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Wrist Type Blood Pressure Monitor BPM11 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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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 ................10 Description of LCD Display ..................11 Battery Installation ....................13 Setting the Date and Time ..................14 Applying Your Cuff ....................16 Measurement of Pulse Rate and Blood Pressure ...........18 Hypertension Indicator ..................20...
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Cleaning and Disinfecting ..................29 Technical Specification ...................31 EMC Tables ......................33 Explanation of Symbols ..................37...
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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.
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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 ...
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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.
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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 ...
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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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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.
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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.
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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.
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(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.
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Description of LCD Display Memory sets Memory Symbol Average Measurement Symbol Low Battery Symbol Inflation Symbol Deflation Symbol Date...
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Time Digital Display Pulse Rate Heartbeat Symbol Hypertension Indicator Irregular Heart Beat Symbol...
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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: - Open 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.
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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.
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Press the“M”button to advance the display to the desired “Year”, press“POWER” button to confirm the“Year”. Next, the “Month” will blink. Repeat steps 1 and 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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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.
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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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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.
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begin to show the decreasing pressure; the screen will display an arrow pointing down while you feel the pressure of the cuff decrease. To detect the heartbeat, the heartbeat symbol will appear and continuous flashes on the LCD display. Your blood pressure measurement and pulse will display simultaneously on the screen.
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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.
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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.
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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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All results for a given measurement will display, including measurement results, pulse rate, Hypertension Indicator, and date/time stamp. When the number of readings exceeds default numbers, the oldest data will be replaced with the new record. Press the Power button to turn the monitor OFF at any time during review of the stored measurements.
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Error Codes Error Code Cause Corrective Action Err 00 No pulse or detect Take off heavy clothes and retry again. pulses not enough. Err 01 Leakage in Cuff The wrist cuff is not fastened properly. Pressure/Inflation too low. Overpressure protection Err 02 Measured abnormal Take a rest for 3~5 minutes.
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Error Code Cause Corrective Action Low batteries Replace all batteries with new ones.
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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.
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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.
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Problem Cause Remedy Errors with The machine must be wrist positional adjusted according to the instruction manual and with professional Cleaning and Disinfecting • Only use a soft, damp cloth to clean the monitor. Please do not use thinner, alcohol, detergents or solvents. •...
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a disinfectant. Use a disinfectant that is compatible with the cuff materials, e.g. 75 % ethanol or isopropyl alcohol. • Keep the monitor in the appropriate carriage to protect it from external influences. And store it at appropriate condition.
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EMC Tables BPM11 is intended for use in the electromagnetic environment specified below. The customer or the user of BPM11 must make sure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions CISPR 11...
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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.
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RF communications equipment (transmitters) and the BPM11 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 from...
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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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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...
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Authorized representative in the European Community Date of manufacture (YYYY-MM-DD or YYYY-MM) Batch code (YYMMWWWW) Serial number (YYMWWWXXXXX)
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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.
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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.
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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.
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Distributor Model Number Country of Manufacturer Unique Device Identifier...
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Keep away from sunlight Electronic IFU available at http://www.avita.com.tw BPM11P-22500AV 2022-12-25...
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