WITHINGS WPM05 Digital Automatic Blood Pressure Monitor Instruction Manual

Withings BPM Connect
INSTRUCTION MANUAL

THANK YOU FOR CHOOSING Withings BPM CONNECT

This guide is available in additional languages at: www.withings.com/guides

Overview

A. Button
B. Cuff
C. USB plug

Quick start from your smartphone

1. Visit go.withings.com from your smartphone or tablet and follow the instructions to install the Health Mate app.
2. In the app, follow the instructions to install Withings BPM Connect.

How to take a blood pressure measurement

1. Sit down in a comfortable position, legs uncrossed, feet flat on the floor, arm and back supported. Uncover your left arm. Rest for 5 minutes before the first measurement.
2. Unroll the cuff. Place your left arm inside it. The button should be closer to your elbow, and the Withings logo should be closer to your shoulder.
3. Tighten the cuff around your arm. The stethoscope should be facing the rib cage, with the metal tube facing down about one inch above the elbow.
4. Close the cuff at an angle if needed to ensure there are no gaps on both the top and bottom.
5. Place your left arm on a table with the cuff at heart level and your palm facing up. Make sure the cuff is not touching the left side of your chest. Your arm should be resting comfortably on the table. Do not speak or move during the measurement.
6. Press the button to turn on the blood pressure monitor. You can select a single or triple measurement with a long press on the button. Press the button again to start the measurement.
7. If an error message appears on screen, please refer to the troubleshooting explanation described on page 17, or see the Help Center section available in the Health Mate app.

LED colors

The LED on BPM Connect may appear:
Blue: If BPM Connect hasn’t yet been paired with a mobile device.
Green: If you have normal and optimal blood pressure measurements. The LED may also appear green if BPM Connect has been paired with a mobile device.
Orange: If you have high normal blood pressure measurements. The LED may also appear orange if the battery is low. You can still take a measurement.
Red: If hypertension (grade 1, 2, 3) or isolated systolic hypertension are detected. The LED may also appear red if BPM Connect does not have a battery, or if there is an error during the blood pressure measurement.
Pink: Press and hold the monitor button for 6 seconds until “System” displays on the screen. The LED may also appear purple during firmware updates or when BPM Connect has undergone a factory reset.
Note: The LED color displayed on the device may vary depending on the classification guidelines of your country. Please go to support.withings.com for more information on blood pressure measurement classification.

Box contents

Blood pressure monitor
Charging cable
Instruction manual

Important information

Requirements
In order to use your BPM Connect, you need an iOS (10.0 or higher) or Android (6.0 and higher) device to install it. Thereafter, the product can be used without your mobile device on you, thanks to the Wi-Fi and Bluetooth® connections.
Important safety information
Consult your doctor during pregnancy, or if you suffer from arrhythmia or arteriosclerosis. Please read this section carefully before using the BPM Connect Wi-Fi Smart Blood Pressure Monitor.
Intended use
The BPM Connect is a digital monitor intended for use in measuring blood pressure and heart rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches to 17 inches (22 cm to 42 cm). BPM Connect is a medical device. Contact your physician if hypertensive values are indicated.

General safety and precautions
– Do not forcibly bend the arm cuff.
– Do not inflate the arm cuff when it is not wrapped around your arm.
– Do not apply strong shocks and vibrations to the blood pressure monitor or drop it.
– Do not take measurements after bathing, drinking alcohol, smoking, exercising or eating.
– Do not immerse the arm cuff in water.
– Do not use a pacemaker, a defibrillator or other electric implant.
– Use on adults only.
– Do not use it on children or pets.
Android is a trademark of Google Inc. iOS is a trademark of Apple Inc.
Portable and mobile RF communications equipment should be used no closer to any part of the equipment or system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Interference may occur in the vicinity of equipment marked with the following symbol.

Caution

General usage
Always consult your doctor. Self-diagnosis of measurement results and self- treatment are dangerous. People with severe blood flow problems or blood disorders should consult a doctor before using the blood pressure monitor. Cuff inflation can cause internal bleeding. Operational factors such as common arrhythmias, ventricular premature beats, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia or renal disease can affect the performance of the automated sphygmomanometer and/or its blood pressure reading. This is a precision measuring device that may be understood by lay users,  but should still be handled with care. Exposing the device to prolonged lint, dust or sunlight might reduce its life or damage it. A damaged cuff or sensor may lead to incorrect measurements. The USB port should only be used for recharging the device. The user is an intended operator. Parts in contact with the skin: cuff. Measurements can be affected by extreme temperatures, humidity & altitude. Following REACH Regulation 1907/2006, there is an open risk on plomb and D6.

– Do not leave the blood pressure monitor unattended with infants or people who cannot express their consent.
– Do not use the blood pressure monitor for any purpose other than measuring blood pressure, recording an ECG, and recording heart sounds.
– Do not disassemble the blood pressure monitor.
– Do not operate the blood pressure monitor in a moving vehicle (car, airplane).
– Do not use the device with the USB cable plugged in.
– Improper continuous pressure of cuff or too-frequent measurements may interfere with blood flow and result in injury to the user. Check to ensure that the use of the device does not result in prolonged impairment of your blood circulation.
– Do not apply the cuff over the user’s arm if it has a wound or medical treatment, as this can cause further injury.
– Consult your physician before using this monitor if you have had a mastectomy.
– Use of the device can temporarily cause the loss of function of equipment that is used simultaneously on the same limb.

After use

Cleaning
– Do not use an alcohol-based or solvent agent to clean the device.
– Clean the device with a soft and dry cloth.
– The dirt on the cuff can be cleaned with a damp cloth and soap.
– Do not flush the device and cuff with a lot of water.
– Do not dismantle the device, disconnect the cuff, or try to repair it by yourself. If a problem occurs, please check with the distributor.
– Do not operate the device in a severe environment of extreme temperature, humidity, or direct sunshine.
– Do not shake the unit violently.
– Do not submerge the device or any of the components in water.
– Do not use the device after a strong shock, such as dropping the unit on the floor.

Storage
– Store the device and the components in a clean and safe location.
– If storage conditions are different from the usage conditions indicated in this document, please wait 30 minutes before taking a measurement.
Maintenance
If you cannot fix the problem using the troubleshooting instructions, request service from your dealer. The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist the manufacturer’s staff or authorized representative with the repair. It is generally recommended to have the device inspected every 2 years to ensure proper functioning and accuracy. Do not use the device while doing maintenance steps.

Error messages

Measurement could not be performed. Please try
again. If the problem occurs again, please contact
customer service.| Hardware auto-check error| Measurement could not be performed. Please
try again. If the problem occurs again, please
contact customer service.
Connection error. Quit the application and reconnect your blood pressure monitor.| Communication error between the blood pressure
monitor and the
collateral
device| 1. Push the blood pressure monitor button for
3 seconds to turn it off. Quit the application
and push the blood pressure monitor button
to turn it on.
2. If the problem occurs again, please contact
customer service.
Please wait until the cuff is totally deflated before starting a new measurement. Stay still during the measurement.| – Cuff is not deflated before measurement
– Noise interference
– Excessive user movements| 1. Please wait until the cuff is totally deflated
before starting a new measurement. Stay still
during the measurement.
2. If the problem occurs again, please contact
customer service.
Check that the blood pressure monitor is correctly positioned on your arm and that the measurement is being performed under good conditions.| – User movement or user is not relaxed or is talking
– Cuff is not correctly fastened
– Cuff is broken
– Pump or valve failure
– Pressure overflow
– Noise interference
– User has special characteristics, e.g., some forms of arrhythmia can trigger errors while measuring blood pressure
– Battery level is too low| 1. Check that the blood pressure monitor is
correctly positioned on your arm and that
the measurement is being performed under
good conditions.
2. Low battery level. Charge your BPM Connect
with a micro USB cable.
3. If the user has special characteristics, please
contact your physician.
4. If the problem occurs again, please contact
customer service.
Low battery level| The battery level is too low| Charge the device with the provided charging
cable

Troubleshooting

The inflation action cannot be performed or the air
pressure cannot rise| 1. Check the cuff position, fasten the cuff correctly and remeasure blood pressure again
2. Check the blood pressure monitor’s connection to the iOS or Android device
The low battery icon is displayed on the device| Charge the device with the cable provided
The blood pressure cannot be taken and the application
shows an error message| 1. Re-fasten the cuff
2. Relax and sit down
3. Keep the cuff at the same level as your heart during the measurement period
4. Keep silent and still during the measurement
5. If you have a severe heartbeat problem, your blood pressure may not be read correctly
Under normal circumstances, the measurement taken
at home may differ from the measurement taken in a
medical setting| 1. The variation is due to the different environments
2. The blood pressure is changing according to the physiological or psychological status of
the person being measured
3. Show your recorded values to your physician

Specifications & technical data

mmHg
Measurement range (pulse)| 40 to 180 beats/min
Pressure sensor accuracy| Within +- 3 mmHg or 2% of reading
Clinical accuracy (blood pressure)| BPM Connect’s performance in measuring blood pressure measurement was validated in a clinical trial. The results are within the margin of acceptance defined by the internationally recognized
evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 810602:2014, developed by the European Society of Hypertension, British Hypertension Society, and Association for the Advancement of Medical Instrumentation/American Heart Association.
For more information, go to: withings.com/support

altitude: 2000m
Storage and transport conditions| -25 to 70°C, 10 to 95% RH, atmospheric 86Kpa~106kpa, altitude: 2000m
Arm type| Use on left arm
Power source| 5V 1A
Weight| Approx. 245g
Accessories| Charging cable, Instruction manual
Product life| 3 years
Wireless transmission| Wi-Fi and BLE

Note: Specifications are subject to change without prior notice or any obligation on the parts of the manufacturer

Disposal

Actuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for a reduction in use of dangerous substances in the electric and electronic device and for garbage disposal. The symbol applied on the device or its packaging means that at the end of its useful life, the product must not be disposed of with domestic waste.

At the end of the device’s useful life, the user must deliver it to collection centers for electric and electronic garbage, or give it back to the retailer when purchasing a new device. Disposing of the product separately prevents possible negative consequences for the environment and for health deriving from inadequate disposal. It also allows the recovery of materials of which the device is made up in order to obtain an important saving of energy and resources and to avoid negative effects to the environment and health. Failure to comply with the rules for sorting or recycling waste may make the user liable for a fine. The device and its parts are made with regard to disposal, as appropriate, in accordance with national or regional regulations.
Version 1.1 September 2020

FCC Statement

Federal Communications Commission (FCC) Statement 15.2You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) 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 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 of the device.
FCC RF Radiation Exposure Statement:
This equipment 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.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
FCC ID: XNAWPM05

RF Statement

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following. | Interference may occur in the vicinity of equipment marked with the following symbol: | Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. | The use of accessories and cables other than those specified may result in increased emissions or decreased  immunity | The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment | The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes | Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter | The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Any other accessories, transducers, and cables may result in increased emissions or decreased immunity and EMC performance. | The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, which should be observed to verify normal operation in the configuration in which it will be used. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following. Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the unit.
Guidance and manufacturer’s declaration-electromagnetic emissions
This Wi-Fi Smart Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wi-Fi Smart Blood Pressure The monitor should ensure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment — guidance
---|---|---
CE emissions
CISPR11| Group 1| The Wi-Fi Smart Blood Pressure Monitor 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.
RE emissions
CISPR11| Class B
Harmonic emissions
IEC 61000-3-2| Not applicable| This Wi-Fi Smart Blood Pressure Monitor 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.
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3| Not applicable

Declaration – electromagnetic emissions and immunity

for equipment and systems that are not life-supporting and are specified for use only in a shielded location
The Wi-Fi Smart Blood Pressure Monitor declaration electromagnetic immunity
This Wi-Fi Smart Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the- Fi Smart Blood Pressure Monitor should ensure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted
RFIEC 61000-4-6| 3 Vrms
150 kHz to 80 MHz| N/A
N/A| N/A
Radiated RF IEC 61000-4-3| 3 V/m
80 MHz to 2.5 GHz| N/A| Portable and mobile RF communications equipment should be used no closer to any part of the equipment or system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Interference may occur in the vicinity of equipment marked with the following symbol.

Declaration – electromagnetic immunity
This Wi-Fi Smart Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Wi-Fi Smart Blood Pressure Monitor should ensure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Electrostatic discharge (ESD)IEC 61000-4-2| Contact: ±8 kV
Air: ±2 kV, ±4 kV, ±8 kV,
±15 kV| Contact: ±8 kV
Air: ±2 kV, ±4 kV, ±8 kV,
±15 kV| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/
burst IEC 61000-4-4| 2 kV for power supply lines
1 kV for input/output lines| N/A
N/A| The main power quality should be similar to that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| line(s) to line(s): ±1 kV line(s) to earth: ±2 kV 100 kHz repetition frequency| ine(s) to line(s): ±1 kV
100 kHz repetition
frequency| The main power quality should be similar to that of a typical commercial or hospital environment.
Voltage dips,
short interruptions and voltage variations on powersupply input lines IEC 61000-4-11| -5% UT(95% dip in UT) for 0.5 cycle, -40 % UT (60% dip in UT) for 5 cycles,
-70% UT(30 % dip in UT) for 25 cycles, -5% UT (95% dip in UT) for 5 sec| 0% UT for 0.5 cycle,
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% UT; 1 cycle
and 70% UT ; 25/30 cycles Single phase at 0° 0% UT; 300 cycle| The main power quality should be that of a typical
commercial or hospital environment. If the user of the equipment or system requires continued operation during power main interruptions, it is recommended that the equipment or system be powered from an uninterruptible power supply or a battery.
---|---|---|---
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 Hz and 60 Hz| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital environment.

Warranty

Withings Two (2) Years Commercial Guarantee – Withings BPM Connect | WiFi Smart Blood Pressure Monitor Withings SA, 2 rue Maurice Hartmann, 92130 Issy- les-Moulineaux, France (“Withings”) warrants the Withingsbranded hardware product (“Withings”) against defects in materials and workmanship when used normally in accordance with Withings’ published guidelines for a period of TWO (2) years from the date of original retail purchase by the end-user purchaser (“Warranty Period”). Withings’ published guidelines include but are not limited to information contained in technical specifications, safety instructions or Quick Installation Guide. Withings does not warrant that the operation of the Withings Product will be uninterrupted or error-free. Withings is not responsible for damage arising from failure to follow instructions relating to Withings Product’s use.

Information for users in Canada

This device complies with Part 15 of the FCC Rules and with Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by  Withings may void the FCC authorization to operate this equipment. Radiofrequency radiation exposure information: The radiated output power of the device is far below the FCC radio frequency exposure limits. Nevertheless, the device shall be used in such a manner that the potential for human contact during normal operation is minimized.

Reference to standards

This device complies with the following normative documents: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993  concerning medical devices as amended by Directive 2007/47/EC

EN ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes. Reference to standards contd. | EN ISO 14971: Medical devices – Application of risk management to medical devices. | IEC/EN 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. | EN 1060-3: Non-invasive sphygmomanometers, Part 3: Supplementary requirements for electromechanical blood pressure measuring systems. | EN 1060-4: Non-invasive sphygmomanometer. Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. | IEC/EN 60601-1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. | IEC 80601-2-30: Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. | EN 300 328: Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the Directive (2014/53/EU). | EN 301 489-1: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements. | EN 301 489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements | IEC/EN60601-1-2: Medical electrical equipment: Part 1-2:  General requirements for basic safety and essential performance-collateral standard electromagnetic compatibility | EN 55011: Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement. | FCC part B 15B: Electromagnetic Compatibility. | FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0). | EN ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. | EN ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | EN ISO 10993- 10: Biological evaluation of medical devices. Tests for irritation and skin sensitization | IEC/EN 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard:  Usability | ANSI/AAMI/ ISO 81060-2 Non-invasive sphygmomanometer Part 2: Clinical validation of automated measurement type | EN ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements

2019

| Manufacturer
WITHINGS SA,
2 rue Maurice Hartmann,
92130 Issy-les-Moulineaux, FRANCE
+33141460460

IP22

| Ingress of water or particulate matter
| Dry storage environment
| Storage temperature
| Complies with waste electrical and electronic equipment directive
| Type BF Applied Part (cuff)
| Read this manual before use

Frequency band: 2402 – 2480 MHz
Maximum output power: 4.45 dBm
Withings SA hereby declares that the device Withings BPM Connect is in conformity with the essential requirements and other relevant requirements of Directive 2014/53/EU. The declaration of conformity can be found at: withings.com/compliance.

? Need help?
→ withings.com/support

Withings
Withings BPM Connect | Wi-Fi Smart Blood Pressure Monitor | V1.1 – Sept. 2020
© 2020 Withings SA. All rights reserved.

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