biosystems BA 400 - Page 132

REPACKAGING RECORD
Company name:
Serial number:
Repackaging date:
PART REPLACEMENT PROCESS
1. Parts to be replaced
Replacement of parts Ok / Not Ok
Update the rmware
and software
Ok / Not Ok
ADJUSTMENT PROCESS
Points to be readjusted Tolerances Value
1. ermostatting of reagent 1 tip
Temperature set point 50,0 55,0
Temperature test 30,0 35,0
2. ermostatting of reagent 2 tip
Temperature set point 50,0 55,0
Temperature test 30,0 35,0
3. ermostatting of reaction rotor
Temperature set point 37,0 39,0
Temperature test 36,8 37,2
4. Photometry Tests
4.1. Luminous intensity
340 nm
6000 25000
405 nm
14000 30000
505 nm
12000 30000
535 nm
4000 30000
560 nm
3000 15000
600 nm
6000 25000
635 nm
6000 20000
670 nm
4000 15000
4.2. Number of counts of main photodiode
340 nm
600000 950000
405 nm
850000 950000
505 nm
850000 950000
535 nm
850000 950000
560 nm
550000 950000
600 nm
850000 950000
635 nm
850000 950000
670 nm
450000 950000
4.3. Number of counts of reference photodiode
340 nm
100000 400000
405 nm
400000 800000
505 nm
400000 800000
535 nm
400000 800000
560 nm
400000 950000
600 nm
300000 800000
635 nm
400000 800000
670 nm
200000 950000
4.4. Dark current counts
Value 3300 4500
4.5. Repeatability Tolerances CV(%)
For all the lters < 10%
4.6. Stability
For all the lters < 10%
FINAL FUNCTIONAL CHECK
5. Biochemical precision
Tolerances CV(%)
Value
Control serum Level I
Glucose
< 2
Control serum Level II
Glucose
< 2
Control serum level I
ALT
< 4
Control serum Level
II ALT
< 2
FINALISATION
6. Completed
Label the renovated
equipment
Ok / Not Ok
Add a full box of acces-
sories
Ok / Not Ok
Check the packaging Ok / Not Ok
7. Acceptance of repackaging
Repackaging OK
Available for sale
Ok / Not Ok
Signed:
Prepared by:
Page 1/1 Rev 1.0 Operative date: 25-06-12