Transtek Medical Electronics AW8001-LS Bluetooth Module with Body Fat Analyzer as host User Manual GBF 1257 B 20130102
Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Module with Body Fat Analyzer as host GBF 1257 B 20130102
Contents
User manual Rev01
version:1.0
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development
District, Zhongshan, Guangdong, 528437, China
TEL:86-760-88282982 www.transtek.cn
User Manual
Body Fat Analyzer GBF-1251-B1
Please do read the user manual carefully and thoroughly so as to ensure
the safe usage of this product, and keep the manual well for further
reference in case you have problems.
Thank you very much for selecting the Transtek Body Fat Analyzer
GBF-1251-B1.
Contains FCC ID: OU9AW8001-LS
1
Table of Contents
Table of Contents
Safety Information
Safety and Usage Information
Tips
Overview
Device Components
List
LCD Display
Initial Start-Up
General Instructions
Power Supply
Insert the Batteries
Pair-up
Set Up Your Profile
Select Measurement Unit
Initialising Your Scale
Weight Only Operation
Start Measuring
First Measurement
Daily Measurement
Fast Measurement
Manage Your Health
Body Fat Indicator
Data Transmission
Troubleshooting
Error Prompt
When Measuring ...
When Data Transmitting...
Specifications
Maintenance
Warranty
FCC Regulations
Appendix
Table of Body Fat Level
Table of Body Water Level
Muscle Mass Percentage
Bone Mass Percentage
Health Tips – About Body Fat
EMC Guidance
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4
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5
6
6
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7
8-9
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10
10
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14
15
15-16
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19
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20
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22-25
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2 3
The warning signs and symbols are essential to ensure your correct and safe use of
this product and protect you and others from injury. Please kindly find the meanings of the
warning signs and symbols, which you may encounter in the label and user manual, as
follows:
Safety and Usage Information
Tips
Safety InformationSafety Information
To ensure the accuracy of measurement, please follow below instructions when
you start measurement.
Place the scale on a flat, hard surface. Soft surface such as carpet will affect the
performance of the scale.
Step onto the platform with bare feet. Stand still and keep full contact with the electrodes
until the measurement is complete.
Start measurement at least two hours after Getting up or Dinning.
Avoid measurement immediately after strenuous exercise, sauna or bath, drinking, and
dinning.
Always start measurement in the same time slot and on the same scale located on the
same flat, hard surface.
INDICATIONS FOR USE
The Transtek Body Fat Analyzer measures weight and uses bio-electrical impedance analysis
(BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle
mass in generally healthy children 10-17 years old and healthy adults.
It is intended for use in the domestic setting only.
Transtek’s Body Fat Analyzer GBF-1251-B1 offers you a seamless way to manage your
health. Please be aware that this device is designed for healthy population over 10 years old
self-measuring and self-monitoring body compositions. Any information provided by this
device is in no way meant to treat, cure or prevent any disease or illness from happening.
If in doubt, contact your physician.
This device is contraindicated for any female subject who may be suspected of, or is
pregnant. Otherwise, the effects of this device on the fetus are unknown.
This device is contraindicated for any person who is connected to a wearable or implantable
electronic device or instrument such as a pacemaker or defibrillator.
This device should not be used for anyone who is acutely or chronically ill because of
suffering from a disease or taking medications that affect your water levels. The accuracy of
readings for these patients has not been verified. Specific medical advice should be obtained
from a physician.
GBF-1251-B1 is equipped with data transmission function. It may emit electromagnetic
energy so as to perform its intended function. Nearby portable and mobile RF communications
equipment can affect the performance of GBF-1251-B1. And the device can interfere vicinity
electrical equipment.
Manufacturer will make available on request circuit diagrams, component parts list,etc.
WARNING:No modifications of this equipment is allowed. This may result in increased
EMISSIONS or decreased IMMUNITY of GBF-1251-B1.
Please use the device according to the user manual. Any misuse can cause electric shock,
burns, fire and other unexpected hazards.
Please use and storage the device under the environment which was provided in the user
manual.
Don’t expose the device to extreme temperatures, direct sunlight, moist or corrosive
environment.
Do not step on the scale when your body or feet are wet, especially after bathing or
showering to prevent slipping.
CAUTION
For maximum accuracy and repeatability , it is recommended that you should use the
device in the same time of the day and on the same location.
Body fat percentage estimates will vary with the amount of water in the body, and can
be affected by dehydration or over-hydration due to such factors as alcohol consumption,
menstruation, illness, intense exercise, etc.
The condition of the skin on the bottom of your feet can affect the reading. The natural
effects of aging or activity can make this skin hard. Take the reading with clean, slightly
damp feet for best accuracy. If you are having a problem on operating this scale please
contact customer service.
To prevent you from injury, please pay attention to the following Notice.
A list of known devices or other sources that can potentially cause interference problems
(example 1 Heat from a fireplace or radiant heater. example 2 Moisture from a nebuliser
or steam kettle).
Small parts being inhaled or swallowed.
Potential allergic reactions to accessible materials used in the ME EQUIPMENT.
Contact injuries.
Use accessories, detachable parts and materials not described in the instructions for use.
The effects caused by pets, pests or children
The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade
performance or cause other problems
Symbol for “THE OPERATION
GUIDE MUST BE READ” Symbol for “MANUFACTURER”
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
PARTS”
The Bluetooth Combination Mark
Symbol for “SERIAL NUMBER”
Symbol for “MANUFACTURE
DATE”
Symbol for “DIRECT CURRENT”
4 5
OverviewOverview
List
1. Body Fat Analyzer GBF-1251-B1
2. Four AAA-size Batteries (1.5V each)
3. User Manual
Up Sensor Key
Set Sensor Key
Down Sensor Key
LCD Display
Electrode
Electrode
Device Components
Battery Compartment
UNIT Key Body Fat Level: Low
Body Fat Level: Normal
Body Fat Level:Above Average
Body Fat Level: High
User Interface: Setting
Body Fat Analysis Result
Water Analysis Result
Muscle Mass Analysis Result
Bone Mass Analysis Result
Pound
Kilogram
Percentage
Foot
Centimeter
Age
Man
Sportsman
Woman
Sportswoman
User ID (Range from U1 to U8 )
Successful Bluetooth Connection
Data transmitting / pending to
transmit to wireless wellness system
Low Battery
LCD Display
Body Mass Index
7
6
Transtek Body Fat Analyzer GBF-1251-B1 applies BIA (Bio-impedance Analysis)
technology. A small amount of weak current flows through the human body so as to detect
the bio-impedance and estimate BMI, body fat, body water, muscle mass and bone mass.
The electrical current is small and may not be felt.
This BIA technology is cheap, safe, non-invasive, toxic-free and harmless. It also
possesses the characteristics of simple operation and abundant information.
The current mentioned above is less than 0.5mA. However, please be aware that
anyone with an wearable or implantable medical electronic instrument, such as a
pacemaker, must avoid using this device.
The intended use of this device is for healthy children 10-17 years old and healthy adults.
General Instructions
If SUCCEED, symbol will be shown on the LCD.
If FAIL, symbol “E1” will be shown on the LCD.
Initial Start-UpInitial Start-Up
Pair-Up
With the advanced Bluetooth 4.0 technology applied, the mobile or portable equipments,
which are equipped with Bluetooth function in line with BLE Technical Specifications
established by global organization Bluetooth SIG, are capable to receive your personal
health data.
Turn on Bluetooth and the App. Make sure both are ON when pair-up is proceeding.
Press and hold “UNIT” button in the back of the scale to start pair-up.
Symbol and symbol will be shown on the
LCD alternatively, indicating pair-up is proceeding.
CAUTION
When the symbol appears, the device will power off. Then you shall replace with a new set of
batteries. Please replace all four batteries at the same time. Do NOT mix the old batteries with the new
one.
Worn batteries are hazardous waste. Do NOT dispose of them together with the household garbage.
Please refer to the local ordinances and recycling instructions regarding disposal of the worn batteries
and scrapped device.
If you do not intend to use this unit for a prolonged period of time, it is advisable to remove the batteries
before storing.
Insert the Batteries
Open the battery door in the back of the scale.
Insert the batteries (4 x 1.5V AAA) into the battery
compartment according to the polarity indications
marked inside the compartment.
* The digits “ ” will be shown on the LCD.
Close the battery door and wait until the digits “ ”
are shown on the LCD.
Power Supply
Battery Life: Approx. 120 days
(Battery capacity: 230 mAH. If measured three times per day, each measurement takes about 46s.
The current for measurement is about 30 mA , while the current when shutdown is about 30 uA.)
Battery Mode: 6V, 4 x AAA batteries
9
8
Initial Start-UpInitial Start-Up
The body fat analyzer GBF-1251-B1 supports multiple users (Up to Eight). You may
follow below instructions to assign User ID and set up your own profile, including Gender,
Stature, and Age.
With batteries correctly installed, touch “SET” key to turn on the
device,then touch “SET” key again for about 3s to enter setting.
The system will request User ID selection first. As pictured on the
right, “1” blinks. The operator may touch the function key or
to select User ID among U1 to U8.
Touch “SET” key to confirm User ID.
1.Assigning User ID
2.Setting Data deletion
Set Up Your Profile
After confirming User ID, the system will divert to Data deletion
setting.
As pictured on the right, the letter “n” blinks. The operator may
touch the function key or to select “ ” or “ ”.
Touch “SET” key to confirm Data deletion.
Note: Select the “ ” means the settings of all the users won’t be
deleted;select the “ ” means the settings of all the users will be
deleted.
5.Setting Age
After confirming Stature, the system will divert to Age setting.
As pictured on the right, the digits “30” blinks. The operator may
touch the function key or to increase or decrease the
numeral. (Range: 10 to 85 years old)
You may touch and hold the function key or for fast changing
the numeral.
Touch “SET” key to confirm Age.
When the LCD displays “ ” and “ ” alternately, you may start
measuring.
3.Setting Gender
After confirming Data deletion, the system will divert to Gender
setting.
As pictured on the right, the portrait blinks. The operator may
touch the function key or to select Gender.
Touch “SET” key to confirm Gender.
With batteries correctly installed, press “UNIT” key in the back of the scale to select
measurement unit. The default measurement unit is “lb”. You may press “UNIT” key to
choose between pound and kilogram.
Select Measurement Unit
Note: If there is no operation in the weighing mode, the scale will turn off after about
20 seconds.
4.Setting Stature
After confirming Gender, the system will divert to Stature setting.
As pictured on the right, the digits “ 5’5.0” ” blinks. The operator
may touch the function key or to increase or decrease the
numeral. (Range: 3’3.5” ft to 7’2.5” ft /100 cm to 220 cm)
You may touch and hold the function key or for fast changing
the numeral.
Touch “SET” key to confirm Stature.
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10
Start MeasuringInitial Start-Up
Please process the user setting before your first measurement.
(Refer to Set Up Your Profile for more details)
STEP 3: The measuring results will be displayed
sequentially four times:Weight,BMI, Body
Fat, Muscle Mass,Total Body Water, Bone
Mass,and then turn off.
* If it fails to complete the analysis, the LCD will only display
the weight data.
(To find out the solutions, please refer to Troubleshooting for
more details.)
STEP 1: Step on the platform barefooted.
First Measurement
When your scale is successfully paired with your smartphone and the Bluetooth is ON,
GBF-1251-B1 will process data transmission instead.
(Please refer to Data Transmission for more details.)
Weight Only Operation
Your TRANSTEK Body Fat Analyzer will operate as a conventional
weight - reading scale. No special programming steps are required.
Once the scale is initialized, as previously described, you may simply step on
the scale to measure your current weight. For only weight reading.
1. Position the scale on a flat, hard
surface. Carpeted or uneven
floors may affect accuracy.
2. Step onto the scale platform
and remain still while the
scale computes your weight.
3. The scale will display your
weight value.
4. The scale will automatically
turn off after a few seconds.
Note: The weight value won’t be saved in the scale, and won’t be transmitted to the APP.
1. Press the platform centre and remove your foot.
2. “0.0” will be displayed.
3. The scale will switch off and is now ready for use.
This initialisation process must be repeated if the scale is moved.
At all other times step straight on the scale.
Initialising Your Scale
STEP2: Stand still and the weight data will be locked
with the unit stop blinking.Keep full contact
with the electrodes until the LCD stop displaying
moving “ ”.
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Start Measuring
With original SENSE ON patent technology, GBF-1251-B1
will switch on as you step on the platform barefooted.
If it fails to identify the possible User ID, the LCD will only display the weight data.
(To find out the solutions, please refer to Troubleshooting for more details.)
When your scale is successfully paired with your smartphone and the Bluetooth is ON,
GBF-1251-B1 will process data transmission instead.
(Please refer to Data Transmission for more details.)
Daily Measurement
Stand still and keep full contact with the electrodes until
the LCD stops displaying moving “ ”.
After the weight is locked, if identify the stored weight is
during this weight within+/-4.5 kg,it will identify the
specific user ID.Then the measuring results will be
displayed sequentially four times and then turn off.
If it identifies two or more users,the User ID will be
displayed alternately,for example, U1 and U2,you
may touch or key to select the relative user,
then touch “SET” key to confirm. The measuring
results will then be sorted into the User ID you
selected and displayed sequentially four times and
then turn off.
13
Start Measuring
Your body fat level will also be displayed when the
measuring results are shown on the LCD.
As pictured to the right, the user’s body fat level is LOW.
(Please refer to Table of Body Fat Level for more details.)
If the User ID had set the profile,then the LCD will display “ ”
and “ ” alternately, you may start measuring. The analysis
result will be displayed sequentially four times and then turn off.
Body Fat Indicator
Fast Measurement
If the User ID had’t set the profile,then the scale will turn off
after 3s.
With batteries correctly installed, press “SET” key to turn on the
scale, and the LCD displays 0.0, then you may touch the
function key or to select the User ID.
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Manage Your Health Troubleshooting
When Measuring ...
Problem Root Cause Solution
Incorrect posture
Abnormal
measuring results:
- Too high; OR
- Too low; OR
- Huge difference
between two recent
measurement.
Please step on the platform
barefooted and stand still.
The device is located on
the soft ground such as a
carpet OR on a rugged
surface.
Please place the device on a
flat, hard surface.
Error Prompt
Error Description Solution
Overload. The device will
power off.
Stop using this scale for
measurement.
Low Battery. The device
will power off after about
3s.
Replace all four batteries in the
same time. Please purchase the
authorized batteries for
replacement.
Please check below items:
-Bluetooth is ON.
-App Collector is ON.
-Both devices are within the
transmission distance of Bluetooth.
Failure of pairing up your
scale with your
smatrphone.
With GBF-1251-B1 successfully pair-up with your
smartphone, the measurement data will be
transmitted to your mobile via Bluetooth.
ONLY when the measuring results are attached to a
specific User ID will it be transmitted to your mobile
after measurement.
The symbol will disappear after successful data
transmission, and you may check your personal
health data stored in your smartphone.
If the data transmission fails, the symbol will
remain. The pending measurement data will be
temporarily kept in the scale and transmitted to your
smartphone when next measurement is complete.
Successful Bluetooth
Connection
Data transmitting to
wireless wellness system:
-If SUCCEED, the symbol
disappears;
-If FAIL, the symbol
remains.
Data Transmission
CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol . And
the Analyzer may interfere vicinity electrical equipment.
To enable the data transmission function, this product should be paired to a Bluetooth 4.0 end.
How to mitigate possible interference?
1. The range between the Analyzer and the Bluetooth end should be reasonably close, from 1
meter to 10 meters. Please ensure no obstacles between the Analyzer and the Bluetooth end
so as to obtain quality connection.
2. To avoid interference, other electronic devices (particularly those with Bluetooth transmission
/ Transmitter) should be kept at least 1 meter away from the Analyzer.
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Problem Root Cause Solution
Bluetooth is OFF.
Data transmission
failed.
Turn ON the Bluetooth via
“Setting >> General >> Bluetooth”.
The App is OFF. Press the icon to turn ON your
app.
Place your smartphone closer to
the scale.
Please assign a User ID following
the instruction in Set Up Your
Profile.
Out of range of Bluetooth
transmission.
None of the user ID is
assigned.
Troubleshooting Troubleshooting
When Data Transmitting ...
Problem Root Cause Solution
Either your hands or your
feet are too dry.
Abnormal
measuring results:
- Too high; OR
- Too low; OR
- Huge difference
between two recent
measurement.
No display on
LCD when the
device powers on.
CANNOT proceed
to analyze body fat,
total body water,
muscle mass and
bone mass.
The device
powers off.
Wipe your feet with a damp
cloth, keeping them slightly damp
when starting measurement.
Batteries not yet installed.
Worn batteries.
Low battery.
Install the batteries.
(Please refer to Insert the
Batteries)
Replace all four batteries at the
same time. Please purchase the
authorized batteries for
replacement.
Step onto the platform
wearing socks or shoes.
Please keep barefooted during
the measurement, and keep full
contact with the electrodes as
well.
Replace all four batteries at the
same time. Please purchase the
authorized batteries for
replacement.
The system cannot
identify the possible User ID
with most similar data.
Please assign a User ID
following the instruction in Set Up
Your Profile.
The user fails to select
the User ID from what the
system found.
Please assign a User ID
following the instruction in Set Up
Your Profile.
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Specifications Maintenance
When carrying out usual maintenance, please ensure practice of the following Do’s and
Don’ts:
Transtek warrants its products free of defects in materials and workmanship in normal
use for a period of FIVE years from the date of retail purchase.
This warranty does NOT cover damages caused by misuse or abuse, including but not
limited to:
Failure caused by unauthorized repairs or modifications;
Damage caused by shock or drop during transportation;
Failure caused by improper operation inconsistent with the instructions stated in this user
manual;
Malfunction or damage from failure to provide the recommended maintenance;
Damage caused by improper use of power supply.
Should this device require maintenance (or replacement at our option) under warranty,
please deliver the original package to GUANGDONG TRANSTEK MEDICAL
ELECTRONICS CO., LTD prepaid. Please return the store receipt (with the retail
purchase date) and a note with reasons to return on it as well.
Maintenance
Warranty
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District,
Zhongshan, 528437, Guangdong, China
Tel: 86-760-88282982
Website: http://www.transtek.cn
DO use a dry soft cloth to wipe the dust.
DO use a wet soft cloth, dipped into water and wrung out, to wipe the dirt. Then use a
dry soft cloth to dry up the device.
DON’T wash the device with water or immerse it in water.
DON’T use propellant, abrasive or other chemicals to wipe the dirt in avoidance of
discolor or malfunction.
DON’T disassemble this device. If you have any problems, please contact Transtek.
(Please refer to Warranty for contact information)
Do not dispose of batteries in fire. Batteries may explode or leak. Remove the batteries if
the scale will not be used for a long period.
Specifications
Product Name
Dimension Scale: 310x310x24mm (Approximately)
Net Weight Approximately 1.75kg ( Excluding the dry cells)
Display Digital LCD with White Backlight
Measurement Unit Kilogram / Pound
Measurement Range 5kg to 200kg / 11lb to 441lb
Division 0.1kg / 0.2lb
Accuracy 5-50kg: ±0.3kg;
100-150kg: ±0.5kg;
Working Environment Temperature: 5℃ to 40℃
Storage Environment Temperature: -20℃ to 60℃
Power Source 6V (Four AAA-size Batteries)
Turn on Method SENSE ON technology
Auto-OFF
Accessories 1. Four AAA-size batteries
2. User Manual
50-100kg: ±0.4kg;
150-200kg: ±0.7kg
Humidity: ≤93% RH
Mode of Operation Continuous Operation
Humidity: ≤90% RH
Degree of protection Type BF applied part
Protection Against
Ingress of Water
Software Version
IPX0
1.0
Bluetooth Module No. AW8001
Body Fat Analyzer (GBF-1251-B1)
About 20s after LCD display “0.0”,
or about 15s after the weight is locked,
or about 20s when the weight is unstable.
Atmospheric pressure: 50kPa to 106kPa
Atmospheric pressure: 80kPa to 106kPa
Protection against
ingress of water
IP21, It means the device could protected against solid
foreign objects of 12.5 mm and greater, and against
vertically falling water drops
FCC User Guide Information
Radio Frequency Interface Requirements - FCC
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. 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.
Radio Transmitters (Part 15)
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.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
FCC RF Exposure Guidelines
Safety Information
Reducing RF Exposure - Use Properly
Only operate the device in accordance with the instructions supplied.
This device complies with FCC radiation exposure limits set forth for an uncontrolled
environment.
FCC Regulations
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20
AppendixFCC Regulations
Muscle Mass Percentage
(Source: International Commission on Radiological Protection,1975)
Men
Women
Approximately 40% of total body weight
Approximately 30% of total body weight
Table of Body Fat Level (Unit: %)
Table of Body Water Level (Unit: %)
Standard for Men
Rating
low
Normal
Moderately High
High
Age
20-29
<13 <14 <16 <17 <18
14-20 15-21 17-23 18-24 19-25
21-23 22-24 24-26 25-27 26-28
>23 >24 >26 >27 >28
30-39 40-49 50-59 60+
Standard for Women
Rating
low
Normal
Moderately High
High
Age
20-29
<19 <20 <21 <22 <23
20-28 21-29 22-30 23-31 24-32
29-31 30-32 31-33 32-33 33-35
>31 >32 >33 >34 >35
30-39 40-49 50-59 60+
a) The body fat percentage (%): 5%-60%/0.1%
Source: University of Illinois Department of Food Science and Human Nutrition.
Body Fat Percentage Calculator.
b) The body water percentage (%): 43%-73%/0.1%
Men
Women
BF % RANGE
4 to 14%
15 to 21%
22 to 24%
25 and over
4 to 20%
21 to 29%
30 to 32%
33 and over
70 to 63%
63 to 57%
57 to 55%
55 to 37%
70 to 58%
58 to 52%
52 to 49%
49 to 37%
OPTIMAL TBW % RANGE
Source: Derived from Wang & Deurenberg: “Hydration of fat-free body mass”. American Journal
Clin Nutr 1999,69833-841.
Bone Mass Percentage
(Source: Rico et al.1993)
The average bone mass percentage for both men and women is between 4 to 5%.
Fat is essential for human body. It can not only store energy and protect viscera, but also
regulate body temperature and maintain normal physiological function of human body.
However, too much body fat is harmful to human body. It is always accompanied by Fatty
Liver, diabetes, coronary heart disease, etc.
Therefore self-measuring and self-monitoring body fat level are beneficial to your health.
Since we can’t judge body fat level simply by our weight, this body fat analyzer
GBF-1251-B1, with BIA (Bio-impedance Analysis) technology applied, is an accurate
device that offers a quick and comfortable way to obtain your body fat level.
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Appendix Appendix
Not applicable
Not applicable
Not applicable
Table 2 – Guidance and
MANUFACTURER
’
S
declaration – electromagnetic
IMMUNITY
–
for all
ME EQUIPMENT
and
ME SYSTEMS
Compliance levelElectromagneti c environment
–
guidance
± 6 kV contact
± 8 kV air
ro etercnoc ,doow eb dluohs sroolF
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
a fo taht eb dluohs ytilauq rewop sniaM
typical commercial or hospital
environment.
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
a fo taht eb dluohs ytilauq rewop sniaM
typical commercial or hospital
environment.
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 s
sdleif citengam ycneuqerf rewoP
m/A 3 m/A 3 should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered from an uninterruptible
power supply or a battery.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
IMMUNI TY test
Electrostatic
discharge (ES D)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
lines
EMC Guidance
Health Tips - About Body Fat
Table 1 – Guidance and
MANUFACTURER
’
S
declaration –
ELECTROMAGNETIC EMISSIONS
for all
ME EQUIPMENT
and
ME SYSTEMS
Guidance and manufacturer’s declaration
– electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
The device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may be
affected.
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS.
2. Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell
phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of
3 V/m)
Not applicable
Table 4 – Guidance and
MANUF ACTURER
’
S
declaration – electromagnetic
IMMUNITY
–
for
ME EQUIPMENT
and
ME SYSTEMS
that are not
LIFE
-
SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
I
MMUN I TY
test IEC 60601
TEST
LEVE L
Compliance
level
Electromagnetic environment
–
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 V/m
Recommended separation di stance
P
V
=d ]
5,3
[
1
P=d 2.333
800 MHz to 2,5 GHz
where P is the m aximum output power rat ing 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 deter-
mined 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 transm itters, 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 device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ V1] V/m.
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
device, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
P=d
80 MHz to 800 MHz
1.167
Table 6 – Recommended separation distances between portable and mobile
RF communications equipment and the ME EQUIPMENT or ME SYSTEM –
forME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the device as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum output power
of transmitter
W
150 kHz to 80 MHz
P
V
=d ]
5,3
[
1
80 MHz to 800 MHz 800 MHz to 2,5 GHz
10,0
1,0
1
01
001
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 At 80 MHz and 800 MHz, the separation distance for 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.
0.2330.117
0.7380.369
2.3331.167
7.3783.690
23.3311.67
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
P=d 2.333
P=d 1.167
Appendix
24 25
Appendix