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Service Manual - Frank`s Hospital Workshop
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1. 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 Customer Service or your local distributor Cleaning the AED Case Gently clean the surface of the AED case with a damp sponge or with a cloth and mild soap A CAUTION Case Cleaning Solutions 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 No periodic safety analysis tests referred to by the IEC 60601 1 international standard are required 2023491 201 Rev B 2007 General Electric Company Page 23 of 33 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 Customer Service A WARNING Shock Hazard Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to authorized service personnel D Note The warranty will be void upon unauthorized disassembly or service of the AED DEFIB TESTING e Required Equipment Dynatech Nevada Impulse 3000 Defib Analyzer or equivalent Method Note Detailed instructions for using the ServiceLink software can be found in the ServiceLin
2. The Responder AED Pro Manual and any and all information contained herein do not constitute any warranty as to the Responder AED Pro or any related products in any manner whatsoever The Limited Warranty is shipped with the AED and serves as the sole and exclusive warranty provided by Cardiac Science regarding Responder AED Pro products HOW TO REACH US To order supplies or accessories contact your representative or distributor For technical support contact your local GE customer service Please have the serial and model numbers available The serial and model numbers are located on the back of the Responder AED Pro Responder AED Pro is manufactured for GE Medical Systems Information Technologies Inc 8200 West Tower Avenue Milwaukee WI 53223 USA Tel 800 558 7044 USA only Fax 800 421 6841 Canada Tel 800 668 0732 GE Medical Systems Information Technologies GmbH Munzinger Str 3 D 79111 Freiburg Germany Tel 49 761 4543 0 Fax 49 761 4543 233 Responder AED Pro is manufactured by Cardiac Science Corporation Bothell WA 98021 USA EC REP MDSS GmbH L Schiffgraben 41 D 30175 Hannover Germany Tel 49 511 62 62 86 30 Fax 49 511 62 62 86 33 NOTICE OF RIGHTS 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 General Electric Company Information in this documentation is subject to change witho
3. 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 The unit is safe for human use in compliance with the IEC 60601 1 Safety Analysis Tests standard EMMISIONS Field Standard or Compliance E M IEC 55011 CISPR 11 Group 1 Class B Magnetic ANSI AAMI DF39 0 5mT on surface except for within 5 of the lid magnet and the speaker IMMUNITY Field Standard or Compliance E M IEC 61000 4 3 Level X 20V m IEC 60601 2 4 Section 36 202 3 20 V m AAMI DF39 Section 3 3 21 2 1 Magnetic IEC 61000 4 8 2001 IEC 60601 2 4 2002 Section 36 202 8 AAMI DF39 Section 3 3 21 2 3 80A m 47 5Hz 1 320Hz ESD IEC 61000 4 2 Level 3 IEC 60601 2 4 2002 Section 36 202 2 6KV contact discharge 8KV air gap discharge Page 28 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 4 TECHNICAL DATA ENVIRONMENTAL CONDITIONS Field Standard or Compliance Free Fall 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 2KHz 0 005 0 0012 g2 Hz IEC 60068 2 6 1995 10Hz 60Hz 0 15 mm and 60Hz 150 Vibration Sine Hz 2g Enclosure Protection 60529 2001 IP24 SHIPPING AND TRANSPORT CONDITIONS ISTA Procedure 2A 2023491 201 Rev B 2007 General Electric Company Page 29 of 33 STAR BIPHASIC WAVEFORM The STAR Bip
4. 20 SECTION 3 MAINTENANCE amp TROUBLESHOOTING 21 OVERVIEW ia 21 SELF PES FS tiara 21 INDICATOR TROUBLESHOOTING TABLE eese nennen 22 SCHEDULED 777 eren nns 22 AUTHORIZED REPAIR 24 DEFIBTES TNG 24 SEGTION 4 TECHNICAL DATA 25 OVERVIEW 25 PARAMETERS tei E eei rte eni ET 25 SAFETY AND PERFORMANCE 8 28 STAR BIPHASIC WAVEFORM a 30 STAR BIPHASIC RESCUE PROTOCOLS FOR RESPONDER AED 32 ECG ANALYSIS PERFORMANCE 33 2023491 201 Rev B 2007 General Electric Company Page iii of 33 THIS PAGE INTENTIONALLY LEFT BLANK FOR YOUR NOTES Page iv of 33 2007 General Electric Company 2023491 201 Rev B SECTION 1 SAFETY SECTION 1 SAFETY OVERVIEW This section presents safety information to guard against injury to persons and damage to the Responder AED PRO Topic Page Safety Alert Definitions Safety Alert Descriptions Symbols Descriptions SAFETY TERMS AND DEFINITIONS BEFORE OPERATING THE RESPONDER AED Pro Become familiar with the various safety alerts in this section Safety
5. YY Ey Latex Free 9 Disposable Single patient use only D Tear here to open 2 Do not recharge battery A Position of pads on the chest of patient If flashing check pads The pads are missing not connected or have compromised functionality Gn Dispose of properly in accordance with all state province and country regulations 4 Do not incinerate or expose to open flame Explosion Hazard Do not use in the presence of a flammable gas including Concentrated oxygen 120 F sr Upper and lower temperature limits oC Device Model Number Battery Model Number SN Serial Number LOT Lot Number Rev Revision Default start up screen Lithium Sulfur Dioxide Lithium lon Additional information is provided in the AED Pro Operator s Manual Points to important information regarding the use of the AED Lift Here Manufacturer Authorized European Representative ES Indicates placement of ECG leads and electrodes 2023491 201 Rev B 2007 General Electric Company Page 9 of 33 Symbol for the marking of electrical and electronic equipment that must be recycled Fragile handle with care Iz oe oe oe Keep away from rain Keep dry This way up Stacking limit by number General symbol for recovery recyclable Humidity Limitations Atmospheric Pressure Limitations In November 2005 the American Heart Association AHA and
6. a rescue A CAUTION Lithium ion Battery Never short circuit puncture deform or expose to temperatures above 65 C 149 F Page 16 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 2 INTRODUCTION DEFIBRILLATION ELECTRODES PADS The defibrillation pads come 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 each rescue The pads have a limited shelf life and shall not be used beyond the expiration date Keep a fresh unopened pair of pads plugged into the AED at all times Refer to the pad package label for operation temperatures On the Responder AED PRO an audible and visual alert will indicate after the self test if the pads are missing unplugged or damaged CAUTION Possible Improper AED Performance Using pads that are damaged or expired may result in improper AED performance PAD INSTALLATION Open the lid of the AED Place the package into the lid so that the expiration label is visible through the clear window on the lid The expiration date of the pads will then be readable without opening the lid of the AED Match the color of the connectors red to red slightly lift the tab of the pad socket and then plug the pad connector into the AED case as shown in the drawing Tuck the excess cable length in the bottom holder as shown in the drawing With the packa
7. alerts identify potential hazards using symbols and words to explain what could potentially harm you the patient or the Responder AED PRO SAFETY TERMS AND CONDITIONS The triangle attention symbol shown below left identifies the potential hazard categories The definition of each category is as follows DANGER This alert identifies hazards that will cause serious personal injury or death A WARNING This alert identifies hazards that may cause serious personal injury or death A CAUTION This alert identifies hazards that may cause minor personal injury product damage or property damage PRODUCT REFERENCES For purposes of retaining simple clear instructions in this manual note the product references used Features specifications operating instructions and maintenance common to the Responder AED Pro will be referred to as AED Features and specifications vary so please read this manual carefully 2023491 201 Rev B 2007 General Electric Company Page 5 of 33 SAFETY ALERT DESCRIPTIONS The following is a list of AED safety alerts that appear in this section and throughout this manual You must read understand and heed these safety alerts before attempting to operate the AED AN AN Depp B gt amp e DANGER Fire and Explosion Hazard Do not use the AED in the presence of flammable gases including concentrated oxygen to avoid possible explosion or fire hazard WARNING Shock Hazard Defibrillati
8. pads The Z Bar is used in the assessment of Adequate pad placement Pad quality and integrity Pad adhesion to the patient s skin Proper pad connection to the AED Provides for quick assessment between pad off and pads shorted 2023491 201 Rev B 2007 General Electric Company Page 19 of 33 CONTROL BUTTONS The AED has two buttons SHOCK BUTTON The SHOCK button is located at the far right of the control panel Delivers a defibrillation shock The word SHOCK and the shock button indicator LED will illuminate RED when the AED is ready to deliver a defibrillation shock to the patient Note modification to behavior below when in manual mode SHOCK MANUAL OVERRIDE BUTTON The MANUAL OVERRIDE button is located at the far left of the control panel and converts the device from automated mode to manual This feature should only be used by ALS personnel MANUAL OVERRIDE Lift the cover to access the button Converts to manual standby mode when pushed once a voice prompt Press Manual Button Again to Confirm will be heard Converts to manual mode when MANUAL button is pressed again If the rescuer does not confirm within 30 seconds of the capacitors charging the AED will revert back to AED Mode If the Medical Director has disabled this feature Servicelink an icon indicating No MANUAL MODE will appear in the bottom left of the display REMAIN IN MANUAL MODE This feature is intended for advanced
9. the rescue when the lid was first opened D HEART RATE Indicator This indicator displays the patient s heart rate E ECG Display Four and a half seconds of the patient s ECG is displayed F PAD PLACEMENT Display Visually assists the rescue with pad placement with the directions for use Appropriate text prompts are also displayed G TEXT Display The text display has 2 lines of text It provides the operator with information regarding system initialization text version of the voice prompts and data during a rescue and diagnostics System initialization occurs when the lid is first opened The text display shows the operator the identifiers for the internal code voice prompts and text prompts versions H CPR Counter During CPR a countdown timer will be displayed l SERVICE Indicator When apparent indicates that service is required that can only be performed by qualified service personnel Note When Status Indicator is RED or Service Indicator is illuminated device cannot be used to perform a rescue J PAD Indicator When flashing with voice and text prompt indicating Check Pads indicates to check pads when pads are Not properly connected to the AED Not within operational specifications cold dried damaged Disconnected from the patient during a rescue K Z BAR Indicator Z Bar provides a relative visual graphical indicator of the total transthoracic impedance between the two defibrillation
10. CKS DELIVERED Indicator ELAPSED RESCUE TIME Indicator HEART RATE Indicator ECG Display PAD PLACEMENT Display CHECK PADS indicator TEXT Display CPR Counter SERVICE Indicator Pad Indicator Manual Mode Indicator ECG Monitoring Mode Indicator Z BAR Indicator RESCUE DATA STORAGE Storage Capacity Internal 60 minutes ECG data with event annotation DIMENSIONS Measurement Dimension Height 8 cm 3 3 in Width 27 cm 10 6 in Depth 31 cm 12 4 in 2023491 201 Rev B 2007 General Electric Company Page 25 of 33 WEIGHT Model Weight with Batteries and Pads 9300 3 20 kg 7 0 Ib ENVIRONMENTAL OPERATION AND STANDBY CONDITIONS Atmosphere Condition Temperature 0 to 50 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 4 572m 15 000ft to 103kPa 152m 500ft SHIPMENT AND TRANSPORT ENVIRONMENTAL CONDITIONS for up to 1 week Atmosphere Condition Temperature 30 C to 65 C 22 F to 149 F Humidity 5 to 95 non condensing Pressure 57kPa 4 572m 15 000ft to 103kPa 152m 500ft PADS Self adhesive disposable defibrillation pads Minimum combined surface area 228cm2 Extended length of lead wire 1 3m LITHIUM BATTERY SPECIFICATIONS e Output voltage 12VDC max Batteries are non rechargeable Lithium contents 9 20 max e Check local regulations for disposal information Model Estimated Shelf Life Typical Shocks 2023681 Lithium 5 Years Up to 290 shoc
11. European Resuscitation Council ERC released new guidelines for CPR and defibrillation This symbol indicates that the AED contains the new AHA ERC AHA ERC guidelines for CPR and defibrillation I Page 10 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 2 INTRODUCTION SECTION 2 INTRODUCTION OVERVIEW This section presents information about the AED its use and the training requirements for operation Topic Page AED Description Indications for Use Intended Use RHYTHMx AED ECG Analysis Algorithm Operator Training Requirements Intellisense Battery Rechargeable Battery Pads AED Indicators Setting the AED Internal Clock AED DESCRIPTION The AED is a self testing battery operated automated external defibrillator AED After applying the AED s pads to the patient s chest the AED automatically analyzes the patient s electrocardiogram ECG and advises the operator to push the button and deliver a shock if needed The AED uses one button and guides the operator through the rescue using a combination of voice prompts audible alerts and visible indicators At the discretion of Advanced Life Support ALS personnel the AED can be converted to manual override mode and deliver a shock by pushing the SHOCK button The AED can also provide non diagnostic ECG monitoring INDICATIONS FOR USE INTENDED USE The AED with STAR Biphasic Waveform is intended to be used by personnel who have b
12. Service Manual Aespomier AED Pro EB Responder AED Pro emat externa 2023491 201rB REVISION HISTORY Part number Date Comment 2023491 201 RevA August 2006 Initial Release 2023491 201 Rev B November 2007 Revised for misc minor updates and new symbols Corrected shock criteria in Defib testing section IMPORTANT Read this 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 TRADEMARK INFORMATION FirstSave Powerheart MasterTrak ServiceLink STAR IntelliSense RescueReady RescueLink and Survivalink are trademarks and registered trademarks of Cardiac Science Corp Microsoft and Windows are registered trademarks of Microsoft Corporation All other trademarks are the property of their respective owners PATENTS This device may be 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 EP00756878 Other U S and foreign patents pending 2023491 201 Rev B 2007 General Electric Company Page i of 33 LIMITED WARRANTY
13. ServiceLink and RescueLink that are included with the AED When using older version of ServiceLink and RescueLink are used to communicate with this AED there may be features described in this manual that are not available to be used Also when communicating with an older AED with the version of ServiceLink and RescueLink included with this new AED there may be features described in this manual that cannot be edited The software in most cases will give an error message when incompatibilities occur 1 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 2023491 201 Rev B 2007 General Electric Company Page 7 of 33 SYMBOL DESCRIPTIONS The following symbols may appear in this manual on the AED or on its optional components Some of the symbols represent standards and compliances associated with the AED and its use 4 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 Attention Identifies important information in this manual on the AED or on its component parts regarding the safe and proper use of the AED Defibrillator Proof BF Equipment The AED when connected to the patient s chest by the R pads can withstand the effects of an externally applied defibrillation shock C CE Mark This equipment conforms to essential requirements of the Medical Device Directi
14. Tested Daily Battery pads internal electronics SHOCK CONTINUE button and software no charge Weekly Battery pads internal electronics SHOCK CONTINUE button 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 2023491 201 Rev B 2007 General Electric Company Page 27 of 33 SAFETY AND PERFORMANCE STANDARDS AED MODEL 2023440 The AED has been designed and manufactured to conform to the highest standards of safety and performance including electromagnetic compatibility EMC The Responder AED Pro Model 2023440 and pads conform to the applicable requirements of the following CE CE Marked by BSI 0086 per the Medical Device Directive 93 42 EEC of European Union 0086 ETL Classified by ETL Semko with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA 22 2 No 601 1 M90 EN60601 1 c T EN60601 2 4 Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard casted 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 IEC 60601 1 4 2000
15. able ACT IR220LN115 from ACTiSys Corp on Windows based PCs only Please contact customer service to order P N 162 0108 001 Other IR products may interfere with the transmission and are not for use with the AED Page 20 of 33 O 2007 General Electric Company 2023491 201 Rev B SECTION 3 MAINTENANCE AND TROUBLESHOOTING SECTION 3 MAINTENANCE amp TROUBLESHOOTING OVERVIEW This section presents information about the AED diagnostics self tests maintenance and service indications Topic Page Self Tests 21 Indicator Troubleshooting Table 22 Scheduled Maintenance 22 Authorized Repair Service 24 Defib Testing 24 SELF TESTS The AED has a comprehensive self test system that automatically tests the electronics battery pads and high voltage circuitry Self tests are also activated every time you open and close the AED lid These self tests eliminate the need for in depth periodic annual maintenance testing The comprehensive self tests insure that the Responder AED Pro is RescueReady with minimal user involvement and maintenance costs Once a month during the daily self tests the AED performs a full charge of the capacitors During this test the AED monitors the charge time voltage level and proper discharge function When the Responder AED Pro requires maintenance audible and or visual indicators are activated By monitoring the visual and audible indicators the user can be assured that the Responder AED Pro is ready to cond
16. and is selectable by Service between 160 and 300 bpm or NO THERAPY FOR SVT can be selected by Service using the ServiceLink software RESCUE PROTOCOL mu The AED rescue protocol is consistent with the guidelines recommended by the American Heart Papa Association AHA European Resuscitation Council ERC and the International Liaison Committee AHA ERC on Resuscitation ILCOR Upon detecting a shockable cardiac rhythm the AED advises the operator to press the SHOCK button to deliver a shock and then advises the operator to start CPR I Note The standard CPR protocol of 120 seconds can be modified from 60 to 180 seconds in ServiceLink OPERATOR TRAINING REQUIREMENTS Persons authorized to operate the AED must have all of the following minimum training Defibrillation training and other training as required by state province or country regulations Training on operation and use of the AED Additional training as required by the physician or Medical Director A thorough understanding of the procedures in this manual I Note Keep valid certificates of training and certification as required by state province or country regulations 1 Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care American Heart Association Circulation Vol112 Issue 24 Suppl Dec 13 2005 2023491 201 Rev B 2007 General Electric Company Page 13 of 33 INTELLISENSE Battery The Responder AED PRO IntelliSens
17. ation Voltage Duration Energy ohms Volts ms Volts ms J oules 5 33 99 32 2539 ENERGY LEVELS AND PATIENT IMPEDIANCE The Biphasic Truncated Exponential BTE waveform utilizes variable energy The actual energy delivered will 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 above waveform tables 2023491 201 Rev B 2007 General Electric Company Page 31 of 33 STAR BIPHASIC RESCUE PROTOCOLS FOR RESPONDER AED Pro The patented STAR Biphasic defibrillation waveform will deliver variable escalating energy that is customized to each patient s needs based upon a patient s thoracic impedance This customization adjusts for the unique physical differences between patients The range of impedance over which the device will deliver a shock is 25 180 Ohms The Responder AED Pro comes equipped with five different FDA cleared biphasic rescue protocols The operator with guidance direction and implementation from its designated AED program Medical Director may select from one of these five protocols when placing the into service The AED s factory default rescue protocol is 200 300 300 Joule J escalating Variable Energy VE The first shock is delivered within the range of 140J 250J 200J nominal Subs
18. d to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once See Section 7 Technical Data Parameters Operation and Standby Conditions 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 Approved Equipment Using batteries pads cables or optional equipment other than those approved by GE 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 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 2 meters of the AED turn power OFF to the radiotelephone and other like equipment near the incident Page 6 of 33 2007 General Electric Company 2023491 201 Rev B AN gt gt SECTION 1 SAFETY CAUTION Possible Interference with Implanted Pacemaker Therapy should not be de
19. e battery technology offers you the most advanced battery capabilities available for defibrillators Responder AED Pro IntelliSense batteries contain an integrated memory chip that automatically stores important usage information enabling the battery to maintain a complete history of its operating life The actual battery history can be reviewed using the RescueLink software This history includes Battery Identification Battery Type Original Date of Installation in an AED Number of Charges completed Time in Operation hours minutes Days of Standby Operation Battery Capacity Remaining BATTERY OPERATING LIFE The battery operating life depends on the type of battery actual usage and environmental factors The following table represents the expected life of the Responder AED Pro when used in Standby Mode Model Estimated Shelf Life Typical Shocks 2023681 9145 Lithium 5 Years Up to 290 shocks BATTERY SHELF LIFE The Responder AED Pro 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 AED without degrading its performance Note Storing the battery outside its specific range 0 50 C will decrease battery life Page 14 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 2 INTRODUCTION BATTERY INSTALLATION 1 With the label on the battery facing the AED battery compartment insert the battery as shown in t
20. een trained in its operation The operator should be qualified by training in basic life support CPR AED or other physician authorized emergency medical response The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest that are unresponsive and not breathing If the victim is breathing post resuscitation 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 or when in manual override mode ALS personnel will monitor the ECG display and deliver a shock by pushing the shock button to deliver therapy A WARNING When the patient is a child or infant under 8 years of age or weighs less than 55 Ibs 25kg the AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrode Pads Therapy should not be delayed to determine the patient s exact age or weight 2023491 201 Rev B O 2007 General Electric Company Page 11 of 33 RHYTHMX AED ECG ANALYSIS ALGORHITHM RhythmX AED ECG analysis algorithm provides superior ECG detection capabilities allowing it to be placed on patients at risk for sudden cardiac arrest The features available with the AED include the following Detection Rate Asystole Threshold Noise Detection Non Committed Shock Synchronized Shock Pacemaker Pulse Rejection SVT Discriminators Suprav
21. entricular Tachycardia SVT Rate DETECTION RATE All ventricular fibrillation VF and ventricular tachycardia VT rhythms at or above this rate will be classified as shockable All rhythms below this rate will be classified as non shockable This rate is configurable between 120 bpm beats per minute and 240 bpm Service can change this rate using the ServiceLink software The default Detection Rate is 160 bpm The Responder AED Pro detection rate is 160 bpm ASYSTOLE THRESHOLD The Asystole baseline to peak threshold is set at 0 08 mV ECG rhythms at or below 0 08 mV will be classified as Asystole and will not be shockable NOISE DETECTION The AED will detect noise artifact in the ECG Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular radiotelephones When noise is detected the AED will issue the prompt ANALYSIS INTERRUPTED STOP PATIENT MOTION to warn the operator The AED will then proceed to reanalyze the rhythm and continue with the rescue NON COMMITTED SHOCK After the AED advises a shock it continues to monitor the patient ECG rhythm If the patient s rhythm changes to a non shockable rhythm before the actual shock is delivered the AED will advise that the rhythm has changed and issue the prompt RHYTHM CHANGED SHOCK CANCELLED The AED will enter CPR mode and prompt START SYNCHRONIZED SHOCK The AED is designed to synchronize
22. equent shocks are delivered within a range of 190J 360J 300J nominal These protocols are selected by using our ServiceLink software program The five biphasic energy protocols available are as follows Rescue Protocols Shock Sequence Energy Level Factory Default 1 200 2 300VE 3 300VE Protocol 2 1 200 2 200 3 300VE Protocol 3 1 150VE 2 200VE 3 200VE Protocol 4 1 150VE 2 150VE 3 200VE Protocol 5 1 200VE 2 200VE 3 200VE Energy Range J 140J 250J 190J 360J 190J 360J 140J 250J 140J 250J 190J 360J 105J 195J 140J 250J 140J 250J 105J 195J 105J 195J 140J 250J 140J 250J 140J 250J 140J 250J 1 The ultra low current low current high current shocks are variable energy The actual energy is determined by the patient s impedance Page 32 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 4 TECHNICAL DATA RHYTHMX ECG ANALYSIS PERFORMANCE The AED RHYTHMx ECG Analysis system analyzes the patient s ECG and advises you when the AED 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 CARDIAC RHYTHMS USED TO TEST THE RHYTHM RECOGNITION DETECTION SYSTEM FOR CARDIAC SCIENCE AED Rhythm Class Specifications Shockable Rhythm VF Meets AAMI DF 39 requirement and AHA recomme
23. from the Responder AED PRO the rechargeable battery can only be recharged when removed from the Responder AED PRO ST lt gt Plug the charger into an appropriate electrical outlet 2 Insert the charger cable into the rechargeable battery and ensure the yellow LED above the rechargeable battery symbol is on Charging is complete when the yellow ES Charge LED goes out and the four green Fuel Gauge LEDs are continuously lit TAR Remove the charger cable from the battery when done charging Charging may be terminated early by removing the charger cable from the battery If the battery is charged for a minimum of 3 hours the stated capacities will be met Model Estimated Shelf Life Warranty Typical Shocks 1 Year of 12 hours 5 Years of use whichever Up to 290 shocks occurs first 2023681 Lithium Sulfur Dioxide If the yellow Charge LED blinks continuously a charging error has occurred Contact customer service in the event of a charging error Insert Charger Here Y LII ESTE ET Rechargeable with LED Battery Capacity Test Button Rechargeable Battery Also located on back A CAUTION Use only Approved Equipment The Rechargeable battery is made solely for Powerheart AED G3 Pro and is NOT to be used with any other AED models Using batteries pads cables or optional equipment other than those approved by the manufacturer may cause the AED to function improperly during
24. ge completely secured to the AED lid close the lid Make sure the expiration date is visible through the clear window of the lid Make sure that the STATUS INDICATOR is GREEN CAUTION Use only Approved Equipment Using batteries pads cables or optional equipment other than those approved by General Electric 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 DIRECTIONS FOR USE T Do NOT open until ready to use short term use only 2 Ensure the skin site is clean and dry 3 Separate one pad from liner 4 Place one pad on skin in either location 5 Peel and place remaining pad 2023491 201 Rev B 2007 General Electric Company Page 17 of 33 AED INDICATORS The following indicators are located on the AED RESCUEREADY STATUS INDICATOR The STATUS INDICATOR is located on the AED handle When this indicator is GREEN the device is RescueReady This means the Responder AED Pro self tests have verified the following Battery has an adequate charge Pads are properly connected to the Responder AED Pro and in working order Integrity of the internal circuitry is good M When the STATUS INDICATOR is RED maintenance is required Note When Status Indicator is RED or Service Indicator is illuminated device cannot be used to perform a rescue AUDIBLE MAINTENANCE INDICATOR Whe
25. hasic Waveform is designed to measure the patient s impedance and deliver a customized shock This allows the delivery of an optimized energy level to each patient The energy levels for the Responder AED Pro are available in three on next page for additional information The waveform generated by the Responder AED Pro 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 See figure A1 and Tables A1through High Energy Waveform with 50 Ohm Resistive Load 2000 0 1500 0 1000 0 500 0 VOLTS 0 0 500 0 1000 0 1500 0 1 000 0 000 1 000 2 000 3 000 4 000 5 000 6 000 7 000 8 000 9 000 10 00 TIME ms Figure A1 STAR BIPHASIC WAVEFORM Table A1 Ultra Low Current Responder AED Pro all values are typical Dom m Era Voltage pia Energy ms Volts ms J oules Ohms a m 33 7 32 3S 5 im 4s 35 32 Page 30 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 4 TECHNICAL DATA Table A2 Low Variable Energy Waveform Responder AED Pro all values are NES ime pg e Voltage Duration Voltage Duration Energy Ohms Volts ms Volts ms J Table A3 High Variable Energy Waveform Responder AED Pro all values are Du mes pue E NM Impedance Voltage Dur
26. he drawing 2 Push the latched end of the battery firmly into the AED as shown in the drawing until the battery snaps into place The exposed side of the battery should be flush with the outside of the AED case 3 Open the lid for 5 seconds to initiate self test If the battery is installed properly the STATUS INDICATOR will turn GREEN Close the lid RESCUE READY A WARNING Battery Model 2023681 001 is Not Rechargeable Do not attempt to recharge the battery Any attempt to recharge the battery may result in an explosion or fire hazard A 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 A 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 A CAUTION Use only General Electric Approved Equipment Using batteries pads cables or optional equipment other than those approved by General Electric may cause the Responder AED Pro to function improperly during a rescue 2023491 201 Rev B 2007 General Electric Company Page 15 of 33 RECHARGEABLE BATTERY The rechargeable battery P N 2023489 001 and charger P N 2023490 001 are separately sold accessories for the Responder AED PRO DIRECTIONS FOR USE Remove the rechargeable battery
27. ironmental conditions within the acceptable operating parameters at once See Section 7 Technical Data Parameters Operation and Standby Conditions 2023491 201 RevB 2007 General Electric Company Page 21 of 33 INDICATOR TROUBLESHOOTING TABLE The following is a troubleshooting table for the AED indicators VIEW SYMPTOM SOLUTION Red SERVICE indicator LED is indicated on the screen Red PADS indicator LED is indicated on the screen The LAST BATTERY indicator LED is red and flashing STATUS INDICATOR is RED and no other indicators on the diagnostic panel are lit Maintenance by authorized service personnel is required Call Customer Service or your local distributor Connect the pads or replace with a new pair The battery is low Replace with a new battery The battery power is completely depleted Replace with a new battery If STATUS INDICATOR remains RED refer to the Responder AED Pro for maintenance Call Customer Service or your local distributor SCHEDULED MAINTENANCE DAILY MAINTENANCE Check the STATUS INDICATOR to ensure that it is GREEN When the indicator is GREEN the Responder AED Pro is ready for a rescue If the indicator is RED refer to the Troubleshooting Table in this Observe the change of the STATUS INDICATOR to RED After less than 5 seconds verify that the chapter MONTHLY MAINTENANCE 1 Open the AED lid 2 Wait for the AED to indicate stat
28. k manual provided on the ServiceLink software CD 1 Use ServiceLink to ensure the AED is set to a known protocol 200VE 200VE 150VE 150VE 200VE e Acceptance Criteria 300VE 200VE 200VE 150VE 200VE 150VE Shock Acceptable range is 120J to 180J 200VE Shock Acceptable range is 170J to 230J 300VE Shock Acceptable range is 230J to 310J Page 24 of 33 300VE 300VE 200VE 200VE 200VE Set the defibrillator tester to output a Ventricular Fibrillation ECG Power on the AED Connect the AED defibrillator pads to the defibrillator tester The AED should automatically analyze and charge Press the Flashing shock button on the AED Record the energy delivered as displayed on the defibrillator analyzer Repeat for a total of three shocks Replace electrodes 0 Close the lid and verify that the indicator turns green after approximately 5 seconds 2007 General Electric Company 2023491 201 Rev B SECTION 4 TECHNICAL DATA SECTION 4 TECHNICAL DATA OVERVIEW This section presents technical data about the AED Topic Page Parameters Safety and Performance Standards STAR Biphasic Waveform STAR Biphasic Energy Protocols for Responder AED PRO RHYTHMx ECG analysis performance PARAMETERS OPERATION Semi Automatic shock advisory AUDIBLE ALERTS Voice Prompt Maintenance Alert VISIBLE INDICATORS STATUS INDICATOR Display Panel BATTERY Indicator NUMBER OF SHO
29. ks The battery operating life depends on the type of battery actual usage and environmental factors RECHARGEABLE BATTERY SPECIFICATIONS Battery Voltage 11 1V Chemistry Lithium ion Refer to local regulations Compatibility Responder AED Pro Model 2023440 Battery Capacity 60 shocks minimum 100 shocks typical or 3 hours minimum 6 hours typical of ECG display time Battery Charge Time 3 hours for stated capacity 4 5 hours to fully charge completely depleted battery Battery Standby 6 months Battery Life 2 5 years or 300 Battery charge discharge cycles whichever comes first Battery Weight 1 lb 3 oz Page 26 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 4 TECHNICAL DATA BATTERY CHARGER e Power Requirements 90 to 132 VAC or 198 to 264 VAC at 47 to 63 Hz The Charger operates from and accepts standard IEC mains power cables It is recommended that you keep a spare non rechargeable battery nearby 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 The maximum time from Power On to Ready to Shock is 28 seconds for a new rescue The maximum time from Analyze to Ready to Shock is 22 seconds for a new rescue AED SELF TEST SEQUENCE Frequency of Self Test What is
30. layed 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 Placing Pads Do not place the pads directly over an implanted device Place the pad at least one inch from any implanted device 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 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 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 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 CAUTION The AED is programmed with software that has been tested to work with versions of
31. medical personnel with the ability to differentiate between shockable and non shockable cardiac rhythms With Remain In Manual Mode enabled and the user enters manual mode the AED will remain in the manual mode Further AED rhythm analysis and CPR prompting are disabled when Remain in Manual Mode is enabled SETTING THE AED INTERNAL CLOCK The internal clock is preset at Central Standard Time and should be reset to the correct date and local time The AED will automatically adjust itself for daylight savings time This feature can be turned off using the ServiceLink software To set the clock you will need a PC with Windows 95 or later operating system RescueLink software installed an IR port on the PC and an IR cable as specified below To set the clock settings Open the lid and remove pads from the pads socket Ensure that the PC is set at the correct local time and date Point IR port on the AED to IR eye on the PC and select G3 Pro Run the RescueLink software on the PC Verify that the voice prompt states Communications Mode Click Communications on the main menu Select AED Date and Time Click on the Get button to review the current time in the AED If the time and date is incorrect click Set to set new time and date The AED date and time will automatically be updated to the PC s time and date Reinstall pads per instructions on page 19 Close the lid Note The IR port on the AED is designed to work with IR c
32. n the daily weekly or monthly self test determines service is required an audible beep is sounded 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 automatic self test the beep will be reactivated DIAGNOSTIC PANEL A D SHOCKS 3 K 00 04 57 p ae H CPR 01 00 DO NOT TOUCH PATIENT ANALYZING RHYTHM G F J I A SMARTGAUGE BATTERY Indicator This indicator displays the battery capacity At maximum charge the battery is GREEN With use the GREEN level will gradually go out from right to left as the battery capacity decreases Once the battery level is depleted the battery indicator will turn to RED and flash and the battery should be replaced Note When the battery indicator is initially RED upon lid opening or at any time during a rescue a BATTERY LOW prompt will be issued at once However the AED is capable of delivering at least nine more defibrillation shocks after the first time a BATTERY LOW prompt is issued Page 18 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 2 INTRODUCTION B NUMBER OF SHOCKS DELIVERED Indicator This indicator counts and displays the number of shocks delivered ELAPSED RESCUE TIME Indicator This indicator times and displays the elapsed rescue time DS Note There is a 3 second delay between the time the AED lid is opened and the start of
33. ndation of Sensitivity of gt 90 Shockable 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 all other rhythms Meets AAMI DF 39 requirement and AHA recommendation of Specificity of gt 95 2023491 201 Rev B 2007 General Electric Company Page 33 of 33 Responder AED Pro automated external defibrillator
34. on 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 and ECG electrodes clear of other pads or metal parts in contact with patient Disconnect all non defibrillator proof equipment from the patient before defibrillation 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 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 WARNING Shock Hazard Do not disassemble the AED Failure to observe this warning can result in personal injury or death Refer maintenance issues to authorized service personnel CAUTION Temperature Humidity Pressure Extremes 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 AEDs operating parameters a SERVICE REQUIRED alert will be issue
35. shock delivery on the R wave The AED will automatically attempt to synchronize to the R wave lf delivery cannot be synchronized within one second a non synchronized shock will be delivered PACEMAKER PULSE DETECTION The AED contains pacemaker pulse detection circuitry to detect pulses from an implanted pacemaker SVT Superventricular Tachycardia DISCRIMINATORS The Responder AED Pro is supplied with the SVT Discriminator enabled and with the default setting NO THERAPY FOR SVT With the factory default setting of NO THERAPY FOR SVT the Responder AED Pro will not shock an SVT rhythm SVT Discriminators are sophisticated filters that analyze the morphology of the ECG waveforms and distinguish VF VT from SVT and Normal Sinus Rhythms NSR The SVT Discriminator will only be applied to rhythms that fall between the Detection Rate and the SVT Rate The factory default setting for this feature is NO THERAPY FOR SVT however Service can change the settings for this feature using the ServiceLink software Page 12 of 33 2007 General Electric Company 2023491 201 Rev B SECTION 2 INTRODUCTION SVT RATE All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminators to classify them into VF VT or SVT Rhythms classified as SVT between the two set rates are not shockable All SVT rhythms above the rates will be classified as shockable The SVT Rate must be greater than the Detection Rate
36. uct a rescue When performing the self tests the AED completes the following steps automatically Turns itself ON and the STATUS INDICATOR changes to RED Performs the self test If successful the STATUS INDICATOR reverts to GREEN Turns itself OFF if the lid is closed There are three types of automatic self tests The Daily Self Test checks the battery pads and the electronic components The Weekly Self Test completes a partial charge of the high voltage electronics current in addition to the items tested in the Daily Self Test During the Monthly Self Test the high voltage electronics are charged to full energy Self tests will be initiated upon opening the lid and again upon closing the lid If the self test detects an error the STATUS INDICATOR will remain RED Upon closing the lid an audible alert will be issued The Diagnostic Panel under the lid will indicate the source of the problem according to the Indicator Troubleshooting Guide Table on the next page CAUTION Temperature Humidity Pressure Extremes 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 the SERVICE REQUIRED alarm will sound to prompt the user to move the AED to env
37. us 3 STATUS INDICATOR returns to GREEN 4 Observe the expiration date on the pads 5 Listen for the voice prompts 6 Close the lid and confirm that STATUS INDICATOR remains GREEN Page 22 of 33 2007 General Electric Company 2023491 201 RevB SECTION 3 MAINTENANCE AND TROUBLESHOOTING ANNUAL MAINTENANCE Perform the following tests annually to confirm that the diagnostics are functioning properly and to verify the integrity of the case Bex Check the Integrity of the Pads and Circuitry T 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 Make sure the expiration date is visible through the clear window of the lid Check to make sure that the STATUS INDICATOR is GREEN 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 pad s 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 SHOCK button and confirm that the SERVICE LED is lit Release the SHOCK button Close the lid Verify that the STATUS INDICATOR remains RED Open the lid and confirm that no diagnostic indicators are lit Close the lid Verify the STATUS INDICATOR turns GREEN
38. ut notice Names and data used in the examples are fictitious unless otherwise noted Page ii of 33 2007 General Electric Company 2023491 201 Rev B TABLE OF CONTENTS SECTION T SAFETY 5 OVERVIEW iato Bi RE AE MR RR DONE Ha DETUR 5 SAFETY TERMS AND 6 22 46242 0 0 nennen nnns 5 SAFETY TERMS AND 5 SAFETY ALERT 6 SYMBOL DESCRIPTIONS sates eet de RE ea ee oae 8 SECTION 2 INTRODUCTION 6 soviscsescescecocscnececortte seeceesensietsnececescecceceneceseesestteceedencice 11 OVERVIEW itii ba coe eens eae 11 AED DESCRIPTION lt 11 INDICATIONS FORUSE etie tester alates 11 AED ECG ANALYSIS 12 OPERATOR TRAINING 2 13 INTELLISENSEO Battery 5 ette tea eer a rege aa dea 14 RECHARGEABLE BATTERY reaa a eaaa aa iaaiiai 16 DEFIBRILLATION ELECTRODES 8 444000040 40 rennen 17 AED INDICATORS aia 18 SETTING THE AED INTERNAL CLOCK
39. ve 93 42 EEC 0086 IP24 The AED is protected against the effects of splashing water in accordance with IEC 60529 accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 EN60601 1 and EN60601 2 4 EM Classified by ETL Semko with respect to electric shock fire and mechanical hazards only in Nise YS Conforms to UL Standard UL60601 1 Certified to CAN CSA Standard C22 2 No 601 1 90 y International symbol for ON Open the lid to turn on the AED Open the lid to turn ON the AED Indicates the AED battery status The illuminated areas indicate the remaining battery capacity Indicates AED requires maintenance by authorized service personnel When the SHOCK indicator is lit push this button to deliver a defibrillation shock The Z bar provides a relative visual indicator of the total transthoracic impedance between the two defibrillation pads red indicator with a BLACK X means the Responder AED Pro requires operator attention or maintenance and is not RescueReady This symbol will be referred to as RED in the remainder of this manual MN A green indicator without a BLACK X means the Responder AED Pro is RescueReady This symbol will be referred to as GREEN in the remainder of this manual 52 Use pads by this date install battery by this date q Date of manufacture MM YYYY Page 8 of 33 O 2007 General Electric Company 2023491 201 Rev B SECTION 1 SAFETY NN 2 Date of factory recertification R MY Y
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