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user manual | Users Manual | 4.00 MiB | February 12 2019 | |||
1 | RF Exposure Info | February 12 2019 | ||||||
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1 | block diagram | Block Diagram | December 02 2019 | confidential | ||||
1 | Cover Letter(s) | February 12 2019 | ||||||
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external photos | External Photos | 571.81 KiB | February 12 2019 | |||
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internal photos | Internal Photos | 558.60 KiB | February 12 2019 | |||
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1 | Cover Letter(s) | February 12 2019 | ||||||
1 | operation description | Operational Description | December 02 2019 | confidential | ||||
1 | schematic diagram | Schematics | December 02 2019 | confidential | ||||
1 | Test Report | February 12 2019 | ||||||
1 | Test Setup Photos | February 12 2019 |
1 | user manual | Users Manual | 4.00 MiB | February 12 2019 |
BT Accurate home blood pressure measurements with the WatchBP Home A BT. Instruction Manual Bluetooth EN 3 BT Federal Communications Commission (FCC) Statement changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance.) 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. Microlife WatchBP Home A is the worlds first digital blood pressure measurement device that strictly follows European Society of Hypertension (ESH)1, 2 and American Heart Association (AHA) recommendations for home blood pressure measurement. Using the WatchBP Home A device helps you collect accurate home blood pressure measurements your doctor can trust. This WatchBP Home A device has been clinically validated according to the ESH protocol 3.
# WatchBP Home A BT is the same WatchBP Home A with Bluetooth (BT) capability. Indications For Use The WatchBP Home A BT is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. The device has Bluetooth capability. The memory data can be transferred to the Bluetooth enable phone by connecting wirelessly. 1 OBrien E, Asmar R, Beilin L, Imai Y, et al. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. European Society of Hypertension Working Group on Blood Pressure Monitoring. J Hypertens 2003;21:821-848. 2 Stergiou GS, et al. A tool for reliable self-home blood pressure monitoring designed according to the European Society of Hypertension recommendations: The Microlife WatchBP Home monitor. Blood press Monit. 2007;12:127-131. 3 Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to The International Protocol. Blood Press Monit. 2007;12(3):185-188. b Table of Contents Before using WatchBP Home A BT for the first time Product description .....................................................45 Activating the device ...................................................... 6 Selecting the correct cuff ................................................ 7 Taking measurements using WatchBP Home A BT DIAG. Mode ..............................................................89 USUAL Mode ............................................................. 11 Eight steps for measure blood pressure properly Blood pressure measurement procedures ............. 1213 Special Function Atrial Fibrillation Detection .......................................... 16 About Atrial Fibrillation ................................................ 17 Atrial Fibrillation Detector ............................................ 18 Atrial fibrillation detection instructions ....................... 19 Information for the doctor ............................................ 19 Viewing, deleting, and transferring measurements Viewing measurements ......................................... 2021 Deleting measurements ......................................... 2223 Transferring measurement ..................................... 2427 Appendix Batteries and power adaptor ................................. 2829 Safety, care, accuracy test and disposal ................. 3031 Error messages ....................................................... 3233 Important facts ....................................................... 3435 Technical specifications................................................. 36 3 ENBT BT Cuff Socket USUAL DIAG. NOCTURNAL Bluetooth SYS mmHg DIA mmHg PUL
/min Serial Port Mode Switch 4 Display ON/OFF Button Battery Compartment Bluetooth symbol Power Socket M Button (Memory) Mode Indication Doctor Symbol Atrial Fibrillation Detection Outside Measurement Time Relax Battery Display Delete Memory Data Stored Value Morning Data Evening Data Date/Time Systolic Value Diastolic Value Pulse Indicator Pulse Rate Number of Stored Data 5 EN BT Before using WatchBP Home A BT for the first time Activating the Device Pull out the protective strip from the battery compartment. PUL
/min Bluetooth Press M Button to make selection Press ON/OFF Button to confirm DIA mmHg 2) Set the month Press the M Button to set the Month. Press the ON/OFF Button to confirm. 1) Set the year Upon removing the protective strip or installing new batteries, the Year number flashes in the display. Use the M Button to select the Year. Press the ON/OFF Button to confirm your selection. 3) Set the day Press the M Button to set the Day. Press the ON/OFF Button to confirm. 6 4) Set the time Once you have set the Hour and Minutes and pressed the ON/OFF Button, the date and time are set, and the current time is displayed. Selecting the correct cuff The WatchBP Home A BT device is available with different cuff sizes. If the cuff provided with the device is an unsuitable size , please consult your doctor.
* please use only Microlife cuffs!
5) If you want to change the date and time, take out one battery from the battery compartment briefly and put it back. The Year number will flash. Complete the process as described above. M (Medium size) 22 - 32 cm (8.7 - 12.6 inches) M is the correct size for most people. L (Large size) 32 - 42 cm (12.6 - 16.5 inches) 7 ENBT Taking measurements using WatchBP Home A BT Prior to each measurement, use the Mode Switch on the right side of the device to select the proper measurement mode. The two options include:
DIAG. (Diagnostic) or USUAL (Usual) mode. DIAG. Mode The DIAG. mode should be selected as requested by your doctor when blood pressure is measured in accordance with the measurement guidelines of the European Society of Hypertension (ESH). DIAG. USUAL 8 DIAG. No measurements on non-work days In DIAG. mode, blood pressure measurements are taken on 7 consecutive working days (or normal week days). No readings should be taken on non-working days (or particularly relaxing days) in this mode!
Two sets of measurements per day ESH guidelines recommend one double measurement taken in the morning between 06:00 - 09:00 and one in the evening between 18:00 - 21:00. Always perform measurements before taking your medication, unless otherwise directed by your doctor. Jan JAN 30 7 working days X1 06:00 - 09:00 X1 18:00 - 21:00 ESH Guidelines 9 ENBT Taking measurements using WatchBP Home A BT (cont.) Extended measurement period WatchBP Home A BT has an extended measurement period and allows morning measurements between 04:00 - 12:00 and evening measurements between 18:00 - 24:00. Evaluation After measurements have been carried out for a total of 7 working days, take the device to your doctor for evaluation of your home blood pressure data. X1 04:00 - 12:00 X1 18:00 - 24:00 Extended Time Outside these times, measurements cannot be taken and the symbol on the right will be displayed on the screen. 10 When measurements have been carried out for the full 7 days, the doctor symbol will flash on the screen. DIAG. USUAL Mode The USUAL mode is selected for regular blood pressure measurement with Afib detection. In USUAL USUAL mode, three consecutive measurements are taken automatically at 15 second intervals. The results are averaged and displayed. The averaged readings are automatically stored for later evaluation by your doctor. 250 measurements safely stored The WatchBP Home A BT device can store up to 250 averaged measurement readings in USUAL mode. 250Measurements DIAG. Anytime USUAL 1 2 3 15 sec. 15 sec.
* When memory is full, each new reading will automatically overwrite the earliest measurement.
* To review the last three individual measurements, press and hold the M button until a 1 is displayed on the screen. The values of the last three individual measurements are displayed sequentially. 11 ENBT Eight steps for measure blood pressure properly Step 1 Avoid taking measurements directly after eating, drinking or smoking. Allow at least one hour between these activities and measurement of your blood pressure. Step 2 Prepare a chair and table for the measurement. The chair should have a vertical back-rest and the table should allow your upper arm to rest at the same height as your heart. 1 Hour Before 12 Step 3 Remove all clothing covering or constricting the arm to be measured. Apply the cuff. Make sure the lower edge of the cuff is exactly 23cm from the inner fold of your arm. The tube connecting the cuff to the device should be placed on the inside of the arm. (Additional visual instruction can be found on the cuff) Step 4 Sit down and relax for at least five minutes prior to the measurement. 13 ENBT Eight steps for measure blood pressure properly (cont.) Step 5 Sit upright and lean comfortably against the chairs backrest. Press the start button. The device will initiate a 60-second countdown in DIAG. mode or a 15-second countdown in USUAL mode. During the measurement do not move, cross your legs, or tense your arm muscles. Breath normally and do not talk. USUAL DIAG. NOCTURNAL SYS mmHg DIA mmHg PUL
/min Bluetooth 14 Step 6 (in DIAG. mode) One measurement cycle includes two measurements. Once the first measurement is complete, continue to relax as you wait for the second measurement. The second measurement will start after 60-seconds. During this time avoid any movement. 1 2 60 sec. Step 7 (in DIAG. mode) Once the two readings are complete, measurement data is automatically stored for future reference by your doctor. If an error displays after the readings, please repeat the first six steps once again. Step 8 (in DIAG. mode) When seven days of measurements have been collected, the Doctor Symbol will flash on the display. Do not forget to take your WatchBP Home A BT device with you on your next visit to the doctor. (Note: the doctor symbol is only displayed for measurements in DIAG. Mode.) Automatically stored 15 ENBT Special Function Atrial fibrillation detection This device is designed to screen for atrial fibrillation during blood pressure measurements both in USUAL Mode and DIAG. Mode. If atrial fibrillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Afib icon is displayed. If the Afib icon is displayed after a blood pressure measurement follow the instructions on page 21.
* Joseph Wiesel, et al. Detection of Atrial Fibrillation Using a Modified Microlife Blood Pressure Monitor. American Journal of Hypertension 2009; 22, 8, 848852. 16 IAD
* Atrial fibrillation, a major cause of stroke can be detected by this device. However, not all risk factors for stroke, including atrial flutter, may be detected by this device.
* This device may not detect atrial fibrillation in people with pacemakers or defibrillators. People with pacemakers or defibrillators should therefore not use this device to detect atrial fibrillation. About Atrial Fibrillation Atrial fibrillation is a common heart rhythm problem and a common cause of major strokes. It affects more than 2 million people in North America. It is more common in old age and found in 10% of people over 80 years old. About 20% of all strokes are caused by atrial fibrillation. The elderly, or those with high blood pressure, diabetes or heart disease are more likely to get a stroke if they have atrial fibrillation. Atrial fibrillation is a rhythm problem that can last from a few minutes, to days or weeks and even years. Atrial fibrillation can lead to the formation of blood clots in the upper chambers of the heart (the atria). These clots can break off and flow to the brain causing stroke. The use of blood thinners, such as warfarin , can lower the risk of stroke in patients with atrial fibrillation. A doctor can confirm the presence of atrial fibrillation by using an EKG. Atrial fibrillation can sometimes come and go. So a doctor may not see its symptoms on regularly scheduled visits. One sign of atrial fibrillation is palpitations. But, many people dont feel anything. These people can still get a stroke and should be checked for atrial fibrillation regularly. Diagnosing atrial fibrillation earlier and followed by treatment can lower the chances of getting a stroke. 17 ENBT Atrial Fibrillation Detector The WatchBP home A can screen for atrial fibrillation during blood pressure measurement. Some people may have atrial fibrillation occasionally that lasts longer than a day. In this situation the WatchBP Home A allows frequent screening on multiple days for optimal diagnosis of atrial fibrillation. Sometimes the device might falsely detect atrial fibrillation which can have two causes:
1) The arm has moved during blood pressure measurement. For this reason it is of essential importance that the arm is kept still during the measurement. 2) Some arrhythmia (irregular heart beat) other than atrial fibrillation might be present. In such a case it is still recommended to pay a visit to the doctor. 18 For people with pacemakers or defibrillators it is not recommended to use the WatchBP Home A for diagnosing atrial fibrillation. Measurement If atrial fibrillation is detected during all readings of the triple measurements in USUAL Mode or all four readings of one day in DIAG. Mode then atrial fibrillation is most likely present. Since atrial fibrillation sometimes lasts for only a few minutes. It is recommended to perform another measurement session one hour later. If this also shows the presence of atrial fibrillation then a doctor should be seen. It is recommended to take the device when visiting the doctor. Atrial fibrillation detection instructions Use this device regularly, once per week, or once per month to screen for atrial fibrillation. If atrial fibrillation is detected during all readings of the triple measurements, another measurement session should be done approximately one hour later. If this last reading shows atrial fibrillation contact your doctor. Take this device with you when you see the doctor. Information for the doctor This device is designed to detect atrial fibrillation and false negative readings are very rare. Though it is programmed to specifically detect atrial fibrillation, frequent premature beats, marked sinus arrhythmia or other rhythm abnormalities might cause false positive readings. If atrial fibrillation is detected by the device at home, we suggest another reading done in the doctors office. If the atrial fibrillation icon is not displayed then the previous abnormal readings may have been due to transient atrial fibrillation. If the atrial fibrillation icon is displayed then it is suggested to perform an EKG to determine the exact rhythm abnormality. 19 ENBT Viewing, deleting and transffering measurements Viewing measurements 1) Use the Mode switch to first select the type of In DIAG. Mode 1) When the M Button is pressed, it briefly displays the measurements you wish to view. total number of measurements stored, e.g. N=20 and then switches to the average of all readings. DIAG. USUAL 2) Then press the M Button. DIAG. USUAL 20
* A is displayed when the number shown is the average of all data.
* - - will display when the number of measurements is less than 12. 2) Press the M Button again to display the average of all morning data. Press the M Button once again to show the average of all evening data. In USUAL Mode 1) When the M Button is pressed, the number of readings detected with Afib are displayed. 2) Press M Button again, the number of total readings stored, e.g. N=63, is displayed; followed immediately by the average of all measurements stored in memory. 3) Press the M Button repeatedly to review all the individual readings one by one. 4) The daily average is displayed after the individual readings of the day. 3) All individual readings can be viewed by repeatedly pressing the M Button. Individual Reading 21 ENBT Viewing, deleting and transffering measurements (cont.) Deleting measurements Data from DIAG. and USUAL can be deleted independent of each other.
* Only delete the stored measurements when you are sure that you no longer need the data. DIAG. DIAG. USUAL USUAL DIAG. DIAG. USUAL USUAL 22 1) Use the Mode switch to select the mode of measurements you want to delete. 3) Release the M Button and press it once more while the Delete symbol flashes. The deleting is confirmed by the beep sound. DIAG. USUAL 2) Press the M Button and hold the Delete symbol flashes. DIAG. it for 7 seconds until USUAL Press and hold for 7 seconds...
* Only measurements in the selected mode will be deleted. 23 ENBT Viewing, deleting and transferring measurements (cont.)
* System Requirements for Software: 1GHz CPU. 512MB Memory, 4.5GB free hard disk space, Microsoft Windows 7 SP1 / 8 / 10 Installation of the software program The latest WatchBP Analyzer Software is available from the Microlife website. https://www.microlife.com/support/
softwareprofessional-products Double click the download installer and simply follow the instructions provided in the installation window on the PC screen. 24 Transferring data to the computer 1) Start the software program and connect the device to the computer using the cable supplied. 2) The date and time on the device automatically synchronize with the date and time on the PC when successfully connected with WatchBP Analyzer PC software. 3) Click <Download> button in the WatchBP Analyzer to transfer the measurement data on the device to a PC.
*
See instruction manual of the WatchBP Analyzer for details. 25 ENBT Viewing, deleting and transferring measurements Bluetooth connectivity The measurement data in DIAG. and USUAL can be transferred to a Bluetooth enabled cell phone (android, windows, iphone). Make sure that the phone has Bluetooth turned on before transferring measurements. Before connecting with the phone, please check if Bluetooth pairing is necessary. Press and hold the M button for around 5 seconds, the unique 6-digit device ID of the unit is displayed. Connect the device and confirm pairing. The screen of the device will show the bt if successfully connected. USUAL DIAG. NOCTURNAL USUAL DIAG. NOCTURNAL SYS mmHg DIA mmHg PUL
/min SYS mmHg DIA mmHg PUL
/min Bluetooth Bluetooth Bluetooth 26 When you press the start button to take the measurement, the Bluetooth also turns on and displays the 6-digit device ID awaiting the connection. The screen will show FL if the connection fails.
* If the Bluetooth connection keeps failing, please reset the Bluetooth Bonding by pressing and holding the Start/
Stop button of the device for 7 seconds and start the connection again. USUAL DIAG. NOCTURNAL SYS mmHg DIA mmHg PUL
/min USUAL DIAG. NOCTURNAL SYS mmHg DIA mmHg PUL
/min Bluetooth Bluetooth 27 ENBT Batteries and power adaptor Battery indicator When the batteries have power supply left, the Battery Symbol will flash each time the device is switched on. Replacing low batteries When the batteries need to be replaced, the Battery Symbol will flash each time the device is switched on. 1) Open the battery compartment at the back of the device. 2) Replace the batteries ensure correct polarity as shown by the symbols in the compartment.
* Use 4 new, long-life 1.5V, size AA batteries.
* Do not use batteries beyond their date of expiry.
* Remove batteries, if the device will not be used for a prolonged period. 28 Using a power adaptor The WatchBP Home A BT device can also be operated using a Microlife power adaptor (DC 6V, 600mA).
* Only use Microlife branded power adaptors. 1) Plug the adaptor cable into the Power Plug in the WatchBP Home A BT device. 2) Plug the adaptor plug into the wall socket. When the power adaptor is connected, no battery power is consumed.
* External power adaptor shall be fulfilled in compliance with the requirements of IEC 60601-1:2005. 29 ENBT Safety, care, accuracy test and disposal Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Observe the storage and operating conditions described in the Technical specifications section of this manual. Safety and protection This device may be used only for the purpose described in this booklet. The device comprises of sensitive components and must be treated with caution. The manufacturer cannot be held liable for damage caused by incorrect application. Caution: Federal law restrics this device to sale by or on the order of a physician. Strangulation due to cables and hoses, particularly due to excessive length. Inhalation or swallowing of small parts,if some parts are small enough to be swallowed. Only activate the pump when cuff is installed. Do not use the device if you think it is damaged or if anything appears unusual. Protect the device from water and moisture Protect the device from direct sunlight Protect the device from extreme heat and cold Do not use this device close to strong electromagnetic fields such as mobile telephones or radio installations.maintain a minimum distance of 3.3m from such devices when using this unit. Never open device Protect device from impact and drops Read the further safety instructions in the individual sections of the instruction manual. Do not connect the device to a computer until prompted to do so by the computer software. Keep dry IP20: Protected against solid foreign particles with a diameter of more than 12.5 mm, no protection against water, please do not drop water on device for avoid performance influence. 30 Device care Clean the device with a soft, dry cloth. Cuff care DO NOT wash the cuff. DO NOT iron the cuff cover. Accuracy test We recommend the WatchBP Home A BT device be tested for accuracy every 2 years or after mechanical impact (e.g. being dropped). Please contact Microlife to arrange for an accuracy test. Do not wash the cuff!
Do not iron the cuff!
31 ENBT Error messages If an error occurs during measurement, the measurement is interrupted and an error message Er is displayed. Please consult microlife, if this or any other problem occurs repeatedly. If you think the results are unusual, please read through the information in this instruction manual carefully. 32 Error Description Potential cause and remedy Er 1 Signal too weak Er 2 Error signal The pulse signals on the cuff are too weak. Re-position the cuff and repeat the measurement. During the measurement, error signals were detected by the cuff, caused for instance by movement or muscle tension. Repeat the measurement, keeping your arm still. Er 3 No pressure in the cuff Er 5 Abnormal result An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the batteries if necessary. Repeat the measurement. The measuring signals are inaccurate and no result can therefore be displayed. Read through the checklist for performing reliable measurements and then repeat the measurement. HI Pulse or cuff pressure too high The pressure in the cuff is too high (over 300 mmHg) OR the pulse is too high (over 200 beats per minute). Relax for 5 minutes and repeat the measurement. LO Pulse too low The pulse is too low (less than 40 beats per minute). Repeat the measurement. 33 ENBT Important facts about blood pressure and home measurements diastolic (lower) value, are always measured. The pulse rate is the number of times the heart beats in a minute. Permanent high blood pressure can damage your health and therefore must be treated!
Always discuss your home blood pressure measurement data with your doctor and tell him/her if you have noticed anything unusual or feel unsure. Never rely on single blood pressure readings. There are many causes of excessively high blood pressure. Your doctor will explain them in more detail and offer treatment when appropriate. Blood pressure is subject to wide fluctuations as the day progresses, and can be impacted by emotions, physical exertion and other conditions . Blood pressure is the pressure of the blood flowing in the arteries generated by the pumping of the heart. Two data readings, the systolic (upper) value and the 34 Evaluating blood pressure data The table on the right classifies blood pressure data for adults in accordance to the guidelines of the European Society of Hypertension (ESH). (Data in mmHg) The higher value is the one that determines the evaluation. Example: a readout value between 150/85 or 120/98 mmHg indicates Grade 1 Hypertension. Category Optimal Normal High normal Systolic Diastolic
< 120
< 80 120 - 129 80 - 84 130 - 139 85 - 89 Grade 1 Hypertension 140 - 159 90 - 99 Grade 2 Hypertension 160 - 179 100 - 109 Grade 3 Hypertension lsolated Systolic Hypertension 180 140 110
< 90 35 ENBT Technical specifications Operating condition:
Storage condition. Weight:
Dimensions:
Measuring procedure:
Method:
Measurement range:
Cuff pressure display:
Voltage source:
36 10 to 40 C (50 to 104 F) 15 - 90 % relative maximum humidity, Air pressure 700 to 1040 hPa.
-20 to 50 C (-4 to 131 F) 15 - 90 % relative maximum humidity 385 g (including batteries) 150 x 100 x 50 mm Oscillometric, corresponding to Korotkoff Phase I systolic, Phase V diastolic SYS: 60 to 255 mmHg DIA:40 to 200 mmHg Pulse:40 to 199 per minute Range: 0 - 299 mmHg Resolution: 1 mmHg Static accuracy: pressure within 3 mmHg Pulse accuracy: 5 % of the readout value 4 x 1.5 V Batteries; size AA Mains adapter DC 6V, 600 mA (optional) Battery life:
Reference to standards:
Electromagnetic compatibility:
Expected service life:
Cuff service life:
Approximately 250 measurements Device corresponds to the requirements of the standard for noninvasive blood pressure monitor. EN 1060-1; EN 1060-3 ; IEC 60601-1 IEC 60601-1-2; IEC 60601-1-11, ESH protocol Device fulfills the stipulations of the standard IEC 60601-1-2. 5 years or 10,000 measurements (batteries and cuff are not included. Approximately 2 years Type BF applied part Microlife reserves the right to alter technical specifications without prior written notice. Guarantee card This device is covered by a five-year guarantee from the date of purchase. This guarantee is valid only on presentation of the guarantee card completed by the owner confirming date of purchase or purchase receipt. Batteries, cuff and wearing parts are not covered by this guarantee. Name:
Address:
Date:
Telephone:
Email:
Model: WatchBP Home A BT ERP Model Number: BP3MX1-3C Date:
BT Manufacturers Declaration of the Product
(Altogether 4 pages) Guidance and manufacturers declaration electromagnetic emission for all EQUIPMENT AND SYSTEMS Row 1 Guidance and manufacturers declaration electromagnetic emission 2 3 4 5 6 7 The model BP3MX1-3C(WatchBP Home A BT) is intended for use in the electromagnetic environment specified below. The customer or the user of the model BP3MX1-3C(WatchBP Home A BT) 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 IEC 61000-3-3 Electromagnetic environment guidance The Model BP3MX1-3C(WatchBP Home A BT) 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. is The Model BP3MX1-3C(WatchBP Home A BT) 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. Compliance Group 1 Class B A Complied Guidance and manufacturer's declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturers declaration electromagnetic immunity The Model BP3MX1-3C(WatchBP Home A BT) are the electromagnetic environment specified below. The customer or the user of the Model BP3MX1-3C(WatchBP Home A BT) should assure that it is used in such an environment. Immunity test Electromagnetic environment -
Compliance level intended for use in IEC 60601 test level guidance Electrostatic discharge (ESD) IEC 61000-4-2 Electrostatic transient / burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field 6 kV contact 6 kV contact 8 kV air 8 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 %. 2 kV for power supply lines 1 kV for input/output lines 1 kV differential 2 kV common mode mode 2 kV for power supply lines 1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment.
< 5 % UT
(>95 % dip in UT ) for 0.5 cycle
< 5 % UT
(>95 % dip in UT ) for 0.5 cycle 40 % UT
(60 % dip in UT ) for 5 cycles 40 % UT
(60 % dip in UT ) for 5 cycles 70 % UT
(30 % dip in UT ) for 25 cycles 70 % UT
(30 % dip in UT ) for 25 cycles
< 5 % UT
(>95 % dip in UT ) for 5 sec
< 5 % UT
(>95 % dip in UT ) for 5 sec 3 A/m 3 A/m Mains power quality should be that of a typical commercial or hospital environment. If the user of the models BP3MX1-3C(WatchBP Home A BT) product name requires operation during power mains interruptions, it is recommended that the models BP3MX1-3C(WatchBP Home A an BT) uninterruptible power supply or a battery. continued powered from be Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. IEC 61000-4-8 NOTE: UT is the a. c. mains voltage prior to application of the test level. Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturers declaration electromagnetic immunity The BP3MX1-3C(WatchBP Home A BT) is intended for use in the electromagnetic environment specified below. The customer or the user of the BP3MX1-3C(WatchBP Home A BT) should assure that it is used in such an environment. IEC 60601 test Compliance Electromagnetic environment - guidance Immunity test level level Conducted RF 3 Vrms 3 V IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the Models BP3MX1-3C(WatchBP Home A BT), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 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:
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 Model BP3MX1-3C(WatchBP Home A BT) are used exceeds the applicable RF compliance level above, the Model BP3MX1-3C(WatchBP Home A BT) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model BP3MX1-3C(WatchBP Home A BT). b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM -
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING portable and mobile RF communications equipment and the model BP3MX1-3C(WatchBP Home A Recommended separation distances between radiated RF disturbances are controlled. The customer or The Model BP3MX1-3C(WatchBP Home A BT) is intended for use in an electromagnetic environment in which the Model BP3MX1-3C(WatchBP Home A BT) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Model BP3MX1-3C(WatchBP Home A BT) as recommended below, according to the maximum output power of the communications equipment. the user of Separation distance according to frequency of transmitter BT) Rated maximum output of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz P d P d m
]5.3[
E 1 0.12 0.38 1.2 3.8 12
]7[
E 1 P 0.23 0.73 2.3 7.3 23 d
]5.3[
V 1 0.12 0.38 1.2 3.8 12 W 0.01 0.1 1 10 100 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. Distributed by:
Microlife USA, Inc. 1617 Gulf To Bay Blvd., 2nd Floor Clearwater, FL 33755, USA Tel
+1 727 442 5353 Fax +1 727 442 5377 Email:
msa@microlifeusa.com www.watchbp.com Made in China Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. IB WatchBP Home A BT 3MX1-3C EN 4619
1 | external photos | External Photos | 571.81 KiB | February 12 2019 |
Report No. : EED32L00271801 Page 57 of 63 PHOTOGRAPHS OF EUT Constructional Details Test model No.:WhatchBP Home A BT View of Product-1 View of Product-2 Report No. : EED32L00271801 Page 58 of 63 View of Product-3 View of Product-4 Report No. : EED32L00271801 Page 59 of 63 View of Product-5 View of Product-6 Report No. : EED32L00271801 Page 60 of 63 View of Product-7 View of Product-8
1 | internal photos | Internal Photos | 558.60 KiB | February 12 2019 |
Report No. : EED32L00271801 Page 60 of 63 View of Product-7 View of Product-8 Report No. : EED32L00271801 Page 61 of 63 View of Product-9 View of Product-10 Report No. : EED32L00271801 Page 62 of 63 View of Product-11 View of Product-12 Report No. : EED32L00271801 Page 63 of 63 View of Product-13 View of Product-14
*** End of Report ***
The test report is effective only with both signature and specialized stamp, The result(s) shown in this report refer only to the sample(s) tested. Without written approval of CTI, this report cant be reproduced except in full.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-12-02 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-12-02
|
||||
1 | Applicant's complete, legal business name |
Microlife Corporation
|
||||
1 | FCC Registration Number (FRN) |
0016306045
|
||||
1 | Physical Address |
9F, 431, RuiGuang Road, Nei-Hu
|
||||
1 |
Taipei, N/A
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@TIMCOENGR.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
U7I
|
||||
1 | Equipment Product Code |
BP3MX1-3C
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J**** D********
|
||||
1 | Title |
Regulatory Manager
|
||||
1 | Telephone Number |
886-2********
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
j******@microlife.com.tw
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
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?: | No | ||||
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) | Digital 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 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 |
Centre Testing International Group Co., Ltd
|
||||
1 | Name |
J****** L******
|
||||
1 | Telephone Number |
86 75********
|
||||
1 |
j******@cti-cert.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 | 0.0003000 |
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