Safety Checks - Primedic HeartSave PAD Operating Instructions Manual

Safety checks

15 Safety checks
In accordance with the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV) § 6 (Safety checks) the user is obliged to have regular checks carried out.
In accordance with the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV) § 6, METRAX stipulate these checks be carried out in a 24-month cycle.
The safety checks may only be assigned to people who, because of their training, their
knowledge and their experience gained through practical activity, can carry the checks
out properly and do not need instruction to do so.
If defects are found during a safety check which could endanger
patients, device users or third parties, in accordance with the Ordinance on the
Operation and Use of Medical Devices (MPBetreibV) § 3, the operator must
immediately inform the responsible authority.
In the medical products log to be kept in accordance with the Ordinance on the
Operation and Use of Medical Devices (MPBetreibV) § 7, the following data is to
entered:

Time of carrying out the work

Name of person or company carrying out the work

Measures taken.
The responsibility of METRAX only covers the information provided in the operating
instructions. This applies in particular for readjustments, repairs and changes to the
device.
To always be able to keep the records up to date, you will find our STK test reports on
the Internet at
www.primedic.de
in the area "Service."
Operating instructions HeartSave PAD 22289 / GB / C
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