Powerheart G3 Series Operator and Service Manual Rev A

Information in this document is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted. Trademark Information Cardiac Science, the Shielded Heart logo, Powerheart, FirstSave, Mastertrak, MDLink, STAR, Intellisense, Rescue Ready, RescueCoach, Rescuelink, RHYTHMx and Survivalink are trademarks of Cardiac Science Corporation. All other product and company names are trademarks or registered trademarks of their respective companies. Copyright © 2019 Cardiac Science Corporation. All Rights Reserved. Patents This device is covered by the following U.S. and foreign patents: 5,792,190; 5,999,493; 5,402,884; 5,579,919; 5,749,902; 5,645,571; 6,029,085; 5,984,102; 5,919,212; 5,700,281; 5,891,173; 5,968,080; 6,263,239; 5,797,969; D402,758; D405,754; 6,088,616; 5,897,576; 5,955,956; 6,083,246; 6,038,473; 5,868,794; 6,366,809; 5,474,574; 6,246,907; 6,289,243; 6,411,846; 6,480,734; 6,658,290; 5,850,920; 6,125,298; EP0725751; EP0757912; EP00756878

Other U.S. and foreign patents pending.

® ®

Cardiac Science Corporation 500 Burdick Parkway Deerfield, WI 53531, USA 800.426.0337 (USA) 262.953.3500 [email protected] www.cardiacscience.com ii

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Contents

Contents Chapter 1: Product Information and Safety Contact information ... 1-2 Defibrillator tracking ... 1-2 Product models... 1-3 Product references... 1-3 Warranty information... 1-3 Safety terms and definitions ... 1-3 Safety alert descriptions... 1-4 Symbol descriptions ... 1-8 Electromagnetic emissions standards compliance ... 1-11 Guidance and manufacturer’s declaration - electromagnetic emissions.. 1-11 Guidance and manufacturer’s declaration - electromagnetic immunity. 1-13 Recommended separation distances between portable and mobile RF communications equipment and the AED... 1-19

Chapter 2: Introduction AED description ... 2-1 Indications for use ... 2-2 Powerheart AED G3 and Powerheart AED G3 Automatic... 2-2 9131 Defibrillation Electrodes... 2-2 RHYTHMx AED ECG analysis algorithm ... 2-3 Detection rate... 2-3 Asystole threshold... 2-3 Noise detection... 2-3 Non-committed shock... 2-4 Synchronized shock ... 2-4 Pacemaker pulse detection ... 2-4 SVT discriminators... 2-4 SVT rate... 2-4 Rescue protocol ... 2-5 STAR® biphasic waveform ... 2-5 STAR biphasic energy protocols for Powerheart G3 AEDs ... 2-6 Operator training requirements ... 2-8 70-02062-02 A

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Contents

Chapter 3: Getting Started AED indicators ... 3-2 Rescue Ready status indicator ... 3-2 Audible maintenance indicator ... 3-2 Diagnostic panel ... 3-3 Setting the AED internal clock... 3-5 RescueCoach™ voice prompts and text display ... 3-6

Chapter 4: Data Management Recording rescue data ... 4-1 Reviewing rescue data ... 4-2

Chapter 5: Troubleshooting and Maintenance Self-tests... 5-1 Indicator troubleshooting table ... 5-3 Scheduled maintenance... 5-4 Daily maintenance... 5-4 Monthly maintenance... 5-4 Annual maintenance ... 5-5 Authorized repair service ... 5-6 Frequently Asked Questions... 5-7

Chapter 6: Technical Data Parameters ... 6-1 STAR biphasic waveform ... 6-7

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Limited Warranty Limited Warranty Cardiac Science Corporation (“Cardiac Science”) warrants to the original purchaser that its AEDs and stated battery operating life will be free of any defect in material and workmanship according to the terms and conditions of this Limited Warranty (“Limited Warranty”). For purposes of this Limited Warranty, the original purchaser is deemed to be the original end user of the product purchased. This Limited Warranty is NONTRANSFERABLE and UNASSIGNABLE.

For How Long? This Limited Warranty covers the following products or parts for the following time periods:

1.

Seven (7) years from the date of the original shipment to the original purchaser for Powerheart AED automated external defibrillators. Warranty duration for the pads, batteries and accessories are covered below.

2.

Disposable defibrillation pads shall be warranted until the expiration date.

3.

Lithium batteries P/N (9146) have a full operational replacement guarantee of four (4) years from the date of installation into a Powerheart AED.

4.

One (1) year from the date of original shipment to the original purchaser for Powerheart AED accessories. The terms of the Limited Warranty in effect as of the date of original purchase will apply to any warranty claims.

What You Must Do: Please complete and submit the Product Registration online at http:// www.cardiacscience.com/services-support/product-registration/. To obtain warranty service for your product: Inside the US, call us toll free at 800.426.0337 seven days a week, 24 hours a day. Our technical support representative will try to resolve your issue over the phone. If necessary, and at our sole discretion, we will arrange for service or a replacement of our product. Outside the US, contact your local Cardiac Science representative.

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What We Will Do: If your Cardiac Science product is returned within 30 days of the date it was purchased, at the direction of a technical support representative, we will repair or replace it with a new product of equal value at no charge to you or offer a full refund of the purchase price, provided the warranty applies. Cardiac Science retains the exclusive right to repair or replace the product or offer a full refund of the purchase price at its sole discretion. SUCH REMEDY SHALL BE YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF WARRANTY. If your Cardiac Science product is returned, at the direction of a technical support representative, after 30 days but within the warranty period, Cardiac Science, at its sole discretion, will repair your product or replace it. The repaired or replacement product will be warranted subject to the terms and conditions of this Limited Warranty for either (a) 90 days or (b) the remainder of the original warranty period, whichever is longer, provided the warranty applies and the warranty period has not expired.

Obligations and Warranty Limits: Limited Warranty Obligation: Exclusive Remedy THE FOREGOING LIMITED WARRANTY IS IN LIEU OF AND SPECIFICALLY EXCLUDES AND REPLACES ALL OTHER EXPRESSED 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 WARRANTY CONCERNING CARDIAC SCIENCE PRODUCTS, EXCEPT TO REFER PURCHASERS TO THIS LIMITED WARRANTY. YOUR EXCLUSIVE REMEDY WITH RESPECT TO ANY AND ALL LOSSES OR DAMAGES RESULTING FROM ANY CAUSE WHATSOEVER SHALL BE AS SPECIFIED ABOVE. CARDIAC SCIENCE SHALL IN NO EVENT BE LIABLE FOR ANY SPECIAL, PUNITIVE, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO, EXEMPLARY DAMAGES, COMMERCIAL LOSS FROM ANY CAUSE, BUSINESS INTERRUPTION OF ANY NATURE, LOSS OF PROFITS OR PERSONAL INJURY OR DEATH, EVEN IF CARDIAC SCIENCE HAS BEEN ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES, HOWEVER OCCASIONED, WHETHER BY NEGLIGENCE OR OTHERWISE. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

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What This Warranty Does Not Cover: This Limited Warranty does not cover defects or damages of any sort resulting from, but not limited to, accidents, damage while in transit to our service location, product tampering, unauthorized product alterations, unauthorized service, unauthorized product case opening, failure to follow instructions, improper use, abuse, neglect, fire, flood, war or acts of God. Cardiac Science makes no warranty claim as to the compatibility of Cardiac Science products with any non-Cardiac Science products, parts or accessories.

This Limited Warranty is Void if: 1.

Any Cardiac Science product is serviced or repaired by any person or entity other than Cardiac Science unless specifically authorized by Cardiac Science.

2.

Any Cardiac Science product case is opened by unauthorized personnel or if a product is used for an unauthorized purpose.

3.

Any Cardiac Science product is used in conjunction with incompatible products, parts or accessories, including but not limited to batteries. Products, parts and accessories are not compatible if they are not Cardiac Science products intended for use with the Powerheart AED.

If The Warranty Period has Expired: If your Cardiac Science product is not covered by our Limited Warranty: Inside the US, call us toll free at 1-800-426-0337 for advice as to whether we can repair your Powerheart AED, and for other repair information, including charges. Charges for non-warranty repairs will be assessed and are your responsibility. Upon completion of the repair, the terms and conditions of this Limited Warranty shall apply to such repair or replacement product for a period of 90 days. Outside the US, contact your local Cardiac Science representative. This warranty gives you specific legal rights, and you may also have other rights, which vary from state to state.

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1

Product Information and Safety Contents ◆

Contact information

1-2

◆

Defibrillator tracking

1-2

◆

Product models

1-3

◆

Product references

1-3

◆

Safety terms and definitions

1-3

◆

Safety alert descriptions

1-4

◆

Symbol descriptions

1-7

◆

Electromagnetic emissions standards compliance

1-11

Before Operating the Powerheart G3 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 Powerheart G3 AED.

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1-1

Product Information and Safety

Contact information Inside the United States: To order additional Powerheart G3 AEDs or accessories, contact Cardiac Science Customer Care: ◆

Toll Free (USA): 1.800.426.0337 (option 2)

◆

Telephone: +1.262.953.3500 (option 2)

◆

Fax: +1.262.953.3499

◆

Email: [email protected]

Cardiac Science provides 24-hour telephone technical support. You can also contact Technical Support though fax, email, or live web chat. There is no charge to the customer for a technical support call. Please have the serial and model numbers available when contacting Technical Support. (The serial and model numbers are located on the underside of the AED.) ◆

Toll Free (USA): 1.800.426.0337 (option 1)

◆

Telephone: +1.262.953.3500 (option 1)

◆

Fax: +1.262.798.5236

◆

Email: [email protected]

◆

www.cardiacscience.com

Outside the United States: Contact your local Cardiac Science representative to order devices or accessories and to receive technical support for your AED products.

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 Cardiac Science Technical Support in the event that your defibrillator is sold, donated, lost, stolen, exported, destroyed or if it was not purchased directly from Cardiac Science or an authorized dealer.

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Product models

Product models This manual is for Powerheart G3 Plus model 9390E and Powerheart G3 Plus Automatic 9390A AED models. They share a basic set of features and differences are noted throughout the manual.

Product references For purposes of retaining simple, clear instructions in this manual, note the product references used. Features, specifications, operating instructions and maintenance common to product models will be referred to as: “Powerheart G3 AED”, “AED”, or “device” refers to both Powerheart G3 model 9390E and Powerheart G3 Automatic model 9390A AEDs unless otherwise noted.

Warranty information The Powerheart G3 AED Operator and Service Manual and any and all information contained herein (except for the Limited Warranty chapter) do not constitute any warranty as to the Powerheart G3, Powerheart G3 Automatic or any related products in any manner whatsoever. The Limited Warranty chapter in this manual serves as the sole and exclusive warranty provided by Cardiac Science regarding Powerheart G3 AED products.

Safety terms and definitions The symbols shown below identify 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.

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Product Information and Safety

Safety alert descriptions The following is a list of Powerheart G3 AED safety alerts that appear in this section and throughout this manual. Read and understand these safety alerts before operating the AED.

! ! !

!

1-4

Caution: Read this Operator and Service Manual carefully. It contains information about your safety and the safety of others. Become familiar with the controls and how to use the AED properly before operating the product. DANGER! Fire and Explosion Hazard To avoid possible fire or explosion hazard, do not operate the AED: •

In the presence of flammable gases

•

In the presence of concentrated oxygen

•

In a hyperbaric chamber

WARNING! Shock Hazard and Possible Equipment Damage Defibrillation shock current flowing through unwanted pathways is potentially a serious electrical shock hazard and potential damage to the equipment. To avoid this hazard during defibrillation abide by all of the following: •

Do not use in standing water or rain. Move patient to dry area

•

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! 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.

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Safety alert descriptions

!

!

WARNING! Possible Radio Frequency (RF) Susceptibility. RF susceptibility from cellular phones, CB radios, FM 2-way radios and other wireless devices 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. WARNING! 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. (Cummins, R., ed., Advanced Cardiac Life Support; AHA (1994): Ch. 4) When placing Pads: • •

!

Do not place the pads directly over an implanted device. Place the pad at least one inch from any implanted device.

WARNING! Electromagnetic Compatibility. Use of accessories or cables other than those specified, with the exception of accessories and cables sold by Cardiac Science Corporation as replacement parts for internal components, may result in increased emissions or decreased immunity of the AED.

!

WARNING! Improper Equipment Placement. Position the AED away from other equipment. If it is necessary to use the AED adjacent to or stacked with other equipment, then observe the AED to verify normal operations.

!

Caution: Restricted Use. Federal law restricts this device for sale by or on the order of a physician or practitioner licensed by law of the state in which he/she practices.

!

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.

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Product Information and Safety

!

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 Cardiac Science Approved Equipment. Using batteries, pads, cables, or optional equipment other than those approved by Cardiac Science 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.

!

! !

1-6

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: Moving the Patient During a Rescue. During a rescue attempt, excessive jostling or moving of the patient may cause AEDs to improperly analyze the patient’s cardiac rhythm. Stop all motion or vibration before attempting a rescue. Caution: Systems Statement. Equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Anybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-11.

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Symbol descriptions

! !

Caution: Equipment Malfunction. Portable and RF communications equipment may affect the AED. Always observe the recommended separation distances as defined in the EMC declaration tables. Caution: Equipment Malfunction. The AED requires special precautions regarding EMC. Use the AED according to the guidelines of the EMC declaration tables.

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.

Symbol

IP24

Description

Symbol

Description

Caution. Consult accompanying documentation.

Additional information is provided in the AED Operation and Service Manual.

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.

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.

The AED is protected against the effects of splashing water in accordance with IEC 60529.

Do not recharge battery.

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Product Information and Safety

Symbol

Description

Symbol

Description

Classified by CSA International with respect to electric shock, fire and mechanical hazards only in accordance with CAN/CSA C22.2 No. 60601-1:08, EN60601-1 and EN60601-24. Certified to CAN/CSA Standard C22.2 No. 606011:08. Symbol for ON. Open the lid to turn on the AED.

0%

100%

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, press this button to deliver a defibrillation shock.

Serial communication port

A red indicator with a BLACK X means the AED requires operator attention or maintenance, and is not Rescue Ready.

A green indicator without a BLACK X means the AED is Rescue Ready.

Date of manufacture: year and month.

Date of factory recertification (R): year and month.

2 R

Latex free.

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Disposable. Single patient use only.

Powerheart® AED G3 PLUS 9390A AND 9390E

Symbol descriptions

Symbol

Description

Symbol

Description

Tear here to open.

Position of pads on the chest of patient.

For use by or on the order of a Physician, or persons licensed by state law.

Separate one pad from blue liner by peeling from the tabbed corner.

Do not incinerate or expose to open flame.

Upper and lower operating temperature limits.

Use pads by this date.

Serial Number

Device model number; battery model number

REF MODEL

2797

Device model number; battery model number

LOT

Lot number

Lithium sulfur dioxide

Authorized representative in the European Community

CE Mark: This equipment conforms to essential requirements of the Medical Device Directive 93/42/EEC.

Manufacturer

Waste Electronic Electrical Equipment (WEEE). Separate collection for waste electrical and electronic equipment.

Waste Electronic Electrical Equipment (WEEE) containing lead. Separate collection for waste electrical and electronic equipment.

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Pb

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Product Information and Safety

Symbol

Description Recycle cardboard according to local law.

1-10

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Symbol

Description Dispose of properly in accordance with all state, province, and country regulations.

Powerheart® AED G3 PLUS 9390A AND 9390E

Electromagnetic emissions standards compliance

Electromagnetic emissions standards compliance

Guidance and manufacturer’s declaration-electromagnetic emissions The AED is intended for use in the electromagnetic environment specified below. The customer or the user of the AED should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment-guidance

RF emissions

Group 1

The AED uses RF energy only for its internal function. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

CISPR 11

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Emissions test

Compliance

Electromagnetic environment-guidance

RF emissions

Class B

The AED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 Harmonic emissions

Not applicable

IEC 61000-3-2 Voltage fluctuations/flicker emissions

Not applicable

IEC 61000-3-3

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Electromagnetic emissions standards compliance

Guidance and manufacturer’s declaration-electromagnetic immunity The AED is intended for use in the electromagnetic environment specified below. The customer or the user of the AED should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Electrostatic discharge ±6 kV contact (ESD)

Compliance level ±6 kV contact

±8 kV air

±8 kV air

Electrical fast transient/burst

±2 kV for power supply lines

Not applicable

IEC 61000-4-4

±1 kV for input/output lines

Surge

±1 kV differential mode

IEC 61000-4-5

±2 kV common mode

IEC 61000-4-2

Powerheart® AED G3 PLUS 9390A AND 9390E

Electromagnetic environment- guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Not applicable

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