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Summary of Contents for Avita BPM27B
- Page 1 Wrist Type Blood Pressure Monitor BPM27B 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 ..................12 Applying Your Cuff ...................... - Page 3 Troubleshooting ......................27 Cleaning and Disinfecting ................... 30 Technical Specification ....................31 EMC Tables ......................... 33 Explanation of Symbols ....................37...
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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 1. Display 2. ON/OFF button 3. Wrist Cuff 4. WHO Indicator 5. Memory 1 button, USER1 6. Memory 2 button, USER2... -
Page 12: Description Of Lcd Display
Description of LCD Display Date and Time Systolic Pressure Diastolic Pressure Pulse Value Pulse Symbol Irregular Heart Beat Symbol Memory space number / memory display average value( ), morning( ), evening( User memory Classification of measurements 10. Low Battery Symbol... -
Page 13: 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 ON/OFF button is pressed. Replacing the Battery: 1. Press down on latch and lift the cover on the bottom of the monitor. 2. - Page 14 greatly in quality and strength. Use of rechargeable batteries may affect the performance of this device. - Please properly dispose of the batteries away from small children and heat. - It is recommended to remove the batteries if the unit will not be used for an extended period of time.
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Page 15: Setting The Date And Time
Setting the Date and Time This menu allows you to set the following functions, one after another. It is essential to set the date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later. - Page 16 • Select the month using the USER1/USER2 memory buttons and confirm with the ON/OFF button The day flashes on the display. • Select the day using the USER1/USER2 memory buttons and confirm with the ON/OFF button Noted: If the hour format is set as 12h, the day/month display sequence is reversed.
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Page 17: Applying Your Cuff
Applying Your Cuff Positioning cuff • Bare your left Wrist, making sure that the circulation in the Wrist is not restricted by any clothes etc. That is too tight. Position the cuff on the inside of your Wrist. • Fasten the cuff with the Velcro fastening so that the upper edge of the monitor is positioned approx. -
Page 18: Measurement Of Pulse Rate And Blood Pressure
Measurement of Pulse Rate and Blood Pressure Correct posture • Rest for approx. 5 minutes before each measurement. Otherwise there may be divergences. • You can perform the measurement while sitting or lying. • To carry out a blood pressure measurement, make sure you are sitting comfortably with your Wrists and back leaning on some- thing. -
Page 19: Measuring Blood Pressure
Measuring blood pressure • Make sure to rest your arm and move it so that the device is at heart level as described previously. • Press the ON/OFF button to start the blood pressure monitor. All displays will illuminate briefly. •... -
Page 20: Hypertension Indicator
Hypertension Indicator This unit features our unique Hypertension Indicator. The World Health Organization has established globally accepted standards for the assessment of high or low blood pressure readings. The below chart should be considered only as a guideline, always consult with your physician or health care professional to interpret your individual results. -
Page 21: Irregular Heartbeat Detector
Irregular Heartbeat Detector Your digital blood pressure monitor features an Irregular Heartbeat Detector. This feature allows users to accurately monitor blood pressure even if an irregular heartbeat should occur. When an irregular heartbeat is detected, the “ ” icon will appear on the display. Note: Please consult with your physician or trained healthcare professional for further information regarding an irregular heartbeat and if this symbol... -
Page 22: Memory Function
Memory Function User memory • The results of each successful measurement are stored together with date and time. With more than 100 items of measured data, the earliest items of data measured are lost. • To recall measurements, press the memory button USER1 or USER2 . The device first shows the number of used memory spaces and then changes automatically to the average of all stored measurements... - Page 23 • Press the relevant memory button (USER1 or USER2). Note: Press the USER1 button if you have selected user memory 1. Press the USER2 memory button if you have selected user memory 2. appears on the display. The average value of all saved measured values in this user memory is displayed.
- Page 24 displayed. • By pressing the memory button USER1 or USER2 again, the most recent individual measurements are displayed with the date, time and graphic WHO classification, while the blood pressure values and the pulse are displayed in turn. • In the display of the individual measured values, you have the option of clearing the memory by pressing the memory button USER1 or USER2 for 5 seconds.
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Page 25: 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 26 (5) The app should automatically detect your BPM27B. Tap the BPM27B that is showed in the device list. (6) Your BPM27B is now successfully connected to your mobile device. Every measure reading will be transfer to your mobile device automatically.
- Page 27 mobile phone, and the password will be displayed on the device's LCD ensure the security of the data transmission. Note: When connecting to the mobile phone for the first time, make sure that the pairing password is not leaked. You can send results in memory zone as following step: 1.
- Page 28 immediately.
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Page 29: Error Codes
Error Codes In case of faults, the message appears in the display. Error messages may appear if: • It was not possible to record the pulse( appears on the display), • Inaccurate reading / movement( appears on the display), • The cuff is not fastened correctly( appears on the display), •... -
Page 30: Troubleshooting
Troubleshooting Problem Probable Cause Recommended Action Nothing Batteries are drained. Replace all batteries with appears in the new ones. display even Batteries are not correctly Reinsert batteries in the when the aligned with terminals. correct position. power is turned on. Low Battery Batteries are drained. - Page 31 Problem Probable Cause Recommended Action is inconsistent. same time with same brand batteries. No reading Batteries are drained. Replace all batteries with after new ones. measurement. Suspicious Perhaps the cuff was Adjust patient and Arm blood pressure improperly positioned. cuff to measure. results.
- Page 32 Problem Probable Cause Recommended Action Power switches System design. Push the power button again, and then begin automatically. measure again. During It could be a normal action if Relax, and try to take a measuring, air the user's blood pressure is measure again.
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Page 33: 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 34: 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 35 • Weight : approx. 115g (exclude batteries) • Dimensions : approx. L mm x W mm x H • Cuff circumference : approx. 125~210 cm (4.9” ~ 8.3”) • Frequency : 2402~2480GHz • Output power range : <=4dBm • Life time: 3 years; •...
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Page 36: Emc Tables
EMC Tables BPM27B is intended for use in the electromagnetic environment specified below. The customer or the user of BPM27B must make sure that it is used in such an environment. Guidance and manufacturer’s declaration - Electromagnetic emissions CISPR 11... - Page 37 and flickering Group 1 Class A (Not BLE Function) 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 38 RF communications equipment (transmitters) and the BPM27B 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 39 RATED power IEC 61000-4-8 30 A/m c) 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.
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Page 40: 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 41 Authorized representative in the European Community Date of manufacture (YYYY-MM-DD or YYYY-MM) Batch code (YYMMWWWW) Serial number (YYMWWWXXXXX)
- Page 42 Keep dry Temperature limit Humidity limitation Atmospheric pressure limitation...
- Page 43 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 44 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 45 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 46 Distributor Model Number Country of Manufacturer Unique Device Identifier BPM27BP-22006AV 2022-12-14...
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