FAQ software update ARM 3.19

 

Notes and definitions of terms

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

Battery 3', 'Battery 6' and 'AkuPak LITE' are described together with 'energy module'.

The memory card provided by Metrax with the update software is referred to as the 'Update SaveCard', the memory card that comes with every AED is referred to as the 'Original SaveCard'.

The FAQ refer to the update process using an 'Update SaveCard' provided by Metrax and ready to use. The alternative procedure of downloading the update software and using the original SaveCard is analogous.

 

What is the update about?

Metrax GmbH has found that in very rare cases, some AEDs from the HeartSave series may malfunction during device start-up in the form of a complete loss of functionality. The devices can fail spontaneously during the device start and can no longer be operated. This would be an undesirable situation, especially in an acute emergency. The update is a corrective measure by Metrax GmbH to prevent this possible functional impairment of your AED.

 

Is the update mandatory for me as an end customer?

The Medical Device Operator Ordinance stipulates (MPBetreibV § 4 Para. 6) that before using a medical device, the user must convince himself of the functionality and the proper condition of the medical device and that the instructions for use and the other attached safety-related information and maintenance instructions must be observed. This includes the implementation of corrective measures.

 

What is the risk if the update is not carried out?

You know that helpless feeling when a device didn't work exactly when you needed it most urgently?

How would you feel if, in a real emergency, the AED that you bought for exactly such a case doesn't work? What if the AED just can't help you save someone else's life?

The update aims to ensure that your AED is ready to use when you need it.

 

Does the update absolutely have to be carried out?

We cannot force anyone to make changes to their property. However, we strongly recommend performing the update on each affected AED to ensure it is safe and reliably operational in the event of an emergency.

Specialist trade and service partners of Metrax GmbH are obliged to help with corrective measures in the field in accordance with § 14 (4) MDR.

 

What exactly does 'obliged to help according to § 14 (4) MDR' mean?

In the event of an FSCA (Field Safety Corrective Action), Metrax must contact every end customer of an affected device. This can be done directly or via the sales and service partner responsible for the respective end customer.

If you would like to inform your customers yourself, please let us know. We will then send you the correct Update SaveCard for each customer, and please forward this to each customer along with the necessary update information.

If you would prefer us to handle this, please send us a list of end user details for the affected serial numbers and we will do the rest.

 

would like to inform my customers myself. How is the process?

We will send you a list of the affected serial numbers that you have sold, as well as the corresponding update save card for each serial number along with the update instructions.

You inform your affected customers about the update as soon as possible and please send them the appropriate update save card as soon as possible. If you have any questions about the update, you are available to the customer as a contact person and ensure that the update is installed on the affected devices.

The confirmation form for the update, which you send back to us after the update, serves as proof of this

 

I would like Metrax to inform my customers. How is the process?

We will send you a list of affected serial numbers sold by you. Please send us the complete contact details of the respective end customer for each serial number as soon as possible, ideally that of the person responsible for the device or the person commissioned by the operator within the meaning of the MPBetreibV.

We will then contact each of these customers and send them the appropriate update save card and instructions for the update. If you have any questions about the update, we are available to the customer as a contact person.

 

Who bears the costs if I want to inform my customers myself?

Sending the update save card and update instructions to the end customer by post is part of the regular after-sales support of every sales and service partner and is already covered by the specialist trade discount granted for the AED. The same applies to customer support by telephone or in writing before, during and after the update itself.

If the customer wants on-site support from the respective sales and service partner, the costs incurred must be agreed and settled directly between the partner and the end customer.

Metrax only assumes the costs for services that have been agreed and commissioned in writing in advance.

 

Who is allowed to perform the update?

The update process and the associated instructions were designed by Metrax GmbH for laypersons. This means that the person responsible for the device (in Germany, the person commissioned by the operator within the meaning of the MPBetreibV) can carry out the update on the AED.

This can also be done by the responsible specialist dealer and/or service partner from whom the AED was purchased, or by Metrax GmbH directly.

 

As an end customer, will I incur any costs as a result of the update?

Metrax GmbH or your specialist dealer and service partner will send you the update save card required for the update with the update software it contains by post. This service is of course free of charge for you.

The same applies to telephone support or advice by e-mail, both from the responsible specialist dealer and/or service partner from whom the AED was purchased, or from Metrax GmbH directly.

If, at the customer's request, service is carried out by one of our specialist dealers or service partners at the customer's site, costs may arise for this that Metrax GmbH will not reimburse.

Metrax itself does not carry out any on-site services.

 

I bought my AED through a dealer. Who is my contact now?

If you purchased your AED from one of our specialist dealers or service partners, this is your first point of contact.

 

Can I catch up on the update at a later date?

We recommend that you install the update as soon as possible. The responsible authorities set deadlines for this, which all parties involved must prove that they have been observed.

In justified exceptional cases, the update is also possible at a later point in time.

 

What do I do if I don't trust myself to carry out the update?

If you purchased your AED through a retailer, they would be your first point of contact. All of our specialist trade and service partners have received training offers and information material from us for the update and should be able to support you with the implementation. Alternatively, you are of course also welcome to contact Metrax GmbH directly and send us your AED with a cover letter:

Metrax GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Germany

Technical service

Phone:	+49 741 257 275
E-Mail:	Service@primedic.com

 

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

No. You send us your AED with a corresponding note, and the update will be installed, checked and documented on your AED by our service technicians. You will then receive your AED back. This process is completely free of charge for you.

All you have to do is pay for the shipping costs of your AED from you to us.

 

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

This question cannot be answered in general in advance. As a rule, you should receive your AED back within two to four weeks of receipt by us.

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

In any case, please ask our service department about the current processing times before you send your AED to us.

 

Am I entitled to a (free) loan device?

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

 

Can Metrax provide me with a loaner during this time?

Our service department has a certain contingent of replacement and loan devices. If and when a rental device is available, please inquire in advance with our service department. The provision of a loan device is a chargeable service and must be borne by the customer himself.

 

What happens if my AED's serial number doesn't match the serial number printed on the Update SaveCard?

The software update must match the hardware, software, and installed languages of your AED. For this reason, exactly one device type with its associated serial number and the appropriate language pack is specified on each Update SaveCard, and the Update SaveCard may only be used for the specified device.

Update software that does not match the respective AED is recognized by the AED and no update is carried out.

 

Can an update be performed with the wrong update software (not compatible with the AED)?

No. If the update software is not compatible with the AED or the AED does not require a software update, the AED will automatically stop attempting the update.

 

How does the AED behave if the update software does not match the AED?

If the update software is not compatible with the AED and the update cannot be installed or attempted, the AED will boot as usual. You will then hear the voice prompts for the normal operating mode.

 

If AED and update software fit together - does the update always work?

In very rare cases, the update does not work right the first time. In this case, start the update again as described in the instructions.

 

How does the AED behave if the update is canceled?

If the update installation or attempt fails, the AED switches to standby mode and the red service symbol appears in the status display.

 

What to do if the AED has aborted the update?

In this case, start the update again as described in the instructions. Please contact Metrax Technical Service if the update is unsuccessful on the second attempt.

 

Does it affect the quality of the update if it was only successful on the second?

Once the update is successfully completed, the number of previous attempts is no longer relevant.

 

Is the AED still operational after the update is canceled?

Please run the AED self-test first, as described in the update instructions. If the self-test was successful, the AED is ready for use. However, please contact Metrax Technical Service immediately to install the update on the AED as soon as possible.

 

Can my AED be damaged if I accidentally use the wrong update save card / update software?

No, this will not damage your AED as the AED will automatically stop trying to update before any changes can be made to the software.

 

What if I (accidentally) try to update an AED that is not affected by the update?

In this case nothing happens. The update software automatically detects if the AED is not one of the affected devices. No update is performed and the AED boots normally. In this case, you will hear the voice instructions for the normal operating mode.

Remove the update SaveCard and replace it with the original SaveCard.

 

What happens if the update and original SaveCard are swapped?

The update can only be carried out with the files contained on the update save card. These are not available on the original SaveCard.

The (accidental) use of the original SaveCard instead of the update SaveCard does not trigger an update process. In this case, the AED starts normally.

 

Who is liable for any damage to the AED during or as a result of the update?

If the update is carried out correctly according to the instructions described, damage or functional impairments caused by or as a result of the update can be almost completely ruled out.

If you notice any unusual or non-described behavior on your AED during or after the update, you are welcome to send the AED to Metrax GmbH for inspection.

If damage or functional impairments are detected that are not due to improper or intentional actions on the part of the user, Metrax GmbH will carry out the repair at its own expense.

This does not affect damage to the device that is not related to the software update or caused by third-party influence.

 

What are the consequences if the Update SaveCard is accidentally left in the device?

If the update save card remains in the AED, it will attempt to install the update again each time it is switched on. The regular functions of the AED are not available during this time. In a real emergency, this can mean that life-saving measures are delayed or not taken at all, and the person concerned suffers damage to their health or even death.

After a successful update, the update save card should be removed and replaced with the original save card!

 

Can the update be canceled if an emergency requiring resuscitation occurs during the update?

Once the update process has started, it can only be interrupted by turning off the AED. However, this is strongly discouraged, since the AED may then no longer be able to be started.

Therefore, before the update, make absolutely sure that a real emergency in your immediate vicinity is ruled out as far as possible during the update, or have a replacement device ready during the update.

 

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

Turning off your AED during the update process may result in your AED not booting afterwards. In this case, your AED must be sent to the service department of Metrax GmbH and repaired at your expense.

 

What happens if I close the lid of the AED during the update?

Closing the device lid turns off your AED. Switching off the AED before the update process is complete can result in your AED no longer being able to start up afterwards. In this case, your AED must be sent to the service department of Metrax GmbH and repaired at your expense.

 

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

Switching off the AED before the update process is complete can result in the AED no longer being able to start up afterwards. In this case, your AED must be sent to the service department of Metrax GmbH and repaired at your expense.

It is essential that you carry out the update with an energy module that has sufficient capacity reserves for the update process.

Before starting the update, use the status display on your AED to check that the capacity of the energy module is sufficient.

 

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

Removing the power module will shut down your AED. Switching off the AED before the update process is complete can result in your AED no longer being able to start up afterwards. In this case, your AED must be sent to the service department of Metrax GmbH and repaired at your expense.

 

Can any power module be used for the update?

Any energy module approved for your AED can be used for the update process (Battery 3, Battery 6, AkuPak LITE). Before starting the update, use the status display on your AED to check that the capacity of the energy module is sufficient.

 

Can I have written confirmation that the update was successful?

If the update is carried out by our service department, you will then receive written confirmation of a successful software update. Please put this confirmation in the medical device book of your AED.

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

If you carry out the update yourself, please document the update yourself in the medical product book of your AED.

In any case, please place a copy of the completed and returned confirmation form in the medical device booklet of your AED.

 

What should I do with the update save card after the update?

After the update has been successfully completed, you are welcome to keep the update save card for free use. In this case, please be sure to delete all data on the update save card beforehand so that it is not accidentally used with another AED.

It is not necessary to send it back to your specialist dealer or service partner or to Metrax GmbH.

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