Philips Heart Rate Monitor 861304 User Manual

H E A R T S T A R T F R x D E F I B R I L L A T O R  
O W N E R ’ S M A N U A L  
861304  
Edition 8  
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HeartStart FRx Defibrillator  
QUICK REFERENCE  
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Intentionally blank.  
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HeartStart FRx  
861304  
Automated External Defibrillator  
O W N E R ’ S M A N U A L  
Edition 8  
IMPORTANT NOTE:  
It is important to understand that 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  
Authorized EU Representative  
The information in this guide applies to the  
HeartStart FRx Defibrillator 861304. This  
information is subject to change. Please  
heartstart or your local distributor for  
information on revisions.  
Philips Medizin Systeme Boeblingen GmbH  
Hewlett-Packard Strasse 2  
71034 Boeblingen, Germany  
(+49) 7031 463-2254  
CAUTION  
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE  
BY OR ON THE ORDER OF A PHYSICIAN.  
Edition History  
Edition 8  
The Philips HeartStart is designed to be used only with  
Philips-approved accessories. The HeartStart may perform  
improperly if non-approved accessories are used.  
Publication date: April 2007  
Publication #: 989803138731  
Assembly #: 012569-0008  
Printed in the USA  
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.  
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.  
Device Manufacturer  
The HeartStart FRx Defibrillator is manufactured by Philips  
Medical Systems, Seattle, Washington, USA.  
Patents  
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  
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.  
information to users and operators alike.  
HEARTSTART FRx 861304 OWNER’S MANUAL  
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CONTENTS  
1 Introduction to the HeartStart FRx  
Description ...........................................................................................................  
Sudden Cardiac Arrest .......................................................................................  
Indications for Use ..............................................................................................  
Training and practice ..........................................................................................  
State and local requirements ............................................................................  
For more information .........................................................................................  
1
1
2
2
2
3
2 Setting up the HeartStart FRx  
Package contents .................................................................................................  
Setting up the FRx ...............................................................................................  
Recommended accessories ...............................................................................  
3
4
6
3 Using the HeartStart FRx  
Overview ...............................................................................................................  
STEP 1: Press the green on/off button ...........................................................  
STEP 2: Follow the FRx’s voice instructions .................................................  
STEP 3: Press the flashing orange Shock button if instructed ...................  
7
8
8
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
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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  
HEARTSTART FRx 861304 OWNER’S MANUAL  
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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  
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
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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  
training programs in your area.  
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.  
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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  
Package contents  
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.  
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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 package and take out the Pads Case  
(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.  
1A. Remove Pads  
Case from packaging.  
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  
2. Insert battery in FRx.  
(B).  
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  
1B. Plug in pads  
cable connector.  
* Unless otherwise noted, references to pads in this document are to HeartStart  
SMART Pads II.  
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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  
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.  
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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.  
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.”  
Infant/Child Key  
accessory.  
See Appendix A for a list of accessories and training products for the  
FRx available from Philips.  
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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.  
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.  
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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.  
Press green On/Off  
button.  
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.  
Open Pads Case.  
Peel one pad from case.  
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.  
Pads icons flash.  
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Where to place pads on infants or  
children under 55 pounds or  
8 years old (anterior-posterior).  
Where to place pads on adults and children over  
55 pounds or 8 years old (anterior-anterior).  
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  
Caution light begins flashing as a reminder.  
Caution  
light  
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  
Shock  
Button  
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.  
Shock button flashes.  
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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.  
i-button flashes.  
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  
I-button  
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.  
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.  
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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.  
Insert the Infant/Child  
Key if available.  
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/  
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.  
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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  
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 stored in the FRx. To hear the summary data, hold  
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.  
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Reminders  
Remove any medicine patches and residual adhesive from the  
patient’s chest before applying the pads.  
Do not place the pads directly over an implanted pacemaker or  
defibrillator. A noticeable lump with a surgical scar should  
indicate the position of an implanted device.  
Do not allow the pads to contact other electrodes or metal  
parts that are in contact with the patient.  
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. (For ease of  
handling, the pad is designed with a non-gel area around the  
connector cable.)  
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  
FRx 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  
FRx will pause briefly to allow you to deal with the source of the  
noise, then resume analysis.  
The FRx will only deliver a shock if the flashing orange Shock  
button is pressed when the instruction is given. If the Shock  
button is not pressed within 30 seconds after the instruction, the  
FRx 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 FRx will  
continue to analyze the heart rhythm. If the patient’s rhythm  
changes before you press the Shock button, and a shock is no  
longer needed, the defibrillator will disarm and tell you a shock is  
not advised.  
If for any reason you want to turn off the defibrillator during a  
use, you can press the On/Off button holding it down for at  
least one second to return the device to standby mode.  
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4 After using the HeartStart FRx  
After each use  
1. Check the outside of the FRx for signs of damage, dirt, or  
contamination. If you see signs of damage, contact Philips for  
technical support. If the defibrillator is dirty or contaminated,  
clean it according to the guidelines in Chapter 5, “Maintaining the  
HeartStart FRx.”  
2. Plug the cable connector for a new set of SMART Pads II into the  
FRx (do not open the pads case). 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  
FRx.The single-use pads must be replaced after being used.  
3. Unless your protocol requires that the battery remain installed,  
remove the battery for five seconds, then reinstall it to run the  
battery insertion self-test to check the operation of the  
*
defibrillator. When the test is complete, check that the green  
Ready light is blinking.  
4. Return the FRx to its storage location so it will be ready for use  
when needed.  
* If you leave the battery in the FRx 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.  
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FRx data storage  
The FRx 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  
Follow your local protocol with regard to prompt data transfer for  
*
medical review after using the FRx. Details about data transfer and  
timing are provided in Event Review documentation.  
The information automatically stored by the FRx includes a summary  
of last-use data and detailed data about its last clinical use. You can  
get a voice summary of information about the last use of the  
defibrillator by holding the i-button down until it beeps once. The  
FRx 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 FRx automatically stores information about its last clinical use in its internal  
memory for at least 30 days, so the data can be downloaded to a computer  
running appropriate Event Review software. (If the battery is removed during  
this period, the defibrillator retains the files. When the battery is reinstalled,  
the last-use ECG recording will be kept in defibrillator memory for an additional  
30 days.) After this time, the last-use ECG recordings will automatically be  
erased to prepare for a future use.  
† If ECG recordings from a previous use have not been erased, the maximum time  
for new ECG recordings may be less.  
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the FRx’s status (entire incident)  
the FRx’s rhythm analysis decisions (entire incident)  
the elapsed time associated with stored events (entire incident)  
5 Maintaining the HeartStart FRx  
Routine maintenance  
The FRx is very simple to maintain. The defibrillator performs a  
self-test every day. In addition, a battery insertion self-test is run  
whenever a battery is installed in the device. The defibrillator’s  
extensive automatic self-test features eliminate the need for any  
manual calibration.  
WARNING: Electrical shock hazard. Do not open the FRx, remove  
its covers, or attempt repair. There are no user-serviceable  
components in the FRx. If repair is required, return the FRx to an  
authorized service center.  
Reminders:  
Do not leave the defibrillator without a set of pads connected;  
the defibrillator will start chirping and the i-button will start  
flashing.  
Do not store the FRx with the Infant/Child Key installed.  
The FRx runs daily self-tests. As long as the green Ready light is  
blinking, it is NOT necessary to test the defibrillator by initiating  
a battery insertion self-test. This uses battery power and risks  
draining the battery prematurely.  
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Periodic checks  
Other than the checks recommended after each use of the FRx,  
maintenance is limited to periodically checking the following:  
Check the green Ready light. If the green Ready light is not  
blinking, see Troubleshooting Tips, below.  
Replace any used, damaged or expired supplies and accessories.  
Check the outside of the defibrillator. If you see cracks or other  
signs of damage, contact Philips for technical support.  
Cleaning the FRx  
The outside of the HeartStart FRx can be cleaned with a soft cloth  
dampened in soapy water, chlorine bleach (2 tablespoons per quart  
or liter of water), ammonia-based cleaners, or 70% isopropyl  
(rubbing) alcohol. It is recommended that the carry case be cleaned  
with a soft cloth dampened in soapy water.  
Reminders:  
Do not use strong solvents such as acetone or acetone-based  
cleaners, abrasive materials, or enzymatic cleaners to clean the  
FRx and accessories.  
Do not immerse the FRx in fluids. Do not sterilize the FRx or its  
accessories.  
Disposing of the FRx  
The FRx and its accessories should be disposed of in accordance  
with local regulations.  
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Troubleshooting tips  
The FRx’s green Ready light is your guide to knowing if the  
defibrillator is ready for use.  
If the Ready light is blinking: The FRx 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 FRx is in use or running a self-test.  
If the Ready light is off, the FRx is chirping, and the i-button is  
flashing: A self-test error has occurred, there is a problem with  
the pads, the Infant/Child Key has been left installed, or the  
battery power is low. Press the i-button for instructions.  
If the Ready light is off but the FRx is not chirping and the  
i-button is not flashing: there is no battery inserted, the battery is  
depleted, or the defibrillator needs repair. Insert/replace battery  
and run the self-test. As long as the FRx passes the self-test, you  
can be assured it is ready for use.  
More detailed testing and troubleshooting information is available in  
Appendix G.  
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APPENDICES  
A Accessories  
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 data required for European conformity  
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Notes  
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A
Accessories  
Accessories* for the HeartStart FRx Defibrillator 861304 available separately from  
include.  
Batteries (spare is recommended)  
Battery [REF: M5070A]  
Aviation applications battery [REF: 989803139301]  
HeartStart SMART Pads II [REF: 989803139261] (spare is recommended)  
Carry Cases  
FRx carry case [REF: 989803139251]  
Hard-shell carry case [REF: YC]  
Cabinets and Mounts  
Wall mount bracket [REF: M3857A]  
Defibrillator cabinet, semi-recessed [REF: PFE7023D]  
Defibrillator cabinet, wall surface mount [REF: PFE7024D]  
Defibrillator cabinet, basic [REF: 989803136531]  
Infant/Child Key [REF: 989803139311]  
Fast Response Kit (pouch containing a pocket mask, a disposable razor, 2 pairs  
of disposable gloves, a pair of paramedic’s scissors, and an absorbent wipe)  
[REF: 68-PCHAT]  
Data Management Software  
HeartStart Configure PDA software [REF: 989803143041]  
HeartStart Case Capture 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]  
* Certain accessories require a prescription in the Untied States.  
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Infrared adapter for use with HeartStart Event Review software  
[REF: ACT-IR]  
HeartStart FRx Defibrillator Quick Reference Guide [REF: 989803138601]  
Training  
HeartStart Training Pads II (kit containing one set of Training Pads II in  
training pads case, adult pads placement guide, Instructions for Use, and  
illustrated guide) [REF: 989803139271]  
Replacement Training Pads II (pair of training pads on disposable liner for  
use in training pads case provided with HeartStart Training Pads II)  
[REF: 989803139291]  
Adult pads placement guide [REF: M5090A]  
Infant/Child pads placement guide [REF: 989803139281]  
HeartStart FRx Defibrillator Instructor's Training Toolkit, NTSC  
[REF: 989803139321] or PAL [REF: 989803139331]  
HeartStart FRx Defibrillator Training DVD [REF: 989803139341]  
Internal Manikin Adapter [REF: M5088A]  
External Manikin Adapter, 10 pack [REF: M5089A]  
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B
Glossary of terms  
The terms listed in this Glossary are defined in the context of the Philips  
HeartStart FRx Defibrillator 861304 and its use.  
AED  
Automated external defibrillator (a semi-automatic defibrillator).  
AED mode  
The standard treatment mode for the HeartStart FRx Defibrillator. It provides  
voice instructions guiding the rescuer through applying the adhesive pads, waiting  
for rhythm analysis, and delivering a shock if needed.  
analysis  
arrhythmia  
artifact  
See “SMART analysis.”  
An unhealthy, often irregular, beating of the heart.  
Electrical “noise” caused by sources such as muscle movements, CPR, patient  
transport, or static electricity that may interfere with rhythm analysis.  
battery  
Caution light  
configuration  
The sealed lithium manganese dioxide battery used to power the HeartStart FRx  
Defibrillator. It is provided in a pack that fits into a compartment on the back of  
the defibrillator.  
A light on the front of the HeartStart FRx Defibrillator that flashes during rhythm  
analysis and is on solid when a shock is advised, as a reminder not to touch the  
patient  
The settings for all operating options of the HeartStart FRx Defibrillator, including  
treatment protocol. The factory default configuration can be modified by  
authorized personnel using HeartStart Event Review software.  
CPR  
Cardiopulmonary resuscitation. A technique for providing artificial respiration and  
heart compressions.  
CPR Coaching  
Basic verbal instructions for performing cardiopulmonary resuscitation, including  
hand placement, rescue breathing, compression depth and timing, provided by the  
FRx when the flashing blue i-button is pressed during the first 30 seconds of a  
patient care pause.  
defibrillation  
ECG  
Termination of cardiac fibrillation by applying electrical energy.  
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.  
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HeartStart Event Review  
A suite of data management software applications for use by trained personnel to  
review and analyze FRx Defibrillator patient use and by authorized personnel to  
alter FRx configuration. Information is available from Philips Medical Systems on  
i-button  
A blue “information” button on the front of the HeartStart FRx Defibrillator. If the  
i-button is pressed during the 30 seconds it flashes during a patient care pause, the  
FRx provides CPR Coaching;* if the i-button is pressed when it is flashing and the  
FRx is chirping, the FRx provides troubleshooting guidance. At other times, if the  
i-button is pressed and held until it beeps once, the FRx 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.  
Infant/Child Key  
A “key” recommended for use when defibrillating a potential SCA victim under  
55 pounds or 8 years old. When inserted into a dedicated slot on the FRx’s front  
panel, the Infant/Child Key illustrates correct pads placement, with lighted icons,  
on these young victims. With the Infant/Child Key inserted, the HeartStart FRx  
automatically reduces the energy of any shock delivered to 50 J and provides CPR  
Coaching, if selected, appropriate for infants and children.  
infrared (IR)  
communications  
A method of sending information using a special part of the light spectrum. It is  
used to transmit information between the HeartStart FRx Defibrillator and a  
computer running HeartStart Event Review software.  
NSA  
“No Shock Advised,” a decision made by the HeartStart FRx Defibrillator that a  
shock is not needed, based on analysis of the patient’s heart rhythm.  
NSA pause  
A pause provided by the HeartStart FRx Defibrillator following an No Shock  
Advised (NSA) decision. The pause can be configured to a “standard” NSA pause  
or a “SMART” NSA pause. During a standard NSA pause the defibrillator  
performs no background monitoring of patient rhythm. During a SMART NSA  
pause, the defibrillator conducts background monitoring and, if it detects an  
artifact-free shockable rhythm, will exit the pause and begin rhythm analysis. If the  
HeartStart FRx detects artifact such as that created by CPR, or if the user presses  
the i-button for CPR Coaching during a SMART NSA pause, the defibrillator will  
not exit the pause for rhythm analysis in order to allow CPR to be completed  
uninterrupted.  
non-shockable rhythm  
A heart rhythm that the HeartStart FRx Defibrillator determines is not  
appropriate for defibrillation.  
* Pressing the i-button for CPR Coaching during a SMART NSA pause turns off  
background monitoring.  
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A green button located on the front of the HeartStart FRx Defibrillator. Pressing  
On/Off button  
the On/Off button when the defibrillator is in standby mode turns the defibrillator  
on; pressing and holding the On/Off button for one second when the defibrillator  
is on turns the defibrillator off and disarms the defibrillator. In addition, pressing  
the On/Off button stops the battery insertion self-test that automatically runs  
when a battery is inserted.  
pads  
patient care pause  
periodic self-tests  
See “SMART Pads II.”  
A defined period to allow CPR. See “NSA pause” and “protocol pause.”  
Daily, weekly, and monthly tests automatically conducted by the HeartStart FRx  
Defibrillator when it is in its standby mode. The tests monitor many key functions  
and parameters of the defibrillator, including battery capacity, pads readiness, and  
the state of its internal circuitry.  
protocol  
A sequence of operations performed by the HeartStart FRx Defibrillator to direct  
patient care in the AED mode.  
protocol pause  
A period provided by the HeartStart FRx Defibrillator after a shock series, during  
which the responder can administer CPR. The defibrillator does not conduct  
background monitoring of the patient’s heart rhythm during this pause.  
Quick Shock  
Ready light  
The ability of the FRx to deliver a defibrillation shock very quickly – typically  
within 8 seconds – after the end of a patient care pause.  
A green LED showing the readiness for use of the HeartStart FRx Defibrillator.  
A blinking Ready light means the defibrillator is ready for use; a solid Ready light  
means the defibrillator is being used.  
rhythm analysis  
Shock button  
See “SMART analysis.”  
An orange button with a lightning bolt symbol on it, located on the front of the  
HeartStart FRx Defibrillator. The Shock button flashes when a shock is advised.  
You must press the button for the shock to be delivered.  
shockable rhythm  
SMART analysis  
A heart rhythm that the HeartStart FRx Defibrillator determines is appropriate  
for defibrillation, such as ventricular fibrillation and some ventricular tachycardias  
associated with sudden cardiac arrest.  
The proprietary algorithm used by the HeartStart FRx Defibrillator to analyze the  
patients heart rhythm and determine whether a shock is advised.  
SMART biphasic  
waveform  
The patented, low-energy defibrillation shock waveform used by the HeartStart  
FRx Defibrillator. It is an impedance-compensated biphasic waveform. It delivers  
150 Joules, nominal, into a 50 ohm load; when the Infant/Child Key is inserted, it  
delivers 50 Joules, nominal, into a 50 ohm load.  
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SMART NSA pause  
SMART Pads II  
See “NSA pause.”  
The adhesive pads used with the HeartStart FRx Defibrillator to defibrillate  
patients of any age or weight. 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.  
standby mode  
The operating mode of the HeartStart FRx Defibrillator when a battery has been  
installed, and the unit is turned off and ready for use when needed. Shown by  
blinking green READY light.  
standard NSA pause  
See “NSA pause.”  
sudden cardiac arrest  
(SCA)  
The sudden stopping of the heart’s pumping rhythm, accompanied by loss of  
consciousness, absence of respiration, and lack of a pulse.  
waveform  
See “SMART biphasic waveform.”  
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C
Glossary of symbols/controls  
symbol  
description  
On/Off button. Green. Pressing the On/Off button when the defibrillator is in  
standby mode turns the defibrillator on; pressing and holding the On/Off button  
for one second when the defibrillator is on turns the defibrillator off and disarms  
the defibrillator. In addition, pressing the On/Off button stops the battery  
insertion self-test that automatically runs when a battery is inserted.  
Information button (i-button). Blue. Pressing the i-button while it is flashing  
during a patient care pause provides CPR Coaching in default configuration;  
pressing it while it is flashing and the defibrillator is chirping provides  
troubleshooting guidance. Pressing it until it beeps at other times provides  
summary information about the defibrillator’s last clinical use. Pressing it briefly in  
standby mode gives 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. If a shock is needed, flashes when the defibrillator is  
charged. The defibrillator directs the user to press the Shock button to deliver a  
shock to the patient.  
Refer to operating instructions.  
Lithium manganese dioxide battery.  
TSO C-142 certified battery (989803139301 only)  
One battery in package.  
Do not crush the battery.  
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symbol  
description  
Do not expose the battery to high heat or open flames. Do not incinerate the  
battery.  
Do not mutilate the battery or open the battery case.  
Do not expose to moisture.  
Handle with care.  
This side up.  
Defibrillation protection. Defibrillation protected, type BF patient connection.  
Meets IEC 529 class IPx5 for sealing against jetting water and class IP5x for  
sealing against solid objects (dust protected).  
Certified by the Canadian Standards Association.  
Meets the requirements of the European medical device directives 93/42/EEC.  
Meets the requirements of the applicable European directive.  
Printed on recycled paper.  
Storage requirements (refer to associated thermometer symbol).  
Transportation requirements (refer to associated thermometer symbol).  
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symbol  
description  
Environmental (temperature and relative humidity) requirements.  
Install the battery in the defibrillator before the date (MM-YYYY) shown on the  
associated label.  
Reference order number.  
Serial number.  
Lot number.  
Date of manufacture (989803139301 only)  
Class 9 miscellaneous dangerous goods. (Symbol required on outer packaging by  
freight carrier regulations to identify shipments containing lithium batteries.)  
On HeartStart SMART Pads II (989803139261 only). These pads are disposable  
and are for single patient use only.  
Contents: one set of two defibrillation pads.  
ꢄꢂ  
ꢃꢁꢁ  
#
&
Store the pads at temperatures between 32° and 122° F (0° and 50° C).  
ꢀꢁ  
#
&
This product does not contain natural rubber latex.  
This product is not sterile.  
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symbol  
description  
Replace pads after 24 hours.  
Expiration (refer to associated date code).  
Expiration date.  
Federal law (USA) restricts this device to sale by or on the order of a physician.  
Not for use with Laerdal defibrillator models 911, 1000, 2000, or 3000.  
Not for use with HeartStart HS1 defibrillators, including HeartStart Home and  
HeartStart OnSite.  
Fits Philips HeartStart designated connector ports, including FR2+ and MRx.  
Pads placement illustration.  
For use on infants and children under 55 pounds (25 kg).  
Insert Infant/Child Key into slot on FRx.  
Dispose of in accordance with your national or local requirements.  
Indicates that this device is optimized for Guidelines 2005.  
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D
Warnings and Precautions  
It is important to understand how to use your HeartStart FRx 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 FRx, loss of data stored in the FRx, or less chance of successful  
defibrillation.  
NOTE: The HeartStart FRx Defibrillator is designed to be used only with  
Philips-approved accessories. The FRx may perform improperly if non-  
approved accessories are used.  
Warnings  
flammable gases  
If the FRx 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  
FRx on someone wearing an oxygen mask.)  
battery  
fluids  
The HeartStart M5070A and 989803139301 batteries are not rechargeable. Do  
not try to recharge, open, crush, or burn the battery, or it may explode or catch  
fire.  
Do not let fluids to get into the FRx. Avoid spilling any fluids on the FRx or its  
accessories. Spilling fluids into the FRx may damage it or cause a fire or shock  
hazard. Do not sterilize the FRx or its accessories.  
accessories  
Using damaged or expired equipment or accessories may cause the HeartStart  
FRx Defibrillator to perform improperly, and/or injure the victim or the user.  
patient handling  
Performing CPR or otherwise handling or moving the patient while the FRx is  
analyzing heart rhythm can cause an incorrect or delayed analysis. If the FRx 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 FRx time to reconfirm the analysis before telling you to press the  
Shock button.  
cell phones  
The FRx 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 FRx. However, it is best to keep such  
equipment only as close as necessary to the patient and the FRx.  
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pads  
Do not allow the pads to contact other electrodes or metal parts that are in  
contact with the patient.  
Precautions  
device handling  
The FRx was designed to be sturdy and reliable for many different use conditions.  
However, handling the FRx too roughly can damage it or its accessories and will  
invalidate the warranty. Check the FRx and accessories regularly for damage,  
according to directions.  
maintenance  
skin burns  
Improper maintenance may damage the FRx or cause it to function improperly.  
Maintain the FRx according to directions.  
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 patients  
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.  
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E
Technical information  
HeartStart FRx 861304 Defibrillator specifications  
The specifications provided in the following tables are nominal values. Additional  
information can be found in the Technical Reference Manual for HeartStart  
Physical  
category specifications  
size 2.4” H x 7.1” D x 8.7” W  
(6 cm H x 18 cm D x 22 cm W).  
weight Approximately 3.5 lbs (1.6 kg) with battery and pads installed.  
pads compatibility HeartStart SMART Pads II 989803139261  
(In an emergency or during use, HeartStart DP2/DP6 pads may be used.  
However, the FRx should not be stored with DP2/DP6 pads installed, as the  
daily self-test will not give a “pass” result and the device will chirp.)  
Environmental  
category specifications  
temperature and Operating and standby (battery installed, pads connected):  
relative humidity 32° to 122° F (0° to 50° C);  
10% to 75% RH (non-condensing).  
Storage/shipping (with battery and pads case):  
-4° to 140° F (-20° to 60° C) for up to 1 week;  
0% to 85% RH (non-condensing) for up to 2 days, thereafter 65% RH maximum  
altitude 0 to 15,000 feet (0 to 4,572 m).  
shock/drop abuse Withstands 1 meter drop on any edge, corner, or face of the device onto  
tolerance masonry surface.  
vibration Operating: meets MILSTD 810F Fig. 514.5C-17, random.  
Standby: meets MILSTD 810F Fig. 514.5C-18, swept sine (helicopter).  
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category specifications  
sealing Meets IEC 529 class IPx5 for jetting water and class IP5x for solid objects (dust  
protected).  
ESD/EMI (radiated and See Appendix F.  
immunity)  
aircraft: method Meets RTCA/DO-160D:1997 Section 21 (Category M - Charging).  
Controls and indicators  
category specifications  
controls Green On/Off button  
Blue i-button  
Orange Shock button  
Optional Infant/Child Key accessory  
indicators Ready light: green, blinks when the defibrillator is in standby mode (ready for  
use); solid when the defibrillator is being used.  
i-button: blue, flashes when information is available, on solid during patient care  
pause.  
Caution light: flashes when the defibrillator is analyzing, comes on solid when  
the defibrillator is ready to deliver a shock.  
Shock button: orange, flashes when the defibrillator is charged and ready to  
deliver a shock.  
Pads Placement LEDs: flash when FRx is turned on; off once pads are placed on  
patient. Also operates with Infant/Child Key inserted to indicate pads placement  
on infants and children under 55 pounds (25 kg) or 8 years old.  
audio speaker Provides voice instructions and warning tones during normal use.  
beeper Provides chirps when troubleshooting is needed.  
status indicator Status indicator LCD displays device readiness for use.  
low battery detection Automatic during daily periodic self-testing.  
low battery indicator Alarm chirps and flashing blue in-button.  
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Defibrillation waveform  
category nominal specifications  
waveform parameters Biphasic truncated exponential. Waveform parameters are automatically  
adjusted as a function of patient defibrillation impedance. In the diagram at left,  
D is the duration of phase 1 and E is the duration of phase 2 of the waveform, F  
is the interphase delay (500 µs), and Ip is the peak current.  
The HeartStart FRx 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  
energy (J)  
resistance (Ω) duration (ms) duration (ms) current (A)  
25  
50  
75  
100  
125  
150  
175  
2.8  
4.5  
6.25  
8.0  
9.65  
11.5  
12.0  
2.8  
4.5  
5.0  
5.3  
6.4  
7.7  
8.0  
65  
40  
30  
24  
21  
18  
16  
128  
150  
155  
157  
159  
160  
158  
pediatric defibrillation  
(using Infant/Child Key 989803139311)  
load  
phase 1  
phase 2  
peak  
delivered  
energy (J)  
resistance (Ω) duration (ms) duration (ms) current (A)  
25  
50  
75  
100  
125  
150  
175  
2.8  
4.5  
6.3  
8.0  
9.0  
9.0  
9.0  
2.8  
4.5  
5.0  
5.3  
6.0  
6.0  
6.0  
35  
22  
16  
13  
11  
10  
9
43.4  
50.2  
51.8  
52.4  
52.3  
50.2  
48.1  
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36  
category nominal specifications  
energy Using HeartStart SMART Pads II for adult defibrillation: 150 J nominal ( 15%)  
into a 50 ohm load.  
Using HeartStart SMART Pads II with Infant/Child Key inserted: 50 J nominal  
( 15%) into a 50 ohm load. Sample pediatric energy doses:  
age  
energydose  
newborn  
1 year  
2 - 3 years  
4 - 5 years  
6 - 8 years  
14 J/kg  
5 J/kg  
4 J/kg  
3 J/kg  
2 J/kg  
Doses indicated are based on CDC growth charts for the 50th percentile  
weights for boys.*  
* 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.  
shock-to-shock cycle time < 20 seconds typical, including analysis.  
“charge complete” Shock button flashes, audio tone sounds; device is able to deliver a shock as  
indicator soon as a shock is advised.  
patient care Quick Shock. 8 seconds, typical, from end of patient care pause to shock  
pause-to-shock time delivery.  
disarm (AED mode) Once charged, the HeartStart FRx will disarm if:  
• patient’s heart rhythm changes to non-shockable rhythm,  
• a shock is not delivered within 30 seconds after the FRx is armed,  
• the On/Off button is pressed for one second to turn off the FRx,  
• the Infant/Child Key is inserted or removed,  
the battery has been removed or is completely depleted, or  
• the impedance between pads is out of range.  
adult shock delivery vector Via SMART Pads II placed in the anterior-anterior (Lead II) position.  
infant/child shock delivery Via SMART Pads II typically placed in the anterior-posterior position.  
vector  
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ECG analysis system  
category specifications  
function Evaluates impedance of adhesive pads for proper contact with patient 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, including  
ventricular flutter and polymorphic ventricular tachycardia (VT). The  
HeartStart FRx Defibrillator uses multiple parameters to determine if a rhythm  
is shockable.  
NOTE: Some very low-amplitude or low-frequency rhythms may not be interpreted as  
shockable VF rhythms. Also, for safety reasons, some VT rhythms often associated with  
circulation may not be interpreted as shockable rhythms.  
non-shockable rhythms On detection of any non-shockable rhythm, 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 that interferes with accurate rhythm  
analysis, analysis will be delayed until the ECG signal is clean.  
analysis protocol Depending on results of analysis, either prepares for shock delivery or provides  
a pause. For details of protocol, see Appendix F, Configuration.”  
ECG analysis performance  
b
meets AHA recommendations for adult defibrillation  
ECG test  
observed  
90% one-sided  
lower  
a
rhythm class  
sample size  
performance  
confidence limit  
shockable rhythm —  
ventricular fibrillation  
300  
100  
300  
100  
sensitivity >90%  
sensitivity >75%  
specificity >99%  
specificity >95%  
(87%)  
(67%)  
(97%)  
(92%)  
shockable rhythm —  
ventricular tachycardia  
non-shockable rhythm —  
normal sinus rhythm  
non-shockable rhythm —  
asystole  
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38  
b
meets AHA recommendations for adult defibrillation  
ECG test  
observed  
90% one-sided  
lower  
a
rhythm class  
sample size  
performance  
confidence limit  
non-shockable rhythm — all  
other non-shockable  
450  
specificity >95%  
(88%)  
c
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 recommendationsb  
and the AAMI standard DF80.  
Accessories specifications  
HeartStart SMART Pads II 989803139261  
category specifications  
2
pads for defibrillation, Disposable, adhesive pads with a nominal active surface area of 80 cm each,  
pacing, monitoring, provided in a disposable plastic case, and an integrated 48 inch (121.9 cm),  
cardioversion typical, cable. Pads in case are designed to fit into carry cases.  
SMART Pads II compatibility  
defibrillator model  
adult  
patient use  
infant/child patient use  
FRx*  
yes  
yes  
FR2/FR2+  
yes  
yes  
no, use M3870A  
no  
manual mode only  
no; use M5072A  
manual mode only  
FR/ForeRunner  
MRx/XL/XLT/4000  
HS1/OnSite/Home  
competitive adapters  
yes  
no; use M5071A  
yes  
* Pre-connectable to FRx defibrillator only.  
pads shelf life Pads package is labeled with a use-by date of at least two years from date of  
manufacture.  
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M5070A battery and 989803139301 TSO C-142* battery  
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 25° C  
(77° F). (IEC 60601-2-4, 2002)  
shelf life A minimum of 5 years from date of manufacture when stored and maintained  
(prior to insertion) according to directions provided in this document.  
standby life Typically, 4 years when stored and maintained according to directions provided  
(after insertion) in this document.  
training life Supports 10 hours of use in training mode.  
battery limitations Never charge, short circuit, puncture, deform, incinerate, heat above 60° C, or  
expose contents to water. Remove the battery when discharged.  
maintenance and calibration There are no periodic maintenance or calibration requirements that are  
requirements for continued necessary for continued airworthiness of the 989803139301 battery. For  
airworthiness battery maintenance with respect to performance within the AED, please see  
(989803139301 only) Chapter 5. There are no user-serviceable parts in the battery.  
environmental qualification Meets following acceptance criteria: No leaking, venting, distortion, fire, or  
per RTCA/DO-227, Section rupture. Change in open circuit voltage <2%.  
2.3  
Infant/Child Key 989803139311  
category specifications  
size 6.3” x 2.4” x 0.2” (16 cm x 6 cm x 0.5 cm).  
weight 1.0 oz (29 g).  
material Polycarbonate.  
*
The conditions and tests required for TSO approval of this article are minimum performance standards. It is the responsibility of those  
installing this article either on or within a specific type or class of aircraft to determine that the aircraft installation conditions are within  
the TSO standards. TSO articles must have a separate approval for installation in an aircraft. The article may be installed only if performed  
under 14 CFR Part 43 or the applicable airworthiness requirements.  
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40  
Environmental considerations  
By complying with your national or local regulations regarding disposal of electric,  
electronic, and battery waste, you can make a positive contribution to our shared  
environment.  
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 or local  
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. Dispose  
of them as infectious waste. Recycle the case at an appropriate recycling facility.  
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F
Configuration  
Overview  
The Philips HeartStart FRx Defibrillator comes with a factory default configuration  
designed to meet the needs of most users. This configuration can only be changed  
by using HeartStart Configure version 1.0 or higher, Event Review version 3.2 or  
higher, or Event Review Pro 3.1 or higher. This software is for use by trained  
personnel. Information about HeartStart data management products is available  
information.  
Device options  
The following table includes the features of FRx operation that are not related to  
patient treatment  
parameter  
settings  
default  
8
default description  
speaker volume  
1, 2, 3, 4,  
5, 6, 7, 8  
The volume of the FRxs speaker is set to 8,  
highest.  
auto send periodic  
self-test (PST) data  
On, Off  
On  
On  
Enables the periodic self-test data to be  
broadcast through the device's infrared  
data port.  
ECG out data  
On, Off  
Enables the ECG data to be broadcast  
through the device's infrared data port.  
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42  
Patient treatment protocol options  
parameter  
settings  
default  
default description  
“call EMS” voice • At power on (when the  
At the start of Provides a voice reminder to  
reminder timing  
user turns on the FRx)  
the first  
make sure emergency medical  
services have been called, at  
the start of the first patient  
care pause.  
patient care  
pause.  
• At power on and at the  
start of the first patient  
care pause  
• At the start of the first  
patient care pause  
• No reminder  
shock series  
1, 2, 3, 4  
1
The automatic protocol pause  
for CPR is activated each time  
a shock is delivered.*  
During the protocol pause,  
the FRx does not perform  
rhythm analysis.  
The length of the protocol  
pause after a shock series is  
completed is determined by  
the protocol pause timer  
setting.  
shock series interval  
(minutes)  
1.0, 2.0,  
(infinity)  
1.0  
A delivered shock must occur  
within 1 minute of the  
previous shock to be counted  
as part of the current shock  
series.  
NOTE: This parameter is only  
applicable when the shock series  
is not configured to the default 1  
shock.  
* A shock series begins when a shock is delivered after the FRx 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.  
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parameter  
settings  
default  
2.0  
default description  
protocol pause timer  
(minutes)  
0.5, 1.0, 1.5,  
2.0, 2.5, 3.0  
A 2-minute protocol pause for  
CPR automatically starts after  
voice instruction is given when  
a shock series is completed.  
After the protocol pause, the  
defibrillator returns to rhythm  
analysis.  
If the user presses the  
i-button for optional CPR  
coaching, the FRx 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.  
NSA pause type • Standard NSA pause: FRx  
does not perform rhythm  
analysis during the NSA  
pause.  
SMART NSA  
pause  
During a SMART NSA pause,  
the defibrillator conducts  
background monitoring. If a  
potentially shockable rhythm  
is detected in a motionless  
patient, the defibrillator  
terminates the SMART NSA  
pause and resumes rhythm  
analysis.  
• SMART NSA pause: FRx  
conducts background  
monitoring during the  
SMART NSA pause. If a  
potentially shockable  
rhythm is detected, FRx  
terminates the SMART  
NSA pause and resumes  
rhythm analysis.  
NOTE: If the FRx detects CPR in  
progress or if the responder has  
pressed the i-button for CPR  
Coaching, the SMART NSA  
pause will be converted to a  
standard NSA pause. During the  
standard NSA pause, the  
defibrillator does not perform  
rhythm analysis.  
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parameter  
settings  
default  
2.0  
default description  
NSA pause timer  
(minutes)  
0.5, 1.0, 1.5,  
2.0, 2.5, 3.0  
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 FRx 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.  
CPR prompt • CPR1: Instructs the user  
to begin CPR.  
CPR4:  
The CPR reminder voice  
Instructs the  
user that it is  
safe to touch  
instructions provided at the  
beginning of a pause interval  
assures the user that it is safe  
• 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.  
the patient, to to touch the patient, instructs  
begin CPR,  
and to press  
the i-button  
for CPR  
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.  
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.  
* 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 interval 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.  
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parameter  
settings  
yes, no  
default  
yes  
default description  
CPR Coaching  
adult ventilation instruction  
Optional CPR Coaching  
includes rescue breaths at the  
rate determined by the CPR  
Coaching compression:  
ventilation ratio for adults  
when an adult pads set is  
installed.  
Note: if this parameter is  
configured to NO, CPR Coaching  
will always be compressions-only  
when an adult pads set is  
installed.  
CPR Coaching  
infant/child ventilation  
instruction  
yes, no  
yes  
Optional CPR Coaching  
includes rescue breaths at the  
rate determined by the CPR  
Coaching compression:  
ventilation ratio for infants and  
children when an infant/child  
pads set is installed.  
Note: if this parameter is  
configured to NO, CPR Coaching  
will always be compressions-only  
when an infant/child pads set is  
installed.  
CPR Coaching • 30:2 adult and  
30:2 adult and When the user presses the i-  
compression:ventilation  
ratio  
30:2 infant/child  
30:2 infant/  
child  
button for optional CPR  
Coaching during a protocol  
pause or NSA pause, the FRx  
will provide coaching in basic  
CPR for cycles of 30  
• 30:2 adult and  
15:2 infant/child  
• 15:2 adult and  
15:2 infant/child  
compressions and 2  
ventilations for adults,  
children, and infants. Pauses  
begin and end with  
compressions.  
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46  
G
Testing and troubleshooting  
Testing  
The HeartStart FRx Defibrillator automatically tests its battery, connected SMART  
Pads II, and internal circuitry every day. It alerts you if it finds a problem. See the  
for a detailed discussion of the self-tests.  
You can also test the defibrillator at any time by removing the battery for five  
seconds then reinstalling it. This test takes about one minute. Because the battery  
insertion self-test is very detailed and uses battery power, running it more often  
than necessary will drain the battery prematurely. It is recommended that you run  
the battery insertion self-test only:  
when the defibrillator is first put into service.  
after each time the defibrillator is used to treat a patient.  
when the battery is replaced.  
when the defibrillator may have been damaged.  
Note: If the FRx turns off when you install the battery instead of running the  
battery insertion self-test, check to be sure that the pads case is not open. If  
the pads case is open, the FRx assumes that it may be in use and so will not run  
the self-test.  
If you need to use the defibrillator to treat a victim of SCA while you are running a  
battery self-test, press the On/Off button to stop the test and turn on the  
HeartStart FRx for use.  
Troubleshooting  
The FRx’s green Ready light is the signal that tells you if the defibrillator is ready  
for use. The defibrillator chirps and the i-button flashes to alert you to a problem.  
Recommended action when you need to use the device  
If the FRx is chirping and the blue i-button is flashing, it is possible that the  
defibrillator still has enough battery power to be used to treat a victim of SCA.  
Press the On/Off button.  
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If the FRx does not turn on when you press the On/Off button, remove the  
battery and replace it with a new battery if available and press the On/Off button  
to turn on the defibrillator. If no spare battery is available, remove the installed  
battery for five seconds, then reinsert it and run a battery insertion self-test.  
If the problem continues, do not use the defibrillator. Attend to the patient,  
providing CPR if needed, until emergency medical personnel arrive.  
Troubleshooting while the FRx is being used  
(green Ready light is solid)  
Always follow any instructions the device gives.  
defibrillator says: possible cause  
recommended action  
... to replace the The battery is nearly depleted. The  
battery immediately FRx will turn off unless a new battery  
is installed.  
Install a new battery immediately.  
... to plug in pads • The pads connector has been  
• Plug in the pads connector.  
• Replace the damaged pads.  
connector  
unplugged.  
... to replace pads  
• The pads have been damaged.  
• The pads have been peeled from the  
case, but have not been successfully  
attached to the patient. There may  
be a problem with the pads.  
• Replace the pads on patient with  
new pads to continue with the  
rescue.  
... to press the pads firmly • The pads are not properly applied to • Make sure that the pads are sticking  
to the skin  
the patient.  
completely to the patients skin.  
... to make sure the pads  
have been removed  
from the case  
• The pads are not making good  
contact with the patient's bare chest  
because of moisture or excessive  
hair.  
• If the pads are not sticking, dry the  
patient's chest and shave or clip any  
excessive chest hair.  
... the pads should not  
be touching the  
• The pads are touching each other.  
• Reposition the pads.  
• Make sure pads are not in the case  
or on patient’s clothing.  
patient’s clothing  
• The pads may not have been  
removed from the case or may be on  
the patient’s clothing.  
... to make sure the pads  
connector is fully inserted  
• Pads connector is not fully inserted.  
• Make sure the pads connector is fully  
inserted.  
If the voice instruction continues after  
you do these things, replace the pads  
set.  
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defibrillator says: possible cause  
recommended action  
... to stop all motion • The patient is being moved or  
jostled.  
• Stop CPR; do not touch the patient.  
Minimize patient motion. If the  
patient is being transported, stop the  
vehicle.  
• Responders and bystanders should  
minimize motion, particularly in dry  
environments that can generate  
static electricity.  
• Check for possible causes of radio  
and electrical interference and turn  
them off or remove them from the  
area.  
• The 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 shock was not • The pads may not be making good  
• Press the pads firmly to the patient's  
chest.  
delivered  
contact with the patients skin.  
• The pads may be touching each  
other.  
• Make sure the adhesive pads are  
correctly positioned on the patient.  
• Replace the pads if necessary.  
• The pads may be damaged.  
... the shock button was Shock has been advised but the shock  
When next prompted, press the Shock  
not pressed button has not been pressed within 30 button to deliver shock.  
seconds.  
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Troubleshooting while the FRx is not being used  
(green Ready light is not on)  
Press the blue i-button to check defibrillator status, and follow any instructions the  
device gives.  
behavior possible cause  
recommended action  
chirps or • The battery power is low or the pads  
• Press the blue i-button. Replace the  
battery or pads if instructed.  
i-button flashes  
need to be replaced.  
• The pads may be damaged or the  
adhesive dried out.  
• Replace the pads with a new set  
and do not open the case until pads  
are needed in an emergency.  
• The pads case may be open.  
• Make sure the pads case is closed.  
• The defibrillator may have been turned • Make sure the pads are properly  
off without a pads set installed.  
installed. (See Chapter 2 for  
directions.)  
• The Training Pads II set has been left in • Remove the Training Pads II set  
the defibrillator.  
and replace it with a set of SMART  
Pads II.  
• The Infant/Child Key may have been  
left installed.  
• Remove the Infant/Child Key.  
• The defibrillator has been stored  
outside the recommended  
temperature range.  
• Remove the battery for five  
seconds then reinstall it to start  
the battery insertion self-test. If it  
fails, insert a new battery to repeat  
the test. If it fails again, do not use  
the defibrillator. If it passes, store  
the defibrillator within the  
recommended temperature range.  
• The defibrillator has detected an error • Contact Philips for service if  
during a self-test or cannot perform a  
self-test, or the Shock button is  
damaged.  
needed.  
no chirping • The battery is missing or completely  
and/or  
i-button does not flash,  
• Remove the battery for five  
seconds then reinstall it to start  
the battery insertion self-test. If it  
fails, insert a new battery and  
repeat the test. If it fails again, do  
not use the defibrillator.  
depleted.  
or  
no response to  
pressing i-button  
• The defibrillator may have been  
physically damaged.  
• Contact Philips for service.  
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50  
H
Additional technical data required for European conformity  
Electromagnetic conformity  
Guidance and manufacturer’s declaration: The HeartStart FRx is intended for use  
in the electromagnetic environment specified in the tables below. The customer or  
user of the HeartStart FRx should assure that it is used in such an environment.  
Electromagnetic emissions  
emissions test  
compliance  
electromagnetic environment – guidance  
RF  
CISPR 11  
Group 1  
Class B  
The FRx 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 FRx 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.  
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Electromagnetic immunity  
immunity test  
IEC 60601  
test level  
compliance  
level  
electromagnetic environment - guidance  
electrostatic discharge  
(ESD)  
6 kV contact  
8 kV air  
6 kV contact There are no special requirements with  
a
respect to electrostatic discharge.  
8 kV air  
IEC 61000-4-2  
power frequency  
(50/60 Hz) magnetic field  
IEC 61000-4-8  
3 A/m  
3 A/m  
Power frequency magnetic fields should  
be at levels characteristic of a typical  
location in a typical commercial/hospital  
environment.  
There are no special requirements for  
non-commercial/non-hospital  
environments.  
radiated RF  
IEC 61000-4-3  
10 V/m  
80 MHz to 2.5  
GHz  
[E1] V/m  
Portable and mobile RF communications  
equipment should be used no closer to  
any part of the HeartStart FRx, including  
b,c  
cables, than is absolutely necessary.  
The recommended separation distances  
for various transmitters and the AED  
are shown in the following table.  
Interference may occur in the  
vicinity of equipment marked  
with the following symbol:  
NOTE 1.At 80 MHz and 800 MHz, the higher frequency range applies.  
NOTE 2.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from  
structures, objects and people.  
a. Generally, AEDs are sometimes susceptible to interference generated by patient and/or responder motion in environments in which a high  
static electric field is present (e.g., low humidity, synthetic carpets, etc.). As a safety measure, Philips AEDs incorporate a patented method  
to sense possible corruption of the ECG signal by such interference and to respond by directing the user to stop all motion. In these cases,  
it is important to minimize movement in the vicinity of the patient during rhythm analysis in order to ensure that the signal being analyzed  
accurately reflects the patient’s underlying heart rhythm.  
b. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13, 567 MHz;  
26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.  
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,  
AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment  
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which  
the HeartStart FRx is used exceeds the applicable RF compliance level above, the HeartStart FRx should be observed to verify normal  
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HeartStart.  
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52  
Recommended separation distances between portable and mobile RF  
communications equipment and the HeartStart FRx Defibrillator  
The HeartStart FRx Defibrillator is intended for use in an electromagnetic  
environment in which radiated RF disturbances are controlled. The customer or  
the user of the FRx can help prevent electromagnetic interference by maintaining a  
minimum distance between portable and mobile RF communications equipment  
(transmitters) and the FRx as recommended below, according to the maximum  
output power of the communications equipment.  
separation distance according to frequency of transmitter (m)  
rated maximum output  
power of transmitter (W)  
80 MHz to 800 MHz  
800 MHz to2.5 GHz  
d = 0.6P  
d = 1.15P  
0.01  
0.1  
1
0.06  
0.19  
0.6  
0.115  
0.36  
1.15  
3.64  
11.5  
10  
1.9  
100  
6.0  
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.  
NOTE 5. Transmitters/antenna of this power-level are most likely mounted on an emergency vehicle chassis. The distances  
cited here are for open field. For an external antenna, the separation distance is most likely shorter.  
HEARTSTART FRx 861304 OWNER’S MANUAL  
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53  
Shock cycle timing  
The FRx’s Quick Shock feature allows it to deliver a shock within 8 seconds,  
typical, following a CPR pause. From shock to shock, the FRx takes <20 seconds,  
typical, including analysis. After 15 shocks, the FRx takes <30 seconds from  
analyzing to ready-to-shock. After 200 shocks, the FRx takes <40 seconds from  
initial power-on to ready-to-shock.  
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Notes  
HEARTSTART FRx 861304 OWNER’S MANUAL  
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Intentionally blank.  
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P O W E R T O S A V E  
A
L I F E  
Philips Medical Systems  
United States  
Philips Medical Systems is part of  
Royal Philips Electronics  
Philips Medical Systems  
2301 Fifth Avenue, Suite 200  
Seattle, WA, USA 98121  
(800) 263-3342  
Canada  
Philips Medical Systems  
281 Hillmount Road  
Markham, Ontario  
L6C 2S3  
(800) 291-6743  
Europe, Middle East, and Africa  
Philips Medizin Systeme Boeblingen GmbH  
Cardiac and Monitoring Systems  
Hewlett-Packard Strasse 2  
71034 Boeblingen, Germany  
+49 7031 463 2254  
Latin America  
Philips Medical Systems  
1550 Sawgrass Corporate Parkway, Suite 300  
Sunrise, FL 33323, USA  
(954) 835-2660  
Asia Pacific  
Philips Electronics Hong Kong Ltd.  
30th Floor, Hopewell Centre,  
17, Kennedy Road, Wanchai,  
Hong Kong  
(852) 2821 5888  
REF: 989803138731  
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