Safety Checks - Primedic HeartSave AED Operating Instructions Manual

Safety checks

15 Safety checks
(it is possible that other national regulations may be applicable)
In accordance with the German Medical Products User Regulations (MPBetreibV) § 6
(safety checks) the operator in the event of commercial and economic use undertakes
to carry out regular checks or have them carried out. METRAX recommends carrying
out safety checks in accordance with the MPBetreibV §6 every 24 months. The safety
checks may only be carried out by or be assigned to the persons described in the
MPBetreibV §6 (4).
The safety checks carried out are to be documented in accordance with MPBetreibV §7.
In accordance with the German Medical Products User Regulations (MPBetreibV) § 6
(Safety checks) the operator is obliged to have regular checks carried out. In
accordance with the German Medical Products User Regulations (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 during the safety check, faulty are found which could be hazardous to patients,
employees or third parties, then the operator must immediately inform the responsible
authorities in accordance with German Medical Products User Regulations
(MPBetreibV) § 3.
In the medical products log to be kept in accordance with the German Medical
Products User Regulations (MPBetreibV) § 7, the following data is to entered:
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The responsibility of METRAX GmbH only covers the information provided in the
operating instructions. This applies in particular for readjustments, repairs and changes
to the device.
Operating Instructions
54
Time of carrying out the work
Name of person or company carrying out the work and
Measures taken.
HeartSave AED / AED-M, 21212 / GB / E02