Gram bioline BioCompact II User Manual

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b i o l ine
Measurement – Pull-down
ID Description Accepted
Yes No
P-11
The test is intended to provide substantiation for the time it takes for the inside of the
cabinet to reach the setpoint temperature specied in P-5.
The initial temperature in the working space is the ambient temperature specied in P-5.
The temperature inside the cabinet must be stabilized in all points of the working space.
When the system is stable. Turn on the power to the cabinet.
The measurements, throughout the pull-down test, must be documented and
attached the PQ.
Duration:
Attachment:
Notes:
P-12 The time it takes the inside of the cabinet to achieve the setpoint temperature
measured in the absolute centre, must not exceed the time-frame specied in
the appendix.
Have the criteria been met?
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 – Hold-over
ID Description Accepted
Yes No
P-13
The test is intended to provide substantiation for the time it takes for the temperature
inside the cabinet to reach the end temperature specied in the appendix.
Ambient temperature and setpoint temperature is specied in P-5.
The temperature inside the cabinet must be stabilized – where all the points in the
working space have reached and maintained the same temperature throughout,
the tolerances are specied in P-6.
When the system is stable, turn o the power to the cabinet.
The measurements, throughout the hold-over test, must be documented and
attached the PQ.
Attachment:
Notes:
P-14 The times it takes the inside of the cabinet to reach the end temperature,
must at least be the time specied in the appendix.
Duration:
Have the criteria been met?
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.
Conducted by:
Inspected / veried by:
Name: Signature: Approved
(Yes / No):
Date:
Model: ________________________ SN: ________________________
Conducted by:
Inspected / veried by:
Name: Signature: Approved
(Yes / No):
Date:
Model: ________________________ SN: ________________________

Gram bioline BioCompact II Specifications

General

Brand	Gram
Model	bioline BioCompact II
Category	Medical Equipment
Language	English