Inform your specialist dealer of any location
changes!
If the unit is set up at a different location by the
owner or the unit officer, inform the responsible
medical product advisor about the change of loca-
tion.
An operating log must be maintained for this unit in line with the
Medical Devices Operator Ordinance.
The operating log contains the following information about the unit:
n
Set-up location
n
Maintenance
n
Modifications
n
Repairs
The medical product book contains the following information about
the unit:
n
Description and other information for identifying the medical
product
n
Proof of function testing and of staff instruction
n
Proof of instruction
n
Name of unit officer, date of instruction, and name of instructed
person
n
Information on safety checks and maintenance
n
Information on malfunctions and operating errors
n
Reporting of incidents to the authorities and to KIRSCH
The stock directory contains at least the following information:
n
Description, sort and type
n
Lot code or serial number
n
Year of procurement of the medical product
n
Name or company and address of the owner
n
Identification number of the CE marking added by the notified
body (where required according to the regulations of the Med-
ical Devices Act)
n
In-company identification number (if available)
n
Location and company allocation
n
The deadline for safety inspection specified by the owner
Operating log
Medical product book
Stock directory
Safety
Obligations of the owner
26.05.2021
Refrigerator/freezer BL series
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