BS-480/490 Installation Acceptance Report

Version 1.0 Four Pages in Total

Hospital Name:__________________________

Contact:______________ Tel:______________
SN:______________ Installation Date:______________
Installer:______________ Branch:______________

(1) Acceptance of Appearance, Quantity, etc.

1. External and internal packaging (intact, without damage, bumps, wet, damp, deformation, etc.)
Qualified Unqualified
2. Appearance of the main unit and accessories (without damage, rust, bumps, etc.)
Qualified Unqualified
3. The models, specifications, configurations and quantities of the main unit and accessories
match the packing list.
Qualified Unqualified
4. Complete delivery attached documentation (software CD, operating instructions, maintenance
card, product certification, etc.)
Qualified Unqualified

If the appearance is damaged, please indicate the quantity and the degree of damage. If the number of
accessories is abnormal, please indicate the name and quantity of the materials that are not qualified:
(Exception record)

Acceptance Personnel (Signature/Seal):

Acceptance Date:

(II) Basic Performance Acceptance

1. Working Environment
Ambient Temperature
Ambient Humidity (35% - 85%)
(15 - 30 °C)
Grid Voltage (V) Grid Frequency (Hz)
Zero Ground Voltage
Atmospheric Pressure
(≤5V)
DI Water/Wash Solution Temp
Reac Temp (37±0.3℃)
(15-30℃)

No.:OSH-19047-BS-480&490 Version: V1.0 1

2. System Status Check

a) The Main unit program is OK, without exception in red Qualified Unqualified
b) The Sub-unit program is OK, without exception in red Qualified Unqualified
c) The Power options in system status is OK,
without exception in red Qualified Unqualified
d) Vacuum pressure (operating software) < -20Kpa Qualified Unqualified
e) Vacuum pressure (pressure gauge) < -20KPa Qualified Unqualified
f) The DI Water pressure(pressure gauge) 34~40Kpa Qualified Unqualified

If there is any unqualified item, please check the hardware connection and pipeline connection of
the instrument and adjust the pressure.

3. Movement Positioning Performance Test

a) Rotation positions of sample carousel, reagent carousel

and reaction carousel Qualified Unqualified
b) Positions of sample probe to wash well, reagent carousel, and reaction carousel, which is in the
center of sample/cuvette Qualified Unqualified
c) Positions of reagent probe to wash well, reagent carousel, and reaction carousel, which is in the
center of sample/cuvette Qualified Unqualified
d) Positions of sample/reagent mixer to wash well and reaction
carousel, which is in the center of wash well and cuvette Qualified Unqualified
e) Position of auto wash probe assembly to reaction carousel, which is in the center of cuvette
f ) Position of vertical movement of sample/reagent syringe Qualified Unqualified

If there is any unqualified item, please use the debugging fixture for calibration and record the
parameters.

Unqualified item Original parameter Calibration parameter

______________________________ ________ ________
______________________________ ________ ________
______________________________ ________ ________
______________________________ ________ ________
______________________________ ________ ________

No.:OSH-19047-BS-480&490 Version: V1.0 2

4. Optical Performance Test

a) Photometer detection (the lamp status is normal) Qualified Unqualified

b) Cuvette check (cuvette without red mark) Qualified Unqualified
If there is any unqualified item, please check the installation of the lamp and any overflow in the
cuvette.

5. Bar Code Performance Test (Optional)

a) Reagent bar code stability test Qualified Unqualified

b) Sample bar code stability test Qualified Unqualified

Acceptance Personnel (Signature/Seal):

Acceptance Date:

(III) Clinical Performance Acceptance

1. Repeatability Test
Take a 2mL fresh serum and repeat the tests 10 times for the following items. K, Na, Cl are

Item
ALT γ-GT TG Urea Ca LDH K Na Cl
Parameter

1
2
3
4
5
6
7
8
9
10
MEAN
SD
CV
Judging standard CV≤ 5.0% 3.0% 3.0% 2.5% 2.5% 3.0% 1.0% 1.5% 1.5%
Conclusion
Qualified/Unqualifi
ed

No.:OSH-19047-BS-480&490 Version: V1.0 3

optional (configuration ISE should be tested)

If there is any unqualified item, please check the preparation processes of the serum sample and the
reagent.

Acceptance Personnel (Signature/Seal):

Acceptance Date:

Overall conclusion of installation acceptance: Qualified Unqualified

Abnormal description and solution suggestions:
________________________________________________________________________
________________________________________________________________________
______________________________________________________________________。
Remarks:
1. The acceptance test process must be carried out by a technician designated or authorized by Mindray.
2. The acceptance test procedure must be carried out in strict accordance with the Performance Test Guide of BS-
480/490 Auto Biochemical Analyzer.
3. This acceptance report only describes the working status and performance of the instrument under test at the time
of testing.
4. Mindray has the final right to interpret this installation acceptance report.

No.:OSH-19047-BS-480&490 Version: V1.0 4