Philips M5066A Users Manual HS1 OM ENG

M5066A to the manual d30c345d-743f-4e9d-82ce-5292b2e39e1c

2015-02-05

: Philips Philips-M5066A-Users-Manual-375154 philips-m5066a-users-manual-375154 philips pdf

Open the PDF directly: View PDF .
Page Count: 70

HeartStart Defibrillator

OWNER’S MANUAL

Guide to Set Up, Operation, Maintenance, and Accessories

M5066A

Edition 7

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

The HeartStart Defibrillator M5066A

Pads Cartridge Handle.

Pull the handle to turn on the

HeartStart and remove the

cartridge’s hard cover.

Ready Light. This green light

tells you the readiness of the

HeartStart.

Blinking: standby mode

(ready for use)

Solid: in use

Off: needs attention

(HeartStart

“chirps” and

i-button flashes)

On/Off Button. Press this

green button to turn on the

HeartStart. To turn off the

HeartStart, press the green button

again and hold it down for one (1)

second.

Information Button. This

blue “i-button” flashes when it

has information you can access by

pressing it. It also flashes at the

beginning of a patient care pause

when CPR coaching is enabled.

Caution Light. This triangular

light flashes during rhythm

analysis and is on when a shock is

advised, as a reminder that no one

should be touching the patient.

Shock Button. When

instructed by the HeartStart to

deliver a shock, press this flashing

orange button .

Infrared (IR)

Communications Port. This

special lens, or “eye,” is used to

transfer HeartStart data directly to

or from a computer.

Speaker. When the device is

being used, its voice instructions

come from this speaker.

Beeper. The HeartStart

“chirps” through this beeper to

alert you when it needs attention.

SMART Pads Cartridge. This

disposable cartridge contains self-

adhesive pads with attached cable.

Shown with adult pads cartridge.

SMART Pads Cartridge

Latch. Slide the latch to the right

to release the pads cartridge for

replacement.

Battery. The non-

rechargeable battery is inserted in

a recess on the back of the

HeartStart.

top top

front view

back view

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

HeartStart Defibrillator M5066A

QUICK REFERENCE

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

HeartStart

M5066A

Automated External Defibrillator

Edition 7

IMPORTANT NOTE:

It is important to understand that survival rates for sudden cardiac arrest

are directly related to how soon victims receive treatment. For every

minute of delay, the chance of survival declines by 7% to 10%.

Defibrillation cannot assure survival. In some victims, the underlying problem

causing the cardiac arrest is simply not survivable despite any available care.

OWNER’S MANUAL

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

HEARTSTART M5066A

About this edition

The information in this guide applies to

the model M5066A HeartStart Defibrillator. Its

technical contents apply to all models

in the HeartStart HS1 family of defibrillators,

including the HeartStart, the HeartStart OnSite,

and the HeartStart First Aid Defibrillator. This

information is subject to change. Please contact

Philips at www.medical.philips.com/heartstart or

contact your local Philips representative for

information on revisions.

Edition history

Edition 7

Publication date: July 2007

Publication #: M5066-91901

Assembly #: 011872-0007

Printed in the U.S.A.

No part of this publication may be reproduced,

transmitted, transcribed, stored in a retrieval

system or translated into any human or

computer language in any form by any means

without the consent of the copyright holder.

Unauthorized copying of this publication may

not only infringe copyright but also reduce the

ability of Philips Medical Systems to provide

accurate and up-to-date information to users

and operators alike.

Authorized EU representative

Philips Medizin Systeme Boeblingen GmbH

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

(+49) 7031 463-2254

CAUTION: Federal law (USA) restricts this

device to sale by or on the order of a physician.

The Philips HeartStart Defibrillator is designed to

be used only with Philips-approved accessories.

The HeartStart may perform improperly if non-

approved accessories are used.

Device tracking

In the U.S.A., this device is subject to tracking

requirements by the manufacturer and distributors.

If the defibrillator has been sold, donated, lost,

stolen, exported, or destroyed, notify Philips

Medical Systems or your distributor.

Device manufacturer

The HeartStart Defibrillator is manufactured by

Philips Medical Systems, Seattle, Washington, USA.

Patents

This product is manufactured and sold under one

or more of the following United States patents:

US6047212, US6317635, US5892046, US5891049,

US6356785, US5650750, US6553257, US5902249,

US6287328, US6662056, US5617853, US5951598,

US6272385, US6234816, US6346014, US6230054,

US6299574, US5607454, US5803927, US5735879,

US5749905, US5601612, US6441582, US5889388,

US5773961, US6016059, US6075369, US5904707,

US5868792, US5899926, US5879374, US5632280,

US5800460, US6185458, US5611815, US6556864,

US5607454, and other patents pending.

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

CONTENTS

1 Introduction to the HeartStart

Description ........................................................................................................... 1-1

Sudden Cardiac Arrest ....................................................................................... 1-1

Indications for Use .............................................................................................. 1-1

Training and practice .......................................................................................... 1-2

National and local requirements ...................................................................... 1-2

For more information ......................................................................................... 1-2

2 Setting up the HeartStart

Package contents ................................................................................................. 2-1

Setting up the HeartStart ................................................................................... 2-1

Recommended accessories ............................................................................... 2-3

3 Using the HeartStart

Overview ............................................................................................................... 3-1

STEP 1: PULL the green handle ........................................................................ 3-2

STEP 2: PLACE the pads .................................................................................... 3-3

STEP 3: PRESS the Shock button ..................................................................... 3-3

Treating infants and children ............................................................................ 3-4

When emergency medical services arrive ..................................................... 3-6

4 After using the HeartStart

After each use ...................................................................................................... 4-1

HeartStart data storage ..................................................................................... 4-1

5 Maintaining the HeartStart

Routine Maintenance .......................................................................................... 5-1

Periodic checks .................................................................................................... 5-1

Cleaning the HeartStart ..................................................................................... 5-2

Disposing of the HeartStart .............................................................................. 5-2

Troubleshooting tips ........................................................................................... 5-2

Philips Medical Systems

HEARTSTART M5066A

APPENDICES

A Accessories for the HeartStart

B Glossary of terms

C Glossary of symbols/controls

D Warnings and precautions

E Technical information

F Configuration

G Testing and troubleshooting

H Additional technical information required for European conformity

Philips Medical Systems

1-1

1 Introduction to the HeartStart

Description

The HeartStart Defibrillator M5066A is part of the Philips HeartStart HS1 family

of defibrillators. Small, lightweight, and battery powered, it is designed for simple

and reliable operation.

Sudden Cardiac Arrest

The HeartStart is used to treat the most common causes of sudden cardiac arrest

(SCA), including ventricular fibrillation (VF). SCA is a condition that occurs when

the heart unexpectedly stops pumping. SCA can occur to anyone – infant, child,

adult, male or female – anywhere, at any time. Many victims of SCA do not have

warning signs or symptoms.

VF is a chaotic quivering of the heart muscle that prevents it from pumping blood.

The only effective treatment for VF is defibrillation. The HeartStart treats VF by

sending a shock across the heart, so it can start beating regularly again. Unless this

is successful within the first few minutes after the heart stops beating, the victim is

not likely to survive.

Indications for Use

The HeartStart should be used to treat someone you think may be a victim of

SCA. A person in SCA:

• does not respond when shaken, and

• is not breathing normally.

If in doubt, apply the pads. Follow the voice instructions for each step in using the

defibrillator.

1-2

Philips Medical Systems

HEARTSTART M5066A

Training and practice

The HeartStart is one part of a well-designed emergency response plan. Any

emergency response plan should be under the oversight of a physician and should

include training in cardiopulmonary resuscitation (CPR). Philips recommends that

you train on the device you will be using.

Several national and local organizations offer combined CPR/defibrillator training.

Contact your Philips representative, or visit us on-line at

www.medical.philips.com, for information about training programs in your area.

NOTE: Training accessories are available from Philips for practicing use of the

HeartStart. See Appendix A for information on ordering accessories.

National and local requirements

Check with your local health department to see if there are any national or local

requirements about owning and using a defibrillator.

For more information

Contact your local Philips representative for additional information about the

HeartStart. They will be happy to answer any questions you may have and to

provide you with copies of the clinical summaries of several key studies using

Philips automated external defibrillators.*

You can also find the clinical summaries online at www.medical.philips.com/

heartstart. Technical information about all Philips HeartStart automated external

defibrillators is also available online, in the Technical Reference Guide for HeartStart

Defibrillators.

* Clinical summaries also include Heartstream ForeRunner and FR2 Defibrillators.

Philips Medical Systems

2-1

2 Setting up the HeartStart

Package contents

Check the contents of the HeartStart Defibrillator M5066A box to be sure it

contains:

• 1 HeartStart Defibrillator

• 1 battery M5070A

• 1 Adult SMART Pads Cartridge M5071A,

containing one set of adhesive defibrillation pads

• 1 Owner’s Manual

• 1 Quick Reference Guide

Training materials and optional accessories for the HeartStart are also available

from Philips. See Appendix A for a description of these items.

Setting up the HeartStart

Setting-up the HeartStart Defibrillator is simple and quick.

1. Remove the HeartStart from its packaging.

2. Remove a new SMART Pads Cartridge from its package.*

* To replace a used cartridge or insert a different cartridge,

first locate the latch at the top edge of the defibrillator, and

slide it to the side. The pads cartridge will be released. Lift

out the cartridge and replace as described in steps 2 and 3.

2-2

Philips Medical Systems

HEARTSTART M5066A

3. Insert the cartridge into the cartridge well on the front of the defibrillator. It

should click into place when properly seated. The green PULL handle should

be all the way down.

NOTE: To prevent the pads’ adhesive gel from drying out, do not open the hard

cover or film seal of the cartridge until you need to use the pads.

4. Remove the battery from its packaging. Install it in the battery compartment

on the back of the defibrillator.

5. The HeartStart will automatically run a self-test when the battery is inserted.

Press the Shock button when instructed. When the self-test is over, the

defibrillator will report the result, and tell you to push the green On/Off

button in case of an emergency. (Do not push the green button unless this is an

actual emergency.) Then the defibrillator will turn off and go to standby mode.

The green Ready light will be blinking to show the HeartStart is ready

for use.*

NOTE: Always store the HeartStart with a pads cartridge and a battery installed,

so it will be ready to use and can perform daily self-tests.

* As long as a battery is installed, turning the HeartStart “off” puts it into standby mode,

which means that it is ready for use.

55+ lbs / 25+ kg

2-3

Philips Medical Systems

6. Place the defibrillator in the carry case, pressing it firmly into place. Insert the

Quick Reference Guide,* face up, in the clear plastic window on the inside of

the case. If you purchased a spare SMART Pads Cartridge or an Infant/Child

Pads Cartridge, place it in the storage area in the case.

NOTE: Do not store anything in the defibrillator carry case that it is not

designed to accommodate. Store all objects in their intended location in the

case.

7. Store the HeartStart in accordance with your site’s emergency response

protocol. Typically, this will be in a high-traffic area that is easy to access,

convenient for checking the Ready light periodically, and easy to hear the

alarm chirp if the battery power gets low or the defibrillator needs attention.

Ideally, the HeartStart should be stored near a telephone, so the Emergency

Response Team or Emergency Medical Services can be alerted as fast as

possible in the event of a possible SCA. If possible, keep the spare SMART

Pads Cartridge and other accessories with the defibrillator – in the carry case

if one is used – for quick access when needed. In general, treat the HeartStart

as you would any piece of electronic equipment, such as a computer. Be sure

to store the defibrillator according to its specifications. See Appendix E for

details. As long as a battery and a pads cartridge are installed, the green Ready

light should be blinking to show that the HeartStart has passed its most

recent self-test and is therefore ready to use.

NOTE: If you have a training pads cartridge, it is recommended that you

store it separately from the HeartStart, so the training pads cannot be confused

with the regular pads in an emergency.

* The illustration on the cover of the Quick Reference Guide is a 3-step guide to using the

HeartStart. Detailed illustrated directions are inside, for reference in an emergency, or if

you are hearing impaired or using the HeartStart where it is hard to hear the voice

instructions.

2-4

Philips Medical Systems

HEARTSTART M5066A

Recommended accessories

It is always a good idea to have a spare battery and a spare pads set. Other things

that are useful to keep with the HeartStart include:

• scissors — for cutting the victim’s clothes if needed

• disposable gloves — to protect the user

• a disposable razor — to shave the chest if hair prevents good pads

contact

• a pocket mask or face shield — to protect the user

• a towel or absorbent wipes — to dry the victim's skin for good pads

contact

Philips has a Fast Response Kit with all these items. See Appendix A for details.

If you may need to defibrillate an infant or a child under 25 kg (55 pounds) or 8 years

old, it is recommended that you order the Infant/Child SMART Pads Cartridge,

available separately. When the Infant/Child Pads Cartridge is installed in the

HeartStart, the HeartStart automatically reduces the defibrillation energy to an

energy level more appropriate for infants and children. In addition, if optional CPR

coaching is selected, the HeartStart provides coaching appropriate for infants and

children. Directions for using the Infant/Child SMART Pads are provided in

Chapter 3, “Using the HeartStart.”

Philips Medical Systems

3-1

3 Using the HeartStart

IMPORTANT NOTE: Be sure to read the Reminders section at the end of this

chapter as well as the warnings and precautions in Appendix D.

Overview

If you think someone is in SCA, act quickly and calmly. If someone else is available,

ask him or her to call for emergency medical assistance while you get the

HeartStart. If you are alone, follow these steps:

• Call your emergency services provider.

• Quickly get the HeartStart and bring it to the victim’s side. If there is any

delay in getting the defibrillator, check the patient and perform

cardiopulmonary resuscitation (CPR) if needed until the HeartStart is

available.

• If the patient is an infant or child, first perform CPR, then call for

emergency medical services (EMS) before you apply the HeartStart. See

special section on treating infants and children on page 3-5.

• Check the immediate environment for flammable gases. Do not use the

HeartStart in the presence of flammable gases, such as an oxygen tent.

However, it is safe to use the HeartStart on someone wearing an oxygen

mask.

There are three basic steps to using the defibrillator to treat someone who may be

in sudden cardiac arrest:

1. PULL up the handle on the SMART Pads Cartridge.

2. PLACE the pads on the patient’s bare skin.

3. PRESS the flashing Shock button if instructed.

The following pages provide details about each step.

3-2

Philips Medical Systems

HEARTSTART M5066A

STEP 1: PULL the green handle

Turn on the HeartStart by pulling the SMART Pads Cartridge’s green handle.*

Remove the hard cover from the pads cartridge and set it aside. Remain calm and

follow the HeartStart’s instructions.

The HeartStart starts by directing you to remove all clothes from the patient’s

chest. If necessary, rip or cut off the clothing to bare the person’s chest

* You can also turn on the HeartStart Defibrillator by pressing the green On/Off button.

55+ lbs / 25+ kg

3-3

Philips Medical Systems

STEP 2: PLACE the pads

Pull the tab at the top of the pads cartridge to peel off the film seal. Inside are two

adhesive pads on a plastic liner. Remove the pads from the cartridge.

Peel one pad off the liner. Place the pad on the patient’s bare skin, exactly as shown

in the picture on the pad. Press the pad down firmly. Then repeat this with the other

pad. Be sure the pads have been removed from the liner before placing them.

Where to place pads on adults and children over

25 kg/55 pounds or 8 years old (anterior-anterior).

Where to place pads on infants or children under

25 kg/55 pounds or 8 years old (anterior-posterior).

3-4

Philips Medical Systems

HEARTSTART M5066A

STEP 3: PRESS the Shock button

As soon as the HeartStart detects that the pads are attached to the patient, it

begins analyzing the patient’s heart rhythm. It tells you that no one should be

touching the patient, and the Caution light begins flashing as a reminder.

If a shock is needed:

The Caution light goes from flashing to solid, the orange Shock button

starts flashing, and the defibrillator tells you to press the flashing orange button.

Before you press the button, make sure no one is touching the patient. When you

press the Shock button, the defibrillator tells you that the shock has been

delivered. Then the HeartStart tells you it is safe to touch the patient, instructs

you to begin CPR, and invites you to press the flashing blue i-button for CPR

Coaching if desired.

If a shock is not needed:

The HeartStart tells you it is safe to touch the patient and instructs you to

perform CPR if needed. (If CPR is not needed – for example, if the patient is

moving or regaining consciousness – follow your local protocol until emergency

medical personnel arrive.) Then the HeartStart invites you to press the flashing

blue i-button for CPR Coaching, if desired.

For CPR Coaching:

Press the flashing blue i-button during the first 30 seconds of the patient care

pause to activate CPR Coaching.* (If the Infant/Child SMART Pads Cartridge is

inserted, CPR Coaching will provide coaching for infant/child CPR.) When the

pause is over, the defibrillator tells you to stop CPR, so it can analyze the patient’s

heart rhythm. The motion caused by CPR can interfere with analysis, so be sure to

stop all motion when instructed.

* The default configuration for the HeartStart provides CPR Coaching when you press the

i-button in this situation; however, the default setting can be revised by your Medical

Director using Philips software available separately. See Appendix F for more

information.

3-5

Philips Medical Systems

Treating infants and children

WARNING: Most cardiac arrests in children are not caused by heart problems.

When responding to cardiac arrest in an infant or child:

• Provide infant/child CPR while a bystander calls EMS and brings the

HeartStart.

• If no bystander is available, provide 1-2 minutes of CPR before calling EMS

and retrieving the HeartStart.

• If you witnessed the child's collapse, call EMS immediately and then get the

HeartStart.

Alternatively, follow your local protocol.

If the patient is under 55 pounds or 8 years old, and you have an Infant/Child Pads

Cartridge:

• Remove the Infant/Child Pads Cartridge from its package.*

• Locate the latch at the top edge of the defibrillator, and slide it to the

side. The pads cartridge will be released. Remove the old cartridge.

• Install the new cartridge: slide the bottom end of the cartridge into the

recess, then press in the cartridge until the latch clicks into place. Be sure

the green handle is pressed down firmly. The HeartStart will tell you that

Infant/Child pads have been inserted, then it will turn off to be ready for

use.

• Pull the green handle to start the rescue.

• Remove all clothing from the upper body, to bare both the chest and the

back. Place one pad in the center of the chest between the nipples, and

the other in the center of the back (anterior-posterior).

With the Infant/Child Pads Cartridge inserted, the HeartStart automatically

reduces the defibrillation energy from the adult dose of 150 joules to 50 Joules†

and provides optional infant/child CPR Coaching. Place the pads exactly as shown

on the illustration on the pads.

* Philips recommends that the HeartStart be stored with an adult pads cartridge installed,

as pediatric cardiac arrest is not common.

† This lower energy level may not be effective for treating an adult.

3-6

Philips Medical Systems

HEARTSTART M5066A

If the patient is under 55 pounds or 8 years old, but you do NOT have an Infant/Child

Pads Cartridge:

• DO NOT DELAY TREATMENT.

• Remove all clothing from the torso, to bare both the chest and the back.

• Apply the HeartStart using the adult pads cartridge, but place one pad in the

center of the chest between the nipples, and the other in the center of the

back (anterior-posterior).

If the patient is over 55 pounds or 8 years old, or if you are not sure of the exact weight

or age:

• DO NOT DELAY TREATMENT.

• Remove all clothing from the chest.

• Apply the HeartStart using the adult pads cartridge, and place the pads as

illustrated on the pads (anterior-anterior). Make sure the pads do not overlap

or touch each other.

When emergency medical services arrive

When Emergency Medical Services (EMS) personnel arrive to care for the patient,

they may decide to apply another defibrillator to allow monitoring of the patient.

The SMART Pads should be removed from the patient prior to using another

defibrillator. EMS personnel may want a summary of the last-use data* stored in

the HeartStart. To hear the summary data, hold down the i-button until the

HeartStart beeps.

NOTE: After the EMS team removes the SMART Pads from the patient,

remove the used pads cartridge, and insert a new pads cartridge before

returning the HeartStart to service, to be sure it is ready for use.

* See Chapter 4, “After using the HeartStart” for details about data storage.

3-7

Philips Medical Systems

Reminders •Remove any medicine patches and residual adhesive from the patient’s chest

before applying the pads.

•Do not allow the pads to contact other electrodes or metal parts that are in

contact with the patient.

•Avoid placing the pads directly over an implanted pacemaker or defibrillator.

A noticeable lump with a surgical scar should indicate the position of an

implanted device.

•If the pads do not stick well, check that the pads adhesive has not dried out.

Each pad has a layer of adhesive gel. If the gel is not sticky to the touch,

replace the pads with a new set.

•Keep the patient still and keep any movement around the patient to a

minimum during rhythm analysis. Do not touch the patient or the pads while

the Caution light is on solid or flashing. If the HeartStart is unable to analyze

due to electrical “noise” (artifact), it will tell you to stop all movement and

remind you not to touch the patient. If the artifact continues for more than

30 seconds, the HeartStart will pause briefly to allow you to deal with the

source of the noise, then resume analysis.

•The HeartStart will not deliver a shock unless you press the flashing orange

Shock button. If you do not press the Shock button within 30 seconds after

the defibrillator tells you to, it will disarm itself, and (for the first CPR

interval) give a reminder to make sure emergency medical services have been

called, then begin a CPR interval. This is designed to minimize interruption of

CPR and help ensure ongoing patient support.

•While waiting for you to press the Shock button, the HeartStart will

continue to analyze the heart rhythm. If the patient’s rhythm changes before

you press the Shock button, and a shock is no longer needed, the

defibrillator will disarm and tell you a shock is not advised.

•If for any reason you want to turn off the defibrillator during a use, you can

press the On/Off button – holding it down for at least one second – to

return the device to standby mode.

Philips Medical Systems

HEARTSTART M5066A

Notes

Philips Medical Systems

4-1

4 After using the HeartStart

After each use

1. Check the outside of the HeartStart for signs of damage, dirt, or

contamination. If you see signs of damage, contact Philips for technical

support. If the defibrillator is dirty or contaminated, clean it according to the

guidelines in Chapter 5, “Maintaining the HeartStart.”

2. Insert a new SMART Pads cartridge into the HeartStart. Check supplies and

accessories for damage and expiration dates. Replace any used, damaged or

expired items. For directions on changing the pads and replacing the battery,

please see Chapter 2, “Setting up the HeartStart.” The single-use pads must

be replaced after being used.

3. Unless your protocol requires that the battery remain installed, remove the

battery for five seconds, then reinstall it to run the battery insertion self-test

to check the operation of the defibrillator.* When the test is complete, check

that the green Ready light is blinking.

4. Return the HeartStart to its storage location so it will be ready for use when

needed.

HeartStart data storage

The HeartStart automatically stores data about its last clinical use in its internal

memory. The stored data can be conveniently transferred to a personal computer

or a handheld computer running the appropriate application in the Philips

HeartStart Event Review data management software suite. Event Review software

is for use by trained personnel only. Information about HeartStart Event Review is

available online at www.medical.philips.com/goto/eventreview.

* If you leave the battery in the HeartStart after using the defibrillator, then transfer the

last-use data to a computer running HeartStart Event Review software, the software will

calculate the local date and time of the device use. However, if you remove the battery

prior to transferring the data, the software will only show elapsed time.

4-2

Philips Medical Systems

HEARTSTART M5066A

Follow your local protocol with regard to prompt data transfer for medical review

after using the HeartStart.* Details about data transfer and timing are provided in

Event Review documentation.

The information automatically stored by the HeartStart includes a summary of

last-use data and detailed data about its last clinical use. You can get a voice

summary of information about the last use of the defibrillator by holding the i-

button down until it beeps once. The HeartStart will tell you how many shocks

were delivered and how long it has been since it was turned on. Summary data are

available anytime the defibrillator is ready for use (the battery and pads are

installed, and the defibrillator is not turned on) or while it is actually in use.

Removing the battery erases the summary data for the last use.

Last-use data stored in internal memory include:

• ECG recordings (a maximum of 15 minutes following pads application†)

• the HeartStart’s status (entire incident)

• the HeartStart’s rhythm analysis decisions (entire incident)

• the elapsed time associated with stored events (entire incident)

* The HeartStart automatically stores information about its last clinical use in its internal

memory for at least 30 days, so the data can be downloaded to a computer running

appropriate Event Review software. (If the battery is removed during this period, the

defibrillator retains the files. When the battery is reinstalled, the last-use ECG recording

will be kept in defibrillator memory for an additional 30 days.) After this time, the last-

use ECG recordings will automatically be erased to prepare for a future use.

† If ECG recordings from a previous use have not been erased, the maximum time for new

ECG recordings may be less.

Philips Medical Systems

5-1

5 Maintaining the HeartStart

Routine Maintenance

The HeartStart is very simple to maintain. The defibrillator performs a self-test

every day. In addition, a battery insertion self-test is run whenever a battery is

installed in the device. The defibrillator’s extensive automatic self-test features

eliminate the need for any manual calibration. The HeartStart has no user-

serviceable parts.

WARNING: Electrical shock hazard. Do not open the HeartStart, remove its

covers, or attempt repair. There are no user-serviceable components in the

HeartStart. If repair is required, return the HeartStart to Philips for service.

Reminders:

• Do not leave the HeartStart without a pads cartridge installed; the

defibrillator will start chirping and the i-button will start flashing. For

directions on changing the pads cartridge, see Chapter 2, “Setting up the

HeartStart.”

• The HeartStart runs daily self-tests. As long as the green Ready light is

blinking, it is not necessary to test the defibrillator by initiating a battery

insertion self-test. This uses battery power and risks draining the battery

prematurely.

Periodic checks

Other than the checks recommended after each use of the HeartStart,

maintenance is limited to periodically checking the following:

• Check the green Ready light. If the green Ready light is not blinking, see

Troubleshooting Tips, below.

• Replace any used, damaged or expired supplies and accessories

• Check the outside of the defibrillator. If you see cracks or other signs of

damage, contact Philips for technical support.

5-2

Philips Medical Systems

HEARTSTART M5066A

Cleaning the HeartStart

The outside of the HeartStart and its carry case can be cleaned with a soft cloth

dampened in soapy water, chlorine bleach (2 tablespoons per quart or liter of

water), or ammonia-based cleaners.

Reminders:

•Do not use isopropyl (rubbing) alcohol, strong solvents such as acetone or

acetone-based cleaners, abrasive materials, or enzymatic cleaners to clean

your HeartStart.

•Do not immerse the HeartStart in fluids or allow fluids to spill onto it.

Do not sterilize the defibrillator or its accessories.

Disposing of the HeartStart

The HeartStart and its accessories should be disposed of in accordance with local

regulations.

Troubleshooting tips

The HeartStart’s green Ready light is your guide to knowing if the defibrillator is

ready for use.

• If the Ready light is blinking: The HeartStart has passed the battery

insertion self-test and the last periodic self-test and is therefore ready

for use.

• If the Ready light is solid: The HeartStart is in use or running a self-test.

• If the Ready light is off, the HeartStart is chirping, and the i-button is

flashing: A self-test error has occurred, there is a problem with the pads

or the battery power is low. Press the i-button for instructions.

• If the Ready light is off but the HeartStart is not chirping and the i-button

is not flashing: there is no battery inserted, the battery is depleted, or the

defibrillator needs repair. Insert/replace battery and run the self-test. As

long as the HeartStart passes the self-test, you can be assured it is ready

for use.

More detailed testing and troubleshooting information is available in

Appendix G.

Philips Medical Systems

A-1

A Accessories for the HeartStart

Accessories* for the HeartStart Defibrillator available separately from your Philips

representative or on-line at www.medical.philips.com/heartstart include:

• Battery (spare recommended) [REF: M5070A]

•Pads

• Adult SMART Pads Cartridge (spare recommended) [REF: M5071A]

• Infant/Child SMART Pads Cartridge [REF: M5072A]

• Carry Cases

• Standard carry case, with paramedic’s scissors and room for spare pad

cartridge and battery [REF: M5075A]

• Slim carry case, with paramedic’s scissors [REF: M5076A]

• Plastic waterproof hardshell carry case [REF: YC]

• Fast Response Kit (pouch containing a pocket mask, a disposable razor, 2 pairs

of gloves, a pair of paramedic’s scissors, and an absorbent wipe)

[REF: 68-PCHAT]

• Data Management Software

• HeartStart Configure PDA software [REF: 989803143041]

• HeartStart CaseCapture PDA software [REF: 989803143051]

• HeartStart Review Express Connect [REF: 861311 option A01]

• HeartStart Event Review, single PC license [REF: M3834A]

• HeartStart Event Review, organization-wide license [REF: 989803141811]

• HeartStart Event Review Pro, single PC license [REF: 861276 option A01]

• HeartStart Event Review Pro, three-PC license [REF: 861276 option A02]

• HeartStart Event Review Pro, organization-wide license

[REF: 861276 option A03]

• Infrared cable for use with HeartStart Event Review software [REF: ACT-IR]

• HeartStart Defibrillator Quick Reference [REF: M5066-97800]

* Certain accessories require a prescription in the United States.

A-2

Philips Medical Systems

HEARTSTART M5066A

• Training

• Adult Training Pads Cartridge [REF: M5073A]

• Adult Training Replacement Pads [REF: M5093A]

• Adult Pads Placement Guide [REF: M5090A]

• Infant/Child Training Pads Cartridge [REF: M5074A]

• Infant/Child Training Replacement Pads [REF: M5094A]

• Infant/Child Pads Placement Guide [REF: 989803139281]

• HeartStart HS1 and FR2+ Instructor's Training Toolkit, NTSC

[REF: M5066-89100] or PAL [REF: M5066-89101]

• HeartStart Trainer [REF: M5085A]

• Internal Manikin Adapter [REF: M5088A]

• External Manikin Adapter, 5 pack [REF: M5089A]

Philips Medical Systems

B-1

BGlossary of terms

The terms listed in this Glossary are defined in the context of the Philips

HeartStart Defibrillator and its use.

AED Automated external defibrillator (a semi-automatic defibrillator).

AED mode The standard treatment mode for the HeartStart Defibrillator. It provides voice

instructions guiding the rescuer through applying the adhesive pads, waiting for

rhythm analysis, and delivering a shock if needed.

analysis See “SMART analysis.”

arrhythmia An unhealthy, often irregular, beating of the heart.

artifact Electrical “noise” caused by sources such as muscle movements, CPR, patient

transport, or static electricity that may interfere with rhythm analysis.

battery The sealed lithium manganese dioxide battery used to power the HeartStart

Defibrillator. It is provided in a pack that fits into a compartment on the back of

the defibrillator.

Caution light A triangular light on the front of the HeartStart Defibrillator that flashes during

rhythm analysis and is on solid when a shock is advised, as a reminder not to touch

the patient.

configuration The settings for all operating options of the HeartStart Defibrillator, including

treatment protocol. The factory default configuration can be modified by

authorized personnel using HeartStart Event Review software.

CPR Cardiopulmonary resuscitation. A technique for providing artificial respiration and

heart compressions.

CPR Coaching Basic verbal instructions for performing cardiopulmonary resuscitation, including

hand placement, rescue breathing, compression depth and timing, provided by the

HeartStart when the flashing blue i-button is pressed during the first 30 seconds of

a patient care pause.

defibrillation Termination of cardiac fibrillation by applying electrical energy.

ECG Electrocardiogram, a record of the electrical rhythm of the heart as detected

through defibrillation pads.

B-2

Philips Medical Systems

HEARTSTART M5066A

fibrillation A disturbance of the normal heart rhythm that results in chaotic, disorganized

activity that cannot effectively pump blood. Ventricular fibrillation (fibrillation in

the lower chambers of the heart) is associated with sudden cardiac arrest.

HeartStart Event Review A suite of data management software applications for use by trained personnel to

review and analyze HeartStart Defibrillator patient use and by authorized

personnel to alter HeartStart configuration. Information is available from Philips

Medical Systems on the internet at http://www.medical.philips.com/goto/

eventreview.

i-button A blue “information” button on the front of the HeartStart Defibrillator. If the

i-button is pressed during the 30 seconds it flashes during a patient care pause, the

HeartStart provides CPR Coaching;* if the i-button is pressed when it is flashing

and the HeartStart is chirping, the HeartStart provides troubleshooting guidance.

At other times, if the i-button is pressed and held until it beeps once, the

HeartStart provides summary information about its last clinical use and device

status. When the i-button is on solid (not flashing), it indicates the user may safely

touch the patient.

infrared

communications

A method of sending information using a special part of the light spectrum. It is

used to transmit information between the HeartStart Defibrillator and a computer

running HeartStart Event Review software.

NSA “No Shock Advised,” a decision made by the HeartStart Defibrillator that a shock

is not needed, based on analysis of the patient’s heart rhythm.

NSA pause A pause provided by the HeartStart Defibrillator following an NSA decision. The

pause can be configured to a “standard” NSA pause or a “SMART” NSA pause.

During a standard NSA pause the defibrillator performs no background

monitoring of patient rhythm. During a SMART NSA pause, the defibrillator

conducts background monitoring and, if it detects an artifact-free shockable

rhythm, will exit the pause and begin rhythm analysis. If the HeartStart detects

artifact such as that created by CPR, or if the user presses the i-button for CPR

Coaching during a SMART NSA pause, the defibrillator will not exit the pause for

rhythm analysis in order to allow CPR to be completed uninterrupted.

non-shockable rhythm A heart rhythm that the HeartStart Defibrillator determines is not appropriate for

defibrillation.

On/Off button A green button located on the front of the HeartStart Defibrillator. Pressing the

On/Off button when the defibrillator is in standby mode turns the defibrillator on;

pressing and holding the On/Off button for one second when the defibrillator is on

turns the defibrillator off and disarms the defibrillator. In addition, pressing the

* Pressing the i-button for CPR Coaching during a SMART NSA pause turns off

background monitoring.

B-3

Philips Medical Systems

On/Off button stops the battery insertion self-test that automatically runs when a

battery is inserted.

pads See “SMART pads.”

patient care pause A defined pause to allow patient assessment, treatment, and/or CPR. See

“NSA pause” and “protocol pause.”

periodic self-tests Daily, weekly, and monthly tests automatically conducted by the HeartStart

Defibrillator when it is in its standby mode. The tests monitor many key functions

and parameters of the defibrillator, including battery capacity, pads cartridge

readiness, and the state of its internal circuitry.

protocol A sequence of operations performed by the HeartStart Defibrillator to direct

patient care in the AED mode.

protocol pause A pause provided by the HeartStart Defibrillator after a shock series, during which

the responder can administer CPR. The defibrillator does not conduct background

monitoring of the patient’s heart rhythm during this pause.

Ready light A green LED showing the readiness for use of the HeartStart Defibrillator. A

blinking Ready light means the defibrillator is ready for use; a solid Ready light

means the defibrillator is being used.

rhythm analysis See “SMART analysis.”

Shock button An orange button with a lightning bolt symbol on it, located on the front of the

HeartStart Defibrillator. The Shock button flashes when a shock is advised. You

must press the button for the shock to be delivered.

shockable rhythm A heart rhythm that the HeartStart Defibrillator determines is appropriate for

defibrillation, such as ventricular fibrillation and some ventricular tachycardias

associated with sudden cardiac arrest.

shock series interval A configurable interval between shocks, used by the HeartStart Defibrillator to

decide if the shocks are part of the same shock series.

SMART analysis The proprietary algorithm used by the HeartStart Defibrillator to analyze the

patient’s heart rhythm and determine whether the rhythm is shockable.

SMART biphasic

waveform

The patented, low-energy defibrillation shock waveform used by the HeartStart

Defibrillator. It is an impedance-compensated biphasic waveform. Used with the

Adult SMART Pads, it delivers 150 Joules, nominal, into a 50 ohm load; used with

the Infant/Child SMART Pads, it delivers 50 Joules, nominal, into a 50 ohm load.

SMART NSA pause See “NSA pause.”

SMART Pads The adhesive pads, supplied in a cartridge, used with the HeartStart Defibrillator.

Pulling the handle on the cartridge turns on the defibrillator and opens the

B-4

Philips Medical Systems

HEARTSTART M5066A

cartridge. The pads are applied to the patient’s bare skin and used to detect the

patient’s heart rhythm and to transfer the defibrillation shock. Only HeartStart

SMART Pads can be used with the HeartStart Defibrillator.

standby mode The operating mode of the HeartStart Defibrillator when a battery has been

installed, and the unit is turned off and ready for use when needed. Shown by

blinking green READY light.

standard NSA pause See “NSA pause.”

sudden cardiac arrest

(SCA)

The sudden stopping of the heart’s pumping rhythm, accompanied by loss of

consciousness, absence of respiration, and lack of a pulse.

waveform See “SMART biphasic waveform.”

Philips Medical Systems

C-1

C Glossary of symbols/controls

symbol description

Pads cartridge handle. Green. Pulling the handle turns on

the defibrillator and opens pads cartridge for use.

Refer to operating instructions.

On/Off button. Green. Pressing the On/Off button when

the defibrillator is in standby mode turns the defibrillator

on; pressing and holding the On/Off button for one

second when the defibrillator is on turns the defibrillator

off and disarms the defibrillator. In addition, pressing the

On/Off button stops the battery insertion self-test that

automatically runs when a battery is inserted.

Information button (i-button). Blue. Pressing the i-button while it is

flashing during a patient care pause provides CPR Coaching; pressing it

while it is flashing and the defibrillator is chirping provides

troubleshooting guidance. Pressing it until it beeps at other times

provides summary information about the defibrillator’s last clinical use

and device status.

Caution light. Flashes during rhythm analysis, and is on

but not flashing when a shock is advised, as a reminder

not to touch the patient.

Shock button. Orange. Flashes when the defibrillator is

charged. If a shock is needed, the defibrillator directs the

user to press the Shock button to deliver a shock to the

patient.

Defibrillation protection. Defibrillation protected, type

BF patient connection.

Meets the requirements of the European medical device directives 93/

42/EEC.

Indicates that this device is optimized for Guidelines 2005.

PULL

C-2

Philips Medical Systems

HEARTSTART M5066A

Certified by the Canadian Standards Association.

Reference order number.

Expiration date.

Lithium manganese dioxide battery.

One battery in package.

Do not crush the battery.

Do not expose the battery to high heat or open flames.

Do not incinerate the battery.

Do not mutilate the battery or open the battery case.

Class 9 miscellaneous dangerous goods. (Symbol

required on outer packaging by freight carrier regulations

to identify shipments containing lithium batteries.)

Install the battery in the defibrillator before the date

(MM-YYYY) shown on the associated label.

Do not expose to moisture.

Handle with care.

symbol description

C-3

Philips Medical Systems

This side up.

Transportation requirements (refer to associated thermometer

symbol).

Storage requirements (refer to associated thermometer symbol).

Environmental (temperature and relative humidity) requirements.

These pads are disposable and are for single patient use

only.

Cartridge contents: one set of two defibrillation pads.

Store the pads at temperatures between 0° and 43° C

(32° and 110° F).

This product is not sterile.

This product does not contain natural rubber latex.

Meets the requirements of the European electromagnetic compatibility

directive 89/336/EEC.

Pads intended for use on infant or child under 8 years or 55 pounds

(25 Kg).

Expiration (see associated date code).

symbol description

N O N -

S T E R I L E

L A T E X

C-4

Philips Medical Systems

HEARTSTART M5066A

Serial number.

Lot number.

Federal law (USA) restricts this device to sale by or on the order of a

physician.

Dispose of in accordance with your country's requirements.

Printed on recycled paper.

symbol description

Philips Medical Systems

D-1

D Warnings and precautions

It is important to understand how to use your HeartStart Defibrillator safely.

Please read these warnings and precautions carefully.

A warning describes something that could cause serious personal injury or death.

A precaution describes something that could cause minor personal injury,

damage to the HeartStart, loss of data stored in the HeartStart, or less chance of

successful defibrillation.

NOTE: The HeartStart Defibrillator is designed to be used only with Philips-

approved accessories. The HeartStart may perform improperly if non-

approved accessories are used.

Warnings

flammable gases If the HeartStart is used to give a shock in the presence of flammable gases such as

in an oxygen tent, there is a risk of explosion. Move supplemental oxygen and

oxygen delivery devices away from the defibrillation pads. (However, it is safe to

use the HeartStart on someone wearing an oxygen mask.)

battery The HeartStart M5070A battery is not rechargeable. Do not try to recharge,

open, crush, or burn the battery, or it may explode or catch fire.

fluids Do not let fluids get into the HeartStart. Avoid spilling any fluids on the HeartStart

or its accessories. Spilling fluids into the HeartStart may damage it or cause a fire

or shock hazard. Do not sterilize the HeartStart or its accessories.

accessories Using damaged or expired equipment or accessories may cause the HeartStart

Defibrillator to perform improperly, and/or injure the patient or the user.

patient handling Performing CPR or otherwise handling or moving the patient while the HeartStart

is analyzing heart rhythm can cause an incorrect or delayed analysis. If the

HeartStart tells you a shock is advised while you are handling or moving the

patient, stop the vehicle or CPR and keep the patient as still as possible for at least

15 seconds. This will give the HeartStart time to reconfirm the analysis before

telling you to press the Shock button.

cell phones The HeartStart can work correctly when it is fairly close to equipment like

emergency two-way radios and cell phones. Normally, using a cell phone near the

patient should not cause a problem for the HeartStart. However, it is best to keep

such equipment only as close as necessary to the patient and the HeartStart.

D-2

Philips Medical Systems

HEARTSTART M5066A

pads Do not allow the pads to contact other electrodes or metal parts that are in

contact with the patient.

Precautions

device handling The HeartStart was designed to be sturdy and reliable for many different use

conditions. However, handling the HeartStart too roughly can damage it or its

accessories and will invalidate the warranty. Check the HeartStart and accessories

regularly for damage, according to directions.

maintenance Improper maintenance may damage the HeartStart or cause it to function

improperly. Maintain the HeartStart according to directions.

skin burns Do not let the pads touch each other or other electrodes, lead wires, dressings,

medicine patches, etc. Such contact can cause electrical arcing and skin burns

during a shock and may also divert the electrical current away from the patient’s

heart. During a shock, air pockets between the skin and pads can cause skin burns.

To help prevent air pockets, make sure pads stick well to the skin. Do not use

dried out pads because they will not provide good contact with the skin.

patient handling Before delivering a shock, it is important to disconnect the patient from other

medical electrical equipment, such as blood-flow meters, that may not incorporate

defibrillation protection. In addition, make sure the pads are not in contact with

metal objects such as a bed frame or stretcher.

Philips Medical Systems

E-1

E Technical information

HeartStart Defibrillator specifications

The specifications provided in the following tables are nominal values. Additional

information can be found in the Technical Reference Manual for HeartStart

Automated External Defibrillators, located online at www.medical.philips.com.

Physical

Environmental

category specifications

size 2.80” H x 7.40” D x 8.30” W (7.1cm H x 19cm D x 21cm W).

weight Approximately 3.3 lbs (1.5 kg) with battery and pads cartridge installed.

category specifications

temperature and

relative humidity

Operating (battery and pads cartridge installed):

32° to 122° F (0° to 50° C)

0% to 95% RH (non-condensing).

Standby (battery and pads cartridge installed):

50° to 109° F (10° to 43° C)

10% to 75% RH (non-condensing).

Storage/shipping (with battery and pads cartridge):

-4° to 140° F (-20° to 60° C) for up to 2 days

0% to 85% RH (non-condensing)

altitude Operates at 0 to 15,000 feet; can be stored at up to 8,500 feet, in standby

mode.

shock/drop abuse

tolerance

Withstands 1 meter drop to any edge, corner, or surface.

vibration Operating: meets EN1789 random, road ambulance.

Standby: meets EN1789 swept sine, road ambulance.

E-2

Philips Medical Systems

HEARTSTART M5066A

Controls and indicators

sealing Drip proof per EN60529 class IPx1.

Solid Objects per EN60529 class IP2x.

ESD/EMI (radiated and

immunity)

See Electromagnetic Conformity tables.

category specifications

controls Green SMART Pads cartridge handle

Green On/Off button

Blue i-button

Orange Shock button

indicators Ready light: green; blinks when the defibrillator is in standby mode (ready for

use); solid when the defibrillator is being used.

i-button: blue, flashes when information is available, on solid during patient care

pause.

Caution light: flashes when the defibrillator is analyzing, comes on solid when

the defibrillator is ready to deliver a shock.

Shock button: orange, flashes when the defibrillator is charged and ready to

deliver a shock.

audio speaker Provides voice prompts and warning tones during normal use.

beeper Provides chirps when troubleshooting is needed.

E-3

Philips Medical Systems

Defibrillation Waveform

category specifications

waveform parameters Biphasic truncated exponential. Waveform parameters are automatically

adjusted as a function of patient defibrillation impedance. In the diagram at left,

D is the duration of phase 1 and E is the duration of phase 2 of the waveform, F

is the interphase delay (500 µs), and Ip is the peak current.

The HeartStart delivers shocks to load impedances from 25 to 180 ohms. The

duration of each phase of the waveform is dynamically adjusted based on

delivered charge, in order to compensate for patient impedance variations, as

shown below:

adult defibrillation

load phase 1 phase 2 peak delivered

resistance (Ω) duration (ms) duration (ms) current (A) energy (J)

25 2.8 2.8 65 128

50 4.5 4.5 40 150

75 6.25 5.0 30 155

100 8.0 5.3 24 157

125 9.65 6.4 21 159

150 11.5 7.7 18 160

175 12.0 8.0 16 158

pediatric defibrillation

(using M5072A infant/child reduced-energy defibrillator pads)

load phase 1 phase 2 peak delivered

resistance (Ω) duration (ms) duration (ms) current (A) energy (J)

25 4.1 2.8 28 35

50 5.1 3.4 20 46

75 6.2 4.1 15 52

100 7.2 4.8 12 54

125 8.3 5.5 10 56

150 9.0 6.0 9 57

175 9.0 6.0 8 55

E-4

Philips Medical Systems

HEARTSTART M5066A

energy*

(pediatric doses indicated

are based on CDC

growth charts for the

50th percentile weights

for boys.)

Using HeartStart Adult SMART Pads: 150 J nominal (±15%) into a 50 ohm load.

Using HeartStart Infant/Child SMART Pads: 50 J nominal (±15%) into a 50 ohm

load. Sample pediatric energy doses:

age energy dose

newborn 14 J/kg

1 year 5 J/kg

2 − 3 years 4 J/kg

4 − 5 years 3 J/kg

6 − 8 years 2 J/kg

* National Center for Health Statistics in collaboration with the National Center for Chronic

Disease Prevention and Health Promotion. CDC growth charts: weight-for-age percentiles, revised

and corrected November 28, 2000. Atlanta, GA: Centers for Disease Control and Prevention ©

2000.

charge control Controlled by Patient Analysis System for automated operation.

“charge complete”

indicator

Shock button flashes, audio tone sounds.

shock-to-shock cycle time <20 seconds, typical, including analysis.

patient care

pause-to-shock time

Quick Shock. 8 seconds, typical, from end of patient care pause to shock

delivery.

disarm (AED mode) Once charged, the defibrillator will disarm if:

• the patient’s heart rhythm changes to non-shockable rhythm,

• a shock is not delivered within 30 seconds after the defibrillator has charged

for shock delivery,

• the On/Off button is pressed and held down for at least one (1) second to

turn off the defibrillator,

• the adhesive pads are removed from the patient or the pads cartridge is

disconnected from the defibrillator,

• the battery is removed or is completely depleted or

• the impedance between pads is out of range.

adult shock

delivery vector

Via adhesive pads placed in the anterior-anterior (Lead II) position.

infant/child shock

delivery vector

Via adhesive pads typically placed in the anterior-posterior position.

category specifications

E-5

Philips Medical Systems

ECG analysis system

category specifications

function Evaluates impedance of adhesive pads for proper contact with the patient’s skin,

and evaluates the ECG rhythm and signal quality to determine if a shock is

appropriate.

shockable rhythms Ventricular fibrillation (VF) and some ventricular tachycardias associated with a

lack of circulation, including ventricular flutter and polymorphic ventricular

tachycardia (VT). The HeartStart uses multiple parameters to determine if a

rhythm is shockable.

NOTE: For patient safety reasons, some very low-amplitude or low-frequency rhythms

may not be interpreted as shockable VF rhythms. Also, some VT rhythms usually

associated with circulation will not be interpreted as shockable rhythms.

non-shockable rhythms SMART Analysis is designed to detect non-shockable rhythms as defined by

AHA/AAMI DF-80. See following table. On detection of any non-shockable

rhythm, the HeartStart prompts user to perform CPR if needed.

pacemaker detection Pacemaker artifact is removed from the signal for rhythm analysis.

artifact detection If electrical “noise” (artifact) is detected which interferes with accurate rhythm

analysis, analysis will be delayed until the ECG signal is clean.

analysis protocol Depending on results of analysis, either prepares for shock delivery or provides

a pause. For details of protocol, see Appendix F, “Configuration.”

E-6

Philips Medical Systems

HEARTSTART M5066A

ECG analysis performance

rhythm class ECG test

samplea size

meets AHA recommendationsb for adult defibrillation

observed 90% one-sided

performance lower confidence limit

shockable rhythm —

ventricular fibrillation

300 sensitivity >90%

(meets AAMI DF80 requirement)

(87%)

shockable rhythm —

ventricular tachycardia

100 sensitivity >75%

(meets AAMI DF80 requirement)

(67%)

non-shockable rhythm —

normal sinus rhythm

300 specificity >99%

(meets AAMI DF80 requirement)

(97%)

non-shockable rhythm —

asystole

100 specificity >95%

(meets AAMI DF80 requirement)

(92%)

non-shockable rhythm —

all other non-shockable

rhythmsc

450 specificity >95%

(meets AAMI DF80 requirement)

(88%)

a. From Philips Medical Systems Heartstream ECG rhythm databases.

b. American Heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public

Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New

Waveforms, and Enhancing Safety. Circulation 1997;95:1677-1682.

c. Supraventricular tachycardia (SVT) is specifically included in the non-shockable rhythm class, in accordance with AHA recommendationsb

and the AAMI standard DF80.

E-7

Philips Medical Systems

Accessories specifications

Battery M5070A

HeartStart Adult SMART Pads M5071A and

Infant/Child SMART Pads M5072A

category specifications

battery type 9 VDC, 4.2 Ah, lithium manganese dioxide. Disposable, long-life primary cell.

capacity When new, a minimum of 200 shocks or 4 hours of operating time at 77° F

(25° C). (IEC 60601-2-4 2002)

shelf life

(prior to insertion)

A minimum of 5 years from date of manufacture when stored and maintained

according to directions provided in this Owner’s Manual.

standby life

(after insertion)

Typically, 4 years when stored and maintained according to directions provided

in this Owner’s Manual.

training life Supports 10 hours of use in training mode.

category specifications

adult pads Disposable, adhesive defibrillation pads with a nominal active surface area of 85

cm2 each, provided in a snap-in cartridge with an integrated 54” (137.1 cm),

typical, cable.

infant/child pads Disposable, adhesive defibrillation pads with a nominal active surface area of 85

cm2 each, provided in a snap-in cartridge with an integrated 40 inch (101.6 cm),

typical, cable. Cartridge incorporates teddy bear icon on cover of seal for ready

identification.

defibrillation pad

requirements

Use only HeartStart Adult SMART Pads M5071A or Infant/Child SMART Pads

M5072A with the HeartStart Defibrillator.

E-8

Philips Medical Systems

HEARTSTART M5066A

Environmental considerations

By complying with your national regulations regarding disposal of electric,

electronic, and battery waste, you can make a positive contribution to our shared

environment. Such waste can introduce harmful elements into the environment as

a whole and may also endanger human health.

product information

defibrillator The defibrillator contains electronic components. Do not dispose of it as

unsorted municipal waste. Collect such electronic waste separately and dispose

of it at an appropriate recycling facility according to your country's regulations.

battery The battery cells contain chemicals. The chemistry used in each battery is

identified by a symbol on the label; symbols are defined in the defibrillator

User's Guide/Instructions for Use/Owner's Manual. Recycle the battery at an

appropriate recycling facility.

pads The used pads may be contaminated with body tissue, fluid, or blood. Cut them

off and dispose of them as infectious waste. Recycle the remaining cartridge

components at an appropriate recycling facility in accordance with local

regulations.

Philips Medical Systems

F-1

FConfiguration

Overview

The Philips HeartStart Defibrillator comes with a factory default configuration

designed to meet the needs of most users. This configuration can only be

changed by an authorized person using HeartStart Configure PDA software or

Event Review software. This software is for use by trained personnel.

Information about HeartStart data management products is available online at

http://www.medical.philips.com/goto/eventreview.

Device options

The following table includes the features of HeartStart Defibrillator operation that

are not related to patient treatment.

parameter settings default default description

speaker volume 1, 2, 3, 4,

5, 6, 7, 8

8 The volume of the HeartStart’s speaker is set

to 8, highest.

auto send periodic

self-test (PST) data

On, Off On Enables the periodic self-test data to be

broadcast through the device's infrared data

port.

ECG out data On, Off On Enables the ECG data to be broadcast

through the device's infrared data port.

F-2

Philips Medical Systems

HEARTSTART M5066A

Patient treatment protocol options

parameter settings default default description

“call EMS” voice

reminder timing

• At power on (when

the user turns on

the HeartStart)

• At power on and at

the start of the first

patient care pause

• At the start of the

first patient care

pause

•No reminder

At the start of

the first

patient care

pause

Provides a voice reminder to make

sure emergency medical services have

been called, at the start of the first

patient care pause.

shock series 1, 2, 3, 4 1 The automatic protocol pause for CPR

is activated each time a shock is

delivered.*

During the protocol pause, the

HeartStart does not perform rhythm

analysis.

The length of the protocol pause after

a shock series is completed is

determined by the protocol pause

timer setting.

shock series interval

(minutes)

1.0, 2.0,

∞ (infinity)

1.0 A delivered shock must occur within 1

minute of the previous shock to be

counted as part of the current shock

series.

NOTE: This parameter is only applicable

when the shock series is not configured to

the default 1 shock.

* A shock series begins when a shock is delivered after the HeartStart is turned on. A new shock series begins after a

protocol pause. If shock series is configured for 2 or more, a new shock series also begins if the time since the previous

shock exceeds the shock series interval setting.

F-3

Philips Medical Systems

protocol pause timer

(minutes)

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

2.0 A 2-minute protocol pause for CPR

automatically starts after voice

instruction is given when a shock

series is completed. After the protocol

pause, the defibrillator returns to

rhythm analysis.

If the user presses the i-button for

optional CPR coaching, the HeartStart

provides coaching for 5 cycles of CPR,

starting and ending with compressions,

when the CPR Coaching parameters

are also set to their default values. The

number of CPR cycles varies for other

protocol pause timer and CPR

Coaching parameter settings.

Note: Because the protocol pause ends

upon completion of a CPR cycle in order

to maximize the benefits of CPR, the

actual duration of the pause may differ

slightly from the timer setting.

NSA pause type • Standard NSA

pause: HeartStart

does not perform

rhythm analysis

during the NSA

pause.

• SMART NSA pause:

HeartStart con-

ducts background

monitoring during

the SMART NSA

pause. If a poten-

tially shockable

rhythm is detected,

HeartStart termi-

nates the SMART

NSA pause and

resumes rhythm

analysis.

SMART NSA

pause

During a SMART NSA pause, the

defibrillator conducts background

monitoring. If a potentially shockable

rhythm is detected in a motionless

patient, the defibrillator terminates the

SMART NSA pause and resumes

rhythm analysis.

NOTE: If the HeartStart detects CPR in

progress or if the responder has pressed

the i-button for CPR Coaching, the SMART

NSA pause will be converted to a

standard NSA pause. During the standard

NSA pause, the defibrillator does not

perform rhythm analysis.

parameter settings default default description

F-4

Philips Medical Systems

HEARTSTART M5066A

NSA pause timer

(minutes)

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

2.0 A 2-minute NSA pause for CPR

automatically starts after voice

instruction is given when no shock is

advised (NSA).*

If the user presses the i-button for

optional CPR coaching, the HeartStart

provides coaching for 5 cycles of CPR,

starting and ending with compressions,

when the CPR Coaching parameters

are also set to their default values. The

number of CPR cycles varies for other

NSA pause timer and CPR Coaching

parameter settings.

Note: Because the NSA pause ends upon

completion of a CPR cycle in order to

maximize the benefits of CPR, the actual

duration of the pause may differ slightly

from the timer setting.

CPR prompt • CPR1: Instructs the

user to begin CPR.

•CPR2: Instructs the

user that it is safe

to touch the

patient and to begin

CPR.

•CPR3: Instructs the

user to begin CPR

and to press the

i-button for CPR

Coaching.

•CPR4: Instructs the

user that it is safe

to touch the

patient, to begin

CPR, and to press

the i-button for

CPR Coaching.

CPR4:

Instructs the

user that it is

safe to touch

the patient, to

begin CPR, and

to press the

i-button for

CPR Coaching.

The CPR reminder voice instructions

provided at the beginning of a pause

interval assures the user that it is safe

to touch the patient, instructs the user

to begin CPR, and invites the user to

press the i-button for guidance in the

basic steps of CPR.

Note: CPR Coaching is available only with

the CPR3 and CPR4 settings.

parameter settings default default description

* If the shock series is configured to 2 or more, and a shock has been delivered as part of a series, the length of the first

NSA pause within that shock series is determined by the protocol pause timer setting. Otherwise, the length of an NSA

pause is determined by the NSA pause timer setting.

F-5

Philips Medical Systems

CPR Coaching

adult ventilation

instruction

Yes, No Yes Optional CPR Coaching includes

rescue breaths at the rate determined

by the CPR Coaching

compression:ventilation ratio for

adults when an adult pads cartridge is

installed.

NOTE: if this parameter is configured to

NO, CPR Coaching will always be

compressions-only when an adult pads

cartridge is installed.

CPR Coaching

infant/child ventilation

instruction

Yes, No Yes Optional CPR Coaching includes

rescue breaths at the rate determined

by the CPR Coaching

compression:ventilation ratio for

infants and children when an infant/

child pads cartridge is installed.

NOTE: if this parameter is configured to

NO, CPR Coaching will always be

compressions-only when an infant/child

pads cartridge is installed.

CPR Coaching

compression:ventilation

ratio

• 30:2 adult and

30:2 infant/child

• 30:2 adult and

15:2 infant/child

• 15:2 adult and

15:2 infant/child

30:2 adult and

30:2 infant/

child

If the user presses the i-button for

optional CPR Coaching during a

protocol pause or NSA pause, the

HeartStart provides coaching in basic

CPR for cycles of 30 compressions and

2 ventilations for adults, children, and

infants. Pauses begin and end with

compressions.

parameter settings default default description

Philips Medical Systems

HEARTSTART M5066A

Notes

Philips Medical Systems

G-1

G Testing and troubleshooting

Te s t i n g

As long as a battery is installed, the HeartStart Defibrillator automatically tests

itself every day and alerts you if it finds a problem. The self-test includes pads

readiness testing. In addition, it runs a pads self-test each time a pads cartridge is

inserted. It alerts you if it finds a problem. See the Technical Reference Manual,

available online at www.medical.philips.com, for a detailed discussion of the self-

tests.

You can also test the defibrillator at any time by removing the battery for five

seconds then reinstalling it. This test takes about one minute. Because the battery

insertion self-test is very detailed and uses battery power, running it more often

than necessary will drain the battery prematurely. It is recommended that you run

the battery insertion self-test only:

• when the defibrillator is first put into service.

• after each time the defibrillator is used to treat a patient.

• when the battery is replaced.

• when the defibrillator may have been damaged.

If you need to use the defibrillator in an emergency while you are running a

battery self-test, pull the SMART Pads cartridge handle to stop the test and to turn

on the HeartStart for use.

Troubleshooting

The HeartStart’s green Ready light is the signal that tells you if the defibrillator is

ready for use. The defibrillator also uses chirps and the i-button flashes to alert

you to a problem.

Recommended action during an emergency

If for any reason the HeartStart does not turn on when you pull the SMART Pads

cartridge handle, press the On/Off button.

If that does not turn on the defibrillator, remove the battery and replace it with a

new battery if available and press the On/Off button to turn on the defibrillator. If

G-2

Philips Medical Systems

HEARTSTART M5066A

no spare battery is available, remove the installed battery for five seconds, then

reinsert it and run a battery insertion self-test.

If the problem continues, do not use the HeartStart. Attend to the patient,

providing CPR if needed, until Emergency Medical Services Personnel arrive.

Troubleshooting while the HeartStart is in use

(green Ready light is solid)

HeartStart tells you: possible cause recommended action

... to replace the battery

immediately

The battery is nearly depleted. The

defibrillator will turn off if a new

battery is not inserted.

Replace the battery with a new battery

immediately.

... there is no cartridge

installed, and

... to insert a pads cartridge

• The pads cartridge has been

removed.

• The pads cartridge has been

damaged.

Insert a new pads cartridge.

... to press the pads firmly to

the skin

... to make sure the pads

have been removed from

the liner

... the pads should not be

touching the patient’s

clothing.

• The pads are not properly applied

to the patient.

• The pads are not making good

contact with the patient's bare

chest because of moisture or

excessive hair.

• The pads are touching each other.

• The pads may not have been

removed from the liner or may be

on the patient’s clothing.

• Make sure that the pads are sticking

completely to the patient’s skin.

• If the pads are not sticking, dry the

patient's chest and shave or clip any

excessive chest hair.

• Reposition the pads.

• Make sure the pads are not on the

liner or the patient’s clothing.

If the voice instruction continues after

you do these things, insert another

pads cartridge.

... to insert new

pads cartridge

The pads cartridge has been opened

and the pads peeled off the liner, but

the pads have not been successfully

attached to the patient. There may

be a problem with the pads cartridge.

Replace the damaged pads cartridge.

Pull up the handle on the cartridge

cover, and replace pads on patient

with new pads to continue with the

rescue.

G-3

Philips Medical Systems

... to stop all motion • The patient is being moved or

jostled.

• The environment is dry and

movement around the patient is

causing static electricity to

interfere with ECG analysis.

• Radio or electrical sources are

interfering with ECG analysis.

• Stop CPR; do not touch the patient.

Minimize patient motion. If the

patient is being transported, stop

the vehicle.

• Responders and bystanders should

minimize motion, particularly in dry

environments that can generate

static electricity.

• Check for possible causes of radio

and electrical interference and turn

them off or remove them from the

area.

... the shock was not

delivered

• The pads may not be making good

contact with the patient’s skin.

• The pads may be touching each

other.

• The pads may be damaged.

• Press the pads firmly to the patient's

chest.

• Make sure the adhesive pads are

correctly positioned on the patient.

• Replace the pads if necessary.

... the shock button was not

pressed

Shock has been advised but the shock

button has not been pressed within

30 seconds.

When next prompted, press the Shock

button to deliver shock.

HeartStart tells you: possible cause recommended action

G-4

Philips Medical Systems

HEARTSTART M5066A

Troubleshooting while the HeartStart is not in use

(green Ready light is not on)

behavior possible cause recommended action

chirps or

i-button flashes

• The battery power is low or the

SMART Pads cartridge needs to be

replaced.

• The defibrillator may have been

turned off without a pads cartridge

installed, or the installed pads

cartridge may not have its hard

cover in place.

• The training pads cartridge has been

left in the defibrillator.

• The defibrillator has been stored

outside the recommended

temperature range.

• The defibrillator has detected an

error during a self-test or cannot

perform a self-test, or the Shock

button is damaged.

• Press the blue i-button. Replace the

battery or pads cartridge if

instructed.

• Make sure the pads cartridge is

properly installed with the hard

cover in place. (See Chapter 5,

“Maintaining the HeartStart,” for

directions on installing the pads

cartridge.)

• Remove the training pads cartridge

and replace it with an Adult or

Infant/Child Pads Cartridge.

• Remove the battery for five

seconds then reinstall it to start

the battery insertion self-test. If it

fails, insert a new battery to repeat

the test. If it fails again, do not use

the defibrillator. If it passes, store

the defibrillator within the

recommended temperature range.

• Contact Philips for service if

needed.

no chirping and/or

i-button does not flash

• The battery is missing or completely

depleted.

• The defibrillator may have been

physically damaged.

Remove the battery for five seconds

then reinstall it to start the battery

insertion self-test. If it fails, insert a

new battery and repeat the test. If it

fails again, do not use the defibrillator.

Contact Philips for service.

Philips Medical Systems

H-1

H Additional technical information required for European

conformity

Electromagnetic conformity

Guidance and manufacturer’s declaration: The HeartStart is intended for use in the

electromagnetic environment specified in the tables below. The customer or user

of the HeartStart should assure that it is used in such an environment.

Electromagnetic emissions

emissions test compliance electromagnetic environment – guidance

CISPR 11

Group 1

Class B

The HeartStart 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.

The HeartStart 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.

H-2

Philips Medical Systems

HEARTSTART M5066A

Electromagnetic immunity

immunity test IEC 60601

test level compliance level electromagnetic environment -

guidance

electrostatic discharge

(ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

There are no special requirements

with respect to electrostatic

discharge.a

power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical

commercial/hospital environment.

There are no special requirements for

non-commercial/non-hospital

environments.

radiated RF

IEC 61000-4-3

10 V/m

80 MHz to 2.5

GHz

20 V/m Portable and mobile RF

communications equipment should be

used no closer to any part of the

HeartStart, including cables, than is

absolutely necessary.b,c The

recommended separation distances

for various transmitters and the AED

are shown in the following table.

Interference may occur in the

vicinity of equipment marked

with the following symbol:

NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

a. Generally, AEDs are sometimes susceptible to interference generated by patient and/or responder motion in environments in which a high

static electric field is present (e.g., low humidity, synthetic carpets, etc.). As a safety measure, Philips AEDs incorporate a patented method

to sense possible corruption of the ECG signal by such interference and to respond by directing the user to stop all motion. In these cases,

it is important to minimize movement in the vicinity of the patient during rhythm analysis in order to ensure that the signal being analyzed

accurately reflects the patient’s underlying heart rhythm.

b. The ISM (industrial, scientific and medial) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz;

26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the

HeartStart is used exceeds the applicable RF compliance level above, the HeartStart should be observed to verify normal operation. If

abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HeartStart.

H-3

Philips Medical Systems

Recommended separation distances between portable and mobile RF

communications equipment and the HeartStart

The HeartStart is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the

HeartStart can help prevent electromagnetic interference by maintaining a

minimum distance between portable and mobile RF communications equipment

(transmitters) and the HeartStart as recommended below, according to the

maximum output power of the communications equipment.

separation distance according to frequency of transmitter (m)

rated maximum output

power of transmitter (W)

80 MHz to

800 MHz

d = 0.6√ P

800 MHz to

2.5 GHz

d = 1.15√ P

0.01 0.06 0.115

0.1 0.19 0.36

1 0.6 1.15

10 1.9 3.64

100 6.0 11.5

For transmitters rated at a maximum output power not listed above, the recommended separation distance d

in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is

the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2. The ISM (industrial, scientific and medial) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;

13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

NOTE 3. An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the

ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the

likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into

patient areas.

NOTE 4. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

H-4

Philips Medical Systems

HEARTSTART M5066A

Important warnings and reminders

• Do not allow the pads to contact other electrodes or metal parts that are in

contact with the patient.

• Before delivering a shock, it is important to disconnect the patient from other

medical electrical equipment, such as blood-flow meters, that may not

incorporate defibrillation protections. In addition, make sure the pads are not

in contact with metal objects such as a bedframe or stretcher.

• Check supplies, accessories, packaging, and spares for damage and expiration

dating.

Environmental considerations

• The defibrillator contains electronic components. Dispose of it at an

appropriate recycling facility.

• The battery cells contain chemicals. Recycle the battery at an appropriate

recycling facility.

• The used pads may be contaminated. Cut them off and dispose of them

properly. Recycle the remaining cartridge components at an appropriate

recycling facility.

Shock cycle timing

The HeartStart Quick Shock feature allows it to deliver a shock within 8 seconds,

typical, following the prompt ending a CPR Interval. From shock to shock, the

HeartStart takes <20 seconds, typical, including analysis. After 15 shocks, the

HeartStart takes <30 seconds from analyzing to ready-to-shock. After 200 shocks,

the HeartStart takes <40 seconds from initial power-on to ready-to-shock.

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

Intentionally blank.

Philips Medical Systems

Intentionally blank.

POWER TO SAVE A LIFE

Philips Medical Systems is part of

Royal Philips Electronics

Philips Medical Systems

United States

Philips Medical Systems

2301 Fifth Avenue, Suite 200

Seattle, WA, USA 98121

(800) 263-3342

Canada

Philips Medical Systems

281 Hillmount Road

Markham, Ontario

L6C 2S3

(800) 291-6743

Europe, Middle East, and Africa

Philips Medizin Systeme Boeblingen GmbH

Cardiac and Monitoring Systems

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

+49 7031 463 2254

Latin America

Philips Medical Systems

1550 Sawgrass Corporate Parkway, Suite 300

Sunrise, FL 33323, USA

(954) 835-2660

Asia Pacific

Philips Electronics Hong Kong Ltd.

30th Floor, Hopewell Centre

17, Kennedy Road, Wanchai

Hong Kong

(852) 2821 5888

REF: M5066-91901

Philips M5066A Users Manual HS1 OM ENG

M5066A to the manual d30c345d-743f-4e9d-82ce-5292b2e39e1c

Navigation menu

Versions of this User Manual:

Views

Navigation