viatom AirBP 2 Blood Pressure Monitor User Manual

AirBP 2
Blood Pressure Monitor

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.

• 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 the measurement is repeated successively.

• 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 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. The 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 are 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.

• 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.

Introduction

2.1 Device Description
The blood pressure monitor includes two models, BP1 and BP1A. It uses the oscillometric method to measure blood pressure with Bluetooth technology. The monitor is comprised of a cuff, the main unit, a rubber hand pump, an exhaust valve, and an air hose. The blood pressure data is displayed, stored, and reviewed including the systolic and diastolic blood pressure, as well as pulse rate in an application that is installed on a smartphone.
2.2 Intended Use
The subject device is intended to measure diastolic and systolic blood pressure, as well as the pulse rate of the adult population in-home and hospital facilities by using a non-invasive, oscillometric technique with a single upper arm cuff (22-42 cm).
2.3 Contraindications
The use of this device is prohibited in ambulatory environments. The use of this device is prohibited on aircraft.
2.4 Symbols

SN

| Serial number

| Indicates a medical device that is not to be disposed of as unsorted municipal waste.
| Follow Instructions for Use.
| Type BF Applied Part
| No alarm system
| MRI unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.

IP22

| Resistant to liquid ingress

0197

| CE marking
| Authorized Representative in the European community
| UKCA marking
| Authorized Representative in the United Kingdom
| This product complies with the rules and regulations of the Federal Communication Commission.

Using the Monitor

Download the App
AirBP iOS: App Store
Android: Google Play
Note: if you’ve downloaded the app before, please update to the latest version.
3.1 Charging the Battery
Charge the monitor by using the USB cable to connect a USB charger or to the PC USB Port. It takes 2 hours to fully charge the monitor In the App, you can check the battery level.
Note: The device cannot be used while charging.
3.2 Beep indications

3.3 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.

3.4 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 both your back and arm being supported. Place your arm on a table so the cuff is level with your heart. 3.5 Connect to the App

1. Turn on the Phone’s Bluetooth.
2. Press the button to power on the monitor.
3. Open the Air BP APP on your smartphone. The App will search for the device. Choose your device “AirBP xxxx” in the App.

Note:

• Keep the monitor and the phone within 1.5 meters of each other.
• 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 speakers are turned on and the volume is loud enough. Follow the text and voice guide in the App to use.
In-App- >Measure,

• Follow the instructions to inflate the cuff by squeezing the pump at the rate indicated in the App.
• Stop pumping according to the instructions of the App, hold the pump without squeezing it, and wait for further instructions. In some cases, if the App senses that the pressure in the cuff is not high enough for use, then the user will be instructed to “pump again”.

Note: During use, you should keep your body still. Otherwise, the blood pressure readings may be inaccurate.
Stop pumping when the screen of the monitor show “Out of Range” and beep 3 short beeps (pressure is too high).
3.7 After the Test

• The blood pressure readings will appear on the App interface when the test has finished. You need to manually press the exhaust valve to deflate the cuff. If you forget to deflate the cuff manually after use, the monitor will automatically deflate the cuff, which takes less than 30s for full automatic deflation.
• On the results page, you can add user names and ID’s to help you manage multiple users’ data, add notes, share results or delete them.
• If the monitor detects an irregular heartbeat, then the corresponding symbol will display below the PR value.

Note: The device will turn off automatically after two minutes if not working.
3.8 Reviewing the History
3.9 Measurement without App
After you have learned how to use the App for measurement. You can also perform measurements without connecting to the app when you do not need to store data.

1. Refer to sections 3.3 and 3.4 to wear the cuff.
2. Inflate the cuff by squeezing the pump at the similar rate you have learned in the App.
3. Stop pumping when the monitor beep twice, hold the pump without squeezing it and wait for further instructions. In some cases, if the monitor senses that the pressure in the cuff is not high enough for use, then the user will be instructed to “Pump” again.
4. After the test. The blood pressure readings will appear on the screen of the monitor when the test has finished. You need to manually press the exhaust valve to deflate the cuff.

Note:

• If you want to start a new measurement, you can short press the power button of the monitor. Or pump
• When the monitor is not connected to App for measurement, the results will not be saved.

3.10 Trouble Shooting

Problem

| Possible Cause|

Recommended Action

---|---|---
The monitor cannot be connected to the phone| The phone’s Bluetooth is OFF| Turn on the phone Bluetooth in the settings menu.
---|---|---
The phone doesn’t support the Bluetooth 4.0 BLE| Change to a compatible phone.
The monitor doesn’t respond when pressing the button.| The monitor is running in an unexpected status.| Reset the device by pressing and holding the button for 5s.
Cannot get blood pressure readings.| The measurement is interrupted by arm movement or unexpected bulb squeezing during use| **** Keep the arm still and don’t squeeze the bulb during deflation.
There is pressure leakage.| Check the hose connection to see if it is loose.

Accessories

Model

|

Description

---|---
CU-10| Adult, arm size 22-42cm
540-00240-00| MICRO USB charger cable

 Specifications

Classifications

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
Charger input| Micro USB, DC5V
Battery type| Rechargeable

lithium-polymer battery

Estimated charging time| Approximately 2 hours
Blood Pressure
Technology| Oscillometric method
Cuff pressure Range| 0 – 300 mmHg
Pressure measurement accuracy| ±3mmHg
Pulse rate range| 40 to 200 bpm
Pulse rate accuracy| ±2 bpm
Mobile APP
** APP function| Guided measurement, displayed results, stored and shared results
---|---
IOS software/hardware| IOS 12.0, iPhone
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

6.1 Maintenance

To protect your monitor from damage, store the monitor and the components in a clean, safe location.
Caution: DO NOT disassemble or attempt to repair this monitor or other components. This may cause inaccurate blood pressure readings.
6.2 Cleaning

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and the arm cuff and then wipe them with a dry cloth.
• When electrodes are dirty, use a soft cloth or cotton swab moistened with an alcohol-based sanitizer to clean the electrodes.
• Do not use gasoline, thinners, or similar solvents to clean your monitor and arm cuff or other components.

6.3 Storage

Keep your monitor and other components in the storage case when not in use.

• Store your monitor and other components in a clean, safe location.
• Do not store your monitor and other components in locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors, such as bleach.

Disposal

7. Electromagnetic Compatibility
The device meets the requirements of EN 60601-1-2.

• Using accessories other than those specified in this manual may result in increased electromagnetic emissions or decreased electromagnetic immunity for the device.
• 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 CISPR requirements.
• When the inputted signal is below the minimum amplitude provided in the technical specifications, erroneous measurements could result.
• Portable and mobile communication equipment may affect device performance.
• Other devices that have RF transmitters or sources may affect this device (e.g. cell phones, PDAs, and PCs with wireless functionality).

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

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