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FUDAKANG INDUSTRIAL

Technical File

File No

TCF-004-8

Rev. No

1

Co., Ltd.

8. Instruction for Use

Rev. Date

07.09..2017

Page

4/13

3

Electrode: insert this end into the corresponding place of the blood glucose tester to start the device,

please keep the blue arrowhead side upwards in inserting.

1.Testing scope: 2.2 mmol/L

27.8mmol/L (40mg/dL

500mg/dL).

2.Testing time: ≤10s.

1.Model No.: eB-G-BT

(Suitable for eB-D12-BT,eB-D33-BT,eB-D34-BT,eB-D43-BT,eB-D44-BT,eB-D45-BT,eB-D52-BT

eB-G,eB-D11,eB-D12,eB-D21,eB-D31,eB-D32,eB-D33,eB-D34,eB-D35,eB-D41,eB-D42,eB-D43,

eB-D51,eB-D52)

2.Parameters of blood glucose monitor:

(a) Power supply: DC 3.0V (two AAA alkaline batteries);

(b) Display mode: mmo1/L or mg/dL display and testing time display;

(c) Times of result memory: 180 times;

(d) Dimensions: 80mm*58mm*23mm ;

(e) Weight: 46g

(f) Rated power: 30mW.

3.Type of test strip: Siphon type

4.Parameters of test strip

(a) Dimensions: 32mm×8mm×0.8mm (L*W*D)

(b) Nominal weight: 0.5g/piece

·

The product must be used together with siphon blood glucose test strip produced.

·

Blood glucose monitor is applicable for out-of-body test only.

·

Blood glucose monitor is applicable for the test of ending whole blood.

Ambient conditions (normal working conditions)

(a) Ambient temperature: 10

-40

(50 °F

104 °F);

(b) Relative humidity: ≤80%;

(c) Atmospheric pressure: 700hPa

1060hPa;

(d) Power supply: DC 3.0V (two AAA alkaline batteries);

1. Use the blood glucose monitor to test the blood glucose. Step

1: adjustment of time

Power On: Press Power switch for five seconds to enter the setup interface of time. Firstly the Year place shall
blink, press Memory key to adjust the year and then further press Power key to enter the adjustment interface of
month, use the same operation to finish the adjustment of day, hour and minute.

Step 2: Installation of pinhead

(1)Open the protective cover of blood taking device;

Summary of Contents for eB-D11

Page 1: ...for Use Rev Date 07 09 2017 Page 1 13 Instruction for Use Blood Glucose Monitor and Blood Glucose Test Strip eB G BT eB D12 BT eB D33 BT eB D34 BT eB D43 BT eB D44 BT eB D45 BT eB D52 BT eB G eB D11 e...

Page 2: ...s 5 VII Description and explanation of icon on LCD 6 VIII Troubleshooting and precautions 7 VIIII Knowledge on blood glucose and diabetes 8 X Statements and Declarations 9 Hand hold quick blood glucos...

Page 3: ...ingle package has been opened for three months and do NOT use them 2 Introduction to the package of test strip It should finish the test within five minutes after the test strip is opened the test str...

Page 4: ...mW 3 Type of test strip Siphon type 4 Parameters of test strip a Dimensions 32mm 8mm 0 8mm L W D b Nominal weight 0 5g piece The product must be used together with siphon blood glucose test strip prod...

Page 5: ...Step 7 Application of sample 1 Please apply the blood sample at the siphon mouth of reaction area when the LCD displays Blood Entry 1 Press Button Power shortly to turn on and 88 8 will be fully disp...

Page 6: ...and then the result 27 8 mmol L 500mg dL LCD displays HI g When LCD displays Err it means the test has error h When the symbol displays it means the batteries is used up and should be replaced i When...

Page 7: ...ll b The initial blood sample is not enough measuring the test after adding the blood again c The blood sample is polluted d The test strip is pulled out and then inserted e It s stored in the low tem...

Page 8: ...lysaccharide could not be called blood glucose until they are converted to glucose The thickness of blood glucose of a normal person should be stable and balance Reference standard of blood glucose va...

Page 9: ...r stacked with other equipment and that if adjacent or stacked use is necessary this machine should be observed to verify normal operation in the configuration in which it will be used Warning changes...

Page 10: ...G BT use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The e...

Page 11: ...by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF...

Page 12: ...Hz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended sepa...

Page 13: ...with your local Authority or retailer for recycling advice Symbol for TYPE BF APPLIED PART Symbol for Follow operating instructions IP22 Symbol for the IP classification Symbol for RF transmitters Ma...

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