Information on

MDR (EU) 2017/745

EG Declarations of conformity

EG Declaration of Conformity for KayserBetten according to the EU Medical Device Regulation (EU) 2017/745 (MDR) for download:

PDF

KayserBett TIMMY

KayserBett IDA

KayserBett EMMA

KayserBett OLAF

KayserBett HANNAH

KayserBett Lotte

Reisebetten

Monitoring of products in the market

Post-Market Surveillance

The MDR defines Post-Market Surveillance (PMS) as "all activities undertaken by manufacturers, in collaboration with other economic operators, to establish and keep up to date a systematic procedure to proactively collect and evaluate experience with their products placed on the market, made available or put into service, in order to determine whether it is necessary to take the necessary corrective or preventive action without delay"

As economic operators, specialized distributors keep a register of complaints and non-compliant products and keep the manufacturer informed of these monitoring activities.

In order for us as manufacturers to meet the PMS requirements, you as specialist distributors play an important role in monitoring the products on the market.

In particular, trend reporting under Article 88 MDR challenges us to collect data on non-serious incidents or adverse events that, if they increase in frequency, may lead to risks to the health or safety of patients, users or others.

Since these events or complaints are not reportable incidents and we usually have no knowledge of the location of our products, obtaining this data is a challenge for which we rely on your support.

For this purpose, we would like to ask you, in the course of the annual maintenance of KayserBetten, to query possible incidents or complaints at the facilities or families.

Please use the following form and send it to us:

Meldeformular Art.88 - Rev. 1.0

Thank you for your support!

Clearance certificate/ Biocompatibility

The declaration of conformity also serves as a clearance certificate, as the MDR requires proof of biocompatibility for all materials that come into direct or indirect contact with patients or users.

MDR, Appendix I, Paragraph10.2:

Devices shall be designed, manufactured and packaged in such a way as to minimize the risks posed by contaminants and residues to patients - taking into account the intended purpose of the device - and to transport, storage and operating personnel. Special attention is paid to tissues exposed to these contaminants and residues, as well as to the duration and frequency of exposure.

more information about quality and safety

Quality and environmental management

  • DIN EN 13485 Medical devices- Quality management systems - requirements for regulatory purposes
  • DIN EN 9001 Quality management systems - requirements
  • DIN EN 14001 Environmental management systems - requirements

PDF

ISO 13485 Zertifikat

ISO 9001 Zertifikat

ISO 14001 Zertifikat

Reuse of beds from KayserBetten

KayserBetten beds provided before 26.05.2021 can be used again without restriction after professional "reprocessing" by cleaning, disinfection, as well as testing and restoration of the technical and functional safety.

Background:

The so-called "sell-off provision" (Art. 120(4) MDR) is intended to limit the period during which MDD-compliant products that were already placed on the market (for the first time) before 26.05.2021 may be made available, e.g. by a distributor.

After 27 May 2025, these products may no longer be made available/put into service. Such products that are still in the commercial chain on that day - i.e. have not yet been made available to the end user (e.g. institution, family) as a ready-to-use product - are no longer "tradable".

Trade in used products is not covered by the so-called "sell-off" rule (see MDR recital 3 *). This means that once a product has been made available to the end user (e.g. institution, family) as a ready-to-use product, the further making available of this product on the market does not fall under the scope of the MDR.

* MDR, Legal Notice, Recital 3: "This Regulation is not intended to harmonise rules concerning the continued making available on the market of medical devices that have already been put into service, for example in connection with the sale of used devices."
Source: Federal Ministry of Health NACI - National Working Group for the Implementation of the EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR EU Regulation on In Vitro Diagnostic Medical Devices).

Definitions:

Placing on the market
"the making available on the Union market of a product, other than a device for testing, for the first time;".

Making available on the market
"any supply of a product, other than investigational devices, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge".

Source: MDR

Lifetime and spare parts guarantee

Lifetime

The expected service life of care beds is generally stated to be between 2 and 10 years.

The expected service life of beds from KayserBetten is 5 years when used as intended and is due to the fact that children's care beds are usually exposed to high loads.
Conditions of use and frequency of use can reduce the service life.

Spare part guarantee

We guarantee the supply of spare parts for the expected service life.
This availability is limited to parts which, according to experience, are subject to wear within the normal service life of KayserBeds. The guarantee of availability does not apply to other parts which exceed the service life of the beds from KayserBetten.
Technical changes also limit the availability period of spare parts, as our products are continuously developed to ensure that they always comply with the current state of the art and legal requirements when they are placed on the market. This results from our quality management and is a common procedure in the manufacture of medical products.

Maintenance and safety control

According to the MPBetreibV §7, operators of care beds are obliged to ensure the safe condition of the medical device over the entire period of use.

To ensure safe operation, we as the manufacturer recommend that a visual and functional inspection with electrical testing be carried out at least once a year in accordance with DIN EN 62353.

The test according to DIN EN 62353 includes the following minimum requirement:

  • Visual inspection
  • Insulation resistance measurement
  • Leakage current measurement
  • Functional test
  • Overall evaluation

You can download the KayserBetten maintenance protocol below:

Wartungsprotokoll

Meldeformular Art.88 - Rev.1.0 >> For more info, see Monitoring products on the market

Operating instructions

In accordance with MDR Article 10 Paragraph 11, all our products are supplied with an up-to-date operating manual.

If you require additional operating instructions (printed or as a PDF file), please call us or send us an e-mail. For a quick processing we need the corresponding serial number. You will find it on the product label.

Contact

Storage and transport

Store and transport the unassembled nursing home bed as follows:

  • In the original packaging,
  • In the original packaging,
  • secured against falling over,
  • dry and clean

under the following ambient conditions:

  • emperature range for storage and transport: -25˚ C to + 70˚ C.
  • Humidity: 15 % to 93 % rel. humidity.
  • Air pressure: 700 hPa to 1060 hPa
  • rel. air pressure: 700 hPa to 1060 hPa

This information and further technical data can also be found in the operating instructions.