Transtek Medical Electronics AW8001-LS User Manual

User Manual
version:1.0
Body Fat Analyzer
GBF-1251-B1
Contains FCC ID: OU9AW8001-LS
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
Thank you very much for selecting the Transtek Body Fat Analyzer GBF-1251-B1.
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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3
4
4
5
6
6
6
7
8-9
9
10
10
11
12
13
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14
15
15-16
17
18
19
19
20
21
21
21
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22
22-25
1
Safety and Usage Information
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 InformationSafety Information
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.
Tips
Symbol for “THE OPERATION GUIDE MUST BE READ”
The Bluetooth Combination Mark
Symbol for “TYPE BF APPLIED PARTS”
Symbol for “MANUFACTURE DATE”
Symbol for “SERIAL NUMBER”
Symbol for “MANUFACTURER”
Symbol for “DIRECT CURRENT”
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”
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.
CAUTION
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.
Always start measurement in the same time slot and on the same scale located on the same flat, hard surface.
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.
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.
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.
To prevent you from injury, please pay attention to the following Notice.
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.
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).
The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems
The effects caused by pets, pests or children
2 3
OverviewOverview
Device Components
LCD Display
Electrode
Up Sensor Key
Set Sensor Key
Down Sensor Key
Electrode
UNIT Key
Battery Compartment
LCD Display
Body Fat Level: Low
Body Fat Level: Normal
Body Fat Level:Above Average
Body Fat Level: High
User Interface: Setting
Body Mass Index
Percentage
Foot
Centimeter
Age
Man
Sportsman
List
1. Body Fat Analyzer GBF-1251-B1
2. Four AAA-size Batteries (1.5V each)
3. User Manual
Body Fat Analysis Result
Muscle Mass Analysis Result
Water Analysis Result
Bone Mass Analysis Result
Pound
Kilogram
Woman
Sportswoman
User ID (Range from U1 to U8 )
Successful Bluetooth Connection
Data transmitting / pending to transmit to wireless wellness system
Low Battery
4 5
Initial Start-UpInitial Start-Up
General Instructions
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.
Power Supply
Battery Mode: 6V, 4 x AAA batteries 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.)
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.
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.
If SUCCEED, symbol will be shown on the LCD.
If FAIL, symbol “E1” will be shown on the LCD.
Close the battery door and wait until the digits “ ” are shown on the LCD.
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.
6
7
Set Up Your Profile
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.
1.Assigning User ID
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.
2.Setting Data deletion
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.
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.
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.
Select Measurement Unit
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.
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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9
Start MeasuringInitial Start-Up
Initialising Your Scale
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.
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.
First Measurement
Please process the user setting before your first measurement. (Refer to Set Up Your Profile for more details)
STEP 1: Step on the platform barefooted.
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 “ ”.
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.)
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Note: The weight value won’t be saved in the scale, and won’t be transmitted to the APP.
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.)
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Start Measuring
Start Measuring
Daily Measurement
With original SENSE ON patent technology, GBF-1251-B1 will switch on as you step on the platform barefooted.
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.
Fast Measurement
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.
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.
If the User ID had’t set the profile,then the scale will turn off after 3s.
Body Fat Indicator
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.)
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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.)
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Manage Your Health Troubleshooting
Error Prompt
Data Transmission
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.
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.
Successful Bluetooth Connection
Data transmitting to wireless wellness system:
-If SUCCEED, the symbol disappears;
-If FAIL, the symbol remains.
Error Description Solution
Overload. The device will
power off.
Low Battery. The device will power off after about 3s.
Failure of pairing up your scale with your smatrphone.
Stop using this scale for
measurement.
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.
When Measuring ...
Problem Root Cause Solution
Abnormal
measuring results:
- Too high; OR
- Too low; OR
- Huge difference between two recent measurement.
Incorrect posture
The device is located on the soft ground such as a carpet OR on a rugged surface.
Please step on the platform
barefooted and stand still.
Please place the device on a
flat, hard surface.
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13
15
Troubleshooting Troubleshooting
Problem Root Cause Solution
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.
Either your hands or your
feet are too dry.
Batteries not yet installed.
Worn batteries.
Step onto the platform
wearing socks or shoes.
The system cannot identify the possible User ID with most similar data.
Wipe your feet with a damp cloth, keeping them slightly damp when starting measurement.
Install the batteries.
(Please refer to Insert the Batteries)
Replace all four batteries at the same time. Please purchase the authorized batteries for replacement.
Please keep barefooted during the measurement, and keep full contact with the electrodes as well.
Please assign a User ID following the instruction in Set Up Your Profile.
When Data Transmitting ...
Problem Root Cause Solution
Bluetooth is OFF.
The App is OFF.
Data transmission
failed.
Out of range of Bluetooth
transmission.
None of the user ID is
assigned.
Turn ON the Bluetooth via
“Setting >> General >> Bluetooth”.
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.
powers off.
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The device
The user fails to select the User ID from what the system found.
Low battery.
Please assign a User ID following the instruction in Set Up Your Profile.
Replace all four batteries at the same time. Please purchase the authorized batteries for replacement.
17
Specifications
Specifications
Product Name
Dimension Scale: 310x310x24mm (Approximately)
Net Weight
Display Digital LCD with White Backlight
Measurement Unit
Measurement Range
Division
Accuracy
Working Environment
Storage Environment
Power Source
Turn on Method
Auto-OFF
Accessories
Mode of Operation Continuous Operation
Degree of protection Type BF applied part
Protection against
ingress of water
Protection Against
Ingress of Water
Body Fat Analyzer (GBF-1251-B1)
Approximately 1.75kg ( Excluding the dry cells)
Kilogram / Pound
5kg to 200kg / 11lb to 441lb
0.1kg / 0.2lb
5-50kg: ±0.3kg; 100-150kg: ±0.5kg;
Temperature: 5 to 40 Atmospheric pressure: 80kPa to 106kPa
Temperature: -20 to 60
Atmospheric pressure: 50kPa to 106kPa
6V (Four AAA-size Batteries)
SENSE ON technology
About 20s after LCD display “0.0”, or about 15s after the weight is locked, or about 20s when the weight is unstable.
1. Four AAA-size batteries
2. User Manual
IP21, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops
IPX0
50-100kg: ±0.4kg; 150-200kg: ±0.7kg
Humidity: ≤90% RH
Humidity: ≤93% RH
Maintenance
Maintenance
When carrying out usual maintenance, please ensure practice of the following Do’s and
Don’ts:
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.
Warranty
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.
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
Software Version
Bluetooth Module No.
18
1.0
AW8001
19
AppendixFCC Regulations
FCC Regulations
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
Table of Body Fat Level (Unit: %)
a) The body fat percentage (%): 5%-60%/0.1%
Standard for Men
Rating
20-29
low
Normal
Moderately High
High
Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator.
<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
Age
30-39 40-49 50-59 60+
Standard for Women
Rating
20-29
low
Normal
Moderately High
High
<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
Age
30-39 40-49 50-59 60+
Table of Body Water Level (Unit: %)
b) The body water percentage (%): 43%-73%/0.1%
Source: Derived from Wang & Deurenberg: “Hydration of fat-free body mass”. American Journal
Clin Nutr 1999,69833-841.
OPTIMAL TBW % RANGE
70 to 63%
63 to 57%
57 to 55%
55 to 37%
70 to 58%
58 to 52%
52 to 49%
49 to 37%
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
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.
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Muscle Mass Percentage
(Source: International Commission on Radiological Protection,1975)
Men
Women
Approximately 40% of total body weight
Approximately 30% of total body weight
Bone Mass Percentage
(Source: Rico et al.1993)
The average bone mass percentage for both men and women is between 4 to 5%.
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Appendix Appendix
Health Tips - About Body Fat
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.
EMC Guidance
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)
Tab le 1 – G uid ance and
Guidan ce and m anufact urer’ s d ecl arati on – elec tro magne tic e mis sions
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 te st Compliance Electromagnetic environment-guidance
MAN UFAC TURER’S
for all
ME EQ UIPMEN T
de cla rat ion –
an d
ME SY STEM S
ELE CTROM AGNE TIC E MISSIONS
Tab le 2 – Gu idan ce and
MANU FACTUR ER’S
ME EQUI PMENT
for all
de cla rati on – elec tro mag net ic
and
ME SYST EMS
Guid ance a nd manuf act ure r’s de cla ration – ele ctr oma gne tic immu nit y
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.
I
MMUNI TY
Electros tatic discharge (ESD)
IEC 61000-4 -2
Elec trical fa st transi ent/burst
IEC 61000-4 -4
Surge
IEC 61000-4 -5
Volt age dips , short inte rrupti ons and volt age var iations on power suppl y input li nes
IEC 61000-4 -11
Powe r frequ ency (50/60 H z) magneti c field
IEC 61000-4 -8
NOTE U
IEC 60601
tes t
test le vel
± 6 k V conta ct
± 8 k V air
± 2 kV for p ower
supply lines
± 1 k V for input /output lines
± 1 k V line(s) t o line(s )
± 2 k V line(s) t o e arth
<5 % U
T
(>95 % dip in UT) for 0, 5 cyc le
40 % U
T
(60 % di p in UT) for 5 cycles
70 % U
T
(30 % di p in UT) for 25 cycles
<5 % U
T
(>95 % dip in U for 5 s
is t he a.c. m ains vol tage p rior to a pplication of the test l evel.
T
)
T
m/A 3 m/A 3
Compliance l evel
± 6 k V conta ct
± 8 k V air
Not applicab le
Not applicab le
Not applicab le
Electroma gnetic environment
guidance
cerami c tile. If floors a re cov ered wit h synt hetic m aterial, the relativ e humidi ty should be at leas t 30 %.
typi cal co mmercial or hospit al envir on
ment.
typi cal co mmercial or hospit al envir onment.
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.
should be at le vels c haracteris tic o f a typi cal lo cation in a typica l commerci al or hos pital envir onment.
IMM UNITY
ro etercnoc ,doow eb dluohs sroolF
a fo taht eb dluohs ytilauq rewop sniaM
a fo taht eb dluohs ytilauq rewop sniaM
sdleif citengam ycneuqerf rewoP
22
RF em issions
CISPR 11
RF em issions
CISPR 11
Harmonic emissions
IEC 6100 0-3-2
Vol tage fl uctuatio ns/ flick er emissions
IEC 6100 0-3-3
Group 1
Class B
Not app licab le
Not app licab le
The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
23
Appendix
Appendix
Tabl e 4 – G uidanc e and
for
ME EQUIP MENT
MANU FACTUR ER’S
and
ME SYSTEM S
dec laratio n – el ect roma gnetic
tha t are n ot
LIFE-SUPPOR TING
IMMUNI TY
Guid ance an d manufa cturer’ s decl aration – ele ctro magnet ic i mmunity
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.
I
MMUNIT Y
tes t
IEC 60601
LEVEL
Conducted RF
IEC 61000-4-6
Radiate d RF
IEC 61000-4-3
NOTE 1 At 80 M Hz and 800 MHz, the higher f requency range ap plies.
NOTE 2 These guidelin es may not apply in al l sit uations. Electrom agnetic propagati on is affected by absor ption and refle ction fr om st ructures, obje cts an d peopl e.
Field stre ngths from fi xed transmit ters, such as base stat ions for radio (cell ular/c ordless) telep hones and land
a
Over the f requency range 1 50 kHz t o 80 MH z, field s trengths should be less than [ V1] V/m.
b
3 Vr ms
150 kHz to 80 MHz
3 V/ m
80 MHz to 2,5 GHz
mobile radi os, amateur ra dio, AM and FM radio bro adcast and TV broadcas t c annot b e p redicted theo retica lly with accuracy . 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.
To assess the elect romagneti c env ironment due t o fixed RF tr ansmitters, an e lectrom agnetic site
TEST
Complia nce
level
Not a pplicabl e
Electroma gnetic 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.
Recommended separation distance
5,3
P
=d ]
[
V
1
1.167
P=d
P=d 2.333
800 MHz to 2,5 GHz
b
80 MH z to 8 00 MHz
3 V/m
where P is the m aximum output p ower r ating of the transmi tter in watts (W) a ccording to the transm itter manufac turer an d d i s the reco mmended sep aration dist ance in metres ( m).
Fiel d strengt hs from f ixed RF tr ansmitters , as det er­mined by an el ectrom agnetic s ite surv ey, less than t he complian ce level in eac h freque ncy range.
Interf erence may occur in the vi cinity of equi pment marked with the followin g sym bol:
guidance
a
sho uld be
Tab le 6 – Reco mme nded sep ara tion dis tance s betwee n por tab le and m obile
RF commu ni catio ns eq uip ment and the
ME EQ UIP MEN T and ME SYS TEMS tha t a re no t L IFE-S UPPORTING
for
portable an d mob ile RF c omm unic ati ons e quipm ent a nd 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.
Recomm end ed se paration d istan ces b etw een
Separati on distance according to frequenc y of t ransmitter
Rate d maximum output power
of t ransmit ter
W
150 kHz to 80 M Hz
5,3
P
=d ]
[
V
1
Not app lica ble
Not app lica ble
Not app lica ble
Not app lica ble
Not app lica ble
For tr ansmitters rat ed at a m aximum output po wer not listed a bove, the re commended s eparatio n di stance d i n met res (m) can be esti mated u sing the e quation a pplicabl e to the freq uency of the t ransm itter, where P is t he
maxi mum out put power rating o f the transm itter in watts (W) accordi ng to the transm itter manufa cturer .
NOTE 1 At 80 MHz a nd 800 MHz, the s eparati on dista nce f or the h igher f req uency ra nge applies .
NOTE 2 T hese guide lines m ay not apply in all s ituations . Electrom agnetic prop
refle cti on from struct ures, object s and peop le.
ME EQ UIPMEN T o r M E SYS TEM
m
80 MH z to 800 M Hz 800 M Hz to 2, 5 GHz
1.167
P=d
2.333
P=d
10,0
0.2330.117
1,0
0.7380.369
1
2.3331.167
01
7.3783.690
23.3311.67
001
agatio n is affected by absorption and
24 25
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