861304
HEARTSTART FRx DEFIBRILLATOR
OWNER’S MANUAL
861304
Edition 8
Philips Medical Systems
HeartStart FRx Defibrillator
QUICK REFERENCE
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Philips Medical Systems
HeartStart FRx
861304
Automated External Defibrillator
OWNER’S MANUAL
Edition 8
IMPORTANT NOTE:
It is important to understand t hat survival rates for sudden cardiac arrest are
directly related to how soon victims are defibrillated. For every minute of
delay, the chance of survival declines by 7% to 10%.
Defibrillation cannot assure survival, no matter how rapid the treatment. In
some patients, 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
HeartStart FRx Defibrillator 861304. This
information is subject to change. Please
contact Philips at www.medical.philips.com/
heartstart or your local distributor for
information on revisions.
Authorized EU Representative
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Strasse 2
71034 Boeblingen, Germany
(+49) 7031 463-2254
CAUTION
Edition History
Edition 8
Publication date: April 2007
Publication #: 989803138731
Assembly #: 012569-0008
Printed in the USA
Copyright
© 2007 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 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.
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE
BY OR ON THE ORDER OF A PHYSICIAN.
The Philips HeartStart 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 USA, 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 FRx 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: U.S. Pat. No
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,
and other patents pending.
Philips Medical Systems
HEARTSTART FRx 861304 OWNER’S MANUAL
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CONTENTS
1 Introduction to the HeartStart FRx
Description ........................................................................................................... 1
Sudden Cardiac Arrest ....................................................................................... 1
Indications for Use .............................................................................................. 2
Training and practice .......................................................................................... 2
State and local requirements ............................................................................ 2
For more information ......................................................................................... 3
2 Setting up the HeartStart FRx
Package contents ................................................................................................. 3
Setting up the FRx ............................................................................................... 4
Recommended accessories ............................................................................... 6
3 Using the HeartStart FRx
Overview ............................................................................................................... 7
STEP 1: Press the green on/off button ........................................................... 8
STEP 2: Follow the FRx’s voice instructions ................................................. 8
STEP 3: Press the flashing orange Shock button if instructed ................... 9
Treating infants and children ............................................................................ 10
When emergency medical services arrive ..................................................... 12
4 After using the HeartStart FRx
After each use ...................................................................................................... 14
FRx data storage .................................................................................................. 15
5 Maintaining the HeartStart FRx
Routine maintenance .......................................................................................... 16
Periodic checks .................................................................................................... 17
Cleaning the FRx .................................................................................................. 17
Disposing of the FRx ........................................................................................... 17
Troubleshooting tips ........................................................................................... 18
i
ii
APPENDICES
A Accessories ..................................................................................................................... 21
B Glossary of terms ........................................................................................................ 23
C glossary of symbols/controls ................................................................................. 27
D Warnings and Precautions ..................................................................................... 31
E Technical information ............................................................................................... 33
F Configuration .................................................................................................................41
G Testing and troubleshooting ................................................................................. 46
H Additional technical data required for European conformity ............ 50
Philips Medical Systems
HEARTSTART FRx 861304 OWNER’S MANUAL
1 Introduction to the HeartStart FRx
Description
The Philips HeartStart FRx Defibrillator 861304 (“FRx”) is an
automated external defibrillator (AED). Small, lightweight, rugged,
and battery powered, it is designed for simple and reliable operation
by minimally trained users. The FRx is highly configurable for local
protocol considerations.
Sudden Cardiac Arrest
The FRx is used to treat ventricular fibrillation (VF), the most
common cause of sudden cardiac arrest (SCA). SCA is a condition
that occurs when the heart unexpectedly stops pumping. SCA can
occur to anyone – young or old, male or female – anywhere, at any
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time. Many victims of SCA do not have warning signs or symptoms.
Some people may have a higher risk for SCA than others. Causes
vary and may be different for infants and children than for adults.
*
VF is a chaotic quivering of the heart muscle that prevents it from
pumping blood. The only effective treatment for VF is
defibrillation.The FRx 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.
* Configurability includes timing of the “Call Emergency Medical Services”
reminder, CPR protocol variations, and other features. See Appendix F,
“Configuration,” for details.
1
2
Indications for Use
The FRx 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.
Training and practice
The FRx is intended to be used under the oversight of a physician as
part of a well-designed emergency response plan. Any emergency
response plan should provide for training of FRx users in
cardiopulmonary resuscitation (CPR) and defibrillator use. 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/heartstart, for information about
training programs in your area.
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NOTE: Training accessories are available from Philips for
practicing use of the FRx. See Appendix A for information on
ordering accessories.
State and local requirements
Check with your state health department to see if there are any local
or state requirements about owning and using a defibrillator.
HEARTSTART FRx 861304 OWNER’S MANUAL
For more information
Contact your local Philips distributor for additional information
about the FRx. 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.
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 Manual for HeartStart
Defibrillators.
2 Setting up the HeartStart FRx
3
*
Package contents
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Check the contents of the FRx box to be sure it contains:
• 1 Philips HeartStart FRx Defibrillator 861304
• 1 four-year battery M5070A
• 1 package of HeartStart SMART Pads II 989803139261,
containing a pair of single-use adhesive defibrillation pads in a
disposable plastic case
• 1 Owner’s Manual
• 1 Quick Reference Guide
* Clinical summaries also include defibrillators sold as Heartstream ForeRunner
and FR2.
† The FRx sold for aviation applications includes a TSO-certified battery,
REF: 989803139301, instead of the M5070A.
†
4
2. Insert battery in FRx.
1A. Remove Pads
Case from packaging.
1B. Plug in pads
cable connector.
IMPORTANT NOTE: The FRx is designed to be used with a carry
case. A number of carry cases are offered to meet the needs of
your individual defibrillation program. These include a standard
carry case and a hard-shell carry case. See Appendix A for
information about these as well as a list of training materials and
other accessories available from Philips.
Setting up the FRx
Setting up the FRx is simple and quick.
*
1. Open the SMART Pads II
(A). Do not open the pads case until you need to use the pads in an
emergency. Plug the pads cable connector into the connector
port on the FRx (B). Store the unopened Pads Case in the
pocket provided in the defibrillator carry case.
2. Open the battery package and remove
the battery. Place the bottom end (A)
of the battery into the bottom of the
compartment on the back of the FRx,
then firmly press down the top (latch)
end of the battery into the
compartment, until it clicks into place
(B).
package and take out the Pads Case
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HEARTSTART FRx 861304 OWNER’S MANUAL
3. Set the FRx and the Pads Case on a flat surface and let the FRx
run its automatic battery insertion self-test. Testing the Shock
button and the On/Off button is part of the self-test. The FRx
will say “shock button test” and then instruct you to push the
Shock button. It will then say “On/Off button test” and instruct
you to push the On/Off button. Push the buttons when
* Unless otherwise noted, references to pads in this document are to HeartStart
SMART Pads II.
5
instructed. When the self-test is over, the FRx will report the
results, then turn off and go to standby mode. The blinking green
Ready light shows the defibrillator is ready for use.
*
4. Place the Quick Reference Guide, a brief illustrated guide for
using the FRx to treat a victim of sudden cardiac arrest, in the
defibrillator carry 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.
5. Store the FRx 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. Keep a spare
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SMART Pads II cartridge and other accessories with the
defibrillator – in the carry case – for quick access when needed.
Be sure to store the defibrillator according to its specifications.
See Appendix E for details.
NOTE: Always store the FRx with a set of SMART Pads II
connected and a battery installed, so it will be ready to use.
* As long as a battery is installed and a set of SMART Pads II is connected, turning
the FRx “off” puts it into standby mode, which means that it is ready for use.
† Any of the carry case options has room for storing the Quick Reference Guide.
6
Infant/Child Key
accessory.
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 FRx 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.
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If you may need to defibrillate an infant or a child under 55 pounds
(25 kg) or 8 years old, it is recommended that you order the
Infant/Child Key accessory, available separately. When the
Infant/Child Key is inserted in the FRx, the FRx automatically
reduces the defibrillation energy to 50 joules and, if optional CPR
Coaching is selected, provides coaching appropriate for infants and
children. Directions for using the Infant/Child Key are provided in
Chapter 3, “Using the HeartStart FRx.”
HEARTSTART FRx 861304 OWNER’S MANUAL
See Appendix A for a list of accessories and training products for the
FRx available from Philips.
7
3 Using the HeartStart FRx
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 FRx. If you are alone, follow these steps:
• Call your emergency services provider.
• Quickly get the FRx 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
FRx is available.
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• If the victim is an infant or child, see directions for treating
infants and children starting on page 10.
• Check the immediate environment for flammable gases. Do not
use the FRx in the presence of flammable gases, such as an
oxygen tent. However, it is safe to use the FRx 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. Press the green On/Off button.
2. Follow the FRx’s voice instructions.
3. Press the flashing orange Shock button if instructed.
8
Press green On/Off
button.
Pads icons flash.
Open Pads Case. Peel one pad from case.
STEP 1: Press the green on/off button
Press the On/Off button to turn on the FRx.
The FRx tells you to remove all
clothes from the person’s chest.
If necessary, rip or cut off the
clothing to bare the person’s
chest.
STEP 2: Follow the FRx’s voice instructions
Remove the SMART Pads II case from the carry case. Clean and dry
the patient's skin, and, if necessary, clip or shave excessive chest hair
to ensure good pads contact with the bare skin.
Open the pads case as shown below. Peel off one pad.
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HEARTSTART FRx 861304 OWNER’S MANUAL
Pads placement is very important. The icons on the pads placement
diagram on the FRx front panel will be flashing, to help guide you.
Place the pad on the patient’s bare skin exactly as shown in the
following drawing. Press the adhesive portion of the pad down firmly.
Then repeat this with the other pad.
9
Shock button flashes.
Caution
light
Shock
Button
Where to place pads on adults and children over
55 pounds or 8 years old (anterior-anterior).
Where to place pads on infants or
children under 55 pounds or
8 years old (anterior-posterior).
STEP 3: Press the flashing orange Shock button if
instructed
As soon as the HeartStart FRx detects that the pads are
attached to the patient, the pads icons turn off. The FRx
begins analyzing the patient's heart rhythm. It tells you
that no one should be touching the patient, and the
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Caution light begins flashing as a reminder.
If a shock is needed:
The Caution light stops flashing and stays on, and the
orange Shock button starts flashing. The FRx tells you to
press the flashing orange button. You must press the
Shock button for a shock to be delivered. Before you
press the button, make sure no one is touching the
patient. When you press the Shock button, the FRx tells you that the
shock has been delivered. Then the defibrillator 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.
10
I-button
i-button flashes.
If a shock is not needed:
The blue i-button comes on solid, to show that it is safe to touch the
patient. The FRx also tells 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 FRx 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 Key is inserted, the CPR Coaching
provided will be 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.
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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 FRx.
• If no bystander is available, provide 1-2 minutes of CPR before
calling EMS and retrieving the FRx.
• If you witnessed the child's collapse, call EMS immediately and
then get the FRx.
Alternatively, follow your local protocol.
* The default configuration for the FRx 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.
HEARTSTART FRx 861304 OWNER’S MANUAL
11
Insert the Infant/Child
Key if available.
If the victim is under 55 pounds or 8 years old, and you have an
Infant/Child Key:
• Insert the Infant/Child Key into the slot at the top center of the
front panel of the FRx (see illustration at left). The pink portion
of the Key pivots (1) and fits into the slot (2), with the front of
the Key lying flat on the surface of the FRx so the infant/child
pads placement diagram is visible. (The back of the Infant/Child
Key also has a diagram showing how to insert it.)
• Turn on the FRx and follow instructions to remove all clothing
from the torso, to bare both the chest and the back.
• Place the pads on the child’s front and back, as illustrated. It does
not matter which pad is placed on the chest or the back.
NOTE: It does not matter whether you insert the Infant/Child
Key before or immediately after turning on the FRx. However, the
Key should be inserted before placing the pads on the patient.
With the Infant/Child Key inserted, the FRx will announce “Infant/
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Child Mode,” automatically reduce the defibrillation energy from the
*
adult dose of 150 Joules to 50 Joules,
and provide optional infant/
child CPR Coaching.
If the Infant/Child Key is removed during use, the FRx will announce
“Adult Mode.” Any shocks delivered will be at adult energy, and
optional CPR Coaching will be for adult CPR.
* This lower energy level may not be effective for treating an adult.
12
If the victim is under 55 pounds or 8 years old, but you do NOT have an
Infant/Child Key:
• DO NOT DELAY TREATMENT.
• Turn on the FRx and follow instructions to remove all clothing
from the torso, to bare both the chest and the back.
• Place the one pad in the center of the chest between the nipples,
and the other in the center of the back (anterior-posterior).
If the victim is over 55 pounds or 8 years old, or if you are not sure of the
exact weight or age:
• DO NOT DELAY TREATMENT.
• Turn on the FRx without inserting the Key and follow
instructions to remove all clothing from the chest.
• Place the pads as illustrated on each pad (anterior-anterior).
Make sure the pads do not overlap or touch each other.
When emergency medical services arrive
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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. Depending on their equipment, the
EMS team may apply different pads. In that case, the SMART Pads II
should be removed. EMS personnel may want a summary of the
last-use data
down the i-button until the FRx beeps.
NOTE: After the EMS team removes the SMART Pads II from the
patient, remove the Infant/Child Key, if used, and install a new
pads set before returning the FRx to service, to be sure it is ready
for use.
* See Chapter 4, “After Using the HeartStart FRx,” for details about data storage.
HEARTSTART FRx 861304 OWNER’S MANUAL
*
stored in the FRx. To hear the summary data, hold
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