Philips M5066A User Manual 2

HeartStart OnSite Defibrillator

OWNER’S MANUAL
Guide to Set Up, Operation, Maintenance, and Accessories

M5066A

Edition 8

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PHILIPS MEDICAL SYSTEMS

The HeartStart OnSite Defibrillator M5066A

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top

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front view

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back view

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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.

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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.

special lens, or “eye,” is used to
transfer HeartStart data directly to
or from a computer.

This

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 self­adhesive 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.

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HeartStart OnSite Defibrillator

QUICK REFERENCE

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PHILIPS MEDICAL SYSTEMS

HeartStart OnSite

M5066A
Automated External Defibrillator

OWNER’S MANUAL

Edition 8

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%.

Treatment cannot assure survival. In some victims, the underlying problem
causing the cardiac arrest is simply not survivable despite any available care.

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About this edition

The information in this guide applies to the
model M5066A HeartStart OnSite 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.philips.com/
productdocumentation or your local Philips
representative for information on revisions.

Edition history

Authorized EU representative

Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Strasse 2
71034 Boeblingen, Germany
([phone]

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.

Edition 8
Publication date: February 2009
Publication #: M5066-91900
Assembly #: 011666-0008
Printed in the U.S.A.

Copyright

© 2009 Philips Electronics North America Corp.

No part of this publication may be reproduced,
transmitted, transcribed, stored in a retrieval
system or translated into any human or

PHILIPS MEDICAL SYSTEMS

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.

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

Philips Medical Systems, Seattle, WA, USA 98121-1825.

Patents

This product is manufactured and sold under one or
more of the following United States patents:
US6047212, US6317635, US5891046, 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.

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CONTENTS

1 INTRODUCTION TO THE HEARTSTART ONSITE

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 ONSITE

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

Setting up the OnSite ......................................................................................... 2-1

Recommended accessories .............................................................................. 2-4

3 USING THE HEARTSTART ONSITE

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

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

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

STEP 3: PRESS the Shock button .................................................................... 3-4

Treating infants and children ............................................................................ 3-5

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

4 AFTER USING THE HEARTSTART ONSITE

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

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

5 MAINTAINING THE HEARTSTART ONSITE

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

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

Cleaning the OnSite ........................................................................................... 5-2

Disposing of the OnSite .................................................................................... 5-2

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

i

APPENDICES

A Accessories for the HeartStart OnSite

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

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ii

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1

1 INTRODUCTION TO THE HEARTSTART

DESCRIPTION

The Philips HeartStart OnSite 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 OnSite 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 OnSite 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 OnSite 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.

1-1

TRAINING AND PRACTICE

The OnSite 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 online at www.philips.com/
essentials for information, including certified training and web-based refresher
training through Philips HeartStart Essentials program management services.

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

Technical information about all Philips HeartStart automated external defibrillators
is also available online at www.philips.com/productdocumentation in the Technical
Reference Manuals for HeartStart Automated External Defibrillators.

*

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1-2

* Clinical summaries also include Heartstream ForeRunner and FR2 Defibrillators.

2 SETTING UP THE HEARTSTART ONSITE

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PACKAGE CONTENTS

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

• 1 HeartStart OnSite 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

• 1 Quick Start poster

Training materials and optional accessories for the HeartStart OnSite are also
available from Philips. See Appendix A for a description of these items.

SETTING UP THE HEARTSTART ONSITE

Setting-up the OnSite is simple and quick.

1. Remove the OnSite from its packaging.

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

*

2

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

first locate the latch at the top edge of the OnSite, 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.

2-1

3. Insert the cartridge into the cartridge well on the front of the OnSite It should

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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 OnSite.

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5. The OnSite will automatically run a self-test when the battery is inserted.
Press the Shock button when instructed. When the self-test is over, the
OnSite 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 OnSite will turn off and go to standby mode. The green
Ready light will be blinking to show the OnSite is ready for use.

*

NOTE: Always store the OnSite 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 OnSite “off” puts it into standby mode,

which means that it is ready for use.

2-2

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6. Place the OnSite 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 OnSite 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 OnSite
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 OnSite 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.

2

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

OnSite. Detailed illustrated directions are inside, for reference in an emergency, or if you
are hearing impaired or using the OnSite where it is hard to hear the voice instructions.

2-3

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 OnSite 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
OnSite, the OnSite automatically reduces the defibrillation energy to an energy
level more appropriate for infants and children. In addition, if optional CPR
coaching is selected, the OnSite provides coaching appropriate for infants and
children. Directions for using the Infant/Child SMART Pads are provided in
Chapter 3, “Using the HeartStart OnSite.”

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2-4

3 USING THE HEARTSTART ONSITE

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

PHILIPS MEDICAL SYSTEMS

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 OnSite.
If you are alone, follow these steps:

• Call your emergency services provider.

• Quickly get the OnSite and bring it to the victim’s side. If there is any
delay in getting the OnSite, check the patient and perform
cardiopulmonary resuscitation (CPR) if needed until the OnSite is
available.

• If the patient is an infant or child, first perform CPR, then call for
emergency medical services (EMS) before you apply the OnSite. See
special section on treating infants and children on page 3-5.

• Check the immediate environment for flammable gases. Do not use the
OnSite in the presence of flammable gases, such as an oxygen tent.
However, it is safe to use the OnSite on someone wearing an oxygen
mask.

There are three basic steps to using the OnSite 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.

3

The following pages provide details about each step.

3-1

STEP 1: PULL THE GREEN HANDLE

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Turn on the OnSite 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 OnSite’s instructions.

The OnSite 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

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3-2

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

STEP 2: PLACE THE PADS

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).

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.

3

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3-3

STEP 3: PRESS THE SHOCK BUTTON

As soon as the OnSite 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 OnSite 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 OnSite tells you that the shock has been delivered. Then the
OnSite 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 OnSite 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 OnSite invites you to press the flashing blue i-button

for CPR Coaching, if desired.

For CPR Coaching:

Press the flashing blue i-button
pause to activate CPR Coaching.
inserted, CPR Coaching will provide coaching for infant/child CPR.) When the
pause is over, the OnSite 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.

during the first 30 seconds of the patient care

*

(If the Infant/Child SMART Pads Cartridge is

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3-4

* The default configuration for the OnSite 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.

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
OnSite.

• If no bystander is available, provide 1-2 minutes of CPR before calling EMS
and retrieving the OnSite.

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

Alternatively, follow your local protocol.

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

Cartridge:

3

PHILIPS MEDICAL SYSTEMS

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

*

• Locate the latch at the top edge of the OnSite, 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 OnSite 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 OnSite 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 OnSite 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.

3-5

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 OnSite 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 OnSite 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
the OnSite. To hear the summary data, hold down the i-button until the OnSite
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 OnSite to service, to be sure it is ready for use.

*

stored in

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3-6

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

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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 OnSite 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 OnSite will pause briefly to allow you to deal with the source of
the noise, then resume analysis.

• The OnSite 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
OnSite 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 OnSite 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 OnSite will disarm and tell
you a shock is not advised.

• If for any reason you want to turn off the OnSite 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.

3

3-7

NOTES

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4AFTER USING THE HEARTSTART ONSITE

AFTER EACH USE

1. Check the outside of the OnSite for signs of damage, dirt, or contamination. If
you see signs of damage, contact Philips for technical support. If the OnSite 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 OnSite. 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 OnSite.” 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 OnSite.
the green Ready light is blinking.

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

*

When the test is complete, check that

4

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ONSITE DATA STORAGE

The OnSite 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.philips.com/eventreview.

* If you leave the battery in the OnSite 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.

4-1

Follow your local protocol with regard to prompt data transfer for medical review
after using the OnSite.

*

Details about data transfer and timing are provided in

Event Review documentation.

The information automatically stored by the OnSite 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 OnSite by holding the i-button down until it
beeps once. The OnSite 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 OnSite’s status (entire incident)

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

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

PHILIPS MEDICAL SYSTEMS

4-2

* The OnSite 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
OnSite retains the files. When the battery is reinstalled, the last-use ECG recording will
be kept in OnSite 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 MAINTAINING THE HEARTSTART ONSITE

ROUTINE MAINTENANCE

The OnSite is very simple to maintain. The OnSite performs a self-test every day.
In addition, a battery insertion self-test is run whenever a battery is installed in the
device. The OnSite’s extensive automatic self-test features eliminate the need for
any manual calibration. The OnSite has no user-serviceable parts.

WARNING: Electrical shock hazard. Do not open the OnSite, remove its covers,
or attempt repair. There are no user-serviceable components in the OnSite. If
repair is required, return the OnSite to Philips for service.

REMINDERS:

• Do not leave the OnSite without a pads cartridge installed; the OnSite will
start chirping and the i-button will start flashing. For directions on changing
the pads cartridge, see Chapter 2, “Setting up the HeartStart OnSite.”

• The OnSite runs daily self-tests. As long as the green Ready light is blinking, it
is not necessary to test the OnSite by initiating a battery insertion self-test.
This uses battery power and risks draining the battery prematurely.

PERIODIC CHECKS

5

Other than the checks recommended after each use of the OnSite, 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 OnSite. If you see cracks or other signs of

damage, contact Philips for technical support.

5-1

CLEANING THE ONSITE

The outside of the OnSite 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 OnSite.

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

• Do not sterilize the OnSite or its accessories.

DISPOSING OF THE ONSITE

The OnSite and its accessories should be disposed of in accordance with local
regulations.

TROUBLESHOOTING TIPS

The OnSite’s green Ready light is your guide to knowing if the defibrillator is ready
for use.

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

• If the Ready light is off, the OnSite 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 OnSite is not chirping and the i-button is

not flashing: there is no battery inserted, the battery is depleted, or the
OnSite needs repair. Insert/replace battery and run the self-test. As long
as the OnSite 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

5-2

PHILIPS MEDICAL SYSTEMS

A

A ACCESSORIES FOR THE HEARTSTART ONSITE

Accessories* for the HeartStart OnSite Defibrillator available separately from your
Philips representative or on-line at www.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 OnSite Defibrillator Quick Reference [REF: M5066-97800]

* Certain accessories require a prescription in the United States.

A-1

• 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 OnSite Instructor's Training Toolkit [REF: M5066-89100]

• HeartStart Trainer [REF: M5085A]

• Internal Manikin Adapter [REF: M5088A]

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

PHILIPS MEDICAL SYSTEMS

A-2

B GLOSSAR Y OF TERMS

PHILIPS MEDICAL SYSTEMS

The terms listed in this Glossary are defined in the context of the Philips
HeartStart OnSite Defibrillator and its use.

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

AED mode The standard treatment mode for the HeartStart OnSite 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

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

Caution light A triangular light on the front of the HeartStart OnSite 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 OnSite 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.

B

CPR Coaching Basic verbal instructions for performing cardiopulmonary resuscitation, including

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

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.

B-1

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

review and analyze HeartStart OnSite Defibrillator patient use and by authorized
personnel to alter OnSite configuration. Information is available from Philips
Medical Systems on the internet at www.philips.com/eventreview.

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

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

*

the OnSite provides CPR Coaching;

if the i-button is pressed when it is flashing
and the OnSite is chirping, the OnSite provides troubleshooting guidance. At other
times, if the i-button is pressed and held until it beeps once, the OnSite 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 OnSite Defibrillator and a
computer running HeartStart Event Review software.

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

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

NSA pause A pause provided by the OnSite 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 OnSite performs no background monitoring of patient
rhythm. During a SMART NSA pause, the OnSite conducts background monitoring
and, if it detects an artifact-free shockable rhythm, will exit the pause and begin
rhythm analysis. If the OnSite 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
OnSite 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 OnSite Defibrillator determines is not

appropriate for defibrillation.

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

Pressing the On/Off button when the OnSite is in standby mode turns the OnSite
on; pressing and holding the On/Off button for one second when the OnSite is on
turns the OnSite 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.

pads See “SMART pads.”

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

pause” and “protocol pause.”

PHILIPS MEDICAL SYSTEMS

B-2

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

background monitoring.

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

Defibrillator when it is in its standby mode. The tests monitor many key functions
and parameters of the OnSite, including battery capacity, pads cartridge readiness,
and the state of its internal circuitry.

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

direct patient care in the AED mode.

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

during which the responder can administer CPR. The OnSite 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 OnSite Defibrillator.

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

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

B

PHILIPS MEDICAL SYSTEMS

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

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

SMART biphasic

waveform

SMART NSA pause See “NSA pause.”

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

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

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

Defibrillator. Pulling the handle on the cartridge turns on the OnSite and opens the
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 OnSite.

been installed, and the unit is turned off and ready for use when needed. Shown by
blinking green READY light.

B-3

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

B-4

PHILIPS MEDICAL SYSTEMS

C GLOSSARY OF SYMBOLS/CONTROLS

symbol description

Pads cartridge handle. Green. Pulling the handle turns on
the OnSite and opens pads cartridge for use.

C

Refer to operating instructions.

On/Off button. Green. Pressing the On/Off button when
the OnSite is in standby mode turns the OnSite on;
pressing and holding the On/Off button for one second
when the OnSite is on turns the OnSite 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
OnSite is chirping provides troubleshooting guidance.
Pressing it until it beeps at other times provides summary
information about the OnSite’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 OnSite is
charged. If a shock is needed, the OnSite 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.

C-1

symbol description

Indicates that this device is optimized for Guidelines

2005.

Certified by the Canadian Standards Association.

Reference order number.

Authorized representative in the European Community.

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.

PHILIPS MEDICAL SYSTEMS

C-2

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

NO N-

ST ER ILE

LA TE X

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).

C

PHILIPS MEDICAL SYSTEMS

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
25 Kg (55 lb).

Expiration (see associated date code).

Serial number.

C-3

symbol description

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.

PHILIPS MEDICAL SYSTEMS

C-4

D WARNINGS AND PRECAUTIONS

It is important to understand how to use your HeartStart OnSite 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 OnSite, loss of data stored in the OnSite, or less chance of
successful defibrillation.

NOTE: The HeartStart OnSite Defibrillator is designed to be used only with
Philips-approved accessories. The OnSite may perform improperly if non­approved accessories are used.

PHILIPS MEDICAL SYSTEMS

WARNINGS

D

flammable gases If the OnSite 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
OnSite 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 OnSite. Avoid spilling any fluids on the OnSite or its

accessories. Spilling fluids into the OnSite may damage it or cause a fire or shock
hazard. Do not sterilize the OnSite or its accessories.

accessories Using damaged or expired equipment or accessories may cause the OnSite to

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

patient handling Performing CPR or otherwise handling or moving the patient while the OnSite is

analyzing heart rhythm can cause an incorrect or delayed analysis. If the OnSite
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 OnSite time to reconfirm the analysis before telling you to press the
Shock button.

cell phones The OnSite 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 OnSite. However, it is best to keep such
equipment only as close as necessary to the patient and the OnSite.

D-1

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

contact with the patient.

PRECAUTIONS

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

conditions. However, handling the OnSite too roughly can damage it or its
accessories and will invalidate the warranty. Check the OnSite and accessories
regularly for damage, according to directions.

maintenance Improper maintenance may damage the OnSite or cause it to function improperly.

Maintain the OnSite 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

D-2

E TECHNICAL INFORMATION

HEARTSTART ONSITE DEFIBRILLATOR SPECIFICATIONS

The specifications provided in the following tables are nominal values. Additional
information can be found in the Technical Reference Manuals for HeartStart
Automated External Defibrillators, located online at www.philips.com/
productdocumentation.

PHYSICAL

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.

ENVIRONMENTAL

PHILIPS MEDICAL SYSTEMS

category

temperature and

relative humidity

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

shock/drop abuse

tolerance

vibration Operating: meets EN1789 random, road ambulance.

specifications

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)

mode.

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

Standby: meets EN1789 swept sine, road ambulance.

E

E-1

category

sealing Drip proof per EN60529 class IPx1.

Solid Objects per EN60529 class IP2x.

specifications

ESD/EMI (radiated and

immunity)

category specifications

controls Green SMART Pads cartridge handle

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

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

beeper Provides chirps when troubleshooting is needed.

See Electromagnetic Conformity tables.

CONTROLS AND INDICATORS

Green On/Off button
Blue i-button
Orange Shock button

PHILIPS MEDICAL SYSTEMS

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 OnSite is analyzing, comes on solid when the

OnSite is ready to deliver a shock.
Shock button: orange, flashes when the OnSite is charged and ready to deliver a

shock.

E-2

DEFIBRILLATION WAVEFORM

category specifications

PHILIPS MEDICAL SYSTEMS

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

E-3

category specifications

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 (
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”

Shock button flashes, audio tone sounds.

indicator

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 OnSite has charged for
shock delivery,

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

• the adhesive pads are removed from the patient or the pads cartridge is
disconnected from the OnSite,

• the battery is removed or is completely depleted or

• the impedance between pads is out of range.

±15%) into a 50 ohm

PHILIPS MEDICAL SYSTEMS

E-4

adult shock

delivery vector

infant/child shock

delivery vector

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

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

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.

PHILIPS MEDICAL SYSTEMS

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

E-5

ECG ANALYSIS PERFORMANCE

rhythm class ECG test

sample

a

size

meets AHA recommendationsb for adult defibrillation
observed 90% one-sided
performance lower confidence limit

shockable rhythm —

ventricular fibrillation

shockable rhythm —

ventricular tachycardia

non-shockable rhythm —

normal sinus rhythm

non-shockable rhythm —

asystole

non-shockable rhythm — all

other non-shockable

rhythms

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 recommendations

and the AAMI standard DF80.

c

300 sensitivity >90%

(meets AAMI DF80 requirement)

100 sensitivity >75%

(meets AAMI DF80 requirement)

300 specificity >99%

(meets AAMI DF80 requirement)

100 specificity >95%

(meets AAMI DF80 requirement)

450 specificity >95%

(meets AAMI DF80 requirement)

(87%)

(67%)

(97%)

(92%)

(88%)

b

PHILIPS MEDICAL SYSTEMS

E-6

ACCESSORIES SPECIFICATIONS

BATTERY M5070A

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)

PHILIPS MEDICAL SYSTEMS

shelf life

(prior to insertion)

standby life

(after insertion)

training life Supports 10 hours of use in training mode.

A minimum of 5 years from date of manufacture when stored and maintained
according to directions provided in this Owner’s Manual.

Typically, 4 years when stored and maintained according to directions provided
in this Owner’s Manual.

HEARTSTART ADULT SMART PADS M5071A AND
INFANT/CHILD SMART PADS M5072A

category specifications

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

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

defibrillation pad

requirements

2

cm

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

typical, cable.

2

cm

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.

Use only HeartStart Adult SMART Pads M5071A or Infant/Child SMART Pads
M5072A with the HeartStart OnSite Defibrillator.

E

E-7

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

E-8

F CONFIGURATION

OVERVIEW

The Philips HeartStart OnSite 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 software.
This software is for use by trained personnel. Information about HeartStart data
management products is available online at www.philips.com/eventreview.

DEVICE OPTIONS

The following table includes the features of HeartStart OnSite Defibrillator
operation that are not related to patient treatment.

parameter settings default default description

PHILIPS MEDICAL SYSTEMS

speaker volume 1, 2, 3, 4,

5, 6, 7, 8

auto send periodic

self-test (PST) data

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

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

8 The volume of the OnSite’s speaker is set to

8, highest.

broadcast through the device's infrared data
port.

through the device's infrared data port.

E

F-1

PATIENT TREATMENT PROTOCOL OPTIONS

parameter settings default default description

“call EMS” voice
reminder timing

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

shock series interval

(minutes)

• At power on (when
the user turns on
the OnSite)

• At power on and at
the start of the first
patient care pause

• At the start of the
first patient care
pause

•No reminder

1.0, 2.0,

∞ (infinity)

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.

is activated each time a shock is
delivered.

*

During the protocol pause, the OnSite
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.

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.

PHILIPS MEDICAL SYSTEMS

* A shock series begins when a shock is delivered after the OnSite 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-2

parameter settings default default description

PHILIPS MEDICAL SYSTEMS

protocol pause timer

(minutes)

NSA pause type • Standard NSA

pause: OnSite does
not perform
rhythm analysis
during the NSA
pause.

• SMART NSA pause:
OnSite conducts
background moni­toring during the
SMART NSA pause.
If a potentially
shockable rhythm is
detected, OnSite
terminates the
SMART NSA pause
and resumes
rhythm
analysis.

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 OnSite returns to rhythm
analysis.

If the user presses the i-button for
optional CPR coaching, the OnSite
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.

SMART NSA

pause

During a SMART NSA pause, the
OnSite conducts background
monitoring. If a potentially shockable
rhythm is detected in a motionless
patient, the OnSite terminates the
SMART NSA pause and resumes
rhythm analysis.

NOTE: If the OnSite 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 OnSite does not perform
rhythm analysis.

E

F-3

parameter settings default default description

NSA pause timer

(minutes)

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

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.

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 OnSite
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.

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.

PHILIPS MEDICAL SYSTEMS

* 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-4

parameter settings default default description

PHILIPS MEDICAL SYSTEMS

CPR Coaching

adult ventilation

instruction

CPR Coaching

infant/child ventilation

instruction

CPR Coaching

compression:ventilation

ratio

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.

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.

• 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
OnSite provides coaching in basic CPR
for cycles of 30 compressions and 2
ventilations for adults, children, and
infants. Pauses begin and end with
compressions.

E

F-5

NOTES

PHILIPS MEDICAL SYSTEMS

PHILIPS MEDICAL SYSTEMS

G TESTING AND TROUBLESHOOTING

TE S T I NG

As long as a battery is installed, the HeartStart OnSite 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.philips.com/productdocumentation, for a detailed
discussion of the self-tests.

You can also test the OnSite 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 OnSite is first put into service.

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

• when the battery is replaced.

• when the OnSite may have been damaged.

If you need to use the OnSite in an emergency while you are running a battery self­test, pull the SMART Pads cartridge handle to stop the test and to turn on the
HeartStart for use.

E

TROUBLESHOOTING

The OnSite’s green Ready light is the signal that tells you if the OnSite is ready for
use. The OnSite also uses chirps and the i-button flashes to alert you to a
problem.

RECOMMENDED ACTION DURING AN EMERGENCY

If for any reason the OnSite does not turn on when you pull the SMART Pads
cartridge handle, press the On/Off button.

If that does not turn on the OnSite, remove the battery and replace it with a new
battery if available and press the On/Off button to turn on the OnSite. If no spare

G-1

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 OnSite. Attend to the patient, providing
CPR if needed, until Emergency Medical Services Personnel arrive.

TROUBLESHOOTING WHILE THE ONSITE IS IN USE

(green Ready light is solid)

OnSite tells you: possible cause recommended action

... to replace the battery

immediately

... there is no cartridge

installed, and

... to insert a 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.

... to insert new

pads cartridge

The battery is nearly depleted. The
OnSite will turn off if a new battery is
not inserted.

• The pads cartridge has been
removed.

• The pads cartridge has been
damaged.

• 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.

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 battery with a new battery
immediately.

Insert a new pads cartridge.

PHILIPS MEDICAL SYSTEMS

• 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.

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-2

OnSite tells you: possible cause recommended action

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

... the shock was not

... the shock button was not

PHILIPS MEDICAL SYSTEMS

delivered

pressed

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.

• 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.

Shock has been advised but the shock
button has not been pressed within
30 seconds.

• 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.

• 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.

When next prompted, press the Shock
button to deliver shock.

E

G-3

TROUBLESHOOTING WHILE THE ONSITE IS NOT IN USE

(green Ready light is not on)

behavior possible cause recommended action

chirps or

i-button flashes

no chirping and/or

i-button does not flash

• The battery power is low or the
SMART Pads cartridge needs to be
replaced.

• The OnSite 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 OnSite.

• The OnSite has been stored outside
the recommended temperature
range.

• The OnSite has detected an error
during a self-test or cannot perform
a self-test, or the Shock button is
damaged.

• The battery is missing or completely
depleted.

• The OnSite may have been
physically 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
OnSite,” 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 OnSite. If it passes, store the
OnSite within the recommended
temperature range.

• Contact Philips for service if
needed.

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 OnSite.
Contact Philips for service.

PHILIPS MEDICAL SYSTEMS

G-4

H ADDITIONAL TECHNICAL INFORMATION REQUIRED

FOR EUROPEAN CONFORMITY

ELECTROMAGNETIC CONFORMITY

Guidance and manufacturer’s declaration: The HeartStart OnSite Defibrillator is
intended for use in the electromagnetic environment specified in the tables below.
The customer or user of the OnSite should assure that it is used in such an
environment.

ELECTROMAGNETIC EMISSIONS

emissions test compliance electromagnetic environment – guidance

PHILIPS MEDICAL SYSTEMS

RF

CISPR 11

Group 1

Class B

The OnSite 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 OnSite 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.

E

H-1

ELECTROMAGNETIC IMMUNITY

immunity test IEC 60601

electrostatic discharge

(ESD)

IEC 61000-4-2

power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

test level

± 6 kV contact

± 8 kV air

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

compliance level electromagnetic environment -

guidance

± 6 kV contact

± 8 kV air

There are no special requirements
with respect to electrostatic
discharge.

a

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
OnSite, 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.

PHILIPS MEDICAL SYSTEMS

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
OnSite is used exceeds the applicable RF compliance level above, the OnSite should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the OnSite.

H-2

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE
AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE ONSITE

The OnSite is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the OnSite
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and
the OnSite 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)

0.01 0.06 0.115

0.1 0.19 0.36

10.6 1.15

10 1.9 3.64

100 6.0 11.5

PHILIPS MEDICAL SYSTEMS

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.

80 MHz to

800 MHz

d = 0.6

√

800 MHz to

2.5 GHz

P

d = 1.15

√

P

E

H-3

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 OnSite 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

PHILIPS MEDICAL SYSTEMS

H-4

The OnSite’s 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
OnSite takes <20 seconds, typical, including analysis. After 15 shocks, the OnSite
takes <30 seconds from analyzing to ready-to-shock. After 200 shocks, the OnSite
takes <40 seconds from initial power-on to ready-to-shock.

Intentionally blank.

PHILIPS MEDICAL SYSTEMS

Intentionally blank.

PHILIPS MEDICAL SYSTEMS

Intentionally blank.

PHILIPS MEDICAL SYSTEMS

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 98121-1825
[phone]

Canada

Philips Medical Systems
281 Hillmount Road
Markham, Ontario
L6C 2S3
[phone]

Europe, Middle East, and Africa

Philips Medizin Systeme Boeblingen GmbH
Cardiac and Monitoring Systems
Hewlett-Packard Strasse 2
71034 Boeblingen, Germany
[phone]

Latin America

Philips Medical Systems
1550 Sawgrass Corporate Parkway, Suite 300
Sunrise, FL 33323, USA
[phone]

REF: M5066-91900

Asia Pacific

Philips Electronics Hong Kong Ltd.
30th Floor, Hopewell Centre
17, Kennedy Road, Wanchai
Hong Kong
(852) 2821 5888