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Chapter 6. Test, Calibration and Upgrade
6.3 Calibration
System calibration should be performed every year or as frequent as dictated by hospital policy.
If calibration is needed, please contact After Sales Service.
6.3.1 Calibration procedures
On completion of each test and/or inspection, Test personnel should record the result of each
test and whether it meets specified requirements, the final device will be confirmed. If a
nonconformity is seen, complete non-conformity will be recorded.
The record of acceptance activities includes following items:
1.An explanation of activities carried out for the acceptance
2.Data of above activities
3.Results
4.Signature of personal (s) carrying out these activities
5.If applicable the serial number of used equipment
These records will be considered as a part of DHR. (Device History Record)
First, the temperature and approximate humidity should be recorded and the test is carried out
only if temperature and humidity are in allowed limitation.
6.4 Upgrade Test
On completion of each test and inspection, Test personnel should record the result of each
Upgrade test and whether it meets specified requirements, the final device will be confirmed. If
one nonconformity seen, complete nonconformity will be recorded.
The record of acceptance activities includes following items:
1. An explanation of activitiescarried out for the acceptance
2. Data of above activities
3. Results
4. Signature of personal (s) carrying out these activities
5. If applicable the serial number of used equipment
First record the temperature and approximate humidity and carry the test only if it is in allowed
limitation.
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Service Manual – Dena 350
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