Standard Operating Procedure of Mindray BS-600M Biochemistry Analyzer

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Title: Standard Operating Procedure for Mindray BS-600M

state: Under Page:/1
Biochemistry Analyzer
control
No.: XX-SH-001 Version: 1.0 Revision: Revision 0 Effective date:
Prepared Approved
Reviewed by
by by
Preparation Approval
Review Date
Date Date
Revision record
Software
Version Overview of modifications Revised by Date
version
1.0 / New Liuyang Xuan
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Contents
1. Purpose ......................................................................................................................................................... 3
2. Scope ............................................................................................................................................................ 3
3. Operating Environment ................................................................................................................................ 3
4. Safety Information........................................................................................................................................ 3
5. Check before Powering on ........................................................................................................................... 5
6. Powering on the System ............................................................................................................................... 6
7. Checking System Status ............................................................................................................................... 7
8. Tests Setup.................................................................................................................................................. 14
9. Calibration Setup ........................................................................................................................................ 16
10. QC Setup .................................................................................................................................................... 19
11. Loading Biochemical Reagents .................................................................................................................. 21
12. Loading special reagents ............................................................................................................................ 23
13. Calibration .................................................................................................................................................. 25
14. QC test........................................................................................................................................................ 27
15. Sample test ................................................................................................................................................. 29
16. Twin chemistry ........................................................................................................................................... 33
17. Maintenance ............................................................................................................................................... 35
18. Powering off ............................................................................................................................................... 38
19. Check after powering off ............................................................................................................................ 38
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Standard Operating Procedure of Mindray BS-600M

1. Purpose
To standardize the operation of the Mindray BS-600M biochemical analyzer.

2. Scope
Applicable to the daily operation, maintenance, troubleshooting, and learning of the system.
3. Operating Environment
Ambient temperature: 15℃~30℃

Humidity: 35 %RH~85 %RH, without condensation.
Note: Be sure to operate the system in the specified environment and humidity range.
Otherwise, the results may be unreliable. If the ambient temperature and humidity are out of
range, use the air conditioning equipment.
4. Safety Information
4.1 Biohazard protection

1) Wear gloves and lab coat, if necessary, goggles and mask.
2) Inappropriate handling of samples may result in infection. Do not touch the samples,
controls, calibrators, mixtures or waste with your hands.
3) If the sample accidentally touches the skin, handle it according to the user's standard and
consult a doctor.
4.2 Chemical hazard protection
1) Some reagent and concentrated wash solution may hurt your skin. Use reagent and
concentrated wash solution carefully to prevent your hands and clothes from contacting
them.
2) If your hands or clothes contact them, wash them with clean water immediately.
3) In case of eye contact, flush with plenty of water immediately and consult an
ophthalmologist.
4.3 Electric shock prevention
1) Do not open the rear cover or side cover when the mains power is turned on by an
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unauthorized service person.
2) Spillage of reagent and sample on the instrument may lead to instrument failure and
electric shock.
3) Do not place samples and reagent on the instrument. If spillage occurs, switch off the
power immediately and contact your service department.
4.4 To prevent personal injury caused by moving parts
1) When the system is in operation, do not touch the moving parts of the system. These
moving parts include the sample probe, reagent probe, mixers, cuvette wash station,
rack supply push-in part, and rack storage push-in part.
2) Do not put your finger or hand into any open part when the system is in operation.
3) Do not place racks when the rack supply push-in part is moving forward. Do not
aspirate racks when the retrieval push-in part is moving.
4.5 To prevent personal injury caused by light source
1) When the system is working or standby, do not remove the lamp of the photometer in
case the light beam from the lamp may hurt your eyes.
2) Use the Replace Lamp command in the Maintenance function when replacing the lamp.
Ensure that the lamp is not touched before the countdown for lamp cooling ends, lest it
would be burnt.
4.6 Laser Hazards
1) Light sent by the bar code reader may hurt your eyes. Do not stare into the laser beam
radiated from the bar code reader when the system is in operation.
4.7 Dispose of Waste and Solid Waste
2) Some substances contained in reagent、controls、calibrators、concentrated wash solution
and waste are subject to regulations of contamination and disposal. Follow your local
emissions regulations and consult your reagent manufacturer or distributor.
3) The used solid waste such as reagent bottles and reaction cuvettes are subject to
contamination regulations. Dispose of the waste in accordance with local laws and
regulations.
4) When disposing of waste and solid waste, wear gloves and lab coat, if necessary,
goggles and mask.
4.8 Prevent fire and explosion
1) The alcohol is flammable. Exercise caution when using the alcohol near the analyzer to
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avoid fire and explosion.
4.9 Cleaning the Analyzer
1) If reagent or sample drops accidentally on the device surface, clean the device surface in
accordance with laboratory safety regulations. If a lot of liquid enters the system,
contact our customer service department or your local distributor.
2) Do not use cleaning agents that may cause risks due to chemical reactions with
components or materials inside the equipment. Do not use strong acidic or alkaline
solutions to clean the equipment.
3) If you have questions about the compatibility of the wash solution with components or
materials in the system, consult our customer service department or your local
distributor.
5. Check before Powering on
5.1 Check water supply

1) Check the deionized water tank or other water reservoirs, and make sure that water can
be supplied continuously.
2) Check if the connections between the water supply, water supply module, and analyzer
are correct and tight, and the length of the inlet tubing does not exceed 10m.
3) Check if the water tubes are free of twists and leaks.
5.2 Check the power supply
1) Check if the power supply is available and can provide correct voltage
Power supply: 110/115V~60Hz, 220-240V~50Hz, 220/230V~60Hz, voltage fluctuation:
±10%.
2) Check the connections among the sample delivery module, operation unit and printer.
Make sure the connections are correct and secure. Check the power cords of the sample
delivery module, operation unit and printer and make sure they are well connected to
the power sockets.
5.3 Check the printing paper.
Check if there is enough printing paper in the printer. If not, add printing paper.
5.4 Check Waste Connection
The waste fluid of the system is discharged in two flows: High-concentration waste and
low-concentration waste. Drain the high-concentration waste through the waste tank and
then dispose of it specially, or drain it through the sewer (in accordance with local
regulations). Low-concentration waste is discharged directly to the sewer.
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1) Check if the high-concentration waste tank has been emptied. If not, empty the waste
tank.
2) Check if the low-concentration waste tube is not bent and the sewer opening is lower
than the waste outlet of the system.
5.5 Check probes and mixers
Check the sample probe, reagent probe, sample mixers and reagent mixers for dirt,
bend, scratch, and another surface damage. If it is polluted, clean it immediately. If it is bent,
replace it immediately.
Every day before analysis, remove the anti-condensate plug from the reagent carousel cover.
Otherwise, mechanical reset may fail and the probe reagent may be bent.
5.6 Checking Wash Solutions and Probe Detergents.
Insufficient wash solutions or probe detergent s may terminate the measurements.
Check the wash solution according to the following steps:
1) Check the alkaline and acid wash solution s placed on the reagent carousel. If necessary,
fill more or replace them.
2) Check the DA, DB, DC probe detergent on the panel.
3) Open the front door of the analyzer and check the CD 80 detergent. If necessary, fill
more or replace the wash solution.
6. Powering on the System
6.1 After connecting correctly, the system to the power sockets, switch on the power in the
sequence presented below:
1) Turn on the circuit breaker.
Switch to to turn on.
Switch to to turn off.

2) Turn on the printer.
3) Turn on the monitor of the operation unit.
4) Turn on the display monitor of the computer installed with the Data Management
Software or LIS (optional)
5) Turn on the computer of operation unit.
6) Turn on the computer installed with the Data Management Software or LIS
(optional).
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7) When the operation unit (computer) is turned on, the operating software will run
automatically.
8) Enter the username and password in the Login window, and then select OK.
9) When the startup check is passed, the main screen shows. The startup procedure is
finished.
6.2 Auto startup Setup
The system allows you to auto awake the system every day by setting up the auto startup
time.
Select " " > System, select Auto Sleep/Awake, and then select Auto Awake to set up
the auto startup time. When the time is reached, the system will be started up automatically if it
is off.
7. Checking System Status
7.1 Screen areas

The software screen is divided into the following areas:
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(1) Status display area (2) Function buttons area

(3) Function window
1) Status display area

The status display area shows the system status, including: biochemistry/ISE system status, test time left,
countdown for pausing, LIS connection, printer, login user, and module status.
Status Description
Biochemistry ISE / SDM status This indicator appears on the left of the status display area. If an
ISE module is installed, the ISE status appears.
The biochemistry status of both analyzing module includes:
Initialize, Wakeup Incubation, Standby, Running, Reagent Load,
Inventory, Stopped, Restore, Sleep, Maintenance, and
Shutdown. The status of the ISE module includes: Initialize,
Restoring, Stopped, Shutdown, Sleep, Wake Up, Standby, and
Running.
Remaining Time This is displayed in status display area, indicating the remaining
time for the test.
Date and time This indicator appears on the upper right corner of the main
screen. It indicates the system date and time.
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LIS connection status
This indicator appears on the left of the status display area. The
following information is indicated:
If the icon appears in green, the LIS host is connected

and online.
If the icon appears in red, the LIS host is offline.

Printer status
This indicator appears on the upper right corner of the main
screen It indicates the status of the printer: not printing and
printing.
If the icon appears in red, the printer is not performing print
tasks or unconnected.
If the icon appears in green, the printer is connected.
When printing reports, select this icon to stop the printing.
Select this button to view warnings and prompts
Select this button to open online help.
Login user This indicator appears in the middle of the status display area. It
indicates the user who logs in the system.
Module Status This icon shows the configured analyzing unit and its status.
Select this icon to display the System Status screen, on which
the detailed status of the analyzer and sample delivery module
are provided.
The module status includes:
Error – red: An error occurs. The analyzer icon appears in
red.
Warning – yellow: A warning occurs. The analyzer icon
appears in yellow.
Normal: The system is running normally.
2) Shortcut icons area

The shortcut icons area contains the following icons used to quickly access certain function window or
perform an operation:
: Start icon. Select it to display the Start Conditions window , on which you are allowed to
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start new analysis or resume early testing.
: Emergency stop icon. Select it to stop all tests and other actions. To restore the system into
Standby status, execute the Home command.
: log off or exit the system.
: Online help icon. Select it to display the online help of the current window, where you will find
description of parameters and operations.
3) Function window
The function window contains options, buttons and other controls used to perform various functions of
the system.
4) Function buttons area
The function buttons area contains the following buttons used to access various function windows of the
system:
⚫ : used to order sample tests and control samples, and view samples and tests, sample
results and r ack status.
⚫ : used to load view reagent and consumable statuses and inventory check.
⚫ : used to define/edit controls and rules, request QC tests and recall QC results and
summary.
⚫ : Calibration Used to define calibrators, request calibration tests and view calibration
results and data.
⚫ : used to perform maintenance, view system statuses and view edit log and error log.
⚫ : used to set up test and system
7.2 Checking Alarm Status
Select “ ” and the warning list and prompt list pops up.
View Error log
⚫ Select System.
⚫ Select Error Log
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⚫ Select Error Details
⚫ Troubleshoot according to the recommended method
7.3 Checking Reagent/ Consumable Status
Select “ ”˃ Reagent Overview.
1) The reagent has the following three statuses
⚫ Sufficient: No color is marked for the
⚫ Low inventory: The background is orange.
⚫ Exhausted: The background is red.
2) The Consumable has the following three statuses
⚫ Sufficient: blueish green
⚫ Insufficient for inventory alarm limit: orange.
⚫ Exhausted: red.
View via Reagent Carousel
The consumable status is as follows:
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7.4 Checking Maintenance Status

When a maintenance procedure is expired, the following buttons and options will be
indicated by corresponding color:
1) Select “ ”˃ Maintenance ˃ Maintenance Procedures.

2) Check if the maintenance procedures tabs appear in yellow. If they do, it indicates that
at least one maintenance procedure is expired.
3) Select perform manually or auto perform to find the expired maintenance procedure,
and then perform the maintenance.
4) Repeat steps 2 and 3 until the maintenance frequency tabs and maintenance procedures
are displayed in normal color.
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7.5 Checking Subsystems

The subsystem status indicates the current working status of each subsystem and hardware
component, which includes the status summary, cycle count, temperature, power supply,
Hydropneumatic subsystem, and control modules.
⚫ Select “ ”˃ System Status.

⚫ Choose a subsystem tab;
⚫ Check the subsystem status.
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8. Tests Setup
8.1 Import Tests

Import default list of tests
1) Select Setup Tests.
2) Select Import
3) Select Default.
All tests contained in the default parameter form are displayed in the Available Tests list.
4) Select Import.
All imported tests are enabled by default and can be used for measurement. If the result
unit is changed, the corresponding test must be recalibrated.
5) Select OK.
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Import list of specified tests

Open reagent tests can be imported from a .csv file. The open reagent tests include bio
chemical tests, as well as the processing parameters, error detection limits, slop and offset,
and sample type
1) Select Setup Tests.
2) Select Import.
3) Select Open File.
4) Locate the path of the parameter form, and then select a .csv file .
5) Select Open.
6) Select Import.
7) Select OK.
8.2 Defining/Editing Chemistries
1) Select“ ”-Test-New.
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2) The user-defined chemistries are set with basic parameters and error detection limits based
on the H version provided by the manufacturer.
9. Calibration Setup
9.1 New Calibrator

1) Select " " > "Cal Setup." These are three Input Calibrator:
⚫ Scan Barcode
⚫ Add Manually
⚫ Remote Download
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2) Select “New”, click "Add Manually" enter the calibrator name, expiration date, lot number
and Number of concentrations, and then click "Calibration chemistry". Select Tests, and then
click “Submit”.
3) Select“Rack”、“Position”and “Sample Cup”，then Set “Concentration”.
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4) To set up the dilution factors, select the calibrator and Test, click Dil. Setup, enter the
calibrator concentration, sample volume for analysis (1.5μl~25μl), Aspirated (1.5μl~25μl)
and diluent volume (75μl~ 200 μl), and then click OK. Sample volume and concentration
must be entered.
9.2 Setting up calibration rules
1) Select " " > "Tests" -Cal Para. Set up calibration math model, K factor and
replicates.
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2) Select " " > "Select Calibrators". Select calibrators, then click OK.
10. QC Setup
10.1 Defining a Control
1) Choose “ ”> Ctrl Setup.
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2) Select “New,” enter the control name, sample Type, lot number, expiration date and
Manufacture, then select “QC Test”, Click Submit.
3) Choose a control, select “Rack” and “Position”, set up the mean and SD for the control,
and then click Submit.
4) Click QC Rules, set up Westgard multi-rule batch setup, and then click OK.
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11. Loading Biochemical Reagents
11.1 Load reagent manually

1) Check the system status and operate accordingly.
◼ Standby, Incubation or Sleep: Proceed to the next step.
◼ Running: Select “ ”˃ Reagent List. Select Reagent Stop to request
reagent load. When the countdown for reagent load becomes 0 and the system
status is Reagent Load, a message box pops up. Select OK, and then proceed to
the next step.
2) Select “ ”˃ Reagent List ˃ Reagent.
3) Choose a position to which you want to load a reagent.
4) Select Load. The Load Reagent window is displayed.
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5) Select Load to save the input information.

6) Select Prev or Next to load reagents for other tests on the module
7) Remove the reagent carousel cover.
8) Place reagent in an idle position of the reagent carousel and open the rea gent cap.
9) Restore the reagent carousel cover.
11.2 Auto load reagent
Auto load is to load bar coded reagents to the reagent carousel, which are identified by
bar code scanning.
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the next step.
3) Place reagent in an idle position of the reagent carousel and open the rea gent cap.
4) Restore the reagent carousel cover. The system scans all reagent positions
automatically and read the following reagent information from the bar code
12. Loading special reagents
12.1 Loading CD80 Detergent

Select “ ” and select Consumables, click Load Cons, enter the reagent
information, and place the concentrated wash solution in the 2L concentrated wash
solution tank in the front door of the analyzer. Note: The concentrated wash solution can
only be loaded manually. Enter the volume required for loading.
12.2 Load sample probe wash solution

Standby, Incubation or Sleep: Proceed to the next step.
2) Select “ ”˃ Reagent List ˃ Consumable.
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3) Select DA/DB/DC of sample probe on the panel.
4) Select Load
5) Place CD80 detergent in the DB position, acid wash solution in the DA position and
detergent cleanser in the DC position.
6) Enter the following information:Volume ( 100% by default), Serial number,
Expiration date, Lot number.
7) Select Load.
12.3 Load reagent probe wash solution

the next step.
2) Select “ ”˃ Reagent List ˃ Consumable.
3) Select DA/DB/Physiological saline you want to load.
4) Select Load. The Load Consumable window is displayed.
6) Place in the designated positions.
8) Enter the following information:
Volume (100 by default)
Serial number
Expiration date
Lot number
Bottle type
9) Select Load.
12.4 Load physiological saline

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the next step.
2) Select “ ”˃ Reagent List ˃ Consumable
3) Select Physiological Saline in No. 80 position that you want to load.
4) Select Load.
6) Place the physiological saline in position 80W.
8) Enter the following information of physiological saline for sample blanks and
sample dilution:
Volume (100 be default)
Bottle type
9) Select Load.
13. Calibration
13.1 Calibration request via Overview

1) Select Calibration Overview.
2) Select tests you want to calibrate.

3) Select Request Cal.
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4) Select Calibration Request Options
Full
Reagent blank
5) Select OK.
6) If you want to abort the calibration requests, select No Cal.
7) Calibration tests can be canceled only when they have not been started or are
interrupted.
13.2 Calibration request via Reagent List screen

1) Select “ ”>Reagent List Reagent.
2) Choose the test you want to request calibration.
3) Select Request Calibration
4) Select Calibration Request Options.
Full
Reagent blank
5) Select OK.
6) If you want to abort the calibration requests, s elect No Cal.
Calibration tests can be canceled only when they have not been started or are interrupted.
13.3 Calibration request via Reagent List screen
1) Select " " Calibration Overview.
2) Choose an analyzer or All to run calibration.
3) Choose ISE Serum or ISE Urine, or choose both of them.
4) Select Cal.
5) To cancel the calibration requisition, select No Cal.
Only calibrations in Requested status can be cancelled.
13.4 Recalling Calibration Results

1) Select“ ”> Overview.
2) You can select the filter icon “ ”to search for results within a certain period.
The screen shows all the calibrations requested on the day, including the following
information:
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Reagent carousel
Test name
Result flag
Calibration status
Calibration date and time
Reagent Lot No.
Reagent Serial No.
Math model.
14. QC test
14.1 Programming Control Samples
1) Select “ ”＞Order QC.
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2) Select a control.
3) Input Rack ID and Position.
4) Choose a sample cup type to be used by the selected control.
5) Choose desired tests and panels in the test list.
You can select Test View
6) If you want to perform QC on certain reagent, select Assign Rgt. Select a reagent and
select OK on the popup window.
7) Select Submit.
14.2 Recalling QC Results
1) Select Sample Current Results or History Results.
The Current screen displays all incomplete patient samples and control samples, as
well as those ordered on the current day.
The History screen displays all patient samples and control samples ordered before
the current day.
2) Choose a result recall mode:
View samples
View tests
3) Select filter icon“ ” to filter the QC results. Enter the date range and select QC from
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sample type
4) When recalling results by sample, choose a control in the left list. The right list displays
all results of the control. When recalling results by test, choose a test in the left list. The
right list displays all results of the test
5) Select Details to view result flags, alarm information, reaction curve and data. Select
Return to return to previous screen.
6) Choose the following buttons as needed:
Delete: to delete the QC results of the selected QC test.
Print : to print control results.
Host : to transmit the selected control results to the LIS host.
15. Sample test
15.1 Programming Samples
1) Select “ ” ˃ S orders.
2) Select Routine or STAT
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3) Enter the sample ID and barcode.

4) Enter the sample position.
5) Select a sample type from the Sample Type pull down list.
The options include serum, plasma, urine, CSF and other.
6) Select Sample Cup
7) Enter comments.
8) If you want to auto dilute sample, select Increased or decreased. If you want to manual
dilute the sample, input the Offline Dilution factor.
9) Choose desired tests and panels.
10) Tests in various statuses are indicated by symbols and color.
11) Select Options.
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12) Select OK.

13) Select Assign Reagent to assign reagent for the sample test.
14) Select Submit
If you want to batch order the samples, select Batch Order and input Number of
samples and End Sample ID and then select Submit
15.2 Batch programming:
1) Select “ ” ˃ Sample Orders.

2) Enter the sample ID /barcode or other information to search for sample.
3) Enter the following information:
• STAT status
• Sample type
• Bar code
• Comment
• Chemistries and panels
4) Select Batch, enter the position number of the last sample, and then select OK.
5) Load samples to the assigned positions of the assigned racks.
6) Put the racks into the rack supply unit.
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15.3 Recalling sample results
1) Select “ ”> Current Results or History Result.
2) Enter the sample ID, bar code, position, patient name or patient ID to search for samples.
The system supports fuzzy query.
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The retrieved sample information is automatically displayed on the screen.
3) Select OK. The samples matching the condition are displayed on the screen.
4) Select a function button to perform relevant operations.
Search sample via Date/Status/Sample ID
1) Select “ ”> Current Results.
2) Select Filter button“ ” on the upper right of the screen.
3) Enter Search Conditions.

Select the order date range from the pull down list.
The options include yesterday, within 1h, 3h and 5h.
Enter the single sample ID or ID range in the ID/bar code field.
4) Select STAT, routine or control in the Sample Type field.
5) Select OK. Select Reset to clear the filter condition before confirmation.
The searched results are automatically displayed on the screen. Select of Search Conditions to
clear the search conditions and display all sample results.
16. Twin chemistry
Twin chemistries are run and calculated based on the same reagent. Results of the two twin
chemistries are calculated through the same test. Take the reagent HbA1c as an example. It can
be used for running two chemistries in the same test. The chemistry Hb is measured during the
former reaction period, while the chemistry HbA1c measured during the latter one. Finally,
HbA1c (%) can be calculated based on results of the two chemistries.
Similar to normal chemistries, twin chemistries can be run only when the following settings
are finished:
1) defining chemistries
2) assigning reagent position
3) setting up calibrator and calibration rule
4) setting up control and QC rule
16.1 Chemistry definition
Twin chemistries can be defined in the same way as normal chemistries. The following
parameters, however, must be set up differently for two twin chemistries:
1) Sample type
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2) Normal sample volume, increased sample volume, and decreased sample volume
3) Volume of the same reagent type
4) Prozone check
For setup of chemistry parameters, see 8.2
16.2 Reagent setup

Twin chemistries are run with the same reagent in the same position. The reagent can be
loaded manually or through bar code scanning.
After enabling the pretreatment function, HbA1c chemistry needs to be loaded with R0
reagent (pretreatment solution).
1) Manual load
You are only required to manually set up reagents for one of the twin chemistries. The
reagent of the same type for the other twin chemistry will be automatically set up with the same
position.
2) Automatic load
Place the bar-coded reagents of twin chemistries on the reagent carousel, the system will
scan the reagent bar code and automatically assign the same position for the same reagent of the
twin chemistries.
If reagent loading fails for either of the twin chemistries, both chemistries cannot be run.
For details of reagent loading, see11.1and 11.2
16.3 Setting up and requesting calibration

1) Calibration setup
The calibrator, number of replicates and auto calibration conditions must be the same for
two twin chemistries.
For calibration settings, see 9.1and 9.2
2) Requesting calibration
Twin chemistries can be requested for calibration in the same way as normal chemistries.
When either of the twin chemistries is requested, the other twin will be requested automatically,
and finally both chemistries will be calibrated. You are allowed to recall the calibration results,
calibration curves and reaction curves of the two chemistries.
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16.4 Setting up and requesting quality control
1) QC setup
Twin chemistries must be defined with the same control, and the QC setup of twin
chemistries is the same as that of normal chemistries.
For QC settings, see 10.1
2) Programming controls
Twin chemistries can be requested for quality control in the same way as normal chemistries.
When either of the twin chemistries is requested, the other twin will be requested automatically,
and finally both chemistries will be run for quality control. You are allowed to recall the QC
results and QC reaction curves of the two chemistries.
16.5 Sample programming and processing

Twin chemistries can be requested for sample analysis in the same way as normal
chemistries. When either of the twin chemistries is requested, the other twin will be requested
automatically, and finally both chemistries will be run for sample analysis. You are allowed to
recall the sample results and sample reaction curves of the two chemistries.
17. Maintenance
17.1 Daily maintenance

1) Check Probes/Mixers/Wash Wells
⚫ Open the upper shielding cover and back cover of the analyzer.
⚫ Select “ ”> Maintenance, and then select Confirm Manually.

⚫ Choose the Check Probes/Mixers/Wash Wells procedure.
⚫ Select Execute to enter probe interior/exterior wash well maintenance command
screen.
⚫ Select System > Maintenance, and then select Confirm Manually
⚫ Choose the Check Probes/Mixers/Wash Wells procedure
⚫ This system updates the current maintenance time and status after maintenance
2) Check Sample/reagent Syringe
Prior to measurements everyday, check the sample syringe and reagent syringe for leak
and air bubbles.
3) Check DI Water Connection
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Prior to measurements everyday, check the water inlet tube connection in the back panel
of the analyzer. Check that there is sufficient deionized water in the water tank or in
other water containers, and that the tubes are not bent or leaking. Check if the water
supply module (or its recommended configuration) is powered on.
4) Check Waste Connection
Check if the waste drainage system is normal every day before analysis. Ensure that the
waste tubes are not bent or folded, and the high/low-concentration waste is handled
properly in accordance with local regulations. Empty the high-concentration waste tank.
5) Check Concentrated/Diluted Wash Solution
Before test every day, check if the concentrated wash solution and diluted wash solution
are sufficient.
6) Check Sample Probe Special Wash Solution
If the concentrated wash solution is insufficient, the sample probe may be clogged and
carryover may occur. Prior to measurements everyday, check if the sample probe wash
solution is sufficient.
7) Special Wash Probes/Mixers
⚫ Select “ ”> Maintenance, and select Auto Perform.

⚫ Select Probe/Mixer Special Wash and select Execute.
⚫ Make sure the inventory of probe detergent on the desk panel is greater than 5%,
and the inventory of CD80 in the cabinet is greater than 5%.
⚫ Select OK. When Start is select ed, the maintenance procedure starts and the
maintenance countdown i s displayed on the screen.
8) Clean ISE Tubes
⚫ Select System > Maintenance, and then select Auto Perform.
⚫ Select Clean ISE Tubes and then s elect Execute
⚫ Make sure the ISE cleaning solution is sufficient on the desk panel. If you are using
a sample tube to load ISE cleaning solution, make sure the inventory is no less than
300ul. If you are using a 75 ml sample tube to load ISE cleaning solution, make
sure the inventory is no less than 3 ml.
⚫ Select Execute and then OK to start the procedure
⚫ When the maintenance procedure is finished, the current maintenance time and
status are refreshed automatically.
36
Controlled
control
17.2 Weekly maintenance
17.2.1 Biochemistry Maintenance
Biochemistry Maintenance screen
17.2.2 Clean Probes/Mixers
1) Select “ ”> Maintenance, and then select Semi Auto Perform.

2) Choose the Clean Probe s /Mixer s maintenance procedure.
3) Select Execute.
4) After the probes/mixers finish moving, open the upper shielding cover and back
cover of the analyzer.
5) Use clean gauze moistened with ethanol to clean the exterior of the sample probe,
probe reagent and mixer until the surface is clean and free of dirt. When wiping the
probe s and mixer, do not push or pull them horizontally to avoid bending the
probes or mixer.
6) Use clean gauze moistened with deionized water to clean the exterior of the sample
probe, probe reagent and mixer to clear the ethanol on the surface.
7) Select Continue. The system starts cleaning the mixer
8) Select Done. The system resets automatically.
9) The software automatically updates the current maintenance time and status.
10) Close the upper shielding cover and back cover of the analyzer.
17.2.3 Weekly Special Wash and Cuvette Check
37
Controlled
control
1) Open the upper shielding cover of the analyzer.
2) Load wash solution in positions 78 DA and 79 DB of Reagent carousel. Fill wash
solution in DB/DA/ DC on the desk panel. The CD80 wash solution inventory in
the cabinet is greater than 5%.
3) Select “ ”> Maintenance, select Auto Perform, select the weekly special
wash and cuvette check procedure, and then select Execute.
4) After maintenance, select the maintenance data button on the Maintenance History
window to view cuvette check results.
5) Close the upper shielding cover of the analyzer.
17.2.4 Phase 7/8 Wash Probe
1) Select “ ”> Maintenance, select Auto Perform, select the phase 7/8 wash
probe procedure, and then select Execute.
2) After maintenance, select the maintenance data button on the Maintenance History
window to view phase 7/8 wash p robe results.
18. Powering off
1) Select Exit “ ”on the lower left corner of the main screen.
2) Select Shutdown. The shutdown maintenance dialog box pops up. Select OK. If the
consumables for the shutdown maintenance procedure s are insufficient, the
corresponding dialog box pops up prompting which consumables are insufficient.
Select OK to return to the main screen of the operating software. After replenishing
the consumables, repeat step 1.
19. Check after powering off
1) Remove the sample carousel cover and take out the calibrators, controls and samples.
2) Check the analyzer panel for stains. If yes, use clean soft cloth to wipe away the stains.
3) Check the high-concentration waste tank. If there is waste, empty the waste tank.
38

Standard Operating Procedure of Mindray BS-600M Biochemistry Analyzer

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Standard Operating Procedure of Mindray BS-600M Biochemistry Analyzer

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Title: Standard Operating Procedure for Mindray BS-600M

1.0 / New Liuyang Xuan

Standard Operating Procedure of Mindray BS-600M

To standardize the operation of the Mindray BS-600M biochemical analyzer.

Ambient temperature: 15℃~30℃

4.1 Biohazard protection

5.1 Check water supply

Switch to to turn on.

Switch to to turn off.

7. Checking System Status

7.1 Screen areas

(1) Status display area (2) Function buttons area

1) Status display area

If the icon appears in green, the LIS host is connected

If the icon appears in red, the LIS host is offline.

Select this button to open online help.

2) Shortcut icons area

: log off or exit the system.

⚫ : used to set up test and system

7.2 Checking Alarm Status

The consumable status is as follows:

7.4 Checking Maintenance Status

1) Select “ ”˃ Maintenance ˃ Maintenance Procedures.

7.5 Checking Subsystems

⚫ Select “ ”˃ System Status.

8.1 Import Tests

Import list of specified tests

8.2 Defining/Editing Chemistries

9.1 New Calibrator

3) Select“Rack”、“Position”and “Sample Cup”，then Set “Concentration”.

9.2 Setting up calibration rules

10.1 Defining a Control

1) Choose “ ”> Ctrl Setup.

11. Loading Biochemical Reagents

11.1 Load reagent manually

5) Select Load to save the input information.

1) Check the system status and operate accordingly.

12. Loading special reagents

12.1 Loading CD80 Detergent

12.2 Load sample probe wash solution

12.3 Load reagent probe wash solution

12.4 Load physiological saline

13.1 Calibration request via Overview

2) Select tests you want to calibrate.

13.2 Calibration request via Reagent List screen

13.4 Recalling Calibration Results

14.1 Programming Control Samples

1) Select “ ”＞Order QC.

Print : to print control results.

Host : to transmit the selected control results to the LIS host.

15. Sample test

15.1 Programming Samples

3) Enter the sample ID and barcode.

12) Select OK.

15.2 Batch programming:

1) Select “ ” ˃ Sample Orders.

15.3 Recalling sample results

1) Select “ ”> Current Results or History Result.

Search sample via Date/Status/Sample ID

1) Select “ ”> Current Results.

2) Select Filter button“ ” on the upper right of the screen.

3) Enter Search Conditions.