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.
Contents 1. The Basics...........................................................1 2. Introduction.........................................................3 3. Using the Monitor...............................................6 4. Accessories....................................................... 12 5. Specifications....................................................13 6. Maintenance and Cleaning................................14 7. FCC Statement..................................................16 8.
1. 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.
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.
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. 2. Introduction 1.
The blood pressure data is displayed, stored and reviewed including the systolic and diastolic blood pressure and pulse rate in an application which is installed in smart phone or the machine itself. 1.2 Intended Use The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).
Date of manufacture SN Serial number Indicates a medical device that is not to be disposed of as unsorted municipal waste. IP22 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.
3. 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.
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 line up with the artery. 3.3 How to Sit Correctly To take a measurement, you need to be relaxed and comfortably seated.
Measuring Result 3.5 Connect the Monitor to Phone App 1. 2. 3. Turn on the Phone Bluetooth. Press the button to power on the monitor, the indicator will be blue-flash that indicates Bluetooth ready-to-connect status. Run the APP AirBP on your smartphone. App will search the device. Choose your device “AirBP xxxx” in App. Note: Keep the distance between monitor and phone within 1.5 meter. DO NOT pair in your phone settings.
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.
3.7 After Measurement The blood pressure readings will appear on the app interface when the measurement finished. You need to manually press 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 for finishing the whole automatic deflation. On result page, you can add the user name or ID (help you manage multiple users data), add note, share the results or delete it.
3.8 Review the history In App History, you can check the history list. You can select a specific ID or All.
3.9 Trouble Shooting Problem The monitor cannot be connected to the phone The monitor doesn’t response to the button press. Cannot get blood pressure readings. 4. Possible Cause The phone Bluetooth is OFF The phone doesn’t support the Bluetooth 4.0 BLE The monitor is running in an unexpected status. The measurement is interrupted by arm movement or unexpected bulb squeeze. There is an over-leakage of press Recommended Action Turn on the phone Bluetooth from the setting menu. Change to a compatible phone.
5.
Mobile APP APP function IOS software / hardware Guide measure, display results, store and share results IOS 12.0, iPhone launched subsequently Android 6.0 or above, mobile phone with Bluetooth 4.0BLE Android software / Hardware Bluetooth RF Frequency range 2.402 – 2.480 GHz Durable period for Monitor Expected service life 2 years 6. Maintenance and Cleaning 6.1 Maintenance To protect your device from damage, • Store the device and the components in a clean, safe location.
way. Avoid strong vibrations. • Never open the device! Otherwise the manufacturer calibration becomes invalid! 6.2 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. 6.
7. 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.
8.
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 adult 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.
9. 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.
