HeartSave series

What does the abbreviation 'AED' stand for?

The abbreviation 'AED' stands for Automated External Defibrillator.

How many electrodes are included in one package?

One pair of electrodes is included in each package of SavePads.

What is the prescribed interval for the TSC (technical safety check) for the AED?

The Medical Devices Operator Ordinance (MPBetreibV) has stipulated since 1/1/2017 that AEDs, among other things, must be subjected to a regular TSC (technical safety check).

The maximum interval is set at 24 months.

Deviations from this are only possible in justified exceptional cases.

How long is the warranty period for the AED?

Depending on the type of device, there is a manufacturer's warranty of 2 or 6 years.

For most devices, this warranty can also be optionally extended to 10 years.

I am interested in purchasing an AED – who can advise me and prepare a quote?

Our colleagues in the field service are at your disposal for detailed advice. They have decades of experience with our equipment and are very familiar with the needs and requirements of our customers.

You can find your regional contact here:

Ansprechpartner

 

 

Can anyone buy an AED?

There are no legal restrictions on the purchase of an AED. Any natural or legal person can purchase an AED in Germany.

The regulations of the Medical Devices Operator Ordinance (MPBetreibV) apply to the operation of an AED.

Are your devices really 'Made in Germany'?

Yes, they really are.

Our devices are developed and manufactured at our company headquarters in Rottweil.

Technical service and international sales are also located there.

What is the maximum energy your AEDs can deliver?

All AEDs in the HeartSave series can deliver biphasic energies of up to 360 J.

After buying an AED, who will explain to me how it works? Do you offer any training course for that?

Upon request, we or one of our certified service partners will be happy to provide on-site instruction in the operation and handling of your AED.

What is the shelf life of the AED electrodes?

The adult electrodes in our AEDs (the 'SavePads PreConnect-Set', 'SavePads-Set', 'SavePads Connect') have a shelf life of at least 36 months, usually several months more.

The paediatric electrodes ('SavePads Mini') have a shelf life of approx. 12 - 18 months.

Can I still use the electrodes after the expiration date?

The defibrillation electrodes (the 'SavePads PreConnect-Set', 'SavePads-Set', 'SavePads Connect') - like the AED itself - are considered a medical device.

If a shelf life is defined for a medical device, it may no longer be used after this period has expired.

Why do the electrodes have an expiration date at all?

The electrodes are equipped with a gel layer, which has several purposes. It enables transmission of electrical signals (patient's ECG) to the AED, conducts the energy of the shock to the patient during defibrillation and allows the electrodes to stick to the patient's skin.

The gel can only perform these tasks if it is in perfect condition.

Over time, the gel dries out, loses its adhesive properties and no longer conducts the electric current to a sufficient degree. Efficient and goal-oriented therapy is then no longer possible.

The expiry date of the electrodes therefore indicates the time frame in which the above points can be reliably fulfilled. After that, proper application and use is no longer guaranteed.

Who is permitted to use an AED?

The AEDs of the HeartSave series are designed specifically for use by laypersons.

This means that any first aider can and may use such an AED on a patient during an emergency.

Don't I need training before I use an AED?

Basically no.

The AEDs of the HeartSave series were developed as so-called 'self-explanatory' devices. Once turned on, the first aider is safely guided through the operation of the AED and cardiopulmonary resuscitation with the help of concise verbal instructions and a graphic display.

Previous knowledge of the functioning of the AED is not required.

Don't I need training before I buy an AED for my company?

The Medical Devices Operator Ordinance (MPBetreibV) stipulates the following in this regard:

"The operator of an AED must appoint a 'person appointed by the operator'. This person acts as the equipment supervisor and serves as the first point of contact for questions about the AED.

This person appointed by the operator must be instructed by the manufacturer (or a person acting in agreement with the manufacturer, e.g. a certified dealer) in the handling and operation of the AED.

From that moment on, any other employee in the same company may use the AED as part of emergency patient care."

Is the training voluntary or mandatory?

Training for the person appointed by the operator is required by law. Otherwise, the AED must not be operated or used. Training or instruction can only be dispensed with if one (or more) identical devices are already available within the facility or on the premises.

Training or instruction is therefore by no means a voluntary or optional decision, but a statutory requirement.

How expensive is a training course with you?

Depending on the type of device, we charge a training lump sum of € 195 to € 260 € net plus VAT. In exceptional cases, additional travel costs may be incurred.

The package includes the following services:

  • Travel to and from destination throughout Germany
  • 60 - 90 minutes training at your location
  • Provision of training materials
  • If necessary, commissioning and functional testing of your AED
  • If necessary, documentation of commissioning report and MDD book
  • Free access to our e-learning platform 'myPRIMEDIC Academy'
  • Upon request, certification of individual or several staff members

How many people may be present at such training?

At the moment, the maximum number of participants depends primarily on the respective framework conditions of the COVID-19 restrictions.

Otherwise, it is advisable not to exceed a number of approx. 10 participants, as experience has shown that the ability of larger groups to maintain concentration and attention is strongly reduced.

Are the training costs calculated per participant?

No, of course not.

The training lump sum is calculated per appointment, regardless of the number of persons present.

How do you handle training/instruction with regard to COVID-19 restrictions or lockdown periods?

In order to protect the public and our employees, we naturally fully comply with the applicable rules on contact restriction or social distancing. Therefore, there may be periods when we are unfortunately unable to offer and conduct face-to-face events at your location.

Do you offer online training as an alternative then?

Absolutely!

We have already started to consistently implement contactless training concepts at the beginning of 2020 when the COVID-19 restrictions came into force. This made us the first AED manufacturer in Germany to offer this online service to our customers.

We are continuing this concept with great success. The extremely positive response from our customers shows us that we abreast of the times.

What are the technical requirements for online training?

You basically only need what you probably already have anyway.

We conduct our online training courses via 'Microsoft Teams'.
We will email you a link in advance which you can click to join the training.
If you do not have 'Microsoft Teams' installed, clicking on the link will open a browser-based version of the software.

This also works completely cross-platform, so you can attend the training with a PC, laptop, tablet or even your smartphone if need be.

Is there a charge for the online training as well?

If you would like to arrange a personal appointment with us, we charge a flat rate of € 99 net plus VAT.

The respective instructor will then familiarise you with your AED online, demonstrate all functionalities and of course answer any questions.

As with the face-to-face training courses, please plan a time frame of approx. 60-90 minutes for this. In contrast to face-to-face training, the number of participants on your side is not subject to any restrictions.

Is there also a free alternative?

Yes, of course there is.

As a service to our customers, we regularly offer public online training for each model of our AEDs at scheduled dates. Registration for this service is free of charge and without obligation. In terms of content, these public training dates are structured in the same way as the individually agreed training dates.
However, depending on the number of participants, it may not be possible to answer every question from every participant.

These fixed and public training sessions are more suitable for refreshing or repeating existing knowledge on your side.

Do I have to repeat the AED training on a regular basis?

No, you don't have to.

However, regular refresher training is recommended, for example as part of a first aid course or company first aid training.

Alternatively, you are welcome to participate in our regular online trainings.

Do you also offer training material?

Of course.

On our online platform 'myPRIMEDIC Academy' you will find interactive e-learning modules and tutorials for our AEDs.
Of course, you can also use these for your in-house employee training courses free of charge.

Do you have a reminder service when my battery/ electrodes need to be replaced?

Our service department offers a free reminder service for electrodes, batteries, TSC (technical saftey check) and software or guideline updates.

You can simply register free of charge and without any obligations and will then be reminded in good time of the next deadline.

Do your AEDs operate according to the current guidelines?

Currently - due to COVID-19 - the ERC-2015 guidelines are still valid.

It goes without saying that our AEDs operate according to the specifications of the ERC-2015 guidelines and comply with them in full.

What is sudden cardiac death?

Sudden cardiac death is a life-threatening cardiac arrhythmia that, in Germany alone, kills up to 100,000* people of all ages every year.

Immediate cardiopulmonary resuscitation and the use of a defibrillator or AED is recommended as therapy.

*(source: ERC-2021-Guidelines)

What is defibrillation?

Defibrillation is an electrical therapy against certain forms of life-threatening cardiac arrhythmia, in particular ventricular fibrillation and ventricular flutter.

Defibrillation uses a powerful electrical impulse (the 'shock') to restore normal electrical activity to the heart.

Can an AED be used for children?

Basically, an AED can be used on both adults and children. The HeartSave range of AEDs has a special paediatric mode that reduces the energy delivered (the 'shock') during defibrillation to a level appropriate for children.

However, ERC guidelines recommend not using an AED on children under one year of age.

How should an AED be stored?

In simple terms, dry and at room temperature.

For more detailed information on storage, transport and operating conditions, refer to the operating instructions of your AED.
For the HeartSave series AEDs, the following storage conditions apply:

  • -20 °C … +50 °C
  • 15…95% rel. humidity, non-condensing
  • 620 … 1060 hPa

What is a defibrillator?

A defibrillator (or 'defib’ for short) is used to treat cardiac arrhythmias. These are, for example, ventricular fibrillation, ventricular flutter or ventricular tachycardia.

Therapy is provided by the administration of powerful electrical energy - defibrillation. Defibrillators are designed for professional and medically trained users, i.e. doctors, intensive care staff, emergency medical services, fire brigades.

Since the beginning of the 1990s, defibrillators have also been developed that may be used by medical laypersons. These special defibrillators are called AED, which stands for automated external defibrillator. 'Automated' means that only the AED can decide about the need for defibrillation. The user is not involved in this decision, cannot influence it and therefore cannot do anything wrong.

For this reason, the use of an AED has been made permissible even for laypersons – the rescuer cannot knowingly or unknowingly cause harm to the patient. The application is completely safe for both first aiders and affected persons.

What does a defibrillator do?

A defibrillator - specifically an AED - is used in cases of sudden cardiac death.

In such situations, the AED can treat life-threatening cardiac arrhythmia in the patient by means of a strong electrical impulse (defibrillation, more commonly referred to as the 'shock') and improve the patient's chances of survival. In addition, cardiopulmonary resuscitation must be performed by the first aider.

Both measures are equally crucial for the survival of the affected person and cannot replace one another.

Can I harm or injure the patient with a defibrillator?

If you were to, for some reason, wildly beat your patient with the AED - yes.

Otherwise, only the AED determines if there is a need for defibrillation.
Only if the AED determines during its analysis of the patient's ECG that a 'shock' is needed, is the required energy charged and the shock button released at all.

If no shock is needed, the AED does not charge, and therefore shock delivery is impossible, even if you wanted to. You cannot accidentally or intentionally cause harm to the affected person.

Can anyone use a defibrillator?

Generally, yes.

Anyone who is confident in the use and application of an AED in first aid may also use and apply an AED.

What is a technical saftey check/ TSC?

TSC is the abbreviation for Technical Safety Check. This is used to check the technical functionality and readiness of your AED.

An AED usually hangs on the wall for many years completely unnoticed because - fortunately - there is no reason to use it. And with an AED the same holds true as with all other things that do not get any attention: nobody notices when something is wrong. And when you do need to use it in an emergency ,it could literally be fatal to have an AED but not be able to use it due to an undetected error.

All AEDs in the HeartSave series automatically perform a daily self-test to detect and alert operators of technical faults and other malfunctions as early as possible. However, only a regular and extensive technical inspection by trained and certified personnel can guarantee the best possible safety.

For this reason, the legislator even makes the STC mandatory in the Medical Devices Operator Ordinance (MPBetreibV). An interval of a maximum of 24 months is defined for this purpose.

The TSC can be performed either by our own service department in Rottweil or by one of our service partners throughout Germany.

My AED started talking after I removed the yellow transport strip, what should I do?

Close the lid of the AED or press the ON-OFF button on the device.

Consumables & Accessories

Which SavePads do I need?

To do this, simply and conveniently use our SavePads Finder.

I would like to order SavePads/ a battery (consumables), who do I turn to?

For orders please contact our sales department: Kontaktformular

What information do I need to order consumables?

The HeartSave series has undergone several technical advancements over the years. The consumables were also adapted to the new requirements. In order for us to be able to supply you with the right accessories for your device, we need the following information from you:

  • Device type (e.g. 'HeartSavePAD')
  • Serial number of the device

The serial number enables unambiguous identification of your device, and the risk of incorrect orders can thus be avoided.

Where can I find the SN of my device?

Each AED of the HeartSave series has a type plate on the back of the device, which states the device type, the serial number of the AED as well as the production date.

What is the best way to disposed of SavePads?

There are no special requirements regarding disposal of the electrodes of our defibrillators/AEDs - the 'SavePads'. You can simply dispose of them with your normal household waste.

The LED lights on my Rotaid wall box are not working, what should I do?

  1. Check the function of the socket
  2. Check whether the heater is connected correctly according to the operating instructions (pay attention to polarity!)
  3. Socket ok, heating connected correctly -> Notify vigilance@primedic.com

The heater of my Rotaid wall box is not working, what should I do?

  1. Check the function of the socket
  2. Check whether the heater is connected correctly according to the operating instructions (pay attention to polarity!)
  3. Socket ok, heating connected correctly -> Notify vigilance@primedic.com

Monitoring with the Skintact electrodes does not work.

Check whether the liquid gel in the middle of the Skintact electrodes has dried out. If so, order new electrodes. If Skintact electrodes okay send in for service.

Service

Where can I find the SN of my device?

Each AED of the HeartSave series has a type plate on the back of the device, which states the device type, the serial number of the AED as well as the production date.

How can a battery be disposed?

You can take our energy modules to your local waste disposal service or recycling centre and have them disposed of professionally. This is free of charge for you.

What is the best way to disposed of SavePads?

There are no special requirements regarding disposal of the electrodes of our defibrillators/ AEDs - the 'SavePads'. You can simply dispose of them with your normal household waste.

Who do I contact if my device has a defect and needs to be repaired?

Repairs on your AED are performed by our technical service department. Please fill out our Wartungsformular.

Do you also offer an on-site repair service?

Maintenance and repair of your device is carried out by our service technicians at our company headquarters in Rottweil.
If you need a rental replacement device during this time, we can gladly organise this through our service.

How should an AED be stored?

In simple terms, dry and at room temperature.

For more detailed information on storage, transport and operating conditions, refer to the operating instructions of your AED.
For the HeartSave series AEDs, the following storage conditions apply:

  • -20 °C … +50 °C
  • 15…95% rel. humidity, non-condensing
  • 620 … 1060 hPa

I would like to send in my device for a STC, who do I turn to?

The TSC of your AED is performed by our technical service department. Please fill out our maintenance form.

I would like to carry out an update to the latest ERC guidelines for my AED. Who do I need to contact?

Software and/or guideline updates on your AED are performed by our technical service department. Please fill out our maintenance form.

Is there a STC requirement if my AED is placed in a public space?

The Medical Devices Operator Ordinance (MPBetreibV) has stipulated since 1/1/2017 that AEDs, among other things, must be subjected to a regular TSC (technical safety check). The maximum interval is set at 24 months. Deviations from this are only possible in justified exceptional cases.

A so-called 'STC exemption' can only be issued by the operator of an AED on their own responsibility. For this purpose, a documented and regular risk assessment is necessary for the respective AED, which must consider numerous aspects. The corresponding specifications for this can be found in the Medical Devices Operator Ordinance (MPBetreibV).

If you have any questions, we will of course be happy to advise you.

Am I still required to have a STC performed on my AEDs if I bought them before 2017? At that time the description said something about 'STC-exempt'...?

The Medical Devices Operator Ordinance (MPBetreibV) in its current version defines neither transition periods nor grandfathering for AEDs sold with the indication of a possible STC exemption. This means that, since 1/1/2017, the STC requirement applies equally to all AEDs, including those already in use.

Do your AEDs operate according to the current guidelines?

Currently – due to COVID-19 – the ERC-2015 guidelines are still valid.
It goes without saying that our AEDs operate according to the specifications of the ERC-2015 guidelines and comply with them in full.

What happens when the new guidelines are published?

When new guidelines are published, we will adjust the algorithm of our AEDs accordingly, if necessary. All newly manufactured AEDs will then be delivered in accordance with the new guidelines.

Is there a matching guideline update for my (older version) AED then?

In recent years, we have always been able to offer a suitable update for our older AEDs as well. So chances are high that your AED will also get an update to the new guidelines. For this purpose, our service department will be pleased to check your existing hardware and software with regard to an update option.

How is a guideline update performed?

For this purpose, please fill in the maintenance request form.

Vigilance

How and where can I report incidents related to the AEDs?

All incidents related to our AEDs are recorded and handled by our vigilance team.

Please contact them directly under: vigilance@primedic.com

Who do I contact if my AED did not work as it should in an emergency?

All incidents related to our AEDs are recorded and handled by our vigilance team.

Please contact them directly under: vigilance@primedic.com

What do I do if a patient or aider is harmed during treatment?

All incidents related to our AEDs are recorded and handled by our vigilance team.

Please contact them directly under: vigilance@primedic.com