Powerheart AED G3 Plus Instructions for Use
Contents
1. CARDIAC J science CE Em Cardiac Science Corporation 0086 3303 Monte Villa Parkway MDSS GmbH Bothell WA 98021 USA Schiffgraben 41 800 426 0337 U S A and Canada D 30175 Hannover 425 402 2000 Germany techsupport cardiacscience com 49 511 62 62 86 30 www cardiacscience com FAX 49 511 62 62 86 33 ii 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Contents Chapter 1 Product Information and Safety Indications for WSe esseeri n r aiana 1 2 Warranty Information ccscccssssccessscesessecessseesseecees 1 3 Cleaning and Cainer inn oan raD 1 4 Safety Alert Descriptions s sssessssesssssssessrssessressrsseesees 1 5 Warnings and Cautions sssssessssessssssesesssseressssrressss 1 6 Symbols and Labels s ccsssccssssccessssessseccesseteeseee 1 11 Chapter 2 About the AED AED DeScription sensira ssis n n sess 2 2 AED Modes erseearee seer eenen aeea EEE ELE ENEAS 2 3 AED Patt ioniene e E N ES 2 4 IntelliSense Battery cccccssssccccessssececcssseeeeeeeesnaees 2 5 Battery Operating Life ecsecssceeseceseeceteeeeeees 2 6 Battery Shelf Life ccccccccsseccsssscecssecessesseeeeeees 2 6 Battery Installation ccccsssscccsssssscceccsssseceeeeeees 2 6 Defibrillation Pads c c cccsscccessecessseccessceessseeesesseeeens 2 8 Pad Installation oiis eneee eE Eai ESE 2 8 Directions for Use cs ccccsscccssstssssesccesseeessssees 2 92. Analysis interrupted Stop patient motion The AED restarts the analysis Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 7 Perform a Rescue Step 5 Deliver a Shock When the AED prompts Preparing shock Move away from the patient Do this Ensure that no one is touching the patient For the Powerheart AED G3 When the AED is ready to deliver a defibrillation shock the Shock button flashes Press red flashing button to deliver shock 1 Ensure that no one is touching the patient 2 Press the Shock button If you do not press the Shock button within 30 seconds of hearing the prompt the AED disarms the charge and prompt you to start CPR For the Powerheart AED G3 Automatic Shock will be delivered in three two one The AED delivers a shock Ensure that no one is touching the patient After the AED delivers the defibrillation shock Shock delivered It is now safe to touch the patient 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 and then prompts you to start CPR 3 8 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Step 6 Administer CPR Step 6 Administer CPR y After the AED delivers a shock or detects a N non shockable rhythm
3. Behind blue rubber data access cover Pad holders Speaker Electrode connector SHOCK button 9390E only 2 4 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Intellisense Battery Intellisense Battery gt bP PB The IntelliSense battery automatically stores important usage information enabling the battery to maintain a complete history of its operating life The battery history can be reviewed using RescueLink software Dispose of the battery according to local regulations Warning Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard Caution Lithium Sulfur Dioxide Battery Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged Caution Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal state and local laws To avoid fire and explosion hazard 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 cause the AED to function improperly during a rescue Caution Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance No
4. PEEL SECOND PAD OFF BLUE PLASTIC LINER Prompts the rescuer to remove the liner from the second pad Firmly place the second pad on the opposite PRESS PAD FIRMLY Repeats until second pad placement is sensed If the pad is placed before prompt starts then this prompt location exactly as AS SHOWN will be skipped This illustrated prompt will be interrupted when second pad is placed Table 2 4 Analysis Voice Prompt Text Display Situation Do not touch patient Analyzing wait DO NOT TOUCH PATIENT heart rhythm Please ANALYZING RHYTHM Repeats until analysis of the patient s cardiac rhythm is completed This prompt will be interrupted when ready to shock Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 15 About the AED Table 2 4 Analysis Voice Prompt Text Display Preparing shock Move away from the patient NO CONTACT WITH THE PATIENT Situation Repeats while the AED is preparing to deliver a defibrillation shock charging Table 2 5 Delivering Shock Semi Automatic Voice Prompt Text Display Press red flashing button to deliver shock PRESS BUTTON Situation Prompts after the AED is fully charged and ready to deliver the defibrillation shock The RED TO DELIVER SHOCK SHOCK indicator flashes and the phrase repeats for 30 seconds or until the SHOCK button is pushed Shock Delivered SHOCK D
5. Place heel of one hand on center of chest between nipples PLACE ONE HAND ON CENTER OF CHEST Prompts rescuer to correctly place one hand for giving compressions Place heel of other hand directly on top of first hand Lean over patient with elbows straight PLACE OTHER HAND ON TOP OF FIRST HAND Prompts rescuer to correctly place other hand and body for giving compressions Press the patient s chest down rapidly one third depth of chest then release PRESS CHEST DOWN FIRMLY Prompts the rescuer to press down one third depth of patient s chest Start CPR Powerheart Automated External Defibrillator 9390A and 9390E START CPR Prompts to start CPR 112 0038 201 A 2 17 About the AED Table 2 7 CPR Prompts continued Voice Prompt Text Display Press 30 times at 100 minute or Metronome 30 times at 100 minute CPR COUNTER or No prompt silence Note Option is selected in MDLink software Situation CPR counter shows the amount of time remaining for the CPR session Stop compressions STOP COMPRESSIONS Prompts at the end of each CPR round Give breath give Prompts to give two breath SIVE BREATH breaths to patient Prompts in subsequent rounds of the same CPR Continue with CONTINUE WITH session compressions COMPRESSIONS Note This prompt is available only in Enhanced Mode Stop CPR S
6. If service is required the service indicator illuminates Note When the last battery indicator is red the battery is low Replace the battery right away A new battery typically takes 10 seconds to charge the AED to maximum energy Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 7 About the AED Defibrillation Pads Defibrillation pads come already installed in the AED They are stored in a ready to use sealed package containing one pair of self adhesive pads with an attached cable and connector The pads are disposable and should be discarded after a rescue The pads have a limited shelf life and should not be used beyond the expiration date Keep a fresh unopened pair of pads plugged into the AED at all times After an AED self test an audible and visual alert indicates that the pads are missing unplugged or damaged Pad Installation To install the pads 1 Open the lid of the AED 2 Place the pad package into the lid so that the expiration label is visible through the window on the lid 3 Match the color of the connectors red to red then plug the pad connector into the AED case Once the pad connector is plugged in the PAD indicator should extinguish 4 Store the excess cable length in the bottom holder With the pad package secured to the AED lid close the lid 5 Make sure the expiration date is visible through the window of the lid and ensure that the status indic
7. 201 A Powerheart Automated External Defibrillator 9390A and 9390E Step 2 Prepare the Patient Step 2 Prepare the Patient When the AED prompts Do this 1 Open the AED lid 2 Wait until the LEDs illuminate Stay calm Follow these voice instructions Make sure 911 is called n now Begin by exposing the patient s bare chest and torso Remove or cut clothing if needed 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 Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 5 Perform a Rescue Step 3 Place Pads When the AED prompts Do this 1 Keeping the pads connected to the When patient s chest and torso are AED tear open the package exposed remove square foil package 2 from lid of AED Tear open foil package across dotted line and remove pads Leave the package attached to the pad wires Remove the pads from the package 3 With a firm steady pull peel one pad Next separate one of the white pads away from the completely from blue plastic liner blue plastic Begin peeling from the tabbed liner corner It does not matter which pad to use 4 Place the pad on the bare a Firmly place the pad without the liner upper chest on the patient exactly as illustrated as shown This pa
8. 3 2 Step 1 Assess the Patient 3 4 Step 2 Prepare the Patient 3 5 Step 3 Place Pads 3 6 Step 4 Analyze the ECG 3 7 Step 5 Deliver a Shock 3 8 Step 6 Administer CPR 3 9 Step 7 Prepare the AED for the Next Rescue3 11 This section presents information about how to use the AED to perform a rescue These are the general steps in performing a rescue Assess the patient Prepare the patient Place the defibrillation pads Analyze the patient s ECG Deliver a defibrillation shock Administer CPR Cy Gt Pee a Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 1 Perform a Rescue Warnings and Cautions A A gt gt gt 3 2 These warnings and cautions must be observed to prevent problems during a rescue DANGER Fire and Explosion Hazard Do not use in the presence of flammable gasses including concentrated oxygen to avoid possible explosion or fire hazard WARNING Shock Hazard Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard To avoid this hazard during defibrillation abide by all of the following 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 defibrillati
9. LED illuminates To continue the rescue leave the lid open remove the battery and replace with a fresh battery If battery replacement takes longer than 60 seconds the first rescue terminates and a second rescue begins when the battery is inserted Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 11 About the AED Pads Indicator An illuminated Pads LED indicates one of these conditions Pads improperly connected to the AED Pads not within operational specifications cold dried damaged Pads disconnected from the patient during a rescue Service Indicator The Service LED illuminates when the AED requires maintenance to be performed by qualified service personnel Shock Indicator For the Powerheart G3 model 9390E only The AED has a single button the Shock Continue button The word Shock and the shock button indicator LED illuminates red when the AED is ready to deliver a defibrillation shock to the patient SHOCK 2 12 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Text Display Text Display The text display has two lines of text The text display provides information about system initialization text prompts and data during a rescue and diagnostics SHOCKS 0 00 22 SHOCKS 0 00 22 PRESS PAD FIRMLY AS SHOWN When the lid is opened the text display shows version identifiers for the internal code voice prompts and text prompts The text display
10. Make the patient as comfortable as possible and wait for Emergency Medical Services EMS personnel to arrive Continue to follow the voice prompts until the EMS personnel arrive or proceed as recommended by the medical director 3 10 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Step 7 Prepare the AED for the Next Rescue Step 7 Prepare the AED for the Next Rescue After transferring the patient to EMS personnel prepare the AED for the next rescue 1 Retrieve the rescue data stored in the internal memory of the AED Use RescueLink software installed on a PC Connect a new pair of pads to the AED Close the lid Verify that the status indicator on the AED handle is green m EOS Key RESCUE READY Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 11 Perform a Rescue a 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E 4 Maintenance and Troubleshooting What s in this chapter Indicator Troubleshooting Table 4 2 Cleaning and Care 4 4 Scheduled Maintenance 4 5 Authorized Repair Service 4 7 This section presents information about the AED diagnostics self tests maintenance and service indications Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 4 1 Maintenance and Troubleshooting Indicator Troubleshooting Table The following is a troubleshooting table for the AED indicators Table 4 1
11. also shows the current date and time During a rescue the text display shows instructional prompts the number of shocks delivered and the elapsed time from the beginning of the rescue when the lid was first opened During CPR a countdown timer is displayed The text version of the voice prompts are also displayed Note There is a three second delay between the time the AED lid is opened and the start of the rescue This three second delay is not included in the elapsed rescue time Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 13 About the AED Voice Prompts and Text Display The voice prompts activate when the AED lid is opened and help guide the operator through a rescue The AED text display provides a visual display of most of the voice prompts These tables list the voice and text prompts and descriptions of when the prompts are issued Table 2 2 Initial Instructions Voice Prompt Stay calm Follow these voice instructions Make sure CALL 911 911 is called now Text Display Situation Plays after lid opening self test default ON Stay calm Follow these voice instructions Make sure CALL EMERGENCY Emergency Services are called now Table 2 3 Preparation Medical Director may use MDLink to select this prompt instead of CALL 9111 MDLink also allows the emergency services and 911prompt to be disabled SERVICES NOW Voice Pr
12. connected to the AED and functioning e Integrity of the internal circuitry is good Red The AED requires maintenance Audible Maintenance Indicator 2 10 112 0038 201 A When the daily weekly or monthly self test determines service is required the AED beeps every 30 seconds until the lid is opened or the battery power is depleted Opening and closing the lid may deactivate the beep If the error is not corrected by the next self test the AED begins beeping again Powerheart Automated External Defibrillator 9390A and 9390E AED Indicators Diagnostic Panel The diagnostic panel has these indicators 23 4 SmartGauge Battery Indicator Pads Indicator Service Indicator Shock Button Powerheart G3 model 9390E only kh WRD SmartGauge Battery Status Indicator The SmartGauge battery status indicator has five LEDs four green and one red The four green LEDs display the remaining capacity of the battery With use the green LEDs extinguish from right to left as battery capacity decreases When the red LED illuminates replace the battery Note When the red LED initially illuminates upon lid opening or at any time during a rescue a BATTERY LOW prompt appears However the AED is capable of delivering at least 9 more defibrillation shocks after the first BATTERY LOW prompt appears When the AED battery cannot deliver any more shocks BATTERY LOW appears on the text display and the red battery
13. for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing Post resuscitation if the victim is breathing 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 operator to deliver therapy G3 or automatically deliver the shock G3 Automatic When a patient is a child or infant up to 8 years of age or up to 55 lbs 25kg the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes The therapy should not be delayed to determine the patient s exact age or weight 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Warranty Information Warranty Information The AED limited warranty for defects in materials or workmanship is seven years from the date of purchase For the complete warranty statement see the warranty paper packaged with your AED or refer to the Operator and Service Manual on the Quick Start CD ROM Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 3 Product Information and Safety Cleaning and Care Keep system components clean Perform preventive maintenance as needed For information on cleaning and maintenance of components see Chapter 4 Maintenance and Troubleshooting 1 4 112 0038 201 A Powerheart Automated External Defibrillator 93
14. 01 A 1 9 Product Information and Safety CAUTION Equipment Malfunction mn Portable and RF communications equipment may affect the AED Always observe the recommended separation distances as defined in the EMC declaration tables CAUTION Equipment Malfunction N The AED requires special precautions regarding EMC Use the AED according to the guidelines of the EMC declaration tables 1 10 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Symbols and Labels Symbols and Labels The following symbols may appear in this manual on the AED or on its accessories Some of the symbols represent standards and compliances associated with the AED and its use Symbol Description A N Caution Consult accompanying documentation Dangerous 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 A Defibrillator Proof Type BF Equipment The AED when R 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 0086 requirements of the Medical Device Directive 93 42 EEC IP24 The AED is protected against the effects of splashing water in accordance with IEC 60529 Classified by ETL Semko with respect to electric shock fire MTERTe and m
15. 3303 Monte Villa Parkway 425 402 2000 Bothell WA 98021 techsupport cardiacscience com USA www cardiacscience com 112 0038 201A
16. 90A and 9390E Safety Alert Descriptions Safety Alert Descriptions The symbols shown below identify potential hazard categories The definition of each category is as follows WARNING A N This alert identifies hazards that may cause serious personal injury or death CAUTION AN This alert identifies hazards that may cause minor personal injury product damage or property damage Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 5 Product Information and Safety Warnings and Cautions AN AN gt gt gt 1 6 This section lists general warnings and cautions Those pertaining to specific functions and procedures are included in the text where appropriate DANGER Fire and Explosion Hazard Do not use in the presence of flammable gasses including concentrated oxygen to avoid possible explosion or fire hazard WARNING Shock Hazard Defibrillation shock current flowing through unwanted pathways 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 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 defibrillatio
17. 9390E 112 0038 201 A 2 1 About the AED AED Description The G3 Plus is a self testing battery operated automated external defibrillator AED The AED automatically analyzes the patient s electrocardiogram ECG through defibrillation pads applied to the patient s bare chest If a shock is required the AED advises the operator to press the button to deliver a shock The Powerheart AED G3 Automatic automatically delivers a shock if needed The AED uses a single button and guides the operator through the rescue using a combination of voice prompts audible alerts and visible indicators 2 2 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E AED Modes AED Modes Operating Mode Defined as having the battery installed and the lid open This is the mode the AED would be in during an actual rescue situation Standby Mode When the battery is installed but the lid is closed In this mode the AED is not being used in a rescue The device will conduct its routine self tests to ensure proper operation Storage Mode When the battery is removed such as during shipping or transport With the battery removed the AED is unable to perform self tests or rescues Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 3 About the AED AED Parts The following drawings show the AED parts and their locations Battery compartment Pad expiration window Serial communication port MA
18. AED Indicators ciessscssiescessetecedsetesesteetsveraesscceseesceesss 2 10 RescueReady Status Indicator ccccccssssseceeees 2 10 Audible Maintenance Indicator cccssccceeees 2 10 Diagnostic Panel sassoni eiedh Nice dees 2 11 SmartGauge Battery Status Indicator 06 2 11 Pads Indicato ieee ereere eeen EERE 2 12 Service Indicator cccccsssseccesscesessecceseeessseeeeseees 2 12 Shock Indicator 3 ssid nescence 2 12 PERE DISP lay AEE E E ES 2 13 Voice Prompts and Text Display ceeeeeeseceeeeees 2 14 Chapter 3 Perform a Rescue Warnings and Cautions cccsssccccsssssccecsssseeeceseees 3 2 Step 1 Assess the Patient cccessccessseeccesceeeseeeeeees 3 4 112 0038 201 A Contents iii iv Step 2 Prepare the Patient ccsseesseseseeesceeeeeeteees 3 5 Step 3 Place Pads visent msl cas ina itn 3 6 Step 4 Analyze the ECG ccccesccessecssseereeeeseeeteeeesees 3 7 Step 5 Deliver a Shock cescccssseesteserseeneceeeeeeeeeesees 3 8 Step 6 Administer CPR csccsssessteseseceeeeeseceeeeeaees 3 9 Step 7 Prepare the AED for the Next Rescue 3 11 Chapter 4 Maintenance and Troubleshooting Indicator Troubleshooting Table cccccceeseeeeeneees 4 2 Cleaning and Care c cccccecessscsesssccessccesssecceseeeeseseeees 4 4 Scheduled Maintenance sccssscssseseseeereceeeceeseceneees 4 5 Daily Maintenance oinera r 4 5 Monthly Maintenance ccccsscc
19. C The 9390 and pads conform to the applicable requirements of the following CE 0086 CE CE Marked by BSI 0086 per the Medical Device Directive 93 42 EEC W ETL Classified by ETL Semko with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 EN60601 1 and EN60601 2 4 Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 Electrical Construction Safety and Performance IEC 60601 1 1998 Amendments 1 1991 amp 2 1995 IEC 60601 2 4 2002 ANSI AAMI DF 39 1993 Electromagnetic Compatibility EMC IEC 60601 1 2 2001 IEC 60601 2 4 Section 36 ANSI AAMI DF 39 1993 Section 3 3 21 Emissions 5 4 112 0038 201 A EM EN 55011 CISPR 11 Group 1 Class B Magnetic ANSI AAMI DF39 lt 0 5mT on surface except for within 5cm of the lid magnet and the speaker Powerheart Automated External Defibrillator 9390A and 9390E Parameters Table 5 1 Parameters continued Parameter Immunity Detail EM e EC 61000 4 3 Level X 20V m e EC 60601 2 4 Section 36 202 3 20V m e AAMI DF39 Section 3 3 21 2 1 Magnetic e IEC 61000 4 8 2001 e IEC 60601 2 4 2002 Section 36 202 8 e AAMI DF39 Section 3 3 21 2 3 80A m 47 5Hz 1 320Hz ESD e IEC 61000 4 2 Level 3 e IEC 60601 2 4 2002 Section 36 202 2 e 6KV contact discharge 8KV air gap discharge Environmental Free Fal
20. ELIVERED Prompts when the shock is delivered Table 2 6 Delivering Shock Fully Automatic Voice Prompt Text Display Situation After the AED is fully charged and ready to deliver the defibrillation Shock Will be SHOCK IN shock The SHOCK will automatically Delivered in be administered approximately three seconds after the end of the voice prompt Three THREE Prompts approximately three seconds prior to delivering shock Two Two Prompts approximately two seconds prior to delivering shock One ONE Prompts approximately one second prior to delivering shock Shock Delivered SHOCK DELIVERED Prompts when the shock is delivered 2 16 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Table 2 7 CPR Prompts Voice Prompts and Text Display Voice Prompt Text Display Situation Note The AED is shipped from the factory with ENHANCED MODE ON The Medical Director may modify the CPR options in MDLink This table lists ENHANCED CPR prompts It is now safe to touch the patient NOW SAFE TO TOUCH THE PATIENT Advises the rescuer that it is safe to touch the patient e After the AED delivers a shock e After the AED detects a non shockable cardiac rhythm When instructed give 30 rapid compressions then give 2 breaths 30 COMPRESSIONS 2 BREATHS Prompts rescuer to correctly give compressions and breaths
21. F to the radiotelephone and other like equipment near the incident Pacemaker CAUTION Possible Interference with Implanted 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 The AED has pacemaker detection and rejection however with some pacemakers the AED may not advise a defibrillation shock When placing pads Do not place the pads directly over an implanted device Place the pad at least an inch from any implanted device 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 CAUTION Moving the Patient During a Rescue Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 3 Perform a Rescue Step 1 Assess the Patient 3 4 Determine that the patient is over 8 years of age or weighs more than 55 pounds 25 kg and is both Unresponsive Not breathing DO NOT delay therapy to determine the patient s exact age or weight See the directions for use accompanying pediatric pads to replace adult pads with pediatric pads CALL EMERGENCY MEDICAL SERVICES Note When the patient is a child under 8 years of age or weighs less than 55 pounds 25kg the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Pads 112 0038
22. INSTRUCTIONS FOR USE J ie aes F POWERDHEARTAEDG3Ph POWERHEART AUTOMATED EXTERNAL DEFIBRILLATOR G3 PLUs 9390A AND 9390E 112 0038 201 A CARDIAC AT THE HEART OF SAVING science EES Notice of Rights 2010 Cardiac Science Corporation All rights reserved No part of this documentation may be reproduced or transmitted in any form by any means without the express written permission of Cardiac Science Corporation Information in this documentation is subject to change without notice Names and data used in the examples are fictitious unless otherwise noted Trademark Information FirstSave Powerheart MasterTrak MDLink STAR IntelliSense RescueReady RescueCoach RescueLink RHYTHMx and Survivalink are trademarks and registered trademarks of Cardiac Science Corporation Microsoft and Windows are registered trademarks of Microsoft Corporation All other trademarks are the property of their respective owners PATENTS This device is covered by the following U S and foreign patents 5 792 190 5 999 493 5 402 884 5 579 919 5 749 902 5 645 571 6 029 085 5 984 102 5 919 212 5 891 172 5 674 266 5 700 281 5 891 173 5 968 080 6 263 239 5 797 969 D402 758 D405 754 5 909 138 6 173 203 6 088 616 5 897 576 5 955 956 6 083 246 6 064 909 6 038 473 5 868 794 6 115 638 6 366 809 5 474 574 6 246 907 6 289 243 6 411 846 6 480 734 6 658 290 EP00756878 Other U S and foreign patents pending
23. Indicator Troubleshooting Table View Symptom Solution Maintenance by authorized service personnel is required Call Cardiac Science Customer Service see page 4 or your local Cardiac Science distributor I Red SERVICE indicator DA LED is lit Red Pads indicator LED Connect the pads or replace is lit with a new pair The last battery indicator The battery is low Replace with LED is red a new battery The battery power is completely depleted Replace with anew battery If STATUS INDICATOR remains RED call Cardiac Science Customer Service or your local Cardiac Science distributor ENS STATUS INDICATOR is Q RED and no other RESCUE indicators on the EEAS diagnostic panel are lit 4 2 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Indicator Troubleshooting Table CAUTION Temperature Extremes mn Exposing the AED to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly The RescueReady daily self test verifies the impact of extreme environmental conditions on the AED If the daily self test determines environmental conditions outside of the AED s operating parameters a SERVICE REQUIRED alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Technical Data on page 5 1 Powerheart Automated External Def
24. TATUS INDICATOR to RED After approximately 5 seconds verify that the STATUS INDICATOR returns to GREEN Annual Maintenance Perform the following tests annually to confirm that the diagnostics are functioning properly and to verify the integrity of the case Check the Integrity of the Pads and Circuitry Open the AED lid Remove the pads Close the lid Confirm that the STATUS INDICATOR turns RED Open the lid and confirm that the Pad indicator is lit Reconnect the pads and close the lid aS oe ee Make sure the expiration date is visible through the clear window of the lid Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 4 5 Maintenance and Troubleshooting 8 Check to make sure that the STATUS INDICATOR is GREEN If the pads are not installed properly the PAD indicator will illuminate call Customer Service for assistance 9 Open the lid and confirm that no diagnostic indicators are lit 10 Check the expiration date of the pads if expired replace them 11 Check the pads packaging integrity 12 Close the lid Check the Integrity of the Service Indicator LED and Circuitry 1 Immediately after opening the AED lid press and hold the oP ef 6 7 Shock button and confirm that the Service LED is lit Release the Shock Continue button Close the lid Verify that the STATUS INDICATOR remains RED Open the lid and confirm that no diagnostic indicators are lit Close the
25. TOP CPR Prompts to stop CPR Prompts when Enhanced Mode is not selected in Continue CPR CONTINUE CPR pee Prompts when lid is reopened during CPR cycle 2 18 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Table 2 8 Pad Issues Voice Prompts and Text Display Voice Prompt Text Display Make sure pad connector is plugged into AED CHECK CONNECTOR IS PLUGGED INTO AED Situation Prompts when defibrillation pads connector is not correctly inserted into pad socket Press pads firmly to PRESS PADS FIRMLY patient s bare skin TO BARE SKIN Prompts when better pad connectivity to the patient s skin is required because impedance is too high Table 2 9 Other Prompts Voice Prompt Text Display Situation Battery Low BATTERY LOW Occurs once when the battery voltage becomes low although a rescue can continue for approximately 9 more shocks When the battery is too low to doa rescue the following will occur 1 BATTERY LOW appears on the LCD 2 Status indicator becomes red 3 AED beeps once every 30 seconds You must replace the battery before continuing with the rescue If the battery is depleted all AED activity terminates Analysis Interrupted Stop Patient Motion ANALYSIS INTERRUPTED STOP PATIENT MOTION When the AED detects ECG noise artifact stop moving or touching the patient Remove other electronic devi
26. ator is 2 8 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Defibrillation Pads green If the pads are not installed properly the status indicator will be red Call technical support for assistance Caution Use only Cardiac Science Approved Equipment gt Using batteries pads cables or optional equipment other than those approved by Cardiac Science may cause the AED to function improperly during a rescue Caution Possible Improper AED Performance gt Using pads that are damaged or expired may result in improper AED performance Directions for Use Pads are for short term use only Do not open until ready to use Caution Equipment Damage AN Do not pull on the lead wire to separate the pads from the blue liner Follow directions on the pad packaging Ensure that the skin site is clean and dry Separate one pad from the blue liner Place one pad on the bare skin in either location Pw Do Peel and place the remaining pad in the opposite location Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 9 About the AED AED Indicators The following indicators are located on the AED RescueReady Status Indicator The status indicator is located on the Powerheart G3 AED handle Indicator Color Key Green RESCUE Status The AED is RescueReady Self tests have verified that e Battery has an adequate charge e Pads are properly
27. ble Rhythm VT Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity of gt 75 Non shockable Rhythm NSR Meets AAMI DF 39 requirement gt 95 and AHA recommendation gt 99 of Specificity Non shockable Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity of gt 95 Non shockable Meets AAMI DF 39 requirement and AHA recommendation of Specificity all other rhythms of gt 95 For detailed information contact Cardiac Science for white papers e P N 112 2013 001 Pediatric Defibrillation Instructions e P N 110 0033 001 RHYTHMx White Paper e P N 400781 STAR Biphasic White Paper 5 6 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Star Biphasic Waveform Star Biphasic Waveform The waveform generated by the AED is a Biphasic Truncated Exponential waveform that is compliant with ANSI AAMI DF2 and DF39 The following is a graph of the waveform voltage as a function of time when the AED is connected to a 50 Ohm resistive load High Energy Waveform with 50 Ohm Resistive Load High Variable Energy 50 ohm 2000 0 1500 0 1000 0 500 0 VOLTS 00 500 0 1000 0 1500 0 1 1 1 1 1 1 1 4 000 0 000 1 000 2 000 3 000 4000 5000 6 000 7 000 8000 9 000 10 000 TIME ms The Biphasic Truncated Exponential BTE waveform uses variable energy The actual energy delivered wi
28. ces within a 5 meter radius Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 19 About the AED Table 2 9 Other Prompts continued Voice Prompt Open Lid to Continue Rescue Text Display OPEN LID TO CONTINUE RESCUE Situation When the lid is inadvertently closed during a rescue this prompt will repeat for 15 seconds When the device is prepared Rhythm Changed Shock Cancelled RHYTHM CHANGED SHOCK CANCELLED to shock then detects a change in rhythm and therefore cancels the shock Remove Cable to Continue Rescue REMOVE CABLE TO CONTINUE RESCUE When a serial communication cable is connected to the AED during a rescue the phrase repeats until the cable is disconnected Communications Mode COMMUNICATIONS MODE When the lid is open and the serial communication cable is plugged into the AED Occurs after the self tests Service Required SERVICE REQUIRED determine that the AED is functioning improperly The prompt service required is heard when the lid is opened The red service indicator illuminates and service required repeats until the lid is closed After the lid is closed an alarm beeps until the battery is removed or becomes depleted 2 20 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E 3 Perform a Rescue What s in this chapter Warnings and Cautions
29. d can be placed on either of the two locations shown ey Next peel the blue plastic liner off of 5 Pull the blue liner from the second the second white pad Firmly place the pad second pad on the opposite location 6 Place the pad on the bare lower exactly as illustrated chest as shown Note Cardiac Science s standard defibrillation pads are non polarized and can be placed in either position as shown on the pad package 3 6 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Step 4 Analyze the ECG Step 4 Analyze the ECG When the AED prompts Do this Do Not Touch Patient Analyzing 1 Do not touch the patient Heart Rhythm Please Wait 2 Wait for the next prompt The AED begins analyzing the cardiac rhythm of the patient During the analysis phase you may hear one or more of these prompts If the AED prompts This is the problem Do this n The pads are Ensure that the connector Make sure pad connector di df h 5 lv pl di is plugged into AED isconnected trom the Is properly plugged into PDI AED the AED Press pads firmly to The pads are not properly Ensure that pads are firmly patient s bare skin placed or are loose placed on clean dry skin The patient is excessively jostled or there is astrong Remove the electronic electromagnetic emitting device or stop the device nearby within 5 excessive motion meters
30. e environmental conditions outside of its operating parameters may compromise the ability of the AED to function properly The RescueReady daily self test verifies the impact of extreme environmental conditions on the AED If the daily self test determines environmental conditions outside of the AED s operating parameters a Service Required alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Chapter 5 Technical Data CAUTION Lithium Sulfur Dioxide Battery Pressurized contents never recharge short circuit puncture deform or expose to temperatures above 65 C 149 F Remove the battery when discharged CAUTION Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal state and local laws To avoid fire and explosion hazard 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 cause the AED to function improperly during a rescue 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Warnings and Cautions CAUTION Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance CAUTION Serial Communication Cable The AED will not function during a rescue when the serial communica
31. eart G3 Waveform Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts MS Volts MS Joules 25 1869 3 3 997 3 2 260 351 50 1906 4 5 1220 3 2 230 311 75 1918 5 8 1306 3 2 210 283 100 1925 7 0 1351 3 2 195 263 125 1928 8 3 1378 3 2 184 248 150 1931 9 5 1396 3 2 176 238 175 1933 10 8 1408 3 2 170 230 All values are typical Allowable energy range Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 5 9 Technical Data Ea 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Contact Information Contact Powerheart customer service to order additional Powerheart G3 AEDs and accessories For assistance with the product contact technical support Cardiac Science Corporation provides customer service and technical support through these numbers and addresses Customer Service Powerheart Technical Support 1 800 991 5465 US 1 888 466 8686 US 1 425 402 2690 US and Canada 1 425 402 2495 US and Canada customerservice cardiacscience com techsupport cardiacscience com Outside the United States contact International Operations or your local representative International Operations Kirke Vaerloesevej 14 Vaerloese Denmark DK3500 45 4438 0500 112 0038 201 A Contact 1 112 0038 201 A Contact 2 CARDIAC Cardiac Science Corporation 800 426 0337 U S A and Canada
32. echanical hazards only in accordance with UL 60601 1 K CAN CSA C22 2 No 601 1 M90 EN60601 1 and EN60601 c us 2 4 Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 Verieie iy International symbol for ON Open the lid to turn on the AED TR Indicates the AED battery status The illuminated areas 0 100 ite wee indicate the remaining battery capacity Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 11 Product Information and Safety Symbol Description compromised functionality Rg Check pads The pads are missing not connected or have Indicates AED requires maintenance by authorized service personnel SHOCK When the SHOCK indicator is lit press this button to deliver a defibrillation shock Ky A red indicator with a BLACK X means the AED requires ae operator attention or maintenance and is not RescueReady RESCUE READY Key A green indicator without a BLACK X means the AED is RescueReady READY Use pads by this date Date of manufacture year and month MMI YYYY Date of factory recertification R MM YYYY R MMI YYYY ore Latex free 1 12 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Symbols and Labels Symbol Description Disposable Single patient use only Tear here to open Do not recharge battery Position of
33. ent Guarantee from date of installation 4 Years Estimated Shelf Life from date of manufacture 5 Years Typical Shocks up to 290 shocks Note The battery operating life depends on the type of battery actual usage and environmental factors Batteries and Capacitor Charge Times A new battery typically takes 10 seconds to charge the AED to maximum energy A battery with reduced capacity causes the red LED light to initially turn ON and typically takes 13 seconds to charge a fully discharged AED to maximum energy AED Self test Sequence Daily Battery pads internal electronics Shock Continue or button and software no charge Weekly Battery pads internal electronics Shock Continue and software partial charge Monthly every 28 days Battery under load pads internal electronics full energy charge cycle Shock Continue button and software full charge Open Lid when lid is opened Battery pads internal electronics Shock Continue button and software Close Lid when lid is closed Battery pads internal electronics Shock Continue button and software Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 5 3 Technical Data Table 5 1 Parameters continued Parameter Safety and Performance Detail Model 9390 The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EM
34. fibrillator 9390A and 9390E 112 0038 201 A 5 1 Technical Data Parameters Table 5 1 Parameters Parameter Detail Semi Automatic shock advisory Operation P Automatic Voice P t Audible Alerts eee Sn Maintenance Alert Status Indicator Battery Status Indicator Visible Indicators Service Indicator Pads Indicator Text Display Internal with 60 minutes ECG data with event Rescue Data Storage P annotation Height 8 cm 3 3 in Dimensions Width 27 cm 10 6 in Depth 31 cm 12 4 in Weight Batteries and 9390 3 10 kg 6 6 Ib Pads Environmental Temperature 0 C to 50 C 32 F to 122 F Operation and Standby Humidity 5 to 95 non condensing Conditions Pressure 57kPa 15 000ft to 103kPa 500ft Shipmentand Transport Temperature 30 C to 65 C 22 F to 149 F environmental Conditions for up to 1 week Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 500ft Self adhesive disposable defibrillation pads Pads Minimum combined surface area 228cm Extended length of lead wire 1 3m 5 2 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Parameters Table 5 1 Parameters continued Parameter 9146 Lithium Battery Specifications Detail Output voltage 12VDC max Batteries are non rechargeable Lithium contents 9 2g max Check local regulations for disposal information Full Operational Replacem
35. ibrillator 9390A and 9390E 112 0038 201 A 4 3 Maintenance and Troubleshooting Cleaning and Care Use a cloth dampened with an approved cleaning solution to wipe the case Dry the case with a clean cloth Do not spray or pour the cleaning solution on the case or submerge the AED Use one of these solutions to clean the case of the AED soapy water ethanol 91 isopropyl or 3 bleach solution The AED and its accessories cannot be sterilized CAUTION Case Cleaning Solutions IN When disinfecting the case use a non oxidizing disinfectant such as ammonium salts or a glutaraldehyde based cleaning solution to avoid damage to the metal connectors 4 4 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Scheduled Maintenance Scheduled Maintenance Perform the following tests per the schedule indicated Daily Maintenance Check the Status Indicator to ensure that it is GREEN When the indicator is GREEN the AED is ready for a rescue If the indicator is RED refer to the Troubleshooting Table in this chapter Monthly Maintenance Perform the following procedure each month 28 days 1 Open the AED lid 2 Wait for the AED to indicate status Observe the change of the STATUS INDICATOR to RED After approximately 5 seconds verify that the STATUS INDICATOR returns to GREEN 3 Check the expiration date on the electrodes Listen for the voice prompts 5 Close the lid and observe the change of the S
36. it enters CPR mode AS omen Os Ta When the AED prompts Place heel of one hand on center of chest between nipples Place heel of other hand directly on top of first hand Lean over patient with elbows straight Press the patient s chest down rapidly one third depth of chest then release Do this Give the patient chest compressions 1 Place the heel on one hand on the chest between the nipples 2 Place the heel of the other hand on top of the first hand 3 Lean over the patient keeping your elbows straight 4 Press the patient s chest down rapidly one third the depth of the chest then release When instructed give 30 rapid compressions Then give two breaths Start CPR Stop compressions Stop the chest compressions Give breath repeated Give the patient two breaths Continue with compressions Give the patient chest compressions as directed above Follow the countdown timer on the text display for the number of compressions and breaths This cycle continues until the CPR time expires At the end of CPR the AED prompts Stop CPR The AED returns to the ECG Analysis Mode see Step 4 Analyze the ECG on page 3 7 Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 3 9 Perform a Rescue If the patient is conscious and breathing normally leave the pads on the patient s chest connected to the AED
37. l Drop IEC 60068 2 32 1975 AM 2 1990 1 meter Bump IEC 60068 2 29 1987 40g and 6000 bumps Vibration Random IEC 60068 2 64 1993 10Hz Conditions 2KHz 0 005 0 0012 g2 Hz Vibration Sine IEC 60068 2 6 1995 10Hz 60Hz 0 15 mm and 60Hz 150Hz 2g Enclosure Protection IEC 60529 2001 IP24 Shipping and Transportation ISTA Procedure 2A Conditions The AED RHYTHMx ECG Analysis system analyzes the patient s ECG and advises you when the AED detects a hockabl shockable rhythm RHYTHMxECG Analysis or non snoc lt ao e rayram l Perf This system makes it possible for a person with no erformance training in the interpretation of ECG rhythms to offer defibrillation therapy to victims of sudden cardiac arrest Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 5 5 Technical Data Table 5 1 Parameters continued Parameter Cardiac Rhythms Used to Test the Rhythm Recognition Detection System for Powerheart G3 AEDs Detail Shockable Rhythm VF Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity of gt 90 Automatic External Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety AHA AED Task Force and approved by the AHA Science Advisory and Coordinating Committee Circulation 1997 95 pp 1677 1682 Shocka
38. lid Verify that the STATUS INDICATOR turns GREEN Check the Integrity of the Case Examine the molded case of the AED for any visible signs of stress If the case shows signs of stress contact Cardiac Science Customer Service or contact your local Cardiac Science distributor see Contact Information 4 6 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Authorized Repair Service Authorized Repair Service The AED has no user serviceable internal components Try to resolve any maintenance issues with the AED by using the Troubleshooting Table presented in this chapter If you are unable to resolve the problem contact Cardiac Science Customer Service or contact your local Cardiac Science distributor see Contact Information WARNING Shock Hazard A N Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to Cardiac Science authorized service personnel Note The warranty will be void upon unauthorized disassembly or service of the AED Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 4 7 Maintenance and Troubleshooting 4 8 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E 5 Technical Data What s in this chapter Parameters 5 2 Star Biphasic Waveform 5 7 This section lists the AED parameters and describes the Star Biphasic waveform Powerheart Automated External De
39. ll vary with the patient s impedance and the device will deliver a shock when impedance is between 25 180 Ohms Energy will be delivered at three different levels referred to as ultra low variable energy low variable energy and high variable energy as shown in the waveform tables on the following pages Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 5 7 Technical Data Table 5 2 Ultra low Variable Energy 150 VE Powerheart G3 Waveform Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts MS Volts MS Joules 25 1393 3 3 743 3 2 145 196 50 1420 4 5 909 3 2 128 173 75 1430 5 8 973 3 2 116 156 100 1434 7 0 1007 3 2 108 146 125 1437 8 3 1027 3 2 102 138 150 1439 9 5 1040 3 2 98 132 175 1441 10 8 1049 3 2 95 128 Table 5 3 Low Variable Energy 200 VE Powerheart G3 Waveform Phase 1 Phase 2 Patient s Impedance Voltage Duration Voltage Duration Energy Ohms Volts MS Volts MS Joules 25 1609 3 3 858 3 2 193 260 50 1640 4 5 1050 3 2 170 230 75 1651 5 8 1124 3 2 155 209 100 1656 7 0 1163 3 2 144 194 125 1660 8 3 1186 3 2 136 184 150 1662 9 5 1201 3 2 131 176 175 1663 10 8 1212 3 2 126 170 5 8 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Star Biphasic Waveform Table 5 4 High Variable Energy 300 VE Powerh
40. n WARNING Shock and Possible Equipment Damage Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock and potential damage to the equipment WARNING Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment WARNING Battery is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Warnings and Cautions WARNING Shock Hazard Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to Cardiac Science authorized service personnel gt WARNING Possible Radio Frequency RF Susceptibility RF susceptibility from cellular phones CB radios and FM 2 way radio may cause incorrect rhythm recognition and subsequent shock advisory When attempting a rescue using the AED do not operate wireless radiotelephones within 1 meter of the AED turn power OFF to the radiotelephone and other like equipment near the incident gt WARNING Possible Interference with Implanted A N 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 The AED has pacemaker detectio
41. n 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 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 WARNING Electromagnetic Compatibility Position the AED away from other equipment If it is necessary to use the AED adjacent to or stacked with other equipment then observe the AED to verify normal operations WARNING Improper Equipment Placement Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 7 Product Information and Safety A A A gt amp AN 1 8 CAUTION Restricted Use 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 Read this Operation and Service Manual 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 CAUTION Temperature Extremes Exposing the AED to extrem
42. ompt Begin by exposing patient s bare chest and torso Remove or cut clothing if needed Text Display Situation Prompts the rescuer to remove patient clothing BARE PATIENT S TORSO REMOVE CLOTHING When patient s chest and torso are exposed remove square foil package from lid of AED Prompts the rescuer to remove the pads from AED lid WHEN CHEST IS BARE REMOVE FOIL PACKAGE Tear open foil package across dotted line and remove pads 2 14 112 0038 201 A Prompts the rescuer to open the pad package and remove pads TEAR OPEN PACKAGE REMOVE PADS Powerheart Automated External Defibrillator 9390A and 9390E Voice Prompts and Text Display Table 2 3 Preparation continued Voice Prompt Next separate one of the white pads completely from blue plastic liner Begin peeling from the tabbed corner Text Display PEEL ONE PAD FROM BLUE PLASTIC LINER Situation 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 Firmly place the pad without the liner on the patient exactly as illustrated This pad can be placed on either of the two locations shown PRESS PAD FIRMLY TO CHEST AS SHOWN Prompts the rescuer to place one pad on the patient Next peel the blue plastic liner off of the second white pad
43. on WARNING Shock and Possible Equipment Damage Disconnect all non defibrillator proof equipment from the patient before defibrillation to prevent electrical shock and potential damage to the equipment WARNING Electric Shock and Fire Hazard Do not connect any telephones or unauthorized connectors to the socket on this equipment 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 function improperly during a rescue 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Warnings and Cautions CAUTION Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance CAUTION Serial Communication Cable The AED will not function during a rescue when the serial communication cable is connected to its serial port When the serial communication cable is connected to the AED during a rescue the prompt Remove cable to continue rescue will be heard until you remove the serial communication cable from the AED gt gt CAUTION Possible Radio Frequency RF Susceptibility RF susceptibility from cellular phones CB radios and FM 2 way radio may cause incorrect rhythm recognition and subsequent shock advisory When attempting a rescue using the AED do not operate wireless radiotelephones within 1 meter of the AED turn power OF
44. pads on the chest of patient For use by or on the order of a Physician or persons licensed by state law Dispose of properly in accordance with all state province and country regulations Do not incinerate or expose to open flame Explosion hazard Do not use in the presence of a flammable gas including concentrated oxygen Upper and lower temperature limits Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 13 Product Information and Safety Symbol Description Serial Number Device model number battery model number Lot number OPTION Option number LiSO5 p DJE i i g Lithium sulfur dioxide IOIOI Serial communication port Additional information is provided in the AED Operation and Service Manual an bil Manufacturer z Authorized representative in the European Community R Waste Electronic Electrical Equipment WEEE Separate collection for waste electrical and electronic equipment 14 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E 2 About the AED What s in this chapter AED Description 2 2 AED Modes 2 3 AED Parts 2 4 IntelliSense Battery 2 5 Defibrillation Pads 2 8 AED Indicators 2 10 Voice Prompts and Text Display 2 14 This section presents information about the AED and its use Powerheart Automated External Defibrillator 9390A and
45. ssssecceseeeesseeeees 4 5 Annual Maintenance areias serina ai 4 5 Authorized Repair Service sssseeeseesessressessressesseeee 4 7 Chapter 5 Technical Data PATAMEtERS on ssacescsesdscesssceaesadedee sectacsecestevedecevesceceeds veves 5 2 Star Biphasic Waveform cscccssecssseeseceeceeeeceteceseees 5 7 Contact Information cccccescsssceeseeees Contact 1 Contents 112 0038 201 A 1 Product Information and Safety What s in this chapter e Indications for use 1 2 Cleaning and Care 1 4 Warranty Information 1 3 Safety Alert Descriptions 1 5 Warnings and Cautions 1 6 Symbols and Labels 1 11 Before Operating the Powerheart G3 AED Become familiar with the various safety alerts in this section Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you the patient or the Powerheart G3 AED For additional information about the G3 Plus AED see the Powerheart Automated External Defibrillator G3 Plus Operator and Service Manual Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 1 1 Product Information and Safety Indications for use 1 2 The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are intended to be used by personnel who have been trained in its operation The user should be qualified by training in basic life support or other physician authorized emergency medical response The device is indicated
46. te Battery model 9146 is for use only with the Powerheart AED G3 and Powerheart AED G3 Automatic Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 201 A 2 5 About the AED Battery Operating Life The battery operating life depends on the type of battery actual use and environmental factors Table 2 1 Normal Battery Operating Life Full Operational Estimated Shelf Replacement Guarantee Life from date from date of pei Model of manufacture installation Shocks oe Up to 9146 Lithium 5 Years 4 Years 290 Battery Shelf Life The batteries have a shelf life of five years Shelf life is defined as the length of time a battery can be stored prior to installation into an AED without degrading its performance Note Storing the battery outside its specific range 0 50 C will decrease battery life Battery Installation To install the battery 1 With the label on the battery facing the AED battery compartment insert the battery as shown Zp a 2 Push the latched end of the battery into the AED until the battery snaps into place The battery should be flush with the AED case QP KJ LZ gt gt CH Ki 2 6 112 0038 201 A Powerheart Automated External Defibrillator 9390A and 9390E Intellisense Battery 3 Open the lid for 5 seconds to initiate a self test If the battery is installed properly the SmartGauge battery indicator LEDs illuminate additionally the status indicator turns green
47. tion cable is connected to its serial port When the serial communication cable is connected to the AED during a rescue the prompt Remove Cable to Continue Rescue will be heard until you remove the serial communication cable gt gt CAUTION Moving the Patient During a Rescue AN 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 CAUTION Serial Communication Cable The serial communication cable is only for use with the AED it is not to be used with a telephone CAUTION Systems Statement Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment gt gt Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Anybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the system standard IEC 60601 1 1 CAUTION Case Cleaning Solutions IN When disinfecting the case use a non oxidizing disinfectant such as ammonium salts or a glutaraldehyde based cleaning solution to avoid damage to the metal connectors Powerheart Automated External Defibrillator 9390A and 9390E 112 0038 2
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