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General Questions

Ready Light

What exactly does the green Ready light mean?
As long as a battery is installed, the OnSite’sgreen 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 Defibrillatorpassed its latest self-test and is ready for use. If the light is not blinking and the Defibrillatoris chirping, the blue information button will be blinking. Press the blue i-button for troubleshooting guidance.Tend to immediately as this uses batterypower and risks draining the batteryprematurely.

Life Guidance

What is the Philips HeartStart Life Guidance?
A voice prompt that act as your personal coach to guide you through a cardiac emergency with a simple, step-by-step process; plus it does not skip ahead like other AED brands. If needed, the prompts will automatically be repeated or rephrased, and may include additional instructions to help you understand.

AED Bundle

When I purchase the HeartStart Defibrillator or FRx Defibrillator, what comes with it?
When you purchase the HeartStart AED, you get all the items needed to respond to a cardiac arrest:

  • HeartStart AED with its Owner’s Manual, a battery, a SMART Pads cartridge, and a Quick Reference.
  • Carrying Case is sold separately due to its many available case options, depending on which AED is purchased.

Printed Reports

How can I get printed reports of the HeartStart AED data?
The information recorded in the internal memory of the AED can be transferred to a computer using one of the HeartStart Event Review software products, and then printed out.

Environment/Physical Requirements for Philips Defibrillators

What Sealing Protection is offered and the meaning for the HeartStart AED units?
IP (Ingress Protection) Rating is a ratings standard that measures a device’s degree of protection from dust and water(##). The higher the number, the greater the resistance.

  • OnSite IP Rating is 21 — solid object class IP 2X and drip-proof class IPX1 (preferably for indoor storage area)
  • FRx IP Rating is 55 — solid object class IP 5X and drip-proof class IPX5 (maximum # for durable outdoor storage area)
  • FR3 IP Rating is 55 — solid object class IP 5X and drip-proof class IPX5 (maximum # for durable outdoor storage area)

AED Unit Specifications

Does the HeartStart Defibrillator meet AAMI DF 80 requirements?
Yes. The HeartStart Defibrillator meets all applicable performance and safety requirements as outlined in AAMI DF 80-2003.

Pacemaker Artifact

What about pacemaker interference?
The SMART Analysis algorithm used in the HeartStart Defibrillator 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.

Infant/Child Pads or Key

How do I know when to use an Infant/Child Pads (OnSite AED) or Key (FRx & FR3 AED units) for Pediatric defibrillation?
ediatric Pads or a Key is used for children 8-years / 55 pounds or under. The OnSite has Pads for both Adult and Children. The FRx & FR3 units feature a unique Infant/Child Key that allows you to use the same pads for both adults and children (under 55 lbs or 8 years old). Simply insert the key into the FRx or FR3. The defibrillator automatically adjusts the shock strength and adapts the Life Guidance to provide pad placement and CPR instructions appropriate for children—all without the need for different pads.

Battery

Battery Shelf Life

How do you know your non-rechargeable batteries have a five (5)-year shelf life?
Philips, a dominant manufacturer of consumer and industrial batteries, specifies the shelf life of the lithium manganese dioxide battery used in the OnSite, FRx, and FR3 units.

Battery Service Life

How do you know that the battery has a typical life of four (4)-years when the HeartStart AED unit is in standby mode?
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)

Battery Performance in Stay By Mode – Upon Installation or Before Shelf Life Date

If battery is inserted before “Install Before” date, how will the battery perform with the Philips HeartStart unit in stand-by mode?
Provided the battery has been installed upon purchase or stored within the recommended standby date and in temperature range, its service life/warranty will still be at least 4-years, and it will still provide approximately 200 shocks or 4 hours of operation time for the OnSite & FRx, and 300 shocks or 4 hours of operation time for FR3 device.

Battery Verification

If I find a “loose” battery, how do I know it’s good?
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 AED will signal a “ready” condition by blinking the “ready” light.

Dependability

Why are lithium manganese dioxide batteries so dependable?
Lithium manganese dioxide batteries have been used for years in consumer and medical devices, and have proven to be safe and reliable.

Battery Temperature

Don’t lithium batteries perform poorly in cold temperatures?
All battery performance worsens in low temperatures. The advantage provided by the HeartStart AED is it will chirp and the ibutton will flash if the unit has been stored below its storage temperature range. Note, temperature control carrying cases are available upon request.

Low Battery Indicator

When the low battery indicator is given, how much time does the device really have left?
When the Defibrillator unit starts chirping, the Ready light goes off, and the i-button blinks to indicate low battery power. Note, there is sufficient energy left to perform a typical code: at least 9 shocks and 15 minutes of operation.

Charge/Discharge

Does the daily self-test involve a full energy charge and discharge of the defibrillation system?
The daily tests are designed to test the battery and the general functionality of the HeartStart AED unit. The full energy test is performed monthly to check high voltage circuits and to automatically recalibrate, as needed.

SMART Pads

Reversed Pads Placement

What will happen if I reverse pad location according to the diagrams on each pad?
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, due to Philips Biphasic waveform technology.

A/P Pads Location

Can I place the pads in an anterior/posterior location?
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.

Defibrillation Shock

SMART Biphasic

How does SMART Biphasic work?
Biphasic waveform delivers high peak current from the first shock, yet has low energy to avoid stunning a fragile heart. If waveform has sufficient peak current from the start, escalating to high energy levels is not necessary, even for high and low impedance patients; in turn lessens long term side effects potentially caused by the shock from an AED. In conclusion, it provides maximized shock strength with minimized side effect risk.

AED Shock Strength in Current & Energy, Plus Number of Shocks and Operating Time

How is shock strength measured using Current and Energy?
The two most common ways to talk about AED shock strength are by current (measured in amps) and energy (measured in joule). It is a common assumption that energy is the most important measurement but that is incorrect. You defibrillate a heart by driving current through it. HeartStart AEDs are designed to deliver high current in their low-energy shocks to maximize effectiveness, from the very first shock dose.

Maximum Energy

What is the highest amount of energy that the HeartStart units deliver?
The HeartStart units has been designed to deliver 150 J (joules) defibrillation shock when used with the HeartStart Adult SMART Pads cartridge and 50 J (joules) when used with the HeartStart Infant/Child SMART Pads cartridge or Key.

No Escalating Energy

Why doesn’t the HeartStart defibrillator deliver escalating high energy?
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

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”?
The outstanding performance of Philips SMART Biphasic waveform in treating sudden cardiac arrest has been reported in over 20 peer reviewed 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. 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.

IP Rating

AED IP Ratings (IP ##)

What does the IP code or numbers mean listed on the HeartStart AED units and in the product brochure?
The “IP” code/numbers stands for “Ingress Protection Rating” which classifies the level of entrance/access protection that electrical equipment such as defibrillators provide against the intrusion of solid objects or dust (IP #x – 1st number listed) and jetting water (IP x# – 2nd number listed).

Temperature

Effects of Temperature

How does temperature affect the HeartStart AED units and the SMART Pads?
The HeartStart units are 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 or under warrantee. Temperature control storage cases are available upon request. 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.

Rhythm Analysis

Shockable Rhythms

What types of rhythms does the HeartStart unit shock?
Heart rhythms that the HeartStart 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)

How does the HeartStart unit differentiate PEA from NSR?
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. 32S

Defibrillation Quick Shock

Quick Shock

What is Quick Shock and what is its benefit?
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

If I turn the device off, or don’t press the shock button, is the defibrillation charge dumped?
Yes. Energy is safely discharged in a special circuit that is fully isolated from the patient.

Voice Instructions

Excessive Noise

If I can’t hear the voice instructions (for example, because of excessive noise at the scene) what should I do?
The orange Shock button will flash if a shock is advised. After the resuscitation is over you may want to confirm that your HeartStart defibrillator voice instructions have been set at their highest volume. In addition, the Quick Reference provides visual information on device operation.

Data Recording and Transmission

Data Stored & Retrieved

How much data is stored for the HeartStart AED units and what is used to retrieve it?
The OnSite and FRx unit stores the first 15 minutes of ECG and the entire incident’s events and analysis decisions. A wireless transmission of event data to a Smartphone or PC is available when using the IrDA protocol. HeartStart Event Review Software is also available upon request (optional for additional fee), in order to download and review of data retrieved through defibrillator’s infrared data port.

Self-Tests

Automatic Function

How often does the HeartStart Defibrillators conduct self-tests and what does it include?
It conducts daily, weekly, and monthly tests automatically (more than 85 self-tests regularly) by the HeartStart when it is in its standby mode. The tests monitor many key functions and parameters of the defibrillator, including battery capacity, pads cartridge readiness, and the state of its internal circuitry. In addition, it runs a pads self-test each time a pads cartridge is inserted. It alerts you if it finds a problem.

Ready Light

What does it mean when the light is blinking through the little window?
The blinking light indicates the Defibrillator passed its latest self-test and is ready for use. If the light is not blinking and the Defibrillator is chirping, the blue information button will be blinking. Press the blue i-button for troubleshooting guidance. Tend to immediately as this uses battery power and risks draining the battery prematurely.

Abort

What happens if I need to use the HeartStart AED when it is performing a self-test?
The HeartStart defibrillator 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

How can you make me confident in the reliability of the HeartStart defibrillator relying on self-tests and the Ready light?
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, however just be aware that frequent battery removal and insertion self-tests can significantly compromise battery life.

Battery Insertion

Is it necessary to conduct our own battery insertion self-check periodically?
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.

Pads Check

Does the daily self-tests also check the defibrillation pads?
The AED’s daily self-tests include a check of the installed SMART Pads cartridge for integrity, gel moisture, and connections.

Disposables

Shelf Life

What is the shelf life of the disposables used with the HeartStart OnSite or FRx AED units?
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).

Warranty

Expiration, AED

How do you interpret the expiration date labeled on each Philips AED?
The OnSite and FRx has a 8-year warranty and the FR3 has a 5-year warranty. On the outside of each AED box, it will indicate the expiration date for each AED product. The serial number will also assist you in determining the approximate expiration date – the AED (add 5 or 8 years), Battery (add 4 years), and Pads (add 2 years) to the specified examples below:

  • A16J-##### —- A (Onsite), 16 (Year manufactured), J (Oct. – Month manufactured) – ##### (5-digit Serial No.)
  • B16C-##### —- B (FRx), 16 (Year manufactured), C (Mar. – Month manufactured) – ##### (5-digit Serial No.)
  • C16B-##### —- C (FR3), 16 (Year manufactured), B (Feb. – Month manufactured) – ##### (5-digit Serial No.)

Expiration, Battery

How do you interpret the “Install Before” labeling on the battery?
The labeling is meant to indicate that the battery should be installed before the last day of the month and year indicated. Typically the battery has a 4-year warranty once installed in AED unit.

Symbols – For OnSite & FRx Units

What does the PULL tab on the OnSite AED mean?
Pads cartridge handle (Green) – Pulling the handle turns on the defibrillator and opens pads cartridge for use.
What does this circular button on the OnSite or FRx AED mean?
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 1-second when the defibrillator is on turns the defibrillator off and disarms the defibrillator. Pressing the On/Off button stops the battery insertion self-test that automatically runs when a battery is inserted.
What does the button with a lightning bolt symbol on the front on the OnSite or FRx AED mean?
Shock Button (Orange) – flashes when a shock is advised. You must press the button for the shock to be delivered.
What does the “I” button on the front on the OnSite or FRx AED mean?
Information button “i-button” (Blue) – Pressing the i-button while it is flashing during a patient care pause provides CPR Coaching; pressing it while it is flashing and the defibrillator is chirping provides troubleshooting guidance. Pressing it until it beeps at other times provides summary information about the defibrillator’s last clinical use and device status.
What does the triangle marking on the OnSite mean? OR What does the hand with line threw it on the FRx mean?
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.

For all other Symbols and their meanings, please refer to the AED’s Owner’s Manual for further information.

Distributor Contact Information – Service/Tech Support/and More

Philips Servicing

How do I get the HeartStart AED Unit serviced?
Call our Customer Service team at 1-800-263-3342 for a returned goods authorization and replacement unit. There are no unserviceable parts in the HeartStart OnSite HS1.

Tech Support Request

If I need technical support regarding the AED unit, pads, battery, or other assistance – who would I call?
Call Philips Tech Support directly at 800-263-3342, Option #1

For More Information – CALL