Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver.

5)
2014/6/16

Exhibit 1: M145M Parameter List Specifications of WBC and PLT, which are reportable parameters
• WBC: WBC-C or WBC-D is used. If the specifications are different between WBC-C/WBC-D, the specification of WBC-C is displayed as <WBC-C> (when WBC-C is used), and that of WBC-D is displayed as <WBC-D> (when WBC-D is used).
• PLT: PLT-I or PLT-O is used. If the specifications are different between PLT-I/PLT-O, the specification of PLT-I is displayed as <PLT-I> (when PLT-I is used), and that of PLT-O is displayed as <PLT-O> (when PLT-O is used).

Reportable(*1): These parameters may become Research parameters depending on the market.
Quality control/Calibrator/Traceability Repeatability Accuracy
Research(*1): Since these parameters may become Reportable parameters as WBC or PLT, the performance is guaranteed.

Whole blood
Parameter
mode (WB) Dilution Body fluid Effective number Whole blood mode Whole blood mode
Parameter name name Analysis ch Parameter Analysis range Display range Reportable Range QC material Calibrator Traceability Dilution mode Body fluid mode Condition Dilution mode Body fluid mode
Low WBC mode (PD) mode (BF) of digits Low WBC mode Low WBC mode
(abbrev.)
mode (LWB)

(Whole blood mode, (Whole blood mode, • 3.0% or less

Low WBC mode) Low WBC mode) • (Low level as reference:
White blood cell 0.00 to 440.00 × 0.00 to 999.99 × 0.03 to 440.00 × XN CHECK ICSH reference 1.50 × 10^3/μL) 8.0% or less 4.00 × 10^3/μL or Within ±3% or ±0.30 Within ±10% or ±
WBC WDF Reportable Yes Yes - x10/μL XN CAL 5.0% or less - -
count 10^3/μL 10^3/μL 10^3/μL XN-L CHECK method • (Low level as reference: more × 10^3/μL 0.40 × 10^3/μL
(Dilution mode) 0.00 (Dilution mode) 0.04 0.50 × 10^3/μL) 15.0% or
to 100.00 × 10^3/μL to 100.00 × 10^3/μL less

Red blood cell 0.00 to 8.60 × 10^6/ 0.00 to 99.99 × 0.01 to 8.60 × 10^6/ XN CHECK ICSH reference 4.00 × 10^6/μL or Within ±2% or ±0.03 Within ±8% or ±
RBC RBC/PLT Reportable Yes Yes - x10^4/μL XN CAL 1.5% or less 4.5% or less - -
count μL 10^6/μL μL XN-L CHECK method more × 10^6/μL 0.12 × 10^6/μL
(Whole blood mode,
0 to 300 g/L Low WBC mode) 1
Hemoglobin • g/L 0 to 260 g/L XN CHECK ICSH reference Within ±2% or ±2 Within ±5% or
HGB HGB Reportable Yes Yes - 0.0 to 18.6 to 260 g/L XN CAL 1.5% or less 4.5% or less - - -
concentration • x10^(-1) mmol/L 0.0 to 16.1 mmol/L XN-L CHECK method g/L ±5 g/L
mmol/L (Dilution mode) 2 to
260 g/L

XN CHECK ICSH reference Within ±3% or ±1.0 Within ±4% or ±

Hematocrit HCT RBC/PLT Reportable Yes Yes - x10^(-1)% 0.0 to 75.0% 0.0 to 100.0% 0.1 to 75.0% XN CAL 1.5% or less 4.5% or less - - -
XN-L CHECK method HCT 2.0 HCT

Mean corpuscular XN CHECK (calculation: RBC, Within ±3% or ± Within ±4% or ±

MCV RBC/PLT Reportable Yes Yes - x10^(-1)fL - - - - 1.5% or less 4.5% or less - - -
volume XN-L CHECK HCT) 2.0fL 3.0fL

Mean corpuscular • x10^(-1)pg XN CHECK (calculation: RBC,

MCH RBC/PLT, HGB Reportable Yes Yes - - - - - 2.0% or less 4.5% or less - - - - -
hemoglobin • amol XN-L CHECK HGB)
Mean corpuscular
• g/L XN CHECK (calculation: HCT,
hemoglobin MCHC RBC/PLT, HGB Reportable Yes Yes - - - - - 2.0% or less 6.0% or less - - - - -
• x10^(-1) mmol/L XN-L CHECK HGB)
concentration
<PLT-I>
• 4.0% or less <PLT-I>
1) <PLT-I> Within
(Whole blood mode, (Whole blood mode, • (Low level as reference: 50 <PLT-I> • Within ±5% or ±10
±10% or ±20 ×
Low WBC mode) 0 Low WBC mode) 2 PLT-I/PLT-O: × 10^3/μL) 8.0% or less • 12.0% or less × 10^3/μL
RBC/PLT or 0 to 9999 × 10^3/ ICSH reference 100 × 10^3/μL or 10^3/μL
Platelet count PLT Reportable Yes Yes - x10^3/μL to 5000 × 10^3/μL to 5000 × 10^3/μL XN CHECK XN CAL • (Low level as reference: 30 - -
RET μL method more <PLT-O> Within
(Dilution mode) 0 to (Dilution mode) 5 to XN-L CHECK × 10^3/μL) 10.0% or less <PLT-O> <PLT-O>
±15% or ±20 ×
1000 × 10^3/μL 1000 × 10^3/μL • 13.0% or less • Within ±7% or ±10
10^3/μL
<PLT-O> × 10^3/μL
• 6.0% or less

Red cell XN CHECK

RDW-SD RBC/PLT Reportable Yes Yes - x10^(-1)fL - - - - - 3.0% or less 6.0% or less - - - - -
distribution width XN-L CHECK

Red cell XN CHECK

RDW-CV RBC/PLT Reportable Yes Yes - x10^(-1)% - - - - - 3.0% or less 6.0% or less - - - - -
distribution width XN-L CHECK

Platelet distribution XN CHECK

PDW RBC/PLT Reportable(*1) Yes Yes - x10^(-1)fL - - - - - 10.0% or less 20.0% or less - - - - -
width XN-L CHECK
Within ±5% or ± Within ±7% or ±
Mean platelet XN CHECK 1.0fL 1.5fL
MPV RBC/PLT Reportable Yes Yes - x10^(-1)fL - - - - - 4.0% or less 8.0% or less - - -
volume XN-L CHECK (PLT 100 × 10^3/μL (PLT 100 × 10^3/μ
or more) L or more)
Platelet-large cell XN CHECK
P-LCR RBC/PLT Reportable(*1) Yes Yes - x10^(-1)% - - - - - 18.0% or less 36.0% or less - - - - -
ratio XN-L CHECK
Within ±5% or ±0.03 Within ±7% or ±
XN CHECK PCT 0.04 PCT
Plateletcrit PCT RBC/PLT Reportable(*1) Yes Yes - x10^(-2)% - - - - - 6.0% or less 12.0% or less - - -
XN-L CHECK (PLT 100 × 10^3/μL (PLT 100 × 10^3/μ
or more) L or more)
(Whole blood mode,
Low WBC mode)
0.03 to 440.00 × XN CHECK SYSMEX internal 1.20 × 10^3/μL or
Neutrophil count NEUT# WDF Reportable Yes Yes - x10/μL - - - 8.0% or less 16.0% or less - - - -
10^3/μL XN-L CHECK method (FCM) more
(Dilution mode) 0.04
to 100.00 × 10^3/μL
(Whole blood mode,
Low WBC mode)
0.03 to 440.00 × XN CHECK SYSMEX internal 0.60 × 10^3/μL or
Lymphocyte count LYMPH# WDF Reportable Yes Yes - x10/μL - - - 8.0% or less 16.0% or less - - - -
10^3/μL XN-L CHECK method (FCM) more
(Dilution mode) 0.04
to 100.00 × 10^3/μL

1 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List

Linearity Carryover Stability

Whole blood Stability relative to

Condition (Whole Body fluid mode Stability relative to Stability relative to Within-a-day stability after
Parameter mode, Low WBC temperature (Human Within-a-day Day-to-day Temperature
Whole blood mode blood mode, Low (Verification Condition (Verification using temperature power supply collection of blood: Average of 5
Parameter name name Analysis ch Dilution mode mode (Verification Carryover blood: average of 3 stability stability cycling Blank
Low WBC mode WBC mode, and using stable stable substance) (Dilution mode: voltage (Control human blood samples
(abbrev.) using stable samples, control (Control blood) (Control blood) (Control blood)
Dilution mode) substance) Human blood) blood) (stored at 18-26°C or at 2-8°C)
substance) blood)
<WBC-C>
1) 0.0 to 100.00 × 10^3/μL 0.30 × 10^3/μL or
1) Within ±3% or
2) 100.01 to 310.00 × 10^3/μ less
White blood cell Within ±3% or ±0.30 × Within ±10% or 0.00 to 100.00 × ±0.30 × 10^3/μL Within 5.0% or 0.50 × Within 5.0% or
WBC WDF - L 1.0% or less Within 5.0% Within 10.0% Within 5.0% Within 5.0% Within ±10.0% (72 hours later)
count 10^3/μL ±0.40 × 10^3/μL 10^3/μL 2) Within ±6% 10^3/μL 0.50 × 10^3/μL
3) 310.01 to 440.00 × 10^3/μ <WBC-D>
3) Within ±11%
L 0.10 × 10^3/μL or
less
Red blood cell Within ±2% or ±0.03 × Within ±8% or ±0.12 0.00 to 8.00 × 10^6/ Within ±4% or ± 0.02 × 10^6/μL or
RBC RBC/PLT - 0.00 to 8.60 × 10^6/μL 1.0% or less Within 3.0% Within 3.0% Within 3.0% Within 5.0% Within 3.0% Within 3.0% Within ±5.0% (72 hours later)
count 10^6/μL × 10^6/μL μL 0.06 × 10^6/μL less

Hemoglobin Within ±5% or ±5 0 to 260 g/L Within ±5% or ±5 0 to 260 g/L

HGB HGB Within ±2% or ±2 g/L - 1.0% or less Within 3.0% Within 5.0% Within 3.0% Within 5.0% Within 3.0% Within 3.0% Within ±5.0% (72 hours later) 1 g/L or less
concentration g/L 0.0 to 16.14 mmol/L g/L 0.0 to 16.14 mmol/L

Within +5.0% (8 hours later)

Within 3.0% Within +8.0% (24 hours later,
Within ±3% or ±1.0 Within ±4% or ±2.0
Hematocrit HCT RBC/PLT 0.0 to 75.0% - - - 1.0% or less (In the case of control Within 5.0% Within 3.0% Within 5.0% Within 3.0% Within 3.0% stored at cold place) -
HCT HCT
blood, within 5.0%) Within +15.0% (24 hours later,
stored at 18 to 26°C)
Within +5.0% (8 hours later)
Change is MCV due to Within +8.0% (24 hours later,
Mean corpuscular 2.00<RBC<7.00 ×
MCV RBC/PLT RBC concentration is - - - - - - - - - - - stored at cold place) -
volume 10^6/μL
within ±2.0fL Within +15.0% (24 hours later,
stored at 18 to 26°C)
Mean corpuscular
MCH RBC/PLT, HGB - - - - - - - - - - - - - - -
hemoglobin
Mean corpuscular
hemoglobin MCHC RBC/PLT, HGB - - - - - - - - - - - - - - -
concentration
1) <PLT-I> Within ±5%
<PLT-I>
or ±10 × 10^3/μL
1) 0.0 to 1000 × 1) Within ±5% or <PLT-I> <PLT-I>
<PLT-O> Within ±7% 1) <PLT-I> Within ± <PLT-I> <PLT-I> <PLT-I> <PLT-I> <PLT-I>
10^3/μL ±10 × 10^3/μL Within 10.0% or 20 × Within 10.0% or
or ±10 × 10^3/μL 10% or ±20 × 10^3/ Within 10.0% or Within 10.0% or Within 10.0% or Within 10.0% or Within ±10% or within ±30 ×
(When RBC is 2) ±Within 6% 10^3/μL 20 × 10^3/μL
RBC/PLT or μL 1) 0 to 1000 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 10^3/μL (48 hours later) 10 × 10^3/μL or
Platelet count PLT approx. 4.00 × - 1.0% or less
RET 2) Change in PLT due <PLT-O> Within ± 2) 1001 to 5000 × 10^3/μL less
10^6/μL) <PLT-O> <PLT-O> <PLT-O>
to RBC is within ±20 × 15% or ±20 × 10^3/ <PLT-O> <PLT-O> <PLT-O> <PLT-O> <PLT-O>
2) 2.00<RBC<7.00 1)2) Within ±7% Within 13.0% or 20 × Within 13.0% or
10^3/μL (When PLT is μL Within 13.0% Within 13.0% Within 13.0% Within 13.0% Within ±15.0% (48 hours later)
× 10^6/μL or ±10 × 10^3/μL 10^3/μL 20 × 10^3/μL
approx. 300 × 10^3/μ
L)
Change in RDW-SD
Red cell due to RBC 2.00<RBC<7.00 ×
RDW-SD RBC/PLT - - - - - Within 10.0% Within 20.0% Within 10.0% Within 10.0% Within 10.0% Within 10.0% - -
distribution width concentration is within 10^6/μL
±3.0 fL
Change in RDW-CV
Red cell due to RBC 2.00<RBC<7.00 ×
RDW-CV RBC/PLT - - - - - Within 10.0% Within 20.0% Within 10.0% Within 10.0% Within 10.0% Within 10.0% - -
distribution width concentration is within 10^6/μL
±1.0 RDW-CV
Platelet distribution
PDW RBC/PLT - - - - - - - Within 10.0% Within 20.0% Within 10.0% Within 10.0% Within 10.0% Within 10.0% - -
width

Mean platelet
MPV RBC/PLT - - - - - - - Within 10.0% Within 20.0% Within 10.0% Within 10.0% Within 10.0% Within 10.0% - -
volume

Platelet-large cell Within 10.0% or Within 20.0% or Within 10.0% or Within 10.0% or Within 10.0% or Within 10.0% or
P-LCR RBC/PLT - - - - - - - - -
ratio 5.0 P-LCR 10.0 P-LCR 5.0 P-LCR 5.0 P-LCR 5.0 P-LCR 5.0 P-LCR

Plateletcrit PCT RBC/PLT - - - - - - - Within 10.0% Within 20.0% Within 10.0% Within 10.0% Within 10.0% Within 10.0% - -

2.0% or 0.05 ×
Neutrophil count NEUT# WDF - - - - - - - - Within 15.0% Within 15.0% Within 10.0% Within 10.0% - -
10^3/μL or less

2.0% or 0.05 ×
Lymphocyte count LYMPH# WDF - - - - - - - - Within 15.0% Within 15.0% Within 10.0% Within 10.0% - -
10^3/μL or less

2 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List Specifications of WBC and PLT, which are reportable parameters
• WBC: WBC-C or WBC-D is used. If the specifications are different between WBC-C/WBC-D, the specification of WBC-C is displayed as <WBC-C> (when WBC-C is used), and that of WBC-D is displayed as <WBC-D> (when WBC-D is used).
• PLT: PLT-I or PLT-O is used. If the specifications are different between PLT-I/PLT-O, the specification of PLT-I is displayed as <PLT-I> (when PLT-I is used), and that of PLT-O is displayed as <PLT-O> (when PLT-O is used).

Reportable(*1): These parameters may become Research parameters depending on the market.
Quality control/Calibrator/Traceability Repeatability Accuracy
Research(*1): Since these parameters may become Reportable parameters as WBC or PLT, the performance is guaranteed.

Whole blood
Parameter
mode (WB) Dilution Body fluid Effective number Whole blood mode Whole blood mode
Parameter name name Analysis ch Parameter Analysis range Display range Reportable Range QC material Calibrator Traceability Dilution mode Body fluid mode Condition Dilution mode Body fluid mode
Low WBC mode (PD) mode (BF) of digits Low WBC mode Low WBC mode
(abbrev.)
mode (LWB)

(Whole blood mode,

Low WBC mode)
0.03 to 440.00 × XN CHECK SYSMEX internal 0.20 × 10^3/μL or
Monocyte count MONO# WDF Reportable Yes Yes - x10/μL - - - 20.0% or less 40.0% or less - - - -
10^3/μL XN-L CHECK method (FCM) more
(Dilution mode) 0.04
to 100.00 × 10^3/μL
(Whole blood mode,
Low WBC mode)
Within 40.0% or
0.03 to 440.00 × XN CHECK SYSMEX internal Within 25.0% or less, or
Eosinophil count EO# WDF Reportable Yes Yes - x10/μL - - - less, or ±0.12 × - - - - -
10^3/μL XN-L CHECK method (FCM) ±0.12 × 10^3/μL
10^3/μL
(Dilution mode) 0.04
to 100.00 × 10^3/μL
(Whole blood mode,
Low WBC mode)
50.0% or less,
0.03 to 440.00 × XN CHECK SYSMEX internal 40.0% or less, or within
Basophil count BASO# WDF Reportable Yes Yes - x10/μL - - - or within ±0.06 × - - - - -
10^3/μL XN-L CHECK method (FCM) ±0.06 × 10^3/μL
10^3/μL
(Dilution mode) 0.04
to 100.00 × 10^3/μL
30.0 NEUT% or
1) r ≥ 0.90 1) r ≥ 0.70
XN CHECK SYSMEX internal more,
Neutrophil percent NEUT% WDF Reportable Yes Yes - x10^(-1)% - - 0.0 to 100.0% - 8.0% or less 16.0% or less - 2) Within ±3.0 2) Within ±3.0 -
XN-L CHECK method (FCM) WBC 4.00 × 10^3/μ
NEUT% NEUT%
L or more
15.0 LYMPH% or
1) r ≥ 0.90 1) r ≥ 0.70
Lymphocyte XN CHECK SYSMEX internal more,
LYMPH% WDF Reportable Yes Yes - x10^(-1)% - - 0.0 to 100.0% - 8.0% or less 16.0% or less - 2) Within ±3.0 2) Within ±3.0 -
percent XN-L CHECK method (FCM) WBC 4.00 × 10^3/μ
LYMPH% LYMPH%
L or more
5.0 MONO% or
1) r ≥ 0.75 1) r ≥ 0.60
XN CHECK SYSMEX internal more,
Monocyte percent MONO% WDF Reportable Yes Yes - x10^(-1)% - - 0.0 to 100.0% - 20.0% or less 40.0% or less - 2) Within ±2.0 2) Within ±2.0 -
XN-L CHECK method (FCM) WBC 4.00 × 10^3/μ
MONO% MONO%
L or more
40.0% or less, 1) r ≥ 0.60
XN CHECK SYSMEX internal 25.0% or less, or within WBC 4.00 × 10^3/μ 1) r ≥ 0.80
Eosinophil percent EO% WDF Reportable Yes Yes - x10^(-1)% - - 0.0 to 100.0% - or within ±2.5 - 2) Within ±1.0 -
XN-L CHECK method (FCM) ±1.5 EO% L or more 2) Within ±1.0 EO%
EO% EO%

50.0% or less, 1) r ≥ 0.50 1) r ≥ 0.50

XN CHECK SYSMEX internal 40.0% or less, or within WBC 4.00 × 10^3/μ
Basophil percent BASO% WDF Reportable Yes Yes - x10^(-1)% - - 0.0 to 100.0% - or within ±1.5 - 2) Within ±1.0 2) Within ±1.0 -
XN-L CHECK method (FCM) ±1.0 BASO% L or more
BASO% BASO% BASO%

(Whole blood mode,

Low WBC mode)
75.0% or less,
Immature 0.03 to 440.00 × XN CHECK SYSMEX internal 25.0% or less, or within IG# 0.10 × 10^3/μL
IG# WDF Reportable(*1) Yes Yes - x10/μL - - - or within ±0.36 × - - - -
granulocyte count 10^3/μL XN-L CHECK method (FCM) ±0.12 × 10^3/μL or more
10^3/μL
(Dilution mode) 0.04
to 100.00 × 10^3/μL
Immature 75.0% or less, IG% 2.0% or more,
XN CHECK SYSMEX internal 25.0% or less, or within 1) r ≥ 0.80
granulocyte IG% WDF Reportable(*1) Yes Yes - x10^(-1)% - - 0.0 to 100.0% - or within ±4.5 - WBC 4.00 × 10^3/μ - -
XN-L CHECK method (FCM) ±1.5 IG% 2) Within ±1.5 IG%
percent IG% L or more
(Whole blood mode,
Low WBC mode)
75.0% or less,
High fluorescence 0.00 to 999.99 × 0.03 to 440.00 × XN CHECK 25.0% or less, or within HFLC# 0.10 × 10^3/
HFLC# WDF Reportable(*1) Yes Yes - x10/μL - - - or within ±0.36 × - - - -
lymphocyte count 10^3/μL 10^3/μL XN-L CHECK ±0.12 × 10^3/μL μL or more
10^3/μL
(Dilution mode) 0.04
to 100.00 × 10^3/μL
HFLC% 2.0% or
High fluorescence 75.0% or less, 1) r ≥ 0.80
XN CHECK 25.0% or less, or within more,
lymphocyte HFLC% WDF Reportable(*1) Yes Yes - x10^(-1)% - 0.0 to 100.0% 0.0 to 100.0% - - or within ±4.5 - 2) Within ±1.5 - -
XN-L CHECK ±1.5 HFLC% WBC 4.00 × 10^3/μ
percent HFLC% HFLC%
L or more
RBC 3.00 × 10^6/μL
(Whole blood mode, (Whole blood mode, 1) r ≥ 0.90 1) r ≥ 0.80
Reticulocyte XN CHECK Manual method or more,
RET% RET Reportable Yes Yes - x10^(-2)% Low WBC mode) 0.00 to 99.99% Low WBC mode) XN CAL 15.0% or less 35.0% or less - 2) Within ±20% or 2) Within ±30% or -
percent XN-L CHECK (CLSI H44-A2) RET% 1.00 to
0.00 to 30.00% 0.00 to 30.00% ±0.30 RET% ±0.50 RET%
4.00%

3 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List

Linearity Carryover Stability

Whole blood Stability relative to

Condition (Whole Body fluid mode Stability relative to Stability relative to Within-a-day stability after
Parameter mode, Low WBC temperature (Human Within-a-day Day-to-day Temperature
Whole blood mode blood mode, Low (Verification Condition (Verification using temperature power supply collection of blood: Average of 5
Parameter name name Analysis ch Dilution mode mode (Verification Carryover blood: average of 3 stability stability cycling Blank
Low WBC mode WBC mode, and using stable stable substance) (Dilution mode: voltage (Control human blood samples
(abbrev.) using stable samples, control (Control blood) (Control blood) (Control blood)
Dilution mode) substance) Human blood) blood) (stored at 18-26°C or at 2-8°C)
substance) blood)

2.0% or 0.03 × Within 40.0% or Within 40.0% or Within 30.0% or Within 30.0% or
Monocyte count MONO# WDF - - - - - - - - - -
10^3/μL or less 0.20 × 10^3/μL 0.20 × 10^3/μL 0.15 × 10^3/μL 0.15 × 10^3/μL

2.0% or 0.03 × Within 15.0% or Within 15.0% or Within 10.0% or Within 10.0% or
Eosinophil count EO# WDF - - - - - - - - - -
10^3/μL or less 0.15 × 10^3/μL 0.15 × 10^3/μL 0.10 × 10^3/μL 0.10 × 10^3/μL

2.0% or 0.03 × Within 50.0% or Within 50.0% Within 40.0% or Within 40.0% or
Basophil count BASO# WDF - - - - - - - - - -
10^3/μL or less 0.10 × 10^3/μL or0.10 × 10^3/μL 0.10 × 10^3/μL 0.10 × 10^3/μL

Within ±8.0 NEUT% (36 hours

later)
Neutrophil percent NEUT% WDF - - - - - - - Within 15.0% Within 15.0% - - - - -
Within ±8.0 NEUT% (48 hours
later)
Within ±7.0 LYMPH% (36 hours
Lymphocyte later)
LYMPH% WDF - - - - - - - Within 15.0% Within 15.0% - - - - -
percent Within ±7.0 LYMPH% (48 hours
later)
Within ±3.0 MONO% (36 hours
Within 40.0% or 2.0 Within 40.0% or later)
Monocyte percent MONO% WDF - - - - - - - - - - - -
MONO% 2.0 MONO% Within ±4.0 MONO% (48 hours
later)
Within ±3.0 EO% (36 hours
Within 15.0% or 1.0 Within 15.0% or later)
Eosinophil percent EO% WDF - - - - - - - - - - - -
EO% 1.0 EO% Within ±3.0 EO% (48 hours
later)
When stored in a refrigerator:
Within ±1.0 BASO% (12 hours
Within 50.0% or 1.0 Within 50.0% or later)
Basophil percent BASO% WDF - - - - - - - - - - - -
BASO% 1.0 BASO% When stored at room
temperature: Within ±1.0
BASO% (24 hours later)

Immature
IG# WDF - - - - - - - - - - - - - - -
granulocyte count

Immature
granulocyte IG% WDF - - - - - - - - - - - - - Within ±2.0 IG% (24 hours later) -
percent

High fluorescence
HFLC# WDF - - - - - - - - - - - - - - -
lymphocyte count

High fluorescence
Within ±2.0 HFLC% (24 hours
lymphocyte HFLC% WDF - - - - - - - - - - - - - -
later)
percent

Reticulocyte Within ±20% or ± Within 20.0% or 0.30 Within 20.0% or Within 20.0% or Within 20.0% or Within 20.0% or Within 20.0% or Within ±20.0% or ±0.3 RET%
RET% RET - - - - 0.00 to 30.00% - -
percent 0.30 RET% RET% 0.30 RET% 0.3 RET% 0.3 RET% 0.3 RET% 0.3 RET% (24 hours later)

4 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List Specifications of WBC and PLT, which are reportable parameters
• WBC: WBC-C or WBC-D is used. If the specifications are different between WBC-C/WBC-D, the specification of WBC-C is displayed as <WBC-C> (when WBC-C is used), and that of WBC-D is displayed as <WBC-D> (when WBC-D is used).
• PLT: PLT-I or PLT-O is used. If the specifications are different between PLT-I/PLT-O, the specification of PLT-I is displayed as <PLT-I> (when PLT-I is used), and that of PLT-O is displayed as <PLT-O> (when PLT-O is used).

Reportable(*1): These parameters may become Research parameters depending on the market.
Quality control/Calibrator/Traceability Repeatability Accuracy
Research(*1): Since these parameters may become Reportable parameters as WBC or PLT, the performance is guaranteed.

Whole blood
Parameter
mode (WB) Dilution Body fluid Effective number Whole blood mode Whole blood mode
Parameter name name Analysis ch Parameter Analysis range Display range Reportable Range QC material Calibrator Traceability Dilution mode Body fluid mode Condition Dilution mode Body fluid mode
Low WBC mode (PD) mode (BF) of digits Low WBC mode Low WBC mode
(abbrev.)
mode (LWB)

(Whole blood mode, RBC 3.00 × 10^6/μL

(Whole blood mode, 1) r ≥ 0.90 1) r ≥ 0.80
0.0 to 999.9 × Low WBC mode) XN CHECK (calculation: RET%, or more,
Reticulocyte count RET# RET, RBC/PLT Reportable Yes Yes - x10^2/μL Low WBC mode) 0.0 - 15.0% or less 35.0% or less - 2) Within ±20% or 2) Within ±30% or -
10^3/μL 10.0 to 720.0 × XN-L CHECK RBC) RET% 1.00 to
to 720.0 × 10^3/μL ±15.0 × 10^3/μL ±20.0 × 10^3/μL
10^3/μL 4.00%
Within ±30% or ±
RBC 3.00 × 10^6/μL
10.0 IRF
Immature or more,
XN CHECK (In the case of Within ±50% or
reticulocyte IRF RET Reportable Yes Yes - x10^(-1)% - 0.0 to 100.0% 0.0 to 100.0% - - 30.0% or less - - RET% 1.00 to -
XN-L CHECK control blood or ±10.0 IRF
fraction 4.00%, IRF 20.0%
calibrator, within
or more
55.0 IRF%)
Within ±30% or ±
RBC 3.00 × 10^6/μL
10.0 LFR
or more,
Low fluorescence XN CHECK (In the case of Within ±50% or
LFR RET Reportable(*1) Yes Yes - x10^(-1)% - 0.0 to 100.0% - - - 30.0% or less - - RET% 1.00 to -
ratio XN-L CHECK control blood or ±10.0 LFR
4.00%, LFR 20.0%
calibrator, within
or more
55.0 LFR%)
Within ±30% or ±
RBC 3.00 × 10^6/μL 10.0 MFR
Medium XN CHECK 50.0% or less, or within or more, (In the case of Within ±50% or ±
MFR RET Reportable(*1) Yes Yes - x10^(-1)% - 0.0 to 100.0% - - - - - -
fluorescence ratio XN-L CHECK ±10.0 MFR RET% 1.00 to control blood or 10.0 MFR
4.00% calibrator, within
40.0 MFR%)
Within ±30% or ±5.0
RBC 3.00 × 10^6/μL HFR
High fluorescence XN CHECK 100.0% or less, or within ± or more, (In the case of Within ±50% or ±
HFR RET Reportable(*1) Yes Yes - x10^(-1)% - 0.0 to 100.0% - - - - - -
ratio XN-L CHECK 2.0 HFR RET% 1.00 to control blood or 5.0 HFR
4.00% calibrator, within
20.0 HFR%)
r ≥ 0.9
Reticulocyte (More than half of
• x10^(-1)pg XN CHECK RET# 20.0 × 10^3/μ
hemoglobin RET-He RET Reportable Yes Yes - - - - - 5.0% or less - - the samples are r ≥ 0.7 -
• amol XN-L CHECK L or more
equivalent RET# 20.0 × 10^3/μ
L or more)

PLT-O 50 × 10^3/μL
Immature platelet XN CHECK
IPF# RET Reportable(*1) Yes Yes - x10^2/μL - - - - - 25.0% or less 40.0% or less - or more, IPF 3.0% r ≥ 0.7 r ≥ 0.5 -
count XN-L CHECK
or more

1) PLT-O 50 ×
10^3/μL or more,
1) 25.0% or less
Immature platelet XN CHECK IPF 3.0% or more
IPF RET Reportable(*1) Yes Yes - x10^(-1)% - 0.0 to 100.0 % - - - 2) (Actual measured value of 40.0% or less - r ≥ 0.7 r ≥ 0.5 -
ratio XN-L CHECK 2) PLT-O 10 to 50 ×
coefficient) 20.0% or less
10^3/μL, IPF 10.0%
or more

(Whole blood mode, (Whole blood mode, • 4.0% or less

Low WBC mode) 0 Low WBC mode) 2 • (Low level as reference: 50
Platelet count 0 to 9999 × 10^3/ XN CHECK 100 × 10^3/μL or Within ±5% or ±10 × 1) Within ±10% or
PLT-I RBC/PLT Research(*1) Yes Yes - x10^3/μL to 5000 × 10^3/μL to 5000 × 10^3/μL XN CAL - × 10^3/μL) 8.0% or less 12.0% or less - -
(PLT channel) μL XN-L CHECK more 10^3/μL ±20 × 10^3/μL
(Dilution mode) 0 to (Dilution mode) 5 to • (Low level as reference: 30
1000 × 10^3/μL 1000 × 10^3/μL × 10^3/μL) 10.0% or less

Micro RBC ratio MicroR RBC/PLT Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -

Macro RBC ratio MacroR RBC/PLT Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
Total nuclear cell 0.00 to 999.99 ×
TNC WDF Research Yes Yes - x10/μL - - - - - - - - - - - -
count 10^3/μL

5 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List

Linearity Carryover Stability

Whole blood Stability relative to

Condition (Whole Body fluid mode Stability relative to Stability relative to Within-a-day stability after
Parameter mode, Low WBC temperature (Human Within-a-day Day-to-day Temperature
Whole blood mode blood mode, Low (Verification Condition (Verification using temperature power supply collection of blood: Average of 5
Parameter name name Analysis ch Dilution mode mode (Verification Carryover blood: average of 3 stability stability cycling Blank
Low WBC mode WBC mode, and using stable stable substance) (Dilution mode: voltage (Control human blood samples
(abbrev.) using stable samples, control (Control blood) (Control blood) (Control blood)
Dilution mode) substance) Human blood) blood) (stored at 18-26°C or at 2-8°C)
substance) blood)

Within ±20% or ± Within 20.0% or 15.0 Within 20.0% or Within 20.0% or Within 20.0% or Within 20.0% or Within 20.0% or Within ±20.0% or ±15 × 10^3/μL
Reticulocyte count RET# RET, RBC/PLT - - - - 00.0 to 720.0 × 10^3/μL - -
15.0 × 10^3/μL × 10^3/μL 15.0 × 10^3/μL 15 × 10^3/μL 15 × 10^3/μL 15 × 10^3/μL 15 × 10^3/μL (24 hours later)

Within 30.0% or 10.0

Immature IRF%
Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within ±30.0% or ±10.0 IRF (24
reticulocyte IRF RET - - - - - - - (In the case of control -
10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF hours later)
fraction blood, within 55.0
IRF%)

Within 30.0% or 10.0

LFR%
Low fluorescence Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within ±30.0% or ±10.0 LFR (24
LFR RET - - - - - - - (In the case of control -
ratio 10.0 LFR 10.0 LFR 10.0 LFR 10.0 LFR 10.0 LFR hours later)
blood, within 55.0
LFR%)

Within 30.0% or 10.0

MFR%
Medium Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within ±30.0% or ±10.0 MFR
MFR RET - - - - - - - (In the case of control -
fluorescence ratio 10.0 MFR 10.0 MFR 10.0 MFR 10.0 MFR 10.0 MFR (24 hours later)
blood, within 40.0
MFR%)

Within 30.0% or 5.0

HFR%
High fluorescence Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within 30.0% or Within ±30.0% or ±5.0 HFR (24
HFR RET - - - - - - - (In the case of control -
ratio 5.0 HFR 5.0HFR 5.0 HFR 5.0 HFR 5.0HFR hours later)
blood, within 20.0
HFR%)

Reticulocyte Within ±8.0% (RET# 10.0 ×

hemoglobin RET-He RET - - - - - - - - - - - - - 10^3/μL or more) (24 hours -
equivalent later)

When stored in a refrigerator:

Within ±30.0% or 10 × 10^3/μL
(PLT-O 100 × 10^3/μL or more,
IPF 2.0% or more) (12 hours
later)
Immature platelet
IPF# RET - - - - - - - - - - - - - When stored at room -
count
temperature:
Within ±30.0% or 10 × 10^3/μL
(PLT-O 100 × 10^3/μL or more,
IPF 2.0% or more) (24 hours
later)
When stored in a refrigerator:
Within ±30.0% or 2.0 IPF (PLT-
O 100 × 10^3/μL or more, IPF
2.0% or more) (12 hours later)
Immature platelet
IPF RET - - - - - - - - - - - - - When stored at room -
ratio
temperature: Within ±30.0% or
2.0 IPF (PLT-O 100 × 10^3/μL or
more, IPF 2.0% or more) (24
hours later)
1) Within ±5% or ±10 1) 0.0 to 1000 ×
× 10^3/μL 10^3/μL 1) Within ±5% or
2) Change in PLT due (When RBC is ±10 × 10^3/μL
Platelet count 1) Within ±10% or ± 1) 0 to 1000 × 10^3/μL Within 10.0% or 20 × Within 10.0% or Within 10.0% or Within 10.0% or Within 10.0% or Within 10.0% or Within ±10% or ±30 × 10^3/μL 10 × 10^3/μL or
PLT-I RBC/PLT to RBC is within ±20 × approx. 4.00 × 2) Within ±6% - 1.0% or less
(PLT channel) 20 × 10^3/μL 2) 1001 to 5000 × 10^3/μL 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL 20 × 10^3/μL (48 hours later) less
10^3/μL (When PLT is 10^6/μL)
approx. 300 × 10^3/μ 2) 2.00<RBC<7.00
L) × 10^6/μL
Micro RBC ratio MicroR RBC/PLT - - - - - - - - - - - - - - -
Macro RBC ratio MacroR RBC/PLT - - - - - - - - - - - - - - -
Total nuclear cell
TNC WDF - - - - - - - - - - - - - - -
count

6 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List Specifications of WBC and PLT, which are reportable parameters
• WBC: WBC-C or WBC-D is used. If the specifications are different between WBC-C/WBC-D, the specification of WBC-C is displayed as <WBC-C> (when WBC-C is used), and that of WBC-D is displayed as <WBC-D> (when WBC-D is used).
• PLT: PLT-I or PLT-O is used. If the specifications are different between PLT-I/PLT-O, the specification of PLT-I is displayed as <PLT-I> (when PLT-I is used), and that of PLT-O is displayed as <PLT-O> (when PLT-O is used).

Reportable(*1): These parameters may become Research parameters depending on the market.
Quality control/Calibrator/Traceability Repeatability Accuracy
Research(*1): Since these parameters may become Reportable parameters as WBC or PLT, the performance is guaranteed.

Whole blood
Parameter
mode (WB) Dilution Body fluid Effective number Whole blood mode Whole blood mode
Parameter name name Analysis ch Parameter Analysis range Display range Reportable Range QC material Calibrator Traceability Dilution mode Body fluid mode Condition Dilution mode Body fluid mode
Low WBC mode (PD) mode (BF) of digits Low WBC mode Low WBC mode
(abbrev.)
mode (LWB)

(Whole blood mode, • 3.0% or less

Low WBC mode) • (Low level as reference:
White blood cell
0.00 to 440.00 × 0.00 to 999.99 × XN CHECK 1.50 × 10^3/μL) 8.0% or less 4.00 × 10^3/μL or Within ±3% or ±0.30 Within ±10% or ±
count (WDF WBC-C WDF Research(*1) Yes Yes - x10/μL - XN CAL - 5.0% or less - -
10^3/μL 10^3/μL XN-L CHECK • (Low level as reference: more × 10^3/μL 0.40 × 10^3/μL
channel)
(Dilution mode) 0.00 0.50 × 10^3/μL) 15.0% or
to 100.00 × 10^3/μL less
Total nuclear cell
0.00 to 999.99 ×
count (WDF TNC-C WDF Research Yes Yes - x10/μL - - - - - - - - - - - -
10^3/μL
channel)
(Whole blood mode, • 3.0% or less
Low WBC mode) • (Low level as reference:
White blood cell
0.00 to 440.00 × 0.00 to 999.99 × XN CHECK 1.50 × 10^3/μL) 8.0% or less 4.00 × 10^3/μL or Within ±3% or ±0.30 Within ±10% or ±
count (WDF WBC-D WDF Research(*1) Yes Yes - x10/μL - XN CAL - 5.0% or less - -
10^3/μL 10^3/μL XN-L CHECK • (Low level as reference: more × 10^3/μL 0.40 × 10^3/μL
channel)
(Dilution mode) 0.00 0.50 × 10^3/μL) 15.0% or
to 100.00 × 10^3/μL less
Total nuclear cell
0.00 to 999.99 ×
count (WDF TNC-D WDF Research Yes Yes - x10/μL - - - - - - - - - - - -
10^3/μL
channel)
0.00 to 999.99 ×
- WBC-D& WDF Research Yes Yes - x10/μL - - - - - - - - - - - -
10^3μL
Nucleated red 0.00 to 999.99 ×
NRBC# WDF Research Yes Yes - x10/μL - - - - - - - - - - - -
blood cell count 10^3/μL
Nucleated red x10^(- 0.0 to
NRBC% WDF Research Yes Yes - - - - - - - - - - - - -
blood cell percent 1)/100WBC 9999.9/100WBC
- NEUT#& WDF Research Yes Yes - x10/μL - - - - - - - - - - - - -
- NEUT%& WDF Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
- LYMP#& WDF Research Yes Yes - x10/μL - - - - - - - - - - - - -
- LYMP%& WDF Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
- NE-SSC WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- NE-SFL WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- NE-FSC WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- LY-X WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- LY-Y WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- LY-Z WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- MO-X WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- MO-Y WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- MO-Z WDF Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
- NE-WX WDF Research Yes Yes - None - - - - - - - - - - - - -
- NE-WY WDF Research Yes Yes - None - - - - - - - - - - - - -
- NE-WZ WDF Research Yes Yes - None - - - - - - - - - - - - -
- LY-WX WDF Research Yes Yes - None - - - - - - - - - - - - -
- LY-WY WDF Research Yes Yes - None - - - - - - - - - - - - -
- LY-WZ WDF Research Yes Yes - None - - - - - - - - - - - - -
- MO-WX WDF Research Yes Yes - None - - - - - - - - - - - - -
- MO-WY WDF Research Yes Yes - None - - - - - - - - - - - - -
- MO-WZ WDF Research Yes Yes - None - - - - - - - - - - - - -
Red blood cell
0.00 to 99.99 × XN CHECK
count RBC-O RET Research Yes Yes - x10^4/μL - - XN CAL - - - - - - - -
10^6/μL XN-L CHECK
(RET channel)
Hemoglobin
• g/L
concentration HGB-O RET, RBC/PLT Research Yes Yes - - - - - - - - - - - - - -
• x10^(-1) mmol/L
(RET channel)

(Whole blood mode,

Low WBC mode)
Platelet count 0 to 9999 × 10^3/ XN CHECK 100 × 10^3/μL or Within ±7% or ±10 × 1) Within ±15% or
PLT-O RET Research(*1) Yes Yes - x10^3/μL 0 to 5000 × 10^3/μL - XN CAL - 6.0% or less 13.0% or less - -
(RET channel) μL XN-L CHECK more 10^3/μL ±20 × 10^3/μL
(Dilution mode)
0 to 1000 × 10^3/μL

Mature RBC
hemoglobin RBC-He
equivalent
- Delta-He
- RET-Y
- RET-RBC-Y
- IRF-Y
- FRC#
- FRC%
- HYPO-He
- HYPER-He
Reticulocyte
RPI
production Index
• x10^(-1)pg
RET Research Yes Yes - - - - - - - - - - - - - -
• amol
• x10^(-1)pg
RET Research Yes Yes - - - - - - - - - - - - - -
• amol
RET Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
XN CHECK
RET Research Yes Yes - x10^(-1)ch - - - XN CAL - - - - - - - -
XN-L CHECK
RET Research Yes Yes - x10^(-1)ch - - - - - - - - - - - - -
RET, RBC/PLT Research Yes Yes - x10^2/μL - - - - - - - - - - - - -
RET Research Yes Yes - x10^(-2)% - - - - - - - - - - - - -
RET Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
RET Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
RET, RBC/PLT Research Yes Yes - None - - - - - - - - - - - - -

7 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List

Linearity Carryover Stability

Whole blood Stability relative to

Condition (Whole Body fluid mode Stability relative to Stability relative to Within-a-day stability after
Parameter mode, Low WBC temperature (Human Within-a-day Day-to-day Temperature
Whole blood mode blood mode, Low (Verification Condition (Verification using temperature power supply collection of blood: Average of 5
Parameter name name Analysis ch Dilution mode mode (Verification Carryover blood: average of 3 stability stability cycling Blank
Low WBC mode WBC mode, and using stable stable substance) (Dilution mode: voltage (Control human blood samples
(abbrev.) using stable samples, control (Control blood) (Control blood) (Control blood)
Dilution mode) substance) Human blood) blood) (stored at 18-26°C or at 2-8°C)
substance) blood)

1) 0.00 to 100.00 × 10^3/μL

1) Within ±3% or
White blood cell 2) 100.01 to 310.00 × 10^3/μ
Within ±3% or ±0.30 × Within ±10% or ± 0.00 to 100.00 × ±0.30 × 10^3/μL Within 5.0% or 0.50 × Within 5.0% or 0.30 × 10^3/μL or
count (WDF WBC-C WDF - L 1.0% or less Within 5.0% Within 10.0% Within 5.0% Within 5.0% Within ±10.0% (72 hours later)
10^3/μL 0.40 × 10^3/μL 10^3/μL 2) Within ±6% 10^3/μL 0.50 × 10^3/μL less
channel) 3) 310.01 to 440.00 × 10^3/μ
3) Within ±11%
L

Total nuclear cell

count (WDF TNC-C WDF - - - - - - - - - - - - - - -
channel)

1) 0.00 to 100.00 × 10^3/μL

1) Within ±3% or
White blood cell 2) 100.01 to 310.00 × 10^3/μ
Within ±3% or ±0.30 × Within ±10% or ± 0.00 to 100.00 × ±0.20 × 10^3/μL Within 5.0% or 0.50 × Within 5.0% or 0.10 × 10^3/μL or
count (WDF WBC-D WDF - L 1.0% or less Within 5.0% Within 10.0% Within 5.0% Within 5.0% Within ±10.0% (72 hours later)
10^3/μL 0.40 × 10^3/μL 10^3/μL 2) Within ±6% 10^3/μL 0.50 × 10^3/μL less
channel) 3) 310.01 to 440.00 × 10^3/μ
3) Within ±11%
L

Total nuclear cell

count (WDF TNC-D WDF - - - - - - - - - - - - - - -
channel)

- WBC-D& WDF - - - - - - - - - - - - - - -

Nucleated red
NRBC#
blood cell count
Nucleated red
NRBC%
blood cell percent
- NEUT#&
- NEUT%&
- LYMP#&
- LYMP%&
- NE-SSC
- NE-SFL
- NE-FSC
- LY-X
- LY-Y
- LY-Z
- MO-X
- MO-Y
- MO-Z
- NE-WX
- NE-WY
- NE-WZ
- LY-WX
- LY-WY
- LY-WZ
- MO-WX
- MO-WY
- MO-WZ
Red blood cell
count RBC-O
(RET channel)
Hemoglobin
concentration HGB-O
(RET channel)
Platelet count
PLT-O
(RET channel)
Mature RBC
hemoglobin RBC-He
equivalent
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
WDF - - - - - - - - - - - - - - -
RET - - - - - - 1.5% or less Within 5.0% - - - - - - -
RET, RBC/PLT - - - - - - - - - - - - - - -
1) Within ±7% or ±10 1) 0 to 1000 × 10^3/
× 10^3/μL μL
2) Change in PLT due (When RBC is
1) Within ±15% or ± 1)2) Within ±7% 1) 0 to 1000 × 10^3/μL Within 13.0% or 20 × Within 13.0% or 10 × 10^3/μL or
RET to RBC is within ±20 × approx. 4.00 × - 1.0% or less Within 13.0% Within 13.0% Within 13.0% Within 13.0% Within ±15.0% (48 hours later)
20 × 10^3/μL or ±10 × 10^3/μL 2) 1001 to 5000 × 10^3/μL 10^3/μL 20 × 10^3/μL less
10^3/μL (When PLT is 10^6/μL)
approx. 300 × 10^3/μ 2) 2.00<RBC<7.00
L) × 10^6/μL
RET - - - - - - - - - - - - - - -

- Delta-He RET - - - - - - - - - - - - - - -

- RET-Y
- RET-RBC-Y
- IRF-Y
- FRC#
- FRC%
- HYPO-He
- HYPER-He
Reticulocyte
RPI
production Index
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET, RBC/PLT - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET, RBC/PLT - - - - - - - - - - - - - - -

8 / 10 page
 Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16

Exhibit 1: M145M Parameter List Specifications of WBC and PLT, which are reportable parameters
• WBC: WBC-C or WBC-D is used. If the specifications are different between WBC-C/WBC-D, the specification of WBC-C is displayed as <WBC-C> (when WBC-C is used), and that of WBC-D is displayed as <WBC-D> (when WBC-D is used).
• PLT: PLT-I or PLT-O is used. If the specifications are different between PLT-I/PLT-O, the specification of PLT-I is displayed as <PLT-I> (when PLT-I is used), and that of PLT-O is displayed as <PLT-O> (when PLT-O is used).

Reportable(*1): These parameters may become Research parameters depending on the market.
Quality control/Calibrator/Traceability Repeatability Accuracy
Research(*1): Since these parameters may become Reportable parameters as WBC or PLT, the performance is guaranteed.

Whole blood
Parameter
mode (WB) Dilution Body fluid Effective number Whole blood mode Whole blood mode
Parameter name name Analysis ch Parameter Analysis range Display range Reportable Range QC material Calibrator Traceability Dilution mode Body fluid mode Condition Dilution mode Body fluid mode
Low WBC mode (PD) mode (BF) of digits Low WBC mode Low WBC mode
(abbrev.)
mode (LWB)

- RET-UPP RET Research Yes Yes - x10^2/μL - - - - - - - - - - - - -

- RET-TNC
- H-IPF
- MCHC-O
- Delta-HGB
RET Research Yes Yes - x10^2/μL - - - - - - - - - - - - -
RET Research Yes Yes - x10^(-1)% - - - - - - - - - - - - -
• g/L
RET, RBC/PLT Research Yes Yes - - - - - - - - - - - - - -
• x10^(-1) mmol/L
• g/L
RET, RBC/PLT Research Yes Yes - - - - - - - - - - - - - -
• x10^(-1) mmol/L

1) 0.005 to 0.015 ×
10^3/μL r ≥ 0.9 and the
1) 30.0% or less
White blood cell WDF (BF 0.000 to 10.000 × 0.00 to 999.999 0.003 to 10.000 × XN CHECK Manual method 2) 0.016 to 0.030 × slope of the
WBC-BF Reportable - - Yes /μL XN CAL - - 2) 20.0% or less - -
count (Body fluid) mode) 10^3/µL × 10^3/μL 10^3/µL BF (CLSI H56-A) 10^3/μL regression line is
3) 15.0% or less
3) 0.031 to 0.050 × within 1±0.3
10^3/μL

40.0% or less, r ≥ 0.8 and the

Red blood cell 0.000 to 5.000 × 0.000 to 99.999 0.002 to 5.000 × XN CHECK Manual method or 0.003 to 0.05 slope of the
RBC-BF RBC (BF mode) Reportable - - Yes x10^3/μL XN CAL - - - -
count (Body fluid) 10^6/µL × 10^6/μL 10^6/µL BF (CLSI H56-A) Max-Min ≤ 0.007 × 10^6/μL regression line is
× 10^6/μL within 1±0.3

r ≥ 0.9 and the

Mononuclear count WDF (BF 0.000 to 999.999 0.003 to 10.000 × XN CHECK Manual method slope of the
MN# Reportable - - Yes /μL - - - - - - - -
(Body fluid) mode) × 10^3/μL 10^3/µL BF (CLSI H56-A) regression line is
within 1±0.5
r ≥ 0.9 and the
Polymorphonuclear WDF (BF 0.000 to 999.999 0.003 to 10.000 × XN CHECK Manual method slope of the
PMN# Reportable - - Yes /μL - - - - - - - -
count (Body fluid) mode) × 10^3/μL 10^3/µL BF (CLSI H56-A) regression line is
within 1±0.5
r ≥ 0.7 and the
Mononuclear 0.0 to 100.0
WDF (BF XN CHECK Manual method slope of the
percent (Body MN% Reportable - - Yes x10^(-1)% - %/0.000 to 1.000 0.0 to 100.0% - - - - - - -
mode) BF (CLSI H56-A) regression line is
fluid) Ratio
within 1±0.5
r ≥ 0.7 and the
Polymorphonuclear 0.0 to 100.0 %/
WDF (BF XN CHECK Manual method slope of the
percent (Body PMN% Reportable - - Yes x10^(-1)% - 0.000 to 1.000 0.0 to 100.0% - - - - - - -
mode) BF (CLSI H56-A) regression line is
fluid) Ratio
within 1±0.5

1) 0.005 to 0.015 ×
10^3/μL r ≥ 0.9 and the
1) 30.0% or less
Total nuclear cell WDF (BF 0.000 to 10.000 × 0.003 to 10.000 × XN CHECK 2) 0.016 to 0.030 × slope of the
TC-BF# Reportable(*1) - - Yes /μL - - - - 2) 20.0% or less - -
count (Body fluid) mode) 10^3/µL 10^3/µL BF 10^3/μL regression line is
3) 15.0% or less
3) 0.031 to 0.050 × within 1±0.3
10^3/μLL

- HF-BF# WDF (BF Research - - Yes /μL - - - - - - - - - - - - -

- HF-BF% WDF (BF Research - - Yes x10^(- - - - - - - - - - - - - -
- NE-BF# WDF (BF Research - - Yes /μL - - - - - - - - - - - - -
- NE-BF% WDF (BF Research - - Yes x10^(-1)% - - - - - - - - - - - - -
- LY-BF# WDF (BF Research - - Yes /μL - - - - - - - - - - - - -
- LY-BF% WDF (BF Research - - Yes x10^(-1)% - - - - - - - - - - - - -
- MO-BF# WDF (BF Research - - Yes /μL - - - - - - - - - - - - -
- MO-BF% WDF (BF Research - - Yes x10^(-1)% - - - - - - - - - - - - -
- EO-BF# WDF (BF Research - - Yes /μL - - - - - - - - - - - - -
- EO-BF% WDF (BF Research - - Yes x10^(-1)% - - - - - - - - - - - - -
- RBC-BF2 RBC (BF mode) Research - - Yes x10^2/μL - - - - - - - - - - - - -

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Exhibit 1: M145M Parameter List
Parameter
Parameter name name
(abbrev.)
- RET-UPP
- RET-TNC
- H-IPF
- MCHC-O
- Delta-HGB
White blood cell
WBC-BF
count (Body fluid)
Red blood cell
RBC-BF
count (Body fluid)
Mononuclear count
MN#
(Body fluid)
Polymorphonuclear
PMN#
count (Body fluid)
Mononuclear
percent (Body MN%
fluid)
Polymorphonuclear
percent (Body PMN%
fluid)
Total nuclear cell
TC-BF#
count (Body fluid)
- HF-BF#
- HF-BF%
- NE-BF#
- NE-BF%
- LY-BF#
- LY-BF%
- MO-BF#
- MO-BF%
- EO-BF#
- EO-BF%
- RBC-BF2
Exhibit 1 M145M Instrument Design Specification (Parameter List) (Ver. 5)
2014/6/16
Linearity Carryover Stability
Whole blood Stability relative to
Condition (Whole Body fluid mode Stability relative to Stability relative to Within-a-day stability after
mode, Low WBC temperature (Human Within-a-day Day-to-day Temperature
Whole blood mode blood mode, Low (Verification Condition (Verification using temperature power supply collection of blood: Average of 5
Analysis ch Dilution mode mode (Verification Carryover blood: average of 3 stability stability cycling Blank
Low WBC mode WBC mode, and using stable stable substance) (Dilution mode: voltage (Control human blood samples
using stable samples, control (Control blood) (Control blood) (Control blood)
Dilution mode) substance) Human blood) blood) (stored at 18-26°C or at 2-8°C)
substance) blood)
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET - - - - - - - - - - - - - - -
RET, RBC/PLT - - - - - - - - - - - - - - -
RET, RBC/PLT - - - - - - - - - - - - - - -
Residual and
residual rate
with respect to
1) 0.000 to 0.050 × 10^3/µL
the reference
WDF (BF 2) 0.051 to 10.000 × 10^3/µL 0.3% or 0.001 × - (Not defined because sample 0.001 × 10^3/μL
- - - - (logical value) Within 5.0% - Within 5.0% Within 10.0% - -
mode) When RBC is less than 10^3/μL or less changes after collection.) or less
1) Within ±
1.000 × 10^6/µL
0.010 × 10^3/μ
L
2) Within ±20%
Residual and
residual rate
with respect to
0.3% or 0.003 × Within 3.0% or 0.010 - (Not defined because sample 0.003 × 10^6/μL
RBC (BF mode) - - - - the reference 0.000 to 5.000 × 10^6/µL - Within 3.0% Within 5.0% - -
10^6/μL or less × 10^6/μL changes after collection.) or less
(logical value)
±2% or ±0.010
× 10^6/µL
WDF (BF - (Not defined because sample
- - - - - - - - - - - - - -
mode) changes after collection.)
WDF (BF - (Not defined because sample
- - - - - - - - - - - - - -
mode) changes after collection.)
WDF (BF - (Not defined because sample
- - - - - - - - - - - - - -
mode) changes after collection.)
WDF (BF - (Not defined because sample
- - - - - - - - - - - - - -
mode) changes after collection.)
Residual and
residual rate
with respect to
1) 0.000 to 0.050 × 10^3/µL
the reference
WDF (BF 2) 0.051 to 10.000 × 10^3/µL 0.3% or 0.001 × - (Not defined because sample
- - - - (logical value) Within 5.0% - Within 5.0% Within 10.0% - - -
mode) When RBC is less than 10^3/μL or less changes after collection.)
1) Within ±
1.000 × 10^6/µL
0.010 × 10^3/μ
L
2) Within ±20%
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
WDF (BF - - - - - - - - - - - - - - -
RBC (BF mode) - - - - - - - - - - - - - - -
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