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Avita BPM13B, Instruction Manual

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Avita BPM13B Instruction Manual Download Page 39

35   

18. EMC Tables 

BPM13B

 is intended for use in the electromagnetic environment 

specified below. The customer or the user of 

BPM13B

 must make sure 

that it is used in such an environment. 

Guidance and manufacturer’s declaration - Electromagnetic 

emissions 

Phenomenon 

Professional healthcare 

facility environment

 a)

 

HOME HEALTHCARE 

ENVIRONMENT

 a)

 

Conducted and 

radiated RF 

EMISSIONS 

a) 

CISPR 11 

Group 1 Class B 

Harmonic 

distortion 

Not applicable 

Voltage 

fluctuations and 

flickering 

Not applicable 

a) The equipment is suitable for use in Home Health Environments and 

Professional Health Care Environments limited to patient rooms and 

Summary of Contents for BPM13B

Page 1: ...AViTA Wrist Type Blood Pressure Monitor Model BPM13B INSTRUCTION MANUAL PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY BEFORE OPERATING THIS UNIT EN RoHS REACH ...

Page 2: ...9F No 78 Sec 1 Kwang Fu Rd San Chung Dist New Taipei City 24158 Taiwan R O C Made in China Importer Distributor ...

Page 3: ...Pressure Monitor Features 5 4 Description of LCD Display 6 5 Battery Installation 8 6 Setting the Date and Time 10 7 Applying Your Cuff 11 8 Taking a blood pressure measurement 13 9 Heartbeat Remind 15 10 Hypertension Indicator 17 11 Memory Function 19 12 Troubleshooting 21 13 Error Codes 24 ...

Page 4: ...14 Data Transferring 26 15 FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT 29 16 Care and Maintenance 32 17 Technical Specification 33 18 EMC Tables 35 19 Explanation of Symbols 39 ...

Page 5: ...ressure and heart rate This device is designed only for adults CAUTION No modification of this equipment is allowed Keep your equipment out of the reach of children pets and pest The Patient is an intended operator Risk of explosion if battery is replaced by an incorrect type Dispose of used batteries according to the instructions ...

Page 6: ...manufacturer 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 Perform your measurement in a quiet place You should be seated in a relaxed position Avoid s...

Page 7: ...in 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 Wait a minimum of 2 3 minutes between readings to allow for the blood vessels to return to normal The wait time may vary depending on your indiv...

Page 8: ...eflation process of the cuff at any time by pressing the POWER button It is recommended that the accuracy should be checked by the manufacturer every two years If you would require any assistance during setting up using or maintaining please contact the manufacturer Note Under any circumstances the measurement taking result is ONLY for reference Any further medical action should follow the advice ...

Page 9: ...5 3 Blood Pressure Monitor Features ...

Page 10: ...6 4 Description of LCD Display Memory sets Memory Symbol Average Measurement Symbol Low Battery Symbol Inflation Symbol Deflation Symbol Date ...

Page 11: ...7 Time Digital Display Pulse Rate Heartbeat Symbol Hypertension Indicator Irregular Heart Beat Symbol ...

Page 12: ... 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 Always use new batteries Close the battery cover Battery operated Always use NEW batteries never mix old and new batteries ...

Page 13: ...e 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 Batteries must be disposed of in accordance with local environmental and institutional policies Remove the battery during extended storage ...

Page 14: ... the Date and Time button the Year will begin to flash on the display 2 Press the MEMORY button to advance the display to the desired Year press POWER button to confirm the Year 3 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 s...

Page 15: ...mption 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 16: ...pward Apply the preformed cuff to your wrist so that the digital display face is positioned on the inside area of your wrist facing you Adjust the cuff 0 5 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 therefore measure your blood pressure on the same wrist to ensure comparabi...

Page 17: ... the self test the values for the last reading will appear on the display The blood pressure monitor start to measure Do not move or speak while the measurement is in progress 4 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 5 When the inflation has reached optimum l...

Page 18: ...easurement and pulse will display simultaneously on the screen 8 The Hypertension Indicator will indicate your reading range on the display separately 9 The reading will automatically be stored in memory 10 Select POWER to turn the unit off and conserve energy and battery life The unit will automatically shut off approximately 2 minutes ...

Page 19: ...ou can take another measurement to make sure the values are not influenced by moving during measurement or Irregular Heartbeat The appearance of the icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement Usually this is not a cause for concern However if the symbol appears often we recommend you seek medical advice Please note that the devic...

Page 20: ...ythmias 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 ...

Page 21: ...hat could potentially indicate increased risk Please note that cues provided by this monitor are only intended to assist you in using this table The table and cues are only provided for convenience to help you understand to the level information They are not a substitute for a medical examination by your physician It is important for you to consult with your physician regularly Your range as well ...

Page 22: ...18 ...

Page 23: ...ements Measurements will appear on the display from most current to oldest the memory number will appear on the lower left corner 3 All results for a given measurement will display including measurement results pulse rate Hypertension Indicator and date time stamp 4 When the number of readings exceeds 60 the oldest data will be replaced with the new record 5 Press the Power button to turn the moni...

Page 24: ...20 Clearing Measurements from Memory From power display off press and hold down the MEMORY button until the display shows CLr This indicates that all measurements have been erased ...

Page 25: ...f is not at heart level Measure while in the correct posture The cuff is not wrapped snugly around the wrist Wrap the cuff correctly The arms and shoulders are tense Relax and try taking the measurement again Movement or talking during measurement Remain still and do not talk during measurement ...

Page 26: ... and how relaxed you are Take several deep breaths and try to remain relaxed before taking a measurement Nothing happens when you press the buttons The batteries have been inserted incorrectly Insert the batteries with the correct polarity Overpressure protection The machine must be adjusted according to the instruction manual and with professional equipment ...

Page 27: ...23 Problem Cause Remedy Errors with wrist positional The machine must be adjusted according to the instruction manual and with professional ...

Page 28: ... Inflation too low The wrist cuff is not fastened properly Reapply the cuff and take a measurement again Err 02 Measured abnormal values Take a rest for 3 5 minutes Re apply the cuff and take a measurement again Err 03 Deflation fault Re apply the cuff and take a measurement again Err Memory error Take off batteries to reboot the device then take another measurement ...

Page 29: ...25 Error Code Cause Corrective Action Low batteries Replace all batteries with new ones ...

Page 30: ...OS device with iOS version 5 or above and hardware support for Bluetooth 4 2 All devices Apple released since the iPhone do the older ones don t Note Please refer to the instruction manual of your smart phone for how to activate the Bluetooth function Set Up Process 1 Download an app which supports Bluetooth 4 0 from the iTune App Store or Google Play ...

Page 31: ...will be transfer to your mobile device automatically You can send results in memory zone as following step 1 1 Press Memory recall button of blood pressure monitor to enter memory mode The symbol AVG and M will appear on the display and the number of memory index is A3 2 2 Turn on the Bluetooth function of device to search the blood pressure monitor Then the blood pressure monitor will be searched...

Page 32: ...28 recall button to display the memory result on LCD Each result showed on LCD the result will be transmitted by Bluetooth immediately ...

Page 33: ... equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the ...

Page 34: ...ed radio TV technician for help CAUTION Any changes or modifications not expressly approved by the grantee of this device could void the user s authority to operate the equipment 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 and 2 this device must accept any interference received including in...

Page 35: ...31 The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment The equipment must not be co located or operating in conjunction with any other antenna or transmitter ...

Page 36: ...ge if water enters Do not use any gas strong detergent or solvents to clean the device including the wrist cuff Use a soft dry cloth to clean your monitor Do not store in direct sunlight dust or excessive humidity Avoid extreme temperatures Do not disassemble the monitor or cuff Remove batteries if the monitor will not be used for an extensive period of time ...

Page 37: ...y 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 Storage Transportation environment 20 50 4 122 with relative humidity up to 85 non condensing Atmospheric Pressure 700 1060 hPa Power Source 2 x 1 5 V AAA batteries ...

Page 38: ...34 Weight approx 115g exclude batteries Dimensions approx 80mm 84mm 33mm W H D Cuff circumference approx 12 5 21 cm ...

Page 39: ...s declaration Electromagnetic emissions Phenomenon Professional healthcare facility environment a HOME HEALTHCARE ENVIRONMENT a Conducted and radiated RF EMISSIONS a CISPR 11 Group 1 Class B Harmonic distortion Not applicable Voltage fluctuations and flickering Not applicable a The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patien...

Page 40: ...ironment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard Guidance and manufacturer s declaration Electromagnetic immunity Enclosure port Phenomenon Basic EMC standard or test method Immunity test levels Professional healthcare facility environment HOME HEALTHCARE ENVIRONMENT ELECTRO...

Page 41: ...mitters and the BPM13B 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 mobile phones or other RF communications transmitters to minimise possible interference RATED power frequency magnetic fields IEC 61000 4 8 30 A m c 50 Hz or 60 Hz a The equipment is suitable for use...

Page 42: ...facilities in hospital or clinics The more restrictive IMMUNITY acceptance limits have been considered and applied b Before modulation is applied c This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields ...

Page 43: ...39 19 Explanation of Symbols Symbol Definition Medical Device Manufacturer Date of manufacture YYYY MM DD or YYYY MM or YYYY ...

Page 44: ...40 Batch code LOT WWWXXXXX LOT Lot Number WWW working sheet XXXXX serial no Serial number SN YYMWWWXXXXX YY year M month WWW working sheet XXXXX serial no Keep dry Temperature limit ...

Page 45: ...41 Humidity limitation Atmospheric pressure limitation Caution ...

Page 46: ... local authority WEEE 2012 19 EU Directives RoHS This product fulfilling the requirements of the RoHS Directive 2011 65 EU REACH 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 the limit of 0 1 No substance s is are present in the parts of the product above ...

Page 47: ...ification type BF 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 ...

Page 48: ...pletely flat batteries must be disposed of through specially designated collection boxes recycling points or electronics retailers You are legally required to dispose of the batteries Importer Distributor Model Number ...

Page 49: ...45 Country of Manufacturer Unique Device Identifier 72 B13BMN AV11 2022 1 6 ...

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