is committed to minimizing the disposal of WEEE as unsorted municipal waste un European Community based Users of the WEEE medical device con tained 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 admon weecare com Powerheart G5 Automated External Defibrillator 70 01704 01 B Waste Electrical and Electronic Equipment WEEE Directive Compliance 70 01704 01 B Powerheart G5 Automated External Defibrillator F Limited Warranty Contents D gt FORM OW IONO 54551 x4 x14x5 0A SA We ae e lr ade k nan F 1 What yoU muist dO yiy 44545045551154 t e a ia E F 1 S WAIT WE Q lO unes ya nar na n Enis Ak 3 ra F 1 Obligations and warranty limitS eeeeeen F 1 What this warranty does NOt COVef ssesssessseesseesseessersseesseessees F 2 This limited warranty is void f eereerneere F 2 If the warranty period has Cxpired sessesssss
21. MIL STD 810G Method 514 5 Procedure 1 Category 24 Helicopter Minimum Integrity Enclosure IEC 60529 IP55 protection Powerheart G5 Automated External Defibrillator Technical Data Table 4 Applicable standards continued Type Detail Shipping and ISTA Procedure 2A transportation Sensitivity and specificity of Rhythm Detection Shockable Rhythm VF Meets IEC 60601 2 4 requirement and AHA recommendation of Sensitivity of gt 90 Shockable Rhythm VT Meets IEC 60601 2 4 requirement and AHA recommendation of Sensitivity of gt 75 Non shockable Rhythm NSR Meets IEC 60601 2 4 requirement gt 95 and AHA rec ommendation gt 99 of Specificity Non shockable Asystole Meets IEC 60601 2 4 requirement and AHA recommendation of Specificity of gt 95 Non shockable all other rhythms Meets IEC 60601 2 4 requirement and AHA recommenda tion of Specificity all other rhythms of gt 95 Defibrillation pads Table 5 Preinstalled defibrillation pads model XELAEDO01 Parameter Detail Pre gelled self adhesive disposable non polar ized identical pads which can be placed in either position defibrillation pads Type Applicable age Older than 8 years or heavier than 25 kg 55 Ib and weight of patient Shelf life 24 months Disposal Check local regulations for disposal information Table 6 Preinstalled defibrillation pads with CPR feedback device model XELAEDOO2 Param
22. aborted in these cases The AED can detect or reject pulses from an implanted pacemaker In addition RHYTHMx optionally shocks selected VT and SVT rhythms Settings for several detection features can be adjusted through AED Manager 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 the patient s rhythm changes to a non shockable rhythm before the actual shock is delivered the AED cancels the shock Synchronized shock The AED automatically attempts to syn chronize shock delivery on the R wave if one is present If delivery cannot be synchronized within one second a nonsynchronized shock is delivered SVT discriminator The AED is configurable to shock SVT waveforms that are above a threshold rate that can be pre set or can be disabled default setting Powerheart G5 Automated External Defibrillator Rescue protocol The AED rescue protocol is consistent with the guidelines recom mended by the AHA ERC 2010 Guidelines for Resuscitation and Emergency Cardiac Care Note For consistency with AHA ERC guidelines the CPR time can be set to allow for 5 cycles of 30 compressions and 2 breaths Use AED Manager to change the protocol For details see the AED Manager User s Guide STAR biphasic waveform The waveform generated by the Cardiac Science AED
23. at a regular interval If no sound is heard contact Cardiac Science Technical Support or outside the U S your local representative 5 Check the expiration date of the pads if expired replace the package 6 Check that the pads packaging is not ripped or punctured Replace the package as needed 7 Open the lid and confirm that the defibrillation pads indicator is lit 8 Reconnect the pads connector put the pads back in the pads holder and close the lid 9 Make sure the expiration date is visible through the window of the lid 10 Make sure that the Rescue Ready indicator is green If the indi cator is red make sure that the pads are installed properly If the indicator remains red contact Cardiac Science Technical Support or outside the U S your local representative 11 Close the lid raf Check that the LEDs work 1 Open the AED lid 2 Confirm that the device briefly illuminates all indicator LEDs 0 25 50 75 100 battery LEDs Pads status LED Service required LED Shock button LED Left function button LED K SN NN 8 Right function button LED 3 Close the lid v Check that the buttons work 1 Open the AED lid 2 Within 15 seconds of opening the lid press the soft buttons and Shock button in turn The buttons should illuminate If one does not contact Cardiac Science Technical Support or outside the U S your local representative 3 Close the lid raf Check the AED case for sig
24. cseseseseessseeseees F 2 Cardiac Science Corporation Cardiac Science warrants to the original purchaser that its AEDs and stated battery operating life will be free of any defect in material and workmanship according to the terms and conditions of this Limited Warranty Limited Warranty For purposes of this Limited Warranty the original purchaser is deemed to be the original end user of the product purchased This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE For how long This Limited Warranty covers the following products or parts for the following time periods Eight 8 years from the date of the original shipment to the original purchaser for Powerheart AED automated external defibrillators Warranty duration for the pads batteries and accessories are covered below Disposable defibrillation pads shall be warranted until the expiration date Lithium batteries part number XBTAEDO01 have a full operational replacement guarantee of four 4 years from the date of installa tion into a Powerheart AED One 1 year from the date of original shipment to the original purchaser for Powerheart AED accessories The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims What you must do Please complete and submit the Product Registration online at www cardiacscience com services support product registration To obtain warranty service for your
25. dix A RescueCoach voice and text prompts for a complete list of audio and visual prompts Basic Firmly place the pad without the blue plastic on patient s bare chest exactly as shown on pads shown on pads This pad can be placed on either of the two locations as shown on pads Next peel second white pad from the blue plastic blue plastic Firmly place the second pad on the other location exactly as shown on pads Powerheart G5 Automated External Defibrillator Firmly place the pad without the blue plastic on patient s bare chest exactly as Next peel second white pad from the Firmly place the second pad on the other location exactly as shown on pads Firmly place the pad on the patient Next peel second white pad from the blue plastic Firmly place the second pad on the other location 70 01704 01 B AED Features CPR behavior types The AED includes optional settings for configuring the style of CPR Combining the prompting levels and CPR behavior types AEDs can be configured in many ways For example an AED can be configured to provide rescue instructions with Advanced prompting and traditional compressions and breaths CPR sessions factory default or Basic prompting and timed CPR sessions or Advanced prompting and compressions only CPR sessions Rescue Coach prompts vary for all CPR styles depending on the prompting level chosen 70 01704 01 B AED device hi
26. ds Important Pediatric pads are not to be pre connected to the AED Follow the instructions for use provided with pediatric pads Intellisense battery The Intellisense battery model XBTAEDO01 automatically stores history of its operating life The battery history can be reviewed with AED Manager software Important See Warnings and cautions on page 3 1 for important safety information How to replace the battery Press tab Lift out Note Ensure that the battery is at room temperature before inserting it into the AED Powerheart G5 Automated External Defibrillator Insert new See Warnings and cautions on page 3 1 for important safety information CPR feedback device The CPR feedback device is about the size of the palm of a hand Its non slip surface and shape transfers the rescuer s com pressions to the patient s chest The CPR feedback device included with optional preinstalled pads with CPR feedback de vice measures the depth and rate of chest compressions The AED uses this information to help guide proper compression rate and compression depth during CPR Note Use of the CPR feedback device is optional If the CPR Feedback Device slips during CPR performance continue chest compressions as trained without interruption If you do not use the CPR feedback device place it on a surface next to the patient DO NOT attempt to detach the device from its cable Contact Cardiac Science
27. ed Pads indicator is lit The battery indicator is red Additionally when the lid is closed a beep sounds intermittently 70 01704 01 B Close and reopen the lid of the AED The Rescue Ready indicator may return to green Enter Diagnostic mode for more information see Diagnostic mode messages on page 5 4 The AED requires service by authorized service personnel Enter Diagnostic mode for more information see Diagnostic mode messages on page 5 4 Contact Cardiac Science Technical Support or your local representative Ensure that the pads are connected securely to the AED During a rescue ensure that the pads connector is securely connected to the AED and the pads are placed properly on the patient s chest The battery capacity is low Replace the battery If the beep continues to sound after the battery is replaced contact Cardiac Science Technical Support or your local representative Powerheart G5 Automated External Defibrillator Troubleshooting Maintenance and service messages These messages may appear during a periodic self test or during a rescue at any prompt level Use the following table to resolve messages that the AED might display Text display Line 1 Voice prompt Line 2 Situation Resolution Battery Low BATTERY LOW The battery charge is low although a rescue can Replace the battery before the next rescue continue for approximately 9 more shocks REPLACE BATTERY NOW Occurs when the lid i
28. eeosseesosseesssseessseeosseees F 2 If the warranty period has expired sesseessseessseeesssessssesssseesssserossseessseessse F 2 70 01704 01 B ES 70 01704 01 B Powerheart G5 Automated External Defibrillator 1 About the AED Contents FED XOY EVI Y Lalo yara eas Aiea e 1 1 O AED Dal lS s2n a n KK ev cosas NO Ha l e e aa deb 1 2 The display panel ou sssecsssssssecssssscsssssesscsssssecssssseccessesesees 1 2 Defibrillation pad wu cssessssesessssesssessesesesssescseesesesessesescseeee 1 3 CPR feedback device ou eeecssssssssessssesssesscssssessssessseesssecsssesseseesees 1 3 Intellisense battery ss sssesssesssessseesseesseesseesseesseesseesseesseesseesseessees 1 3 This section describes parts of the AED and the optional features for use in rescues AED overview The Powerheart G5 automated external defibrillator AED is designed for treating life threatening heart beat irregularities such as ventricular fibrillation that cause Sudden Cardiac Arrest SCA There are two models available fully automatic and semi automatic After the defibrillations pads are applied to the patient the fully automatic model evaluates the heart rhythm and if a shockable rhythm is detected delivers a shock without any rescuer assistance The semi automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected Both models have voice and tex
29. eter Detail Pre gelled self adhesive disposable non polarized identical pads which can be placed in either position defibrillation pads with CPR feedback device Type Applicable age Older than 8 years or heavier than 25 kg 55 Ib and weight of patient Shelf life 24 months Disposal Check local regulations for disposal information Powerheart G5 Automated External Defibrillator Table 7 Pediatric defibrillation pads model XELAEDO03 Parameter Detail Pre gelled self adhesive disposable non polar ized identical pads which can be placed in either position defibrillation pads Type Applicable age Eight years or younger or 25 kg 55 Ib or lighter and weight of patient Shelf life 24 months Disposal Check local regulations for disposal information Intellisense battery model XBTAEDO01 Table 8 Intellisense battery Parameter Detail Type Intellisense lithium battery non rechargeable Output voltage 12 VDC nominal Lithium content 9 2 g approximate Disposal Check local regulations for disposal information Estimated shelf life e 5 years from date of manufacture e Temperature ranges Short term 3 days at either temperature extreme 30 C to 65 C Long term 5 years at either temperature extreme 20 C to 30 C Estimated operating life new and fully charged battery Shocks 420 typical 250 minimum or 16 hours of operating time at 20 30 C or Standb
30. fibrillator 70 01704 01 B RescueCoach Voice and Text Prompts Table A 2 Pads placement Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Begin by exposing patient s BARE PATIENT S CHEST Prompts the rescuer to remove patient clothing X X bare chest REMOVE ALL CLOTHING Remove or cut clothing if BARE PATIENT S CHEST Prompts the rescuer to remove patient clothing X needed REMOVE ALL CLOTHING When patient s chest is bare WHEN CHEST IS BARE Prompts the rescuer to remove the pads package X remove the white square REMOVE PACKAGE from the AED lid package from lid of AED Remove white square package REMOVE WHITE Second prompt to remove pads package from the X from lid of AED SQUARE PACKAGE AED lid Tear open white package across TEAR OPEN PACKAGE Prompts the rescuer to open the pad package and X X dotted line and remove pads REMOVE PADS remove pads Peel one of the white pads PEEL ONE WHITE PAD Prompts rescuer to remove either pad from the X X completely from blue plastic FROM BLUE PLASTIC blue plastic Repeats 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 pad is peeled Begin pulling from the tabbed PULL FROM Prompts rescuer to remove either pad from the X corner TABBED CORNER blue plastic Repeats every 3 seconds until the pads are separated If a pad has been peeled before the prompt
31. he maximum output power rating of the trans mitter in watts W according to the transmitter manufac turer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey c should be less than the compliance level in each frequency range Interference may occur in the vicinity of ce equipment marked with the following symbol A Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference 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 ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast canno
32. imited Warranty does not cover defects or damages of any sort resulting from but not limited to accidents damage while in transit to our service location product tampering unauthorized product alterations unauthorized service unauthorized product case open ing failure to follow instructions improper use abuse neglect fire flood war or acts of God Cardiac Science makes no warranty claim as to the compatibility of Cardiac Science products with any non Cardiac Science products parts or accessories 70 01704 01 B This limited warranty is void if 1 Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifically authorized by Cardiac Science 2 Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose 3 Any Cardiac Science product is used in conjunction with incom patible products parts or accessories including but not limited to batteries Products parts and accessories are not compatible if they are not Cardiac Science products intended for use with the Powerheart AED If the warranty period has expired If your Cardiac Science product is not covered by our Limited Warranty Inside the US call us toll free at 888 466 8686 for advice as to whether we can repair your Powerheart AED and for other repair information including charges Charges for non warranty repairs will be assessed and are you
33. is a biphasic truncated exponential waveform The waveform complies with the IEC 60601 2 4 standard Figure 1 is a graph of the waveform voltage as a function of time when the AED is connected to a 50 ohm resistive load using preinstalled pads model number XELAEDO01 v D S o gt 1 000 0 000 1 000 2 000 3 000 4 000 5 000 6 000 7 000 8 000 9 000 10 000 Time ms Figure 1 High variable energy waveform with 50 ohm resistive load Patient impedance The Cardiac Science Biphasic Truncated Exponential BTE waveform uses variable energy The actual energy delivered varies with the patient s impedance The device delivers a shock to a patient with an impedance in the range of 25 175 ohms Energy is delivered at up to three different levels ultra low variable energy low variable energy and high variable energy see the waveform and energy tables on the following pages 70 01704 01 B ECG Analysis Algorithm and Rescue Waveform Waveform and energy levels for preinstalled defibrillation pads Model number XELAEDO01 Table C 1 Ultra low variable energy waveform all values are typical Phase 2 Patient s Voltage Duration Voltage Duration Energy Impedance Volts Volts Joules Ohms V1 V2 Table C 2 Low variable energy waveform all values are typical Phase 2 Patient s Voltage Duration Voltage Duration Energy Impedance Volts Volts Joules Ohms V1 V2 Table C
34. lectromagnetic emissions The AED is intended for use in the electromagnetic environment specified below The customer or the user of the AED should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The AED uses RF energy only for its internal function Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B The AED is suitable for use in all establishments including domestic establishments and those CISPR 11 directly connected to the public low voltage power supply network that supplies buildings a Harmonic emissions used for domestic purposes Harmonic Not applicable emissions IEC 61000 3 2 Voltage fluctuations Not applicable flicker emissions IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The AED is intended for use in the electromagnetic environment specified below The customer or the user of the AED should assure that it is used in such an environment Compliance Electromagnetic Immunity test IEC 60601 test level level environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors discharge ESD 8 kV air 8 kV air E ae A material the relative humidity IEC 61000 4 2 j Electrical fast 2 kV for power supply lines Not applicable transient DU 1 kV for inpu
35. lisense Datter y s yen yan nne ena i We Hed e AYA Kek 1 3 Chapter 2 Steps to a Rescue TEASSCSS the Datla C Al anl Gul e l Ea Ma N n la KAN AN 2 2 PEP LED ALS Ce Patile Mirano na AANE 2 2 Be Place AGS ninan assed exseaiste snes E A sees Pastas 2 2 A Analyze the EC Gi aes hanya c l e N i e Means 2 3 S Deliver a SiO0 Aw A a wan We A e N WG ry We Ye ANN 2 3 O GIVESC r a NA 2 4 7 Prepare the AED for the next reSCue ss sseesssessseesseessersseersseesneesssersseess 2 4 Chapter 3 Safety CIE ATOMS TOP USE Ken ee n k Na re RI e H N yek E D 3 1 Safety alertdescripllol 8 4 ciyayi Nall A nA Wan kinin n n 3 1 Warnings and cautions sci su lan ned w n n G We W Wu AN 3 1 SymbDols and label sy x RR a 0e HA e EL N NR IN rek 3 3 Chapter 4 AED Features Dua AGUA CS kya E le Noni We e e o A ela e 4 1 Prompting SI Si CEN N n N DD 4 1 CPR DEMAVION p S sucr e Pe kay e r en S 4 2 AED device history and rescue data recording 4 2 AED Manager SOf WaAr ccsssessssssssssssecsssssecscsessssecsssecsessssecsssucaesscsesacseesseseasenss 4 2 Chapter 5 Troubleshooting SOUT Te S Sicecotceectcatactc nates ttensecte bed n erke k a Kay K ra Kere n ke ed K a dan 5 1 Troubleshooting Of indicatorS eseessssesssseessssersssseessseessserosseesssseeosseesssserssss 5
36. n Adv Std Bas Pediatric Pads Connected PEDIATRIC Notifies rescuer that the pediatric pads are connected X X X PADS to the AED Make sure pad connector is CHECK CONNECTOR Prompts when defibrillation pads connector is not X X X plugged into AED IS PLUGGED INTO AED inserted into the pad socket Press pads firmly to patient s PRESS PADS FIRMLY Prompts when better pad contact to the patient s X X X bare chest TO CHEST skin is required Table A 4 Analysis Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Do not touch the patient DO NOT TOUCH PATIENT Repeats until analysis of the patient s cardiac rhythm X X Analyzing heart rhythm ANALYZING RHYTHM is completed This prompt will be interrupted if the Please wait AED is ready to shock Do not touch the patient DO NOT TOUCH PATIENT Repeats until analysis of the patient s cardiac rhythm X Analyzing Rhythm ANALYZING RHYTHM Shock advised Do not touch SHOCK ADVISED the patient DO NOT TOUCH PATIENT Shock not advised SHOCK NOT ADVISED ANALYSIS INTERRUPTED STOP PATIENT MOTION Analysis interrupted Stop patient motion Table A 5 Delivering therapy G5 semi automatic is completed This prompt will be interrupted if the AED is ready to shock Notifies the rescuer that a shockable rhythm has been X X X detected and is preparing to deliver a defibrillation shock charging Notifies the rescuer when the AED detects a X X X non shockable rhythm If the AED detects
37. n multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language ITALIAN On multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language GERMAN On multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language SPANISH On multi lingual AED models only appears above X X X a button on the display panel Press the button to switch the prompting language both audio and text to this language 70 01704 01 B Powerheart G5 Automated External Defibrillator B Technical Data Contents Powerheart G5 parameters ou cesesesssscsssescssssssesesssesssseseseeesesees B 1 Defibrillation Dad 5 54 lt ul kan ia a kal Ka a walan B 3 Intellisense battery model XBTAEDOo 3 B 3 This section lists the physical operating standby and storage parameters of the AED and the physical parameters of the defibrillation pads and AED battery Powerheart G5 parameters Table 1 Physical parameters Parameter Detail Operation e Automatic e Semi automatic e Multi language in specified combinations only Dimensions Height 9 cm 3 4 in Width 23 cm 9 0 in Depth 30 cm 11
38. n the ability to perform a rescue The AED can be used to perform a rescue The AED is hotter than its allowable storage temperature While this condition should be remedied as soon as possible the AED may be used to perform a rescue The AED is cooler than its allowable storage temperature While this condition should be remedied as soon as possible the AED may be used to perform a rescue The battery charge is low although a rescue can continue for approximately 9 more shocks While this condition should be remedied as soon as Replace the battery immediately If the battery charge is completely depleted all AED activity ends Contact Cardiac Science Technical Support or your local representative Move the AED to a cooler location Move the AED to a warmer location Replace the battery before the next rescue possible the AED can be used to perform a rescue PADS EXPIRED REPLACE PADS PADS USED REPLACE PADS CHECK PADS NEXT CLEAR 70 01704 01 B The AED detects that the connected defibrillation pads are older than their use by date CAUTION Use of pads that are damaged or expired may result in improper AED performance The AED detects that the connected defibrillation pads have been used in a rescue WARNING Used pads may not 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
39. nce com www cardiacscience com Outside the United States and Canada contact your local representative Powerheart G5 Automated External Defibrillator Periodic maintenance Periodically perform the following tests Check the color of the Rescue Ready indicator If the color is Do this Green No action needed The AED is ready for a rescue Red Refer to Troubleshooting of indicators on page 5 2 raf Check that the battery has adequate charge to perform a rescue 1 Open the AED lid 2 If the battery indicator is red replace the battery 3 Close the lid v Check that the voice prompts work and the display is readable 1 Open the AED lid 2 Listen for the voice prompts 3 Additionally the display shows text 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 closed the display is not readable or the Rescue Ready indicator remains red there may be an issue with the AED Contact Cardiac Science Tech nical Support or outside the U S your local representative raf Check that the defibrillation pads are ready for use and that the service beep sounds 1 Open the AED lid 2 Disconnect the pads connector and remove the pads package 3 Close the lid 70 01704 01 B 4 Confirm that the Rescue Ready indicator turns red and the AED beeps
40. ngerous voltage The defibrillator output has high voltage and can present a shock hazard Please read and understand all safety alerts in this manual before attempting to operate the AED Defibrillator Proof Type BF Equipment The AED when 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 essential requirements of the Medical Device Directive 0086 93 42 EEC Classified by CSA with respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 No 60601 1 08 EN60601 1 and Us EN60601 2 4 Certified to CAN CSA Standard C22 2 No 60601 1 08 and 60601 2 4 Powerheart G5 Automated External Defibrillator IP55 x as CAUTION Case cleaning solutions When disinfecting the case use a non oxidizing disinfectant such as soapy water denatured ethanol or 91 isopropyl alcohol to avoid damage to the metal connectors CAUTION Equipment damage Keep all cleaning solutions and moisture away from the defibril lation pad connectors and cable connector openings CAUTION Incorrect software version The AED is programmed with software that has been tested to work with the version of AED Manager software included with the AED When an older version of AED Manager is used to com municate with this AED there may be features described in this manual that are not available Also when c
41. ns of stress If you find cracks or other signs of stress contact Cardiac Science Technical Support or outside the U S your local representative 70 01704 01 B Cleaning and care Use a cloth dampened with an approved cleaning solution to wipe the case Do not spray or pour the cleaning solution on the case or submerge the AED Dry the case with a clean cloth Approved cleaning solutions Use one of these solutions to clean the case of the AED soapy water denatured ethanol or 91 isopropyl alcohol The AED and its accessories cannot be sterilized Authorized service The AED has no user serviceable internal components The user is responsible for changing batteries and defibrillation pads only Try to resolve any maintenance issues with the AED by using the infor mation in Chapter 5 Troubleshooting If you are unable to resolve the problem contact Cardiac Science Technical Support or outside the U S your local representative Return the AED for service if the AED experiences a fall that could cause internal damage Note Unauthorized disassembly modification or service of the AED voids the warranty Powerheart G5 Automated External Defibrillator A RescueCoach Voice and Text Prompts Contents OD Start UD gt y y 2525y M tested scene na sieeve eee A 1 Pads Dlacemle nis Eku a HAN iw e kale l A 2 D Pads DIO OS onina A 3 AAI SIS on nE E MO 0 a e ONA RN A nd A 3
42. number XELAEDO01 Energy pediatric pads model number XELAEDOO3 Shock times Automated self tests Audible alerts Indicators USB port communication Escalating energy from 22 J to 82 J e Initiation of rhythm analysis to ready to shock 15 seconds typical 45 seconds maximum With a fully charged battery e 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 e Lid open to ready to shock 15 seconds typical With a battery that has been used for 15 shocks Post CPR to ready to shock 10 seconds typical With these conditions Post CPR begins after the Stop CPR prompt is given English is the selected language semi automatic AED detects persistent VF new unused battery is attached to the AED e Daily Battery pads internal electronics but tons e Weekly every 7 days Battery pads CPR feed back device accelerometer internal electronics buttons high voltage circuit standard tests partial energy charge cycle e Monthly every 28 days Battery under load pads CPR feedback device accelerometer in ternal electronics buttons high voltage circuit advanced tests full energy charge cycle e Voice prompts e Maintenance alerts Battery status e Check pads Rescue Ready e Service e Text display Event download device data configuration and maintenance 70
43. o deliver therapy to the patient Service indicator Lights when the AED detects a need for maintenance or service Powerheart G5 Automated External Defibrillator About the AED Defibrillation pads The AED comes with defibrillation pads installed Pads are stored in a ready to use sealed package The preinstalled pads are for use with adults and children 8 years and older or over 55lbs If the child appears younger or lighter do not delay treatment to determine the child s exact age or weight use the preinstalled pads Pads are self ad hesive with an attached cable and connector for power and ECG transmission Pads are disposable discard after use in a rescue The pads have a limited shelf life and should not be used beyond the expiration date Always keep a fresh unopened pair of pads plugged into the AED The AED can identify the pad type and expiration date The AED is compatible with these types of pads XELAEDOO defibrillation pads XELAEDOO2 defibrillation pads with CPR feedback device XELAEDOO3 pediatric defibrillation pads When the patient is 8 years of age or younger or weighs 25 kg 55 Ibs or less use the AED with pediatric defibrillation pads if available See the instructions for use accompanying pediatric pads to replace preinstalled pads with pediatric pads DO NOT delay therapy to determine the patient s exact age or weight Contact Cardiac Science Customer Care to order replacement pa
44. ommunicating with an older AED with the version of AED Manager included with this new AED there may be features described in this manual that cannot be used The software in most cases will give an error message when incompatibilities occur Description The AED is protected against access to hazardous parts by dust and the effects of water projected by jets in accordance with IEC 60529 Battery capacity indicator LEDs show the remaining battery capacity 100 75 50 25 0 red only Service Indicator indicates AED requires service by authorized service personnel Defibrillation Pads indicator Indicates that the pads are incorrectly connected or unusable Check the connection with the AED check the placement and attachment to the patient If connections are correct replace pads Shock button and indicator When the Shock indicator is lit press this button to deliver a defibrillation shock Rescue Ready indicator A red indicator means the AED requires operator attention or maintenance and is not Rescue Ready Rescue Ready indicator A green indicator means the AED is Rescue Ready 70 01704 01 B Symbol Description Manufacturer Date of manufacture year month and day LE YYYY MM DD Use pads by the date shown Latex free Not made with natural rubber latex Coll a Not made with natural rubber latex Disposable Single patient use only Tear here to open if Do not
45. ompliance If it is necessary to use the AED adjacent to or stacked with other equipment then observe the AED to verify normal operations WARNING Possible improper delivery of therapy If practical move the patient to a firm surface before attempt ing arescue We do not recommend that the CPR Feedback Device be used if the patient cannot be moved onto a firm surface WARNING Patient injury Do not place the CPR feedback device on an open wound WARNING Electromagnetic compatibility Use of accessories or cables other than those specified with the exception of accessories and cables sold by Cardiac Science Corporation as replacement parts for internal components may result in increased emissions or decreased immunity of the AED 70 01704 01 B gt gt gt gt P P P p WARNING Possible interference 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 breathing normally The AED has pacemaker detection and rejection however with some pacemakers the AED may not advise a defibrillation shock Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 When placing pads Do not place the pads directly over an implanted device Place the pad at least one inch from any implanted device WARNING Do not reuse pads Used pads may not adhere properly to the patien
46. ot applicable 12 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be deter mined using the equation applicable to the frequency of the transmit ter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 has been incorporated into the formula used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Powerheart G5 Automated External Defibrillator 800 MHz to 2 5 GHz d 2 3 VP 0 23 0 73 2 3 7 3 23 70 01704 01 B Electromagnetic Emissions Standards Compliance 70 01704 01 B Powerheart G5 Automated External Defibrillator E Waste Electrical and
47. other part of the device However the condition has no immediate effect on the ability to continue with a rescue Powerheart G5 Automated External Defibrillator Enter Diagnostic mode for more informa tion If you cannot resolve the issue contact Cardiac Science Technical Support or your local representative 70 01704 01 B Troubleshooting Diagnostic mode messages Diagnostic mode provides detail on the maintenance and service conditions of the AED For example if the AED is not Rescue Ready diagnostic mode displays additional information about the status To enter Diagnostic mode Press and hold both buttons on the AED display panel for three seconds sen The following prompts appear when the AED is in Diagnostic mode Use the table to resolve the reported conditions Text display Voice Line 1 prompt Line 2 Situation Resolution Diagnostic DIAGNOSTIC MODE The AED enters Diagnostic mode Not applicable Mode SERVICE REQUIRED CONTACT TECH SUPPORT EXTREMELY LOW BATTERY The AED detects a condition that can prevent the AED from continuing a rescue Contact Cardiac Science Technical Support or your local representative immediately The battery charge is too low to support a rescue REPLACE BATTERY MAINTENANCE REQUIRED CONTACT TECH SUPPORT TEMP TOO HOT ADJUST STORAGE TEMP TEMP TOO COLD ADJUST STORAGE TEMP BATTERY LOW CHECK BATTERY The AED detects a condition that has no negative effect o
48. r responsibility Upon completion of the repair the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days Outside the US contact your local Cardiac Science representative This warranty gives you specific legal rights and you may also have other rights which vary from state to state Powerheart G5 Automated External Defibrillator Notes Powerheart G5 Automated External Defibrillator 70 01704 01 B Notes 70 01704 01 B Powerheart G5 Automated External Defibrillator Notes Powerheart G5 Automated External Defibrillator 70 01704 01 B Cardiac Science Corporation N7 W22025 Johnson Drive Waukesha WI 53186 USA e 262 953 3500 US toll free 800 426 0337 Fax 262 953 3499 care cardiacscience com Technical Support US Fax 262 798 5236 techsupport cardiacscience com International internationalservice cardiacscience com Cardiac Science the Shielded Heart logo Powerheart STAR Intellisense Rescue Ready RescueCoach and RHYTHMx are trademarks of Cardiac Science Corporation Copyright 2015 Cardiac Science Corporation All Rights Reserved 70 01704 01 B CARDIAC SCIENCE
49. recharge battery Lithium sulfur dioxide For use by or on the order of a Physician or R ONLY persons licensed by state law O Do not incinerate or expose to open flame 122 F ag NS Upper and lower temperature operating range or 0 C storage range limits SN Serial Number 70 01704 01 B Description Product model number Lot number Dispose of properly in accordance with all state province and country regulations Recycle cardboard according to local law Waste Electronic Electrical Equipment WEEE Separate collection for waste electrical and electronic equipment For more information see Manufacturer s WEEE compliance instructions on page E 1 Waste Electronic Electrical Equipment WEEE containing lead Separate collection for waste electrical and electronic equipment Box stacking limit Fragile handle with care Keep dry Relative humidity Relative pressure UN symbol Packaging is manufactured to conform to United Nations requirements MR Unsafe The AED should not be used or stored in an MRI suite Powerheart G5 Automated External Defibrillator 4 AED Features Contents Dual languages 4k a nane ne n a a Kl E eb S r di 4 1 Prompting levels cuiar an Ende a 4 1 CPR behavior types s sssesssessseesseesseesseesseesseesseesseesseeoseesseeoseeoseeosees 4 2 AED device history and rescue data recording 4 2 A
50. rillation shock current flowing through unwanted path ways is potentially a serious electrical shock hazard To avoid this hazard during defibrillation abide by all of the following Do not use in standing water or rain Move patient to a dry area Do not touch the patient unless performance of CPR is indicated Do not touch metal objects in contact with the patient Keep defibrillation pads clear of other pads or metal parts in contact with patient Disconnect all non defibrillator proof equipment from the patient before defibrillation WARNING Battery is not rechargeable Do not attempt to recharge the battery Any attempt to re charge the battery may result in an explosion or fire hazard WARNING Shock hazard Do not disassemble or modify the AED Failure to observe this warning can result in personal injury or death Refer service issues to Cardiac Science authorized service personnel Note Unauthorized disassembly modification or service of the AED voids the warranty WARNING Possible radio frequency RF susceptibility Do not use the AED in locations where large electromagnetic or RF fields can be expected to occur Refer to Chapter D Electromagnetic Emissions Standards Com pliance for additional information WARNING Improper equipment placement Position the AED away from other equipment in accordance with information in the electromagnetic compliance tables see Appendix D Electromagnetic Emissions Standards C
51. s CPR Give CPR as instructed GIVE COMPRESSIONS Prompts rescuer to prepare to provide compressions X X AND BREATHS and breaths CPR Place heel of one hand on cen PLACE ONE HAND ON Prompts rescuer to put one hand in the correct place X X ter of chest between nipples CENTER OF CHEST for giving compressions Place heel of other hand PLACE OTHER HAND Prompts rescuer to position the other hand for giving X X directly on top of first hand ELBOWS STRAIGHT compressions Lean over patient with elbows straight Press the patient s chest down PRESS CHEST DOWN Prompts the rescuer to press down one third the X rapidly one third the depth of FIRMLY depth of the patient s chest chest then release Give patient 30 rapid 30 COMPRESSIONS Prompts rescuer to give compressions and breaths X X compressions and 2 breaths 2 BREATHS Start CPR START CPR Prompts the rescuer to start CPR X X Start Compressions START COMPRESSIONS Prompts the rescuer to start compressions only CPR X X Press CPR countdown timer The CPR countdown timer on the display shows the X X or amount of time remaining for a CPR session See The voice prompt or metronome paces the speed of No prompt silence compressions given by the rescuer Stop Compressions STOP COMPRESSIONS Prompts at the end of each CPR set X X Give breath GIVE Prompts the rescuer to give breath to the patient X X BREATH Continue with Compressions CONTINUE WITH Prompts in subsequent sets of
52. s opened to perform a rescue Replace the battery before continuing with and the battery charge is low the rescue If the battery charge is com The battery charge is too low to support a rescue Piste See cheapie aan dill Additionally the following occur The Rescue Ready indicator turns red The AED beeps once every 30 seconds Open lid to OPEN LID The lid is closed during a rescue The prompt repeats Ensure that the AED lid is fully open continue TO CONTINUE RESCUE for 15 seconds rescue Make sure pad CHECK CONNECTOR The defibrillation pads have become disconnected Ensure that the pads are securely plugged connector is IS PLUGGED INTO AED from the AED in to the AED Resume the rescue plugged into AED Service Re SERVICE REQUIRED The AED detects a condition that can prevent the Contact Cardiac Science Technical Support quired Contact CONTACTTECHSUPPORT AED from continuing a rescue or your local representative immediately ee For example this condition may occur after a self test Support Maintenance required Continue Rescue MAINTENANCE REQUIRED CONTINUE RESCUE determines that the AED is not functioning properly This prompt plays when the lid is opened The red Service indicator illuminates The prompt repeats until you close the lid After the lid is closed an alarm beep sounds until the battery is removed or is depleted During a rescue the AED detects a condition with the defibrillation pads the internal electronics or an
53. section Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you the patient or the AED Indications for use The Powerheart G5 Automated External Defibrillator AED is intend ed to be used by persons who have been trained in its operation The user should be trained in basic life support or other physician autho rized emergency medical response An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally Post resuscitation if the patient is breathing the AED should be left attached to allow for acquisition and detection of the ECG rhythm If a shockable ventricular tachyar rhythmia recurs the device will charge automatically and advise the operator to deliver a shock or for an automatic AED automatically deliver a shock if needed When a patient is a child up to 8 years of age or up to 25kg 55 Ibs the AED should be used with the Pediatric Defibrillation Pads The therapy should not be delayed to determine the patient s exact age or weight The optional CPR feedback device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older or who weigh more than 25 kg 55 Ibs Operator Training Persons a
54. starts this prompt will be skipped This prompt will be interrupted when pad is peeled Firmly place the pad without PRESS PAD FIRMLY Prompts the rescuer to place one pad on the patient X X the blue plastic on patient s TO CHEST AS SHOWN bare chest exactly as shown on pads Firmly place the pad on the PRESS PAD FIRMLY Prompts the rescuer to place one pad on the patient patient TO CHEST This pad can be placed on PLACE PAD ON Prompts the rescuer to place one pad on the patient X either of the two locations as EITHER LOCATION shown on pads Next peel second white PEEL SECOND PAD Prompts the rescuer to remove second pad from the X X pad from the blue plastic FROM BLUE PLASTIC blue plastic Firmly place the second pad PRESS PAD FIRMLY Repeats until second pad placement is sensed If the X X on the other location exactly as shown on pads Firmly place the second pad on the other location 70 01704 01 B AS SHOWN PRESS PAD FIRMLY AS SHOWN pad is placed before prompt starts then this prompt will be skipped This prompt will be interrupted when second pad is placed Repeats until second pad placement is sensed If the pad is placed before prompt starts then this prompt will be skipped This prompt will be interrupted when second pad is placed Powerheart G5 Automated External Defibrillator RescueCoach Voice and Text Prompts Table A 3 Pads prompts Text display Prompt level Line 1 Voice prompt Line 2 Situatio
55. story and rescue data recording The AED can store up to 90 minutes of data in its internal memory When downloading data you can select what data to download See the AED Manager User s Guide for more information AED Manager software With AED Manager software you can Review rescue data and information See the current status of the AED and the status of the AED at the time of a rescue Archive all data for later review Review AED maintenance and diagnostic messages Configure settings and rescue protocol Powerheart G5 Automated External Defibrillator 5 Troubleshooting Contents Sell T 5i5 4 lt Kine naye Kane ninne A e er A Ke r a We 5 1 Troubleshooting of indicators sssesssesesesssessseesseesseesseesseeoseessees 5 2 Maintenance and Service MESSAGES csscesesssscesssesessesesesesees 5 3 lt Diagnostic mode MESSAGES scsssssesssssseescssssssesceescssseeseeseseeees 5 4 This section presents information about AED diagnostics self tests troubleshooting of indicator lights and descriptions of maintenance and diagnostic messages Self tests The AED has a comprehensive self test system that automatically assesses the electronics battery state defibrillation pads and high voltage circuitry The AED runs automatic self tests at regular time intervals The daily self test checks the battery pads and the electronic components The weekly self test completes a par
56. t 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 WARNING AED may not be rescue ready Keep a battery attached to the AED at all times so that the AED is available to perform rescues WARNING Pediatric pads statement Connect pediatric pads only when attempting a pediatric res cue Upon completion of the rescue reconnect the preinstalled pads Model number XELAEDOO01 prior to placing the AED back into standby mode WARNING CPR feedback device not for use on children The CPR feedback device used with XELAED002 defibrillation pads must not be used on children under 8 years of age or under 55lbs The XELAEDO0O2 defibrillation pads may be used without the CPR feedback device CAUTION Restricted use U S Federal law restricts this device to be sold by or on the order of a physician or practitioner licensed by state law in which he she practices to use or order the use of the device CAUTION Temperature extremes Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly CAUTION Battery handling and operation Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged Do not drop the battery CAUTION Battery disposal
57. t 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 AED is used exceeds the applicable RF compliance level above the AED should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the AED 70 01704 01 B Powerheart G5 Automated External Defibrillator Electromagnetic Emissions Standards Compliance Recommended separation distances between portable and mobile RF com munications equipment and the AED The AED is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AED as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter m Lu 150 kHz to 80 MHz outside 150 kHz to 80 MHz in ISM 80 MHz to 800 MHz ISM bands bands d 1 2 JP 0 01 Not applicable Not applicable 0 12 0 1 Not applicable Not applicable 0 38 1 Not applicable Not applicable 1 2 10 Not applicable Not applicable 3 8 100 Not applicable N
58. t instructions that guide the rescuer through the entire defibrillation process Note Not all configurations described in this document are available in all areas Powerheart G5 Automated External Defibrillator 70 01704 01 B About the AED AED parts Pad expiration window Lid Latch press to open AED is not Rescue Ready assesses the AED battery and pads to ensure they are ready to perform a rescue The display panel Information display Number of shocks delivered 4 Rescue timer Rescue prompts and CPR countdown timer Function buttons Press to enter diagnostic mode or to change the prompt language 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 off and the red LED lights replace the battery 70 01704 01 B Battery compartment on bottom AED is Rescue Ready Rescue Ready technology IOCKS 1 00 00 TO TOUCH PATIENT Rescue Ready status indicator Pad package holders Speaker Pad socket USB port Display details below Defibrillation pads indicator Lights when the pads are improperly connected to the AED cold dried or damaged detached from the patient during a rescue NOW SAFE Shock button semi automatic model only Lights red when the AED is ready to deliver a defibrillation shock Press t
59. t output lines IEC 61000 4 4 Surge 1 kV differential mode Not applicable IEC 61000 4 5 2 kV common mode Powerheart G5 Automated External Defibrillator 70 01704 01 B Electromagnetic Emissions Standards Compliance Compliance Electromagnetic Immunity test IEC 60601 test level level enviroment guidance Voltage dips short lt 5 U Not applicable interruptions and gt 95 dip in U voltage variations for 0 5 cycle par lina PY 40 U p 60 dip in U 61000 4 11 for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Power frequency 3 A m 80 A m Power frequency magnetic fields should be at levels no 50 60 Hz magnetic higher than those characteristic of a typical location in field typical heavy industrial and power plants and the control IEC 61000 4 8 rooms of H V substations Note U is the a c mains voltage prior to application of the test level Conducted RF 3 Vrms Not Applicable IEC 61000 4 6 150 kHz to 80 MHz outside ISM Not bandsa Applicable 10Vrms 150 kHz to 80 MHz in ISM bandsa Radiated RF 10V m 10V m Portable and mobile RF communications equipment IEC 61000 4 3 80 MHz to 2 5 GHz should be used no closer to any part of the AED including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is t
60. the same CPR session X X COMPRESSIONS Stop CPR STOP CPR Prompts the rescuer to stop CPR X X Continue with CPR CONTINUE CPR Prompts the rescuer to continue CPR X X Powerheart G5 Automated External Defibrillator 70 01704 01 B RescueCoach Voice and Text Prompts Table A 8 CPR feedback device optional Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Remove green square package REMOVE GREEN SQUARE Prompts at the beginning of a CPR session The green X X from lid of AED PACKAGE FROM AED LID package contains the CPR device Tear open green package and TEAR OPEN PACKAGE Prompts to remove the CPR device X X remove CPR device REMOVE CPR DEVICE Place CPR device on center PLACE DEVICE ON Prompts rescuer to put the CPR device in the correct X X of patient s chest between CENTER OF CHEST place for giving compressions nipples Place heel of one hand on CPR PLACE ONE HAND ON Prompts rescuer to place one hand on the CPR X X device CPR DEVICE device Press Slower PRESS SLOWER If the rescuer is giving compressions too fast prompts X X X to slow the rate Press Faster PRESS FASTER If the rescuer is giving compressions too slowly X X X prompts to quicken the rate Press Softer PRESS SOFTER If the rescuer is giving compressions that are too X X X deep prompts to lessen the depth Press Harder and fully release PRESS HARDER If the rescuer is giving compressions that are too X X X FULLY RELEASE shallow promp
61. tial charge of the high voltage electronics circuitry in addition to the items tested in the daily self test The monthly self test charges the high voltage electronics to full energy in addition to the items tested in the weekly self test Powerheart G5 Automated External Defibrillator Note If the AED lid is opened during one of these periodic self tests testing stops A subset of the self tests is also run each time the lid of the AED is closed When performing a self test the AED 1 Turns the Rescue Ready indicator red 2 Automatically performs the appropriate self test 3 Shows the Rescue Ready status If the test is successful the Rescue Ready status is green e If the AED detects an error the Rescue Ready indicator remains red A beep sounds every 30 seconds Note When the lid of the AED is opened one or more indicators on the AED display panel may remain lit and service messages may appear on the display To troubleshoot these conditions see the sections in this chapter 70 01704 01 B Troubleshooting Troubleshooting of indicators Use this table to troubleshoot the AED if an indicator is lit Important Do not delay calling emergency medical services and delivering CPR even if the AED cannot assist with the rescue Indicator Symptom Resolution Rescue Ready status indicator is red and the service indicator is NOT lit Both the Rescue Ready status indicator and the service indicator are r
62. tomatic model Press the Shock button If you do not press the Shock button within 30 seconds of hear ing the prompt the AED disarms the charge and prompts you to start CPR Wait for the next prompt Begin CPR Powerheart G5 Automated External Defibrillator Ensure that the lid is fully open Ensure that pads are firmly placed on clean dry skin Ensure that the connector is plugged properly into the AED Remove the electronic device or stop the excessive motion When the AED is charged it continues to analyze the patient s heart rhythm If the rhythm changes and a shock is no longer needed the AED prompts Rhythm Changed Shock Cancelled 70 01704 01 B Steps to a Rescue 6 Give CPR After the AED delivers a shock or detects a non shockable rhythm it enters CPR mode When the AED prompts Do this If needed perform CPR as instructed Perform CPR according to the prompts Follow the countdown timer on the text display Important If the AED is not operating as expected it is preferable to perform CPR without the aid of the AED than to delay providing CPR After the CPR time expires the AED returns to the ECG analysis mode see 4 Analyze the ECG on page 2 3 If the patient is conscious and breathing normally leave the pads on the patient s chest and connected to the AED Make the patient as comfortable as possible and wait for emergency medical services EMS personnel
63. ts to use more effort and release all pressure when moving hands up 70 01704 01 B Powerheart G5 Automated External Defibrillator RescueCoach Voice and Text Prompts Table A 9 Data transfer Text display Prompt level Line 1 Voice prompt Line 2 Situation Adv Std Bas Communications mode COMMUNICATIONS MODE Played when AED enters Communications mode X X X DO NOT DISCONNECT Prompts when data is transferred between the AED X X X USB and the flash drive Disconnecting the flash drive can corrupt the data being transferred SAFE TO REMOVE Prompts after the data transfer completes Remove X X X USB the flash drive UPDATING LANGUAGE Updating the text and audio prompts as part of a X X X software upgrade using the flash drive VERIFYING LANGUAGE The AED is verifying that the text and audio prompts X X X in the flash drive are valid or that they are installed properly UPDATING SOFTWARE Updating the operating software X X X VERIFYING SOFTWARE The AED is verifying that the operating software is X X X installed properly PROMPT TEXT UPDATE After a language update the AED determines that the X X X FAILED update was not installed properly Contact Technical Support or your local representative for help SOFTWARE UPDATE After a software update the AED determines that the X X X FAILED update was not installed properly Contact Technical Support or your local representative for help UPGRADE ERROR There is a problem with the software upgrade X X
64. uthorized to operate the AED should have the following training e Appropriate training as required by state province or country regulations e Additional training as required by the medical director e A thorough understanding of the procedures in this manual Note Keep valid certificates of training and certification as required by state province or country regulations Powerheart G5 Automated External Defibrillator Safety alert descriptions The symbols shown below identify potential 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 may cause serious personal injury or death CAUTION This alert identifies hazards that may cause minor personal injury product damage or property damage Warnings and cautions This section lists general warnings and cautions CAUTION Read these Instructions for Use carefully It contains information about your safety and the safety of others Become familiar with the controls and how to use the AED properly before operating the product DANGER Fire and explosion hazard To avoid possible fire or explosion hazard do not operate the AED In the presence of flammable gases In the presence of concentrated oxygen In a hyperbaric chamber 70 01704 01 B Safety A A gt gt WARNING Shock hazard Defib
65. x C ECG Analysis Algorithm and Rescue Waveform RHYTHMx AED EGG analysis algorithm C1 FRESCO GS Protocole ns nel ayak u k W yA a e SAN C1 STAR biphasic waveform sssssssessssssssscsecsesesscsesesscseseesesesseseseescseseesessesesesseees C 1 Appendix D Electromagnetic Emissions Standards Compliance Guidance and manufacturer s declaration electromagnetic EMISSIONS scsssssessscecsssssecsssesscssceessseseesssecssseseesssesesseescess D 1 Guidance and manufacturer s declaration electromagnetic IMMUNITY y na wa mi kak ik lh D 1 Recommended separation distances between portable and mobile RF communications equipment and the AERP D 3 Appendix E Waste Electrical and Electronic Equipment WEEE Directive Compliance Manufacturer s WEEE Compliance instructions EEEEereere E 1 Appendix F Limited Warranty OE ROW OIG sr xeyl enoe KU lene NA b y s DD die e seye K NA F 1 Wat kel a al C a e e SAW E DN DR E N a A a a F 1 What we willi GO Sc Kiye b ene o N K eres a Ka WW De WO u NYE F 1 Obligations and warranty limits se sssesssessessseessseessecsseesseesseessseeosseesseessse F 1 What this warranty does NOt COVES sesessssesssessseessseesseesserosseesseessseosseesseesss F 2 This limited warranty iS void if es ssseessssesssseesssseesssecoss
66. y 4 years Shelf life is the length of time a battery can be stored prior to installation into an AED without significantly affecting its operating life The battery operating life depends on the type of battery device settings actual usage and environmental factors The number of shocks is estimated at a 300 VE energy level with a three shock stack followed by 60 seconds of CPR using Basic prompt settings between each set of shocks 70 01704 01 B Technical Data Ba 70 01704 01 B Powerheart G5 Automated External Defibrillator ECG Analysis Algorithm and Rescue Waveform Contents RHYTHMx AED EGG analysis algorithm C1 Rescue protocol assis Kad dR la A a b n N C1 STAR biphasic waveform ccecsesessssssssscseseseescscsseseseseeseseseeseseaeees C1 This section describes the ECG analysis algorithm and Star Biphasic waveform RHYTHMx AED ECG analysis algorithm The RHYTHMx AED ECG analysis algorithm provides extensive ECG detection capabilities All ventricular fibrillation VF are classified as shockable Asystole is separated primarily by amplitude ECG rhythms of low amplitude are classified as asystole and are not shockable The AED detects noise artifacts in the ECG form generated from for example movement of the patient adjustment of the defibril lation pads or electronic noise from external sources The analysis is delayed or

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