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User Manual | Users Manual | 565.93 KiB | / October 03 2019 | |||
1 | Cover Letter(s) | |||||||
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1 | External Photos | / October 03 2019 | ||||||
1 | ID Label/Location Info | |||||||
1 | Internal Photos | / October 03 2019 | ||||||
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1 | Test Report | |||||||
1 | Test Report | |||||||
1 | Test Setup Photos | / October 03 2019 |
1 | User Manual | Users Manual | 565.93 KiB | / October 03 2019 |
BW-BT1 1. Armband 3. Cuff tubing connector 5. CPU 2. Socket 4. Connection tube Version: 20180723V4 2 / 19 SYMBOLS DEFINITIONS Refer to instruction manual. Note on the equipment Follow instructions for use Caution Type BF applied part The device, accessories, and the packaging have to be disposed of correctly at the end of usage. Please follow local ordinances and regulations for disposal. Authorized representative in the European community Manufacturer Storage temperature Relative humidity Serial number Batch code Easy broken Keep dry This way up. Version: 20180723V4 3 / 19 THIS PRODUCT COMPLIES WITH IEC 60601-1:2005+A1:2012; IEC 60601-1-11:2015; IEC 80601-2-30: 2009/AMD1:2013; IEC 60601-1-2:2014. WE, VISIOMED, HEREBY DECLARES UNDER OUR SOLE RESPONSIBILITY THAT THE FOLLOWING PRODUCT BW-BT1 MYTENSIO IS IN COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS AND OTHER RELEAVANT PROVISIONS OF THE RED 2014/53/EU DIRECTIVE. THIS CONFORMITY DECLARATION CAN BE FOUND ON OUR WEBSITE AT:
https://bewell-connect.com/en/conformite-produits-bewellconnect/
Table of contents 1. NOTES ON SAFETY ....................................................................................................................................5 1.1 WARNING ..............................................................................................................................................5 1.2 CAUTION ...............................................................................................................................................5 1.3 GENERAL PRECAUTION ....................................................................................................................5 1.4 CYBERSECURITY INFORMATIONS AND RECOMMENDATIONS .........................................6 INFORMATION ............................................................................................................................................6 2. FEATURES ......................................................................................................................................................8 3. 4. USE ..................................................................................................................................................................8 4.1 DESCRIPTION .......................................................................................................................................8 4.2 DOWNLOAD APPLICATION ............................................................................................................8 4.3 INDICATIONS FOR SELF-MEASUREMENT ..................................................................................9 4.4 CONTRADICATIONS FOR SELF-MEASUREMENT ....................................................................9 4.5 PRECAUTIONS BEFORE USE ............................................................................................................9 4.6 SUGGESTIONS BEFORE MEASUREMENT ................................................................................. 10 4.7 INSTRUCTIONS ................................................................................................................................. 10 4.8 USER GUIDE ....................................................................................................................................... 10 INSERT OR REPLACE BATTERIES ........................................................................................................ 12 5. 6. HOW TO MAINTAIN AND STORE THE UNIT ................................................................................. 12 7. HOW TO PREVENT A MALFUNCTION ............................................................................................. 12 8. SPECIFICATIONS ...................................................................................................................................... 13 9. TROUBLESHOOTING .............................................................................................................................. 13 EMC DECLARATION .......................................................................................................................... 14 10. 11. FCC COMPLIANCE ............................................................................................................................. 17 12. CALIBRATION AND SERVICE .......................................................................................................... 17 13. WARRANTY INFORMATION ........................................................................................................... 17 Version: 20180723V4 4 / 19 Log onto our website to find out how to install and use the BewellConnect application https://bewell-connect.com/en/applications-support/
The manufacturer keeps the right to modify without any preliminary opinion technical specifications of the product. Dear Customer, Thank you for purchasing MyTensio BW-BT1 from Visiomed. In order to use it optimally and efficiently, we recommend that you read the operating instructions carefully. 1. NOTES ON SAFETY It is important to read all the warnings and precautions in this manual. They are for your safety, to prevent injuries and avoid situations that could damage the device. Consult your doctor, if you have a serious illness or if you want to know more about using this medical device. 1.1 WARNING
- This product should not encourage you to self-medicate or adapt your treatment.
- Too frequent measurements can cause injury to the patient due to blood flow interference.
- Do not curve the tube during measuring, the curved tube may block deflation and lead to injury.
- Do not measure on an injured arm, thus could cause further injury.
- Stop measurement immediately, if an allergic reaction occurs. 1.2 CAUTION
- Do not inflate the upper arm cuff when it is not wrapped on the upper arm.
- Do not use force to bend or pull the cuff. Always use the specified accessories in the manual, the use of other parts not approved by the manufacturer may cause hazard.
- Do not use accessories that are not specified on this user manual.
- Do not change the detachable components by yourself.
- Do not compress or restrict the connection tubing, in case of damage. 1.3 GENERAL PRECAUTION
- Use this device only for the use for which it is designed as described in this manual.
- This device may be used for personal use at home. Do not use the unit for other purposes.
- This device is designed for external use.
- Use and storage: Refer to the technical features (range of room temperature, relative humidity, atmospheric pressure, altitude)
- This device must always be placed in a clean and dry place.
- Do not expose this device to sunlight or water.
- Do not expose this device to electric shocks. Version: 20180723V4 5 / 19
- Do not use this device outdoors.
- Never drop the device.
- Follow the maintenance instructions specified in this manual.
- Do not attempt to open the device. In case of problems, contact customer service.
- Do not leave this device within the reach of children.
- This appliance is not designed for use by people (including children) with reduced physical, emotional or mental abilities or those lacking experience or knowledge unless used in the presence of someone responsible for their security, under supervision or following instructions about how to use the appliance.
- Discontinue use of the device in case of anomalies or malfunction.
- Stop using the unit in the event of a failure or malfunction.
- This electrical medical equipment requires specific precautions regarding electromagnetic compatibility. It must be installed and used according to the electromagnetic information.
- The equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended at the end of the manual, according to the maximum output power of the communications equipment.
- Readings may be distorted if the unit is used near a television, microwave oven, mobile phone or any other device with an electrical field. 1.4 CYBERSECURITY INFORMATIONS AND RECOMMENDATIONS To get the mobile application to work properly, be sure to get a reliable and secure network connection. For the correct functioning of the app, a Bluetooth connection is necessary. Personal data are stored in a Healthcare data host (with network connection) located in France. For the security of your data, do not share your smartphone/tablet with your app logged in. Data are transferred from your device to the Healthcare data host under a secured protocol. The MyTensio app is compatible with the following operating systems:
Android 4.3 or higher iOS 8.0 or higher Check regularly if the APP has been updated on the stores. Proceed to any product update when applicable. Theses updates may concern security improvement. 2. INFORMATION Blood pressure varies considerably throughout the day, and these variations are even more significant in hypertensive subjects. It is lower in the morning and increases in the afternoon and the evening. When sleeping, it decreases. Blood pressure is lower in summer than in winter, and it rises noticeably with age. Blood pressure also increases during exercise, sex, pregnancy, stress, etc. Version: 20180723V4 6 / 19 Note: One or two blood pressure readings will not provide a true indication of your blood pressure, it is important to measure it daily and regularly to obtain accurate data. Sharing your results with your physician, may help him/her diagnose you and prevent potential health problems. BLOOD PRESSURE CATEGORIES IN UNITED STATES. (2017 ACC/AHA GUIDELINES) Self-measurement of blood pressure
- MAM (Measurement average mode): MAM technology makes it possible to automatically perform three repeated measurements in moments. Repetition is essential when measuring blood pressure oneself, because isolated readings are often wrong for many reasons, including the high variability of blood pressure, and high susceptibility to outside factors such as recent activity or stress. Taking 3 consecutive readings and averaging them can improve the reliability of blood pressure measurement at home by a non-professional. This mode of use is especially recommended by the SFHTA in case of self-measurement. Blacher, J., et al. "Prise en charge de lhypertension artrielle de ladulte. Recommandations 2013 de la Socit franaise dhypertension artrielle." Annales de Cardiologie et d'Angiologie. Vol. 62. No. 3. Elsevier Masson, 2013.
- Rule of 3s: 3 readings recommended while sitting, resting, 3 days in a row: in the morning before taking medications, 3 consecutive readings (MAM); in the evening after taking medications, 3 readings in a row (MAM). A single reading is not necessarily significant, especially in terms of monitoring your blood pressure.
- Self-measurement of blood pressure: The monitoring targets for a known hypertensive Version: 20180723V4 7 / 19 subject using self-measurement at home are different from those of the European Society of Hypertension (ESH, which establishes the classification of the blood pressure) and lower. These targets are based on age and may vary depending on your condition General case: SBP***< 135 mmHg and DBP**** < 85 mmHg Age > 80 years: SBP* < 150 mmHg Chronic renal failure: SBP*** < 130 mmHg and DBP**** < 80 mmHg The figures above are for general, informational purposes only and they must be re-validated in each case with a physician. It is important to check your targets, especially in cases of serious illness or pregnancy. 3. FEATURES
- Oscillometric method
- Pressure sensor inserted in silicon
- Automatic blood pressure and heart rate measurement
- Cuff size: 22-42cm (8.6-16.5in) (suitable for arm width between 22 and 42cm (8,6-16,5in)
- 2 modes of measurement: MAM (Measurement Average Mode) and SINGLE.
- Heart arrhythmia detection
- Automatic switch-off
- Data transfer to Bluetooth 4.0 compatible smartphones/tablets. 4. USE 4.1 DESCRIPTION View diagram B page 2 Indication for use The armband blood pressure monitor BW-BT1 is intended to measure systolic, diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 22 cm to 42 cm using the oscillometric method. The device can detect irregular heartbeats during measurement and give a warning signal with readings. The intended patient population is adult aged from 18 years old for use at home. It is not applied to pregnant patients or patients suffering from pre-eclampsia. Operating principle The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by ACC/AHA. 4.2 DOWNLOAD APPLICATION
- The following information is subject to change. Download the BewellConnect APP on your mobile phone or tablet.
- APP store or Google Play. Then click on the MyTensio icon. Version: 20180723V4 8 / 19 4.3 INDICATIONS FOR SELF-MEASUREMENT Self-measurement of blood pressure is recommended for:
- Patients starting antihypertensive treatment to determine its effectiveness.
- Patients requiring closer monitoring regarding their in between consultations (patients with coronary heart disease, diabetes and / or renal disease).
- Pregnant women looking to prevent preeclampsia.
- Patients with cardiovascular risk.
- People displaying high blood pressure at doctors visits - to eliminate a white coat effect or confirm a real case of hypertension.
- Elderly patients whose blood pressure variability is increased, and whose frequency of white coat effect gradually increases with age.
- People suspected to mask hypertension (not detected at the doctor).
- In case of resistant hypertension.
- Servicing and maintenance are not allowed during device use.
- Pressurization of the CUFF can temporarily cause loss of function of simultaneously used monitoring medical electrical equipment on the same limb. 4.4 CONTRADICATIONS FOR SELF-MEASUREMENT Self-measurement of blood pressure is contraindicated on:
- People under 18 years.
- Patients suffering from:
Atrial fibrillation or other serious heart condition such as a serious heart arrhythmia;
Anxious or obsessional disorders;
Elderly cognitive impairment (unless used by a third party);
Physical disability, Handicap
- An arm wearing a dialysis fistula, peripheral venous catheter: to avoid impaired functioning of the fistula or the catheter, the formation of blood clots in the vein, - An arm having undergone axillary lymphadenectomy. The increase of the pressure in nearby blood vessels can lead to the swelling of the arms and hands (lymphedema).
- A Hemiplegic arm.
- Obesity: Body Mass Index (BMI) > 30 (arm band unsuitable), arm perimeter > 42cm (16,5in).
- Application of the CUFF and its pressurization on the arm on the side of a mastectomy. 4.5 PRECAUTIONS BEFORE USE
- Do not confuse self-monitoring with self-diagnosis. Blood pressure measurements should only be interpreted by a health professional who is familiar with your medical history.
- If you are taking medication, consult with your physician to determine the most appropriate time to measure your blood pressure. NEVER change a prescribed medication without first consulting with your physician.
- This device is designed for adults to use. if this device is used on a child patient, the elderly or toddlers, consult with your physician.
- This product should not encourage self-medication or adaptation of your treatment.
- If there is too much pressure or you feel uncomfortable, please press ON/START button immediately for quick deflation. Version: 20180723V4 9 / 19
- Do not use this unit in a moving vehicle; this may result in erroneous measurement. 4.6 SUGGESTIONS BEFORE MEASUREMENT
- Avoid eating, smoking or exercising 30 minutes before taking measurements. Relax for 15 minutes before taking blood pressure.
- Stress increases blood pressure. Avoid taking measurements during stressful periods.
- You must take blood pressure in a calm environment and you must be relaxed and seated with your arm on a table.
- Remain stationary and do not speak whilst taking blood pressure.
- Users should not attempt to modify the device in any way. The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life. 4.7 INSTRUCTIONS See diagram A page 2
- Insert the cuff tubing connector into the socket in the left side of the monitor. Make certain that the connector is completely inserted to avoid air leakage during blood pressure measurements
- Avoid compression or restriction of the connection tube during measurement This may cause inflation error, or harmful injury due to continuous cuff pressure. Do not take measurements over clothing. Remove jewelry from the arm you are measuring before taking measurement (watch, ring, bracelet, etc).
- Sit down on a chair with your feet flat on the floor (do not cross your legs).
- Ensure your smartphone or tablet with the BewellConnect app is within reach.
- Put the cuff around the arm with the orange marker at the bottom.
- It must be 1-2 cm from elbow crease. The orange marker must lie on the inside arms artery.
- Close the Velcro (not too tight).
- Press START/STOP to turn the blood pressure monitor on.
- Put your arm on the table.
- Remain seated and calm for 5 minutes before taking measurement.
- Do not move during measurement.
- To determine which arm you will continue to take readings on, take a measurement on both arms during your first reading. In the event of asymmetrical blood pressure (right systolic blood pressure-left systolic blood press >20 mmHg), take readings from the arm with the highest value except in the event of contraindications in this arm.
- The measurement will be too low if the armband is higher than the heart or too high if it is lower than the heart. Note: For more reliable results, take measurements on the arm. The measurement results are given for information. If in doubt about your results, please contact your doctor. 4.8 USER GUIDE Note: For an initial use, please insert the batteries into the device (see chapter 5) Setting the time
- The time is set automatically during the synchronisation of your tensiometer with your Version: 20180723V4 10 / 19 smartphone/tablet. There are 2 measurement modes: MAM mode and Single mode MAM mode:
- Three arterial pressure measurements are repeated automatically with 15-second intervals between each measurement. The armband inflates and deflates 3 consecutive times. Do not remove the armband before all 3 pressure readings are finished. Single mode:
- A single measurement is taken. Recording measurements with the BewellConnect application
- Launch the BewellConnect application and click on MyTensio. Activate Bluetooth on your smartphone or tablet.
- Press the ON/OFF button to switch on the device.
- The default measurement mode is MAM mode (3 measures).
- Press the START MEASURING button in the application to launch the measurement. The armband will inflate automatically.
- At the end of measuring, the results are automatically transferred via Bluetooth 4.0 and displayed on the application screen.
- Press the ON/OFF button again to switch the device off. If you forget to switch it off, the device switches itself off after 2 minutes. Recording measurements without the BewellConnect application You can also use your tensiometer without the MyTensio application, the measurements taken will not be saved in the tensiometer or in the phone.
- Press the ON/OFF button to switch the device on.
- Select the measuring mode by pressing the START/STOP button for 5 seconds:
MAM Mode (3 measurements) Single Mode (1 measurement) Version: 20180723V4 11 / 19
- Press START/STOP to begin measuring. The armband will inflate automatically.
- At the end of measuring, the results are displayed on the screen of the device. The colour code on the screen (green, orange, red) indicates your arterial pressure level based on the classification defined by ESH.
- Press the ON/OFF button again to switch the device off. If you forget to switch it off, the device switches itself off after 2 minutes. Notes:
- If you want to stop the blood pressure measurement at any point, press the ON /START to turn it off.
- Speak to your doctor if you have any questions about using the blood pressure monitor.
- You can also launch the measurement with the App. 5. INSERT OR REPLACE BATTERIES When the LCD shows the battery icon and keep flashing, replace all batteries with new ones. 1. Slide the battery cover in the direction of the arrow to open. 2. Insert 4 alkaline AA batteries in the correct polarity direction. Inserting them incorrectly may damage the device and the warranty. Never use rechargeable batteries. Use single use batteries. 3. Replace the battery cover.
- Disposal of discharged batteries to the authorized collecting party subject to the regulation of each individual territory.
- If the unit will not be used for a long period, please take out all batteries to avoid leakage damaging the unit. 6. HOW TO MAINTAIN AND STORE THE UNIT
- Use a dry soft cloth to clean the unit. If necessary, use a cloth lightly dampened with tap water.
- Do not use alcohol, benzene, thinner or other harsh chemicals to clean the device or cuff.
- Before using please wash your hands. Do not wash or wet the cuff.
- Avoid placing the unit where there is direct sunlight, high humidity or dust.
- Roll up the pressure armband and store in its case. 7. HOW TO PREVENT A MALFUNCTION
- Do not drop the device and avoid sudden jars or shocks.
- Do not insert other objects into any holes.
- Do not attempt to disassemble the unit.
- Do not put the unit in water.
- The monitor might not meet its performance specifications or may cause safety hazard if stored or used outside the specified temperature and humidity ranges in specifications. Version: 20180723V4 12 / 19 8. SPECIFICATIONS Product Name Model Classification Measuring method Indication Dimensions Weight Measuring range Accuracy Inflation Deflation Function Cuff Normal conditions of use Storage conditions Technology Bluetooth Technology Battery Device service life Automatic power-off Voltage Supplied with 9. TROUBLESHOOTING Blood Pressure Monitor BW-BT1 Class IIa Oscillography system Digital LCD Display 50*66mm with Backlight:
White, Green, Yellow, Red 132.9*95.9*48.3mm (L*W*H) 245g (without accessories) Cuff pressure: 0~299 mmHg. Pulse: 40~180 Beat/min. Pressure: 3mmHg Pulse: 5% of reading Automatic inflating Automatic exhausting IHB Upper arm cuff 22-42cm Temperature:10~40 Humidity:15~90%RH
(non-condensing) Barometric Pressure: 70~106kPa Temperature: -25~60 Humidity: 10~95%RH
(non-condensing) Barometric Pressure: 80~105Kpa While Infalting technology (MWI) - (Silent pump) Bluetooth 4.0 4 AA alkaline batteries 2 years 3 minutes 3.7V low power 1 device, 1 non-woven pouch, 1 user manual, 4 AA Alkaline batteries If you have one of the following problems, please refer to this troubleshooting guide to help resolve the problem. If the problem persists, please contact customer service. PROBLEM POSSIBLE CAUSE SOLUTION LCD Display shows abnormal The cuff is not positioned correctly or Put the cuff on correctly and try again Version: 20180723V4 13 / 19 result it was not tight enough Incorrect position during measurement You spoke, moved or were agitated, excited, or nervous during measurement. Arrhythmia LCD shows ERR No response when you press button No data transfer to your smartphone/
tablet You moved during measurement. Low battery Bluetooth connection deactivated Incompatible smartphone or tablet The 3 measurements dont complete, the measurement stops Poor contact with the armband Reread instructions and retry Try again when you have calmed down. Do not speak or move during test The appliance is not suitable for people suffering from serious heart arrhythmia. Try again. Do not move during test Change the batteries Activate Bluetooth on your smartphone/tablet Check your smartphone or tablet has Bluetooth 4.0 Retake measurement Note: Relax for at least 10 minutes and then take another measurement. 10. EMC DECLARATION Guidance & Declaration electromagnetic immunity The models BW-BT1 are intended for use in the electromagnetic environment specified below. The customer or the user of the models BW-BT1 should assure that It is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment -
level guidance Electrostatic discharge
(ESD) lEC 61000-4-2 6 kV, 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 Surge lEC 61000-4-5 2kV for power supply lines 1 kV for Input/output lines 1 kV line to line 2 kV line to earth 6 kV, 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Not applicable Not applicable Not applicable Not applicable Version: 20180723V4 14 / 19 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11.
<5 % UT
(>95% dip in UT.) for 0.5 cycle
<5 % UT
(>95% dip in UT) for 1 cycle 70% UT
(30% dip in UT) for 25/30 cycles
<5% UT
(>95 % dip in UT) for 5/6 sec Not applicable Not applicable Power frequency
(50/60 Hz) magnetic field lEC 61000-4-8 3 A/m, 30 A/m 3 A/m, 30 A/m 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. Guidance & Declaration - Electromagnetic immunity The models BW-BT1 are intended for use in.the electromagnetic environment specified below. The customer or the user of the models BW-BT1 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 models BW-BT1, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF lEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands 3V/m, 20 V/m 80 MHz to 2.5 GHz Radiated RF lEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz Not applicable Not applicable d=[3,5/V1]P1/2 3V/m, 20 V/m 80 MHz to 2.5GHz 10 V/m 80 MHz to 2.7GHz d=1.2P1/2 80 MHz to 800 MHz d=2.3P1/2 800 MHz to 2.7 GHz Version: 20180723V4 15 / 19 385MHz-
5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment
(Refer to table 9 of IEC 60601-
1-2:2014) 385MHz-
5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment
(Refer to table 9 of IEC 60601-
1-2:2014) 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 meters (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:
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 models BW-BT1 are used exceeds the applicable RF compliance level above, the models BW-BT1 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the models BW-BT1. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. Recommended separation distances between portable and mobile RF communications equipment and the models BW-BT1 The models BW-BT1 are intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or the user of the models BW-BT1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the models BW-BT1 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter W 0,01 0,1 1 10 100 150kHz to 80MHz d=1.2P1/2 0.12 0.38 1.2 3.8 12 m 80MHz to 800MHz d=1.2P1/2 0.12 0.38 1.2 3.8 12 800MHz to 2,5GHz d=2.3P1/2 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance Version: 20180723V4 16 / 19 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) accordable 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. 11. FCC COMPLIANCE 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: changes or modifications not expressly approved by the party responsible for compliance could void the users 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. 12. CALIBRATION AND SERVICE
- The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life.
- It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy. Please consult your local authorized distributor or dealer. 13. WARRANTY INFORMATION Visiomed will repair or replace this product free of charge in the case of defective parts or manufacturing defects, in accordance with the conditions mentioned below as follows:
DURATION: 24 MONTHS RETURN TO WORKSHOP LIMITS AND EXCLUSIONS: This guarantee concerns only the original final purchaser. A purchase invoice, or another proof of purchase, with this guarantee card will be required to obtain an after-sales service, in accordance with this guarantee. This guarantee card will not be extended to another person only the original final purchaser. This guarantee becomes void Version: 20180723V4 17 / 19 if the serial numbers on the product are modified, replaced, illegible, absent, or if repair has been carried out by a service not approved, including the user. This guarantee covers only the defects of the material or parts, occurring during normal use of the pro-duct. It does not cover the damage caused during the transport of the apparatus, causes due to repairs being carried out by the distributor, by any modifications undertaken, any connection of equipment not approved by Visiomed, or causes contrary to those written in the user manual or notice. Moreover, the present guarantee does not cover damage due to falls, bad handling, bad installations, damage by fire, floods, lightning, or any other natural disaster. This guarantee does not cover the packing of the material, the accessories, the defects caused by commercial exposure of the product, show room, sale space, demonstration etc... Normal maintenance, cleaning and the replacement of parts where wear is normal, are not covered by the terms of this guarantee. Visiomed and its representatives and agents will not in any case be held responsible for any damage and consecutive damages due to the mishandling of this product. This guarantee is the only valid one at Visiomed, any other guarantee (commercial guarantee) except this one will not be taken into account. IMPORTANT: During the guarantee period if you are dissatisfied with the repairs of this product, please contact the Visiomed customer service. Version: 20180723V4 18 / 19 Version: 20180723V4 19 / 19
frequency | equipment class | purpose | ||
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1 | 2018-09-17 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2018-09-17
|
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1 | Applicant's complete, legal business name |
BEWELL CONNECT CORP
|
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1 | FCC Registration Number (FRN) |
0024949059
|
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1 | Physical Address |
575 Boylston Street, Suite 3W
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1 |
Boston, Massachusetts 02116
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1 |
United States
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app s | TCB Information | |||||
1 | TCB Application Email Address |
f******@us.tuv.com
|
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 | Grantee Code |
2AF8T
|
||||
1 | Equipment Product Code |
BW-BT1
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
O**** H********
|
||||
1 | Telephone Number |
857-9********
|
||||
1 | Fax Number |
857-2********
|
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1 |
o******@bewell-connect.com
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app s | Technical Contact | |||||
1 | Firm Name |
Bewell Connect Corp.
|
||||
1 | Name |
O******** H********
|
||||
1 | Physical Address |
Boston, Massachusetts
|
||||
1 |
United States
|
|||||
1 | Telephone Number |
857-9********
|
||||
1 | Fax Number |
857-2********
|
||||
1 |
o******@bewell-connect.com
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|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/10/2019 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Pressure Monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power output listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Shenzhen Accurate Technology Co., Ltd.
|
||||
1 | Name |
S******** L******
|
||||
1 | Telephone Number |
+86-7********
|
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1 |
s******@atc-lab.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0004000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC