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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

7/13

2. Preventive measure before using

(1) Wash hands with clean water and soap and use the alcohol and sponge to disinfect.

(2) Ensure that the needle is new and do NOT use the used one.

3. Measures as per the measuring result

(1) If the result is regarded not to meet the real condition of your body, please check whether the operation is

correct. And test again by the effective test strip, if the result is still same, please consult your physician in
time. Do NOT make change of taking medicine in accordance with the result only.

(2) Regularly compare with the measurement made in hospital is necessary, if you feel the symptom is not

consistent with the results. Please consult your physician for further best treatment.

4. Factors of affecting the accuracy of result, applicable scope and precautions

1

Factors of disease affecting the result:

(a) The packed cell volume is smaller than 35% or bigger than 50%.
(b) The capacity of ending blood circulation obstruction blood is reduced, such as serious dehydration,

hypotension, shock and ending blood vessel diseases.

(c) The level of triglyceride is higher than 57mmol/L.

2

Factors of wrong operation:

(a) The blood volume is not enough, the reaction is not full;
(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 temperature (lower than 10

(50

°F

) or measuring with the deep frozen strip;

(f) Iodine or chlorine disinfection agent is used;
(g) Take blood from the wet finger after being disinfected;
(h) It is placed in the high temperature environment longer than 2 minutes after being unpacked.

3

Why the result of testing the ending blood is not consistent with the value of testing the venous blood glucose

in hospital? Generally, the venous blood test in hospital it take will have 15% difference if compared to the
ending blood test .

1. The blood volume is not enough which shall make the value of testing lower.

2. Pressing the bleeding area shall make a large amount of tissue fluid get into and make the thickness

of blood glucose reduced.

3.The Code card is not used or the password is not consistent with the Code on bottle.

4. The test strip is out of its service life or the bottle has been opened for more than 3 months or longer; the test

strip is damped or polluted;

5.When the alcohol is used for disinfection, the alcohol is not dry or the bleeding area is damped.

6. The iodine is used to make the value higher;

7.The ambient temperature is not proper (the best temperature should be in the range of 10

-40

(50 °F

104 °F))

8. Other factors: the capacity of blood corpuscle is bigger than 60%, other glucides and internal substances,

Содержание eB-D11

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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