Kirsch BL Series - Instruction and Unit Handover; Instructing the Unit Officer; Handing over the Unit

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 Ä Chapter 6 “Commissioning”
on page 40.
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
18.12.2018Refrigerator/freezer BL series46