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Summary of Contents for Avita BPM32-GLB
- Page 1 Wrist Type Blood Pressure Monitor BPM32-GLB RoHS REACH MDSS GmbH Schiffgraben 41 30175 Hannover Germany AViTA Corporation 9F., No. 78, Sec. 1, Kwang Fu Rd., San Chung Dist., New Taipei City 24158, Taiwan, China. China, AViTA(WUJIANG) Importer Distributor...
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Page 2: Table Of Contents
INSTRUCTION MANUAL Please read this instruction manual carefully before operating this unit Contents Intended Use ......................1 Important Information Before Use ................. 6 Blood Pressure Monitor Features ................11 Description of LCD Display ..................12 Battery Installation ....................14 Setting the Date and Time ..................15 Applying Your Cuff ....................17 Measurement of Pulse Rate and Blood Pressure ...........19 Hypertension Indicator ..................21... - Page 3 Troubleshooting ....................32 Cleaning and Disinfecting ..................35 Technical Specification ...................36 EMC Tables ......................38 Explanation of Symbols ..................42...
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Page 4: Intended Use
Intended Use The product automatically measures human beings Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx.4.9 ~ 8.3 inches) and for home use. - Page 5 lead to injury. Never use the cuff on the arm to which these conditions apply. If you are prone to hematoma, do not put on a cuff nor carry out a blood pressure measurement. Consult your doctor before measuring your own blood pressure if… If you have any of the following conditions, it is essential you ...
- Page 6 Caution: Beware of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure. Do not use the device at the same time as other medical electrical devices (ME equipment). This could lead to a malfunction of the device and/or an inaccurate measurement.
- Page 7 minimum storage and transport temperatures and is placed in an environment with a temperature of 20 °C, it is recommended that you wait approx. 2 hours before using the measuring device. Please note that when inflating the cuff, the functions of the limb in ...
- Page 8 or therapy, or an arteriovenous (AV) shunt. Do not use the cuff on people who have undergone a mastectomy. Do not place the cuff over wounds as this may cause further injury. High BMI health condition users may result varied. ...
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Page 9: Important Information Before Use
Users shall notify serious adverse event to the central competent authority or its commissioned agency, legal entity, or manufacture. If the irregular heart beat symbol appears often, it may indicate heart rhythm disorders. Please consult your doctor in that case. Severe heart rhythm disorders may sometimes produce lead to measurements or reduce the measurement accuracy. - Page 10 2. Perform your measurement in a quiet place. You should be seated in a relaxed position. 3. Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your measurement until the feeling subsides.
- Page 11 by your physician to get an accurate indication of change in your true blood pressure. 9. Wait a minimum of 15 minutes between readings to allow for the blood vessels to return to normal. The wait time may vary depending on your individual physiological characteristics. 10.
- Page 12 (every 3 years). To obtain the service please contact AViTA Corp. for the address of the repair location. Enclose with the Proof of Purchase. Include $10.00 USD for the return shipping and handling.
- Page 13 maintaining or to report unexpected operation/adverse events please contact manufacturer or local representative for further assistance.
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Page 14: Blood Pressure Monitor Features
Blood Pressure Monitor Features 1. Hypertension Indicator(WHO indicator) 2. LCD Display 3. Memory Recall Button 4. Power Button 5. Advance Button 6. Retrogress Button... -
Page 15: Description Of Lcd Display
Description of LCD Display Memory sets Memory Symbol Average Measurement Symbol Low Battery Symbol Inflation Symbol(Positioning Indicator Up) Deflation Symbol(Positioning Indicator Down) Date... - Page 16 Time Digital Display Heartbeat Symbol Hypertension Indicator Irregular Heart Beat Symbol Positioning Indicator “OK”...
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Page 17: Battery Installation
Battery Installation Low battery warning: It is necessary to replace the batteries when the Low Battery symbol appears on the display, or when the display does not turn on after the POWER button is pressed. Replacing the Battery: - Slide the battery cover on the bottom of the monitor. - Insert or replace 2 x 1.5 V AAA batteries into the battery compartment, ensuring to match the indicated polarity symbols. -
Page 18: Setting The Date And Time
and heat. - It is recommended to remove the batteries if the unit will not be used for an extended period of time. - Batteries must be disposed of in accordance with local environmental and institutional policies. - Remove the battery during extended storage. - It is recommended not to use rechargeable, unqualified or different spec battery may damage the device or cause circuit shortcut. - Page 19 confirm the “Year”. (3) Next, the “Month” will blink. Repeat steps 2 to set the “Month” and “Day”, then “hour”, then “Minute”. (4) After setting the minute, the unit will automatically exit out or press power button the date/time setting mode and briefly show the word OFF before shutting down.
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Page 20: Applying Your Cuff
Applying Your Cuff It is important to avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If for any reason you are unable to or should not use your left wrist, please modify the instructions for cuff application to your right wrist. Your physician can help you identify which wrist is best for you to take measurements from. - Page 21 of your wrist facing you. - Adjust the cuff approx. 1 cm from the edge of the head of the ulna bone. - The cuff should fit comfortably, yet snugly around your wrist. - Blood pressure naturally varies from one wrist to the other;...
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Page 22: Measurement Of Pulse Rate And Blood Pressure
Measurement of Pulse Rate and Blood Pressure Please read the preceding portions of this manual prior to taking your first reading. Rest your elbow on a solid surface with your palm facing upward. Elevate your wrist so that the cuff is at the same level as your heart. - Page 23 The measurement starts automatically once the correct position has been obtained. Do not move or speak while the measurement is in progress. The cuff will automatically begin to inflate, with the display showing the increasing pressure in the cuff. As the pressure increases, an arrow pointing up will appear on the display.
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Page 24: Hypertension Indicator
Hypertension Indicator This monitor comes equipped with a Hypertension Indicator that automatically compares each reading to defined levels established by the World Health Organization and provides a helpful cue if your reading falls into one of the stages that could potentially indicate increased risk. -
Page 26: Irregular Heartbeat Detector
Irregular Heartbeat Detector Your digital blood pressure monitor features an Irregular Heartbeat Detector. Irregular Heartbeats may influence the results of the measurement. If the monitor detects the Irregular Heartbeats during measurement, the symbol will appear on the display with the measurement values. - Page 27 INPORTANT INFORMATION: This blood pressure monitor is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmia problem. As a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your blood pressure monitor.
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Page 28: Memory Function
Memory Function Recalling Measurements in Memory: Press and release the “M” button. The unit will first display the average of the last 3 stored measurements. Continue to press the “M” button to successively view the next previously stored measurements. Measurements will appear on the display from most current to oldest;... - Page 29 User memory: To select the relevant user memory, press the button “+” or “-“when the device is switched off. Average values: - A3 showed on the display. The average value of the last 3 stored measurements in this user memory is displayed. - Press the button M.
- Page 30 Clearing Measurements from Memory: From power display off, press and hold down the “M” button until the display shows CLr. This indicates that all measurements have been erased.
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Page 31: Data Transferring
Data Transferring This product is a wrist type blood pressure monitor. Design without entering personal information. The device has a transmission function. During the transmission process, the measurement data is designed to be encrypted, and will not be tampered with unauthorized access nor retrieve user-related information. - Page 32 Bluetooth function. Set Up Process (1) Please determine your mobile phone or computer has BLE4.2. (2) Turn on the BPM32-GLB, it means BPM32-GLB is under broadcast condition. (3) Please check the connecting condition from your mobile phone or computer.
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Page 33: Error Codes
2. Turn on the Bluetooth function of device to search the blood pressure monitor. Then the blood pressure monitor will be searched and connected the Bluetooth device. 3. After the connection is completed, you can press memory recall button to display the memory result on LCD. Each result showed on LCD, the result will be transmitted by Bluetooth immediately. - Page 34 Error Code Cause Corrective Action Err 02 Measured abnormal Take a rest for 3~5 minutes. Re-apply values. the cuff and take a measurement again. Err 03 Inflation fault. Re-apply the cuff and take a measurement again. Memory error. Take off batteries to reboot the device, then take another measurement.
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Page 35: Troubleshooting
Troubleshooting Problem Cause Remedy The reading The wrist cuff is not at Measure while in the correct is extremely heart level. posture. low (or The cuff is not wrapped Wrap the cuff correctly. high). snugly around the wrist. The arms and Relax and try taking the shoulders are tense. - Page 36 Problem Cause Remedy The blood pressure is different each Blood pressure readings time. The reading is extremely low (or constantly vary with time of high). day and how relaxed you are. Take several deep breaths and try to remain relaxed before taking a measurement.
- Page 37 Problem Cause Remedy Errors with The machine must be wrist positional adjusted according to the instruction manual and with professional...
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Page 38: Cleaning And Disinfecting
Cleaning and Disinfecting • Only use a soft, damp cloth to clean the monitor. Please do not use thinner, alcohol, detergents or solvents. • The cuff can be cleaned carefully using a slightly damp cloth and mild soap solution. Do not completely immerse the cuff in water. •... -
Page 39: Technical Specification
Technical Specification • Measuring range : Blood Pressure : 40~255 mmHg Pulse Rate : 40~199 beats/min • Calibration Accuracy : Pressure : ± 3 mmHg Pulse rate : ± 4% of reading • Operating environment : 10℃~40℃ (50℉~104℉) 15% to 85% relative humidity (non-condensing) Atmospheric Pressure: 700~1060 hPa •... - Page 40 • Weight : approx. 110g (exclude batteries) • Dimensions : approx. 85mm × 60mm × 24.4mm (L×W×H) • Cuff circumference : approx. 12.5~21 cm • Lifetime : 3 years • Battery life: above 300 times...
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Page 41: Emc Tables
EMC Tables BPM32-GLB is intended for use in the electromagnetic environment specified below. The customer or the user of BPM32-GLB must make sure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions CISPR 11... - Page 42 Group 2 Class A (With BLE Function) a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive acceptance limits of Group 1 Class B (CISPR 11) have been considered and applied.
- Page 43 RF communications equipment (transmitters) and the BPM32-GLB can be requested from supplier using the contact information provided in this manual. However, it is advisable to keep the equipment at an adequate distance of, at least, 0.5 m...
- Page 44 magnetic fields. a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNITY acceptance limits have been considered and applied. b) Before modulation is applied.
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Page 45: Explanation Of Symbols
Explanation of Symbols Symbol Definition The CE marking with the Registration Number of the Notified Body. This denotes the compliance of Regulation (EU) 2017/745 Medical Device Manufacturer... - Page 46 Authorized representative in the European Community Date of manufacture (YYYY-MM-DD or YYYY-MM) Batch code (YYMMWWWW) Serial number (YYMWWWXXXXX)
- Page 47 Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation...
- Page 48 Caution Consult the instruction for use Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority. WEEE 2012/19/EU Directives This product fulfilling the requirements of the RoHS Directive RoHS 2011/65/EU.
- Page 49 This product fulfilling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain Substances of Very High Concern in concentration above REACH the limit of 0.1 %. No substance(s) is/are present in the parts of the product above the concentration of 0.1 % weight by weight.
- Page 50 This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning test (protection against solid foreign objects of 12.5mm ∅ and greater and against vertically falling water drops when enclosure tiled up to 15°) The empty, completely flat batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers.
- Page 51 Distributor Model Number Country of Manufacturer Unique Device Identifier...
- Page 52 Keep away from sunlight Electronic IFU available at http://www.avita.com.tw BPM32-GLBP-22528AV 2023-02-07...
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