Transtek Medical Electronics AW8001-LS Bluetooth Module with Body Fat Analyzer as host User Manual GBF 1257 B 20130102
Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Module with Body Fat Analyzer as host GBF 1257 B 20130102
Contents
User manual Rev01
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| Mirror Download [FCC.gov] | |
| Document ID | 2473645 |
| Application ID | 8vw+wi9a8BSn7Jsl6i4XKQ== |
| Document Description | User manual Rev01 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 396.87kB (4960819 bits) |
| Date Submitted | 2014-12-16 00:00:00 |
| Date Available | 2014-12-16 00:00:00 |
| Creation Date | 2013-01-02 09:32:43 |
| Producing Software | Adobe PDF library 9.90 |
| Document Lastmod | 2014-12-09 09:20:12 |
| Document Title | GBF-1257-B 说明书20130102 |
| Document Creator | Adobe Illustrator CS5 |
| Document Author: | Shuting |
version:1.0 User Manual Body Fat Analyzer 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 GBF-1251-B1 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 ............................................................................................... 2 Tips ........................................................................................................................................... 3 Overview Device Components ................................................................................................................. 4 List .......................................................................................................................................... 4 LCD Display .............................................................................................................................. 5 Initial Start-Up General Instructions ................................................................................................................. 6 Power Supply ........................................................................................................................... 6 Insert the Batteries ................................................................................................................... 6 Pair-up ..................................................................................................................................... 7 Set Up Your Profile ................................................................................................................. 8-9 Select Measurement Unit ........................................................................................................ 9 Initialising Your Scale ............................................................................................................... 10 Weight Only Operation .............................................................................................................. 10 Start Measuring First Measurement ................................................................................................................... 11 Daily Measurement .................................................................................................................. 12 Fast Measurement .................................................................................................................. 13 Manage Your Health Body Fat Indicator .................................................................................................................... 13 .................................................................................................................... Data Transmission 14 Troubleshooting ............................................................................................................................. Error Prompt 15 When Measuring ... .................................................................................................................. 15-16 ........................................................................................................ When Data Transmitting... 17 ............................................................................................................................ Specifications 18 Maintenance ............................................................................................................................... 19 ...................................................................................................................................... Warranty 19 ........................................................................................................................ FCC Regulations 20 Appendix Table of Body Fat Level .......................................................................................................... 21 Table of Body Water Level ...................................................................................................... 21 Muscle Mass Percentage .......................................................................................................... 21 Bone Mass Percentage .............................................................................................................. 21 Health Tips – About Body Fat ................................................................................................. 22 EMC Guidance ......................................................................................................................... 22-25 Safety Information Safety Information INDICATIONS FOR USE 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 “MANUFACTURER” The Bluetooth Combination Mark Symbol for “DIRECT CURRENT” Symbol for “TYPE BF APPLIED PARTS” Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice” Symbol for “MANUFACTURE DATE” Symbol for “SERIAL NUMBER” CAUTION Transtek’s 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. Don’t expose the device to extreme temperatures, direct sunlight, moist or corrosive environment. Do not step on the scale when your body or feet are wet, especially after bathing or showering to prevent slipping. 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 Overview Overview Device Components LCD Display Up Sensor Key Set Sensor Key LCD Display Electrode List 1. Body Fat Analyzer GBF-1251-B1 2. Four AAA-size Batteries (1.5V each) Down Sensor Key Electrode UNIT Key Body Fat Level: Low Percentage Battery Compartment Body Fat Level: Normal Foot Body Fat Level:Above Average Centimeter Body Fat Level: High Age User Interface: Setting Man Body Mass Index Sportsman Body Fat Analysis Result Woman Muscle Mass Analysis Result Sportswoman Water Analysis Result User ID (Range from U1 to U8 ) Bone Mass Analysis Result Successful Bluetooth Connection Pound Data transmitting / pending to transmit to wireless wellness system Kilogram Low Battery 3. User Manual 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. 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. Power Supply Symbol and symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. 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. If SUCCEED, symbol will be shown on the LCD. 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. If FAIL, symbol “E1” 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. 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. 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 the numeral. 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 won’t be deleted;select the “ ” means the settings of all the users will be deleted. for fast changing Touch “SET” key to confirm Age. When the LCD displays “ measuring. 2.Setting Data deletion or ” and “ ” alternately, you may start 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. 3.Setting Gender After confirming Data deletion, the system will divert to Gender setting. Note: If there is no operation in the weighing mode, the scale will turn off after about 20 seconds. 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 “ 5’5.0” ” blinks. The operator may touch the function key or to increase or decrease the numeral. (Range: 3’3.5” ft to 7’2.5” ft /100 cm to 220 cm) You may touch and hold the function key the numeral. or for fast changing Touch “SET” key to confirm Stature. Initial Start-Up Start Measuring Initialising Your Scale First Measurement 1. Press the platform centre and remove your foot. 2. “0.0” will be displayed. 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. 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 “ ”. 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. 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.) 3. The scale will display your weight value. 4. The scale will automatically turn off after a few seconds. Note: The weight value won’t be saved in the scale, and won’t be transmitted to the APP. 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. 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 had’t set the profile,then the scale will turn off after 3s. 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. 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 user’s body fat level is LOW. (Please refer to Table of Body Fat Level for more details.) (Please refer to Data Transmission for more details.) 12 13 Manage Your Health Troubleshooting Error Prompt Data Transmission Error 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 Stop using this scale for measurement. Low Battery. The device will power off after about 3s. Replace all four batteries in the same time. Please purchase the authorized batteries for replacement. Please check below items: -Bluetooth is ON. -App Collector is ON. -Both devices are within the transmission distance of Bluetooth. When Measuring ... CAUTION Problem . And To enable the data transmission function, this product should be paired to a Bluetooth 4.0 end. Abnormal measuring results: - Too high; OR - Too low; OR - Huge difference between two recent measurement. 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. 14 Solution Overload. The device will power off. Failure of pairing up your scale with your smatrphone. Data transmitting to wireless wellness system: -If SUCCEED, the symbol disappears; -If FAIL, the symbol remains. Interference may occur in the vicinity of equipment marked with the following symbol the Analyzer may interfere vicinity electrical equipment. Description 13 Root Cause Incorrect posture The device is located on the soft ground such as a carpet OR on a rugged surface. Solution Please step on the platform barefooted and stand still. Please place the device on a flat, hard surface. 15 Troubleshooting Problem Abnormal measuring results: - Too high; OR - Too low; OR - Huge difference between two recent measurement. Troubleshooting Root Cause The device powers off. 16 When Data Transmitting ... Problem 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. Install the batteries. (Please refer to Insert the Batteries) Worn batteries. Replace all four batteries at the same time. Please purchase the authorized batteries for replacement. No display on LCD when the device powers on. CANNOT proceed to analyze body fat, total body water, muscle mass and bone mass. Solution Step onto the platform wearing socks or shoes. 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. Low battery. Data transmission failed. Root Cause Solution 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. Replace all four batteries at the same time. Please purchase the authorized batteries for replacement. 17 Specifications Maintenance Specifications Product Name Dimension Scale: 310x310x24mm (Approximately) Net Weight Approximately 1.75kg ( Excluding the dry cells) Display Measurement Unit Measurement Range Division Accuracy Digital LCD with White Backlight Kilogram / Pound 5kg to 200kg / 11lb to 441lb 0.1kg / 0.2lb 5-50kg: ±0.3kg; 100-150kg: ±0.5kg; 50-100kg: ±0.4kg; 150-200kg: ±0.7kg Working Environment Humidity: ≤90% RH Temperature: 5℃ to 40℃ Atmospheric pressure: 80kPa to 106kPa Storage Environment Temperature: -20℃ to 60℃ Humidity: ≤93% RH Atmospheric pressure: 50kPa to 106kPa Power Source Turn on Method Auto-OFF Accessories 6V (Four AAA-size Batteries) 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 Mode of Operation Continuous Operation Degree of protection Type BF applied part Protection against ingress of water Protection Against Ingress of Water Software Version Bluetooth Module No. 18 Body Fat Analyzer (GBF-1251-B1) IP21, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops IPX0 Maintenance When carrying out usual maintenance, please ensure practice of the following Do’s and Don’ts: DO use a dry soft cloth to wipe the dust. DO use a wet soft cloth, dipped into water and wrung out, to wipe the dirt. Then use a dry soft cloth to dry up the device. DON’T wash the device with water or immerse it in water. DON’T use propellant, abrasive or other chemicals to wipe the dirt in avoidance of discolor or malfunction. DON’T disassemble this device. If you have any problems, please contact Transtek. (Please refer to Warranty for contact information) Do not dispose of batteries in fire. Batteries may explode or leak. Remove the batteries if the scale will not be used for a long period. Warranty Transtek warrants its products free of defects in materials and workmanship in normal use for a period of 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 1.0 AW8001 19 FCC Regulations FCC Regulations FCC User Guide Information Appendix Table of Body Fat Level (Unit: %) a) The body fat percentage (%): 5%-60%/0.1% Standard for Men Rating Radio Frequency Interface Requirements - FCC Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna; Increase the separation between the equipment and receiver; Connect the equipment into an outlet on a circuit different from that to which the receiver is connected; Consult the dealer or an experienced radio / TV technician for help. Radio Transmitters (Part 15) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. FCC RF Exposure Guidelines Safety Information Reducing RF Exposure - Use Properly Only operate the device in accordance with the instructions supplied. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. Standard for Women Age Rating 20-29 30-39 40-49 50-59 60+ <13 <14 <16 <17 <18 Normal 14-20 15-21 17-23 18-24 19-25 Moderately High 21-23 22-24 24-26 25-27 26-28 >23 >24 >26 >27 >28 low High Age 20-29 30-39 40-49 50-59 <19 <20 <21 <22 <23 Normal 20-28 21-29 22-30 23-31 24-32 Moderately High 29-31 30-32 31-33 32-33 33-35 >31 >32 >33 >34 >35 low High 60+ 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 Men Women OPTIMAL TBW % RANGE 4 to 14% 70 to 63% 15 to 21% 63 to 57% 22 to 24% 57 to 55% 25 and over 55 to 37% 4 to 20% 70 to 58% 21 to 29% 58 to 52% 30 to 32% 52 to 49% 33 and over 49 to 37% 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%. 20 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 can’t 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. Table 2 – Guidance and MANUFACTURER ’ S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s 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. I MMUNITY test IEC 60601 test level Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact ± 8 kV air ± 8 kV air IEC 61000-4-2 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) Electrical fast transient/burst ± 2 kV for power supply lines IEC 61000-4-4 ± 1 kV for input/output lines Surge ± 1 kV line(s) to line(s) IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 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 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions Compliance Group 1 Not applicable Not applicable <5 % U T (>95 % dip in U T ) for 0,5 cycle 40 % U T (60 % dip in U T ) for 5 cycles Not applicable 70 % U T (30 % dip in U T ) for 25 cycles Table 1 – Guidance and MANUFACTURER ’ S declaration – ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions ± 2 kV line(s) to earth Compliance level Electromagnetic environment guidance – Floo rs shoul d be woo d, concr e te or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mai ns po we r qu al i t y s houl d b e t hat of a typical commercial or hospital environment. Mai ns po we r qu al i t y s houl d b e t hat of a typical commercial or hospital environment. 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. <5 % U T (>95 % dip in U T ) for 5 s Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE 3 A/m 3 A/m P o we r f r e q u e n c y m a g n e t i c f i e l d s should be at levels characteristic of a typical location in a typical commercial or hospital environment. U T is the a.c. mains voltage prior to application of the test level. Electromagnetic environment-guidance The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Class B Not applicable Not applicable IEC 61000-3-3 22 23 Appendix Appendix Table 4 – Guidance and MANUFACTURER ’ S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE - SUPPORTING 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 Guidance and manufacturer’s 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. I MMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m IEC 61000-4-3 80 MHz to 2,5 GHz Not applicable 3 V/m d=[ 3,5 V1 Recommended separation distances between portable and mobile RF communications equipment and the device – guidance 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. 150 kHz to 80 MHz 3,5 ] P 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 in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined 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: Separation distance according to frequency of transmitter Rated maximum output power of transmitter d=[ V1 ] P 80 MHz to 800 MHz d = 1.167 800 MHz to 2,5 GHz d= 2.333 0,01 Not applicable 0.117 0.233 0,1 Not applicable 0.369 0.738 Not applicable 1.167 2.333 10 Not applicable 3.690 7.378 100 Not applicable 11.67 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 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. 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. 24 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V 1 ] V/m. 25
Source Exif Data:
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