6.3 Instruction and unit handover
6.3.1 Instructing the unit officer
The nomination and instruction of an unit officer are among the
owner duties as specified in the Medical Devices Operator Ordi-
nance. The instruction covers at least the following contents:
1 - Nominate the unit officer after consultation with the owner.
2 - Instruct the unit officer about the intended purpose, the fore-
seeable misuse and the residual risks of the unit.
3 - Instruct the unit officer in the technically correct and safe han-
dling of the unit.
4 - Inform the unit officer about permitted connections with other
medical products and accessories.
Once instruction is complete, record the following information in the
medical product book:
n
Name of the unit officer
n
Date of instruction
n
Signature of the medical product officer
6.3.2 Handing over the unit
The unit has been commissioned
.
1.
Instruct the unit officer.
2.
Create the medical product book.
3.
Create a stock directory.
4.
Hand the medical product book, stock directory and instruc-
tion manual over to the owner.
Instruction
Handing the unit over to the owner
Commissioning
Instruction and unit handover > Handing over the unit
26.05.2021
Refrigerator/freezer BL series
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