1
M-18D DILUENT
【PRODUCT NAME】
M-18D DILUENT
【MODEL】
M-18D
【PACKAGE SPECIFICATIONS】
5.5L×2、20L
【INTENDED USE】
For use on MINDRAY BC-1800/BC-2600/BC-2800 hematology analyzer. For use as an azide-free, filtered isotonic solution for counting and
sizing blood cells. Only use one time. Don 't use reagent out off date.
【ACTIVE INGREDIENTS】
Sodium Chloride………………………………..……....…3.0-5.5 g/L
Sodium Sulfate Anhydrous………………………...…...7.5-11.5 g/L
Buffering Agents………………….………………..….…..1.0-3.0 g/L
Anti-fungal and Anti-bacterial Agents………………..….0.8-2.5 g/L
【STORAGE CONDITION AND SHELF LIFE】
The product must be stored in the temperature of 2℃~30℃(35℉~86℉), The shelf life is 24 Months.
The product must be used in the temperature of 15℃~30℃(59℉~86℉), and it stays valid for 60 days after being opened.
【APPLICABLE ANALYZER MODELS】
The product applies to Mindray BC-1800/BC-2600/BC-2800 Hematology analyzer manufactured by Shenzhen Mindray Bio-Medical
Electronics Co., Ltd..
【INSTRUCTIONS FOR USE】
1 Keep Hematology Analyzer Reagent between 15℃-30℃ during use.
2 Refer to Mindray Operation Manual to obtain instrument-specific instructions for appropriate use of Hematology Analyzer Reagent.
【WARNINGS AND PRECAUTIONS】
 If the reagent accidentally gets into your mouth, seek medical assistance immediately.
 If the reagent spills on your skin, wash it off with plenty of water immediately.
 If the reagent spills into your eyes, wash it off with plenty of water immediately.
【NOTICE】
 Do not use expired products.
 If the product has been frozen(either partially or completely), warm it up to room temperature and then mix it by gentle inversion. Verify
background results before analyzing patient samples.If background results of the reagent are abnormal due to transportation, keep the
reagent still in room temperature for 24 hours before use.
 If reagents are contaminated or become abnormal due to other reasons, stop using and then replace them at once.
 Be sure to dispose of reagents, waste and contaminated packing materials according to government regulations.
 The following conditions may produce interference to test results: expired reagent; reagent contaminated by dusts; unclean sa mple
dilution; reagent mixed with those of other manufacturers; residue reagent mixed with newly opened reagent; reagent not used as
required. 【CUSTOMER SERVICE DEPARTMENT】
Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray building, Keji 12th Road South, Hi-tech Industrial Park,Nanshan, Shenzhen, 518057 P.R.China
Website:
www.mindray.com
E-mail Address:
service@mindray.com
Tel:
+86 755 81888998
Fax:
+86 755 26582680
© 2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.For this Operator’s Manual, the issue date is 2014-02.
In vitro diagnostic medical
Batch code
Use -by date
Temperature limit
Manufacture
device
P/N：046-006108-00-1.0
M-23D DILUENT
02
【PRODUCT NAME】
M-23D DILUENT
【MODEL】
M-23D
【PACKAGE SPECIFICATIONS】
10L、20L
【INTENDED USE】
For use on Mindray BC-2300/BC-2100 hematology analyzer. For use as an azide-free, filtered isotonic solution for counting and sizing blood
cells. Only use one time. Don’t use reagent out off date.
【ACTIVE INGREDIENTS】
Sodium Chloride………………………………..……....…3.0-5.5 g/L
Sodium Sulfate Anhydrous………………………...…...7.5-11.5 g/L
Buffering Agents………………….………………..….…..1.0-3.0 g/L
Anti-fungal and Anti-bacterial Agents………………..….0.8-2.5 g/L
【STORAGE CONDITION AND SHELF LIFE】
The product must be stored in the temperature of 2℃~30℃(35℉~86℉), The shelf life is 24 Months.
The product must be used in the temperature of 15℃~30℃(59℉~86℉), and it stays valid for 60 days after being opened.
【APPLICABLE ANALYZER MODELS】
The product applies to Mindray BC-2300/BC-2100 Hematology analyzer manufactured by Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd..
【INSTRUCTIONS FOR USE】
1 Keep Hematology Analyzer Reagent between 15℃-30℃ during use.
2 Refer to Mindray Operation Manual to obtain instrument-specific instructions for appropriate use of Hematology Analyzer Reagent.
【WARNINGS AND PRECAUTIONS】
 If the reagent accidentally gets into your mouth, seek medical assistance immediately.
 If the reagent spills on your skin, wash it off with plenty of water immediately.
 If the reagent spills into your eyes, wash it off with plenty of water immediately.
【NOTICE】
 Do not use expired products.
 If the product has been frozen(either partially or completely), warm it up to room temperature and then mix it by gentle inversion. Verify
background results before analyzing patient samples.If background results of the reagent are abnormal due to transportation, keep the
reagent still in room temperature for 24 hours before use.
 If reagents are contaminated or become abnormal due to other reasons, stop using and then replace them at once.
 Be sure to dispose of reagents, waste and contaminated packing materials according to government regulations.
 The following conditions may produce interference to test results: expired reagent; reagent contaminated by dusts; unclean sample dilution;
reagent mixed with those of other manufacturers; residue reagent mixed with newly opened reagent; reagent not used as required.
【CUSTOMER SERVICE DEPARTMENT】
Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray building, Keji 12th Road South, Hi-tech Industrial Park,Nanshan, Shenzhen, 518057 P.R.China
Website:
www.mindray.com
E-mail Address:
service@mindray.com
Tel:
+86 755 81888998
Fax:
+86 755 26582680
© 2010 – 2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.For this Operator’s Manual, the issue date is 2016-08.
In vitro diagnostic medical
Batch code
Use-by date
Temperature limit
Manufacture
device
M-30D DILUENT
03
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other
derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
Mindray are the trademarks, registered or otherwise, of Mindray in China and other
countries. All other trademarks that appear in this manual are used only for informational or
editorial purposes. They are the property of their respective owners.
1. Product Name
M-30D DILUENT.
2. Intended Use
For use on Mindray BC-20/BC-21/BC-10/BC11/BC-3000Plus/BC-3000CT/BC-3200/BC3300/BC-3600/ BC-20s/BC-21s/BC-30s/ BC-31s/BC-30/BC-31/BC-30e/BC-10e hematology
analyzer.
For use as an azide-free, filtered isotonic solution for counting and sizing blood cells.
Only use one time. Don’t use reagent out off date.
3. Active Ingredients
Sodium Chloride…………………………………3.0-5.5g/L
Sodium Sulfate Anhydrous……………………7.5-11.5g/L
Buffering Agents…………………………………1.0-3.0g/L
Anti-fungal and Anti-bacterial Agents…… …...0.8-2.5g/L
4. Warnings and Precautions
Do not inhale and/or ingest. In case of inhalation or ingestion, seek medical advice
immediately.
Avoid skin contact. In case of skin contact, flush the affected area with plenty of water
immediately.
Avoid eye contact. In case of eye contact, flush the affected area with plenty of water and
seek medical advice immediately.
5. Storage and Usage
The product must be stored in the temperature of 2℃ to 30℃(35℉ to 86℉ ), and the
relative humidity must not exceed 90%. The storage room must be well ventilated and
without corrosive gas. The shelf life is 2 years.
The product must be used in the temperature of 15℃ to 30℃(59℉ to 86℉ ), and it stays
valid for 60 days after being opened.
Do not use expired products.
If product has been frozen(either partially or completely), warm it up to room temperature
and then mix it by gentle inversion. You can only proceed to test samples after you have
confirmed that the measured blank value is within the required range.
Dispose of waste product, unused product and contaminated packaging in accordance with
governmental requirements.
The following conditions may produce interference to test results: expired reagent, reagent
contaminated by dusts, unclean sample dilution, reagent mixed with those of other
manufacturers
Warning
If the reagent accidentally gets into your mouth, seek medical assistance
immediately; if the reagent spills on your skin, wash it off with plenty of water
immediately; if the reagent spills into your eyes, wash it off with plenty of water and
seek medical assistance immediately
Note:
This product must only be used by Mindray authorized personnel or skilled/trained clinical
professionals.
GRAPHICAL SYMBOLS
M-50 SERIES HEMATOLOGY REAGENTS
PRODUCT NAME
M-50D DILUENT
4
M-50 LEO (I) LYSE
M-50 LEO (II) LYSE
M-50 LH LYSE
M-50 LBA LYSE
M-50 CLEANSER
PROBE CLEANSER
16
22
SUMMARY AND PRINCIPLE
HEMATOLOGY ANALYZER REAGENT is a series of reagents which are formulated
specially for Mindray hematology analyzers. The reagents are M-50D DILUENT, M-50 LEO
(I) LYSE , M-50 LEO (II) LYSE ,M-50 LH LYSE,M-50 LBA LYSE,M-50 CLEANER, PROBE
CLEANSER.
M-50D DILUENT is an azide-free, filtered isotonic solution used for counting and sizing
blood cells.
M-50LH Lyse is used to break down red blood cell membrane and converts hemoglobin
to a hemoglobin complex to determine the HGB.
M-50LBA Lyse is used to break down red blood cell membrance and 2-differentiates
WBCs to basophils and other WBCs. Use the M-50LBA Lyse as instructed by the
operator’s manual of the analyzer.
M-50LEO(I) Lyse breaks down the red blood cell and cooperates with M-50LEO(II) Lyse
to 4-differentiate WBCs.
M-50LEO(II) Lyse cooperates with M-50LEO(I) Lyse to 4-differentiate WBCs.
M-50 Cleanser is used for shutdown and regular cleaning.
PROBE CLEANSER is used to clean the analyzer regularly.
INTENDED USE
For In Vitro Diagnostic use only one time. Don't use reagent out off date.
INSTRUCTIONS FOR USE
Refer to Mindray Operator’s manual to obtain instrument-specific instructions for
appropriate use of HEMATOLOGY ANALYZER REAGENT.
Keep Hematology Analyzer Reagent between 15℃-30℃during use.
STORAGE AND STABILITY
M-50D DILUENT, M-50 LEO (I) LYSE , M-50 LEO (II) LYSE ,M-50 LH LYSE,M-50 LBA
LYSE have a shelf life of 24 months when stored at 2-30℃.
Probe cleanser has 12months shelf life under 2-30℃.
The open vial life for all the reagents is 60days when the operating environment
temperature is 15℃-30℃.
PROBE CLEANSER needs to be stored in a dark place.
If frozen, the product needs to be thaw completely before mixing. Mix the product by
gentle inversion prior to initial placement on instrument. Verify acceptable background
counts before performing patient sample analysis.
WARNINGS AND PRECAUTIONS
Do not ingest, keep away from foods. Consult a physician if you accidentally ingest it.
Avoid contact with skin and eyes. In case of skin contact, immediately flush with water.
In case of contact with eyes, rinse immediately with plenty of water and seek medical
attention immediately.
M-50P PROBE CLEANSER includes irritating substances. Please keep the container
closed when not in use.
ACTIVE INGREDIENTS
M-50LEO(I) Lyse
Surfactant
<35g/L
M-50LEO(II) Lyse
Surfactant
<40g/L M-50LH lyse
Quarternary Ammonium Salts
<50g/L
Nonionic Surfactant
Isopropanol
Ethanol
<10g/L
0.1-1.5mL/L
<1.5mL/L
M-50LBA lyse
Surfactant
<50g/L
M-50 Cleanser
Surfactant
Buffering agents
Detergent enzyme
0.5-2.0g/L
0.5-3.0g/L
0.05-0.5g/L
Anti-fungal and anti-bacterial agents
0.01-1.0g/L
PROBE CLEANSER
Surfactant
Sodium hypochlorous
Sodium hydroxide
<2.0g/L
<100g/L
<50g/L
MANUFACTURER
Shenzhen Mindray Bio-Medical Electronics Co.，Ltd.
Mindray Building ， Keji 12th Road South ， Hi-tech Industrial Park ， Nanshan ，
Shenzhen
P.R.China，518057
AUTHORIZED REPRESENTATIVE EUROPEAN COMMUNITY
Shanghai International Holding Crop. GmbH(Europe)
Eiffestrasse 80 D-20537 Hamburg Germany
5
M-52D DILUENT
【PRODUCT】
This product applies to BC-5100/BC-5300/BC-5180/ BC5380/BC-5310/BC-5390/BC-5390 CRP/BC-5180 CRP
M-52D DILUENT
Auto Hematology Analyzer produced by Shenzhen Mindray
【PACKAGE SIZE】
Bio-Medical Electronics Co., Ltd.
20L
【INSTRUCTIONS FOR USE】
【INTENDED USE】
M-52D diluent provides a stable environment for counting
and sizing blood cells. Only use one time. Don't use reagent
out off date.
Unpack the reagent container. Insert the pickup pipe from
the analyzer's cap assembly into the container, making
sure the container's cap and the connected assembly
【PRINCIPLE】
M-52D diluent provides stable solution environment for
connector are in the same color. Turn and secure the cap
blood cells, dilutes blood sample, generates sheath fluid
assembly tightly, and replace the reagent in accordance
and provides conductance in blood cell analysis process.
with the instructions in the Operator's Manual of the
analyzer. You can only proceed to test samples after you
【ACTIVE INGREDIENTS】
Sodium Chloride……………………………………3.0-5.5g/L Sodium
Sulfate Anhydrous………………………7.5-11.5g/L
Buffering Agents……………………………………1.0-3.0g/L
Anti-fungal and Anti-bacterial Agents………...…0.8-2.5g/L
【PRODUCT SPECIFICATIONS】
1.
Appearance: Transparent liquid without deposits,
required range. For detailed usage instruction, please refer
to the Operator's Manual of the analyzer.
【WARNINGS】
Do not inhale and/or ingest. In case of inhalation or
ingestion, seek medical advice immediately. Avoid skin
contact. In case of skin contact, flush the affected area
suspended grains or flocks.
2.
have confirmed that the measured blank value is within the
Blank count results: The blank count results tested
on the matched Auto Hematology Analyzer shall meet the
with plenty of water immediately. Avoid eye contact. In
case of eye contact, flush the affected area with plenty of
water and seek medical advice immediately.
requirements of Table 1.
Table 1 Blank Count Requirements
Parameter
Blank Count Requirements
WBC
≤0.3×109/L
RBC
≤0.03×1012/L
PLT
≤10×109/L
HGB
≤1 g/L
【NOTICE】
1. Do not use expired products.
2. If
product
has
been
frozen(either
partially
or
completely),warm it up to room temperature and then
mix it by gentle inversion.
3. Verify back ground results before analyzing patient
samples.
4. Dispose of waste product, unused product and
【STORAGE AND EXPIRATION DATE】
contaminated
This product will be stable for 2 years when stored at 2℃to
30℃(35℉to 86℉).
The product should be used at 15℃to 30℃(59℉to 86℉) once
opened, and it is stable for 60 days.
【APPLICABLE INSTRUMENT】
packaging
governmental requirements.
in
accordance
with
English
1/2
00（1.0） 【GRAPHICAL SYMBOLS】
Batch code
Use-by date
【COMPANY CONTACT】
Temperature limit
In
vitro
diagnostic
medical
device
Manufacture
Authorized
representative in the
European Community
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech
Industrial Park, Nanshan, Shenzhen 518057, P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC-Representative: Shanghai International Holding Corp.
GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
© 2014 Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd. All rights Reserved.
【APPROVAL DATE OF THE OPERATOR’S MANUAL】
2014-07
English
P/N: 046-006524-
2/2
P/N: 046-006524-00（1.0）
6
M-53D DILUENT
【PRODUCT】
This
M-53D DILUENT
product
applies
to
BC-5100/BC-5300/BC-5180/
BC-5380/BC-5310/BC-5390/BC-5390 CRP/BC-5180 CRP
【PACKAGE SIZE】
Auto Hematology Analyzer produced by Shenzhen
20L
Mindray Bio-Medical Electronics Co., Ltd.
【INTENDED USE】
【INSTRUCTIONS FOR USE】
M-53D diluent provides a stable environment for counting
Unpack the reagent container. Insert the pickup pipe from
and sizing blood cells. Only use one time. Don't use reagent
out off date.
【PRINCIPLE】
the analyzer's cap assembly into the container, making
M-53D diluent provides stable solution environment for
connector are in the same color. Turn and secure the cap
blood cells, dilutes blood sample, generates sheath fluid
assembly tightly, and replace the reagent in accordance
and provides conductance in blood cell analysis process.
with the instructions in the Operator's Manual of the
【ACTIVE INGREDIENTS】
sure the container's cap and the connected assembly
analyzer. You can only proceed to test samples after you
Sodium Chloride……………………………………3.0-5.5g/L
have confirmed that the measured blank value is within the
Sodium Sulfate Anhydrous………………………7.5-11.5g/L
required range. For detailed usage instruction, please refer
Buffering Agents……………………………………1.0-3.0g/L
to the Operator's Manual of the analyzer.
【WARNINGS】
Anti-fungal and Anti-bacterial Agents………...…0.8-2.5g/L
【PRODUCT SPECIFICATIONS】
Do not inhale and/or ingest. In case of inhalation or
1. Appearance: Transparent liquid without deposits,
ingestion, seek medical advice immediately.
suspended grains or flocks.
Avoid skin contact. In case of skin contact, flush the
2. Blank count results: The blank count results tested on
affected area with plenty of water immediately.
the matched Auto Hematology Analyzer shall meet the
Avoid eye contact. In case of eye contact, flush the
requirements of Table 1.
affected area with plenty of water and seek medical advice
immediately.
Table 1 Blank Count Requirements
Parameter
Blank Count Requirements
WBC
≤0.3×109/L
RBC
≤0.03×1012/L
PLT
≤10×109/L
HGB
≤1 g/L
【NOTICE】
1. Do not use expired products.
2.
If
product
has
been
frozen(either
partially
or
completely),warm it up to room temperature and then mix it
by gentle inversion.
3. Verify back ground results before analyzing patient
【STORAGE AND EXPIRATION DATE】
This product will be stable for 2 years when stored at 2℃
samples.
to 30℃(35℉ to 86℉).
4. Dispose of waste product, unused product and
The product should be used at 15℃ to 30℃(59℉ to 86℉)
contaminated packaging in accordance with governmental
once opened, and it is stable for 60 days.
requirements.
【APPLICABLE INSTRUMENT】
English
1/2
P/N: 046-006524-00（1.0）
【GRAPHICAL SYMBOLS】
Batch code
Use-by date
Temperature limit
In vitro
diagnostic
medical device
Manufacture
Authorized
representative in the
European Community
【COMPANY CONTACT】
Manufacturer: Shenzhen Mindray Bio-Medical Electronics
Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech
Industrial Park, Nanshan, Shenzhen 518057, P.R.China
Website: www.mindray.com
E-mail Address:
service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC-Representative: Shanghai International Holding Corp.
GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
© 2014 Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd. All rights Reserved.
【APPROVAL DATE OF THE OPERATOR’S MANUAL】
2014-07
English
2/2
P/N: 046-006524-00（1.0）
7
M-58D Diluent
【PRODUCT】
M-58D DILUENT
【PACKAGE SIZE】
20L
【INTENDED USE】
M-58D Diluent provides a stable environment for counting and
sizing blood cells. Only use one time. Don't use reagent out off date.
【ACTIVE INGREDIENTS】
Sodium Chloride……………………………………3.0-5.5g/L
Sodium Sulfate Anhydrous………………………7.5-11.5g/L
Buffering Agents……………………………………1.0-3.0g/L
Anti-fungal and Anti-bacterial Agents………....…0.8-2.5g/L
【PRODUCT SPECIFICATIONS】
1.
Appearance:
Transparent
liquid
without
deposits,
suspended grains or flocks.
2.
Blank count results: The blank count results tested on
the matched Auto Hematology Analyzer shall meet the
requirements of Table 1.
Table 1 Blank Count Requirements
Parameter
Blank Count Requirements
WBC
≤0.3×10 /L
RBC
≤0.03×10 /L
PLT
≤10×10 /L
HGB
1g/L
9
12
9
【STORAGE AND EXPIRATION DATE】
The product will be stable for 2 years when stored at 2℃ to
30℃(35℉ to 86℉).
The product should be used at 15℃ to 30℃(59℉ to 86℉) once
opened, and it is stable for 60 days.
【APPLICABLE INSTRUMENT】
This
product
applies
to
BC-5600
and
BC-5800
Auto
Hematology Analyzer produced by Shenzhen Mindray BioMedical Electronics Co., Ltd.
【INSTRUCTIONS FOR USE】
Unpack the reagent container. Insert the pickup pipe from the
analyzer's cap assembly into the container, making sure the
container's cap and the connected assembly connector are in
the same color. Turn and secure the cap assembly tightly, and
replace the reagent in accordance with the instructions in the
Operator's Manual of the analyzer. For detailed usage
instruction, please refer to the Operator's Manual of the
analyzer.
【WARNINGS】
Do not inhale and/or ingest. In case of inhalation or ingestion,
seek medical advice immediately. Avoid skin contact. In case of
skin contact, flush the affected area with plenty of water
immediately. Avoid eye contact. In case of eye contact, flush