GE Medical Systems Responder AED User Manual

Operator’s Manual
2022105-201rC
REVISION HISTORY
Part number Date Comment
2022105-201 Rev A October 2006 Initial Release 2022105-201 Rev B December 2006 AHA Guidelines added 2022105-201 Rev C July 2007 Revised for misc. minor updates, new symbols
and EMC table added
TABLE OF CONTENTS
SECTION 1: INTRODUCTION .........................................................................................3
OVERVIEW..................................................................................................................................3
INDICATIONS FOR USE/INTENDED USE................................................................................. 3
AED DESCRIPTION....................................................................................................................3
SAFETY TERMS AND DEFINITIONS......................................................................................... 4
SAFETY TERMS AND CONDITIONS.........................................................................................4
SAFETY ALERT DESCRIPTIONS .............................................................................................. 4
SYMBOL DESCRIPTIONS.......................................................................................................... 6
SAFETY AND PERFORMANCE STANDARDS..........................................................................8
OPERATOR TRAINING REQUIREMENTS ................................................................................ 9
SECTION 2: GETTING STARTED.................................................................................11
OVERVIEW................................................................................................................................11
UNPACKING AND INSPECTING.............................................................................................. 11
ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS ........................................... 11
AED PARTS...............................................................................................................................12
INTELLISENSE
PADS ......................................................................................................................................... 15
AED INDICATORS ....................................................................................................................16
SETTING THE AED INTERNAL CLOCK ..................................................................................18
VOICE PROMPTS AND TEXT DISPLAY.................................................................................. 19
SECTION 3: PERFORMING A RESCUE.......................................................................23
OVERVIEW................................................................................................................................23
HOW TO PERFORM A RESCUE..............................................................................................23
WARNINGS ...............................................................................................................................25
AFTER A RESCUE ATTEMPT.................................................................................................. 26
®
BATTERY ...................................................................................................... 13
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SECTION 4: DATA MANAGEMENT ............................................................................. 27
OVERVIEW................................................................................................................................27
RECORDING THE RESCUE DATA .......................................................................................... 27
REVIEWING THE RESCUE DATA ...........................................................................................27
RESCUELINK OVERVIEW .......................................................................................................28
RESCUELINK INSTALLATION INSTRUCTIONS..................................................................... 29
MULTIPLE RESCUE FUNCTIONALITY ...................................................................................29
SECTION 5: MAINTENANCE & TROUBLESHOOTING............................................... 31
OVERVIEW................................................................................................................................31
SELF-TESTS .............................................................................................................................31
INDICATOR TROUBLESHOOTING TABLE ............................................................................. 32
SCHEDULED MAINTENANCE .................................................................................................32
AUTHORIZED REPAIR SERVICE ............................................................................................34
FREQUENTLY ASKED QUESTIONS .......................................................................................35
SECTION 6: TECHNICAL DATA................................................................................... 37
OVERVIEW................................................................................................................................37
PARAMETERS ..........................................................................................................................37
RHYTHMX® AED ECG ANALYSIS ALGORHITHM .................................................................40
STAR BIPHASIC WAVEFORM .................................................................................................42
STAR BIPHASIC ENERGY PROTOCOLS FOR RESPONDER AED ......................................42
ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS .................................................... 44
SECTION 7: ACCESSORIES ........................................................................................ 49
OVERVIEW................................................................................................................................49
RESPONDER AEDs..................................................................................................................49
AED ACCESSORIES ................................................................................................................50
SECTION 8: CONTACT INFORMATION / CUSTOMER SERVICE .............................. 51
ii
Section 1: Introduction
SECTION 1: INTRODUCTION
OVERVIEW
Become familiar with the controls and how to use the AED properly before operating the product.
TOPIC PAGE #
INDICATIONS FOR USE / INTENDED USE 3
AED DESCRIPTION 3
SAFETY TERMS AND DEFINITIONS 5
SAFETY TERMS AND CONDITIONS 5
SAFETY ALERT DESCRIPTIONS 5
SYMBOL DESCRIPTIONS 6
SAFETY AND PERFORMANCE STANDARDS 8
OPERATOR TRAINING REQUIREMENTS 9
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 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.
WARNING: When the patient is a child or infant under 8 years of age or weighs less than 55 lbs (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.
AED DESCRIPTION
The AED is a self-testing, battery-operated automated external defibrillator (AED). After applying the AED 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.
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SAFETY TERMS AND DEFINITIONS
BEFORE OPERATING THE RESPONDER AED
Become familiar with the various safety alerts in this section.
Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you, the patient, or the Responder AED.
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 cause minor personal injury, product damage, or property
damage.
SAFETY ALERT DESCRIPTIONS
The following is a list of Responder 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.
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 Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard. To avoid this hazard during defibrillation abide by all of the following:
Do not touch the patient, unless performance of CPR is indicated
Do not touch metal objects in contact with the patient
Keep defibrillation pads clear of other pads or metal parts in contact with patient
Disconnect all non-defibrillator proof equipment from the patient before 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: 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 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 by checking temperature, humidity and pressure; if the daily self-test determines environmental conditions outside of the AEDs operating parameters for 5 consecutive days, a "SERVICE REQUIRED" alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once. See Section 6 – Technical Data, Parameters, Operation and Standby Conditions.
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Section 1: Introduction
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 GE 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: Serial Communication Cable The AED will not function during a rescue when the serial communication cable is connected to its serial port. When the serial communication cable is connected to the AED during a rescue, the prompt “Remove Cable to Continue Rescue” will be heard until you remove the serial communication cable.
CAUTION: Possible Radio Frequency (RF) Susceptibility RF susceptibility from cellular phones, CB radios and FM 2-way radio may cause incorrect rhythm recognition and subsequent shock advisory. When attempting a rescue using the AED, do not operate wireless radiotelephones within 1 meter of the AED – turn power 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 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: Serial Communication Cable The serial communication cable is only for use with the AED; it is not to be used with a telephone.
CAUTION: Systems Statement Equipment connected to the analog and digital interfaces must be certified to the respective IEC Standards (i.e. IEC 60950-1 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 ServiceLink and RescueLink that are included with the AED. When older versions 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
1
Cummins, R., ed., Advanced Cardiac Life Support; AHA (1994): Ch. 4.
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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.
IP24
0% 100%
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.
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 Type BF Equipment: The AED, when connected to the patient’s chest by the pads, can withstand the effects of an externally applied defibrillation shock.
CE Mark: This equipment conforms to essential requirements of the Medical Device Directive 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-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 areas indicate the remaining battery capacity.
Check pads. The pads are missing, not connected or have compromised functionality.
Indicates AED requires maintenance by authorized service personnel.
When the SHOCK indicator is lit, push this button to deliver a defibrillation shock.
When the CONTINUE indicator is lit, push this button to clear the internal memory to allow storage of new rescue data in the AED. (Only for models not equipped with Multiple Rescue software)
A red indicator with a BLACK X means the Responder AED requires operator attention or maintenance, and is not RescueReady. This symbol will be referred to as RED in the remainder of this manual.
A green indicator without a BLACK X means the Responder AED is RescueReady. This symbol will be referred to as GREEN in the remainder of this manual.
Use pads by this date; install battery by this date.
Expiration Date. Replace by this date.
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Date of manufacture.
Date of factory recertification (R)
Latex Free.
Disposable. Single patient use only.
Tear here to open.
Do not recharge battery.
Position of pads on the chest of patient.
Dispose of properly in accordance with all state, province, and country regulations.
Do not incinerate or expose to open flame.
Explosion Hazard: Do not use in the presence of a flammable gas, including Concentrated oxygen.
Upper and lower temperature limits.
Device Model Number
Serial Number
Lot Number
Rev Revision
Lithium Sulfur Dioxide
Serial Communication Port
Additional information is provided in the AED Operator’s Manual.
Points to important information regarding the use of the AED.
Lift Here
Symbol for the marking of electrical and electronic equipment that must be recycled.
Section 1: Introduction
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Manufacturer
Authorized European Representative
Fragile; handle with care
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 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.
SAFETY AND PERFORMANCE STANDARDS
AED MODELS 2019198
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 2019198 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
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
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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 EN60601­2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard C22.2 No.
601.1-M90.
Section 1: Introduction
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.
Note: Keep valid certificates of training and certification as required by state, province, or country regulations.
Persons authorized to operate AEDs must have training in accordance to state, province or country regulations.
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FOR YOUR NOTES:
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Section 2: Getting Started
SECTION 2: GETTING STARTED
OVERVIEW
This section presents information on unpacking and setting up the AED
TOPIC PAGE #
UNPACKING AND INSPECTING 11
ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS
AED PARTS 12
INTELLISENSE® BATTERY 13
PADS 15
AED INDICATORS 16
SETTING THE AED INTERNAL CLOCK 18
VOICE PROMPTS AND TEXT DISPLAY 19
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.
ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS
See Section 6 – Technical Data, Parameters, Environmental Operation and Standby Conditions.
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 by checking temperature, humidity and pressure; if the daily self test determines environmental conditions outside of the AED’s operating parameters for 5 consecutive days, a "SERVICE REQUIRED" alert will be issued to prompt the user to move the AED to environmental conditions within the acceptable operating parameters at once. See Section 6 – Technical Data, Parameters, Operation and Standby Conditions.
11
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r
(
AED PARTS
The following drawings show the AED parts and their locations.
Battery Compartment
RescueReady Status Indicato
(Push in to open)
Serial Communication Port
Behind rubber data access cover)
Diagnostic Panel
Latch
Lid
Pad Expiration Window
Pad Holders
Speaker
Pad Connector
SHOCK/CONTINUE
Button
Text Display
THE AED HAS THREE MODES:
Operating Mode: Defined as having the battery installed and the lid open. This is the mode the AED would be in during
an actual rescue situation. Standby Mode: When the battery is installed, but the lid is closed. In this mode the AED is not being used in a rescue.
The device will conduct its routine self-tests to ensure proper operation. Storage Mode: When the battery is removed, such as during shipping or transport. With the battery removed, the AED is
unable to perform self-tests or rescues.
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INTELLISENSE® BATTERY
Section 2: Getting Started
INSTALLATION
Insert battery as shown.
Push firmly to snap into place.
Open the lid for 5 seconds.
The Status Indicator turns GREEN
ABOUT THE INTELLISENSE® BATTERY
When the last battery indicator (LED) is red, the battery is low. Replace the battery right away.
A new battery typically takes 10 seconds to charge the AED to maximum energy.
AED batteries will provide up to 290 shocks
Output voltage: 12VDC (max)
Batteries are non-rechargeable
Lithium contents: 9.2g (max)
MODEL TYPICAL SHOCKS
2019437(9142) Lithium Up to 290
Check local regulations for disposal information
2022105-201 Rev C Copyright © 2007 General Electric Company Page 13 of 51
BATTERY SHELF LIFE
The Responder AED 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)(30-122°F) will decrease battery life.
BATTERY INSTALLATION
WARNING: Battery is Not Rechargeable Do not attempt to recharge the battery. Any attempt to recharge the battery may result in an explosion or fire hazard.
CAUTION: Lithium Sulfur Dioxide Battery Pressurized contents: Never recharge, short circuit, puncture, deform, or expose to temperatures above 65°C (149°F). Remove the battery when discharged.
CAUTION: Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal, state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.
CAUTION: Use only General Electric Approved Equipment Using batteries, pads, cables, or optional equipment other than those approved by General Electric may cause the Responder 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
1. With the label on the battery facing the AED battery compartment, insert the battery as shown in the 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.
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Section 2: Getting Started
PADS
On the Responder AED, 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
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.
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 pads package label for operation temperatures.
1. Open the lid of the AED.
2. Place the pads 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.
3. Match the color of the connectors (red to red), 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 pad package completely secured to the AED lid, close the lid.
5. Make sure the expiration date is visible through the clear window of the lid.
Make sure that the STATUS INDICATOR is GREEN.
DIRECTIONS FOR USE:
1. 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 position.
5. Peel and place remaining pad.
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