1.0 PURPOSE
To design a
Standard Operating Procedure that describes the procedure for operation,
maintenance, and calibration of Mindray BC 5000 Vet Auto Hematology Analyzer.
2.0
SCOPE
This Standard
Operating Procedure (SOP) applies to the operation, maintenance, and
calibration of Mindray BC 5000 Vet Auto Hematology Analyzer for Pharmacology
studies.
3.0
RESPONSIBILITY
3.1
All personnel in the
Pharmacology Department shall be responsible for implementation and compliance
with the SOP.
3.2 Head/Designees/Study Directors
of the Pharmacology department shall be responsible to ensure the implementation
and compliance with the SOP.
4.0
DISTRIBUTION
4.1 The Quality Assurance
department is responsible for keeping SOP ‘Master Copy’ approved through the Quality Assurance Head.
4.2 The copy of the ‘Control Copy’ of
SOP is being distributed in the AHF department and placed near related Equipment/Instruments as a Display Copy.
5.0
DEFINITION(S)
5.1
Definition(s)
5.1.1
Auto hematology analyzer is an instrument that is used to analyze the complete blood count (CBC) with a
three-part differential white blood cell (WBC) count.
6.0 ABBREVIATION(S)
6.1 Abbreviations
6.2.1
SOP : Standard Operating
Procedure
6.3 AHF : Animal House Facility
6.4 ˚C : Degree Celsius
6.4.1 CBC : Complete Blood Cell
6.4.2 WBC : White Blood Cell
6.4.3 RBC : Red Blood Cell
6.4.4 FCM : Flow Cytometry
6.4.5 PTL : Platelets
6.4.6 μL : Mico Litre
7.0
PROCEDURE
7.1
Introduction
Hematology
analyzers are the workhorses of the clinical laboratory. High-end, high-volume
analyzers deliver reliable red blood cell counts, platelet counts, and 5-part
differentials of white blood cells, identifying lymphocytes, monocytes,
neutrophils, eosinophils, and basophils. Nucleated red blood cell counts and
immature granulocytes are emerging as the sixth and seventh parameters. While
electrical impedance still has a firm foothold in determining the overall
number and size of cells, flow cytometry techniques have proven their worth in
differentiating white blood cells and identifying abnormal cells.
Figure 1: Mindray
BC 5000 Vet Auto Hematology Analyzer
7.2
Principle
BC 5000 Vet Auto
Hematology Analyzer works on the principles of Flow Cytometry (FCM), Tri-angle
Laser scatters, chemical dye method, and independent Basophil channel Advanced DC
impedance method for RBC and PLT counting Cyanide free reagent for a hemoglobin
test.
7.3
System description
7.3.1
Display: 10.4 inch TFT Touch
Screen
7.3.2 Probe
with aspirate key: which used whole blood volume up to 15 μL and Prediluted volume up to 20
μL
7.3.3
Reagents:
V-52d
diluents, V-52diff lyse, V-52lh lyse, Probe cleanser
7.4
Operation
7.4.1
Turning
on the analyzer and user login
Switch on the
printer if the analyzer is connected to the printer. Then power on the analyzer
by switching on the analyzer at the back. Enter the user name and the password
into the pop-up dialog box to log in to the main screen.
7.4.2
Background
test
7.4.2.1
Background test will be
performed automatically after the analyzer is powered on.
7.4.2.2
If the “Background abnormal” error
will be prompted. Perform troubleshooting as instructed operator’s manual.
7.4.3
Next
Sample
Click “next
sample” on the sample analysis screen. You may select species and input sample
ID, patient ID, and patient name.
7.4.4
Mode
Click “mode” on the sample analysis screen, you may select blood mode, WB (whole blood), and PD
(prediluted).
7.4.5
Standby
7.4.5.1
The analyzer will enter the
standby mode if relevant fluidic operations have stopped for a period out of
the set interval.
7.4.5.2
When the analyzer is in standby
mode, you can press the aspirate key to exit the standby mode.
7.4.6
Shutdown
7.4.6.1
After the analysis, click the
shutdown button on the main menu to shut down the analyzer.
7.4.6.2
When it prompts are you sure to
shut down the analyzer?” click “OK”.
7.4.6.3
When the dialog box prompting probe
cleanser maintenance displays, present probe cleanser to the sample probe, and press the aspirate key. The probe will aspirate the probe cleanser automatically.
7.4.6.4
After shutting down finishes,
the message “Please power off the analyzer” will be displayed. Press the power
on the back of the instrument to power it off.
7.4.7
Troubleshooting
In case of any
error, click the error message at the bottom right of the screen for
troubleshooting information. See Chapter 11 troubleshooting your analyzer of
the operator’s manual for details.
7.4.8
Daily
Maintenance
7.4.8.1
Daily: Shut your analyzer as instructed
and perform probe cleaner maintenance.
7.4.8.2
Monthly: The surface and black plate of
the probe wipe shall be wiped every month. (It is recommended to use alcohol
whose concentration is 75%)
7.4.8.3
If the analyzer is free from use
for a long time (longer than one week), you should perform the “prepare the
ship” procedure and shut down the analyzer.
8.0
PRECAUTIONS
8.1
All personal protective
equipment like aprons, gloves, masks, head caps, and shoe covers should be worn
before using the instrument.
8.2
Press Keys softly.
8.3
Clean the equipment with a dry piece of robe
or a lightly moistened one.
8.4
Never use abrasive products or
dissolvents.
8.5
Never pour water or liquids on the equipment.
8.6
Once you have finished using the equipment
turn it off by using the main switch, clean, and check the equipment so that it is
in optimal condition when you use it again.
8.7
User is only authorized to replace fuses by
the specified type it was necessary.
8.8
Optimal operating temperature:
10 ˚C – 30 ˚C.
8.9
Running temperature: 10 ˚C – 40
˚C.
9.0
REFERENCES
9.1
Reference
9.1.1
Mindray BC 5000 Vet Auto
Hematology Analyzer Service manual.
END
OF THE DOCUMENT
My Recent Gadgets purchased after great research:
Boya Microphone: https://amzn.to/3Sd1AhU
American Touristic Bag: https://amzn.to/3k9fXai
Mobile Phone: https://amzn.to/3SaBdJk
Laptop: https://amzn.to/3IvLMDA
Air Drops: https://amzn.to/3EhuOXc
Vega Trimmer: https://amzn.to/3S6BMUx
Camera: EOS 200D-II, (EF-S 18-55 IS STM) https://amzn.to/417hxKw
Dreaming to update for following
Camera EOS 50 Mark –II EF-M 15-45mm is STM https://amzn.to/417hxKw
Asus Notebook-14 : https://amzn.to/3YGZYzn
You may like to read these links:
1. List of All SOPs and Documents for the Microbiology Laboratory
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the In-vivo Laboratory.
4. List of All SOPs and Documents for Clinical Research
5. List of Instruments and Equipment Used In Laboratory Animal Facility
6. List of All SOPs and Documents for the Animal House Facility
7. List of All SOPs and Documents for the Chemistry Laboratory
8. List of All SOPs and Documents for Quality Control
9. List of All SOPs and Documents For Quality Assurance Dept.
10. List of SOPs and Documents Required to Achieve NABL Accreditation
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment