FAQ software update ARM 3.16

Information and definition of terms

In the following FAQ, the term 'AED' is used uniformly for all devices in the HeartSave series (HeartSavePAD / HeartSaveAED / HeartSaveAS / HeartSaveAED-M).

'Battery 3', 'Battery 6' and 'AkuPak LITE' are jointly described as ’power module’.

The memory card provided by Metrax with the update software is referred to as 'Update-SaveCard’, the memory card belonging to the scope of delivery of all AEDs as 'Original-SaveCard'.

The FAQ relate to the update process using an 'Update-SaveCard’ provided by Metrax which is directly ready for use. The alternative procedure via downloading the update software and used of the original SaveCard is in line with this.

What is the update for?

Metrax GmbH has determined that in very rare cases, upon activating the device, some HeartSave series AEDs may suffer from a malfunction in the form of a complete loss of function when the device is started. The devices may fail without warning and may no longer be operable. Especially in case of an acute emergency this would be an undesirable state. This update is a voluntary, corrective measure from Metrax GmbH in order to avoid this possible functional impairment of your AED.

Is the update binding for me as an end customer?

The German Medical Devices Operator Ordinance provides that (MPBetreibV § 4 para. 6), the user convinces himself/herself of the functionality and orderly state of a medical device prior to using it and must observe the instructions for use as well as the further safety-related information and maintenance information . This includes the implementation of corrective measures.

What risk exists if the update is not implemented?

Do you know the feeling of helplessness when a device has not functioned when you needed it particularly urgently?

How would you then feel if in a genuine emergency case the AED you have purchased for exactly such a case doesn’t function? If the AED cannot just help you to rescue another person’s life?

The update is intended to ensure that the AED is functional when you need it.

Is it compulsory to implement the update?

We cannot force anybody to make changes to their property. However, we urgently recommend implementation of the update for all AEDs concerned so that they are safely and reliably ready for use.

Metrax GmbH specialist dealers and service partners are obliged to help with corrective field measures pursuant to § 14 (4) of the MDR.

The dispatch of the Update-SaveCard and update instructions to the end customer by post belong to normal after-sales support for any sales and service partner and is already compensated for with the specialist trade discount for the AED. The same is true for customer care on the telephone or in writing during the update as such.

If the customer wishes local support by the respective sales and service partner, the costs arising here must be directly agreed and offset between the partner and end customer.

Metrax assumes exclusively the costs for services agreed and commissioned in advance in writing.

Who may implement the update?

The course of the update and the instructions belonging to it was designed by Metrax GmbH for amateurs. Therefore, the respective person responsible for the device (in Germany the person commissioned by the operator in terms of the Medical Devices Operator Ordinance (MPBetreibV)) may implement the update on the AED.

As a representative, this can be done by the responsible specialist trade and/or service partner from whom the AED was purchased or also directly by Metrax GmbH.

Do I incur costs through the update as an end customer?

Metrax GmbH or its specialist dealers and service partners send you the necessary Update-SaveCard for the update including the update software by post. Naturally, this service is free for you.

This also applies to telephone support or advice via E-mail, both from the responsible specialist trade and/or service partner from whom the AED was purchased or also directly from Metrax GmbH.

If services are carried out by one of our specialist trade or service partners at the customer’s request, costs for this may arise which are not reimbursed by Metrax GmbH.

Metrax itself doesn’t carry out any on-site services.

I purchased my AED from a dealer. Who is my contact partner now?

If you purchased your AED from one of our specialist trade or service partners, they are your contact partner.

Can I catch up on the update at a later point in time?

We recommend that you install the update as soon as possible. The responsible authorities specify deadlines for this and all persons involved must furnish proof of adherence to them.

In exceptional substantiated cases, it is still possible to update at a later point in time.

What can I do if I am not confident enough to implement the update myself?

If you purchased your AED from one of our specialist trade dealers, they would be your first contact partner. All our specialist trade and service partners have received training offers and information material for the update from us and should be able to support you when implementing it. Alternatively, it goes without saying that you are welcome to contact Metrax GmbH and to send us your AED with a letter:

Metrax GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Germany

Technical service

Do I have to pay for the update if I send my AED to Metrax for updating?

No. You send us your AED with a corresponding note and our service technicians install the update on your AED, check and document it. You then receive your AED back again. This procedure is fully free of charge for you.

You only bear the costs of sending us your AED.

How long do I have to wait before I get my AED back?

It is impossible to provide a general answer to this question in advance. Normally, you should receive your AED back within two to four weeks after receipt here.

However, if the workload is very high in our service department, processing can also take considerably longer and cost more time.

Please be sure to ask our service department the current processing times before sending us your AED.

Am I entitled to a (free) borrowed device?

No. The provision of replacement or borrowed devices is a voluntary and optional offer from our service department and not part of the update.

Can Metrax provide me with a borrowed device during this period?

Our service department has a certain contingent of replacement devices and devices for borrowing. Please ask our service department in advance whether and when a device is available for borrowing if needed. The provision of a device for borrowing is a service which is subject to costs which must be borne by the customer himself.

What happens if the serial number of my AED doesn’t tally with the serial number printed on the Update-SaveCard?

The software update must match the hardware, software and languages installed on your AED. That is why each Update-SaveCard specifies precisely one device type with its corresponding serial number and the matching language package and die Update-SaveCard may be used exclusively for the specified device.

Update software not matching the respective AED is recognised by the AED and no update is carried out.

Can an update be carried out with the wrong update software (not matching the AED)?

No. If the update software is not compatible with the AED or the AED doesn’t require a software update, the update attempt for the AED is terminated automatically.

How does the AED behave if the update software doesn’t tally with the AED?

If the software is not compatible with the AED and installation of the update or attempting it is not possible as a result, the AED starts as accustomed. You then hear the voice instructions from the normal operating mode.

If the AED and update software tally - does the update always function?

In very rare cases, the update doesn’t function directly the first time. In this case, start the update again as described in the instructions.

How does the AED behave if the update was terminated?

If the installation of the update or the attempt fails, the AED outputs the voice notification “Internal error" and switches to standby mode.

What must be done if the AED has terminated the update?

In this case, start the update again as described in the instructions. Please contact the Metrax technical service if the update also couldn’t be concluded successfully with the second attempt.

Are there quality-related effects on the update if it only succeeded at the second attempt?

Once the update has been concluded successfully, the number of previous attempts is no longer relevant.

Can the AED be used if the update was terminated?

Please first carry out the AED self-test as described in the update instructions. If the self-test was successful, the AED is ready for use. Nonetheless, please refer to the Metrax technical service without delay in order to install the update on the AED as soon as possible.

Can my AED be damaged if I unintentionally use an incorrect Update-SaveCard / update software?

No, it doesn’t damage your AED because the update attempt is automatically terminated by the AED before changes can be made to the software.

What happens if I (accidentally) wish to implement the update on an AED which is not affected by the update at all?

In this case, nothing happens. The AED software recognises automatically that the AED does not belong to the devices affected. No update is implemented and the AED starts as accustomed. You hear the voice instructions from the normal operating mode in this case.

Remove the Update-SaveCard and replace it with the Original-SaveCard.

What happens if the Update and Original-SaveCard have been confused?

The update can only be implemented with the files on the Update-SaveCard. They do not exist on the Original-SaveCard.

The (unintended) use of the Original-SaveCard instead of the Update-SaveCard does not trigger an update procedure. In this case, the AED starts normally.

Who is liable for possible damages to the AED during or as a consequence of the update?

If an update is carried out correctly in accordance with the instructions described, damages or functional impairments resulting from or as a consequence of the update can be more or less ruled-out.

If you establish unusual or undescribed behaviour on your AED during or after updating it, you are welcome to send the AED to Metrax GmbH for checking.

If damages or functional impairments which cannot be attributed to incorrect or deliberate action by the user are recognised here, Metrax GmbH will carry out the repair at its own expense.

Damages to the device not in connection with the software update or have arisen due to third party influence remain unaffected.

What effects does it have if the Update-SaveCard is accidentally left in the device?

If the Update-SaveCard remains in the AED, it will try to re-install the update each time the AED is switched on. The regular functions of the AED are then not available. In case of a genuine emergency case, this can result in life-saving measures being delayed or not even taking place and the person concerned suffering bodily harm even up to death.

The Update-SaveCard must definitely be removed again after successful updating and replaced with the Original-SaveCard!

Can the update be terminated if an emergency case requiring reanimation occurs during the update?

If the update process has been started, it cannot be terminated.

Therefore, ensure before updating that a genuine emergency case in your close surroundings is excluded as far as possible or keep a replacement device as a standby during the update.

What happens if I try to switch the AED off during the update?

If you switch your AED off during the update process, this may result in you not being able to start your AED afterwards. In this case, your AED must be sent to the Metrax GmbH service department and be repaired at your expense.

What happens if I close the AED cover during the update?

Closure of the device cover results in your AED switching itself off. Switching the AED off during the update process may result in you not being able to start your AED afterwards. In this case, your AED must be sent to the Metrax GmbH service department and be repaired at your expense.

What happens if the AED switches off during the update due to a suddenly empty power module?

Switching the AED off before completion of the update process may result in you not being able to start your AED afterwards. In this case, your AED must be sent to the Metrax GmbH service department and be repaired at your expense.

Be sure to carry out the update with a power module with sufficient capacity reserves for the update process.

Check on the status display of your AED whether the power module capacity is sufficient before starting the update.

What happens if I remove the AED power module during the update?

Removal of the power module results in your AED switching itself off. Switching the AED off during the update process may result in you not being able to start your AED afterwards. In this case, your AED must be sent to the Metrax GmbH service department and be repaired at your expense.

Can any power module be used for the update?

All power modules approved for your AED can be used (Battery 3, Battery 6, AkuPak LITE). Check on the status display of your AED whether the power module capacity is sufficient before starting the update.

Can I receive a written confirmation that the update was successful?

If the update is carried out by our service department, you subsequently receive written confirmation of a successful update. Please put this confirmation into the medical device book for your AED.

If the update is carried out by one of our specialist trade and service partners, they can prepare a confirmation for you or note the update in the medical device book.

Carry out the update yourself, please document the update in the medical device book of your AED yourself.

In any case, please place a copy of the filled out confirmation form which you have returned to us in the medical device book for your AED.

What should I do with the Update-SaveCard after the update?

After the update has been concluded successfully, you are welcome to keep the Update-SaveCard for your own free use. In this case, please be sure to delete all the data on the Update-SaveCard beforehand, so that it is not accidentally used together with a different AED.

It is not necessary to return it to your specialist trade or service partner or to Metrax GmbH.

Alternatively, you can also dispose of the Update-SaveCard in accordance with your regionally valid disposal regulations for digital storage media.