BPM Core - Blood pressure monitor WITHINGS - Free user manual and instructions

USER MANUAL BPM Core WITHINGS

Before each measurement, follow these requirements: - Use the product on the left upper arm - Rest 5 minutes before the measurement - Sit down in a comfortable position, legs uncrossed, feet flat on the floor, arm and back supported. - Do not speak or move during the measurement - You can wear one layer of clothes but it should not cover your left arm. The electrodes should be in contact with the skin. - Take the measurement in a calm and quiet areaHow to take a measurement Comment prendre une mesure

In order to use your BPM Core, you need an iOS (10.0 or higher) or Android (6.0 and higher) device to install it. Thereafter, the product can be used in stand-alone, thanks to the Wi-Fi and Bluetooth® connections. Important safety information Consult your doctor during pregnancy, or if you suer from arrhythmia and arteriosclerosis. Please read this section carefully before using the Smart blood pressure monitor, with ECG & digital stethoscope. Intended use The BPM Core is a digital monitor intended for use in measuring blood pressure, heart rate, to record a one derication ECG to detect atrial fibrillation, and uncover valvular heart diseases (aortic stenos, aortic regurgitation, mitral stenosis). The device is intended to be used in a human adult population with an arm circumference between 9 inches to 17 inches (22 cm to 42 cm). The BPM Core is a medical device. Contact your physician if hypertensive values, AFib or VHD are indicated. General safety and precautions - Do not forcibly bend the arm cu. - Do not inflate the arm cu 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 cu 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. Important information

Android is a trademark of Google Inc. iOS is a trademark of Apple Inc.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. Cu 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 aect the performance of the automated sphygmomanometer and/ or its blood pressure reading. This device is a precision measuring equipment liable to be understood by lay user but it still should be handled with care. A long exposure of the device to lint, dust or sunlight might reduce its life time or damage it. Damaged cu or sensor might lead to incorrect measurements. No usage for USB port. The user is an intended operator. Parts in contact with the skin: cu and electrodes. Measurements can be aected by extreme temperatures, humidity & altitude. - Do not leave the blood pressure monitor unattended with infants or persons 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 a cellular phone near the device. - Do not use the device with the USB cable plugged. - Improper continuous pressure of cu or too frequent measurements may interfere blood flow and result harmful injury to the users. Check if the use of the device does not result in prolonged impairment of your blood circulation. - Do not apply the cu over the users’ arm bearing a wound or medical treatment and so on, as this can cause further injury. - Cu should be used on the arm on the side of a mastectomy. - Use of the device can temporarily cause loss of function of simultaneously used equipment on the same limb. Caution 17Cleaning - Do not use an alcoholic-base or solvent agent to clean the device - Clean the device with a soft and dry cloth - The dirt on the cu can be cleaned by a moisten cloth and soap - Do not flush the device and cu with much water - Do not dismantle the device or disconnect the cu or try to repair by yourself. If any problem happens, refer to the distributor - Do not operate the device under severe environment of extreme temperature or humidity, or direct sunshine - Do not shake the unit violently - Do not submerge the device or any of the components in water - Do not let the device under strong shocks, 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 dierent from the usage conditions indicated in this document, please wait 30 minutes before taking a measurement. Maintenance If you can’t fix the problems using the troubleshooting instructions , request service from your dealer. Manufacturer will make available on requested circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist manufacturer’s sta or authorized representative for 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. After use 18Error messages

Error message Causes Countermeasures 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 appli- cation 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 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 measurement.

2. If the problem occurs again, please contact

Error message Causes Countermeasures Check that the Blood Pressure Monitor is correctly positioned on your arm and that mea- surement is performed in good conditions. - User movement, or not relaxed, or talking … - Cuff is not correctly fastened - Cuff broken - Pump or valve failure - Pressure overflow - Noise interference - User movement, or not relaxed, or talking … - User special characteristics - Battery level is too low

1. Check that the Blood Pressure Monitor

is correctly positioned on your arm and that measurement is performed in good conditions.

2. Low battery level. Load your BPM Core with

3. If user has special characteristics, please

contact your physician.

4. If the problem occurs again, please contact

customer service. Low battery level. Battery level is too low. Load the device with the provided charging cable.Troubleshooting

Problem Remedy No results for the ECG measurement Ensure that the three electrodes are in direct contact with the skin. If yes, clean them with a tissue A valvular heart disease analysis cannot be done Check the stethoscope position, the flat surface must be in contact with the chest. Ensure that you did the required number of measurements in order to get a readings The inflation action cannot be done or the air pressure cannot rise

1. Check the cuff position and fasten the cuff correctly ad remeasure the pressure again

2. Check the blood pressure monitor connection to the iOS or Android device

The low battery icon is displayed on the device Reload 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 yourself and sit down

3. Keep the cuff and heart at the same level during the measurement period

4. Keep silent and still during measurement

5. If the patient has sever heart beat problem, then the blood pressure may not be read correctly

Under normal measuring circumstance, the reading at home is different from that of the clinics or each measurement has various reading

1. The variation is due to the different environments

2. The blood pressure is changing according to the physiological or psychological status of

3. Atrial fibrillation may not be permanent at early stage

4. Show your recorded values to your physicianSpecifications Technical data

Product description: Digital automatic Blood Pressure Monitor with EKG and Heart sounds sensor Model: WPM04 Blood pressure measurement method: Cuff oscillometric method Cuff inflation: Automatic inflation with air pump at 15 mmHg/s Pressure sensor: Gauge sensor Measurement range (pressure): 0 to 285 mmHg, DIA 40 to 130 mmHg, SYS 60 to 230 mmHg Measurement range (pulse): 40 to 180 beats/min Accuracy (pressure): 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: -25 to 70°C, 10 to 95% RH, atmospheric 86Kpa~106kpa, altitude: 2000mArm type: Use on left arm. Power source: 3,6 VDC Lithium ion battery Weight: Approx. 430g 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 22 – 2324 At the end of devices useful life, the user must deliver it to the able collecting centers for electric and electronic garbage, or give 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 it’s made up in order to obtain an important saving of energy and resources and to avoid negative eects to the environment and health. In case of abusive disposal of device by the user, will be applied administrative endorsements in compliance with current standard. The device and its parts is mared with regard to disposal, as appropriate, in accordance with national or regional regulations. Version 1.0 April 2019 Disposal Actuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for 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.FCC Statement

Federal Communications Commission (FCC) Statement

You 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 o 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 dierent 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.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 aect 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 aect Medical Electrical Equipment. The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the unit. RF Statement Guidance and manufacturer’s declaration-electromagnetic emissions The Smart blood pressure monitor, with ECG & digital stethoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart blood pressure monitor, with ECG & digital stethoscope should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance CE emissions CISPR11 Group 1 The Smart blood pressure monitor, with ECG & digital stethoscope 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

Not applicable The Smart blood pressure monitor, with ECG & digital stethoscope 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 domesticpurposes. Voltage fluctuations/ Flicker emissions

Not applicable 26The Smart blood pressure monitor, with ECG & digital stethoscope declaration electromagnetic immunity The Smart blood pressure monitor, with ECG & digital stethoscope system is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart blood pressure monitor, with ECG & digital stethoscope system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted

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 emissions and immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded location 27Declaration – electromagnetic immunity The Smart blood pressure monitor, with ECG & digital stethoscope system is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart blood pressure monitor, with ECG & digital stethoscope system should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge

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 Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 1 kV differential mode 2 kV common mode N/A N/A A Mains power quality should be that of a typical commer- cial or hospital environment. Declaration – electromagnetic emissions and immunity for equipment and systems that are not life-supporting and are specified for use only in a shielded locationVoltage dips, short interruptions and voltage variations on power supply input lines