Gram bioline BioCompact II User Manual

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b i o l ine
Measurement – Temperature stabilization
ID Description Accepted
Yes No
P-7
The test is intended to provide substantiation for the temperature stability inside
the cabinet during normal operation.
The temperature inside the cabinet must be stabilized – where all the points in the
working space have reached and maintained the same temperature.
When the system is stable, document ordinary operation of the cabinet at the
setpoint temperature and ambient temperature specied in P-5.
Duration:
The measurements throughout the operation test, must be documented and
attached the PQ.
Attachment:
Notes:
P-8 Are the measurements inside the allowed tolerances specied in P-6 ?
Attachment:
Notes:
Deviations from the specications dictated in the PQ are to be reported in the deviation report.
The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectied or accepted.
Measurement – Door opening test
ID Description Accepted
Yes No
P-9
The test is intended to provide substantiation for the temperature recovery time
inside the cabinet subsequently after a door opening.
The temperature inside the cabinet must be stabilized – where all the points in
the working space have reached and maintained the same temperature, the
setpoint temperature is specied in P-5.
When the system is stable, open the door at 90° for 60 seconds.
The measurements, throughout the door opening test, must be documented
and attached the PQ.
Duration:
Attachment:
Notes:
P-10 Has the setpoint temperature specied in P-5, measured in the absolute centre of
the cabinet, been achieved within the set time-frame specied in the appendix?
Attachment:
Notes:
Deviations from the specications dictated in the PQ are to be reported in the deviation report.
The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectied or accepted.
Model: ________________________ SN: ________________________Model: ________________________ SN: ________________________
Conducted by:
Inspected / veried by:
Name: Signature: Approved
(Yes / No):
Date:
Conducted by:
Inspected / veried by:
Name: Signature: Approved
(Yes / No):
Date:

Gram bioline BioCompact II Specifications

General

Brand	Gram
Model	bioline BioCompact II
Category	Medical Equipment
Language	English