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user manual 1 | Users Manual | 4.93 MiB | November 28 2019 | |||
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user manual 2 | Users Manual | 1.54 MiB | November 28 2019 | |||
1 | RF Exposure Info | November 28 2019 | ||||||
1 | Cover Letter(s) | November 28 2019 | ||||||
1 | block diagram | Block Diagram | November 28 2019 | confidential | ||||
1 | Cover Letter(s) | November 28 2019 | ||||||
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external photos | External Photos | 619.12 KiB | November 28 2019 | |||
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internal photos | Internal Photos | 530.78 KiB | November 28 2019 | |||
1 | ID Label/Location Info | November 28 2019 | ||||||
1 | Cover Letter(s) | November 28 2019 | ||||||
1 | operation description | Operational Description | November 28 2019 | confidential | ||||
1 | schematic diagram | Schematics | November 28 2019 | confidential | ||||
1 | Test Report | November 28 2019 | ||||||
1 | Test Setup Photos | November 28 2019 |
1 | user manual 1 | Users Manual | 4.93 MiB | November 28 2019 |
WatchBP O3 Professional 24-hour Ambulatory Blood Pressure Monitor BP 3SZ1-1 Instruction Manual Instruction Manual EN 3 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:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance.) Indications For Use Microlife WatchBP 03 (BP3SZ1-1) Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, Mean Arterial Pressure (MAP) and pulse rate using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The WatchBP O3 device has been clinically validated according to the ESH and ISO 81060-2: 2013 protocol (equivalence). Function for Options:
AFIB Version: The device can detect atrial fibrillation if present during blood pressure measurement. CBP Version: The device can determine ascending aortic blood pressure values and related parameters during regular brachial cuff blood pressure measurement. WatchBP product support:
https://www.microlife.com/professional-products WatchBP Software support:
https://www.microlife.com/support/software-professional-products Developers support:
https://www.microlife.com/developers1 4 Table of Contents Product description Major parts ..................................................................... 6-7 Product Overview ........................................................... 8-9 Before using the device for the first time Activating the device .........................................................10 Measurement programming Connecting the Device to a Computer ................................11 Start the Software Program ...............................................11 Programmable measurement intervals ...............................12 Day and Night Period (Two measurement periods) ..............12 Setting highest inflation pressure .......................................13 Setting ambulatory options ................................................13 Preparing for blood pressure measurement Confirm the cuff size ..........................................................14 Connecting the cuff tubing to the device .............................14 Preparing the measurement arm ........................................15 Positioning the cuff and device ...........................................15 Taking blood pressure measurement Next measurement indicator ..............................................16 Measurement reminder .....................................................16 During blood pressure measurements ...............................17 Initiating a blood pressure measurement manually ..............18 Special functions Screening for atrial fibrillation during blood pressure measurement ...................................................................19 Central blood pressure parameters ....................................19 How is central blood pressure measured? ..........................20 Recording medication intake .............................................21 Upgrading the version of the device ...................................22 Transferring and deleting measurement data ......................23 Appendix How to replace batteries ....................................................24 Bluetooth connectivity .......................................................25 Safety, care, accuracy test and disposal .............................26 Error messages ........................................................... 29-32 Technical specification .....................................................33 5 ENWatchBP O3 Product description The WatchBP O3 ABPM system consists of two major parts The device, cuffs and accessories. The WatchBP Analyzer Software. With the WatchBP Analyzer Software 1) The device can be programmed for the blood pressure measurement procedure. 2) Measured blood pressure values can be downloaded to the PC. 3) A PDF report and Microsoft Excel spreadsheet (or .csv format.) for data analysis can be generated. Device Version The device is upgradable for obtaining special features. There are three different versions of the device:
Standard version: standard ABPM AFIB version: standard ABPM with Microlife Atrial Fibrillation Detector CBP version: standard ABPM with Microlife Atrial Fibrillation Detector and Central Blood Pressure measurement The Atrial Fibrillation Detector and Central Blood Pressure measurement of the device can be activated through the WatchBP Analyzer Software. Refer to Upgrading the version of the device for details. 6 Contents 1. WatchBP O3 Monitor (dependent on purchase version) 2. WatchBP O3 Cuff Size M 3. WatchBP O3 Cuff Size L 4. Carrying Pouch 5. Data Cable 6. AAA Alkaline Batteries x 4 7. Tube holder x 3 8. 100 cm cuff tube x 2 9. Instruction Manual 10. Patient diary 11. Quick start guide
*
Download the latest WatchBP Analyzer Software from the Microlife website. https://www.microlife.com/support/
softwareprofessional-products WatchBP O3 7 EN Product description Product Overview SYS. mmHg DIA. mmHg PUL.
/min START STOP USB port Medication button Cuff connector Start/Stop button On/Off button Battery compartment 8 Bluetooth indicator Battery indicator AF indicator Count down indicator Medication indicator cPP indicator Heart indicator Time SYS/ cSBP DIA/ cDIA/
Countdown min to next measurement Pulse/ CPP 9 ENWatchBP O3 Before using the device for the first time Activating the device Open the battery compartment on the rear of the device and insert 4x AAA alkaline batteries according to the battery polarities (+ / - ) and close the compartment. Press the On/Off button to activate the device. The device displays sequentially the full screen display, the voltage of the batteries, the number of measurements stored on the device and the countdown minutes before the next measurement based on default schedule programmed on the device. Program the device and clear existing measurements of the device before any new patient session. The default measurement interval is 30 minutes for the awake hours and 60 minutes for the asleep hours. 10 Using WatchBP Analyzer The memory data can be transferred to your PC
(personal computer) running the WatchBP Analyzer Software by connecting the monitor via USB cable or Bluetooth. System Requirements for Software:
1GHz CPU. 512MB Memory, 4.5GB free hard disk space, Microsoft Windows 7 SP1 / 8 / 10 Installing the Software Program Download the latest WatchBP Analyzer Software from the Microlife website. https://www.microlife.com/support/software-
professional-products Double click the download installer and simply follow the instructions provided in the installation window on the computer screen. Measurement programming Connecting the Device to a Computer Connect the device to the PC using the USB cable provided with the device. Start the Software Program Start the software program. The date/time on the device will sync with date/time of PC automatically when successfully connected with WatchBP Analyzer PC software. If the device and WacthBP Analyzer software is connected successfully:
<USb> is displayed on the LCD screen of the device. The device ID, model, version of the Device and batteries condition etc. are displayed on the WatchBP Analyzer software. See also the Instruction manual of the WatchBP Analyzer for details. The instruction manual of the WatchBP Analyzer can be found in the software by clicking <About> in the functional bar. 11 ENWatchBP O3 Measurement programming Programmable measurement intervals Enter name, identity number, and date of birth to create a new record (if required). Select a patient and click
<Program Device>. The device can automatically take measurements at fixed interval times of 5, 10, 15, 20, 30, or 60 minutes, as can be programmed. Day and Night Period (Two measurement periods) The awake (Day) measurement period can be programmed to start at any hour between 00 to 23, and the asleep (Night) measurement period can be set to any hour between 00 to 23. Measurement time-intervals can be set to 5, 10, 15, 20, 30, or 60 minutes for both awake and asleep time periods. Setting Day and Night Period Day Period 06
~ 22 with Central BP measurement Night Period 22
~ 06 with Central BP measurement 30 30 60 60 minutes interval minutes interval minutes interval minutes interval See also instruction manual of the WatchBP Analyzer for details. The option of taking central blood pressure measurement is selectable if the feature of the device is activated. 12 Setting highest inflation pressure Click on the circle left to Enable and click on the arrow to determine the height of the inflation pressure. Disable means that the device will automatically search for the right inflation pressure (default). Setting ambulatory options On default the blood pressure data are hidden, and the device is in silent mode. In order to show the measured blood pressure values on the LCD screen and to provide a beep before each measurement, tick the squares to the left. Setting Highest Inflation pressure Enable Disable(auto) mmHg
* Disable is recommended 180 160 180 200 220 Setting ambulatory options. Hiding BP data Silent mode disabled. The beeper can be enabled or disabled. The display of blood pressure values on the LCD screen can be enabled or Once you have completed the settings, press Program to program the schedule into the device. For further explanation see instruction manual of the WatchBP Analyzer. 13 ENWatchBP O3 Preparing for a blood pressure measurement Confirm the cuff size A variety of different cuff sizes are available. S Only use Microlife cuffs!
Washable cuffs are available in both nylon and cotton. 14 - 22 cm
(5.5 - 8.7 inches) Connecting the cuff tube to the device Push the end of the tube firmly onto the metal cuff connector on the device. M 22 - 32 cm
(8.7 - 12.6 inches) L 32-42 cm
(12.6-16.5 inches) XL 32-52 cm
(12.6-20.5 inches) S, XL size cuffs can be ordered optionally. M & L size cuffs are supplied as standard with the device. 14 Preparing the measurement arm Remove all clothing covering or constricting the measurement arm. WatchBP O3 Positioning the cuff and device Fit the cuff closely, but not too tight. Make sure that the cuff is 2~3 cm (1 inch) above the elbow with the tube on the inside of the arm. The cuff tube should point upwards and should be mounted over the patients shoulder to the other site of the body. 23cm Avoid rolling up long sleeves, as this may lead to constriction of blood flow to the measurement arm. Add the pouch to the belt to carry the device. Adjust the tube holder on the belt of the pouch so it is properly positioned on the shoulder. 15 EN Taking blood pressure measurement 2-3 cm
(3/4 to 1 inch) Next measurement indicator The device will display the next measurement time, indicated by a countdown in minutes on the display. Measurement reminder One minute before the next scheduled measurement, the device will partially inflate to approximately 50 mmHg and immediately deflate the cuff to remind the patient of the upcoming measurement. Measurement reminders will be disabled for asleep hours. Five seconds before the next scheduled measurement, the device can emit a short series of beeps to notify the patient of the coming measurement (optionally). The beep is switched off by default and can be enabled via software setting. (See instruction manual of the WatchBP Analyzer) The beep sound is disabled for asleep measurement The example shows countdown 2 minutes to the next measurement. 16 During blood pressure measurements The patient should be reminded to remain still, refrain from talking, and to breathe normally during the measurement. If the patient is occupied at the start of a measurement, the patient should, where possible, try to relax the measurement arm. At any time, a single measurement can be stopped by pressing the Start/
Stop or ON/OFF button. Repeat the blood pressure measurements in case of an error The device will automatically repeat the measurement after a two-minute countdown should an error occur during measurement. If the repeat measurement encounters an error again, the device will take an extra measurement after a four minutes countdown. If the extra measurement is not successful either, the device will record an error message. If the device stops taking measurements, the patient should return the device to determine the cause of error. Storing measurement data The device can store up to 330 memories, which includes measurements, medication records, errors and start/ stop events. When the memory is full the LCD screen of the device displays Full and no further measurements or medication records can be performed. Upload the measurement data and clear the memory to reset the device. 17 ENWatchBP O3 Initiating blood pressure measurement manually Readings are displayed at the end of the manually initiated blood pressure measurement. When a central blood pressure measurement is performed. The LCD screen switches every 2 seconds after the measurement to display both central and brachial (peripheral) blood pressure values. Press the Start/Stop button during standby to start a measurement. Once the measurement is complete, the measurement value is automatically stored and can be checked with the software. Before starting a measurement, make sure the correct cuff size is used and If Highest Inflation Pressure is enabled (on default it is disabled), the is properly positioned on the arm. selected Highest Inflation Pressure is displayed on the device before starting the measurement. Setting Highest Inflation pressure Enable Disable(auto) 180 mmHg
* Disable is recommended 18 Special functions Screening for atrial fibrillation during blood pressure measurement The device is designed to screen for atrial fibrillation during blood pressure measurements (optional) with high accuracy: a sensitivity of 98% and a specificity value of 92%*. If atrial fibrillation is detected this will be shown in the report. About Atrial Fibrillation Atrial fibrillation is a common heart rhythm problem and a common cause of major strokes. It affects 8% of those 65 years and older and about 20% of all strokes are caused by 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 heart. These clots can break off and flow to the brain causing stroke. One sign of atrial fibrillation is palpitations. However, many people have no symptoms and therefore may remain undetected whereas diagnosing atrial fibrillation early followed by adequate treatment can largely reduce the chance of getting a stroke.
*
Verberk et al. Screening for atrial fibrillation with automated blood pressure measurement: Research evidence and practice recommendations. Int J Cardiol 2016: 465473 Central blood pressure parameters The device is designed to take central blood pressure parameters (optional). Central blood pressure is the pressure in the ascending aorta, the largest artery that originates from the left ventricular of the heart and from where oxygen is distributed to all parts of the body through the systemic circulation. Central Systolic Blood Pressure and Central Pulse Pressure by this monitor is determined directly through pulse volume plethysmography (PVP) waveform analysis. Central Diastolic Blood Pressure by this monitor is calculated by subtraction of Central Systolic Blood Pressure and Central Pulse Pressure. 19 ENWatchBP O3 Special functions How is central blood pressure measured?
The device measures brachial systolic and diastolic blood pressure as usual. However, where the cuff normally totally deflates after the blood pressure measurement, the cuff now stops deflating at approximately 60 mmHg cuff pressure to keep a stable pressure on the brachial artery for approximately 10 seconds which is needed to acquire brachial pulse volume plethysmography (PVP) waveforms (pulse volume recording). During these 10 seconds approximately 10 PVP waveforms are recorded from which one average PVP waveform is determined and analysed. From the average PVP waveform, some characteristic points (parameters) are identified that are directly related to arterial compliance (stiffness) and wave reflections. With these parameters and previously measured peripheral (regular) blood pressure the central systolic blood pressure value and the central pulse pressure value are then determined1. The time that is needed to determine the central blood pressure value may vary among patients; i.e. with faster heart rate, less time is required for collecting the number 20 of required PVP waveforms. It is very important to keep the arm still during the time the PVP waveforms are collected. Accuracy of the central blood pressure parameters The accuracy of central blood pressure parameters performed with this device can only reliably be determined against intra-arterial blood pressure measurement. The device is a certified equivalence with the WatchBP Office Central that has been validated against simultaneous recorded intra-
arterial blood pressure measurement in 85 subjects and showed high accuracy2 . 1. 2. Sung, S.H., et al., Measurement of central systolic blood pressure by pulse volume plethysmography with a noninvasive blood pressure monitor. Am J Hypertens, 2012. 25: 542-8. Cheng, H.M., et al., Measurement accuracy of a stand-alone oscillometric central blood pressure monitor: a validation report for Microlife WatchBP Office Central. Am J Hypertens, 2013. 26: 42-50. Recording intake medication The patient can record the time of medication intake by pressing and holding the medication button for 2 seconds. The pill icon flashes twice and displays for 1 min before the LCD screen returns to display the count down time (min) to next measurement. 21 ENWatchBP O3 Upgrading the version of the device The device is upgradable for obtaining special features. There are three different versions of the device:
Standard version: standard ABPM AFIB version: standard ABPM with Microlife Atrial fibrillation Detector CBP version: standard ABPM with Microlife Atrial fibrillation Detector and Central Blood Pressure measurement The Atrial Fibrillation Detector and Central Blood Pressure measurement of the device can be activated through the WatchBP Analyzer. A 16-digit activation key is needed specifically to match the device ID for activation. Please contact Microlife or the local distributor for additional information. 22 About WatchBP Analyzer: Version 1.0.0.2 User Manual Device ID: 112233445566 Firmware version: RE1.2018.10.07 Options:
AFIB Central BP activate activate Please consult Microlife or local distributor on the options activation Okay Central BP Activation Device ID: 112233445566 Please insert a 16-digit activation key Confir Cancel
1 | user manual 2 | Users Manual | 1.54 MiB | November 28 2019 |
Transferring and deleting measurement data Transferring measurement data Connect the device to the PC. Start the software program. Click <Download> and follow the procedure of the WatchBP Analyzer to transfer the measurement data to a computer. Deleting measurements The measurement data on the device will be automatically deleted after clicking <Program Device>
in the WatchBP Analyzer software to program a measurement schedule for the next patient. See instruction manual of WatchBP Analyzer for details. 23 ENWatchBP O3 Appendix AAA alkaline batteries are the main power source of the device. If the voltage is low, the buzzer of the device beeps in order to remind the user that the batteries need to be replaced. The buzzer keeps beeping until the batteries are replaced. The battery icon and voltage number are also displayed on the LCD screen of the device. How to replace batteries Open the battery compartment at the back of the device. Replace the batteries ensure correct polarity as shown by the symbols in the compartment. Do not use rechargeable batteries. Use 4 new, 1.5V, size AAA alkaline batteries. Do not use batteries out of expiration date. Remove batteries if the device will not be used for a prolonged period. 24 Bluetooth connectivity Bluetooth connection of the WatchBP Analyzer supports Microsoft Windows 10 Regarding the connectivity architecture design, we used proprietary communication protocol to do data transfer process. The specific communication protocol is assured that the information (data) is correct. The program checks ACK firstly. Afterward, the program compares the received checksum with the sum of encoded raw data. If the result is correct, the data is guaranteed during transmission. In contrast, once the device gets wrong communication command, it will not have any response. It is a data encryption and decryption architecture. We used proprietary encryption method to pack blood pressure raw data. In other word, Blood Pressure Analyzer need to use proprietary decryption method to unpack the encrypted data to get blood pressure raw data. Pairing the device Press and hold the Start/Stop button for 7 seconds, the Bluetooth icon flashes and starts pairing mode. The unique 6-
digit device ID of the unit is displayed. Connect the device and confirm pairing. The Bluetooth icon is displayed on the LCD screen of the blood pressure monitor to show the presence of Bluetooth connection. See the instruction manual of WatchBP Analyzer for details Please note the following:
Bluetooth is not active when the blood pressure monitor device is recording data. The blood pressure monitor device will not sound any alarm with or without Bluetooth. The Bluetooth is used only to transfer data from point A to point B. Press and hold the Start/Stop button for 5 seconds to clear the connection. 25 ENWatchBP O3 Safety, care, accuracy test and disposal Safety and protection This device may only be used for the purposes as described in these instructions. The device comprises of sensitive components and must be treated with caution. The manufacturer cannot be held liable for damage caused by incorrect application. Follow the Instructions for Use. This document provides important product operation and safety information regarding this Blood Pressure Monitor. Please read this document thoroughly before using the device and keep for future reference. Ensure that children do not use the device unsupervised; some parts are small enough to be swallowed. Only activate the pump when the cuff is installed. Do not use the device if you think it is damaged or if anything appears unusual. 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. 26 Observe the storage and operating conditions as described in the Technical specifications section of this manual. Caution: Federal law restrics this device to sale by or on the order of a physician. Protect the device from water and moisture Protect the device from direct sunlight Protect the device from extreme heat and cold Avoid proximity to electromagnetic fields, such as those produced by mobile phones Never open the device Protect the device from impact and drops Device care Use a soft cloth with one of the following recommended cleaning solutions to wipe the exterior of the device:
Mild soap and water. Hydrogen peroxide solution (3% diluted with water). Sodium hypochlorite solution (1:10 dilution of household chloride bleach in water). Isopropyl alcohol (70% solution). Then wipe the exterior of the device with a soft, dry cloth. Cleaning the cuff Take out the bladder. Fold and place the cuff cover inside a washing bag. Wash the cuff cover with warm water (43C; 110F) and a mild detergent in the washing machine. Pasteurization: wash the cuff cover in 75C(167F) hot water for 30 minutes. Do not iron the cuff!
27 ENWatchBP O3 Safety, care, accuracy test and disposal Accuracy test We recommend the device to be tested for accuracy every 2 years or after mechanical impact (e.g. Being dropped). Please contact Microlife to arrange an accuracy test. 28 Error messages If an error occurs during measurement, the measurement is interrupted and an error message Er is displayed. Error Description
"Er 1"
Signal too weak
"Er 2"
Error signal The device will take another measurement automatically when an error occurs. Please consult your doctor, 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. Potential cause and remedy The pulse signals on the cuff are too weak. Reposition 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. 29 ENWatchBP O3 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.
"Er 11"
"Er 12"
Signal too weak during central blood pressure measurement Error signal during central blood pressure measurement 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. Error messages
"Er 3"
No pressure in the cuff
"Er 5"
Abnormal result 30
"Er 13"
Cuff pressure errors during central blood pressure measurement
"Er 15"
Abnormal result of central blood pressure reading An adequate pressure cannot be generated in the cuff. A leak may have occurred. Check that the cuff is correctly connected and is not too loose. 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.
"Er F"
The device has gone into single fault condition
"Er A"
Flash memory error Single fault condition means that the measurement is aborted to protect the patient from being harmed or the device from being damaged. Re-position the cuff and repeat the measurement. Replace the batteries if necessary. If the error persists, contact microlife or the local distributor. Possible hardware fault. Try again. If the error persists, contact Microlife or the local distributor. 31 ENWatchBP O3 Error messages
"HI"
Pulse or cuff pressure too high
"LO"
Pulse too low The pressure in the cuff is too high (over 299 mmHg) OR the pulse is too high (over 239 beats per minute). Relax for 5 minutes and repeat the measurement. The pulse is too low
(less than 30 beats per minute). Repeat the measurement. 32 Technical specification Operating temperature:
Storage temperature: -20 to 55 C / -4 to 131 F 10 - 40 C / 50 - 104 F Weight:
Dimensions:
15 - 90 % relative maximum humidity 240g (including batteries) 113 x 77.5 x 33 mm Measuring procedure: oscillometric, corresponding to Korotkoff Method:
Phase I systolic, Phase V diastolic Measurement range: SYS: 60~255 mmHg DIA: 40~200 mmHg Pulse: 30 - 239 beats per minute Cuff pressure display: Range: 0 - 299 mmHg Resolution: 1 mmHg Static accuracy: pressure within 3 Pulse accuracy: 5 % of the readout mmHg value Power source:
4X1.5 V Batteries; size AAA Expected service life:
2 years Reference to Standards Device corresponds to the requirements of the standard for non-
invasive blood pressure monitor. EN 1060-1 EN 1060-3 EN 1060-4 IEC 60601-1 IEC 60601-1-2 Type BF applied part Microlife reserves the right to alter technical specifications without prior written notice. 33 ENWatchBP O3 34 Guarantee Card WatchBP O3 This device is covered by a two-year guarantee from the date of purchase. This guarantee is valid only on presentation of the guarantee card completed by the owner confi rming date of purchase or purchase receipt. Batteries and wearing parts are not covered by this guarantee. Name:
Address:
Date:
Telephone:
Email:
Product: WatchBP O3 Product number: BP3SZ1-1 Serial Number:
Date:
35 EN Distributed by:
Microlife USA, Inc. 1617 Gulf to Bay Blvd 2nd Floor, Suite A Clearwater, FL 33755, USA Tel. +1 727 442 5353 Fax +1 727 442 5377 Email: msa@microlifeusa.com www.watchbp.com IB WatchBP O3 BP3SZ1-1 EN 3819 37 ENWatchBP O3 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 The model BP3SZ1-1(WatchBP O3) is intended for use in the electromagnetic environment specified below. The customer or the user of the model BP3SZ1-1(WatchBP O3) should assure that it is used in such an environment. Compliance Electromagnetic environment guidance The Model BP3SZ1-1(WatchBP O3) uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Model BP3SZ1-1(WatchBP O3) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 2 3 4 5 6 7 Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations
/
flicker emissions IEC 61000-3-3 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 BP3SZ1-1(WatchBP O3) are the electromagnetic environment specified below. The customer or the user of the Model BP3SZ1-1(WatchBP O3) 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 BP3SZ1-1(WatchBP O3) name requires product continued operation during interruptions, power mains it is the models that recommended be BP3SZ1-1(WatchBP powered from an uninterruptible power supply or a battery. O3) 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 BP3SZ1-1(WatchBP O3) is intended for use in the electromagnetic environment specified below. The customer or the user of the BP3SZ1-1(WatchBP O3) should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance 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 Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Models BP3SZ1-1(WatchBP O3), 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 BP3SZ1-1(WatchBP O3) are used exceeds the applicable RF compliance level above, the Model BP3SZ1-1(WatchBP O3) 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 BP3SZ1-1(WatchBP O3). 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 BP3SZ1-1(WatchBP O3) Recommended separation distances between The Model BP3SZ1-1(WatchBP O3) is intended for use in an electromagnetic environment in which radiated RF disturbances are the Model BP3SZ1-1(WatchBP O3) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model BP3SZ1-1(WatchBP O3)as recommended below, according to the maximum output power of the communications equipment. controlled. The the user of customer or Separation distance according to frequency of transmitter 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 d
]5.3[
V 1 0.12 0.38 1.2 3.8 12 W 0.01 0.1 1 10 100 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 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. 38
1 | external photos | External Photos | 619.12 KiB | November 28 2019 |
Report No. : EED32L00270401 Page 45 of 51 PHOTOGRAPHS OF EUT Constructional Details Test model No.: BP3SZ1-1 View of Product-1 View of Product-2 Report No. : EED32L00270401 Page 46 of 51 View of Product-3 View of Product-4 Report No. : EED32L00270401 Page 47 of 51 View of Product-5 View of Product-6 Report No. : EED32L00270401 Page 48 of 51 View of Product-7 View of Product-8
1 | internal photos | Internal Photos | 530.78 KiB | November 28 2019 |
Report No. : EED32L00270401 Page 49 of 51 View of Product-9 View of Product-10 Report No. : EED32L00270401 Page 50 of 51 View of Product-11 View of Product-12 Report No. : EED32L00270401 Page 51 of 51 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 | 2019-11-28 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-11-28
|
||||
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 |
BP3SZ1-1
|
||||
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 | 0.0007000 |
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