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FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
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,eB-D12,eB-D21,eB-D31,
eB-D32,eB-D33,eB-D34,eB-D35,eB-D41,
eB-D42,eB-D43,eB-D51,eB-D52
File No
Rev. No
Rev. Date
Page
TCF-004-8
1
07.09..2017
1/13
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Summary of Contents for Fudakang eB-G-BT
- Page 1 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 1/13 Page 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,eB-D12,eB-D21,eB-D31, eB-D32,eB-D33,eB-D34,eB-D35,eB-D41, eB-D42,eB-D43,eB-D51,eB-D52...
- Page 2 X. Statements and Declarations...................... 9 Hand-hold quick blood glucose testing system consists of the following parts. Standard accessories: Blood glucose monitor 1 set (eB-G-BT and suitable for all Blood Glucose monitor) 1. Blood glucose test strip box 25 PCS 2. Lancing Device 1 PIECE 3.
- Page 3 8. Instruction for Use 3/13 Page All the accessories shall be subject to the real package Description of model no.: eB-G-BT blood glucose monitor Description of the Display Description of test strip 1. Introduction to the package of box Each box have 25 pcs single package test strips to prevent each one of test strips being affected with damp.
- Page 4 ③Electrode: 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:...
- Page 5 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 5/13 Page (2)Insert the new blood needle and then use one hand to hold the needle and use the other hand to open the protective cover;...
- Page 6 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 6/13 Page display the average value of the latest 14 tests. (The calculation could be made only when there are 14 or more testing values) （3）...
- Page 7 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 7/13 Page 2. Preventive measure before using (1) Wash hands with clean water and soap and use the alcohol and sponge to disinfect.
- Page 8 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 8/13 Page medicines (vitamin C) and uric acid. What are blood glucose and the reference standard of blood glucose value? Blood glucose means the glucose in blood, other kinds of glucides such as fructose, disaccharide and polysaccharide, could not be called blood glucose until they are converted to glucose.
- Page 9 File No TCF-004-8 Technical File FUDAKANG INDUSTRIAL Rev. No Co., Ltd. 07.09..2017 Rev. Date 8. Instruction for Use 9/13 Page STATEMENTS AND DECLARATIONS: 1) This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
- Page 10 Should you have any inquire, pls feel free to contact me. Guidance and manufacture’s declaration – electromagnetic emission The eB-G-BT is intended for use in the electromagnetic environment specified below. The customer of the user of the eB-G-BT should assure that it is used in such an environment.
- Page 11 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the eB-G-BT is used exceeds the applicable RF compliance level above, the eB-G-BT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the eB-G-BT.
- Page 12 RF communications equipment and the eB-G-BT . The eB-G-BT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the eB-G-BT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the eB-G-BT as recommended below, according to the maximum output power of the communications equipment.
- Page 13 Symbol for “TYPE BF APPLIED PART” Symbol for “Follow operating instructions” IP22 Symbol for “the IP classification” Symbol for “ RF transmitters” Manufacturer: FUDAKANG INDUSTRIAL CO., LTD Address:No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, Dongguan, Guangdong China. Tel: 86-769-81098181 Fax: 86-769-81098187 Website: www.fudakang.com...
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