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Specifications
B.1
Classification
According to the CE classification, the BC-3000 Plus is an In Vitro Diagnostic device.
B.2
Reagents
Diluent
M-30D DILUENT
Rinse
M-30R RINSE
Lyse
M-30CFL LYSE
E-Z Cleanser
Enzyme cleanser
M-30E E-Z CLEANSER
Probe Cleanser
M-30P PROBE CLEANSER
B.3
Parameters
Table 12-1 Direct ly m easured parameters and hist ograms
Parameter
Abbr eviation
Default Unit
White Blood Cell or leukocyte
WBC
10 /L
Red Blood Cell or erythrocyte
RBC
10 /L
Hemoglobin Concentration
HGB
g/L
Platelet
PLT
10 /L
WBC histogram
WBC Histogram
RBC histogram
RBC Histogram
PLT histogram
PLT Histogram
12
Table 12-2 Parameters d erived f rom his togr ams

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Table 12-2 Parameters d erived f rom his togr ams
Parameter
Abbr eviation
Default Unit
Lymphocyte percentage
Lymph%
Mid-sized cell percentage
Mid%
Granulocyte percentage
Gran%
Mean Corpuscular Volume
MCV
fL
Red Blood Cell Distribution Width Coefficient of
RDW-CV
Red Blood Cell Distribution Width Standard Deviation

Mean Platelet Volume
RDW-SD
MPV
fL
fL
Platelet Distribution Width
PDW
B-1
Appendices
Table 12-3 Calculated parameters
Parameter
Abbr eviation
Default Unit
Lymphocyte
Lymph#
10 /L
Mid-sized cell
Mid#
10 /L
Granulocyte
Gran#
10 /L
Hematocrit
HCT
Mean Cell Hemoglobin
MCH
pg
Mean Cell Hemoglobin Concentration
MCHC
g/L
Mean Platelet Volume
PCT
B.4
9
9
9
Samplin g Features
B.4.1 Sample volum es requir ed for each analys is

Whole Blood Mode (vein blood)
13 L
Prediluted Mode (capillary blood)
20 L
B.4.2 Lyse used for every analys is

Whole blood
0.5 mL
Prediluted
0.36mL
B.4.3 Diluti on rate

WBC/HGB
RBC/PLT
Whole blood
1:308
1:44872
Prediluted
1:428
1:43355
B.4.4 Apertu re size

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Diameter
Length
WBC
100 m
70 m
RBC
70 m
65 m
B.4.5 Throughput
Less than 1 minute / analysis
B-2
Appendices
B.5
Perfo rmance specification s
B.5.1 Operating range

Parameter
Operatin g range
0.0 - 999.9
12
RBC (10 /L)
0.00 - 9.99
HGB (g/L)
0 - 300
MCV (fL)
0.0 - 250.0
WBC (10 /L)
PLT (10 /L)
0 - 2999
B.5.2 Normal backgro und

Parameter
Backgr ound result
WBC
0.3 10 / L
RBC
0.03 10 / L
HGB
1g/L
HCT
0.5 %
PLT
10 10 / L
12
B.5.3 Linearit y range

Parameter
9
WBC (10 /L)

12
Linearity range
0.3 - 99.9
RBC (10 /L)
0.20 - 8.00
HGB (g/L)
10 - 250
PLT (10 /L)
10 - 999
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B-3
Appendices
B.5.4
Reproducibility
These reproducibility requirements applies only to the situation in which 11 normal-level

controls have been run and the results of the 2nd to 11th runs are used to calculate the
reproducibilities.
Parameter
Reproducibility CV%
Condition
9
WBC
7.0 - 15.0 10 / L
12
2.5
RBC
3.50 - 6.00 10 / L
2.0
HGB
110 - 180 g/L
1.5
MCV
80.0 - 110.0 fL
PLT
B.5.5
0.5
9
150 - 500 10 / L
Carryover
Parameter
Carryover
WBC
0.5 %
RBC
0.5 %
HGB
0.5 %
PLT
1%
B.6
5.0
Input/output device
Be sure to use the specified devices only.
B.6.1 Display
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B.6.1 Display
Color LCD, 10.2, 800600.
B.6.2 Keypad
23-key keypad.
B.6.3 Keyboard
PS/2 keyboard.
B-4
Appendices
B.6.4 Bar-co de scann eroptioanl

TYSSO CCD-82 scanner.
B.6.5 Recorder
Built-in thermal recorder that supports two printing formats and auto printing.
B.6.6 Printeroptional
EPSON LQ-300K+.
B.6.7 Interfaces
A keyboard interface.
Two RS-232 interfaces (maximum transmission distance 12 meters);
A parallele port(for printer or floppy disk drive);
A power supply for the floppy disk driveonly to be used with the power cable supplied by
Mindray .
B.7
Power supply
Voltage:AC 100 V 240 V;
Frequency: 50/60 Hz;
Input power: 180 VA;
Fuse:AC 250 V T4 A.
Be sure to use the fuse of the specified type and rating.
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B.8
EMC Description
The product is subject to the EMC test as required by EN61326:1997+A1 1998+A2
2001+A3 2003;
EMS is compliance with experiment environment;

EMC is compliance with Class A.
B-5
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According to the CE classification, the BC-3000 Plus is an In Vitro Diagnostic device.

M-30E E-Z CLEANSER

M-30P PROBE CLEANSER

White Blood Cell or leukocyte

Red Blood Cell or erythrocyte

Table 12-2 Parameters d erived f rom his togr ams

Mid-sized cell percentage

Mean Corpuscular Volume

Red Blood Cell Distribution Width Coefficient of

Red Blood Cell Distribution Width Standard Deviation

Platelet Distribution Width

Mean Cell Hemoglobin

Mean Cell Hemoglobin Concentration

Mean Platelet Volume

B.4.1 Sample volum es requir ed for each analys is

Prediluted Mode (capillary blood)

B.4.2 Lyse used for every analys is

B.4.3 Diluti on rate

B.4.4 Apertu re size

Perfo rmance specification s

B.5.1 Operating range

RBC (10 /L)

WBC (10 /L)

PLT (10 /L)

B.5.2 Normal backgro und

Backgr ound result

B.5.3 Linearit y range

WBC (10 /L)

RBC (10 /L)

PLT (10 /L)

These reproducibility requirements applies only to the situation in which 11 normal-level

110 - 180 g/L

Be sure to use the specified devices only.

B.6.4 Bar-co de scann eroptioanl

Two RS-232 interfaces (maximum transmission distance 12 meters);

A parallele port(for printer or floppy disk drive);

Voltage:AC 100 V 240 V;

Frequency: 50/60 Hz;

Input power: 180 VA;

Be sure to use the fuse of the specified type and rating.

The product is subject to the EMC test as required by EN61326:1997+A1 1998+A2

EMS is compliance with experiment environment;

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