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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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