Bundle
Q: When I purchase the HeartStart OnSite Defibrillator, what comes with it? |
A: When you purchase the HeartStart OnSite, you get all the items
needed to respond to a cardiac arrest: the HeartStart OnSite with its
Owner’s Manual, a battery, a SMART Pads cartridge, and a Quick
Reference. |
Ready Light
Q: What exactly does the green Ready light mean? |
A: As long as a battery is installed, the OnSite's green Ready light is
always visible -- even through the optional carry case -- to let you know
the device's readiness for use. As long as the
Ready light is blinking, you can be confident the OnSite
passed its latest self-test and is ready for use.
ight is not blinking and the OnSite is chirping, the blue
information button will be blinking. Press the blue i-button for
troubleshooting guidance.
If the Ready light itself is physically broken, it may not be blinking. In this
situation, service is required. |
Printed Reports
Q: How can I get printed reports of the HeartStart OnSite's data? |
A: The information recorded in the internal memory of the OnSite can
be transferred to a computer using one of the HeartStart Event Review
software products, and then printed out. |
OnSite Specifications
Q: Does the HeartStart OnSite meet AAMI DF 80 requirements? |
A: Yes. The HeartStart OnSite meets all applicable performance and
safety requirements as outlined in AAMI DF 80-2003. |
Pacemaker Artifact
Q: What about pacemaker interference? |
A: The SMART Analysis algorithm used in the HeartStart OnSite has
been designed so that, in most cases, a pacemaker will not impact its
ability to make a shock or no shock decision. We have designed and
very robust. |
Effects of Temperature
Q: How does temperature affect the HeartStart OnSite and the SMART
Pads? |
A: The HeartStart OnSite is specified to operate between 32° - 122°F
(0º - 50º C) and to be stored between 50° - 109° F (10º - 43º C). While
it may work beyond these temperature ranges, it is not guaranteed.
Low temperatures: The main factor limiting our guarantee of the
HeartStart OnSite in a cold environment is the possibility of slower
charge times due to battery performance limitations below 32º F
(0º C).
High temperatures: Higher temperatures primarily affect the
defibrillation pads; when stored at temperatures higher than 109° F
(43º C), the pads may not meet their shelf-life specifications. |
Servicing
Q: How do I get the HeartStart OnSite serviced? |
A: Call our Customer Service team at 1-800-263-3342 for a returned
goods authorization and replacement unit. There are no userserviceable
parts in the HeartStart OnSite. |
SMART Pads
Reversed Pads Placement
Q: What will happen if I reverse pad location according to the diagrams on
each pad? |
A: The SMART Pads are labeled to provide clear direction to their
location on the patient's chest. But even if pad location is reversed, the
HeartStart OnSite will perform correctly. It is not necessary to correct
their location. |
A/P Pads Location
Q: Can I place the pads in an anterior/posterior location? |
A: We don't recommend that you use this pad positioning. However, it
is appropriate for infants and small children when using the HeartStart
Infant/Child SMART Pads. |
Battery
Battery Shelf Life
Q: How do you know your non-rechargeable batteries have a five-year
shelf life? |
A: Our supplier, a dominant manufacturer of consumer and industrial
batteries, specifies the shelf life of the lithium manganese dioxide
battery used in the OnSite. |
Battery
Battery Service Life
Q: How do you know that the battery has a typical life of four years when
the HeartStart OnSite is in standby mode? |
A: Actual use data based on accelerated test methods show a typical
standby mode life of four years with a fresh battery. (IEC 60601-2-4,
2002)
|
“Install Before” Date
Q: If I install a battery on or before its “Install Before” date how will the
battery perform (with the HeartStart OnSite in stand-by mode)? |
A: Provided the battery has been stored within the recommended
standby temperature range, its service life will still be at least four
years, and it will still provide approximately 200 shocks or 4 hours of
operation at 77º F (25º C). |
Battery Verification
Q: If I find a “loose” battery, how do I know it's good? |
A: If the battery is in its packaging, confirm that the “Install Before”
date hasn't passed. If the battery is not in its packaging, install it in the
HeartStart OnSite and perform the battery insertion self-test. If the
battery is good, the OnSite will signal a “ready” condition by blinking
the “ready” light. |
Dependability
Q: Why are lithium manganese dioxide batteries so dependable? |
A: Lithium manganese dioxide batteries have been used for years in
consumer and medical devices, and have proven to be safe and reliable. |
Battery Temperature
Q: Don't lithium batteries perform poorly in cold temperatures? |
A: All battery performance worsens in low temperatures. The
advantage provided by the HeartStart OnSite is it will chirp and the
i-button will flash if the unit has been stored below its storagetemperature
range. |
Low Battery Indicator
Q: When the low battery indicator is given, how much time does the device
really have left? |
A: When the OnSite starts chirping, the Ready light goes off, and the
i-button blinks to indicate low battery power, there is sufficient energy
left to perform a typical code: at least 9 shocks and 15 minutes of
operation. |
Charge/Discharge
Q: Does the daily self-test involve a full energy charge and discharge of the
defibrillation system? |
A: The daily tests are designed to test the battery and the general
functionality of the HeartStart OnSite. The full energy test is
performed monthly to check high voltage circuits and to automatically
recalibrate, as needed. |
Defibrillation Shock
Maximum Energy
Q: What is the highest amount of energy that the HeartStart OnSite
delivers? |
A: The HeartStart OnSite has been designed to deliver 150 J defibrillation
shock when used with the HeartStart Adult SMART Pads cartridge and 50 J
when used with the HeartStart Infant/Child SMART Pads cartridge. |
No Escalating Energy
Q: Why doesn’t the HeartStart OnSite deliver escalating high energy? |
A: Escalating energy implies that you deliver your first shock with low energy, holding back potency, and only resort to higher potency if the early defibrillation attempts fail. The only reason to hold back potency on early defibrillation attempts would be to avoid the possibility of the side effect of cardiac dysfunction at a time when the heart is most fragile. In fact, there is a downside to high-energy shocks. While high peak current is associated with defibrillation effectiveness, high energy can result in a delay in the return of spontaneous circulation (ROSC)
due to cardiac dysfunction caused by stunning.1 Philips delivers a high peak-current waveform using a low-energy shock. So with Philips SMART Biphasic therapy, the patient receives our most potent therapy with the very first shock and on every subsequent shock. There is no need to escalate when every shock is already at maximum effectiveness. Guidelines 2005 has taken the clear position that there is no demonstrable advantage of escalating therapy over fixed low energy.2 In fact, patients receiving escalating therapy may wait about six minutes to receive the most potent therapy. With Philips SMART Biphasic, patients receive our most effective therapy on the very first shock. 1 Tang et al. Journal of the American College of Cardiology. 2004; 43(7):1228-1235.
2 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation
and Emergency Cardiovascular Care. Circulation. 2005; 112 Supplement IV. |
HeartStart Clinical Trials
Q: Do you have clinical study data on real-world testing of your defibrillator,
rather than testing only in animals or in hospitalized patients with artificially
induced VF and no significant “down time”? |
A: The outstanding performance of Philips SMART Biphasic waveform
in treating sudden cardiac arrest has been reported in over 20 peerreviewed
manuscripts, representing hundreds of VF patients. Most of
these studies were in real-world, out-of-hospital settings. The studies
show a very high first-shock efficacy with long-duration VF, regardless
of patient weight, impedance, or cause of arrest.1,2,3 One study showed
first-shock efficacy of 100% in out-of-hospital cardiac arrest.4 Another
out-of-hospital study showed 96% first-shock efficacy in long-duration
cardiac arrest.1
1 Schneider et al., Circulation, 2000; 102:1780-1787
2 White et al. Critical Care Medicine. 2004; 32(9) Supplement S387-S392.
3 White et al. Resuscitation. 2005 Jan.; 64(1):63-9.
4 Page et al. New England Journal of Medicine. 2000; 343:1210-1216. |
Defibrillation Shock
Quick Shock
Q: What is Quick Shock and what is its benefit? |
A: Recent studies have revealed that CPR is even more beneficial than
previously realized, particularly for longer down-time cardiac arrest
patients.1,2 The beneficial effect of CPR disappears very rapidly once it
is stopped, so time to shock after CPR is very important.3,4
Quick Shock is a unique feature offered only by Philips on HeartStart
automated external defibrillators (AEDs). All HeartStart AED models
can deliver a shock typically in less than 10 seconds after the end of a
CPR interval.
1 Cobb LA, Fahrenbruch CE, Walsh TR, et al. Influence of cardiopulmonary
resuscitation prior to defibrillation in patients with out-of-hospital ventricular
fibrillation. JAMA. 1999 Apr 7;281(13):1182-8.
2 Wik L, Hansen TB, Fylling F, et al. Delaying defibrillation to give basic cardiopulmonary
resuscitation to patients with out-of-hospital ventricular fibrillation: A
Randomized Trial. JAMA.2003 Mar 19; 289(11):1389-95.
3 Yu T, Weil MH, Tang W. Adverse outcomes of interrupted precordial compression
during automated defibrillation. Circulation. 2002; 106:368-372.
4 Eftestol T, Sunde K, Steen PA. Effects of Interrupting precordial compressions in
the calculated probability of defibrillation success during out-of-hospital cardiac
arrest. Circulation. 2002;105:2270-2273. |
Abort
Q: If I turn the device off, or don’t press the shock button, is the defibrillation
charge dumped? |
A: Yes. Energy is safely discharged in a special circuit that is fully
isolated from the patient.
Rhythm Analysis |
Shockable Rhythms
Q: What types of rhythms does the HeartStart OnSite shock? |
A: Heart rhythms that the HeartStart OnSite Defibrillator determines
are appropriate for defibrillation, such as ventricular fibrillation and
some ventricular tachycardias associated with sudden cardiac arrest.
Shock/No Shock decisions using the SMART Analysis algorithm were
validated with 1500 ECG samples collected in pre-hospital and hospital
environments and independently evaluated by three cardiologists.
PEA (Pulseless Electrical
Activity) |
| Q: How does the HeartStart OnSite differentiate PEA from NSR? |
A: Pulseless electrical activity (PEA) and normal sinus rhythm (NSR) are
both non-shockable rhythms. If the patient is not breathing or moving,
CPR should be initiated. |
Voice Instructions
Excessive Noise
Q: If I can’t hear the voice instructions (for example, because of excessive
noise at the scene) what should I do? |
A: The orange Shock button will flash if a shock is advised. After the
resuscitation is over you may want to confirm that your HeartStart
OnSite voice instructions have been set at their highest volume.
In addition, the Quick Reference provides visual information on device
operation. |
Self-Tests
Abort
Q: What happens if I need to use the HeartStart OnSite when it is
performing a self-test? |
A: The HeartStart OnSite immediately aborts the self-test when it is
turned on by pressing the on/off button or by pulling the green handle.
There is no delay in device use. |
Confidence
Q: I don't feel comfortable relying on self-tests and the Ready light; how can
you make me confident in the reliability of the HeartStart OnSite? |
A: Our self-tests and the Ready light have been tested very thoroughly
and Philips is confident in their reliability. If you don't feel comfortable,
go ahead and perform a battery insertion self-test as frequently as you
need, to assure yourself of device readiness. Just be aware that frequent
battery insertion self-tests can significantly compromise battery life. |
Check Pads
Q: Does your daily self-test check the defibrillation pads? |
A: The OnSite's daily self-tests include a check of the installed SMART
Pads cartridge for integrity, gel moisture, and connections. |
Disposables
Shelf Life
Q: What is the shelf life of the disposables used with the HeartStart OnSite? |
A: With the battery and SMART Pads cartridges remaining in their
original packaging, the items have the following shelf lives;
• Battery: 5 years (note “Install Before” date on packaging).
• SMART Pads: at least 2 years from the date of shipment (note “Use
Before” date on packaging). |
Labeling
Expiration, Battery
Q: How do you interpret the “Install Before” labeling on the battery? |
A: The labeling is meant to indicate that the battery should be installed
before the last day of the month and year indicated. |
Expiration, Pads
Q: How do you interpret the “Use Before” labeling on the pads? |
A: The labeling is meant to indicate that the pads expire on the last day
of the month and year indicated. |
Symbol
Q: What does this symbol mean? |
A: It means refer to the Owner’s Manual for further information. |
The Company
More Information
Q: Where do I go for more information? |
A: In the U.S. call Philips HeartStart Operation, at 1-800-26-DEFIB
(Customer Service). You can also call your local Philips Medical Systems
representative or go to www.medical.philips.com/hear |
