Transtek Medical Electronics LS208 B Users manual

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User Manual

version:1.0

Body Fat Analyzer

LS208-B7

Contains FCC ID: OU9LS208-B07

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

Zone A, No.105, Dongli Road, 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 LS208-B7.

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.

Table of Contents

Safety Information

Safety and Usage Information

...........................................................................................................................................

Tips

Overview

Device Components

..........................................................................................................................................

List

LED Display

Initial Start-Up

General Instructions

Insert the Batteries

.....................................................................................................................................

Pair-up

Set Up Your Profile

Select Measurement Unit

Initialising Your Scale

Weight Only Operation

Start Measuring

First Measurement

Daily Measurement

Manage Your Health

Data Transmission

Troubleshooting

Error Prompt

When Measuring ...

When Data Transmitting...

Specifications

Maintenance

Warranty

FCC Regulations Appendix

......................................................................................................................................

Health Tips – About Body Fat

Health Tips – About Body Water

Health Tips – About Muscle Mass

Health Tips – About Bone Mass

Health Tips – About BMI

Health Tips - About Calorie

EMC Guidance

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8-9

14-15

24-27

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”

Symbol for “COMPLIES WITH EU REQUIREMENTS”

Safety InformationSafety Information

INDICATIONS FOR USE

The Transtek Body Fat Analyzer measures weight and uses bio-electrical impedance analysis (BIA) technology to estimate BMI,calories,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.

The Bluetooth Combination Mark

Symbol for “MANUFACTURE DATE”

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

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”

CAUTION

Transtek’s Body Fat Analyzer LS208-B7 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. LS208-B7 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 LS208-B7. 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 LS208-B7. 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.

Please keep the device out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fatal. Please don't use the device out of lifetime any more because degraded sensors and electrodes, or loosened electrodes can degrade performance or cause other problems. If you have an allergy to stainless steel, please avoid to contact to the electrodes of the device. The patient is an intended operator. The patient can measure, transmit data and charge battery under normal circumstances and maintain the device and its accessories according to the user manual.

Tips

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.

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.

2 3

OverviewOverview

Device Components

Up Key

LED Display

Set Key

Down Key

UNIT and activation Button

Battery Compartment

Sensor

LED Display

Body Fat Analysis Result

Total Body Water Analysis Result

Muscle Mass Analysis Result

Bone Mass Analysis Result

Calorie Analysis Result

Body Mass Index

Kilogram

Percentage

Male

Male Athlete

Female

Female Athlete

List

1. Body Fat Analyzer LS208-B7

2. Four AAA-size Batteries (1.5V each)

3. User Manual

Age

Foot

Stone

Pound

Centimeter

Body Fat Level: Healthy

Body Fat Level: Obese

User ID (P1-P8)

Successful Bluetooth Connection

Data transmitting / pending to transmit to wireless wellness system

Low Battery

Body Fat Level: Underfat

Body Fat Level: Overfat

4 5

Initial Start-UpInitial Start-Up

General Instructions

Transtek Body Fat Analyzer LS208-B7 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 calorie, 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.

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 “ 8888 ” will be shown on the LCD.

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

Install APP and 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 as well as BLP Protocol established by global organization Bluetooth SIG, are capable to receive your personal health data.

Just simply install the specially-designed app and pair up your scale with your mobile or portable equipments. Then you may enjoy the comprehensive health solution provided by Transtek.

Note: It is only available for the device which supports Bluetooth 4.0 technology.

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.

CAUTION

When the symbol and “ Lo” 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.

If FAIL, symbol “E1” will be shown on the LCD.

Initial Start-Up

Set Up Your Profile

The body fat analyzer LS208-B7 supports multiple users (Up to 8). 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, press “SET” key to enter setting.

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” key to confirm User ID.

2.Setting Gender

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

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” key 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.

4.Setting Age

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

Press “SET” key to confirm Age.

When the LED displays “0.0lb”, you may start measuring.

Note: You may also set up your profile in the APP, when your smartphone is successfully paired with your scale, the personal profile will be transmitted to your scale via Bluetooth.

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 “lb”. You may press “UNIT” button to choose among kilogram, stone and pound.

3.Setting Stature

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

As pictured below, the digits “ 165 ” 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” key to confirm Stature.

Initial Start-Up

Initialising Your Scale

1. Press the platform centre and remove your foot.

2. “0.0” will be displayed.

Start Measuring

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.

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.

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

STEP 2: Stand still and keep full contact with the electrodes until the LED stops

displaying moving “o”.

STEP 3: Then the measuring results will be displayed sequentially three times:

Body Fat, Total Body Water, Muscle Mass, Bone Mass,Calorie, BMI, and Weight.

* If it fails to complete the analysis, the LED 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, LS208-B7 will process data transmission instead.

(Please refer to Data Transmission for more details.)

Start Measuring

Manage Your Health

Daily Measurement

With original SENSE ON patent technology, LS208-B7 will switch on as you step on the platform barefooted.

Stand still and keep full contact with the electrodes until the LED 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.

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.

Data Transmission

With LS208-B7 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.

If it fails to identify the possible User ID, the LED 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, LS208-B7 will process data transmission instead.

(Please refer to Data Transmission for more details.)

1312

Troubleshooting Troubleshooting

Error Prompt

Error Description Solution

Overload. The device will

power off.

Low Battery. The device

will power off.

Failure of pairing up your scale with your smartphone.

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.

Problem Root Cause Solution

Abnormal

measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement.

No display on LED when the device powers on.

CANNOT proceed to analyze calorie, BMI, 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.

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

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.

The device

powers off.

Low battery.

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

Troubleshooting

Specifications

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

Settings.

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.

Specifications

Product Name

Dimension

Net Weight

Display

Measurement Unit

Measurement Range

Division

Accuracy

Working Environment

Storage Environment

Power Source

Turn on Method

Auto-OFF

Accessories

Body Fat Analyzer (LS208-B7)

Scale: 320x320x25mm (Approximately)

Approximately 1.98kg

Digital LED

Kilogram / Stone/ Pound

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

0.1kg / 0.2lb/1lb (≥20st)

5-50kg: ±0.3kg; 100-150kg: ±0.5kg;

Temperature: 5℃ to 40℃ Humidity: 15% RH to 93%RH

Temperature: -20℃ to 60℃ Humidity: ≤93% RH

6V (Four AAA-size Batteries)

SENSE ON technology

The scale will turn off after about 15 seconds if there is no operation

1. Four AAA-size batteries

2. User Manual

50-100kg: ±0.4kg; 150-180kg: ±0.7kg

Mode of Operation

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.

Continuous Operation

Maintenance

FCC Regulations

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 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, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, 528437, China

Tel: 86-760-88282982 Website: http://www.transtek.cn

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.

Appendix Appendix

Health Tips - About Body Fat

Human body is made up of, amongst other things, a percentage of fat. Body fat is vital for a healthy, functioning body, protects vital organs, helps regulate body temperature, stores vitamins and helps the body sustain itself when food is scarce. However, too much body fat or indeed too little body fat will damage to your health. It is difficult to gauge how much body fat we have in our bodies simply by looking at ourselves in the mirror.

This is why it is important to measure and monitor your body fat percentage. Body fat percentage gives you a better measure of fitness than weight alone–the composition of your weight loss could mean you are losing muscle mass rather than fat-you could still have a high percentage of fat even when a scale indicates‘normal weight’.

The table as follows may be used as a guide:

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

14-20 15-21 17-23 18-24 19-25

21-23 22-24 24-26 25-27 26-28

Age

30-39 40-49 50-59 60+

<13 <14 <16 <17 <18

>23 >24 >26 >27 >28

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+

Health Tips - About Body Water

Body water is the single most important component of body weight. It represents over half of your total weight and almost two thirds of your lean body mass (predominantly muscle). Water performs a number of important roles in the body:

All the cells in the body, whether in the skin, glands, muscles, brain or anywhere else, can only function properly if they have enough water. Water also plays a vital part in regulating the body’s temperature balance, particularly through perspiration.

The combination of your weight and fat measurement could appear to be ‘normal’ but your body hydration level could be insufficient for healthy living.

The table as follows may be used as a guide:

Table of Body Water Level (Unit: %)

b) The body water percentage (%): 43%-73%/0.1%

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 Appendix

Health Tips - About Muscle Mass

According to the American College of Sports Medicine (ACSM), lean muscle mass may

decrease by nearly 50 percent between the age of 20 and 90. If you do nothing with it

you’re losing muscle and increasing fat. It is also important to know your muscle mass %

during weight reduction. At rest, the body burns approximately 110 additional calories for each kilo of muscle gained. Benifits of gaining muscle mass include:

• Reversing the decline in strength, bone density and muscle mass with aging

• Maintenance of flexible joints

• Guide weight reduction when combined with a healthy diet.

The table as follows may be used as a guide:

Muscle Mass Percentage

Men

Women

Approximately 40% of total body weight

Approximately 30% of total body weight

Health Tips - About Bone Mass

Regular exercise and a balanced diet can help maintain healthy bones. Like muscle, bone is a living tissue that can respond to exercise by becoming stronger. For most people, bone mass peaks in their thirties. Then people begin to lose bone. Regular exercise can help prevent that loss.

Calcium and vitamin D, good sources of which are dairy products, green leafy vegetables and fish, contribute to healthy bones.

The bone mass readings given by this product are anestimation of the amount of bone in your body. Those with osteoporosis or low bone densities may not get accurate estimations. If you have any concern regarding your bones please consult your doctor timely.

Health Tips - About BMI

Maintaining proper weight is essential to healthy living. Obesity has been linked to a higher risk of heart disease, diabetes and some forms of cancer. The Body Mass Index (BMI) is the most widely accepted measurement of weight according to health professionals. The Analyzer will calculate your BMI on your height and weight.

The table as follows may be used as a guide:

Bone Mass Percentage

The average bone mass percentage for both men and women is between 4 to 5%.

Appendix Appendix

Health Tips - About Calorie

The device uses your age, height, gender and an activity level setting to calculate the estimated number of calories you can consume a day to maintain your present weight. This estimation may gradually help you with a weight loss, gain or maintenance plan.

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 – 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

MAN UFAC TURER’S

for all

ME EQUI PMENT

de cla ration –

an d

ME SYST EMS

ELE CTROM AGNE TIC EMISSIO NS

Tab le 2 – Guid ance a nd

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

tes t

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

is t he a.c. m ains vol tage p rior to a pplication of the test l evel.

MANU FACTUR ER’S

ME EQUIP MENT

for all

IEC 60601

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

)

m/A 3 m/A 3

de clar ati on – el ect roma gne tic

and

ME SYSTEM S

Compliance l evel

± 6 k V conta ct

± 8 k V air

Not applicab le

Electroma gnetic environment

cerami c tile. If fl synt hetic m aterial, the relativ e humidi ty should be at leas t 30 %.

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.

qerf rewoP 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

guidance

oors ar e cove red wit h

–

ro etercnoc ,doow eb dluohs sroolF

a fo taht eb dluohs ytilauq rewop sniaM

sdleif citengam ycneu

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

Group 1

Class B

Not applic able

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

Appendix

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

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 g uideline s may not apply 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

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

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 .

To assess the elect romagneti c env ironment due t o fixed RF tr ansmitters, an e lectrom agnetic 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.

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

P=d 2.333

800 MHz to 2,5 GHz

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

sho uld be

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.

Recomm end ed sep aration distan ces betw een

Separati on distance according to frequenc y of t ransmitter

Rate d maximum output power

of t ransmit ter

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, where P is t he maxi mum out put power rating o f the transm itter in w atts (W) according to the t ran smitter m anufactu rer.

NOTE 1 At 80 MHz and 8 00 MHz , the sepa ration dis tance for the hi gher fr equency range appl ies.

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

2.333

P=d

10,0

0.2330.117

1,0

0.7380.369

2.3331.167

7.3783.690

23.3311.67

001

agatio n is affected by absorption and

Transtek Medical Electronics LS208 B Users manual

Specifications and Main Features

Frequently Asked Questions

User Manual