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GE 2023681 Скачать руководство пользователя страница 29

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Page 28 of 33

© 2007 General Electric Company

2023491-201 Rev B

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

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)
IEC 60601-1-4 (2000)
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 5cm 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

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Содержание 2023681

Страница 1: ...Service Manual 2023491 201rB ...

Страница 2: ...ink STAR IntelliSense RescueReady RescueLink RHYTHMx 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 ...

Страница 3: ...ck 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 ...

Страница 4: ...RATOR TRAINING REQUIREMENTS 13 INTELLISENSE Battery 14 RECHARGEABLE BATTERY 16 DEFIBRILLATION ELECTRODES PADS 17 AED INDICATORS 18 SETTING THE AED INTERNAL CLOCK 20 SECTION 3 MAINTENANCE TROUBLESHOOTING 21 OVERVIEW 21 SELF TESTS 21 INDICATOR TROUBLESHOOTING TABLE 22 SCHEDULED MAINTENANCE 22 AUTHORIZED REPAIR SERVICE 24 DEFIB TESTING 24 SECTION 4 TECHNICAL DATA 25 OVERVIEW 25 PARAMETERS 25 SAFETY A...

Страница 5: ...Page iv of 33 2007 General Electric Company 2023491 201 Rev B THIS PAGE INTENTIONALLY LEFT BLANK FOR YOUR NOTES ...

Страница 6: ...onder 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 WARNING This alert identifies hazards that may cause serious personal injury or death CAUTION This alert identifies hazards that may cau...

Страница 7: ...ersonnel 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 paramete...

Страница 8: ...edical 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 o...

Страница 9: ...529 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 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 a...

Страница 10: ...ate 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 Device Model Number Battery Model Number Serial Number Lot Number Rev Revision Default start up screen Lithium Sulfur Dioxide Lithium Ion Additional information is provided in the AED Pro Opera...

Страница 11: ...m 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 European Resuscitation Council ERC released new guidelines for CPR and defibrillation This symbol indicates that the AED contains the new AHA ERC guidelines for CPR and defibrillation ...

Страница 12: ...e 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 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 indic...

Страница 13: ...IS 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 RHYT...

Страница 14: ... Liaison Committee 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 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...

Страница 15: ...nal 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 Typic...

Страница 16: ...NG 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 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 ...

Страница 17: ...ted 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 2023681 Lithium Sulfur Dioxide 5 Years 1 Year of 12 hours of use whichever occurs first Up to 290 shocks If the yellow Charge LED blinks continuously a charging error has occurred Contact customer service in...

Страница 18: ...el 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 3 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 4 Tuck the excess cable length in the bottom holder as shown in the drawing With the package complet...

Страница 19: ...nthly 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 SMARTGAUGE BATTERY Indicator This indicator displays the battery capacity At maximum charg...

Страница 20: ...cs 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 I 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 ...

Страница 21: ...bled 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 ...

Страница 22: ...tically 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 ...

Страница 23: ...tery 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 ...

Страница 24: ...y 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 2 Release the SHOCK button 3 Close the lid 4 Verify that the STATUS INDICATOR remains RED 5 Open the lid and confirm that no diagnostic indicators are lit 6 Close the lid 7 Verify the STATUS INDICATOR turns...

Страница 25: ... Note Detailed instructions for using the ServiceLink software can be found in the ServiceLink manual provided on the ServiceLink software CD 1 Use ServiceLink to ensure the AED is set to a known protocol 200VE 300VE 300VE 200VE 200VE 300VE 150VE 200VE 200VE 150VE 150VE 200VE 200VE 200VE 200VE 2 Set the defibrillator tester to output a Ventricular Fibrillation ECG 3 Power on the AED 4 Connect the ...

Страница 26: ...matic shock advisory AUDIBLE ALERTS Voice Prompt Maintenance Alert VISIBLE INDICATORS STATUS INDICATOR Display Panel BATTERY Indicator NUMBER OF SHOCKS 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 Indicat...

Страница 27: ...f lead wire 1 3m LITHIUM BATTERY SPECIFICATIONS Output voltage 12VDC max Batteries are non rechargeable Lithium contents 9 2g max Check local regulations for disposal information Model Estimated Shelf Life Typical Shocks 2023681 Lithium 5 Years Up to 290 shocks The battery operating life depends on the type of battery actual usage and environmental factors RECHARGEABLE BATTERY SPECIFICATIONS Batte...

Страница 28: ...harged 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 Tested Daily Weekly Monthly every 28 days Open Lid when lid is opened Close Lid when lid is closed Battery pads internal electronics SHOCK CONTINUE button and...

Страница 29: ...rd 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 IEC 60601 1 4 2000 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 Sta...

Страница 30: ...pliance 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 Vibration Sine IEC 60068 2 6 1995 10Hz 60Hz 0 15 mm and 60Hz 150 Hz 2g Enclosure Protection IEC 60529 2001 IP24 SHIPPING AND TRANSPORT CONDITIONS ISTA Procedure 2A ...

Страница 31: ...at 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 A3 2000 0 1500 0 1000 0 500 0 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 10 000 TIME ms Figure A1 STAR BIPHASIC WAVEFORM Table A1 Ultra Low Current Re...

Страница 32: ...re typical Phase 1 Phase 2 Patient s Impedance Ohms Voltage Volts Duration ms Voltage Volts Duration ms Energy Joules 25 1885 3 3 990 3 2 265 360 50 1920 4 5 1240 3 2 235 320 75 1930 5 8 1325 3 2 215 295 100 1940 7 0 1380 3 2 200 270 125 1945 8 3 1405 3 2 190 260 ENERGY LEVELS AND PATIENT IMPEDIANCE The Biphasic Truncated Exponential BTE waveform utilizes variable energy The actual energy delivere...

Страница 33: ... 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 Subsequent 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 Res...

Страница 34: ...c 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 recommendation of Sensitivity of 90 Shockable Rhythm VT Meets AAMI DF 39 requirement and AHA recommendation of Sensitivity of 75 Non Shockable Rhythm NSR Meets AAMI DF 39 requirement 95 and AHA recommendation 99 o...

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