Fudakang EBGBT Blood Glucose Monitor User Manual 2nd TCF

Download:
Mirror Download [FCC.gov]
Document ID	3583429
Application ID	IBB+B8rnS27evHFSSKCZ5Q==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	65.82kB (822804 bits)
Date Submitted	2017-09-27 00:00:00
Date Available	2017-09-27 00:00:00
Creation Date	2017-09-21 11:02:18
Document Lastmod	2017-09-21 11:02:18
Document Title	Microsoft Word - 2nd TCF.doc
Document Creator	WPS Office
Document Author:	Administrator

FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
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
1/13
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
2/13
Table of Contents
I. Standard accessories and product description...................................................................... 1
II. Scope and time of testing.............................................................................................................3
III. Specifications................................................................................................................................. 3
IV. Application and operating environment..................................................................................3
V. Operating instructions.................................................................................................................. 4
VI. Additional functions..................................................................................................................... 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 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. Disposable Lancets
25 PCS / BAG
4. Alcohol sponge
25 PCS
5. Blood glucose device
6. Instruction manual
7. Portable bag
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
3/13
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.
The test strips has been sure of being damped after the single 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 strip could be used
for one time only, do NOT wrap the package and scratch the test strip; do NOT touch the reaction
end; ambient temperature: 10℃-40℃(50 °F～104 °F) 。.
3. Introduction to the test strip
The product is designed as a disposable test strip for the blood glucose monitor, each strip comprises the
following parts.
Confirmation window: the user may see whether there is enough blood got into the reaction area through this
window.
②Blood entry: the blood gets into the test strip via this entry.
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
4/13
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:
(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;
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
5/13
(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;
(3)Put the protective cover of blood taking device on;
(4)Select the depth of taking blood (1→2→3→4→5), generally the depth of 3 is advised.
(5)Pull back the pen to start to take the blood. (Note: do NOT pull the pen by big force to avoid pulling it out).
Step 3: Clean your fingers
Please disinfect by the alcohol sponge with dry and clean fingers.
※Note: do NOT use the iodine to disinfect.
Step 4: Load the batteries (Voice function only suitable for voice model)
(1) Press Power switch to turn on the tester and it shall give voice prompt: “Please check the Code card is correctly
inserted and insert the test strip into the slot”. And then please take out the Code card from the box and insert it
into the device, the LCD shall display the password of the bottle/box of test strips, the password must be same
with the correct mode marked on the package.
Step 5: Insert the test strip
Insert one new test strip and the electrode into the corresponding place of tester. The tester shall display the
code of test strip and the blood entry icon shall blink and voice prompt shall be given: “Please get blood for
testing”.
Note: do NOT use your fingers to touch the reaction area and inserting end (electrode area).
Step 6: Take blood
Method: take the ending whole blood: use the disposable blood taking needle to lance the finger to take blood.
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 displayed.
2. Open APK application and select “Blood Glucose Monitor”, then device will be automatically searched out, then
click corresponding device. After automatically match, measurement is ready to start.
3. Insert test paper, and product is going to prompt: Please drip blood to measure.
4. After measurement, the result will be displayed on the blood glucose monitor and cell phone at the same time.
※ If power off, the matched product should be connected to cell phone again.
5. If result needs to be sent, please chose the data first, and select the sending method by means of text message
or email while inputting the receiver information.
6. Bluetooth function only for Bluetooth model.
※It should make the reaction area full of blood by one time, it’s NOT allowed to add the blood for many times.
Note: the blood shall be absorbed automatically by the principle of siphon.
·Do NOT press the bleeding part by the test strip;
·Do NOT use the test strip to scratch blood;
·It should finish the test within five minutes after taking out the strip.
It shall display the testing result in ten seconds after adding the blood sample,
unit: mmol/L or mg/dL.
（1）Memory: Press Memory key to enable the LCD to display the latest result with voice (time shall be also
displayed), further press Memory key to display the second latest result (time shall be also displayed),
operate by the same method till the desired value is displayed.
※Long press Memory key for five seconds to delete all values.
（2）Calculation of average value: Power ON, press Power and Memory keys for 3 seconds to enable the LCD to
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
6/13
display the average value of the latest 14 tests. (The calculation could be made only when there are 14 or
more testing values)
（3）Maintenance after using: Do NOT damp the tester and wipe off any liquid at the insert and inside; it should use
the soft cloth to wipe off the dirt on the surface; and the product should be stored under the normal
temperature, do NOT place it in the electromagnetic environment or fall it down.
（4）Please take out the batteries if it’s not being used for a long time. （5）
Unit: mmol/L or mg/dL （1mmol/L＝18mg/dL）
1. The symbol of displayed on LCD in the measurement
(a) “888”: self-checking;
(b) When “Bottle” displays and blinks, it’s required to insert the Code card;
(c) When “Test Strip” displays and blinks, it’ required to insert the test strip;
(d) When the symbol of “blood” displays at the top side, it’s required to get the blood;
(e) After getting the blood, it shall count down and display at the left side of LCD, the tester enters the self-testing
state;
(f) The result shall be displayed in XXX（mmol/L） or XXX（mg/dL）; when the result ＜2.2mmol/L （40mg/dL）
LCD shall display “LO”, 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 the “thermometer” symbol displays at the upper side of bottle on LCD, it means the ambient
temperature is higher than the normal working condition, it should use the tester in the ambient temperature of
10℃-40℃(50 °F～104 °F).
(j) When the “month”, “day” and “time” symbol display, it means the date and time of the test.
1. Identification of error information and measures
（1）“Err”—it means the test has error.
Possible reasons: the operating method (step) is wrong; invalid test strip is used; the blood is not enough; the
blood is added repeatedly; the ambient temperature is not in the range of 10℃-40℃(50°F～
104 °F)the test strip is moved in testing; the tester has fault(s).
Suggestion:
①Please read the operating manual carefully to use the blood glucose monitor
correctly and make the test once again by the correct method. ②Please
contact our after-sale service department. （2）“LO”—it means the measuring
value is lower than 2.2 mmol/L（40mg/dL）; “HI”—it means the measuring value
is higher than 27.8 mmol/L (500mg/dL).
Suggestion:
①Check whether the operation is correct by doing the test once again with the
effective test strip, if the value is not changed.Please consult your physician.
②Please contact our after-sale service department.
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
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,
Technical File
FUDAKANG INDUSTRIAL
Co., Ltd.
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
8/13
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. The thickness of blood
glucose of a normal person should be stable and balance.
Reference standard of blood glucose value
Unit conversion: 1mmol/L=18mg/dL
Limosis : 70mg/dL-110mg/dL(3.9mmol/L-6.1mmol/L)
30
minutes after dinner: 100mg/dL-180mg/dL (5.6mmol/L-10.0mmol/L)
60
minutes after dinner: 90mg/dL-170mg/dL (5.0mmol/L-9.4mmol/L)
120 minutes after dinner: 75mg/dL-135mg/dL (4.2mmol/L-7.5mmol/L)
180 minutes after dinner: 70mg/dL-110mg/dL (3.9mmol/L-6.1mmol/L)
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
9/13
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.
2) * Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3)
Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
4) * Caution: this machine should not be used adjacent to or 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 or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
Note: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a
particular installation.
Technical File
FUDAKANG INDUSTRIAL
Co., Ltd.
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
10/13
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of
the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
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.
Emission test
Compliance
Electromagnetic environment – guidance
Group 1
The eB-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.
Class B
The eB-G-BT is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
RF emissions
CISPR 11
RF emission
CISPR 11
Guidance and manufacture’s declaration – electromagnetic immunity
The eB-G-BT is intended for use in the electromagnetic environment specified below. The customer or the user of
eB-G-BT should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power
frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
NOTE
IEC 60601 test level
Compliance level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
3 A/m
3 A/m
UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic environment guidance
Floors should be wood, concrete
or ceramic tile. If floor are covered
with synthetic material, the
relative humidity should be at
least 30%.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial
or
hospital
environment.
FUDAKANG INDUSTRIAL
Co., Ltd.
Technical File
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
11/13
Guidance and manufacture’s declaration – electromagnetic immunity
The eB-G-BT is intended for use in the electromagnetic environment specified below. The customer or the
user of the eB-G-BT should assure that it is used in such an environment.
Immunity
IEC 60601 test
Compliance
Electromagnetic environment - guidance
test
level
level
Portable and mobile RF communications equipment should
be used no closer to any part of the eB-G-BT, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Not applicable
3 V/m
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as determined
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:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. 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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
FUDAKANG INDUSTRIAL
Co., Ltd.
File No
Rev. No
Rev. Date
Page
Technical File
8. Instruction for Use
TCF-004-8
07.09..2017
12/13
Recommended separation distances between
portable and mobile 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.
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
(m)
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.12
0.12
0.23
0.38
0.38
0.73
1.2
1.2
2.3
3.8
3.8
7.3
(W)
0.01
0.1
10
12
12
23
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
NOTE 2
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
FCC ID: 2ADNQEBGBT
This device complies with Part 15 of the FCC Rules. Operation is subject to the
Following two conditions:
(1) This device may not cause harmful interference, and (2) This device must accept any interference
received , including interference that may cause undesired operation.
Technical File
FUDAKANG INDUSTRIAL
Co., Ltd.
8. Instruction for Use
File No
Rev. No
Rev. Date
Page
TCF-004-8
07.09..2017
13/13
Explanation of Symbols:
LOT
Symbol for batch code
Symbol for manufacturer
Symbol for ‘CE”
Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be
disposed of with household waste. Please recycle where facilities exist. Check 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”
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
EC Representative:
FANTRONIC COMPOSANTS
Address: Rue Jacques Laurent ZA-Sud-Est-BP11-85150 LA MOTHE ACHARD-FRANCE
Software Version V1.2
Manual Version: V1.0

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.7
Linearized                      : No
Page Count                      : 13
Author                          : Administrator
Comments                        : 
Company                         : 
Create Date                     : 2017:09:21 11:02:18+03:02
Creator                         : WPS Office
Modify Date                     : 2017:09:21 11:02:18+03:02
Producer                        : 
Source Modified                 : D:20170921110218+03'02'
Subject                         : 
Title                           : Microsoft Word - 2nd TCF.doc
Trapped                         : false

EXIF Metadata provided by EXIF.tools