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Summary of Contents for Avita BPM28
- Page 1 Wrist Type Blood Pressure Monitor BPM28 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, 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 ................5 Product Identification ..................... 8 Description of LCD Display ................... 9 Battery Installation ......................10 Setting the Date and Time ..................11 Applying Your Cuff ...................... - Page 3 Cleaning and Disinfecting ................... 31 Technical Specification ....................32 EMC Tables ......................... 34 Explanation of Symbols ....................38...
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Page 4: Intended Use
Intended Use The product automatically measures human begins 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 arm. The intended use of this over-the-counter device is for adults with arm circumference ranging from 125 mm to 210 mm (Approx. - Page 5 CAUTION: • Beware of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure. • Pressurization of the cuff can temporarily cause loss of function of monitoring ME equipment simultaneously being used on the same limb.
- Page 6 • Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g., intravascular access or therapy, or an arteriovenous (AV) shunt. • This product is suitable for use in the home healthcare environment. •...
- Page 7 • Cuff pressure 0 – 300 mmHg • Reduction rate: ≦30S Refer to IEC 80601-2-30 • No modification of this equipment is allowed.
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Page 8: Important Information Before Use
Important Information Before Use Blood pressure measurements should only be interpreted by a physician or a trained health care professional who is familiar with your medical history. Through regular use of this device and recording of your measurements, you can keep your physician informed of the changes in your blood pressure. - Page 9 accurate reading. Remain still; do not talk during the measurement. Record your daily blood pressure and pulse readings on a chart. Take your readings at the same time, each day or as recommended by your physician to get an accurate indication of change in your true blood pressure.
- Page 10 For Customer Service, It is recommended that the accuracy should be checked by manufacture every 2 years. To obtain the service please contact AViTA Corp. for the address of the repair location. Enclose the Proof of Purchase. Include $10.00 USD for the return shipping and handling.
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Page 11: Product Identification
Product Identification... -
Page 12: Description Of Lcd Display
Description of LCD Display... -
Page 13: Battery Installation
Battery Installation Inserting the batteries • Remove the battery compartment lid on the right side of the device. • Insert two 1.5 V AAA micro (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round in accordance with the markings. -
Page 14: Setting The Date And Time
Setting the Date and Time You must make sure that the device has the correct settings before use in order to be able to make full use of all functions. Only by doing so can your measurements with associated date and time be saved and accessed later by you. -
Page 16: Applying Your Cuff
Applying Your Cuff General rules when measuring blood pressure yourself • In order to generate as informative a profile of the progression of your blood pressure as possible and ensure that the measured values can be compared, you should measure your blood pressure regularly and always at the same times of day. - Page 17 make sure always to wait for at least 1 minute between the individual measurements. • Repeat the measurement if you are unsure of the measured value. Attaching the cuff • Fundamentally, blood pressure can be measured on both arms. Certain deviations between the measured blood pressure on the right arm and left arm are due to physiological causes and completely normal.
- Page 18 • Now place the cuff on the wrist so that the palm of your hand and the device display are facing upwards. • Position the cuff so that there is a distance of 1.0 – 1.5 cm between it and the heel of your hand.
- Page 19 table to support your arm. In order to make the measurement even more comfortable for you, you can place your lower arm on a suitable object (e.g. the storage box). • Relax your arm and the palm of your hand. •...
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Page 20: Measurement Of Pulse Rate And Blood Pressure
Measurement of Pulse Rate and Blood Pressure Selecting the user This device has 2 user memories with 100 memory spaces each in order that you can save measurements from 2 different people separately from each other. If multiple people are using the device, make sure that the relevant user is set before each measurement. - Page 21 automatically after approx. 3 seconds. • The cuff inflates automatically while the actual measuring process starts. As soon as a pulse is found, the pulse symbol is displayed. You can cancel the measurement at any time by pressing the START/STOP button •...
- Page 22 against the arterial walls. Arterial blood pressure constantly changes in the course of a cardiac cycle. • Blood pressure is always stated in the form of two values: – The highest pressure in the cycle is called systolic blood pressure. This arises when the heart muscle contracts and blood is pumped into the blood vessels.
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Page 23: 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 25: 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 26 IMPORTANT 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 27: Memory Function
Memory Function Saving, accessing and deleting measured values... -
Page 30: Error Codes
Error Codes... -
Page 31: 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 32 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 33 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 34: Cleaning And Disinfecting
Cleaning and Disinfecting • Clean your blood pressure monitor carefully using a slightly damp cloth only. • Do not use any detergents or solvents. • Never hold the instrument under water as otherwise liquid can penetrate and damage the instrument •... -
Page 35: Technical Specification
Technical Specification • Measuring range : Blood Pressure : 30~280 mmHg Pulse Rate : 40~199 beats/min • Calibration Accuracy : Pressure : ± 3 mmHg Pulse rate : ± 4% of reading • Operating environment : 10℃~40℃ (50℉~104℉) with relative humidity up to 85% (non condensing) Atmospheric Pressure: 700~1060 hPa •... - Page 36 • Weight : approx. 105g (exclude batteries) • Dimensions : approx. L 85 mm x W 60 mm x H 22 mm • Cuff circumference : approx. 125~210 cm • Life time: 3 years • Battery life: above 300 times...
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Page 37: Emc Tables
EMC Tables BPM28 is intended for use in the electromagnetic environment specified below. The customer or the user of BPM28 must make sure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions CISPR 11... - Page 38 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 39 RF communications equipment (transmitters) and the BPM28 can be requested from supplier using the contact information provided in this manual. However, it is advisable to keep the electromechanical aerosol equipment at an adequate distance of, at least, 0.5 m from mobile phones...
- Page 40 frequency 50 Hz or 60 Hz 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 41: Explanation Of Symbols
Explanation of Symbols The CE marking with the Registration Number of the Notified Body. This denotes the compliance of Regulation (EU) 2017/745 Medical Device Manufacturer... - Page 42 Authorized representative in the European Community Date of manufacture (YYYY-MM-DD or YYYY-MM) Batch code (YYMMWWWW) Serial number (YYMWWWXXXXX)
- Page 43 Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation...
- Page 44 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 RoHS Directive 2011/65/EU.
- Page 45 This product fulfilling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain Substances of Very High Concern in REACH concentration above 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 46 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 47 Distributor Model Number Country of Manufacturer Unique Device Identifier BPM28P-22008AV 2022-12-14...
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