Transtek Medical Electronics AW2540-LS User Manual

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User Manual

version:1.0

Body Fat Analyzer

GBF-1319-B

Contains FCC ID:OU9AW2540-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-1319-B.

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.

Safety Information

Safety and Usage Information

Your Scale and Its Environment

Efficient Use of Your Scale

Overview

Device Components

LCD Display

Initial Start-Up

General Instructions

Insert the Batteries

Select Measurement Unit

Pair-up

Set Up Your Profile

Initialising Your Scale

Weight Only Operation

Start Measuring

First Measurement

Daily Measurement

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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Table of Contents

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10-12

15-16

19-20

27-30

Safety InformationSafety Information

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:

Symbol for “THE OPERATION GUIDE MUST BE READ”

The Bluetooth Combination Mark

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

Symbol for “INDOOR USE ONLY”

CAUTION

Transtek’s Body Fat Analyzer GBF-1319-B offers you a seamless way to manage your health. Please be aware that this device is designed for adults’ self-measuring and self-monitoring body fat level. Any information provided by this device is in no way meant to treat, cure or prevent any disease or illness from happening. This device should not be used by anyone who is acutely or chronically ill, 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-1319-B 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-1319-B.

Portable and mobile RF communications equipment can affect the measuring accuracy of GBF-1319-B.

Kindly note that the use of accessories, transducers or cables other than those specified, with the exception of transducers and cables sold by the manufacturer as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of GBF-1319-B.

Be aware that misuse of electrical equipments can cause electric shock, burns, fire and other hazards.

Warning that the GBF-1319-B should not be used adjacent to or stacked with other equipment.

Manufacturer will make available on request circuit diagrams, component parts list,etc.

WARNING:No modifications of this equipment is allowed.

During using the Analyzer, the patient will contact with the surface and the electrode of the Analyzer.

The device doesn’t need to be calibrated in two years lifetime.

Symbol for “MANUFACTURER”

Symbol for “COMPLIES WITH FCC RULES”

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”

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 adults 18 years of age or older. It is intended for use in the home / domestic setting only.

CONTRAINDICATIONS

1. This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects of this device on the fetus are unknown.

2. 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.

Your Scale and Its Environment

To ensure your safety as well as the service life of your scale, please avoid using

the scale under the following circumstances:

Concurrent use of this device and implantable medical electronic instruments, e.g. Cardiac Pacemaker

Concurrent use of this device and wearable medical electronic instruments, e.g. electrocardiograph

Concurrent use of this device and other medical electronic instruments for life support, e.g. mechanical heart

Slippery floor such as tile floor

Jumping onto the platform immediately after bath or with wet hands

Near a cell phone or microwave oven

Avoid storage in the following locations:

Where there is water

Where the device may be exposed to extreme temperatures, humidity, moisture, direct sunlight, dust, or salt air

Where there is risk of shock or drop

Where you store chemicals or full of corrosive gases

Where in reach of the infants or children

2 3

Safety Information

Efficient Use of Your Scale

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.

Device Components

LCD Display

Electrode

Overview

Up Button

Set Button

Down Button

Electrode

Battery Compartment

UNIT Button

List

1. Body Fat Analyzer GBF-1319-B

2. 3xAAA Batteries (1.5V each)

3. User Manual

4 5

Overview

Initial Start-Up

LCD Display

Body Fat Analysis Result

Total Body Water Analysis Result

Muscle Mass Analysis Result

Calorie Analysis Result

Stone

Pound

Male

Male Athlete

Female

Female Athlete

Data hasn’t been sent out

Bluetooth icon

General Instructions

Transtek Body Fat Analyzer GBF-1319-B 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 body fat, body water, muscle mass and CAL-MAX. 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 1mA. 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 adult’s indoor use only.

Insert the Batteries

Open the battery door in the back of the scale.

Insert the batteries (3 x AAA) into the battery compartment according to the polarity indications marked inside the compartment.

* The digits “8888” will be shown on the LCD.

Close the battery door and wait until the digits “0.0” are shown on the LCD.

Kilogram

Percentage

Foot

Centimeter

Target Weight

Difference compare with target weight

More than target weight

Less than target weight

User ID (Range from P1 to P8)

Age

CAUTION

When the symbol “Lo ” appears, the device will power off in four seconds. Then you shall replace with a new set of batteries. Please replace all three 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.

Initial Start-Up

Select Measurement Unit

With batteries correctly installed, press “UNIT” button in the back of the scale to select measurement unit. The default measurement unit is “pound”. You may press “UNIT” button to choose among pound, kilogram, stone.

Note: If there is no operation in the weighing mode, the scale will turn off after a few seconds.

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.

Bluetooth Module No. :AW2540MV1

Frequency Range

Output Power Range

2402MHz - 2480MHz

-1 dBm

Supply Voltage

Transmitting Distance

2-3.6 V

10 meters

Initial Start-UpInitial Start-Up

Set Up Your Profile

The body fat analyzer GBF-1319-B supports multiple users (Up to Eight). You may follow below instructions to assign User ID and set up your own profile, including Gender, Goal Weight, , Stature, Age and Athletic Level.

1.Assigning User ID

With batteries correctly installed, press “SET” button to enter setting when the scale is off.

The system will request User ID selection first. As pictured below, “P1” blinks. The operator may press the function key or to select User ID among P1 to P8.

Press “SET” button to confirm User ID.

2.Setting Gender

After confirming User ID, the system will divert to Gender setting.

As pictured below, the portrait blinks. The operator may press the function key or to select Gender( Male/Female/Male Athlete/ Female Athlete).

Press “SET” button to confirm Gender. Athlete Mode: An athlete is defined as an adult who is involved in intense physial activity of approximate 12 hours per week and who has a resting heart rate of approximately 60 beats per minute or less.

3.Setting Goal Weight

After confirming Gender, the system will divert to Goal Weight setting automatically.

As pictured below, the digits blinks. The operator may press the function key or to increase or decrease the numeral. (Range: 20 kg to 180 kg /44.0 lb to 396.8lb)

You may press and hold the function key or for fast changing the numeral.

Press “SET” button to confirm.

4.Setting Stature

After confirming Goal Weight, the system will divert to Stature setting automatically.

As pictured below, the digits blinks. The operator may press the function key or to increase or decrease the numeral. (Range: 100 cm to 220 cm / 3’3.5”~7’2.5” ft)

You may press and hold the function key or for fast changing the numeral.

Press “SET” button to confirm.

Initial Start-Up

5.Setting Age

Initial Start-Up

After confirming Stature, the system will divert to Age setting.

As pictured below, the digits “30” blinks. The operator may press the function key or to increase or decrease the numeral. (Age Setting Range for Normal Mode: 10 to 85 years old, Age Setting Range for Athlete Mode: 15-85years old)

You may press and hold the function key or for fast changing the numeral.

Press “SET” button to confirm Age.

6.Setting Athletic Level

After confirming Age, the system will divert to Athletic Level setting.

As pictured below, the digit “1” blinks. The operator may press the function key or to increase or decrease the numeral. (Range: AC 1 to AC 5 )

You may press and hold the function key or for fast changing the numeral.

Press “SET” button to confirm Athletic Level.

7. The display will show your settings once, then display “0.0”, you can start measuring.

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.



8. Repeat procedure for a second user, or to change user details. Note: To update or overwrite the memorised data, follow the same procedure, making changes as required.

Note: The weight value won’t be saved in the scale, and won’t be transmitted to the APP.

Start Measuring

First Measurement

Start Measuring

• Position scale on a firm flat surface.

• Press SET button.

• While the user number of the latest measurement is flashing, select your user number by

pressing or button. After 3s, the selected number is locked, the user’s personal data will be shown once, and then the scale shows zero reading. (Note: When the user number is flashing, if you press SET button again, it will enter the setting mode, after all the settings are finished, the settings will be shown once, and then display zero reading. )

STEP 1: Step on the platform barefooted when the LCD displays “0.0”.

STEP 2: Stand still and keep full contact with the

electrodes until the LCD stops displaying moving “o”.

STEP 3: Your weight will be displayed followed by Body Fat, Total Body Water,

Muscle Mass , CAL-MAX and the weight difference value. The data will be displayed three times.

* 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.)

When your scale is successfully paired with your iPhone and the Bluetooth is ON, GBF-1319-B will process data transmission automatically.

(Please refer to Data Transmission for more details.)

Daily Measurement

With original SENSE ON patent technology, GBF-1319-B will automatically switch on as you step on the platform barefooted.

Stand still and keep full contact with the electrodes until the LCD stops displaying moving “o”.

According to the analysis results, the system will automatically identify the possible User ID with most similar history records. Then the measuring results will be displayed sequentially three times .

Start Measuring Data Transmission

When the system finds out two or more users with similar history records, it will notify you to choose between, for example, P1 and P2. You may press key for P1 and or key for P2. The measuring results will then be sorted into the User ID you selected and displayed sequentially three times.

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 iPhone and the Bluetooth is ON, GBF-1319-B will process data transmission instead.

(Please refer to Data Transmission for more details.)

Data Transmission

With GBF-1319-B successfully pair-up with your iPhone, 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 iPhone.

If the data transmission fails, the symbol will remain. The pending measurement data will be temporarily kept in the scale and transmitted to your iPhone 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 end at

2.4 GHz.

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.

Troubleshooting Troubleshooting

Error Prompt

Error Description Solution

Overload. The device will

power off in four seconds.

Low Battery. The device will power off in four seconds.

Measuring error.

Failure of pairing up your scale with your smartphone.

Stop using this scale for

measurement.

Replace all three batteries at the same time. Please purchase the authorized batteries for replacement.

Stand still, and measure again.

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.

No display on LCD when the device powers on.

Incorrect posture

The device is located on the soft ground such as a carpet OR on a rugged surface.

Either your hands or your

feet are too dry.

Batteries not yet installed.

Worn batteries.

Please step on the platform

barefooted and stand still.

Please place the device on a

flat, hard surface.

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 three batteries at the same time. Please purchase the authorized batteries for replacement.

Troubleshooting Troubleshooting

Problem

CANNOT proceed to analyze body fat, total body water, muscle mass and CAL-MAX.

The device powers off.

Root Cause

Step onto the platform

wearing socks or shoes.

The system cannot identify the possible User ID with most similar data.

The user fails to select the User ID from what the system found.

Low battery.

Solution

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.

Replace all three batteries at the same time. Please purchase the authorized batteries for replacement.

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 iPhone closer to the

scale.

Please assign a User ID following the instruction in Set Up Your Profile.

Specifications

Maintenance

Product Name

Dimension

Net Weight

Display

Measurement Unit

Measurement Range

Division

Accuracy

Working Environment

Power Source

Turn on Method

Auto-OFF

Accessories

Mode of Operation

Protection Against

Ingress of Water

Software Version

About the Accuracy of This Product

This product passes strict inspection before delivery and therefore its accuracy is guaranteed by the manufacturer.

Please refer to the above table for the descriptions on accuracy.

This product is specially designed for body fat analysis as well as weight measurement. It should NOT be used by

anyone during the process of transaction for verification of goods’ weight.

Body Fat Analyzer (GBF-1319-B)

Scale: 300x300x23mm

Panel: 300x300x6mm

Approximately 1.85 kg

Digital LCD V.A.: 76x51mm

Kilogram / Stone/ Pound

5kg to 180kg / 0st: 11lb to 28st: 5lb / 11lb to 397lb

0.1kg / 0.2lb

5-50kg: ±0.3kg; 100-150kg: ±0.5kg;

Temperature: 10℃ to 40℃

Temperature: -20℃ to 55℃

4.5V (3xAAA Batteries)

SENSE ON technology

The scale will turn off after about 10s if there is no operation.

1. 3xAAA batteries

2. User Manual

Continuous Operation

IPX0

1.0

50-100kg: ±0.4kg; 150-180kg: ±0.7kg

Humidity: 15%RH to 90% RH

Humidity: ≤90% RHStorage Environment

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)

Warranty

Transtek warrants its products free of defects in materials and workmanship in normal use for a period of TWO 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

FCC Regulations Appendix

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

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. In order to avoid the possiblity of exceeding the FCC radio frequency exposure limits, human proximity to the antenna shall not be less than 20 cm (8 inches) during normal operation.

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.

www.ag.uiuc.edu/~food-lab/ai/bfc.html

<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

Appendix

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%.

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-1319-B, 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

Tab le 1 – Gu idance an d

Guidan ce and ma nufac tur er’ s d ecl ara tio n – elec tromagnet ic emi ssions

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 tes t Compliance Electromagnetic environment-guidance

RF em issions

CISPR 11

RF em issions

CISPR 11

Harmonic emissions

IEC 61000 -3-2

Vol tage fl uctuat ions/ flick er emissions

IEC 61000 -3-3

MAN UFAC TURER’S

for all

Group 2

Class B

Not applic able

ME EQUI PMENT

de cla ration –

an d

The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

ELE CTROM AGNE TIC EMISSIO NS

ME SYST EMS

Appendix

Tab le 2 – Guid ance a nd

MANU FACTUR ER’S

ME EQUIP MENT

for all

de clar ati on – el ect roma gne tic

and

ME SYSTEM S

Guid ance a nd m anufactu rer ’s d eclara tion – ele ctro mag net 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.

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 ea rth

<5 % U

(>95 % dip in UT) for 0, 5 cyc le

40 % U

(60 % di p in UT) for 5 cycles

70 % U

(30 % di p in UT) for 25 cycles

<5 % U

(>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.

)

m/A 3 m/A 3

Compliance l evel

± 6 k V conta ct

± 8 k V air

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 onmen

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

Tabl e 4 – G uidanc e and

–

for

ME EQUIPME NT

MANU FACTUR ER’S

and

ME SYSTEMS

dec laratio n – el ectr omagnet ic

tha t are n ot

LIFE-SUPPOR TING

IMMUNI TY

–

Guid ance an d manufa cturer’ s decl aration – ele ctro magn etic im munity

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.

MMUNIT Y

tes t

IEC 60601

–

ro etercnoc ,doow eb dluohs sroolF

a fo taht eb dluohs ytilauq rewop sniaM

Conducted RF

a fo taht eb dluohs ytilauq rewop sniaM

sdleif citengam ycneuqerf rewoP

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 g uideline s may not a pply in all situati ons. El ectromagn etic pro pagatio n is a ffected by absorpt ion 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

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.

Over the f requency range 1 50 kHz t o 80 MH z, field s trengths should be less than [ V1] V/m.

LEVEL

3 Vr ms

150 kHz to 80 MHz

3 V/ m

80 MHz to 2,5 GHz

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

=d ]

[

1.167

P=d

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:

80 MH z to 8 00 MHz

P=d 2.333

800 MHz to 2,5 GHz

–

guidance

sho uld be

Appendix

Tab le 6 – Re commend ed separation dist ances betwe en por tab le and mobile

RF commu nicat ion s e quipment and th e

ME EQUI PMENT and M E SYS TEMS t hat ar e n ot LIF E-SUPPOR TING

for

portable an d mobile RF communic ati ons equi pme nt and th e 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.

Rate d maximum output power

of t ransmit ter

Recomm end ed sep aration distan ces betw een

Separati on distance according to frequenc y of t ransmitter

150 kHz to 80 M Hz

5,3

=d ]

[

Not app licab le

For tr ansmitters rat ed at a m aximum output po wer not listed a bove, the reco mmended separati on dis tance d in

met res (m) can be e stim ated us ing the eq uation ap plicable to t he frequen cy of the tr ansmitter, wher e P is the

maxi mum out put power rating o f the transm itter in watts (W) accordi ng to the t ran smitter m anufactu rer.

NOTE 1 At 80 MHz and 8 00 MH z, the se paration distan ce for t he hi gher frequenc y range applies.

NOTE 2 Thes e gu idelin es m ay not apply in a ll si tuations. Elec tromagnetic prop

refle ctio n from structures , object s and peopl e.

ME EQUI PMENT or ME SYS TEM –

80 MH z to 800 M Hz 800 MHz to 2,5 GHz

1.167

P=d

agatio n is affected by absorption and

2.333

P=d

10,0

0.2330.117

1,0

0.7380.369

2.3331.167

7.3783.690

23.3311.67

001

Transtek Medical Electronics AW2540-LS User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual