WITHINGS BPM Connect PRO Cellular BO Monitor User Manual

WITHINGS BPM CONNECT PRO
Regulatory information

**IMPORTANT NOTICE

**

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 Pro.

Instructions for use of BPM Connect Pro are described in the Onboarding Guide leaflet provided with this regulatory information leaflet

**INTENDED USE

**

The BPM Connect Pro 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).

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 measurement after bathing, drinking alcohol, smoking, exercising or eating.
• Do not immerse the arm cuff in water.
• Do not use with a pacemaker, a defibrillator or other electric implant.
• Use on adults only.
• Do not use on children or pets.

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 USE

**

This blood pressure monitor is intended to be used in a home environment. 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 such as atrial or, ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia or re- nal disease, patient motion, trembling, shivering 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 patient is an intended operator. Parts in contact with the skin: cuff. Measurements can be affected by extreme temperatures, humidity & altitude

• 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.
• 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.
• When unexpected blood pressure reading is obtained, please contact the customer support.
• The continuous cuff pressure due to connection tubing kinking may cause the effect of blood flow interference and resulting harmful injury to the patient.

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 4 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 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.

TROUBLESHOOTING

Check the cuff position, fasten the cuff correctly and remeasure blood pressure again. If the issue persists, please contact the customer service number of your health program in which you are enrolled.
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

SPECIFICATION & TECHNICAL DATA

40 to 130 mmHg. SYS 60 to 230 mmHg
Measurement range (pulse)| 40 to 180 beats/min
Pressure sensor accuracy| Within +- 3 mmHg or 2% of reading
Accuracy (pulse)| Within +-5% of reading
Sensor| Semiconductor pressure sensor
Operating conditions| 5 to 40°C, 15 to 90% RH, atmospheric 86Kpa-106kpa, altitude: 2000m
Storage and transport conditions| -20 to 60°C.10 to 95% RH. atmospheric 86Kpa- I06kpa, altitude: 2000m
Arm type| Use on left arm
Power source| 5V 1A
Weight| Approx. 245g
Accessories| USB cable. Onboarding guide, Regulatory information leaflet
Product life| 3 years
Wireless transmission| Wi-R, BLE, LTE Cat-ml
Typical operation time| 6 months and 1000 cycles under normal use and good network coverage

electronic recycling
| Follow instructions for use
| Direct current
| The CE labelling certifies thet the product complies with the essential requirements of Directive 2014/53/ EU.
| RCM marking

**CLASSIFICATION

**

Power by: Internally powered by a lithium ion battery

Applied Part level: Type BF (Body Floating)
IP Protection level: IP22
Mode of operation: Continuous Operation

WARNING:

• No modification of this equipment is allowed.
• Potential allergic reaction may occur due to skin irritation.
• Keep away from children, pets, and pests after each use.
• Strangulation may occur due to USB cable.
• Do not open/disassemble the product for battery replacement. When charging, the device will display the battery percentage if the user turns on the device.

Portable RF communications equipment Cincluding peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Withings BPM Connect Pro, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Activate the device at least once every three months to avoid battery leakage. Users must not allow SIP/SOPs and the patient to come into contact at the same time. In case of serious incident that has occurred, please contact the manufacturer and local authorities immediately. Please contact the manufacturer when in need of assistance, setting up, using or maintaining the device or to report unexpected operation or events. Regarding the application of the cuff and its pressurization on any timb where intravascular access or therapy, or an arterio-venous (A-V) shunt is present because of temporary interference with blood flow and could result in injury to the patient. Any blood pressure reading can be affected by the measurement site, the position of the patient (standing, sitting, lying down), exercise, or the patient’s physiologic condition. The performance of the automated sphygmomanometer can be affected by extrernes of temperature, humidity, and altitude. Please follow the manufacturer instruction to use the product.

FCC STATEMENT

FEDERAL COMMUNICATION COMMISSION INTERFERENCE STATEMENT

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 of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet ona circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this 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 in- terference that may cause undesired operation.

IMPORTANT NOTE:
RADIATION EXPOSURE STATEMENT:

The product complies with the US portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.

This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Country Code selection feature to be disabled for products marketed to the US/CANADA. This equipment should be installed and operated with minimum distance 5mm (between the radiator & your body).

Industry Canada statement
This device contains licence-exempt transmit- ter(s)/receiver(s) that comply with Innovation. Science and Economic Development Canada’s licenceexempt RSS(s). Operation is subject to the following two conditions:

1. This device may not cause interference
2. This device must accept any interference, including interference that may cause undesired operation of the device

Caution:
The device for operation in the band 51S0-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems;

Radiation Exposure Statement:
The product comply with the Canada portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manua!. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.

This equipment should be installed and operated with minimum distance of 5mm between the radiator & your body.

IC: T4T1A-WPMO6
Contains: IC: 12732A-GMO2SA

FCC ID: XNAWPMO6
Contains FCC ID: 2AAGMGMO2SA

**EUROPE – EU DECLARATION OF CONFORMITY

**

Hereby, Withings declares that the radio equipment type of Withings BPM Connect Pro is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: withings.com/compliance.

**DECLARATION – ELECTROMAGNETIC EMISSIONS AND IMMUNITY

**

For equipment and systems that are not life-supporting and are specified for use only in a shielded location

Guidance and manufacturer’s declaration-electromagnetic. emissions
This cellular Smart Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the cellular Smart Blood Pressure Monitor should ensure that it is used in such an environment,

Emissions test| Compliance| Electromagnetic environment guidance
---|---|---
CE emissions CISPRIN| Group 1| The cellular 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 ernissions CISPRIN| Class B
Harmonie emissions IEC 61000-3-2| Not applicable| This cellular Smart Blood Pressure Monitor is suitable for use in alt – 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/Filelkee emissions IEC 61000-3-3| Not applicable

The cellular Smart Blood Pressura Monitor declaration electromagnetic immunity
This cellular Smart Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the cellular Smart Blood Pressure Monitor should ensure that it is used in such an environment.

Immunity test| lec 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted RFIEC 61000-4-6| 3 Vrms 180 kHz to 80 MHz| N/A| N/A
Radiated RF (EC 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 oceur in the vicinity of equipment marked with the following symbol.
Electrostatic discharge (ESDIEC 61000-4-2)| Contact: 28 kV:Air, ±2 kV, ±4 kV, ±8 kv, r ±15 kV| Contact: ±8kv 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
IEC 61000-4-4 1kV for input/output lines| 2KV for power transient/burstsupply lines| N/A| The main power quality should be similar to that of 8 typical commercial or hospital environment.
Surge IEC 61000-4-5| 1kV differnetialine (s)to mode 2 kV common mode| Line(s) : ±1kV 100 kHz repetition frequency| The main power quality shouid be similar to that of a typical commercial or hospital environment.
Voltage : dips, short ¢ interruptions = and voltage – variationson power supply i input lines IEC « 61000-4-11 :(4| 5% UT(95% dip in UT) for 0.5 cycle, 40 % UT (60% dip in UT) for 5 cycles, -70% UT(Z0 % dip In UT) for 25 cycles, 5% UT (95% dip In UT) for 5 sec| N/A| 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, itis recommended that the equipment or system be powered from an unin terruptible power supply or a battery.
Power frequen-: cy (50/60 Hz) « magnetic fletd IEC 61000-4-8| 30 A/mm SO Hz 7 60 Hz| 30 A/m SOHz and 60 Hz ‘| Power frequency magnetic flelds should be at levels characteristic of a typical location in 8 typical commercial or hospital environment.

NOTE: UT is the a.c. Main voltage prior to application of the test level

DISPOSAL

Actuation of European directive 2012/19/EU, for reduction in use of dangerous substances in the elecrtic 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 not be disposed of with dometic waste.

At the end of the device’s useful life, the user must deliver it to a collection center for electric and electronic garbage, or return it to the retailer when purchasing a new device. Disposing of the product separately prevents possible negative environmental and health consequences deriving from inadequate disposal. It also allows the recovery of materials it is composed of to save energy and resources and avoid negative effects to the environment and health. In case of abusive disposal of device by

sements in compliance with current standards. The device and its parts must be disposed of as appropriate, in accordance with national or regional regulations.

Version 1.0 April 2021

**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 | 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. Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation|The device should not be used adjacent to or stacked with other equipment and that if sariiacont mr stacked 11c0 ic neceacecary 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.

WARRANTY

Your BPM Connect Pro scale is guaranteed to be free of material and workmanship defects for a period of two (2) years from the date of receipt. This warranty does not apply to the cellular data transmission that requires a data plan subscribed by the entity that has provided you with this blood pressure monitor. Reference to standards

Europe – EU Declaration of Conformity This device complies with the essential requirements of the MDD (Medical Devices Directive) 93/42/EEC as amended by the 2007/47/EC.
The declaration od conformity can be found at: withings.com/compliance.

SAR
This product complies with EU requirements regarding restriction of exposure of persons to radio-frequency energy (RF) emitted by telecommunication and radio devices as it is designed and manufactured in such a way as not to exceed the exposure limits indicated by the European Union Commission. The permitted SAR limit for the general population is 2.0 W/Kg. This limit guarantees an ample safety margin that protects all persons regardless of age and health condition.

Software version: FW 181
Withings website www.withings.com

MODE| Frequency band (MHz)| Maximum
output power (dBm)
---|---|---
BT EDR| 2402 -2480| 1 dBm. 2.4G
BT LE| 2412 – 2472| 8dBm. 2.4G
LTE| 1710 – 1785| 23 dem
LTE| 880 – 915| 23 dam
LTE| 832 – 862| 23 cfBm
LTE| 703 – 748| 23 dam
WLAN| 2400| 20 dam

Distributed by:
Withings Inc., 179 South Street, Floor 5
Boston, MA 02111 USA

| Manufacturer:
WITHINGS, 2 rue Maurice Hartmann,92130 Issy-les-Moulineaux, FRANCE Ingress of water or particulate matter+33141460460
---|---
| Ingress of water or particulate matter
| Dry storage environment
| FCC ID: XNAWPMO6 Contains FCC ID: 2AAGMGMO2SA
| Storage temperature
| Complies with waste electrical and electronic equipment directive
| Type BF Applied Part (cuff)
| Read this manual before use
| California Energy Commission approval

Withings BPM Connect Pro
V1.1 – May 2021
© 2021 Withings. All rights reserved
2 rue Maurice Hartmann
92130 Issy-les-Moulineaux France

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