burmeier Regia, Инструкция по эксплуатации

Страница: 145 / 152

5 Maintenance
WARNING
All “serious incidents”
1
that occurred in relation to the product must be notified to the
manufacturer and the competent authorities in the member state in which the user and/or
the resident resides (in Germany: www.BfArM.de). In other countries outside Germany or
the EU, the relevant national regulations must be complied with!
1:
Incident that had, could have had, or could have, one of the following direct or indirect
consequences: a) death of a patient, user or another person, b) temporary or permanent
serious deterioration of the health of a patient, user or another person, c) serious risk for
public health, (source: MDR (Medical Device Regulation), Art. 2(65)).
Recommendation: Inspect all electrical and mechanical components once a month. In ad-
dition to the above, check the mains cable and handset every time they have been sub-
jected to mechanical stress and after the bed has been moved. Use the following check-
list to help you:
As well as the extensive routine inspections performed by technical personnel, the bed must
also be checked at shorter regular intervals by non-technical users (care staff, family carers
etc.), and be briefly visually inspected and have its functions tested before being occupied by
a new user.
Risk of injury
Failure to heed this warning may result in physical injury due to defective components.
•
If you suspect that it is damaged or defective, take the bed out of service immediately and
disconnect it from the mains supply until the defective pieces are replaced or repaired!
•
Contact the operator who is responsible for you if the defective parts need to be replaced
or repaired.
Check OK Not
OK Description of Fault
Visual inspection of the electrical components
Handset, handset ca-
ble Damage, routing of
cable
Handset Damage, foil
Part C: Care staff and residents 35