File No.:XXXXXX Body Composition Analyzer User Manual Model:CS20C Shenzhen Yolanda Technology Co.,Ltd. Foreword With the continuous development of clinical nutrition, how to accurately and comprehensively evaluate the nutritional status of individuals, better implement clinical nutrition support treatment, and promote early recovery, has been paid more and more attention by the general population. In recent years, the rapid development of human composition determination methods can provide important clinical nutritional information for assessing the nutritional status of the human body. On the one hand, it can be used to prevent epidemic diseases such as obesity, and on the other hand, it can guide the administration of reasonable diet and exercise. Bioelectrical impedance technology (BIA) is a detection technology that extracts the electrical impedance information of the organism to reflect the biomedical information related to the physiology and pathology of the organism. The human body composition analysis is an important application branch of bioelectrical impedance technology, it is through the detection of human body impedance information to get the parameters of each component of the human body. Human body composition analyzer is simple, accurate, non-invasive, safe, low cost and a wide range of people and other advantages, whether it is academic and commercial, have been vigorously developed. Thank you for purchasing the Intelligent Body Composition Analyzer. Copyright 2021 by Shenzhen Yolanda Technology Co.,Ltd. Rev.1.0 Printed in 08/05/2021. Catalogue Product Overview ......................................................................................................................................................... 1 Description of warning and error sign or signal ............................................................................................................ 1 Safety Precautions......................................................................................................................................................... 1 Product introduction ..................................................................................................................................................... 3 Structure and component .............................................................................................................................................. 4 APP Operation Instructions .......................................................................................................................................... 8 Packing list.................................................................................................................................................................. 12 Battery Installation/Replacement ................................................................................................................................ 12 Cleaning/disinfection and Care ................................................................................................................................... 12 Trouble-shooting ......................................................................................................................................................... 13 Standard List ........................................................................................................................................................... 13 Disposal .................................................................................................................................................................. 14 EMC ........................................................................................................................................................................ 14 Warranty and warranty information ........................................................................................................................ 18 Manufacturer and European Authorized Representative Information .................................................................... 19 Product Overview The Body Composition Analyzer mainly through the measurement of body weight, bioimpedance and height, age, gender set to calculate the body's BMI, body fat rate, body water and other indicators; In addition, the data can be directly uploaded to APP via Bluetooth or to server via WiFi connection, and then the server will push the data to APP to generate in-depth test report. The body composition analyzer is suitable for individuals, family users and other long-term monitoring of body obesity, to provide data reference for weight loss and muscle gain. To ensure proper use, please be sure to read this user manual carefully, paying close attention to the safety precautions. In order to use this product correctly, please read the user manual before use. In order to properly use this product, please carefully read the full text of this manual before using, in particular thesafety precautionssection. Please keep this instruction manual in a convenient place for reference. Description of warning and error sign or signal 1.Warning instructions and precautions The warning signs and graphic symbols in the manual are intended to enable you to use the product safely and correctly and to prevent harm to you and others. Warning marks and graphic symbols are described as follows:
Warning/precautions symbols Indicates a potentially hazardous situation which, if not avoided, could Waring result in death or serious injury. Means a possibility of personal injury or property damage in case of cautions improper use. Notes Indicates the need for attention, if not attention may lead to incorrect use of the product or property device damage. 2.Symbol description Manufacturer information:
The manufacturer name and address Manufacture date Serial Number Batch code Pile Limit 4 layers Authorized representative in the European Community. Refer to instruction manual. Medical device Applied part of type BF Fragile,handle with care 1 Keep Dry The product should be vertically up 1639 Complies with the European Medical Device Regulation(2017/745.Notified Body is 1639. Disposal in accordance with Directive 2002/96/EC(WEEE) Safety Precautions Warnings 1Use object The target users of this product are the general population aged 18-60. 2Potential safety hazards and use restrictions 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. Interference may occur in the vicinity of equipment marked with the following symbol
.And the Analyzer may interfere vicinity electrical equipment. No modification of this equipment is allowed. There is a risk of electrocution or injury. Nor can precise analysis be guaranteed. Any modification without permission is prohibited as such modification may result in unacceptable risks. The maintenance of the equipment must be conducted by special personnel. Disassembly and maintenance of the machine by oneself is prohibited. (Circuit diagram, list of components, drawing notes, calibration details and other information have been provided to maintenance personnel.) Cautions 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 To enable the data transmission function, this product should be paired to a Bluetooth end at 2.4 GHz. Do not carry out maintenance or maintenance during use 2 Product introduction 1.Intended use 1.1 The Body Composition Analyzer measures weight, body impedance and uses bioelectrical impedance analysis(BIA)technology to estimate body fat percentage(body fat mass), total body water content, BMI in generally healthy adults. The visceral fat rating and protein are only displayed on the APP. 1.2 It is intended for use in the home only. 2.Efficacy 2.1 This product is simple to use, and requires no specialized facilities or expertise to take measurements. 2.2 Measurements can be taken quickly and easily, causing minimal inconvenience to the patient during. measurements. 3.Contraindication 3.1 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. 3.2 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. 4.Specifications Product name Model Body Composition Analyzer CS20C Measurement Principle Weight measurement range bioelectrical impedance analysis(BIA) 0.2-180kg Pressure starting weight
>5kg Accuracy Resolution ratio Memory Capacity Number of users Power source Size Net weight EMC 0-50kg0.2kg50-100kg0.3kg100-150kg0.4kg150-180kg0.5kg 0~100kg0.05kg>100kg0.1kg 20 8 4*1.5V AAA battery 310*310*25mm 1.8kgincluding battery IClass B Degree of protection against electric shock Type BF applied part Working Environment Transportation and Storage Environment Temperature :540 41104 Humidity 30-90%RH Atmospheric Pressure 70kPa-106kPa Temperature -40-55 -40131 Humidity 0-93%RH (No condensation) Atmospheric Pressure 70kPa-106kPa Applicable period 3 years Manufacture date/Lot number See fuselage and gift box for details 3 5.Wireless technology The specification of wireless transmission For Bluetooth Bluetooth 5.0 Valid Transmission Up to 10 meters Receiver Bluetooth 4.0 enabled smart phones running android 4 and above system version and iPhone 4s and above Signal transmission 2.4G Bluetooth Frequency Bluetooth Modulation Type 2.402-2.480 GHz GFSK For Wi-Fi Transmission type Wi-Fi Valid Transmission(Distance between Wi-Fi APP and Composition Body Analyzer) Frequency Range Up to 50 meters 2412~2462MHz Wi-Fi APP environment running Enable smart devices running android 4 and above system version and iPhone 4s and above WIFI Modulation Type BPSK/QPSK/16QAM/64QAM/DBPSK/DQPSK/CCK Structure and component 1. External component 2. Display 4 3. Product performance a. The products are mainly composed of shell, glass, display screen, battery, weight test module, body fat test module, Bluetooth module, WiFi module and mobile terminal application software b.Product basic information display description 5 4Basic information This product can measure body weight, fat percentage, BMI and other indexes. After the measurement is completed, the data will be transmitted to the mobile terminal application software through Bluetooth 4.0 or WiFi. 1Measurement method 6 Place in a hard and flat place for use, do not use on uneven soft materials (such as: soft floor, carpet or spring pad, etc.), otherwise it can not be measured correctly. Do not place in direct sunlight, near heating equipment, air outlet of air conditioning Do not use in places with drastic temperature changes Do not place it in a humid or steamy place Body fat percentage is obtained by the BIA bioreactance measurement, which is closely related to the following parameters: body resistance coefficient/height/weight/age/sex. So change any one of these parameters and the fat percentage changes. Also please do not measure under the following conditions:
After strenuous exercise After a bath or sauna After overeating After drinking a lot of water or alcohol Cold and fever The body weight changes daily with the change of eating and drinking water, there are 0.5~2KG of the change value. Since body fat percentage = fat weight/body weight, fat percentage also fluctuates, as shown in the figure below. In the morning, before eating and drinking, body fat percentage peaks throughout the day, and in the afternoon and evening, body fat percentage peaks throughout the day as weight gain and water content increase due to eating and drinking. 3Measuring position 7 In order to get accurate measurements, pay attention to the measurement posture Proper measurement with two feet on each side of the conductive film Measure naked as far as possible; When measuring clothes, it also includes the weight of the clothes Barefoot and clean the soles of the feet before measuring; Wearing socks or having dust on the soles of your feet will affect the accuracy of the measurements Do not bend your knees or sit while measuring. Do not shake during measurement. Keep your body relaxed. APP Operation Instructions 1. Bluetooth link a. Turn on the Bluetooth function and click add body fat scale, as shown in Figure 1 b. Wait for the system to scan the surrounding body composition analyzer products, and gently step on the body composition analyzer until the screen lights up as shown in Figure 2 c. Click Bind Now as shown in Figure 3 d. The interface indicates that binding is underway, and wait for binding to complete. Do not close the body fat scale as shown in Figure 4 e. WiFi shall be configured after successful binding, as shown in Figure 5 Figure 1 Figure 2 Figure 3 8 Figure 4 Figure 5 2. WIFI Configuration A. Please select 2.4G WIFI for WIFI configuration. B. In the process of network distribution, the body composition analyzer should be turned on and complete the measurement. Distribution network operation is introduced as follows:
Select 2.4GHzWiFi for connection, as shown in Figure 1 Enter the WiFi password, as shown in Figure 2 Wait for the success of distribution network, as shown in Figure 3 Figure 1 Figure 2 Figure 3 9 3. Data synchronization A. Click "History record" on the detail interface, as shown in Figure 1 B. Wait for the device to connect. Start the body composition analyzer and measure body fat weight. When the measurement is finished, the body weight value is displayed on the screen, and the APP will automatically search for the body composition analyzer device, as shown in Figure 2 C. Connect successfully, wait for synchronization completion, please keep the body composition analyzer on, as shown in Figure 3 D. Data synchronization is completed, as shown in Figure 4 E. Check the body weight and body fat measurement results, as shown in Figure 5 Figure 1 Figure 2 Figure 3 1 4. Historical data Figure 4 Figure 5 A. Click the history to view the user's history measurement data, as shown in Figure 1 B. List of historical data, as shown in Figure 2 C. Click [Select] to delete the historical data, as shown in Figure 3 Figure 1 Figure 2 Figure 3 1 Packing list Quantity 1 pcs 4 pcs 1 pcs 1 pcs 1 pcs Parts Body Composition Analyzer 4 AAA batteries User Manual Gift box Package support Battery Installation/Replacement Too low a battery will show LO and the device will go to sleep. The three batteries can be used for three times a day after installation for four months. The four batteries can be used for six months after installation for three times a day. If the battery is connected in reverse, the device will not be able to start up but there is no damage. The battery specification When the product displays "LO", it means that the battery power has been used up and the battery needs to be replaced. Do not use alkaline batteries and manganese batteries at the same time. Remove the battery when not in use for a long time. Battery replacement process Cleaning/disinfection and Care 1. Cleaning and disinfecting Please pay attention to cleaning and disinfecting after each use because the product is reused. If the product is dirty, gently wipe the surface of the product with a wet cloth to remove the dirt. Do not use strong cleaning agent, do 1 not immerse the product in water, the product is not waterproof. Disinfection of the product: wipe the surface of the product gently with a cotton swab dipped in a little medical alcohol (70%), wipe once or twice and use it after the alcohol has completely evaporated. 2. Cleaning and disinfecting environment Temperature :540 41104 Humidity 30-90%RH Atmospheric Pressure 70kPa-106kPa 3. Storage Before storing, dry it and keep it out of reach of children. Remove the battery if you do not use the product for a long time. Keep the product in a safe and dry place. Avoid sun exposure, extreme heat, cold, or humidity. Please do not shock the product, such as dropping it to the floor. Please use the product in strict accordance with the instructions and instructions in this operation guide. Note: It takes 4 hours for the equipment to return to normal operation after being transferred from the lowest storage ambient temperature to an ambient temperature of 20 C It takes 4 hours for the equipment to return to normal operation after being transferred from the highest ambient storage temperature to an ambient temperature of 20 C Trouble-shooting Returns "FAIL" if the user is trying to network the product:
1. Please check the case of your Wi-Fi password and the way you write special characters. 2. Check your router 2.1 Users are requested to keep mobile phones, body fat scales and routers as close as possible and avoid using them in a wall environment 2.2 The signal of portable Wi-Fi is generally unstable, so it is not recommended to use it 3. If "FAIL" is returned when data is uploaded through WIFI after the product measurement is completed: please check whether the network used by the device is in an abnormal or unstable state Weight overload When the product displays "LO", it means the battery power has been used up. Please replace the battery in time. The device is undergoing an OTA upgrade. Please do not force it to shut down Standard List Shenzhen Yolanda Technology Co.,Ltd. declares that theBody Composition Analyzer complies with following applicable standards:IEC 60601-1,IEC 60601-1-2,IEC 60601-1-11,ISO 10993-1,ISO 10993-5,ISO 10993-10 and 1 IEC 62304,ISO1497. Disposal Dispose of the device in accordance with the regulations applicable at the place of operation. Dispose of at public collection point in the EU countries2002/96/EC WEEE Directive. If you have any queries,please refer to the local authorities responsible for waste disposal. NOTES:
Handing of battery and wastes method,please act according to the native law to proceed to handle. To protect the environment,dispose of empty battery at your retail store or at appropriate collection sites according to national or local regulations. EMC RF STATEMENT/FCC statement RF STATEMENT 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 following section. Interference may occur in the vicinity of equipment marked with the following symbol Portable and mobile RF communication equipment(e.g. cell phones)can affect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity. 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. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Any other accessories, transducers and cables may result in increased emissions or decreased immunity and EMC performance. The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, it should be observed in order to verify normal operation in the configuration in which it will be used. 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 following. Portable and mobile RF communication equipment(e.g.cell phones)can affect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the unit. FCC statement 1 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. Attention that changes or modification not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Note: This product 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 product 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 product 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. EMC DECLATION The analyzer needs special precautions regarding EMC and needs to be installed and put into service according to the below EMC information. Statement:
The equipment with following ESSENTIAL PERFORMANCE is intended used in Home healthcare environment and professional healthcare facility environment. If Essential Performance is lost or degraded due to electromagnetic disturbances,this may result in inaccurate measurement and lead to mislead patients, please read below important information before to avoid possible electromagnetic disturbances. Warning Using cell phone or microwave oven, HF surgical equipment, magnetic resonance imaging or other radio radiant equipment near this product may cause malfunction or lead to loss of essential performance, which means that the measurement accuracy will be affected. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Portable RF communications equipment(including peripherals such as antenna cables and external antennas)should be used no closer than 30 cm(12 inches)to any part of the analyzer.Otherwise,degradation of the performance of this equipment could result. Use of accessories,transducers other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Caution:
Security,antitheft,and radiofrequency identification(RFID)devices.Some electromagnetic anti-theft systems and metal detectors such as those used at entrances or exits of department stores,libraries,and other public places,and airport security screening devices may affect the analyzer.Additionally,RFID devices,which are often used to read identification badges,as well as some tag deactivation devices,such as those used at payment counters at stores and loan desks at libraries,may also affect the analyzer.Please do not use analyzer near these places.If you have to go 1 through one of these devices,turn off your analyzer.Before each usage,checking the status of your analyzer to ensure it can operating normally. Using short-wave diathermy,microwave diathermy,or therapeutic ultrasound diathermy(all now referred to as diathermy)and electrocautery devices near this product may cause malfunction or lead to loss of essential performance,please do not use analyzer near these equipment.Before each usage,observing the device to verify that they are operating normally. Guidance and manufacturers declaration-electromagnetic emissions The device is intended for use in the electromagnetic environment specified below.The customer or the user assure that it is used in such an environment. Emissions test Complianc Electromagnetic environment-guidance e Group 1 RF emissions CISPR11 RF emissions CISPR11 Harmonic emissions lEC61000-3-2 Voltage fluctuations/
Ficker lEC61000-3-3 emissions Class B Not applicable Not applicable The device use 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. The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturers declarationelectromagnetic 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. Basic standard method EMC test or IEC 61000-4-2 IEC 61000-4-3 Professional healthcare facility environment Home healthcare facility environment
+/-8 kV contact
+/-2 kV,+/-4 kV,+/-8 kV,+/-15 kV air 3V/m 80MHz-2.7GHz 80%AM at 1kHz or 2Hz 10V/m 80MHz-2.7GHz 80%AM at 1kHz or 2Hz IEC 61000-4-3 See the RF wireless communication equipment table in"Recommended minimum separation distances". IEC 61000-4-8 30A/m;50 Hz or 60Hz Phenomenon Electrostatic discharge Radiated RF EM fields Proximity fields from RF wireless communications equipment Rated power frequency magnetic fields Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Ban Service Modulatio Maxi Dista Immunit 1 d a) a) n b) mum power(W) nce(m) Test y Level(V/m) frequency
(MHz) 385 450 710 745 780 810 870 930 1720 1845 1970
(M Hz) 380 TETRA
-390 400 430
-470 GMRS 460,FRS 460 704 LTE
-787 Band 13,17 800
-960 170 0-1990 GSM800
/900,TETRA 800,iDEN 820,CDMA 850,LTE Band 5 GSM180 0;CDMA 1900;GSM 1900;DECT;L TE Band 1,3,4,25;UM TS Bluetoot h,WLAN,802
.11 b/g/n,RFID 2450,LTE Band 7 2450 240 0-2570 5240 5500 5785 510 0-5800 WLAN 802.11 a/n Pulse modulation b)18Hz FM c)5kHz deviation 1kHz sine Pulse modulation b)217Hz Pulse modulation b)18Hz Pulse modulation b)217Hz Pulse modulation b)217Hz Pulse modulation b)217Hz 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 2 0.3 28 2 0.3 28 0.2 0.3 9 NOTE If necessary to achieve the IMMUNITY TEST LEVEL,the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.The 1 m test distance is permitted by IEC 61000-4-3. a)For some services,only the uplink frequencies are included. b)The carrier shall be modulated using a 50%duty cycle square wave signal. c)As an alternative to FM modulation,50%pulse modulation at 18 Hz may be used because while it does not represent actual modulation,it would be worst case. 1 Warranty and warranty information Recommended separation distances between portable and mobile RF communication equipment and analyzer The analyzer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of the devices can help prevent electromagnetic interference by communications maintaining equipment(transmitters)and the analyzer as recommended below,according to the maximum output power of the communications equipment. a minimum distance between portable and mobile RF Rated maximum output Separation distance according to frequency of transmitter/m 150kHz 80MHz~800MHz 800MHz2.5GHz power transmitter/W. of 80MHz 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 d=1.2 0.12 0.38 1.2 3.8 12 d=2.3 0.23 0.73 2.3 7.3 23 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 80MHz and 800MHz,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. A. From the date of purchase, the product will enjoy one-year free warranty with the purchase invoice. During the warranty service, if you need to provide circuit diagram, components, necessary materials and electrical circuit maintenance problems, please contact the manufacturer. B. No free warranty service will be provided for failures caused by the following personal reasons:
The following conditions are not covered by the warranty:
1. Damable and consumable parts: cover, battery;
2. Failure caused by unauthorized disassembly and refitting of products;
3. Failure to operate according to the instructions;
4. Failure caused by lack of reasonable maintenance;
5. Fault caused by inadvertence of the product;
6. Damage caused by external forces;
7. The maintenance service outside the warranty scope will be charged according to the regulations. 1 Manufacturer and European Authorized Representative Information Shenzhen Yolanda Technology Co.,Ltd. Address: Room 201,Jinfulai Building, No.49-1, Dabao Road,Dalang Area,Xinan Street,Baoan, Shenzhen,China Tel: +86-755-21635022 Customer service hotline+86-400-998-2913service time: 9:00 to 21:00 of working day E-mail: service@yolanda.hk Website: www.yolanda.hk MedPath GmbH Address: Mies-van-der-Rohe-Strasse 8,80807 Munich,Germany E-mail: info@medpath.pro 1