GE Medical Systems Responder AED Pro User Manual

Operator’s Manual

2023486-201rC

REVISION HISTORY

Part number Date Comment

2023486-201 Rev A October 2006 Initial Release 2023486-201 Rev B December 2006 AHA Guidelines added 2023486-201 Rev C July 2007 Revised for misc. minor updates, new symbols

and EMC table added

TABLE OF CONTENTS

SECTION 1: INTRODUCTION ......................................................................................... 3

OVERVIEW.................................................................................................................................. 3

AED PRO DESCRIPTION ........................................................................................................... 3

INDICATIONS FOR USE / INTENDED USE............................................................................... 3

SAFETY TERMS AND DEFINITIONS......................................................................................... 4

SAFETY TERMS AND CONDITIONS......................................................................................... 4

SAFETY ALERT DESCRIPTIONS .............................................................................................. 4

SYMBOL DESCRIPTIONS.......................................................................................................... 6

SAFETY AND PERFORMANCE STANDARDS.......................................................................... 9

OPERATOR TRAINING REQUIREMENTS .............................................................................. 10

SECTION 2: GETTING STARTED................................................................................. 11

OVERVIEW................................................................................................................................ 11

UNPACKING AND INSPECTING.............................................................................................. 11

ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS ........................................... 11

AED PRO PARTS...................................................................................................................... 12

INTELLISENSE

RECHARGEABLE BATTERY.................................................................................................... 15

DEFIBRILLATION ELECTRODES (PADS)............................................................................... 16

AED PRO INDICATORS ........................................................................................................... 17

SETTING THE AED PRO INTERNAL CLOCK ......................................................................... 19

VOICE PROMPTS AND TEXT DISPLAY.................................................................................. 20

SECTION 3: PERFORMING A RESCUE....................................................................... 23

OVERVIEW................................................................................................................................ 23

OPERATING MODES ............................................................................................................... 23

HOW TO PERFORM A RESCUE.............................................................................................. 24

USING MANUAL OVERRIDE (manual mode) .......................................................................... 27

WARNINGS ............................................................................................................................... 30

BATTERY ...................................................................................................... 13

SECTION 4: DATA MANAGEMENT ..............................................................................31

OVERVIEW................................................................................................................................ 31

RECORDING THE RESCUE DATA .......................................................................................... 31

REVIEWING THE RESCUE DATA ........................................................................................... 31

RESCUELINK OVERVIEW ....................................................................................................... 32

RESCUELINK INSTALLATION INSTRUCTIONS..................................................................... 33

MULTIPLE RESCUE FUNCTIONALITY ................................................................................... 33

SECTION 5: MAINTENANCE & TROUBLESHOOTING................................................35

OVERVIEW................................................................................................................................ 35

SELF-TESTS ............................................................................................................................. 35

INDICATOR TROUBLESHOOTING TABLE ............................................................................. 36

SCHEDULED MAINTENANCE .................................................................................................36

AUTHORIZED REPAIR SERVICE ............................................................................................ 37

FREQUENTLY ASKED QUESTIONS ....................................................................................... 38

SECTION 6: TECHNICAL DATA....................................................................................39

OVERVIEW................................................................................................................................ 39

PARAMETERS .......................................................................................................................... 39

RHYTHMX

STAR BIPHASIC ENERGY PROTOCOLS FOR RESPONDER AED PRO.............................. 45

ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS .................................................... 47

AED ECG ANALYSIS ALGORITHM..................................................................... 43

SECTION 7: ACCESSORIES .........................................................................................51

OVERVIEW................................................................................................................................ 51

RESPONDER AED Pro ............................................................................................................. 51

AED PRO ACCESSORIES........................................................................................................ 51

SECTION 8: CONTACT INFORMATION / CUSTOMER SERVICE ...............................53

Section 1: Introduction

SECTION 1: INTRODUCTION

OVERVIEW

Become familiar with the controls and how to use the AED PRO properly before operating the product.

TOPIC PAGE #

AED PRO DESCRIPTION 3

INDICATIONS FOR USE / INTENDED USE 3

SAFETY TERMS AND DEFINITIONS 4

SAFETY TERMS AND CONDITIONS 4

SAFETY ALERT DESCRIPTIONS 5

SYMBOL DESCRIPTIONS 6

SAFETY AND PERFORMANCE STANDARDS 8

OPERATOR TRAINING REQUIREMENTS 9

AED PRO DESCRIPTION

The AED Pro 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 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 Pro can be converted to manual override mode, and deliver a shock by pushing the SHOCK button. The AED Pro can also provide non-diagnostic ECG monitoring.

INDICATIONS FOR USE / INTENDED USE

The AED PRO with STAR Biphasic Waveform is intended to be used by medical professionals who have been trained in its operation. The operator should be qualified by training in basic life support, CPR/AED, and manual defibrillation. 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 Pro 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.

WARNING: When the patient is a child or infant under 8 years of age or weighs less than 55 lbs (25kg), the AED PRO should be used with the Model 2019199-003 Pediatric Attenuated Defibrillation Electrode Pads. Therapy should not be delayed to determine the patient’s exact age or weight.

SAFETY TERMS AND DEFINITIONS

BEFORE OPERATING THE RESPONDER AED PRO

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 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 cause minor personal injury, product damage, or property

damage.

SAFETY ALERT DESCRIPTIONS

The following is a list of Responder AED Pro 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 Pro.

DANGER: Fire and Explosion Hazard Do not use the AED Pro 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 use in water

• 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: Lithium Sulfur Dioxide Battery 2023681-001 (9145) 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 Pro! Failure to observe this warning can result in personal injury or death. Refer maintenance issues to authorized service personnel.

Section 1: Introduction

CAUTION: Temperature/Humidity/Pressure Extremes Exposing the AED Pro to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED Pro to function properly. The RescueReady environmental conditions on the AED Pro; if the daily self-test determines environmental conditions outside of the AED Pros operating parameters, a "SERVICE REQUIRED" alert will be issued to prompt the user to move the AED Pro to environmental conditions within the acceptable operating parameters at once. See Section 6 – 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 (Model 2023681-001) 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 Pro to function improperly during a rescue.

CAUTION: Damaged or Expired Pads Using pads that are damaged or expired may result in improper AED Pro 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 Pro, do not operate wireless radiotelephones within 2 meters of the AED Pro – 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 Pro has pacemaker detection and rejection, however, with some pacemakers the AED Pro 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 the AED Pro 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 60950-1 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: Environment of use Responder AED Pro is designed for indoor use. Operator must confirm that the environment of use meets the required operating environmental specifications before using.

daily self-test verifies the impact of extreme

Cummins, R., ed., Advanced Cardiac Life Support; AHA (1994): Ch. 4.

CAUTION: Cold Environments If the AED Pro is stored in an environment with a temperature below the operating temperature, the unit should be allowed to warm up to the needed operating temperature before using.

CAUTION: Not a Patient Monitor The AED Pro is not a true patient monitor with the requisite alarms. Medical personnel should attend patients at all times while the AED Pro is in use.

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 using older versions of ServiceLink and RescueLink 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 used. The software in most cases will give an error message when incompatibilities occur.

SYMBOL DESCRIPTIONS

The following symbols may appear in this manual, on the AED Pro, or on its optional components. Some of the symbols represent standards and compliances associated with the AED Pro 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 Pro.

Attention!: Identifies important information in this manual, on the AED Pro, or on its component parts regarding the safe and proper use of the AED Pro.

Defibrillator Proof Type BF Equipment: The AED Pro, 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 Pro 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 Pro.

Open the lid to turn ON the AED Pro.

Indicates the AED Pro battery status. The illuminated areas indicate the remaining battery capacity.

Indicates AED Pro 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.

A 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.

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.

Use pads by this date; install battery by this date.

Date of manufacture.

Date of factory recertification (R)

Latex Free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

1. Position of pads on the chest of patient.

2. When pads on screen are flashing, check defibrillation pads. The pads are missing, not connected or have compromised functionality.

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. Battery Model Number.

Serial Number

Lot Number

Rev Revision

Section 1: Introduction

Default start-up screen

Lithium Sulfur Dioxide

Lithium Ion

Additional information is provided in the AED Pro Operator’s Manual.

Points to important information regarding the use of the AED Pro.

Lift Here

Manufacturer

Authorized European Representative

Indicates placement of ECG leads and electrodes.

Symbol for the marking of electrical and electronic equipment that must be recycled.

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.

Section 1: Introduction

SAFETY AND PERFORMANCE STANDARDS

AED PRO MODELS 2023440

The AED Pro 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

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

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.

OPERATOR TRAINING REQUIREMENTS

Persons authorized to operate the AED Pro 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 Pro.

• Training in manual defibrillation

• 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.

Section 2: Getting Started

SECTION 2: GETTING STARTED

OVERVIEW

This section presents information on unpacking and setting up the AED Pro

TOPIC PAGE #

UNPACKING AND INSPECTING 11

ENVIRONMENTAL OPERATING AND STANDBY CONDITIONS

AED PRO PARTS 12

INTELLISENSE

RECHARGEABLE BATTERY 15

DEFIBRILLATION ELECTRODES (PADS) 16

AED INDICATORS 17

SETTING THE AED PRO INTERNAL CLOCK 19

VOICE PROMPTS AND TEXT DISPLAY 20

BATTERY 13

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 Pro to extreme environmental conditions outside of its operating parameters may compromise the ability of the AED Pro to function properly. The RescueReady environmental conditions on the AED Pro; if the daily self test determines environmental conditions outside of the AED Pro’s operating parameters, a "SERVICE REQUIRED" alert will be issued to prompt the user to move the AED Pro to environmental conditions within the acceptable operating parameters at once. See Section 6 – Technical Data, Parameters, Operation and Standby Conditions.

daily self test verifies the impact of extreme

(

AED PRO PARTS

The following drawings show the AED Pro parts and their locations.

Battery Compartment

RescueReady Status Indicato

(push in to open)

MANUAL OVERRIDE Button

Behind cover)

IR Port

Latch

Lid

Electrode Expiration Window

Pad/Electrode Holders

Speaker

Pad/Electrode Socket

Shock Button

Color Display

THE AED PRO HAS THREE MODES:

Operating Mode: Defined as having the battery installed and the lid open. This is the mode the AED Pro 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 Pro 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

Pro is unable to perform self-tests or rescues.

INTELLISENSE® BATTERY

Section 2: Getting Started

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 Pro to maximum energy.

• AED Pro batteries will provide up to 290 shocks

• Output voltage: 12VDC (max)

• Batteries are non-rechargeable

• Lithium contents: 9.2g (max)

MODEL TYPICAL SHOCKS

2023681 (9145) Lithium Up to 290

• Check local regulations for disposal information

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 Pro, without degrading its performance.

Note: Storing the battery outside its specific range (0-50°C)(30-122°F) will decrease battery life.

WARNING: Lithium Sulfur Dioxide Battery 2023681-001 (9145) 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 Manufacturer 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.

BATTERY INSTALLATION

Note: Batteries with part number 2023489-001 (9144) and 2023681-001 (9145) are for use only with Responder AED Pro and should not be used with other AEDs.

1. With the label on the battery facing the AED Pro battery compartment, insert the battery as shown in the drawing.

2. Push the latched end of the battery firmly into the AED Pro, 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 Pro 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.

Section 2: Getting Started

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 from the Responder AED Pro; the rechargeable battery can only be recharged when removed from the Responder AED Pro.

• Plug the charger into an appropriate electrical outlet.

• 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 Charge LED goes out, and the four green Fuel Gauge LEDs are continuously lit.

• 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.

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

Rechargeable with LED

Battery Capacity

Test Button

Rechargeable Battery (Also located on back)

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 Pro at all times. Refer to the pads package label for operation temperatures.

An audible and visual alert will indicate after the self-test if the pads are missing, unplugged or damaged.

CAUTION: Damaged or Expired Pads

Using pads that are damaged or expired may result in improper AED Pro performance.

PAD INSTALLATION

1. Open the lid of the AED Pro.

2. Place the pad 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

CAUTION: Use only Approved Equipment Using batteries, defibrillation pads, cables, or optional equipment other than those approved by General Electric may cause the AED Pro to function improperly during a rescue.

CAUTION: Possible Improper AED Pro Performance Using defibrillation pads that are damaged or expired may result in improper AED Pro performance.

CAUTION: Both polarized and non-polarized defibrillation pads are available for Responder AED Pro. If using polarized pads, always place sternum and apex pads as shown on the packaging. Non-polarized pads may be placed in either position for a rescue; however, the ECG waveform will be correctly displayed in only one position. To correctly display an inverted ECG, simply reverse the defibrillation pads.

then be readable without opening the lid of the AED Pro.

3. Match the color of the connectors (red to red), slightly lift the tab of the pad socket then plug the pad connector into the AED Pro 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 Pro lid, close the lid.

5. Make sure the expiration date is visible through the clear window of the lid.

6. 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.

5. Peel and place remaining pad.

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