ultraMEDIC defibrillators (AED).

AED stands for Automated External Defibrillator. An AED is a portable medical device used in cases of cardiac arrest to restore the heart to a normal rhythm by delivering electric shocks. They automatically analyze the heart rhythm of the affected person and provide instructions to the user. If ventricular fibrillation or another life-threatening cardiac arrhythmia is detected, the AED prompts the user to deliver a shock that can “reboot” the heart and restore its normal rhythm.

The difference between a semi-automatic and a fully automatic AED lies mainly in the way the shock is delivered: 

• Semi-automatic: The user must deliver the shock by pressing a button, following the instructions given by the device. 
• Fully automatic: The shock is delivered automatically by the device as soon as it detects a shockable heart rhythm.

In Germany and many other countries, both laypeople and medical professionals are allowed to use a defibrillator. However, access and operation depend on the type of device, in particular whether it is a layperson's device (AED) or a professional device: 

• Laypeople are allowed and encouraged to use AEDs. The devices are designed so that even untrained helpers can act effectively. 

• Professional defibrillators are intended for medical personnel and require appropriate training and experience. Overall, AEDs encourage first responders to take action and can save lives when used quickly, even by laypeople.

The initial commissioning of a defibrillator (AED) in accordance with §5 of the Medical Devices Operator Ordinance (MPBetreibV) serves to ensure the safe commissioning and proper operation of the device before it is made available for use for the first time. The regulation ensures that the AED meets the technical requirements and that its function is reliable and safe. 

IMPORTANT: Initial commissioning is not a first aid or resuscitation course. The initial training usually takes about 1 hour and can be carried out online or on site.

When a defibrillator (AED) is put into service for the first time in accordance with the Medical Devices Operator Ordinance (MPBetreibV), it is important that certain persons are present to ensure proper functioning and safe use. Their presence depends on the type of facility and the persons responsible: 

1. Person appointed by the operator 

• The operator of the AED (e.g., company, public institution, sports club) must appoint a responsible person who is in charge of commissioning and regularly checking the device. This person should be familiar with the legal requirements and technical aspects of the device and is responsible for documentation and monitoring. 
• The personnel will be trained in the basic operation and use of the AED so that they can act safely in an emergency.
  

2. Persons to be trained (users) 

• The persons who will later work with the AED or who could operate it in an emergency (e.g., employees, first responders) should also be present during commissioning or at least during training.
• The personnel will be trained in the basic operation and use of the AED so that they can act safely in an emergency.
  

An automated external defibrillator (AED) must be serviced regularly to ensure that it functions properly in an emergency. The maintenance intervals for an AED are generally specified as follows: 

1. Follow the manufacturer's instructions 

The primary guideline for maintenance intervals is the manufacturer's maintenance schedule, which is specified in the operating instructions. Manufacturers usually specify specific intervals for maintenance and also provide instructions for checking wear parts such as the battery and electrode pads.

2. Visual inspection (monthly or weekly) 

Many AED models require regular visual inspections, often weekly or monthly, to ensure that the device is ready for use. The visual inspection checks whether the device is displayed as ready for use in standby mode (often via an indicator light) and whether accessories such as the electrodes and battery are undamaged and present. 

3. Replacing the battery and electrodes 

The battery and electrodes have a limited shelf life and must be replaced according to the manufacturer's instructions – often every 2–5 years, depending on the model and battery type. Even if the AED is not used, the battery ages and should therefore be replaced regularly (please be sure to note the battery's expiration date). 

4. Additional testing after each use 

After each use, the AED must be checked to ensure it is in working order and, if necessary, accessories such as electrodes and batteries must be replaced to prepare it for the next use. This regular maintenance is necessary to ensure the reliability of the AED and to meet the requirements of the Medical Devices Operator Ordinance (MPBetreibV).

STK stands for safety inspection and is a mandatory test for certain medical devices to ensure their safety and functionality. 

Significance of STK in relation to AEDs STK is a comprehensive inspection that aims to ensure that a medical device, such as an automated external defibrillator (AED), does not pose any danger to users or patients and meets all safety requirements. 

STK includes, among other things, checking electrical safety, the condition of components such as batteries and electrodes, and the functionality of the device. 

When is the STK performed? 

The frequency of the STK is based on the requirements of the Medical Devices Operator Ordinance (MPBetreibV) and the manufacturer's specifications. 

In general, the following applies to the STK:

• Every 2 years: The MPBetreibV specifies a maximum inspection cycle of 24 months for the STK, unless the manufacturer specifies otherwise. However, manufacturers may specify shorter intervals, which must then be observed. 

• After special events: An STK should also be performed after special incidents that could compromise the safety of the device, such as after a fall or damage to the AED. 

Who is authorized to perform the STK? 

The STK must be performed by a competent person or a certified technician who is trained in safety inspections of medical devices. This person should have knowledge of how the AED works and the requirements of the MPBetreibV (German Medical Device Operating Ordinance).