User Manual

Code Name Description Value type OBX-3 FIELD

Standard deviation of red
2023 V_RDW_SD NM 2023^V_RDW_SD
blood cell distribution width
Red blood cell distribution
2024 V_RDW_CV NM 2024^V_RDW_CV
width variation coefficient
2025 V_PLT Number of platelet NM 2025^V_PLT
2026 V_MPV Average platelet volume NM 2026^V_MPV
2027 V_PCT Platelet hematocrit NM 2027^V_PCT
2028 V_PDW Platelet distribution width NM 2028^V_PDW
2029 V_P_LCR Platelet-large cell ratio NM 2029^V_P_LCR
2030 V_P_LCC Platelet-large cell count NM 2030^V_ P_LCC
2031 V_CRP C reactive protein NM 2031^V_CRP
Hypersensitive C-reactive
2032 V_HS_CRP ST 2032^V_HS_CRP
protein
RBC histogram PNG data
Remark: in transmission
RBC

D
2101 from median computer to ED 2101^RBC Scattergram.PNG
Histogram.PNG

LT
LIS, the picture format is
PNG
PLT histogram PNG data

.,
Remark: in transmission
PLT
2102 from median computer to ED 2102^PLT Scattergram.PNG
Histogram.PNG
LIS, the picture format is
PNG
CO
BASO scattergram PNG
AL

data
BASO Remark: in transmission
2033 ED 2033^BASO Scattergram.PNG
I

Scattergram.PNG from median computer to

TR

LIS, the picture format is

PNG
S

DIFF scattergram PNG data

Remark: in transmission
DU

DIFF
2034 from median computer to ED 2034^DIFF Scattergram.PNG
Scattergram.PNG
LIS, the picture format is
IN

PNG
Original data
Remark: used in
2035 Dat1 data ED 2035^Dat1
I

transmission from median

RU

computer to host computer

Original data
DI

Remark: used in
2036 Dat2 data ED 2036^Dat2
transmission from median
computer to host computer
Original data
Remark: used in
2037 Dat3 data ED 2037^Dat3
transmission from median
computer to host computer
Original data
Remark: used in
2038 Dat4 data ED 2038^Dat4
transmission from median
computer to host computer

obx_value_type = {“2001^MODE”, “2002^MODE_EX”, “2003^Ref”,

“2004^Note”, “2005^Level”, “2006^V_WBC”,”2007^V_NEU_p”,
“2008^V_LYM_p”,”2009^V_MON_p”,”2010^V_EOS_p”, “2011^V_BAS_p”,
“2012^V_NEU_c”, “2013^V_LYM_c”, “2014^V_MON_c”,”2015^V_EOS_c”,”2016^V_BAS_c”,
“2017^V_RBC”, “2018^V_HGB”, “2019^V_MCV”,”2020^V_HCT”,
“2021^V_MCH”, “2022^V_MCHC”, “2023^V_RDW_SD”,”2024^V_RDW_CV”,
“2025^V_PLT”, “2026^V_MPV”, “2027^V_PDW”,

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 User Manual

“2028^V_PCT”, “2029^V_P_LCR”, “2030^V_P_LCC”,”2031^V_CRP”,”2101^RBC

Scattergram.BMP”,”2102^PLT Scattergram.BMP”,
“2033^BASO Scattergram.BMP”,”2034^DIFF Scattergram.BMP”, “2079^XB_Num”
list[0] = refence.wbcU;
list[1] = refence.rbcU;
list[2] = refence.hgbU;
list[3] = refence.hctU;
list[4] = refence.mcvU;
list[5] = refence.mchU;
list[6] = refence.mchcU;
list[7] = refence.pltU;
list[8] = refence.rdwSDU;
list[9] = refence.rdwCVU;
list[10] = refence.pdwU;
list[11] = refence.mpvU;

D
list[12] = refence.plcrU;

LT
list[13] = refence.plcrsU;

.,
list[14] = refence.pctU;
list[15] = refence.neuCU; CO
list[16] = refence.lymCU;
list[17] = refence.monCU;
AL

list[18] = refence.eosCU;
I

list[19] = refence.basCU;
TR

list[20] = refence.neuPU;
S

list[21] = refence.lymPU;
DU

list[22] = refence.monPU;
list[23] = refence.eosPU;
IN

list[24] = refence.basPU;
list[25] = refence.crpU;
I
RU

B.8 Enumeration type list

Data item Value
DI

0-Whole blood/Closed whole blood 1-Trace whole blood 2-Predilution 3-Automatic whole
Analysis mode
blood
Measurement mode 0- CBC 1-CBC+DIFF 2-CBC+DIFF+CRP 3-CRP 4-CBC+CRP
0 - Normal 1 - Male 2 - Female 3 - Child 4 - Newborn 5 -Self-defined 16- Self-defined 27
Reference group -Self-defined 38 -Self-defined 4
9 -Self-defined 5
QC level 0-high 1-middle 2-low

Example of a complete message section:

(1)Patient sample
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153322||ORU^R01|3|P|2.3.1||||||UTF-8<cr>
PID|1|||||||U|||||||||||||||||||||||1^Y<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1||5|1001^CountResults||20180601091634|20180601091637|||||||20180601091634||||||---||||||||<cr>
OBX|1|IS|2001^MODE||0||||||F||<cr>

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 User Manual

OBX|2|IS|2002^MODE_EX||1||||||F||<cr>
OBX|3|IS|2003^Ref||0||||||F||<cr>
OBX|4|IS|2004^Note||||||||F||<cr>
OBX|5|NM|2006^V_WBC||0|10^9/L|4-10||||F||<cr>
OBX|6|NM|2007^V_NEU_p||0|%|50-70||||F||<cr>
OBX|7|NM|2008^V_LYM_p||0|%|20-40||||F||<cr>
OBX|8|NM|2009^V_MON_p||0|%|3-8||||F||<cr>
OBX|9|NM|2010^V_EOS_p||0|%|0.5-5||||F||<cr>
OBX|10|NM|2011^V_BAS_p||0|%|0-1||||F||<cr>
OBX|11|NM|2012^V_NEU_c||0|10^9/L|2-7||||F||<cr>
OBX|12|NM|2013^V_LYM_c||0|10^9/L|0.8-4||||F||<cr>
OBX|13|NM|2014^V_MON_c||0|10^9/L|0.12-0.8||||F||<cr>
OBX|14|NM|2015^V_EOS_c||0|10^9/L|0.02-0.5||||F||<cr>
OBX|15|NM|2016^V_BAS_c||0|10^9/L|0-0.1||||F||<cr>
OBX|16|NM|2017^V_RBC||0|10^12/L|3.5-5.5||||F||<cr>

D
LT
OBX|17|NM|2018^V_HGB||1|g/L|110-160||||F||<cr>
OBX|18|NM|2019^V_MCV||0|fL|80-100||||F||<cr>

.,
OBX|19|NM|2020^V_HCT||0|L/L|0.35-0.5||||F||<cr>
OBX|20|NM|2021^V_MCH||0|pg|27-34||||F||<cr>
OBX|21|NM|2022^V_MCHC||0|g/L|320-360||||F||<cr>
CO
OBX|22|NM|2023^V_RDW_SD||0|fL|35-56||||F||<cr>
AL

OBX|23|NM|2024^V_RDW_CV||0|%|11-16||||F||<cr>
I

OBX|24|NM|2025^V_PLT||0|10^9/L|100-300||||F||<cr>
TR

OBX|25|NM|2026^V_MPV||0|fL|7-13||||F||<cr>
S

OBX|26|NM|2027^V_PCT||0|%|0.1-0.28||||F||<cr>
DU

OBX|27|NM|2028^V_PDW||0|fL|15-18||||F||<cr>
IN

OBX|28|NM|2029^V_P_LCR||0|%|13-43||||F||<cr>
OBX|29|NM|2030^V_P_LCC||0|10^9/L|13-129||||F||<cr>
OBX|30|NM|2031^V_CRP||0|mg/L|0-6||||F||<cr>
I
RU

OBX|31|ST|2032^V_HS_CRP||0.00|mg/L|0-6||||F||<cr>
OBX|32|ED|2101^V_RBCScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>
DI

OBX|33|ED|2102^V_PLTScattergram.PNG||……PNG binary data converted into BASE64 coding……||||||F||<cr>

OBX|34|ED|2033^V_BASOScattergram.PNG||……PNG binary data converted into BASE64
coding……||||||F||<cr>
OBX|35|ED|2034^V_DIFFScattergram.PNG||……PNG binary data converted into BASE64
coding……||||||F||<cr>
<EB><CR>
Special instructions:
When the median computer sends sample results to LIS, all items are sent by default. The LIS terminal needs to
filter and display according to different measurement modes and the items of concern. The following shows the
default display items in different measurement modes.
Measurement mode 2002^MODE_EX
Code Name OBX-3 FIELD 1-CBC 2-CBC+DIFF 4-CBC
0-CBC 3-CRP
+DIFF +CRP +CRP
2006 V_WBC 2006^V_WBC √ √ √ × √

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 User Manual

Measurement mode 2002^MODE_EX

Code Name OBX-3 FIELD 1-CBC 2-CBC+DIFF 4-CBC
0-CBC 3-CRP
+DIFF +CRP +CRP
2007 V_NEU_p 2007^V_NEU_p × √ √ × ×
2008 V_LYM_p 2008^V_LYM_p × √ √ × ×
2009 V_MON_p 2009^V_MON_p × √ √ × ×
2010 V_EOS_p 2010^V_EOS_p × √ √ × ×
2011 V_BAS_p 2011^V_BAS_p × √ √ × ×
2012 V_NEU_c 2012^V_NEU_c × √ √ × ×
2013 V_LYM_c 2013^V_LYM_c × √ √ × ×
2014 V_MON_c 2014^V_MON_c × √ √ × ×
2015 V_EOS_c 2015^V_EOS_c × √ √ × ×
2016 V_BAS_c 2016^V_BAS_c × √ √ × ×
2017 V_RBC 2017^V_RBC √ √ √ × √

D
LT
2018 V_HGB 2018^V_HGB √ √ √ × √
2019 V_MCV 2019^V_MCV √ √ √ × √

.,
2020 V_HCT 2020^V_HCT √ √ √ × √
2021 V_MCH 2021^V_MCH √ √ CO √ × √
2022 V_MCHC 2022^V_MCHC √ √ √ × √
AL

2023^V_RDW_S
2023 V_RDW_SD √ √ √ × √
D
I

2024^V_RDW_C
2024 V_RDW_CV √ √ √ × √
TR

V
2025 V_PLT 2025^V_PLT √ √ √ × √
S
DU

2026 V_MPV 2026^V_MPV √ √ √ × √

2027 V_PCT 2027^V_PCT √ √ √ × √
IN

2028 V_PDW 2028^V_PDW √ √ √ × √

2029 V_P_LCR 2029^V_P_LCR √ √ √ × √
I
RU

2030 V_P_LCC 2030^V_ P_LCC √ √ √ × √

2031 V_CRP 2031^V_CRP × × √ √ √
DI

2032 V_HS_CRP 2032^V_HS_CRP × × √ √ √

RBC
2101^RBC
2101 Histogram.P √ √ √ × √
Scattergram.PNG
NG
PLT
2102^PLT
2102 Histogram.P √ √ √ × √
Scattergram.PNG
NG
BASO
2033^BASO
2033 Scattergram. √ √ √ × √
Scattergram.PNG
PNG
DIFF
2034^DIFF
2034 Scattergram. × √ √ × ×
Scattergram.PNG
PNG

(2)L-J QC
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153445||ORU^R01|5|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>

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 User Manual

OBR|1|||1||1002^LJQC|20180420|||20180420113307||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||465.11|10^9/L|490-510||||F||<cr>
OBX|3|NM|2007^V_NEU_p||0|%|0-0||||F||<cr>
OBX|4|NM|2008^V_LYM_p||0|%|0-0||||F||<cr>
OBX|5|NM|2009^V_MON_p||0|%|0-0||||F||<cr>
OBX|6|NM|2010^V_EOS_p||0|%|0-0||||F||<cr>
OBX|7|NM|2011^V_BAS_p||0|%|0-0||||F||<cr>
OBX|8|NM|2012^V_NEU_c||0|10^9/L|0-0||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0|10^9/L|0-0||||F||<cr>
OBX|10|NM|2014^V_MON_c||0|10^9/L|0-0||||F||<cr>
OBX|11|NM|2015^V_EOS_c||0|10^9/L|0-0||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0|10^9/L|0-0||||F||<cr>
OBX|13|NM|2017^V_RBC||3.94|10^12/L|0-0||||F||<cr>
OBX|14|NM|2018^V_HGB||110|g/L|0-0||||F||<cr>

D
LT
OBX|15|NM|2019^V_MCV||87.6|fL|0-0||||F||<cr>
OBX|16|NM|2020^V_HCT||0.345|L/L|0-0||||F||<cr>

.,
OBX|17|NM|2021^V_MCH||27.9|pg|0-0||||F||<cr>
OBX|18|NM|2022^V_MCHC||319|g/L|0-0||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||51.2|fL|0-0||||F||<cr>
CO
OBX|20|NM|2024^V_RDW_CV||15|%|0-0||||F||<cr>
AL

OBX|21|NM|2025^V_PLT||135|10^9/L|0-0||||F||<cr>
I

OBX|22|NM|2026^V_MPV||12.2|fL|0-0||||F||<cr>
TR

OBX|23|NM|2027^V_PCT||0.165|%|0-0||||F||<cr>
S

OBX|24|NM|2028^V_PDW||19.2|fL|0-0||||F||<cr>
DU

OBX|25|NM|2029^V_P_LCR||42.5|%|0-0||||F||<cr>
IN

<EB><CR>
(3)XBar QC data sending
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153445||ORU^R01|5|Q|2.3.1||||||UTF-8<cr>
I
RU

PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
DI

OBR|1|||1||1003^XbarQC|20180420|||20180420113307||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||465.11|10^9/L|490-510||||F||<cr>
OBX|3|NM|2007^V_NEU_p||0|%|0-0||||F||<cr>
OBX|4|NM|2008^V_LYM_p||0|%|0-0||||F||<cr>
OBX|5|NM|2009^V_MON_p||0|%|0-0||||F||<cr>
OBX|6|NM|2010^V_EOS_p||0|%|0-0||||F||<cr>
OBX|7|NM|2011^V_BAS_p||0|%|0-0||||F||<cr>
OBX|8|NM|2012^V_NEU_c||0|10^9/L|0-0||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0|10^9/L|0-0||||F||<cr>
OBX|10|NM|2014^V_MON_c||0|10^9/L|0-0||||F||<cr>
OBX|11|NM|2015^V_EOS_c||0|10^9/L|0-0||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0|10^9/L|0-0||||F||<cr>

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 User Manual

OBX|13|NM|2017^V_RBC||3.94|10^12/L|0-0||||F||<cr>
OBX|14|NM|2018^V_HGB||110|g/L|0-0||||F||<cr>
OBX|15|NM|2019^V_MCV||87.6|fL|0-0||||F||<cr>
OBX|16|NM|2020^V_HCT||0.345|L/L|0-0||||F||<cr>
OBX|17|NM|2021^V_MCH||27.9|pg|0-0||||F||<cr>
OBX|18|NM|2022^V_MCHC||319|g/L|0-0||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||51.2|fL|0-0||||F||<cr>
OBX|20|NM|2024^V_RDW_CV||15|%|0-0||||F||<cr>
OBX|21|NM|2025^V_PLT||135|10^9/L|0-0||||F||<cr>
OBX|22|NM|2026^V_MPV||12.2|fL|0-0||||F||<cr>
OBX|23|NM|2027^V_PCT||0.165|%|0-0||||F||<cr>
OBX|24|NM|2028^V_PDW||19.2|fL|0-0||||F||<cr>
OBX|25|NM|2029^V_P_LCR||42.5|%|0-0||||F||<cr>
<EB><CR>
(4)XBar-R QC data sending

D
LT
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153516||ORU^R01|6|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>

.,
PV1|1|||||||||||||||||||<cr>
CO
OBR|1|||1||1006^XbarRQC|20180420|||20180420124717||||||||||||||||||<cr>
OBX|1|IS|2005^Level||1||||||F||<cr>
OBX|2|NM|2006^V_WBC||739.805^512.27|10^9/L|||||F||<cr>
AL

OBX|3|NM|2007^V_NEU_p||0^0|%|||||F||<cr>
I

OBX|4|NM|2008^V_LYM_p||0^0|%|||||F||<cr>
TR

OBX|5|NM|2009^V_MON_p||0^0|%|||||F||<cr>
S

OBX|6|NM|2010^V_EOS_p||0^0|%|||||F||<cr>
DU

OBX|7|NM|2011^V_BAS_p||0^0|%|||||F||<cr>
IN

OBX|8|NM|2012^V_NEU_c||0^0|10^9/L|||||F||<cr>
OBX|9|NM|2013^V_LYM_c||0^0|10^9/L|||||F||<cr>
OBX|10|NM|2014^V_MON_c||0^0|10^9/L|||||F||<cr>
I
RU

OBX|11|NM|2015^V_EOS_c||0^0|10^9/L|||||F||<cr>
OBX|12|NM|2016^V_BAS_c||0^0|10^9/L|||||F||<cr>
DI

OBX|13|NM|2017^V_RBC||5.79^0.0799999|10^12/L|||||F||<cr>
OBX|14|NM|2018^V_HGB||157.5^3|g/L|||||F||<cr>
OBX|15|NM|2019^V_MCV||80.2^0.200005|fL|||||F||<cr>
OBX|16|NM|2020^V_HCT||0.4645^0.005|L/L|||||F||<cr>
OBX|17|NM|2021^V_MCH||27.15^0.700001|pg|||||F||<cr>
OBX|18|NM|2022^V_MCHC||339^8|g/L|||||F||<cr>
OBX|19|NM|2023^V_RDW_SD||38.4^0|fL|||||F||<cr>
OBX|20|NM|2024^V_RDW_CV||13.3^0|%|||||F||<cr>
OBX|21|NM|2025^V_PLT||241.5^25|10^9/L|||||F||<cr>
OBX|22|NM|2026^V_MPV||11.15^1.3|fL|||||F||<cr>
OBX|23|NM|2027^V_PCT||0.2705^0.057|%|||||F||<cr>
OBX|24|NM|2028^V_PDW||15.2^3.6|fL|||||F||<cr>
OBX|25|NM|2029^V_P_LCR||33.55^8.5|%|||||F||<cr>

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<EB><CR>
(5)X-B QC data sending
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153529||ORU^R01|7|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1|||||1004^XBQC||||20180426110445||||||||||||||||||<cr>
OBX|1|NM|2019^V_MCV||97.245|fL|60-100||||F||<cr>
OBX|2|NM|2021^V_MCH||30.735|pg|0-87||||F||<cr>
OBX|3|NM|2022^V_MCHC||316.4|g/L|280-320||||F||<cr>
<EB><CR>
(6)CRP QC data sending
<SB>MSH|^~&|BF-6900||LIS||20190822095204||ORU^R01|4|Q|2.3.1||||||UTF-8<cr>
PID|1||||||||||||||||||||||||||||||^<cr>
PV1|1|||||||||||||||||||<cr>
OBR|1|122|1|1005^CRPQC||20190802|20190802134916|||||||||||||||||||||<cr>

D
LT
OBX|1|IS|2005^Level||0||||||F||<cr>
OBX|2|NM|2031^V_CRP||0.03|mg/L|0-2||||F||<cr>

.,
<EB><CR>
(7)Work order application CO
<SB>MSH|^~&|BF-6900|20180613001|LIS||20110613153408||ORM^O01|4|P|2.3.1||||||UTF-8<cr>
ORC|RF||218||IP<cr>
AL

<EB><CR>
I

(8)Work order obtaining

TR

<SB>MSH|^~\&|LIS||||20180613154025||ORR^O02|4|P^S|2.3.1||||||UTF8<cr>
S

MSA|AA|1||||0<cr>
DU

PID|1||5||T5|||M|||||||||||||||||||||||3^Y<cr>
IN

PV1|1||Orthopedics|||||||||||||||||Medical insurance<cr>
ORC|AF|218|||<cr>
OBR|1|218|5|1001^Count ||20180613153909||||Gu Yisheng||||20180613153919||||||||||||||<cr>
I
RU

OBX|1|IS|2001^MODE||0||||||||<cr>
OBX|2|IS|2002^MODE_EX||0||||||||<cr>
DI

OBX|3|IS|2003^Ref||0||||||||<cr>
OBX|4|ST|2004^Note||test||||||||<cr>
<EB><CR>
(9)Sample and quality control response
<SB>MSH|^~\&|LIS||||20190819160739||ACK^R01|2|P|2.3.1||||||UTF8<cr>
MSA|AA|1||||0<cr>
<EB><CR>

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 User Manual

Appendix C Product description

C.1 Product classification
According to Product Classification Catalog of Medical Devices:
The Analyzer is a blood analyzer belonging to clinical analyzers (6840), and the management class is Class II.
C.2 Product matching reagent
(1)BF-5D diluent
(2)BF-FDT I lyse
(3)BF- FBH lyse
(4)BF-FDO I lyse
C.3 Consumption of product matching reagent
Necessary operations of the instrument Consumption
Sleep (not used for 2 hours) BF-5D diluent 48mL
Wake BF-5D diluent 70mL

D
BF-5D diluent 65mL

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Manual washing capability
Probe cleanser 3mL

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BF-5D diluent 65mL
Automatic rinsing of equipment (setting times of 10-200)
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Probe cleanser 3mL
BF-5D diluent 185mL
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BF-FDOⅠ lyse 1mL

Turn-on
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BF-FDTⅠ lyse 0.12mL

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BF-FBH lyse 3.1mL

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BF-5D diluent 65mL

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Turn-off
Probe cleanser 3mL
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Operations of the instrument during servicing Consumption

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Rinse WBC cell BF-5D diluent 9mL

Rinse RBC cell BF-5D diluent 13mL
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Rinse sheath flow cell BF-5D diluent 14mL

Rinse sample-aspirating probe BF-5D diluent 12mL
Unblocking BF-5D diluent 9mL
Back washing BF-5D diluent 9mL
BF-5D diluent 13mL
Soak WBC
Probe cleanser 0.7mL
BF-5D diluent 20mL
Soak RBC
Probe cleanser 2.3mL
BF-5D diluent 16mL
Soak sheath flow cell
Probe cleanser 4mL

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Operations of the instrument during

Reagent volume for filling/rinsing pipes
servicing
BF-5D diluent 9mL
Fill BF-FDOⅠ lyse (after drainage)
BF-FDOⅠ lyse 10mL
BF-5D diluent 9mL
Fill BF-FDTⅠ lyse (after drainage)
BF-FDTⅠ lyse 5mL
BF-5D diluent 9mL
Fill BF-FBH lyse (after drainage)
BF-FBH lyse 10mL
Fill BF-5D diluent (after drainage) BF-5D diluent 108mL
BF-5D diluent 9mL
Replace BF-FDOⅠ lyse
BF-FDOⅠ lyse 10mL
BF-5D diluent 9mL
Replace BF-FDTⅠ lyse BF-FDTⅠ lyse 5mL
BF-FDOⅠ lyse 2mL

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BF-5D diluent 9mL
Replace BF-FBH lyse
BF-FBH lyse 9mL

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Replace BF-5D diluent BF-5D diluent 108mL
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Reagent consumption for one-time test
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BF-5D diluent (whole-blood) 56mL

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BF-FBH lyse 0.6mL

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BF-FDOⅠ lyse 0.5mL

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BF-FDTⅠ lyse 0.12mL

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C.4 Description of parameters

(1)Parameters from scattergram/histogram
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Name Abbreviations Default unit

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Percentage of lymphocyte LYM% %

Percentage of monocyte MON% %

Percentage of basophil BAS% %

Percentage of eosinophil EOS% %

Mean red blood cell volume MCV fL

Red blood cell distribution width
RDW-CV %
variation coefficient
Red blood cell distribution width
RDW-SD fL
deviation limit
Average platelet volume MPV fL

Platelet distribution width PDW %

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(2)Parameter from calculation

Name Abbreviations Default unit
Percentage of neutrophil NEU% %
Number of lymphocyte LYM# 109／L
Number of monocyte MON# 109／L
Number of neutrophil NEU# 109／L
Number of basophil BAS# 109／L
Number of eosinophil EOS# 109／L
RBC hematocrit HCT L ／L
Mean red blood cell hemoglobin content MCH pg
Mean red blood cell hemoglobin
MCHC g／L
concentration
Platelet hematocrit PCT %

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Appendix D Performance indexes

D.1 Blank counting
(1)RBC≤0.02×1012/L;
(2)WBC≤0.2×109/L;
(3)HGB≤1g/L;
(4)PLT≤5×109/L;
D.2 Linearity
The linear range and deviation of the Analyzer shall conform to Table D-2-1:
Table D-2-1 Linear requirements of the Analyzer
Linearly dependent
Parameters Linear range Allowable deviation range
coefficient (r)
(0~10.0)×109/L Not exceeding ±0.3×109/L
WBC (10.1~100.0)×109/L Not exceeding ±5.0% ≥0.990
9
(100.1~500.0)×10 /L Not exceeding ±10.0%

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12
Not exceeding ±0.03×1012/L

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(0~1.00)×10 /L
RBC ≥0.990
(1.01~8.00)×1012/L Not exceeding ±3.0%

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(0~70) g/L Not exceeding ±2.0g/L
HGB ≥0.990
(71~240) g/L
(0~100)×109/L
CO
Not exceeding ±2.0%
Not exceeding ±10.0×109/L
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PLT (101~1000)×109/L Not exceeding ±5.0% ≥0.990

9/
(1001~5000)×10 L Not exceeding ±10.0%
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D.3 Precision
The precision of the Analyzer shall conform to Table D-3-1.
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Table D-3-1 Requirements on precision of the Analyzer

Parameters Detection range Precision

IN

9
(3.5~9.5)×10 /L ≤2.5%
WBC 9
(9.6~15.0)×10 /L ≤2.5%
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12
(3.50~5.50)×10 /L ≤1.5%
RBC 12
(5.51~6.50)×10 /L ≤1.5%
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(110~160) g/L ≤1.5%

HGB
(161~180) g/L ≤1.5%
9
(100~149)×10 /L ≤5.0%
PLT 9
(150~500)×10 /L ≤4.0%
HCT (30~50)% ≤1.5%
(70~100）fL ≤1.0%
MCV
(101~120）fL ≤1.0%

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D.4 Accuracy
The accuracy deviation of the Analyzer shall conform to Table D-4-1:
Table D-4-1 Requirements on accuracy of the Analyzer

Parameters Detection range Allowable deviation range

9
WBC (3.5~9.5)×10 /L Not exceeding ±4.5%
12
RBC (3.80~5.80)×10 /L Not exceeding ±3.0%
HGB (115~175) g/L Not exceeding ±3.0%
9
PLT (125~350)×10 /L Not exceeding ±7.0%
(35~50)%(HCT)
HCT or MCV Not exceeding ±3.0%
Or (82~100)fL(MCV)

D.5 Accuracy of classification of white blood cell by the Analyzer

The test result of neutrophil, lymphocyte, monocyte, acidophil and basophil shall be limited in the allowable range
of the test method setting result of the Analyzer (99% credibility interval).
Note: if the reference test result is 0 and the result of the Analyzer is ≤1.0%, the test result is also acceptable.

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D.6 Carrying pollution rate

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The carrying pollution rate of the Analyzer shall meet the following requirements:
(1)RBC≤0.5%.

.,
(2)WBC≤0.5%.
(3)HGB≤0.5%. CO
(4)PLT≤0.5%.
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Appendix E Parts list

Parts list (including parts, accessories and consumables)
Replacement Replacement
Part name Location Remarks
cycle method
Please contact This part can be
Sample-aspirating Sample-aspirating Test of 30,000
customer service checked/replaced by the
syringe pump syringe unit samples
personnel manufacturer/agency only
Please contact This part can be
Sheath syringe Test of 30,000
Sheath syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only
Please contact This part can be
BF-FDOⅠ Test of 30,000
Sheath syringe unit customer service checked/replaced by the
syringe pump samples
personnel manufacturer/agency only
Please contact This part can be
BF-FBH syringe Test of 30,000
Rinse syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only
Please contact This part can be
Rinse syringe Test of 30,000
Rinse syringe unit customer service checked/replaced by the
pump samples
personnel manufacturer/agency only

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Sampling probe Sampling unit 100,000 samples 9.4.1
3000 hours Please contact This part can be

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Positive pressure
Pump unit (Continuous customer service checked/replaced by the
pump
work) personnel manufacturer/agency only

Vacuum pump Pump unit

2000 hours
(Continuous
CO
Please contact
customer service
This part can be
checked/replaced by the
work) personnel manufacturer/agency only
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10,000/hour Please contact This part can be

W-B reaction cell
HGB light source (Continuous customer service checked/replaced by the
unit
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work) personnel manufacturer/agency only

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Appendix F Statement on electromagnetic compatibility

1. For requirements of immunity refer to Table F-1.
Table F-1 Requirements of Electromagnetic Compatibility Immunity Test

Standard requirements

EMC Applicable Performance

Port Test items Test value
standard or not criterion

Electrostatic Air discharge: 2kV, 4kV, 8kV

IEC 61000-4-2 Applicable B
discharge (ESD) Contact discharge: 2kKV, 4kV

Radiated
electromagnetic IEC 61000-4-3 3V/m, 80MHz~2.0GHz, 80%AM Applicable A
Shell
fields

Rated
power-frequency IEC 61000-4-8 3A/m, 50Hz Applicable A

D
magnetic field

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0% for 1 cycle; B
IEC

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Voltage sag 40% for 5/6 cycles; Applicable B
61000-4-11
70% for 25/30 cycles C
Voltage
interruption
IEC
61000-4-11
CO
5%, duration: 250/300 cycles Applicable C
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AC power
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) Applicable B
supply
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Surge IEC 61000-4-5 Line to ground: 2kV/line to line: 1kV Applicable B

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Radio-frequency
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IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM Applicable A

conduction
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Not
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) --
applicable
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DC power Line to ground: 2kV/line to ground: Not

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Surge IEC 61000-4-5 --

supply 1kV applicable
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Radio-frequency Not
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM --
conduction applicable

Not
Pulse train IEC 61000-4-4 0.5kV(5/50ns, 5kHz) --
applicable

Not
I/O signal Surge IEC 61000-4-5 None --
applicable

Radio-frequency
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM Applicable A
conduction

Not
Pulse train IEC 61000-4-4 1kV(5/50ns, 5kHz) --
applicable
I/O signal
Not
to main Surge IEC 61000-4-5 None --
applicable
power
Radio-frequency Not
IEC 61000-4-6 3V, 150kHz~80MHz, 80%AM --
conduction applicable

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2. For emission test requirements refer to Table F-2.

Table F-2 Emission Test Items & Requirements

Applicable
Test items EMC standard Test value
or not
Pst value is not greater than 1.0; Plt value is not greater than 0.65;
duration ford(t) value exceeding 3.3% in voltage change period is
Voltage fluctuation
IEC 61000-3-3 nolonger than 500ms; change of relative steady-state voltage (dc) No
and flicker
does not exceed 3.3%; and relative maximum voltage change
(dmax) does not exceed 6%.

Harmonic current It is 1.5 times of the limit value specified in Table 1 of GB/T
IEC 61000-3-2 No
emission 17625.1.

Electromagnetic It meets the requirements on limit value of Class A and Group I

IEC/CISPR 11 Yes
interference equipment in GB4824.

3. Basic performance: “Blank count” indexes meet the requirements.

D
Statement on electromagnetic compatibility:

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● The manufacturer is responsible for providing the consumer/user with the info of electromagnetic
compatibility of the equipment.

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● The user is responsible for guaranteeing the environment for electromagnetic compatibility of the
equipment so that it can work normally. CO
● The equipment meets the specified requirements on emission and immunity in IEC 61326.
● The equipment is designed and tested according to Class A equipment in IEC/CISPR 11. In home
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environment, the equipment may cause radio interference, thus preventive measures should be taken.
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● It is recommended to evaluate electromagnetic environment before using the equipment.

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● It is forbidden to use the equipment beside any source of intense radiation, or it may interfere with normal
operation of the equipment.
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