Shenzhen Viatom Technology BP1A Blood Pressure Monitor User Manual

AirBP
Blood Pressure Monitor
User Manual
Model：BP1, BP1A,
BP1S, BP1SA, BP1B, BP1C

Download Phone App AirBP
iOS: App Store
Android: Google Play

Note: if you’ve downloaded the app before, please update it to the latest version.

The Basics

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

Safety

• Precision components are used in the construction of this device. Extremes in temperature, humidity, direct sunlight, shock or dust should be avoided.
• Clean the device and cuff with a dry, soft cloth or a cloth dampened with water and a neutral detergent. Never use alcohol, benzene, thinner or other harsh chemicals to clean the device or cuff.
• Avoid tightly folding the cuff or storing the hose tightly twisted for long periods, as such treatment may shorten the life of the components.
• Do not use in a location with moisture, or a location where water may splash on the device. This may damage the device.
•  Measurements may be distorted if the device is used close to the television, microwave oven, cellular telephone, X-ray or other devices with strong electrical fields.
• Sources of electromagnetic disturbance may affect this device (e.g. mobile telephones, microwave cookers, diathermy, lithotripsy, electrocautery, RFID, electromagnetic anti-theft systems, and metal detectors), please try to stay away from them when making measurements.
•  When reusing the device, confirm that the device is clean.
• Do not disassemble or attempt to repair the monitor or components. This may cause an inaccurate reading.
• To measure blood pressure, the arm must be squeezed by the cuff hard enough to temporarily stop blood flow through the artery. This may cause pain, numbness or a temporary red mark to the arm. This condition will appear especially when a measurement is repeated successively. Any pain, numbness, or red marks will disappear with time.
•  Stop using this monitor and consult your physician if you experience skin irritation or discomfort.
• Consult your physician before using this monitor on an arm with an arterio-venous (A-V) shunt.
• Consult your physician before using this monitor if you have had a mastectomy or lymph node clearance.
• Consult your physician before using the monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.
• People who have a severe circulatory deficit in the arm must consult a physician before using the device, to avoid medical problems.
• Do not self-diagnose the measurement results and start treatment by yourself. Always consult your physician for evaluation of the results and treatment.
• Do not apply the cuff on the injured arm or the arm under medical treatment.
• Do not apply the cuff on an arm while on an intravenous drip or blood transfusion.
• Do not use the device with another medical electrical (ME) equipment simultaneously.
•  Do not use the device where flammable gases such as anesthetic gases are present. It may cause an explosion.
• Do not use the device in the area of HF surgical equipment, MRI, or CT scanner, or in an oxygen-rich environment.
• Use only the approved arm cuff for this device. Use of other arm cuffs may result in incorrect measurement results.
• Rest for at least 5 minutes before taking the measurement.
• Remove tight-fitting or thick clothing from your arm while taking measurements.
• Remain still and do not talk while taking measurements.
•  If the patients’ arm is outside the specified circumference range (22-42cm) that may result in incorrect measurement results.
• The device is not intended for use with neonatal, pregnant, including pre-eclamptic, patients.
• Do not use the device in a moving vehicle (car, airplane).
• When choosing a third-party charging adaptor, select one that complies with IEC 60950 or IEC 60601-1.
•  Dispose of the device, components, and optional accessories according to applicable local regulations. Unlawful disposal may cause environmental pollution.
•  The patient is an intended operator.
• Do not carry out the servicing and maintenance while the device is in use.
•  The patient can safely use all the functions of the device, and the patient can maintain the device by carefully reading Chapter 6.

 Introduction

1.1 Device Description
The blood pressure monitor includes 6 models, including BP1, BP1A, BP1S, BP1SA, BP1B and BP1C. The difference is shown in the table.

Color of
Enclosure| Bright
silver| Dark
silver| Bright
silver| Dark
silver| Blue
gray| Dark
green

The blood pressure monitor includes six models, BP1, BP1A, BP1S, BP1SA, BP1B, and BP1C. It uses the oscillometric method to measure blood pressure, the BP1, BP1A,  P1S, BP1B supports Bluetooth, while BP1B and BP1C don’t. The monitor is comprised of the cuff, main unit, rubber bulb, exhaust valve, and air hose. The blood pressure data is displayed, stored, and reviewed including the systolic and diastolic blood pressure and pulse rate in an application that is installed on a smartphone or the machine itself.

1.2 Intended Use
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for the adult population in-home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

1.3 Contraindications

•  This device is contraindicated for use in ambulatory
  environments.

•  This device is contraindicated for use on aircraft.

1.4 Symbols

disposed of as unsorted municipal waste.
| Dustproof and waterproof level
| Follow operating instructions
| MR Unsafe – keep away from magnetic
resonance imaging (MRI) equipment.
| CE marking
| Authorized Representative in the European
community
| This product complies with the rules and
regulations of the Federal Communication
Commission.
| Stop pumping
| Pulse rate
| Power off
| Battery low
| Charging

Using the Monitor

Download App AirBP
iOS: App Store
Android: Google Play
Note: if you’ve downloaded the app before, please update to the latest version.
3.1 Charge the Battery
Charge the monitor by using the USB cable to connect a USB charger or to the PC USB Port. A fully charge takes 2 hours.
Note: The device cannot be used during charging.

3.2 Applying the Arm Cuff

•  Wrap the cuff around the upper arm, about 1 to 2cm above the inside of the elbow, as shown.
• Place the cuff directly against the skin, as clothing may cause a faint pulse and result in a measurement error.
• Constriction of the upper arm, caused by rolling up a shirtsleeve, may prevent accurate readings.
• Confirm that the artery position mark is lined up with the artery.

How to Sit Correctly

To take a measurement, you need to be relaxed and comfortably seated. Sit in a chair with your legs uncrossed and your feet flat on the floor. Sit with your back and arm being supported. Place your arm on a table so the cuff is level with your heart.

3.4 Single machine measurement
Press the power button to start the machine and enter the interface of waiting for measurement. Then start pumping according to the instructions. When the stop pumping sign is recognized, stop pumping and wait for the measurement result.

3.5 Connect the Monitor to Phone App

1. Turn on the Phone’s Bluetooth.
2. Press the button to power on the monitor, the indicator will be blue-flash that indicates Bluetooth ready-to-connect status.
3. Run the APP AirBP on your smartphone. The app will search the device. Choose your device “AirBP XXXX” in App.

Note:

• Keep the distance between monitor and phone within 1.5 meters.
• DO NOT pair in your phone settings.
• The APP can be downloaded in Google Play or APP Store with the name “AirBP”, which requires a smartphone.

3.6 Measurement
Make sure your phone voice is turned on and the volume is loud enough. Follow the text and voice guide in App to measure.

In-App- >Measure,

• Click the “START” button on the App Measure Screen to start the measurement, and follow the instruction to pump up the cuff by squeezing the bulb at a speed guided in App.
• Stop pumping after you get the instruction, hold the bulb with no squeeze or pressing, waiting for the next instruction. In some cases, if the App judged that the pressure in the cuff is not high enough for the measurement, then an instruction of “pump again” will be issued.
  Note: During the measurement, you should keep still. Otherwise, the blood pressure readings may be inaccurate. Stop pumping when the indicator blue-red blinks (pressure is too high).

3.7 After Measurement

• The blood pressure readings will appear on the app interface when the measurement is finished. You need to manually press the exhaust valve to deflate the cuff. If you forget to deflate manually after measurement, the monitor will automatically deflate the cuff slowly, and it takes less than 30s to finish the whole automatic deflation.
•  On result page, you can add the user name or ID (help you manage multiple users’ data), add a note, share the results or delete it.
•  If the monitor detects the irregular heartbeat, and the corresponding symbol will display below the PR value.

Note: The device turns off automatically in two minute if no working.

3.8 Review the history

• In App History, you can check the history list. You can select a specific ID or All.

Trouble Shooting

setting menu.
The phone doesn’t support the Bluetooth 4.0 BLE phone.| Change to a compatible
The monitor doesn’t

response to the button press.

| The monitor is

running in an unexpected status.

| Reset the device by press and hold the button for 5s.
Cannot get blood pressure readings.| The measurement is interrupted by arm movement or unexpected bulb squeeze.| Keep arm still and don’t squeeze the bulb during deflating-measure phase.
There is an over-leakage of press| Check if the hose connection is loose.

Accessories

Arm size: The circumference at the biceps.

Classifications

Degree protection against electrical shock| Type BF
Environmental
Item| Operating| Storage
Temperature| 5 to 40°C| -25 to 70°C
Relative humidity

(non-condensing)

| 10% to 95%| 10% to 95%
Barometric| 700 to 1060 hPa| 700 to 1060 hPa
Degree of dust & water resistance| IP22
Physical
Size| 68mm(long)×25mm(diameter)

(main unit)

Weight| Less than 30 g (main unit)
Cuff size| Adult cuff: 22-42cm
Wireless connectivity| Built-in Bluetooth 4.0 BLE
Power Supply
Charge input| Micro USB, DC5V
Battery type| Rechargeable lithium-polymer battery 3.7Vdc, 130mAh
Charge time| 2 hours
Blood Pressure
Technology| Oscillometric Method
Measuring Range| 0 – 299 mmHg
DIA Range| 40-150 mmHg
SYS Range| 60- 230 mmHg
Pressure measurement accuracy| ±3mmHg
Pulse rate range| 40 to 200 bpm
Pulse rate accuracy| ±2 bpm
Mobile APP

APP function| Guide measure, display results, store and share results
IOS software / hardware| IOS 12.0, iPhone launched subsequently
Android software / Hardware| Android 6.0 or above, mobile phone with Bluetooth 4.0BLE
Bluetooth RF
Frequency range| 2.402 – 2.480 GHz
Durable period for Monitor
Expected service life| 2 years

Maintenance and Cleaning

6.1 Maintenance
To protect your device from damage,

• Store the device and the components in a clean, safe location.
• Do not wash the device and any components or immerse them in water.
• Do not disassemble or attempt to repair the device or components.
• Do not expose the device to extreme temperatures, humidity, dust or direct sunlight.
• The cuff contains a sensitive air-tight bubble. Handle this carefully and avoid all types of straining through twisting or buckling.
• Clean the device with a soft, dry cloth. Do not use petrol, thinners or similar solvent. Spots on the cuff can be removed carefully with a damp cloth and soapsuds. The cuff must not be washed!
• Do not drop the instrument or treat it roughly in anyway. Avoid strong vibrations.
• Never open the device! Otherwise the manufacturer calibration becomes invalid!

Cleaning

• Clean the device with a soft, dry cloth with 70% alcohol.
• Do not use petrol, thinners or similar solvent.
• Clean the cuff carefully with cloth soaked 70% alcohol.
• The cuff must not be washed!
• Clean on the monitor and the arm cuff, and then let it air dry.

Disposal

Batteries and electronic instruments must be disposed of in accordance with the locally applicable regulations, not with domestics waste.

FCC Statement

BP1、BP1A FCC ID: 2ADXK-8611
BP1S、BP1SA FCC ID: 2ADXK-8612
1. 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.
(2) This device must accept any interference received, including interference that may cause undesired operation.
Note: The grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the user’s authority to operate the equipment.
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
Note: Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
RF Exposure
The monitor complies with FCC radiation exposure limits set forth for an uncontrolled environment.

Reference to Standards

IEC60601-1:2005+A1:2012

IEC60601-1-2:2014
IEC/EN60601-1-11:2015
IEC80601-2-30:2009+A1:2013
ISO81060-2:2013
FCC part 15

Plot of DBP difference between the paired blood pressure determinations against the reference diastolic measurement

Plot of SBP difference between the paired blood pressure determinations against the reference systolic measurement

The Bland-Altman Plots originated form clinical test, which data was gathered from cadult healthy volunteers in a controlled study.
The clinical test applies for the BP1S device with one cuff size, comparing with Mercury sphygmomanometer.
The result met the criteria specified in ISO 81060-2:2013; In addition, there were no reported adverse effects during these investigations.

 Electromagnetic Compatibility

The device meets the requirements of IEC 60601-1-2. Warnings and Cautionary Advices

•  Using accessories other than those specified in this manual may result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
• The device or its components should not be used adjacent to or stacked with other equipment.
• The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
•  Other devices may interfere with this device even though they meet the requirements of CISPR.
• When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.
• Portable and mobile communication equipment may affect the performance of this device.
• Other devices that have RF transmitter or source may affect this device (e.g. cell phones, PDAs, and PCs with wireless function).

EMC table information is listed on our website:
https://api.viatomtech.com.cn/documents/2017/emc_en.pdf

Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road,
Block 67, Xin’an Street, Baoan District, Shenzhen, 518101, Guangdong, China www.viatomtech.com

WellKang Ltd
The Black Church, St. Mary’s Place,Dublin 7, D07 P4AX, Ireland

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