FCC ID: OU9AW8001-LS Bluetooth Module with Body Pressure Monitor as host

version:1.0 User Manual Body Fat Analyzer LS202-B1 Contains FCC ID: OU9AW8001-LS GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China TEL:86-760-88282982 www.transtek.cn Thank you very much for selecting the Transtek Body Fat Analyzer LS202-B1. Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for further reference in case you have problems. Table of Contents Table of Contents Safety Information Safety and Usage Information Tips

............................................................................................... .......................................................................................................................................... Overview Device Components List LCD Display Initial Start-Up

................................................................................................................. ......................................................................................................................................... ............................................................................................................................. General Instructions Power Supply Insert the Batteries Pair-up Set Up Your Profile Select Measurement Unit Initialising Your Scale Weight Only Operation

................................................................................................................. .......................................................................................................................... .................................................................................................................. .................................................................................................................................... ................................................................................................................ ....................................................................................................... .............................................................................................................. ............................................................................................................. Start Measuring First Measurement Daily Measurement Fast Measurement Clear Your Profile Manage Your Health Body Fat Indicator Data Transmission Troubleshooting

................................................................................................................... ................................................................................................................. ................................................................................................................. ................................................................................................................. ................................................................................................................... ................................................................................................................... Error Prompt When Measuring ... When Data Transmitting... ............................................................................................................................ ................................................................................................................. ....................................................................................................... ........................................................................................................................... .............................................................................................................................. ..................................................................................................................................... ....................................................................................................................... Specifications Maintenance Warranty FCC Regulations Appendix Table of Body Fat Level Table of Body Water Level Muscle Mass Percentage Bone Mass Percentage Health Tips About Body Fat EMC Guidance

.......................................................................................................... ..................................................................................................... ......................................................................................................... ............................................................................................................. ................................................................................................ ........................................................................................................................ 2 3 4 4 5 6 6 6 7 8-9 9 10 10 11 12 13 13 13 14 15 15-16 17 18 19 19 20 21 21 21 21 22 22-25 1 Safety Information Safety 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 MANUFACTURE DATE Symbol for SERIAL NUMBER CAUTION Symbol for MANUFACTURER Symbol for DIRECT CURRENT Symbol for ENVIRONMENT PROTECTION Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice Transteks 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 communications equipment 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. Dont 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. 2 INDICATIONS FOR USE The Transtek Body Fat Analyzer measures weight and uses bio-electrical impedance analysis

(BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy children 10-17 years old and healthy adults. It is intended for use in the domestic setting only. Tips 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. To prevent you from injury, please pay attention to the following Notice. Small parts being inhaled or swallowed. Potential allergic reactions to accessible materials used in the ME EQUIPMENT. Contact injuries. Use accessories, detachable parts and materials not described in the instructions for use. A list of known devices or other sources that can potentially cause interference problems

(example 1 Heat from a fireplace or radiant heater. example 2 Moisture from a nebuliser or steam kettle). The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems. The effects caused by pets, pests or children. 3 Overview Overview Device Components LCD Display LCD Display Down Key Set Key Up Key Conductor Conductor UNIT Button Battery Compartment List 1. Body Fat Analyzer LS202-B1 2. Four AAA-size Batteries (1.5V each) 3. User Manual 4 Body Mass Index Body Fat Analysis Result Muscle Mass Analysis Result Water Analysis Result Bone Mass Analysis Result User Interface: Setting Male Female Male Athlete Female Athlete Age Inch Centimeter Percentage Kilogram Pound User ID (Range from U1 to U8 ) Successful Bluetooth Connection Data transmitting / pending to transmit to wireless wellness system Low Battery 5 Initial Start-Up Initial Start-Up General Instructions Transtek 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. Power Supply Battery Mode: 6V, 4 x AAA batteries Battery Life: Approx. 120 days

(Battery capacity: 230 mAH. If measured three times per day, each measurement takes about 46s. The current for measurement is about 30 mA , while the current when shutdown is about 30 uA.) Insert the Batteries Open the battery door in the back of the scale. Insert the batteries (4 x 1.5V AAA) into the battery compartment according to the polarity indications marked inside the compartment.

* The digits will be shown on the LCD. Close the battery door and wait until the digits are shown on the LCD. CAUTION When the symbol appears, the device will power off. Then you shall replace with a new set of batteries. Please replace all four batteries at the same time. Do NOT mix the old batteries with the new one. Worn batteries are hazardous waste. Do NOT dispose of them together with the household garbage. Please refer to the local ordinances and recycling instructions regarding disposal of the worn batteries and scrapped device. If you do not intend to use this unit for a prolonged period of time, it is advisable to remove the batteries before storing. 6 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. 7 Initial Start-Up Initial Start-Up Set Up Your Profile The 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. 1.Assigning User ID 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. 2.Setting Gender After 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. Note:

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 Stature After confirming Gender, the system will divert to Stature setting. As pictured on the right, the digits 55.0 blinks. The operator may touch the function key or to increase or decrease the numeral. (Range: 33.5 ft to 72.5 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. 4.Setting Age After confirming Stature, the system will divert to Age setting. As pictured on the right, the digits 30 blinks. The operator may touch the function key or to increase or decrease the numeral. (Range: 10 to 85 years old) You may touch and hold the function key or for fast changing the numeral. Touch SET key to confirm Age. When the LCD displays and alternately, you may start measuring. Select Measurement Unit With batteries correctly installed, press UNIT key in the back of the scale to select measurement unit. The default measurement unit is lb. You may press UNIT key to choose between pound and kilogram. 8 9 Initial Start-Up Initialising Your Scale 1. Press the platform centre and remove your foot. 2. 0.0 will be displayed. 3. The scale will switch off and is now ready for use. This initialisation process must be repeated if the scale is moved. At all other times step straight on the scale. Weight Only Operation Your TRANSTEK Body Fat Analyzer will operate as a conventional weight - reading scale. No special programming steps are required. Once the scale is initialized, as previously described, you may simply step on the scale to measure your current weight. For only weight reading. 1. Position the scale on a flat, hard surface. Carpeted or uneven floors may affect accuracy. 2. Step onto the scale platform and remain still while the scale computes your weight. 3. The scale will display your weight value. 4. The scale will automatically turn off after a few seconds. Note: The weight value wont be saved in the scale, and wont be transmitted to the APP. 10 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. STEP2: 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 . 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.) 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.) 11 Start Measuring Daily Measurement With original SENSE ON patent technology, LS202-B1 will switch on as you step on the platform barefooted. Start Measuring Fast Measurement With batteries correctly installed, press SET key to turn on the scale, and the LCD displays 0.0, then you may touch the function key or to select the User ID. Stand still and keep full contact with the conductors until the LCD stops 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. 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 four times and then turn off. If the User ID hadt set the profile, the LCD will display as the following picture, then turn off. Clear Your Profile When the User ID had set up and saved the profile, touch and hold SET key to enter setting interface. 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. 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. 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.) 12 Note: Select the means the settings of the current user wont 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. 13 Manage Your Health Troubleshooting Data Transmission 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 Connection Data transmitting to wireless wellness system:

-If SUCCEED, the symbol disappears;

-If FAIL, the symbol remains. Error Prompt Error Description Solution Overload. The device will power off. Stop using this scale for measurement. Low Battery. The device will power off after about 4s. Failure of pairing up your scale with your smatrphone. 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. 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. When Measuring ... Problem Root Cause Solution Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. Incorrect posture 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. 14 13 15 Troubleshooting Troubleshooting When Data Transmitting ... Problem Root Cause Solution Data transmission failed. Bluetooth is OFF. Turn ON the Bluetooth via Setting >> General >> Bluetooth. The App is OFF. Press the icon to turn ON your app. Out of range of Bluetooth transmission. Place your smartphone closer to the scale. None of the user ID is assigned. Please assign a User ID following the instruction in Set Up Your Profile. Problem Root Cause Solution Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. No display on LCD when the device powers on. CANNOT proceed to analyze body fat, total body water, muscle mass and bone mass. Either your hands or your feet are too dry. Wipe your feet with a damp cloth, keeping them slightly damp when starting measurement. Batteries not yet installed. Worn batteries. Step onto the platform wearing socks or shoes. 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. 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. The device powers off. Low battery. Replace all four batteries at the same time. Please purchase the authorized batteries for replacement. 16 17 Specifications Specifications Product Name Dimension Net Weight Display Body Fat Analyzer (LS202-B1) Scale: 321x321x25mm (Approximately) Approximately 1.98kg ( Excluding the dry cells) Digital LCD with White Backlight Measurement Unit Kilogram / Pound Measurement Range 5kg to 200kg / 11lb to 441lb Division Accuracy 0.1kg / 0.2lb 5-50kg: 0.3kg;

100-150kg: 0.5kg;

50-100kg: 0.4kg;

150-200kg: 0.7kg Working Environment Storage Environment Temperature: 5 to 40 Atmospheric pressure: 80kPa to 106kPa Humidity: 90% RH Temperature: -20 to 60 Atmospheric pressure: 50kPa to 106kPa Humidity: 93% RH Power Source 6V (Four AAA-size Batteries) Turn on Method Auto-OFF Accessories Mode of Operation SENSE ON technology About 20s after LCD display 0.0, or about 15s after the weight is locked, or about 20s when the weight is unstable. 1. Four AAA-size batteries 2. User Manual Continuous Operation Degree of protection Protection against ingress of water Type BF applied part IP21, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops Protection Against Ingress of Water IPX0 Software Version 1.0 Bluetooth Module No. AW8001 18 Maintenance Maintenance When carrying out usual maintenance, please ensure practice of the following Dos and Donts:

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. DONT wash the device with water or immerse it in water. DONT use propellant, abrasive or other chemicals to wipe the dirt in avoidance of discolor or malfunction. DONT disassemble this device. If you have any problems, please contact Transtek.

(Please refer to Warranty for contact information) Do not dispose of batteries in fire. Batteries may explode or leak. Remove the batteries if the scale will not be used for a long period. Warranty Transtek warrants its products free of defects in materials and workmanship in normal use for a period of FIVE years from the date of retail purchase. This warranty does NOT cover damages caused by misuse or abuse, including but not limited to:

Failure caused by unauthorized repairs or modifications;

Damage caused by shock or drop during transportation;

Failure caused by improper operation inconsistent with the instructions stated in this user manual;

Malfunction or damage from failure to provide the recommended maintenance;

Damage caused by improper use of power supply. Should this device require maintenance (or replacement at our option) under warranty, please deliver the original package to GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD prepaid. Please return the store receipt (with the retail purchase date) and a note with reasons to return on it as well. GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District, Zhongshan, 528437, Guangdong, China Tel: 86-760-88282982 Website: http://www.transtek.cn 19 FCC Regulations FCC Regulations FCC User Guide Information Radio Frequency Interface Requirements - FCC Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna;

Increase the separation between the equipment and receiver;

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected;

Consult the dealer or an experienced radio / TV technician for help. Radio Transmitters (Part 15) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the users 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. 20 Appendix Table of Body Fat Level (Unit: %) a) The body fat percentage (%): 5%-60%/0.1%

Standard for Men Standard for Women Rating low Normal Moderately High High 20-29 30-39

<14

<13 14-20 15-21 21-23 22-24

>23

>24 Age 40-49

<16 17-23 24-26

>26 50-59

<17 18-24 25-27

>27 60+

<18 19-25 26-28

>28 Rating low Normal Moderately High High 20-29

<19 20-28 29-31

>31 30-39

<20 21-29 30-32

>32 Age 40-49 50-59

<21

<22 22-30 23-31 31-33 32-33

>33

>34 60+

<23 24-32 33-35

>35 Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator. 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. 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 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 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%. 21 Appendix Appendix Health Tips - About Body Fat Fat is essential for human body. It can not only store energy and protect viscera, but also regulate body temperature and maintain normal physiological function of human body. However, too much body fat is harmful to human body. It is always accompanied by Fatty Liver, diabetes, coronary heart disease, etc. Therefore self-measuring and self-monitoring body fat level are beneficial to your health. Since we cant 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. 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) Table 1 Guidance and MANUFACTURERS declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturers declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance RF emissions CISPR 11 Group 1 The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/

flicker emissions Not applicable 22 IEC 61000-3-3 Table 2 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Electrostatic dischar ge (ESD) 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 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s ) to line(s) 2 kV line(s ) to earth

<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 Compliance level Electromagnetic 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 %. Not applicable a fo taht eb dluohs ytilauq rewop sniaM typical commerc ial or hospital environment. Not applicable a fo taht eb dluohs ytilauq rewop sniaM typical commerc ial or hospital environment. Not applicable 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. Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 m/A 3 m/A 3 sdleif citengam ycneuqerf rewoP 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 applic ation of the t est level. 23 Appendix Appendix Table 4 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment guidance 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 Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Not applicable

=d

]5,3[

V 1 P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m

=d 1.167 P 80 MHz to 800 MHz

=d 2.333 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter i n watts (W) accordi ng to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as deter-

mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, 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. Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W 10,0 1,0 1 01 001

=d

]5,3[

V 1 P Not applicable Not applicable Not applicable Not applicable Not applicable

=d 1.167 P

=d 2.333 P 0.117 0.369 1.167 3.690 11.67 0.233 0.738 2.333 7.378 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the t ransmitter in watts (W) accordi ng 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. 24 25

Version:1.0 User Manual LS808-B Blood Pressure Monitor Arm Type Contains FCC ID: OU9AW8001-LS GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China Thank you very much for selecting TRANSTEK Blood Pressure Monitor LS808-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 your further reference in case you have problems. TABLE OF CONTENTS Table of Contents INTRODUCTION .............................................................2 General Description Indications for Use Measurement Principle Safety Information LCD Display Signal Monitor Components BEFORE YOU START ........................................................7 Power Supply and Charge Power Setting the Time,Date and Unit Pair up with Your Device Tie the Cuff MEASUREMENT .............................................................14 Start Measurement Data Management Recall the Records Delete the Records

......................... ................................. 16 INFORMATION FOR USER .....................................................20 Tips for Measurement Maintenance ABOUT BLOOD PRESSURE....................................................22 What are systolic pressure and diastolic pressure?

What is the standard blood pressure classification?

Why does my blood pressure fluctuate throughout the day?

Why the blood pressure I get from the hospital is different from home?

If the result is the same if measuring on the right arm?

TROUBLESHOOTING .........................................................24 SPECIFICATIONS ............................................................. 25 ATHORIZED COMPONENT

............................................... 26 CONTACT INFORMATION...................................................... 26 COMPLIED STANDARDS LIST 27 FCC STATEMENT

...................................................... 28 EMC GUDIANCE

...................................................... 29

............................................... ..... ..... 1 INTRODUCTION General Description

* Thank you for selecting TRANSTEK Blood pressure Monitor (LS808-B). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime.

* This manual contains important safety information and caution, and provides step by step instructions for using the product.

* Please do read this user manual carefully and thoroughly before use. FEATURES:

86.1mm24mm Blue LCD Display with White Backlight Measure-during-inflating Technology Up to 60 pieces of record stored Indications for Use 1.The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and hearbeat rate with arm circumference ranging from 22cm to 42 cm (about 9-17 inches). 2. The monitor detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. 3. It is intended for adult use in the home/ domestic setting only. Contraindications 1. 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. 2. This device is not intended to be a diagnostic device. Contract your physician if hypertensive values are indicated. INTRODUCTION Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a zero point equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to deter-

mine the systolic pressure and diastolic pressure as well as pulse rate. The device also compares the longest and the shortest intervals of detected pulse wave to with the average value, and then calculates the standard deviation. The monitor will light up a warning symbol when the calculated standard deviation is larger than or equal to 15. Safety Information The below signs might be in the user manual, labeling or other components. They are the requirement of standard and using. Symbol for THE OPERATION GUIDE MUST BE READ Symbol for TYPE BF APPLIED PARTS Symbol for MANUFACTURE DATE Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for ENVIRONMENT PROTECTION - Wast 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 DIRECT CURRENT The Bluetooth Combination Mark F1 T1A/250V 3.6*10CCC Symbol for Class II Equipment Symbol for indoor use only Symbol for Including RF transmitter 2 3 INTRODUCTION CAUTION LCD Display Signal INTRODUCTION This device is intended for adult use only. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment based solely physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please consult your physician about the result. If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the START/STOP button to stop inflation. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch output of batteries/adaptor and the patient simultaneously. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. This device is contraindicated for any female who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects of this device on the fetus are unknown. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patients arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will been impacted and reduced. During using, the patient will contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction. 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. The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to dacron or plastic, please dont use this device. Please keep the unit out of reach of infants, children or pets, since inhalation or swallowing of small parts is dangerous or even fata. The adaptor is specified as a part of ME equipment. If Luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel. The device is not suitable for public use. The device is not intended for PATIENT transport outside a healthcare facility. This device cannot be used with HF surgical equipment at the same time. Be careful to strangulation due to cables and hoses, particularly due to excessive length. Systolic Blood Pressure Diastolic Blood Pressure Pulse Low Battery Unit IHB Detector Data pending to transmit Data transmitting Memory Query User ID High blood pressure Low blood pressure beat/minute Low battery and please charge the power. Measurement unit of blood pressure Irregular Heartbeat Detector Measurement data stored in the device Data transmission succeeds. Recalling the history records Start measurement for selected user, and transmit the measuring result Current time Year/Month/Day(Hour:Minute) Shocking reminder Shocking will result in inaccurate Heartbeat Heartbeat Detection during the measurement 4 5 INTRODUCTION Monitor Components QUERY/UP BUTTON USER 1/SET BUTTON Component list of pressure measuring system 1 PCBA 2 Air pipe 3 Pump 4 Valve 5 Cuff List 1.Blood Pressure Monitor

(LS808-B) 3.User Manual 6 DC POWER SOCKET ON/OFF BUTTON SYSTOLIC PRESSURE DIASTOLIC PRESSURE PULSE RATE USER 2/ACTIVATION BUTTON BEFORE YOU START Power Supply and Charge Power 1. The battery of LS808-B is built-in rechargeable li-polymer battery, the battery current is 1000 mAh. 2. Please use the AC adaptor to charge the battery, just like the following picture:

AC adaptor Charging the power under following circumstances:

displays on the LCD The LCD display dims When powering on the monitor, the LCD doesnt light up. CUFF

(Type BF applied part) CAUTION 1. The battery of LS808-B is built-in rechargeable li-polymer battery, please do not disassemble it by the unauthorized maintenance personel. 2. Under the normal using, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personel. If measured three times per day, and the battery is fully charged, it can be used for about 20 days. 3. Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid to approach to the fire and the heat source, or it will cause the battery explode. 4. Only can use the Transteks authorized AC Adaptor

(Model: UE08WCP-060100SPA) to charge the power. You cannot use the blood pressure monitor during the process of charging. 5. During the process of charging, the blood pressure monitor display When the charging is finished, please pull the plug in time. 6. When charging, shall not touch charging connector and the patient simultaneously. 7 2.AC Adaptor

( Model: UE08WCP- 060100SPA) 4. Cuff (22-42cm) (Type BF Applied Part)

(Please use TRANSTEK authorized cuff.) BEFORE YOU START BEFORE YOU START Setting the Time,Date and Unit To ensure the stored measurement result has correct time record, please set time and unit before device is used. Before use,switch the button to the ON side to turn on the monitor. Note: If the button is on the OFF side, there is no reaction when you press any button.

(1) When the monitor is off, press and hold User 1 button for 3s to enter Time Setting Mode.

(3) Press User 1 button again to confirm [HOUR]. Then the numeral representing [MINUTE] blinks.

(2) As pictured in the right, the blinking numeral representing [HOUR]. Press Query button to change the numeral. Each press will increase the numeral by one in a cycling manner.

(4) Repeat step 2 and 3 to confirm [MINUTE]. 8 9 BEFORE YOU START BEFORE YOU START

(5) Repeat step 2 and 3 to confirm[MONTH], [DAY] and [YEAR].

(7) After confirming the measurement unit, the LCD will display dOnE and the monitor will shut off.

(6) Repeat step 2 and 3 to confirm the measurement unit. 10 11 BEFORE YOU START BEFORE YOU START Pair up the Blood Pressure Monitor with Your Device

(1) Turn on Bluetooth and the app. Make sure both are on when pair-up is proceeding.

(2) When the monitor is off, press and hold the User 2 button to start pair-up. The symbol and the 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 will be shown on the LCD.

(3) The monitor will shut off automatically after pair-up process is complete. Bluetooth Module No. : AW8001 Frequency Range Output Power Range 2.402 - 2.480 GHz 0 dBm Supply Voltage Transmitting Distance 1.8-3.6 V 10 meters CAUTION Interference may occur in the vicinity of equipment marked with the following symbol

. And LS808-B may interfering vicinity electrical equipment. Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement. To enable the data transmission function, this product should be paired to Bluetooth end at 2.4 GHz. How to mitigate possible interference?

1. The range between the device and BT end should be reasonably close, from 1 meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain quality connection and to lower the RF output range. 2. To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor. Tie the Cuff 1. Remove all accessories from your left arm. If your physician has diagnosed you with poor circulation in your left arm, use your right arm. 2. Roll or push up your sleeve to expose the skin. 3. Apply the cuff to your left arm with your palm facing up. 4. Position the edge of the cuff about 2-3 cm. 5. Fasten the arm cuff around your arm, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. 6. Correct Posture for Patients with Hypertension, especially for Hypertension patient

- Bare your arm or wear tights only when starting measurement.

- Sit comfortably with legs uncrossed, feet flat on the floor, back and arm supported. The central of the cuff should maintain at the same level as the right atrium of the heart. Resting for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by a physician. 12 13 MEASUREMENT Start Measurement When the monitor is off, press User 1 button to turn on the monitor and it will finish the whole measurement, and then save the measure data for User 1. The same to the User 2.

(1) When the monitor is off, press the User 1 button to turn on the monitor. LCD display Adjust to zero. MEASUREMENT Inflating and measuring. Display and save the results. The data transmission will proceed.

(2) Press User 1 button to power off, otherwise it will turn off with one minute. Tips:

A. When finish the whole measurement, press another user button, the blood monitor will begin measuring again. B. Maximum 60 records are both for user 1 and user 2. CAUTION 14 1.With LS808-B successfully pair-up with your iPhone, the measurement data will be automatically transmitted to your mobile via Bluetooth. 2.The symbol will disappear after successful data transmission, and you may check your personal health data stored in your iPhone. 3.If the data transmission fails, the symbol will remain. The pending measurement data will be transmitted to your iPhone when next measurement is complete. 15 DATA MANAGEMENT DATA MANAGEMENT Recall the Records

(1) When the monitor is off, press Query button to access the memory.

(2) The LCD will display the latest measuring result of the user ID which completes the last measurement. The record number, measuring date and measuring time will be displayed alternatively.

(3) Press Query button to rotate the history records.

(4) When in the memory mode, press the User 1 button to recall the measurement history of User 1, or press the User 2 button to recall the measurement history.

(5) When no history stored for the specific user in the monitor, press Query button and the LCD will display as pictured to the right. 16 CAUTION The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list. 17 DATA MANAGEMENT DATA MANAGEMENT Delete the Records

(1) When under the query mode, press and hold Query button for 3 seconds to clear the memory.

(3) The LCD will display dEL dOnE and then shut off.

(2) When the LCD display dEL ALL, press Query button to confirm.

(4) If you wish to stop clearing the memory, you may press the other button, rather than Query button to turn off the monitor, or wait until the monitor shuts off. CAUTION 1. When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: too frequent and consecutive multiple measurements;

the application of the CUFF and itspressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present;

Inflating the cuff on the arm on the side of a mastectomy. 2. Do not apply the cuff over a wound, otherwise it can cause further injury. 3. Do not inflate the cuff on the same limb which other monitoring ME EQUIPMENT is applied around simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring ME EQUIPMENT. 4. Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT. 5. Dont kink the connection tube, otherwise, the cuff pressure may continuously increase which can prevent blood flow and result in harmful injury to the PATIENT. 18 19 INFORMATION FOR USER Tips for Measurement It can cause inaccuracy if the measurement is taken in the following circumstances. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine INFORMATION FOR USER Maintenance To obtain the best performance, please follow below instructions. Put in a dry place and avoid the sunshine Avoid immersing it in the water. Clean it with a dry cloth in case. Avoid shaking and collision. Avoid dusty environment and unstable temperature surrounding Use the slightly damp cloth to remove the dirt. CAUTION Avoid washing the cuff Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. The device doesnt need to be calibrated in two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE PERSONNEL of Transtek. Dont open or repair the device by yourself. Please report to Transtek if any unexpected operation or events occur. Please use the soft cloth to clean the whole unit. Dont use any abrasive or volatile cleaners. 20 21 ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE Diastolic blood entering vein Systolic blood discharging artery What are systolic pressure and diastolic pressure?

When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. What is the standard blood pressure classification?

The chart on the right is the standard blood pressure classifi-

cation published by American Heart Association (AHA). AHA Home Guideline for Upper Limit of Normal BP This chart reflects blood pressure categories defined by American Heart Association. High Blood Pressure

(Hypertension) Stage 1 Systolic mmHg (upper#) Diastolic mmHg (lower#) Blood Pressure Category Prehypertension press less than 120 less than 80 relax 120-139 140-159 Normal 80-89 90-99 and or or SYS DIA 135 mm Hg 85 mm Hg High Blood Pressure

(Hypertension) Stage 2 160 or higher Hypertensive Crisis

(Emergency care needed) Higher than 180 or or 100 or higher Higher than 110 CAUTION Please consult a physician if your measuring result falls outside the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point. Irregular Heartbeat Detector This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15, this equipment will light up the IHB symbol on the screen when displaying the measuring result. CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage. 22 Why does my blood pressure fluctuate throughout the day?

1. Individual blood pressure varies every in one day, it is also affected by the way you tie your cuff and the your measurement position, so please take the measurement at the same condition. 2. The varies of the pressure is greater if the person take medicine. 3. Waiting at least 3 minutes for another measurement. Why the blood pressure I get from the hospital is different from home?

The blood pressure is different even during 24 hour because of the weather, emotion, exercise etc, specially the white coat in hospital which makes the results are higher than the ones at home. If the result is the same if measuring on the right arm?

It is ok for both arms, but there will be some different results for different arm, so suggest you measure the same arm every time. The attention need to pay when you measure your blood pressure at home:

If the cuff is tie properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious pressured. You had better take deep breath 2-3 times before beginning. Advice: adjust yourself for 4-5 minutes until you calm down. 23 TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM CHECK THIS REMEDY No power Display will not light up. Low batteries Display is dim or shows Power is exhausted. Charge the power Power is low. Charge the power E1 shows Communication error E 3 shows The cuff is not secure. Check if the App is on or not,try data transmission again. Refasten the cuff and relax for a moment and then measure again. E 10 or E 11 shows E 20 shows E 21 shows The monitor detected motion,talking or the pulse is too poor while measuring. The measurement process does not detect the pulse signal. Relax for a moment and then measure again. Loosen the clothing on the arm and then measure again. The treatment of the measurement failed. Relax for a moment and then measure again. Error massage EExx,shows on the display. A calibration error occurred. Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance.Refer to the warranty for contact information and return instructions. SPECIFICATIONS Power supply Display moder Measurement mode Measurement range Accuracy Normal working condition Storage & transportation condition Measurement perimeter of the upper arm 3.7V 1000mAH Built-in rechargeable li-polymer battery, 6V 1A AC Adaptor Blue LCD with White Backlight V.A.= 86.1mm(L) x24mm(W) Oscillographic testing mode Rated cuff pressure:

0kPa-40kPa (0mmHg-300mmHg) Measurement pressure: 5.3kPa-30.7kPa

(40mmHg-230mmHg) pulse value:(40-199)beat/minute Pressure:

5-40within0.4kPa(3mmHg) pulse value:5%

Temperature:5 to 40 Relative humidity: 85%RH Atmospheric pressure: 86kPa to 106kPa Temperature:-20 to 60 Relative humidity: 10%RH to 93%RH Atmospheric pressure: 50kPa to 106kPa About 22cm-42cm Net Weight Approx.265 g External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification Approx.130.9mm73mm29.4mm AC Adaptor,user manual Continuous operation Type BF applied part IP22, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15 V01 Battery Powered Mode:

Internally Powered ME Equipment AC Adaptor charged Mode:

Class II ME Equipment 24 WARNING: No modification of this equipment is allowed. 25 ATHORIZED COMPONENT Athorized Component Please use the TRANSTEK authorized adaptor Adaptor Type:

Input:

Output:

(Conforms to UL Certification) UE08WCP-060100SPA 100-240V 50-60Hz,400mA 6V 1A Contact Information For more information about our products, please visit www.transtek.cn.you can get customer service, usual problems and customer download, transtek will serve you anytime. Manufactured by: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Company: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Address: Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China COMPLIED STANDARDS LIST Complied Standards List Risk management ISO/EN 14971:2012 Medical devices Application of risk management to medical devices Labeling ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements User manual EN 1041: 2008 Medical equipment manufacturers to provide information General Requirements for Safety IEC 60601-1: 2005+A12012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Electromagnetic compatibility IIEC/EN 60601-1-2:2007 Medical electrical equipment -

Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests Performance requirements IEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Clinical investigation ISO 81060-2:2009 Non-invasive sphygmomanometers -

Part 2 : Clinical validation of automated measurement type Software life-cycle processes IEC/EN 62304:2006+AC: 2008 Medical device software

- Software life cycle processes 26 27 FCC STATEMENT EMC GUIDANCE FCC Statement 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. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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. FCC Radiation Exposure Statement:

This equipment complies with FCC radiation exposure limits set forth for This transmitter must not be co-located or operating in conjunction with an uncontrolled environment. any other antenna or transmitter. 28 EMC Guidance 1. The Blood Pressure Monitor 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) 29

version:1.0 User Manual Glass Body Fat Analyzer LS203-B Contains FCC ID: OU9AW8001-LS GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China TEL:86-760-88282982 www.transtek.cn Thank you very much for selecting the Transtek Glass Body Fat Analyzer LS203-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. Table of Contents Table of Contents Safety Information Safety and Usage Information Indications For Use Contraindications Your Scale and Its Environment Efficient Use of Your Scale

................................................................................................... ............................................................................................................... .......................................................... .......................................................... .............................................................................................. ..................................................................................................... Overview Device Components LCD Display Initial Start-Up

................................................................................................................. ............................................................................................................................. General Instructions Insert the Batteries Install App and Pair-up

................................................................................................................. .................................................................................................................. ............................................... ........................................................... Start Measuring

.......................................................................................................... ................................................................................................................. ................................................................................................................... Error Prompt When Measuring ... When Data Transmitting... ............................................................................................................................ ................................................................................................................. ....................................................................................................... ........................................................................................................................... .............................................................................................................................. ..................................................................................................................................... ....................................................................................................................... Specifications Maintenance Warranty FCC Regulations Appendix Table of Body Fat Level Table of Body Water Level Health Tips About Body Fat EMC Guidance

.......................................................................................................... ..................................................................................................... ................................................................................................ ........................................................................................................................ Select Measurement Unit Daily Measurement Manage Your Health Data Transmission Troubleshooting 2 2 3 3 3 4 5 6 6 7 8 8 9 10 10-11 12 13 14 14 15 16 16 17 17-21 1 Safety Information Safety 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 Symbol for TYPE BF APPLIED PARTS Symbol for MANUFACTURER Symbol for COMPLIES WITH MDD 93/42/ECC REQUIREMENTS Symbol for SERIAL NUMBER Symbol for INDOOR USE ONLY Symbol for DIRECT CURRENT The Bluetooth Combination Mark 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 Transteks Body Fat Analyzer 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. The device is equipped with automatic 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 the device. 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 the device. Be aware that misuse of electrical equipments can cause electric shock, burns, fire and other hazards. The patient is an intended operator. The patient can perform all the operations in the manual, such as measurement, data transmitting, changing batteries. 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. 2 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 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. 3 Overview LCD Display Overview Device Components LCD Display Electrode Electrode UNIT and activation Button Battery Compartment List 1. Glass Body Fat Analyzer LS203-B 2. Four AAA-size Alkaline Batteries (1.5V each) 3. User Manual 4 Kilogram Stone Pound Bioelectrical Impedance Analysis Data transmitting Pending to transmit to wireless wellness system Low Battery 5 Initial Start-Up General Instructions Install App and Pair-Up Initial Start-Up Transtek Glass Body Fat Analyzer LS203-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. 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 adults indoor use only. 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 0.0kg are shown on the LCD. 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. The App is now available in App Store You may search and install the app in your iPhone. Turn on Bluetooth and App. Make sure both are ON when pair-up is proceeding. Press and hold UNIT button in the back of the scale to start pair-up. Symbol and symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. CAUTION When the symbol appears, the device will power off in four seconds. Then you shall replace with a new set of batteries. Please replace all four batteries in 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. To remove primary batteries when me equipment is not likely to be used for some time. Not touch the patient and battery output simultaneously. If SUCCEED, symbol will be shown on the LCD. If FAIL, symbol E1 will be shown on the LCD. 6 7 Start Measuring Manage Your Health 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 kg. You may press UNIT button to choose among kilogram, stone and pound. Data Transmission With the scale successfully pair-up with your iPhone, the measurement data will be automatically transmitted to your mobile via Bluetooth. Daily Measurement With original SENSE ON patent technology, the scale will automatically switch on as you step on the platform barefooted. Stand still and keep full contact with the electrodes until the LCD stops blinking BIA. 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. Data transmitting Data ready to transmit to the App:

-If SUCCEED, the symbol disappears;

-If FAIL, the symbol remains. Bluetooth Module No.: AW8001 RF Frequency Range: 2402MHz to 2480 MHZ Output Power Range: 4 dBm Supply Voltage: 3V to 3.6V When your scale is successfully paired with your iPhone and the Bluetooth is ON, it will process data transmission automatically.

(Please refer to Data Transmission for more details.) CAUTION The normal measuring time cannot over 1 minute. After the measurement, please dont stand on the scale for a long time. Continous to use the scale for a long time, the surface temperature may exceed 41, this will cause burns. 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. 8 9 Troubleshooting Error Prompt Troubleshooting Error Description Solution Problem Root Cause Solution Overload. The device will power off in four seconds. Stop using this scale for measurement. Low Battery. The device will power off in four seconds. Failure of pairing up your scale with your iPhone. Replace all four batteries in the same time. Please purchase the authorized batteries for replacement. Please check below items:

-Bluetooth is ON.

-App is ON.

-Both devices are within the transmission distance of Bluetooth. Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. No display on LCD when the device powers on. Cold Electrodes. Place the device in a warm room for a while and then measure again. Either your hands or your feet are too dry. Wipe your feet with a damp cloth, keeping them slightly damp when starting measurement. When Measuring ... Problem Root Cause Solution Incorrect posture 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. Cold body that may results in bad blood circulation. Warm up your hands and feet to resume blood circulation and then measure again. Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. 10 Batteries not yet installed. Worn batteries. CANNOT proceed to analyze body fat Step onto the platform wearing socks or shoes. The device powers off automatically. Low battery. Install the batteries.

(Please refer to Insert the Batteries) Replace all four batteries in 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. Replace all four batteries in the same time. Please purchase the authorized batteries for replacement. 11 Troubleshooting Specifications When Data Transmitting ... Problem Root Cause Solution Bluetooth is OFF. Turn ON the Bluetooth via Setting >> General >> Bluetooth. App is OFF. Press the icon to turn ON your app. Specifications Product Name Glass Body Fat Analyzer (LS203-B) Dimension Scale: 321x321x23.5mm Panel: 321x321x6mm Net Weight Approximately 2kg ( Excluding the dry cells) Display Blue LCD with White Backlight V.A.: 74x53mm Measurement Unit Kilogram / Stone / Pound Data transmission failed. 12 Out of range of Bluetooth transmission. Place your iPhone closer to the scale. Measurement Range 5kg to 200kg / 0st: 11lb to 31st: 7lb / 11lb to 441lb Division Accuracy Working Environment 0.1kg / 0.2lb 0-50kg: 0.3kg;

100-150kg: 0.5kg;

Temperature: 0 to 40 Pressure: 80kPa to 105kPa 50-100kg: 0.4kg;

150-200kg: 0.7kg Humidity: 90% RH Storage Environment Temperature: -20 to 60 Humidity: 10%RH to 93% RH Power Source 6V (Four AAA-size Alkaline Batteries) Auto-ON Auto-OFF Accessories SENSE ON technology About 10 seconds while showing 0.0 About 15 seconds after the weight data is locked 1. Four AAA-size Alkaline Batteries 2. User Manual Mode of Operation Continuous Operation Protection against electric shock Internally powered ME equipment Protection Against Ingress of Water Software Version IPX0 1.0 Applied part Type BF applied part, including the whole top surface Note: Not intended to be sterilized. Not for use in an oxygen rich environment. 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 13 anyone during the process of transaction for verification of goods weight. Maintenance Maintenance When carrying out usual maintenance, please ensure practice of the following Dos and Donts:

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. DONT wash the device with water or immerse it in water. DONT use propellant, abrasive or other chemicals to wipe the dirt in avoidance of discolor or malfunction. DONT 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 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 users 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. 14 15 Appendix Table of Body Fat Level (Unit: %) Age 20-29 30-39 40-49 50-59 Man / Sportsman Normal High 13.1-20 20.1-23 14.1-21 21.1-24 16.1-23 23.1-26 17.1-24 24.1-27 V. High

>23

>24

>26

>27 Low

<13

<14

<16

<17

<18 18.1-25 25.1-28 60+

Table of Body Water Level (Unit: %) Body Fat

>28 Gender Percentage Range Men Women 4-14 15-21 22-24 25 4-20 21-29 30-32 33 Woman / Sportswoman Normal High V. High 19.1-28 28.1-31 20.1-29 29.1-32 22.1-30 30.1-33 23.1-31 31.1-34 24.1-32 32.1-35

>31

>32

>33

>34

>35 Low

<19

<20

<22

<23

<24 Optimal Total Body Water Percentage Range 70-63 63-57 57-55 55-37 70-58 58-52 52-49 49-37 Appendix EMC Guidance Table 1 Guidance and MANUFACTURERS declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturers declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic environment guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Emission test Compliance RF emission CISPR 11 RF emission CISPR 11 Group 1 Class B Harmonic emissions IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Not applicable Not applicable Source: Derived fr. Wang & Deurenberg: Hydration of fat-free body mass. American Journal Clin Nutr 1999, 69833-841 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 cant judge body fat level simply by our weight, this body fat analyzer LS203-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. 16 17 Appendix Table 2 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for all ME EQUIPMENT and ME SYSTEMS Guidance and manufactures declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Immunity test IEC 60601 test level Compliance level Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 6 kV contact 8 kV air 6 kV contact 8 kV air 2 kV for power supply lines Not applicable Surge IEC 61000-4-5 1 kV line(s) to line(s) Not applicable Voltage dips, short interrup-

tions and voltage variations on power supply input lines IEC 61000-4-11

<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 sec Not applicable Appendix Table 4 Guidance and manufactures declaration electromagnetic immunity for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufactures declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Electromagnetic environment -

guidance 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 d = 1.167 d = 1.167 80 MHz to 800 MHz d = 2.333 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufac-

turer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmit-

ters, as determined by an electromag-

netic site survey,a should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Power frequency

(50Hz) magnetic field IEC 61000-4-8 Power frequency magnetic fields 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. 3A/m 3A/m 18 19 Appendix Appendix At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic NOTE 1 NOTE 2 propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, 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 compliance level above, the device operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. is used exceeds the applicable RF should be observed to verify normal b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment at the LS203-B 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. Rated maximum output power of transmitter

(W) 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter

(m) 150 kHz to 80 MHz d = 1.167 N/A N/A N/A N/A N/A 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.167 0.117 0.369 1.167 3.690 11.67 d = 2.333 0.233 0.738 2.333 7.377 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. 20 21

GuangdongTranstekMedicalElectronicsCo.,Ltd AW8001Bluetooth4.0module Specification Version1.0 2013-7-25 1 GuangdongTranstekMedicalElectronicsCo.,Ltd 1.1 Introduction TheAW 8001 Moduleisdesignedtobeusedinconjunctionwithanexternal Bluetooth low energysubsystemandfeaturesasimple microcontroller runningtheapplication.TheAW8001integratesacompletePHY,Link ControllerandHostsinglemode SPI basedinterfacetotheapplicationmicrocontroller.Qualifiedprofiles,APIsandexample BlueSDKwh ichiseasilyportabletoarangeof applicationareprovidedaspartofthe differentapplicationmicrocontrollers.ThissystemsegmentationallowstheAW8001tobe usedwi ththebest-fitm icrocontrollerforaspecificapplicationaswellaseaseintegration and endproductqualificationasapplicationandprotocolstackdoesnotsharethesame microcontroller. 1.2 Features BluetoothSpecificationv4.0compliantsinglemodelowenergysolution Complete PHY,LinkControllerandH ostsubsystem Profiles andexampleapplicationsprovidedin Blue SDK Cost andpoweroptimizedforslaveoperation SimpleSPI basedApplicationControllerInterface(ACI) FullL ink ControllerandHostsecurity 1.9 to 3.6Voperation Linearvoltageregulator Step-down DC/DCvoltageregulatorprovidingupto20%peakcurrentreduction Sub 14mApeakcurrentwithlinearvoltageregulator Supportssub10Aaveragecurrentoperation Batteryvoltagemonitor Temperaturesensor 1.3 APPLICATIONS Sportsandfitnesssensors Healthcareandmedicalsensors Continua VersionTwocertifiedprodu cts Remote controls Watches Mobile phoneperipherals Automationsensors Proximity tags 2 GuangdongTranstekMedicalElect ronicsCo.,Ltd 2.1ProductInformation AW8001isaBT4.0Module,It smainphysicalfeaturesaretheBluetoothlowenergy PHYandtheBluetoothlowenergystackthathandlesthelinkcontrollerandhoststack.It alsoincludesadditionalanalogsub-systemsneededfortheBluetoothlowenergyoperation, suchaspowermanagementandseveraloscillatoroptions. AW8001blockdiagram AW8001hason-chipnon-volatilememoryforstoringserviceconfigurations.This on-chipstorageletsyouselectandcombinethenecessaryservicesforyou reducing therequiremen ts on yourapplicationcontrollerforhandlingallreal-time operationsrelatedtotheBluetoothlowenergycommunicationprotocol. r application, AW8001includesapowersupplyvoltagemonitorand atemperaturesensorthat furtherreducestherequirementstotheapplicationcontroller.Thesefeaturesare accessiblethroughtheApplicationControllerInterface(ACI). AW8001alsooffersanoptionaloutputsignalthatisactivatedbeforeth er adio becomesactive.Thistimingsignalenablesyoutocontrolthe application,avoidingoverloadofyourpowersupply(formostapplicationsth smallbatter y).You can alsousethis avoidingnoiseinterferencewhentheAW8001radioisoperating. timing signaltocontroltheapplicationcircuitry, peakcurrentdrainofyour is is usually a A separateserialinterface(UART)givesyouaccesstotheBluetoothlowenergyDirect TestMode(DT M).This interfaceisusedtocontroltheBluetoothlowenergyradio(RFPHY) andissupportedbycommerciallyavailableBluetoothtestequipmentuse qualification.Thisserialinterfacealsoenablesyoutotestradioperformanceandto optimize yourantenna. dforBluetooth 3 GuangdongTranstekMedicalElect ronicsCo.,Ltd 2.2Operatingconditions TheoperatingconditionsarethephysicalparametersthatnRF8001canoperatewithin. 2.3DigitalI/Osignallevels ThedigitalI/OsignallevelsaredefinedTable.Theoperatingconditionsare:VDD=3.0V,TA

=40oCto+85oC(unlessotherwisenoted). 2.4Radiocharacteristics nRF8001electricalcharacterizationisdefinedinTable.Theoperatingconditionsare:

VDD=3.0V,TA=40oCto+85oC(unlessotherwisenoted). 4 GuangdongTranstekMedicalElect ronicsCo.,Ltd 3.1MechanicalInformation 3.2PINInformation VCC MOSI SCK

/REQN MISO

/RDYN NC RESET GND 5 GuangdongTranstekMedicalElect ronicsCo.,Ltd 3.3ModuleInstallation Step1:ConnecttheModuletotheconnector,thisconnectorcanbe aPCBorPinheaderor another,seefollowingpicture Step2:ConnecttheModulePCBAtotheMainPCBA,seefollowingpicture Step3:InstalltheMainPCBAtotheProduct,seefollowingpicture Caution:Wheninst allthemodule,youmustpay attentiontothe temperatureofthesoldering iron(thesolderingironshould beconnect toGround),thetem peratureshouldbesetatabout380

; youmust payattentiontothe electrostatictoo,takeactiontoavoidelectrostatic . Andyoumustavoidshortc ircuitwhe nyouconnectthemodu le. ModuleFCCID:OU9AW8001-LS 6 GuangdongTranstekMedicalElect ronicsCo.,Ltd Step4: The final Product, see following picture Make sure that the module is fixed in the host and does not allow users to replace or demolition. 7 Guangdong Transtek Medical Electronics Co., Ltd Caution: Any changed or modifications not expressly approved by the party responsible for compliance could void the user`s authority to operate this equipment. 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. 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. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. This device should be installed and must not be co-located or operating in conjunction with any other antenna or transmitter. The module in this product is labeled with its own FCC ID and the FCC ID is not visible when the module is installed inside another device. To satisfy FCC exterior labeling requirements, the following text must be placed on the exterior of the end product. Contains Transmitter Module FCC ID: OU9AW8001-LS 8

version:1.0 User Manual Body Fat Analyzer GBF-1251-B1 Contains FCC ID: OU9AW8001-LS GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China TEL:86-760-88282982 www.transtek.cn Thank you very much for selecting the Transtek Body Fat Analyzer GBF-1251-B1. 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 Table of Contents Safety Information Safety and Usage Information Tips

............................................................................................... .......................................................................................................................................... Overview Device Components List LCD Display Initial Start-Up

................................................................................................................. ......................................................................................................................................... ............................................................................................................................. General Instructions Power Supply Insert the Batteries Pair-up Set Up Your Profile Select Measurement Unit Initialising Your Scale Weight Only Operation

................................................................................................................. .......................................................................................................................... .................................................................................................................. .................................................................................................................................... ................................................................................................................ ....................................................................................................... .............................................................................................................. ............................................................................................................. Start Measuring First Measurement Daily Measurement Fast Measurement Manage Your Health Body Fat Indicator Data Transmission

................................................................................................................... ................................................................................................................. ................................................................................................................. ................................................................................................................... ................................................................................................................... Troubleshooting Error Prompt When Measuring ... When Data Transmitting... ............................................................................................................................ ................................................................................................................. ....................................................................................................... ........................................................................................................................... .............................................................................................................................. ..................................................................................................................................... ....................................................................................................................... Specifications Maintenance Warranty FCC Regulations Appendix Table of Body Fat Level Table of Body Water Level Muscle Mass Percentage Bone Mass Percentage Health Tips About Body Fat EMC Guidance

.......................................................................................................... ..................................................................................................... ......................................................................................................... ............................................................................................................. ................................................................................................ ........................................................................................................................ 2 3 4 4 5 6 6 6 7 8-9 9 10 10 11 12 13 13 14 15 15-16 17 18 19 19 20 21 21 21 21 22 22-25 1 Safety Information Safety 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 MANUFACTURE DATE Symbol for SERIAL NUMBER CAUTION Symbol for MANUFACTURER Symbol for DIRECT CURRENT Symbol for ENVIRONMENT PROTECTION Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice Transteks Body Fat Analyzer GBF-1251-B1 offers you a seamless way to manage your health. Please be aware that this device is designed for healthy population over 10 years old self-measuring and self-monitoring body compositions. Any information provided by this device is in no way meant to treat, cure or prevent any disease or illness from happening. If in doubt, contact your physician. This device is contraindicated for any female subject who may be suspected of, or is pregnant. Otherwise, the effects of this device on the fetus are unknown. This device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument such as a pacemaker or defibrillator. This device should not be used for anyone who is acutely or chronically ill because of suffering from a disease or taking medications that affect your water levels. The accuracy of readings for these patients has not been verified. Specific medical advice should be obtained from a physician. GBF-1251-B1 is equipped with data transmission function. It may emit electromagnetic energy so as to perform its intended function. Nearby portable and mobile RF communications equipment can affect the performance of GBF-1251-B1. And the device can interfere vicinity electrical equipment. Manufacturer will make available on request circuit diagrams, component parts list,etc. WARNING:No modifications of this equipment is allowed. This may result in increased EMISSIONS or decreased IMMUNITY of GBF-1251-B1. Please use the device according to the user manual. Any misuse can cause electric shock, burns, fire and other unexpected hazards. Please use and storage the device under the environment which was provided in the user manual. Dont 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. 2 INDICATIONS FOR USE The Transtek Body Fat Analyzer measures weight and uses bio-electrical impedance analysis

(BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy children 10-17 years old and healthy adults. It is intended for use in the domestic setting only. Tips 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. To prevent you from injury, please pay attention to the following Notice. Small parts being inhaled or swallowed. Potential allergic reactions to accessible materials used in the ME EQUIPMENT. Contact injuries. Use accessories, detachable parts and materials not described in the instructions for use. A list of known devices or other sources that can potentially cause interference problems

(example 1 Heat from a fireplace or radiant heater. example 2 Moisture from a nebuliser or steam kettle). The effects of degraded sensors and electrodes, or loosened electrodes, that can degrade performance or cause other problems The effects caused by pets, pests or children 3 Overview Overview Device Components LCD Display LCD Display Electrode Up Sensor Key Set Sensor Key Down Sensor Key Electrode UNIT Key Battery Compartment List 1. Body Fat Analyzer GBF-1251-B1 2. Four AAA-size Batteries (1.5V each) 3. User Manual 4 Body Fat Level: Low Body Fat Level: Normal Body Fat Level:Above Average Body Fat Level: High User Interface: Setting Body Mass Index Body Fat Analysis Result Muscle Mass Analysis Result Water Analysis Result Bone Mass Analysis Result Pound Kilogram Percentage Foot Centimeter Age Man Sportsman Woman Sportswoman User ID (Range from U1 to U8 ) Successful Bluetooth Connection Data transmitting / pending to transmit to wireless wellness system Low Battery 5 Initial Start-Up Initial Start-Up General Instructions Transtek Body Fat Analyzer GBF-1251-B1 applies BIA (Bio-impedance Analysis) technology. A small amount of weak current flows through the human body so as to detect the bio-impedance and estimate BMI, body fat, body water, muscle mass and bone mass. The electrical current is small and may not be felt. This BIA technology is cheap, safe, non-invasive, toxic-free and harmless. It also possesses the characteristics of simple operation and abundant information. The current mentioned above is less than 0.5mA. However, please be aware that anyone with an wearable or implantable medical electronic instrument, such as a pacemaker, must avoid using this device. The intended use of this device is for healthy children 10-17 years old and healthy adults. Power Supply Battery Mode: 6V, 4 x AAA batteries Battery Life: Approx. 120 days

(Battery capacity: 230 mAH. If measured three times per day, each measurement takes about 46s. The current for measurement is about 30 mA , while the current when shutdown is about 30 uA.) Insert the Batteries Open the battery door in the back of the scale. Insert the batteries (4 x 1.5V AAA) into the battery compartment according to the polarity indications marked inside the compartment.

* The digits will be shown on the LCD. Close the battery door and wait until the digits are shown on the LCD. CAUTION When the symbol appears, the device will power off. Then you shall replace with a new set of batteries. Please replace all four batteries at the same time. Do NOT mix the old batteries with the new one. Worn batteries are hazardous waste. Do NOT dispose of them together with the household garbage. Please refer to the local ordinances and recycling instructions regarding disposal of the worn batteries and scrapped device. If you do not intend to use this unit for a prolonged period of time, it is advisable to remove the batteries before storing. 6 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. 7 Initial Start-Up Initial Start-Up Set Up Your Profile The body fat analyzer GBF-1251-B1 supports multiple users (Up to Eight). You may follow below instructions to assign User ID and set up your own profile, including Gender, Stature, and Age. 1.Assigning User ID With batteries correctly installed, touch SET key to turn on the device,then touch SET key again for about 3s to enter setting. The system will request User ID selection first. As pictured on the right, 1 blinks. The operator may touch the function key or to select User ID among U1 to U8. Touch SET key to confirm User ID. 2.Setting Data deletion After confirming User ID, the system will divert to Data deletion setting. As pictured on the right, the letter n blinks. The operator may touch the function key or to select or . Touch SET key to confirm Data deletion. Note: Select the means the settings of all the users wont be deleted;select the means the settings of all the users will be deleted. 3.Setting Gender After confirming Data deletion, the system will divert to Gender setting. As pictured on the right, the portrait blinks. The operator may touch the function key or to select Gender. Touch SET key to confirm Gender. 4.Setting Stature After confirming Gender, the system will divert to Stature setting. As pictured on the right, the digits 55.0 blinks. The operator may touch the function key or to increase or decrease the numeral. (Range: 33.5 ft to 72.5 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. 8 5.Setting Age After confirming Stature, the system will divert to Age setting. As pictured on the right, the digits 30 blinks. The operator may touch the function key or to increase or decrease the numeral. (Range: 10 to 85 years old) You may touch and hold the function key or for fast changing the numeral. Touch SET key to confirm Age. When the LCD displays and alternately, you may start measuring. Select Measurement Unit With batteries correctly installed, press UNIT key in the back of the scale to select measurement unit. The default measurement unit is lb. You may press UNIT key to choose between pound and kilogram. Note: If there is no operation in the weighing mode, the scale will turn off after about 20 seconds. 9 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 wont be saved in the scale, and wont be transmitted to the APP. STEP2: Stand still and the weight data will be locked with the unit stop blinking.Keep full contact with the electrodes until the LCD stop displaying moving . STEP 3: The measuring results will be displayed sequentially four times:Weight,BMI, Body Fat, Muscle Mass,Total Body Water, Bone Mass,and then turn off.

* If it fails to complete the analysis, the LCD will only display the weight data.

(To find out the solutions, please refer to Troubleshooting for more details.) When your scale is successfully paired with your smartphone and the Bluetooth is ON, GBF-1251-B1 will process data transmission instead.

(Please refer to Data Transmission for more details.) 10 11 Start Measuring Daily Measurement With original SENSE ON patent technology, GBF-1251-B1 will switch on as you step on the platform barefooted. Stand still and keep full contact with the electrodes until the LCD stops displaying moving . After the weight is locked, if identify the stored weight is during this weight within+/-4.5 kg,it will identify the specific user ID.Then the measuring results will be displayed sequentially four times and then turn off. If it identifies two or more users,the User ID will be displayed alternately,for example, U1 and U2,you may touch or key to select the relative user, then touch SET key to confirm. The measuring results will then be sorted into the User ID you selected and displayed sequentially four times and then turn off. If it fails to identify the possible User ID, the LCD will only display the weight data.

(To find out the solutions, please refer to Troubleshooting for more details.) When your scale is successfully paired with your smartphone and the Bluetooth is ON, GBF-1251-B1 will process data transmission instead.

(Please refer to Data Transmission for more details.) Start Measuring Fast Measurement With batteries correctly installed, press SET key to turn on the scale, and the LCD displays 0.0, then you may touch the function key or to select the User ID. If the User ID had set the profile,then the LCD will display and alternately, you may start measuring. The analysis result will be displayed sequentially four times and then turn off. If the User ID hadt set the profile,then the scale will turn off after 3s. Body Fat Indicator Your body fat level will also be displayed when the measuring results are shown on the LCD. As pictured to the right, the users body fat level is LOW.

(Please refer to Table of Body Fat Level for more details.) 12 13 Manage Your Health Troubleshooting Data Transmission With GBF-1251-B1 successfully pair-up with your smartphone, the measurement data will be transmitted to your mobile via Bluetooth. ONLY when the measuring results are attached to a specific User ID will it be transmitted to your mobile after measurement. The symbol will disappear after successful data transmission, and you may check your personal health data stored in your smartphone. If the data transmission fails, the symbol will remain. The pending measurement data will be temporarily kept in the scale and transmitted to your smartphone when next measurement is complete. Successful Bluetooth Connection Data transmitting to wireless wellness system:

-If SUCCEED, the symbol disappears;

-If FAIL, the symbol remains. Error Prompt Error Description Solution Overload. The device will power off. Stop using this scale for measurement. Low Battery. The device will power off after about 3s. Failure of pairing up your scale with your smatrphone. 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. 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. When Measuring ... Problem Root Cause Solution Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. Incorrect posture 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. 14 13 15 Troubleshooting Troubleshooting When Data Transmitting ... Problem Root Cause Solution Data transmission failed. Bluetooth is OFF. Turn ON the Bluetooth via Setting >> General >> Bluetooth. The App is OFF. Press the icon to turn ON your app. Out of range of Bluetooth transmission. Place your smartphone closer to the scale. None of the user ID is assigned. Please assign a User ID following the instruction in Set Up Your Profile. Problem Root Cause Solution Abnormal measuring results:

- Too high; OR

- Too low; OR

- Huge difference between two recent measurement. No display on LCD when the device powers on. CANNOT proceed to analyze body fat, total body water, muscle mass and bone mass. Either your hands or your feet are too dry. Wipe your feet with a damp cloth, keeping them slightly damp when starting measurement. Batteries not yet installed. Worn batteries. Step onto the platform wearing socks or shoes. 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. 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. The device powers off. Low battery. Replace all four batteries at the same time. Please purchase the authorized batteries for replacement. 16 17 Specifications Specifications Product Name Dimension Net Weight Display Body Fat Analyzer (GBF-1251-B1) Scale: 310x310x24mm (Approximately) Approximately 1.75kg ( Excluding the dry cells) Digital LCD with White Backlight Measurement Unit Kilogram / Pound Measurement Range 5kg to 200kg / 11lb to 441lb Division Accuracy 0.1kg / 0.2lb 5-50kg: 0.3kg;

100-150kg: 0.5kg;

50-100kg: 0.4kg;

150-200kg: 0.7kg Working Environment Storage Environment Temperature: 5 to 40 Atmospheric pressure: 80kPa to 106kPa Humidity: 90% RH Temperature: -20 to 60 Atmospheric pressure: 50kPa to 106kPa Humidity: 93% RH Power Source 6V (Four AAA-size Batteries) Turn on Method SENSE ON technology Auto-OFF Accessories Mode of Operation About 20s after LCD display 0.0, or about 15s after the weight is locked, or about 20s when the weight is unstable. 1. Four AAA-size batteries 2. User Manual Continuous Operation Degree of protection Protection against ingress of water Type BF applied part IP21, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops Protection Against Ingress of Water IPX0 Software Version 1.0 Bluetooth Module No. AW8001 18 Maintenance Maintenance When carrying out usual maintenance, please ensure practice of the following Dos and Donts:

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. DONT wash the device with water or immerse it in water. DONT use propellant, abrasive or other chemicals to wipe the dirt in avoidance of discolor or malfunction. DONT disassemble this device. If you have any problems, please contact Transtek.

(Please refer to Warranty for contact information) Do not dispose of batteries in fire. Batteries may explode or leak. Remove the batteries if the scale will not be used for a long period. Warranty Transtek warrants its products free of defects in materials and workmanship in normal use for a period of FIVE years from the date of retail purchase. This warranty does NOT cover damages caused by misuse or abuse, including but not limited to:

Failure caused by unauthorized repairs or modifications;

Damage caused by shock or drop during transportation;

Failure caused by improper operation inconsistent with the instructions stated in this user manual;

Malfunction or damage from failure to provide the recommended maintenance;

Damage caused by improper use of power supply. Should this device require maintenance (or replacement at our option) under warranty, please deliver the original package to GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD prepaid. Please return the store receipt (with the retail purchase date) and a note with reasons to return on it as well. GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District, Zhongshan, 528437, Guangdong, China Tel: 86-760-88282982 Website: http://www.transtek.cn 19 FCC Regulations FCC Regulations FCC User Guide Information Radio Frequency Interface Requirements - FCC Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna;

Increase the separation between the equipment and receiver;

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected;

Consult the dealer or an experienced radio / TV technician for help. Radio Transmitters (Part 15) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the users 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. 20 Appendix Table of Body Fat Level (Unit: %) a) The body fat percentage (%): 5%-60%/0.1%

Standard for Men Standard for Women Rating low Normal Moderately High High 20-29 30-39

<14

<13 14-20 15-21 21-23 22-24

>23

>24 Age 40-49

<16 17-23 24-26

>26 50-59

<17 18-24 25-27

>27 60+

<18 19-25 26-28

>28 Rating low Normal Moderately High High 20-29

<19 20-28 29-31

>31 30-39

<20 21-29 30-32

>32 Age 40-49 50-59

<21

<22 22-30 23-31 31-33 32-33

>33

>34 60+

<23 24-32 33-35

>35 Source: University of Illinois Department of Food Science and Human Nutrition. Body Fat Percentage Calculator. 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. 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 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 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%. 21 Appendix Appendix Health Tips - About Body Fat Fat is essential for human body. It can not only store energy and protect viscera, but also regulate body temperature and maintain normal physiological function of human body. However, too much body fat is harmful to human body. It is always accompanied by Fatty Liver, diabetes, coronary heart disease, etc. Therefore self-measuring and self-monitoring body fat level are beneficial to your health. Since we cant judge body fat level simply by our weight, this body fat analyzer GBF-1251-B1, with BIA (Bio-impedance Analysis) technology applied, is an accurate device that offers a quick and comfortable way to obtain your body fat level. EMC Guidance 1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. 2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment.

(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m) Table 1 Guidance and MANUFACTURERS declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturers declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance RF emissions CISPR 11 Group 1 The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/

flicker emissions Not applicable IEC 61000-3-3 22 Table 2 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test Electrostatic dischar ge (ESD) 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 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s ) to line(s) 2 kV line(s ) to earth

<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 Compliance level Electromagnetic 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 %. Not applicable a fo taht eb dluohs ytilauq rewop sniaM typical commerc ial or hospital environment. Not applicable a fo taht eb dluohs ytilauq rewop sniaM typical commerc ial or hospital environment. Not applicable 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. Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 m/A 3 m/A 3 sdleif citengam ycneuqerf rewoP 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 applic ation of the t est level. 23 Appendix Appendix Table 4 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment guidance 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 Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz Not applicable

=d

]5,3[

V 1 P Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m

=d 1.167 P 80 MHz to 800 MHz

=d 2.333 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter i n watts (W) accordi ng to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as deter-

mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, 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. Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W 10,0 1,0 1 01 001

=d

]5,3[

V 1 P Not applicable Not applicable Not applicable Not applicable Not applicable

=d 1.167 P

=d 2.333 P 0.117 0.369 1.167 3.690 11.67 0.233 0.738 2.333 7.378 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the t ransmitter in watts (W) accordi ng 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. 24 25