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© 2003 General Electric

201-9198-001 Rev A

AED SELF-TEST SEQUENCE

SAFETY AND PERFORMANCE STANDARDS

AED MODELS 9300

The AED has been designed and manufactured to conform to the highest standards of safety and performance
including electromagnetic compatibility (EMC). The Responder AED Model 9300E and electrodes conform to
the applicable requirements of the following:

CE

CE Marked by TUV Product Services 0123 per the Medical Device Directive 93/42/EEC of
European Nations

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) & 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

The unit is safe for human use in compliance with the IEC 601-1 Safety Analysis Tests standard.

Frequency of Self-Test

Daily

Weekly

Monthly (every 28 days)

Open Lid (when lid is opened)

Close Lid (when lid is closed)

What is Tested?

Battery, electrodes, internal electronics,

SHOCK/CONTINUE

button,

and software (no charge).

Battery, electrodes, internal electronics,

SHOCK/CONTINUE

button,

and software (partial charge).

Battery under load, electrodes, internal electronics, full-energy charge
cycle,

SHOCK/CONTINUE

button, and software (full charge).

Battery, electrodes, internal electronics,

SHOCK/CONTINUE

button,

and software.

Battery, electrodes, internal electronics,

SHOCK/CONTINUE

button,

and software.

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Содержание Responder AED

Страница 1: ...Operation and Service Manual ...

Страница 2: ...ND REPLACES ALL OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Some states do not allow limitations on how long an implied warranty lasts so this limitation may not apply to you NO PERSON INCLUDING ANY AGENT DEALER OR REPRESENTATIVE OF CARDIAC SCIENCE IS AUTHORIZED TO MAKE ANY REPRESENTATION OR WARRANT...

Страница 3: ...nutes Saving Lives SmartGauge STAR IntelliSense RescueReady RescueLink RHYTHMx and Survivalink are trademarks and registered trademarks of Cardiac Science Inc Responder is a registered trademark of General Electric 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...

Страница 4: ...00 Fax 414 355 3790 EUROPE GE Medical Systems Information Technologies Postfach 60 02 65 D 79032 Freiburg Germany Telephone 49 761 4543 0 Fax 49 761 4543 233 UK Customer One Number 0800 018 8678 Eire Customer One Number 1800 931 752 Northern Ireland Customer One Numb 0800 072 0248 UK Service Freefax 0800 018 8680 Belgium Customer One Number 800 74074 Belgium Service Freefax 800 72235 Italy Custome...

Страница 5: ...t to change without notice Names and data used in the examples are fictitious unless otherwise noted DEFIBRILLATOR TRACKING Defibrillator manufacturers and distributors are required under the Safe Medical Devices Act of 1990 to track the location of defibrillators they sell Please notify GEMS IT Customer Service in the event that your defibrillator is sold donated lost stolen exported destroyed or...

Страница 6: ...TOCOLS FOR RESPONDER AED 18 OPERATOR TRAINING REQUIREMENTS 20 SECTION 3 GETTING STARTED OVERVIEW 21 UNPACKING AND INSPECTING 21 AED PARTS 22 INTELLISENSE BATTERY 24 ELECTRODES 26 AED INDICATORS 27 SETTING THE AED INTERNAL CLOCK 30 VOICE PROMPTS AND TEXT DISPLAYS 30 SECTION 4 INSTRUCTIONS FOR USE OVERVIEW 33 STEP 1 ASSESSMENT AND ELECTRODE PLACEMENT 34 STEP 2 ECG ANALYSIS 35 STEP 3 SHOCK DELIVERY A...

Страница 7: ...TENANCE 43 AUTHORIZED REPAIR SERVICE 44 FREQUENTLY ASKED QUESTIONS 45 SECTION 7 TECHNICAL DATA OVERVIEW 47 PARAMETERS 47 SAFETY AND PERFORMANCE STANDARDS 50 STAR BIPHASIC WAVEFORM 52 RHYTHMx ECG ANALYSIS PERFORMANCE 54 SECTION 8 ACCESSORIES OVERVIEW 55 RESPONDER AEDs 55 AED ACCESSORIES 55 AED DELIVERY SYSTEMS 56 SOFTWARE ACCESSORIES 56 EDUCATION ACCESSORIES 56 ...

Страница 8: ...D SAFETY TERMS AND DEFINITIONS 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 WARNING This alert identifies hazards that may cause serious personal injury or death CAUTION This alert identifies hazards that may cause minor pe...

Страница 9: ...nt 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 WARNING Shock Hazard Do not disassemble the AED Failure to observe this warning can result in personal injury or dea...

Страница 10: ...quipment near the incident CAUTION Possible Interference with Implanted Pacemaker Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the patient is unconscious and not breathing The AED has pacemaker detection and rejection however with some pacemakers the AED may not advise a defibrillation shock 1 Placing Electrodes Do not place th...

Страница 11: ...TION 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 1 Cummins R ed Advanced Cardiac Life Support AHA 1994 Ch 4 ...

Страница 12: ...ntial requirements of the Medical Device Directive 93 42 EEC 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 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 ...

Страница 13: ...al Use electrodes by this date install battery by this date Expiration Date Replace by this date Date of manufacture Latex Free Disposable Single patient use only Tear here to open Do not recharge battery Position of electrodes 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 reg...

Страница 14: ...ection 1 Safety Lot Number Option Number Lithium Sulfur Dioxide Serial Communication Port Additional information is provided in the AED Manual Points to important information regarding the use of the AED Lift Here 201 9198 001 Rev A ...

Страница 15: ...page 14 2003 General Electric 201 9198 001 Rev A ...

Страница 16: ...e alerts and visible indicators INDICATIONS FOR USE The AED with STAR Biphasic Waveform is intended to be used by personnel who have been 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 w...

Страница 17: ...al Director The default Detection Rate is 160 bpm The Responder AED detection rate is 160 bpm ASYSTOLE THRESHOLD The asystole peak 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 f...

Страница 18: ...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 and is selectable between 160 and 300 bpm or NO TH...

Страница 19: ...e next page STAR BIPHASIC ENERGY PROTOCOLS FOR RESPONDER AED 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 20 180 Ohms Th...

Страница 20: ... 360J 3 300VE 190J 360J Protocol 2 1 200VE 140J 250J 2 200VE 140J 250J 3 300VE 190J 360J Protocol 3 1 150VE 105J 195J 2 200VE 140J 250J 3 200VE 140J 250J Protocol 4 1 150VE 105J 195J 2 150VE 105J 195J 3 200VE 140J 250J Protocol 5 1 200VE 140J 250J 2 200VE 140J 250J 3 200VE 140J 250J 1 The ultra low current low current and high current shocks are variable energy The actual energy is determined by t...

Страница 21: ...brillation 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 Notes Keep valid certificates of training and certification as required by state province or country regulations ...

Страница 22: ...ED Parts 22 IntelliSense Battery 24 Electrodes 26 AED Indicators 27 Setting the AED Internal Clock 30 Voice Prompts and Text Display 30 UNPACKING AND INSPECTING Every attempt is made to ensure your order is accurate and complete However to be sure that your order is correct verify the contents of the box against your packing slip Section 3 Getting Started 201 9198 001 Rev A ...

Страница 23: ...AED parts and their locations RescueReady Status Indicator Lid Latch Push in to open Battery Compartment Electrode Expiration Window Serial Communication Port Behind blue rubber data access cover Electrode Holders Electrode Connector Speaker Text Display Diagnostic Panel SHOCK CONTINUE Button ...

Страница 24: ...perature 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 by checking temperature humidity and pressure if the daily self test determines environmental conditions outside of t...

Страница 25: ... 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 9142 for Responder AED actual usage and envir...

Страница 26: ...he STATUS INDICATOR will turn GREEN Close the lid 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 Batter...

Страница 27: ...ECTRODE INSTALLATION 1 Open the lid of the AED 2 Place the electrode package into the lid so that the expiration label is visible through the clear window on the lid The expiration date of the electrodes will then be readable without opening the lid of the AED 3 Match the color of the connectors red to red then plug the electrode connector into the AED case as shown in the drawing 4 Tuck the exces...

Страница 28: ...he Responder AED self tests have verified the following Battery has an adequate charge Electrodes are properly connected to the Responder AED and in working order Integrity of the internal circuitry is good When the STATUS INDICATOR is RED maintenance is required AUDIBLE MAINTENANCE INDICATOR When the daily weekly or monthly self test determines service is required an audible beep is sounded every...

Страница 29: ...ny time during a rescue a BATTERY LOW prompt will be issued at once However the AED is capable of delivering at least 9 more defibrillation shocks after the first BATTERY LOW prompt is issued When the AED battery cannot deliver any more shocks it continuously repeats the BATTERY LOW voice prompt To continue the rescue leave the lid open remove the battery and replace with a fresh battery If batter...

Страница 30: ... rescue data has not been cleared from the internal memory The text display has 2 lines of text The text display provides the operator with information regarding system initialization text 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...

Страница 31: ...E PROMPTS AND TEXT DISPLAY The voice prompts activate when the AED lid is opened and help guide the operator through the rescue The Responder AED text display provides a visual display of most of the audible voice prompts The following table lists the voice and text prompts and a description of when the prompts are issued VOICE PROMPT Tear Open Electrode Package and Remove Electrodes Peel One Elec...

Страница 32: ...vious prompt or if previous prompt is disabled After the AED delivers 3 consecutive defibrillation shocks After the AED detects a non shockable cardiac rhythm during cardiac rhythm analysis When 2 1 2 minutes or more has elapsed since CPR was last administered Occurs when patient impedance is too low or too high Occurs once when the battery voltage becomes low although a rescue can continue for ap...

Страница 33: ...MDLink software program Warble Beep occurs when the AED requires mainte nance During CPR mode when enabled or when a rescue is resumed in CPR mode after being interrupted by the lid closing Occurs after the self tests determine that the AED is not functioning properly The prompt SERVICE REQUIRED will be heard when the lid is opened The red SERVICE indicator will illuminate and SERVICE REQUIRED wil...

Страница 34: ... section presents information about how to use the AED to perform a rescue Topic Page Step 1 Assessment and Electrode Placement 34 Step 2 ECG Analysis 35 Step 3 Shock Delivery and CPR Mode 36 Step 4 Post Rescue 37 Warnings 37 Section 4 Instructions for Use 201 9198 001 Rev A ...

Страница 35: ...Tear Open Electrode Package and Remove Electrodes Keep the electrodes connected to the AED tear the electrode package along the dotted line and remove the electrodes from the package Leave the package attached to the electrode wires After the prompt Peel One Electrode From Plastic Liner with a firm steady pull carefully peel one electrode away from the release liner Then after the prompt Place One...

Страница 36: ... Shock will be heard The tone flashing button and voice prompt will continue until the shock is delivered or change in rhythm is detected or 30 seconds elapse 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 will issue the prompt Rhythm Changed Shock Cancelled disarm and reanalyze If no shock is advised the AED...

Страница 37: ...thing Give Patient Two Breaths if this prompt is enabled then Check for Signs of Circulation If No Circulation Start CPR Perform CPR if the patient is not responsive and not breathing During this time out for CPR the Responder AED can continue to monitor the patient s heart rhythm If the patient s condition changes and the Responder AED detects a shockable rhythm during the CPR period the voice pr...

Страница 38: ...d 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 electrodes clear of other electrodes or metal parts in contact with patient Disconnect all non defibrillator proof equipment from the patient before defibrillation WARNING Shock and Possible Equi...

Страница 39: ... radiotelephones within 1 meter of the AED turn power OFF to the radiotelephone and other like equipment near the incident CAUTION Possible Interference with Implanted Pacemaker Therapy should not be delayed for patients with implanted pacemakers and a defibrillation attempt should be made if the patient is unconscious and not breathing The AED has pacemaker detection and rejection however with so...

Страница 40: ...and allow the rescue attempt to continue Note Do not press the CONTINUE button unless you are sure you want to erase the internal memory in the AED REVIEWING RESCUE DATA RETRIEVING DATA FROM MEMORY 1 Open the AED lid 2 Connect the serial cable to the PC and to the AED s serial port under the blue rubber data access cover The voice prompt will say Communications Mode 3 Run the RescueLink software p...

Страница 41: ...page 40 2003 General Electric 201 9198 001 Rev A ...

Страница 42: ...udible and or visual indicators are activated By monitoring the visual and audible indicators the user can be assured that the Responder AED is ready to conduct 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...

Страница 43: ...ert will be issued 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 on page 48 VIEW SYMPTOM Red SERVICE indicator LED is lit Red ELECTRODES indicator LED is lit The last battery indicator LED is red STATUS INDICATOR is RED and no other indicators on the diagnost...

Страница 44: ...REEN 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 Electrodes and Circuitry 1 Open the AED lid 2 Remove the electrodes 3 Close the lid 4 Confirm that the STATUS INDICATOR turns red 5 Open the lid and confirm that the ELECTRODE indicator is lit 6 Reconnect the electr...

Страница 45: ... distributor Cleaning the AED Case Gently clean the surface of the AED case with a damp sponge or with a cloth and mild soap 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 601 1 international...

Страница 46: ...takes longer than 60 seconds the first rescue is terminated and the AED will begin to record the events from then on as a separate rescue 5 Q How do I set the AED internal clock A Set the clock by using the RescueLink Software Program and a PC See Setting the AED Internal Clock in Chapter 3 6 Q What happens if I close the lid in the middle of a rescue attempt A If you close the lid during a rescue...

Страница 47: ...a with RescueLink 9 Q The AED did not sound an audible alert when I removed the electrodes and closed the lid Why A The lid closed electrode self test only activates the STATUS INDICATOR The AED allows time for replacement of the electrodes as removing electrodes is a normal procedure after a rescue or a battery during the post rescue procedure however an audible maintenance indicator will be trig...

Страница 48: ...y and Performance Standards 50 STAR Biphasic Waveform 52 RHYTHMx ECG analysis performance 54 PARAMETERS OPERATION Semi Automatic shock advisory AUDIBLE ALERTS Voice Prompt Maintenance Alert VISIBLE INDICATORS Status Indicator Battery Status Indicator Service Indicator Electrodes Indicator Text Display Section 7 Technical Data 201 9198 001 Rev A ...

Страница 49: ...Weight with Batteries and Electrodes 9300 3 10 kg 6 6 lb ENVIRONMENTAL OPERATION AND STANDBY CONDITIONS Atmosphere Condition Temperature 0 C to 50 C 32 F to 122 F Humidity 5 to 95 non condensing Pressure 57kPa 15 000ft to 103kPa 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 Atmosphe...

Страница 50: ...ating life depends on the type of battery 9142 for Responder AED 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 The maximum time from ...

Страница 51: ...601 1 M90 Electrical Construction Safety and Performance IEC 60601 1 1998 Amendments 1 1991 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 The unit is safe for human use in compliance with the IEC 601 1 Safety Analysis Tests standard Frequency of Self Test Daily Weekly Monthly every 28...

Страница 52: ...2 3 20 V m AAMI DF39 Section 3 3 21 2 1 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 IEC 61000 4 2 Level 3 IEC 60601 2 4 2002 Section 36 202 2 6KV contact discharge 8KV air gap discharge Condition Free Fall Drop Bump Vibration Random Vibration Sine Enclosure Protection Models 9300 9300 9300 9300 9300 Standard or Compliance IEC 60068 2 32 ...

Страница 53: ...ed Start Volts 1393V 1420V 1430V 1434V 1437V 1439V Phase 1 Delivered End Volts 743V 909V 973V 1007V 1027V 1040V Phase 1 Duration ms 3 3 ms 4 5 ms 5 8 ms 7 0 ms 8 3 ms 9 5 ms Phase 2 Delivered Start Volts 743V 909V 973V 1007V 1027V 1040V Phase 2 Delivered End Volts 214V 479V 630V 724V 786V 830V Phase 2 Duration ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms Total Energy Delivered J 170J 150J 136J 127...

Страница 54: ...ms 4 5 ms 5 8 ms 7 0 ms 8 3 ms 9 5 ms Phase 2 Delivered Start Volts 858V 1050V 1124V 1163V 1186V 1201V Phase 2 Delivered End Volts 247V 553V 728V 835V 907V 959V Phase 2 Duration ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms 3 2 ms Total Energy Delivered J 226J 200J 182J 169J 160J 153J Table A2 Low Variable Energy 200VE Waveform into Different Resistive Loads Typical Values Patient s Impedance Ohms 25 50 7...

Страница 55: ...d AHA recommendation of Sensitivity of 75 Non Shockable Rhythm NSR Meets AAMI DF 39 requirement 95 and AHA recommendation 99 of Specificity Non Shockable Asystole Meets AAMI DF 39 requirement and AHA recommendation of Specificity of 95 Non Shockable Meets AAMI DF 39 requirement and AHA recommendation of Specificity all other rhythms of 95 For detailed information contact GEMS IT for white papers P...

Страница 56: ...ium battery Model 9142 internal memory and 1 pair of adult defibrillation electrodes Section 8 Accessories 201 9198 001 Rev A WITH AED QUICK RESOURCE GUIDE KIT 2019198 001 2019198 002 2019198 004 2019198 005 2019198 008 2019198 010 2019198 011 2019198 013 2019198 014 2019198 015 2019198 016 2019198 017 WITHOUT AED QUICK RESOURCE GUIDE KIT 2019436 001 2019436 002 2019436 004 2019436 005 2019436 008...

Страница 57: ...uding Quick Resource Guide serial cable and CD ROM containing manual RescueLink and MDLink 201616 001 AED Quick Start Tool Kit CD ROM AED DELIVERY SYSTEMS 2019199 001 Soft sided carrying case for Responder AED 2019615 001 Ready Kit includes nitrile gloves razor scissors towel 4 gauze antiseptic wipes one way filter mask 2019199 005 AED Wall mount storage case 2019199 006 AED Wall mount storage cas...

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