Why are we revising Cardiac Science AEDs?

Cardiac Science AEDs are undergoing revision so that they support the new AHA/ERC guidelines for CPR and defibrillation released in November, 2005.

What is being changed to our AEDs?

In order to reflect the new AHA/ERC guidelines, appropriate modifications to the behavior of our Powerheart AEDs as well as changes to the voice/text prompts on the devices are being made. Part numbers have been (or will be created) to reflect these modifications.

What is the nature of the changes to the AHA/ERC guidelines?

The changes to the guidelines are designed to reflect the AHA's and ERC's current understanding of the latest science on the resuscitation of an SCA victim - in order to maximize their chances of survival. For example, one of the core modifications reflects a changed cycle of compressions and breaths as compared to their previous recommendations. Basically, the changes include:

• CPR Timeout 2 minutes (changed from 1 minute)
• Shock Protocol is 1 shock followed by CPR timeout (changed from 3 shock protocol) followed by subsequent repetitive cycles of analysis and shock (if necessary) and CPR.
• Remove voice prompt "check for signs of circulation, if no signs of circulation start CPR" and replace with "start CPR"
• CPR Instructions are 30 compressions and 2 breaths for adults and children over one year of age (changed from 15:2 for adults and 5:1 for children)

Can devices with the previous AHA protocol still be used?

Absolutely. Cardiac Science AEDs can (and should be used) until a given device is upgraded or replaced. All of the previous functions remain and voice/text prompts reflect the previous AHA/ERC guidelines.

Are the AHA/ERC guidelines mandatory?

No. The AHA/ERC guidelines are simply that, guidelines. However, Cardiac Science is adopting them because we believe that implementing the AHA's recommendations is important as it reflects the most current understanding of the best practices used to resuscitate a victim of sudden cardiac arrest.

Do the new AHA/ERC guidelines affect every AED?

Yes. All AEDs are affected. Cardiac Science has decided to adopt the new guidelines throughout our entire Powerheart AED product line.

How will the upgrades be installed?

In the United States and Canada we will offer two choices: a) Upgrade kits used by the customer to install the new guidelines supportive prompts and protocols. b) Upgrades performed in the field by Cardiac Science Field Service Engineers at customer location(s)

Internationally, customers will need to contact their local distributor to find out what upgrade options are available to them.

How many Upgrade Kits must be purchased in order to upgrade all AEDs you may have?

In the United States and Canada, we recommend purchasing one upgrade kit per AED that needs to be upgraded. Internationally, customers will need to contact their local distributor to find out what upgrade options are available to them.

What is included in each Domestic Upgrade Kit?

Each kit contains the AHA upgrade CD for a specific domestic model of Powerheart AEDs; printed installation instructions; a Quick Start Toolkit CD that contains electronic updates to your operating instructions and updates to your MD Link software; and a sticker to place on your updated device signifying that it has been upgraded to support the 2005 AHA/ERC guidelines.

How many different translations are affected?

Cardiac Science currently produces AEDs with 38 separate languages; trainer units have multiple languages combined in groups of six (each), such that there is a total of seven different multiple-language versions of our trainer AEDs.

What if a customer doesn't want to replace an AED but would like to have the new guidelines on their AED(s)?

We can accommodate customers who want the new AHA/ERC guidelines but do not wish to purchase new units. Cardiac Science is developing a series of CD Upgrade Kits for each existing version of our Powerheart AEDs as detailed on the attached spreadsheet.

Are the dates for the upgrades firm?

These dates are subject to revision. They represent the best projections of the time required to perform each step of the process. In order to update each type of AED, various activities must occur in sequence. These activities include translation, recording, review of recordings, engineering, production, validation, and other procedures, all accomplished in order. All of these activities are interdependent on previous steps in the process. Thus, completing a given language for a specific AED will only occur as soon as all steps in the sequence are satisfied.

How many different types of AEDs are affected?

Between the different types of AEDs (various models, trainers, single/multi rescue), support for almost 40 different languages, and the option for upgrade CD kits, a total of 400+ different permutations of existing AEDs must be supported.

Why have these updates taken this long?

Updating the software and the other requirements necessary to accommodate the new AHA/ERC guidelines may seem deceptively simple, but is a complex task. In addition to the large number of AED types discussed earlier, as a Class III medical device regulated by the FDA, Cardiac Science must ensure that the software and behavior modifications include confirmation that the new functionality is incorporated into AEDs after the process is complete.