Transtek Medical Electronics AW8001-LS Bluetooth Module with Glass Body Fat Analyzer as host User Manual GBF 1257 B 20130102

Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Module with Glass Body Fat Analyzer as host GBF 1257 B 20130102

LS202-b1 manual

version:1.0GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTDZone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, ChinaTEL:86-760-88282982 www.transtek.cnUser ManualBody Fat Analyzer LS202-B1Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems.Thank you very much for selecting the Transtek Body Fat Analyzer LS202-B1. Contains FCC ID: OU9AW8001-LS
1Table of ContentsTable of ContentsSafety InformationSafety and Usage InformationTipsOverviewDevice ComponentsListLCD DisplayInitial Start-UpGeneral InstructionsPower SupplyInsert the BatteriesPair-upSet Up Your ProfileSelect Measurement UnitInitialising Your ScaleWeight Only OperationStart MeasuringFirst MeasurementDaily Measurement Fast Measurement Clear Your ProfileManage Your HealthBody Fat IndicatorData TransmissionTroubleshootingError PromptWhen Measuring ...When Data Transmitting...SpecificationsMaintenanceWarrantyFCC RegulationsAppendixTable of Body Fat LevelTable of Body Water LevelMuscle Mass PercentageBone Mass PercentageHealth Tips – About Body FatEMC Guidance 23445 66678-991010 11121313 13141515-161718191920212121212222-25................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................
2 3The warning signs and symbols are essential to ensure your correct and safe use of this product and protect you and others from injury. Please kindly find the meanings of the warning signs and symbols, which you may encounter in the label and user manual, as follows:Safety and Usage InformationSafety InformationSafety Information Transtek’s Body Fat Analyzer LS202-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. LS202-B1 is equipped with data transmission function. It may emit electromagnetic energy so as to perform its intended function. Nearby portable and mobile RF communicationsequipment can affect the performance of LS202-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 LS202-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.CAUTIONSymbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “MANUFACTURER”Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”Symbol for “TYPE BF APPLIED PARTS” The Bluetooth Combination MarkSymbol for “SERIAL NUMBER”Symbol for “MANUFACTURE DATE”Symbol for “DIRECT CURRENT”INDICATIONS FOR USEThe 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. TipsTo 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. Body fat percentage estimates will vary with the amount of water in the body, and can be affected by dehydration or over-hydration due to such factors as alcohol consumption, menstruation, illness, intense exercise, etc.The condition of the skin on the bottom of your feet can affect the reading. The natural effects of aging or activity can make this skin hard. Take the reading with clean, slightly damp feet for best accuracy. If you are having a problem on operating this scale please contact customer service. To prevent you from injury, please pay attention to the following Notice.A list of known devices or other sources that can potentially cause interference problems (example 1 Heat from a fireplace or radiant heater. example 2 Moisture from a nebuliser or steam kettle). Small parts being inhaled or swallowed. Potential allergic reactions to accessible materials used in the ME EQUIPMENT. Contact injuries. Use accessories, detachable parts and materials not described in the instructions for use. The effects caused by pets, pests or children.The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems.
4 5OverviewOverviewUser Interface: SettingBody Fat Analysis ResultWater Analysis ResultMuscle Mass Analysis ResultBone Mass Analysis ResultPoundKilogramPercentageInchCentimeterAgeMaleMale AthleteFemaleUser ID (Range from U1 to U8 )Successful Bluetooth ConnectionData transmitting / pending to transmit to wireless wellness systemLow BatteryLCD DisplayBody Mass IndexList1. Body Fat Analyzer LS202-B12. Four AAA-size Batteries (1.5V each)3. User ManualDevice ComponentsLCD Display Up KeySet KeyDown KeyConductor ConductorBattery CompartmentUNIT ButtonFemale Athlete
76Transtek Body Fat Analyzer LS202-B1 applies BIA (Bio-impedance Analysis) technology. A small amount of weak current flows through the human body so as to detect the bio-impedance and estimate BMI, body fat, body water, muscle mass and bone mass. The electrical current is small and may not be felt. This BIA technology is cheap, safe, non-invasive, toxic-free and harmless. It also possesses the characteristics of simple operation and abundant information. The current mentioned above is less than 0.5mA. However, please be aware that anyone with an wearable or implantable medical electronic instrument, such as a pacemaker, must avoid using this device.The intended use of this device is for healthy children 10-17 years old and healthy adults. General InstructionsIf SUCCEED, symbol will be shown on the LCD.If FAIL, symbol “E1” will be shown on the LCD.Initial Start-UpInitial Start-UpPair-UpWith 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.CAUTIONWhen 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 batteriesbefore storing.Insert the BatteriesOpen the battery door in the back of the scale.Insert the batteries (4 x 1.5V AAA) into the battery compartment according to the polarity indications marked inside the compartment.* The digits “ ” will be shown on the LCD.Close the battery door and wait until the digits “ ” are shown on the LCD.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.)Power SupplyBattery Mode: 6V, 4 x AAA batteries
Note: Athlete Mode:An athlete is defined as an adult who is involved in intense physialactivity of approximate 12 hours per week and who has a restingheart rate of approximately 60 beats per minute or less.98Initial Start-UpInitial Start-UpThe body fat analyzer LS202-B1 supports multiple users (Up to Eight). You may follow below instructions to assign User ID and set up your own profile, including Gender, Stature, and Age. With batteries correctly installed, touch and hold “SET” key to enter setting mode.The system will request User ID selection first. As pictured on the right, “1” blinks. The operator may touch the function key or to select User ID among U1 to U8.Touch “SET” key to confirm User ID.1.Assigning User IDSet Up Your Profile4.Setting AgeAfter 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.2.Setting GenderAfter confirming User ID, the system will divert to Gender setting.As pictured on the right, the portrait blinks. The operator may touch the function key or to select Gender. Touch “SET” key to confirm Gender.With batteries correctly installed, press “UNIT” key in the back of the scale to select measurement unit. The default measurement unit is “lb”. You may press “UNIT” key to choose between pound and kilogram.Select Measurement Unit3.Setting StatureAfter 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.
1110Start MeasuringInitial Start-UpPlease process the user setting before your first measurement. (Refer to Set Up Your Profile for more details)STEP 3: The measuring results will be displayed sequentially four times:BMI, Body Fat, Muscle Mass,Total Body Water, Bone Mass, Weight, and then turn off.* If it fails to complete the analysis, the LCD will only display the weight data.(To find out the solutions, please refer to Troubleshooting for more details.)STEP 1: Step on the platform barefooted.First MeasurementWhen your scale is successfully paired with your smartphone and the Bluetooth is ON, LS202-B1 will process data transmission instead. (Please refer to Data Transmission for more details.)Weight Only OperationYour TRANSTEK Body Fat Analyzer will operate as a conventionalweight - reading scale. No special programming steps are required.Once the scale is initialized, as previously described, you may simply step onthe scale to measure your current weight. For only weight reading.1. Position the scale on a flat, hard surface. Carpeted or uneven floors may affect accuracy.2. Step onto the scale platform and remain still while the scale computes your weight.3. The scale will display your weight value.4. The scale will automatically turn off after a few seconds.Note: The weight value won’t be saved in the scale, and won’t be transmitted to the APP.1. Press the platform centre and remove your foot.2. “0.0” will be displayed.3. The scale will switch off and is now ready for use.This initialisation process must be repeated if the scale is moved.At all other times step straight on the scale.Initialising Your ScaleSTEP2: Stand still and the weight data will be locked with the unit stop blinking. Keep full contact with the conductors until the LCD stop displaying moving “ ”.
If the User ID had set the profile, it will display the personal profile. Then the LCD will display “ ” and “ ” alternately, you may start measuring. Fast MeasurementIf the User ID had’t set the profile, the LCD will display as the following picture, then turn off.12Start MeasuringWith original SENSE ON patent technology, LS202-B1 will switch on as you step on the platform barefooted. If it fails to identify the possible User ID, the LCD will only display the weight data. (To find out the solutions, please refer to Troubleshooting for more details.)When your scale is successfully paired with your smartphone and the Bluetooth is ON, LS202-B1 will process data transmission instead. (Please refer to Data Transmission for more details.)Daily MeasurementStand still and keep full contact with the conductors until the LCD stops displaying moving “ ”.13Start MeasuringAccording 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 four times and then turn off.When the system finds out two or more users with similar history records, 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.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.Note: Select the “ ” means the settings of the current user won’t be deleted, and the system will divert to personal profile setting. Select the “ ” means the settings of the current user will be deleted, and the scale will turn off. Clear Your ProfileWhen the User ID had set up and saved the profile, touch and hold “SET” key to enter setting interface. If you touch “SET” key again, the LCD will display as the following picture, the letter “n” blinks. The operator may touch the function key or to select “ ” or “ ”. Touch “SET” key to confirm.
With LS202-B1 successfully pair-up with your smartphone, the measurement data will be transmitted to your mobile via Bluetooth.ONLY when the measuring results are attached to a specific User ID will it be transmitted to your mobile after measurement.The symbol will disappear after successful data transmission, and you may check your personal health data stored in your smartphone.If the data transmission fails, the symbol will remain. The pending measurement data will be temporarily kept in the scale and transmitted to your smartphone when next measurement is complete.Successful Bluetooth ConnectionData transmitting to wireless wellness system:-If SUCCEED, the symbol disappears;-If FAIL, the symbol remains.Data TransmissionCAUTIONInterference 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. 13 1514Manage Your Health TroubleshootingWhen Measuring ...Problem Root Cause SolutionIncorrect postureAbnormal measuring results:- Too high; OR- Too low; OR- Huge difference between two recent measurement.Please step on the platform barefooted and stand still.The device is located on the soft ground such as a carpet OR on a rugged surface.Please place the device on a flat, hard surface.Error PromptError Description SolutionOverload. The device will power off.Stop using this scale for measurement.Low Battery. The device will power off after about 4s.Replace all four batteries in the same time. Please purchase the authorized batteries for replacement.Please check below items:-Bluetooth is ON.-App Collector is ON.-Both devices are within the transmission distance of Bluetooth.Failure of pairing up your scale with your smatrphone.
1716Problem Root Cause SolutionBluetooth is OFF.Data transmission failed.Turn ON the Bluetooth via “Setting >> General >> Bluetooth”.The App is OFF. Press the icon to turn ON your app.Place your smartphone closer to the scale.Please assign a User ID following the instruction in Set Up Your Profile.Out of range of Bluetooth transmission.None of the user ID is assigned.Troubleshooting TroubleshootingWhen Data Transmitting ...Problem Root Cause SolutionEither your hands or your feet are too dry.Abnormal measuring results:- Too high; OR- Too low; OR- Huge difference between two recent measurement.No display on LCD when the device powers on.CANNOT proceed to analyze body fat, total body water, muscle mass and bone mass.The device powers off.Wipe your feet with a damp cloth, keeping them slightly damp when starting measurement.Batteries not yet installed.Worn batteries.Low battery.Install the batteries.(Please refer to Insert the Batteries)Replace all four batteries at the same time. Please purchase the authorized batteries for replacement.Step onto the platform wearing socks or shoes.Please keep barefooted during the measurement, and keep full contact with the electrodes as well.Replace all four batteries at the same time. Please purchase the authorized batteries for replacement.The system cannot identify the possible User ID with most similar data.Please assign a User ID following the instruction in Set Up Your Profile.The user fails to select the User ID from what the system found.Please assign a User ID following the instruction in Set Up Your Profile.
1918Specifications MaintenanceWhen carrying out usual maintenance, please ensure practice of the following Do’s and Don’ts:Transtek warrants its products free of defects in materials and workmanship in normal use for a period of FIVE years from the date of retail purchase.This warranty does NOT cover damages caused by misuse or abuse, including but not limited to: Failure caused by unauthorized repairs or modifications;Damage caused by shock or drop during transportation;Failure caused by improper operation inconsistent with the instructions stated in this user manual;Malfunction or damage from failure to provide the recommended maintenance;Damage caused by improper use of power supply.Should this device require maintenance (or replacement at our option) under warranty, please deliver the original package to GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD prepaid. Please return the store receipt (with the retail purchase date) and a note with reasons to return on it as well.MaintenanceWarrantyGUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTDZone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District, Zhongshan, 528437, Guangdong, ChinaTel: 86-760-88282982Website: http://www.transtek.cn DO use a dry soft cloth to wipe the dust.DO use a wet soft cloth, dipped into water and wrung out, to wipe the dirt. Then use a dry soft cloth to dry up the device.DON’T wash the device with water or immerse it in water.DON’T use propellant, abrasive or other chemicals to wipe the dirt in avoidance of discolor or malfunction.DON’T disassemble this device. If you have any problems, please contact Transtek. (Please refer to Warranty for contact information)Do not dispose of batteries in fire. Batteries may explode or leak. Remove the batteries if the scale will not be used for a long period.Kilogram / Pound5kg to 200kg / 11lb to 441lbBody Fat Analyzer (LS202-B1) About 20s after LCD display “0.0”, or about 15s after the weight is locked, or about 20s when the weight is unstable.Scale: 321x321x25mm (Approximately)Approximately 1.98kg ( Excluding the dry cells)Digital LCD with White BacklightSpecificationsProduct NameDimensionNet WeightDisplayMeasurement UnitMeasurement RangeDivision 0.1kg / 0.2lbAccuracy 5-50kg: ±0.3kg;100-150kg: ±0.5kg;Working Environment Temperature: 5℃ to 40℃Storage Environment Temperature: -20℃ to 60℃Power Source 6V (Four AAA-size Batteries)Turn on Method SENSE ON technologyAuto-OFFAccessories 1. Four AAA-size batteries2. User Manual50-100kg: ±0.4kg;150-200kg: ±0.7kgHumidity: ≤93% RHMode of Operation Continuous OperationHumidity: ≤90% RHDegree of protection Type BF applied partProtection AgainstIngress of WaterSoftware VersionIPX01.0Bluetooth Module No. AW8001Atmospheric pressure: 50kPa to 106kPaAtmospheric pressure: 80kPa to 106kPaProtection against ingress of waterIP21, It means the device could protected against solidforeign objects of 12.5 mm and greater, and againstvertically falling water drops
FCC User Guide InformationRadio Frequency Interface Requirements - FCCNote: 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 GuidelinesSafety InformationReducing RF Exposure - Use ProperlyOnly 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.FCC Regulations2120AppendixFCC RegulationsMuscle Mass Percentage(Source: International Commission on Radiological Protection,1975)MenWomenApproximately 40% of total body weightApproximately 30% of total body weightTable of Body Fat Level (Unit: %)Table of Body Water Level (Unit: %)Standard for MenRatinglowNormalModerately HighHighAge20-29<13 <14 <16 <17 <1814-20 15-21 17-23 18-24 19-2521-23 22-24 24-26 25-27 26-28>23 >24 >26 >27 >2830-39 40-49 50-59 60+Standard for WomenRatinglowNormalModerately HighHighAge20-29<19 <20 <21 <22 <2320-28 21-29 22-30 23-31 24-3229-31 30-32 31-33 32-33 33-35>31 >32 >33 >34 >3530-39 40-49 50-59 60+a) The body fat percentage (%): 5%-60%/0.1%Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator. b) The body water percentage (%): 43%-73%/0.1%MenWomenBF % RANGE4 to 14%15 to 21%22 to 24%25 and over4 to 20%21 to 29%30 to 32%33 and over70 to 63%63 to 57%57 to 55%55 to 37%70 to 58%58 to 52%52 to 49%49 to 37%OPTIMAL TBW % RANGESource: Derived from Wang & Deurenberg: “Hydration of fat-free body mass”. American Journal Clin Nutr 1999,69833-841.Bone Mass Percentage(Source: Rico et al.1993)The average bone mass percentage for both men and women is between 4 to 5%.
Fat is essential for human body. It can not only store energy and protect viscera, but also regulate body temperature and maintain normal physiological function of human body. However, too much body fat is harmful to human body. It is always accompanied by Fatty Liver, diabetes, coronary heart disease, etc. Therefore self-measuring and self-monitoring body fat level are beneficial to your health. Since we can’t judge body fat level simply by our weight, this body fat analyzer LS202-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. 2322Appendix AppendixNot applicableNot applicableNot applicableTable 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMSCompliance levelElectromagneti c environment –guidance± 6 kV contact ± 8 kV air ro etercnoc ,doow eb dluohs sroolF ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. a fo taht eb dluohs ytilauq rewop sniaMtypical commercial or hospital environment. ± 1 kV line(s) to line(s)± 2 kV line(s) to earth a fo taht eb dluohs ytilauq rewop sniaMtypical commercial or hospital environment. <5 % UT(>95 % dip in UT)for 0,5 cycle 40 % UT(60 % dip in UT)for 5 cycles 70 % UT(30 % dip in UT)for 25 cycles <5 % UT(>95 % dip in UT)for 5 s sdleif citengam ycneuqerf rewoP m/A 3 m/A 3 should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the device should assure that it is used in such an environment.IMMUNI TY testElectrostatic discharge (ES D) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 test level± 6 kV contact ± 8 kV air ± 2 kV for power supply lines ± 1 kV for input/output lines EMC GuidanceHealth Tips - About Body FatTable 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONSfor all ME EQUIPMENT and ME SYSTEMSGuidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below.The customer or the user of the device should assure that it is used in such anenvironment.Emissions test Compliance Electromagnetic environment-guidanceRF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Group 1 Class B Not applicableNot applicableThe device must emit electromagneticenergy in order to perform its intendedfunction. Nearby electronic equipment may be affected.1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. 2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment. (Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)
Not applicableTable 4 – Guidance and MANUF ACTURER’S declaration – electromagnetic IMMUNITY – forME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTINGGuidance and manufacturer’s declaration – electromagnetic immunity IMMUN I TY test IEC 60601 TEST LEVE LCompliance levelElectromagnetic environment –guidanceConducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 V/m Recommended separation di stance PV=d ]5,3[1P=d 2.333 800 MHz to 2,5 GHz where P is the m aximum output power rat ing of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.a Field strengths from fixed transm itters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ V1] V/m. The device is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the device should assure that it is used in such an environment.Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.P=d 80 MHz to 800 MHz 1.167 Table 6 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – forME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTINGRecommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.Separation distance according to frequency of transmitter mRated maximum output power of transmitter W150 kHz to 80 MHz PV=d ]5,3[180 MHz to 800 MHz 800 MHz to 2,5 GHz 10,0 1,0 1 01 001For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 0.2330.1170.7380.3692.3331.1677.3783.69023.3311.67Not applicableNot applicableNot applicableNot applicableNot applicableP=d 2.333P=d 1.167Appendix24 25Appendix

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