3

2

1

www.ceragemmedisys.com

3Fast Screening! - Only 5 seconds!

Easy Testing! - Only 1 ul blood sample!

Model no. M 400

GLUCOSE

HEMOGLOBIN

LACTATE

Test Parameters

1Meter

Blood Glucose, Hemoglobin, Lactate Monitoring System

ⓒ 2013 CERAGEM MEDISYS Inc.

M 400 Monitoring SystemGlucose & Hemoglobin & Lactate

www.ceragemmedisys.com

sales@ceragemmedisys.comTEL. +82-70-8894-2725 FAX. +82-41-551-0667

STRIP TECHNOLOGY

Stable results in spite of environmental changes with technology of netro-junction.

Other products: for single parameter use

CERAGEM MEDISYS INC has shown world's first hetero-junction technology in strip technological field. CERA-CHEK 3 in 1 strips are made of plastic not film. It helps the strip to indicate stable results amongst various climatic conditions.

CERAGEM MEDISYS serves OEM/ODM by providing customized system and design a particular market demands. Our accumulated technology and built up know-how produce such superiorly valued products. The world's most extraordi-nary quality control system of CERAGEM MEDISYS has a strong stablized production facility. If you had been searching for decent products that may enhance your brand value, you have just found it. Contact our marketing department this minute!

Code freeFAD-GDH EnzymeGold Electrode0.5ul, 5 secondsNeonatal & gestational testing

CERA-CHEK™ 1 Code

Excellent Performance

1ul, 5 secondsHematocrit displayedNo extra cleaningUSB interfaceExternal Pinter

CERA-CHEK™ Hb plus

Any time, Anywhere, Quick testing

Short testing time(10 sec.)Small blood volume Large capacity of memoryWide measurement rangeNo interference from pH and pO2

CERA-CHEK™ Lactate

Rapid Hand-held Lactate Meter

OEM / ODM service

M40IF0C

00 (07/13)

1

2

3

M 400 Monitoring SystemGlucose & Hemoglobin & Lactate

Fast Screening! – Only 5 seconds!Easy Testing! – Only 1 ul blood sample!

PRODUCT DESCRIPTIONS

MethodologyLED IndicatorParametersMemoryOperating ConditionStorage ConditionBatteryBattery LifePC InterfaceWeightDimension

ElectroChemistryIndication LED Lighting (Red, Blue, Green)Blood Glucose, Hemoglobin, LactateGlu: 500, Hb: 250, Lac: 250 test resultsTemp.: 4 ~ 40 ℃, Humidity: <85%-10 ~ 60 ℃CR-2032 (2 x Lithium coin battery)3,000 testsUSB40 g (with battery) 58(W) x 101.5(L) x 12.5(T) mm

Meter Specification

Strip Specification

Glucose HemoglobinGDH-FAD N/A

10 ~ 900 mg/dL 5 ~ 26 g/dL

mg/dL (mmol/L) g/dL

5 Sec. 5 Sec.

0.5 ㎕ 1 ㎕Capillary, Venous,

AST Capillary, Venous

10 ~ 70 % 20 ~ 60 %

Autocode Code-Key

4 months 3 months

24 months 18 months

ParametersEnzyme

Test Range

UnitTest Time

Sample Volume

Sample Type

Hematocrit Range

Calibration

Expiry Date (After Opening)

Shelf Life

Storage Condition 1 ~ 32 ℃ 1 ~ 32 ℃

LactateLactate Oxidase

0.5 ~ 25 mmol/L

mmol/L (mg/dL)

10 Sec.

1 ㎕

Capillary, Venous

20 ~ 60 %

Code-Key

3 months

18 months

1 ~ 32 ℃

HEMOGLOBIN

SYSMEX KN-21 Hb(g/dL)

CE

RA

-CH

EK

™ H

b(m

g/dL

)

0

5

10

15

20

25

5 10 15 20 25 30

N=100 y = 0.9757x + 0.5201 R² = 0.9606

YSI 2300 Lactate Analyzer(mmol/L)5.0 10.0 15.0 20.0 25.0 30.0

0.0

5.0

10.0

15.0

20.0

25.0

30.0

CE

RA

CH

EK

™ L

acta

te (

mm

ol/L

)

N=48 y = 0.9819x + 0.0094 R² = 0.996

LACTATE

CERA-CHEK™ 3 in 1 GHL provides accurate results of various tests.

Blood G

lucose, Hem

oglobin, Lactate Monitoring System

CERA

-CHEK

™ 3 in 1 G

HL

In fingertip testing, accuracy of the CERA-CHEK™ 3 in1 GHL Hemoglobin Monitoring System was demonstrated by comparing results from 100 patients.

In fingertip testing, accuracy of the CERA-CHEK™ 3 in1 GHL Lactate Monitoring System was demonstrated by comparing results from 48 patients.

1 Meter, 3 Parameters.3 parameters measured with just one meter.Alternative tests measured by simply changing a code key.

Fast and Easy test procedure.Strip grip ensures safety and prevents from blood infections.Simple measuring method for everyone's use.Accurate test results in 5~10 seconds.

Functions for convenient use.Saves 1,000 memories. Durable battery over 3,000 tests.

SYSTEM ACCURACY

CE

RA

-CH

EK

™ (

mg/

dL)

CERA-CHEK™ 3 in 1 GHL provides accurate results of various tests.

The 100 test results, 100(100 %) were in Zone A (clinically accurate).

The CERA-CHEK™ 3in1 GHL Blood Glucose monitoring system demonstrated excellent accuracy.

< 75 mg/dL ≥ 75 mg/dL

within ± 5 mg/dL

within ± 10 mg/dL

within ± 15 mg/dL

70% (7/10)

90% (9/10)

100% (10/10)

72% (65/90)

91% (82/90)

100% (90/90)

within ± 5%

within ± 10%

within ± 15%

Blood Glucose, Hemoglobin, Lactate Monitoring System

Glucose Hemoglobin Lactate

+ +

Sip-in blood absorption

Indicating LED light

Large LCD Window

Alarm set

1000 memories

Easy Handled Button

1. Insert test strip 2. Apply sample 3. Accurate result just in 10 seconds

GLUCOSEy = 1.007 x 0.932

R² = 0.983, N = 100

YSI 2300 STAT Plus (mg/dL)

In fingertip testing, accuracy of the CERA-CHEK™ 3 in1 BGM system was demonstrated by comparing results from 100 patients with the YSI plasma equivalent glucose values.

450

400

350

300

250

200

150

100

50

050 100 150 200 250 300 350 400 450

E

C

B

B D

AA

EC

D