Kirsch BL Series - Obligations of the Owner

NOTICE!
Danger of damage due to blocked outside ven-
tilation!
Without adequate ventilation of the cooling
machine the unit can overheat and be damaged.
– Do not set up units in close proximity to each
other.
– Make sure that the ventilation (back and front)
on the unit is clear.
– Do not cover the cooling machine.
– Allow only qualified staff to install the unit.
3.5 Obligations of the owner
According to the Medical Devices Act, the owner is the natural or
legal person entered in the medical product book.
The owner is obliged to maintain the following documents and
keep them to hand:
n Medical product book
n Stock directory
n Operating log
n Instruction manual
The owner is obliged to make the instruction manual and the med-
ical product book available to the users. They can delegate this
task to an unit officer.
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
Blocked outside ventilation
Owner
Operating log
Safety
Obligations of the owner
18.12.2018 Refrigerator/freezer BL series 25