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EMC Tables

BPM63

is intended for use in the electromagnetic environment

specified below. The customer or the user of

BPM63

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 MISSIONS

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

respiratory treatment facilities in hospital or clinics. The more restrictive

acceptance limits of Group 1 Class B (CISPR 11) have been considered

and applied. The equipment is suitable for use in the mentioned

environments when directly connected to the Public Mains Network.

b) The test is not applicable in this environment 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

ELECTROSTATIC

DISCHARGE

IEC 61000-4-2 ± 8kV contact

± 2 kV, ±4kV ±, ±8 kV, ±15 kV air

Radiated RF EM

fields

IEC 61000-4-3 a)

10 V/m b) 80MHz - 2.7

GHz 80% AM at 1kHz

Proximity fields

from RF wireless

communications

equipment

IEC 61000-4-3 COMPLIANT

NOTE: Further information about

distances to be maintained between

portable and mobile RF

communications equipment

(transmitters) and the

BPM63

can be

Содержание BPM63

Страница 1: ...LEASE READ THIS INSTRUCTION MANUAL COMPLETELY BEFORE OPERATING THIS UNIT EN 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 ...

Страница 2: ...tion 7 Setting the Date and Time 8 Placement of the Pressure Sleeve 9 Measurement of Pulse Rate and Blood Pressure 11 World Health Organization WHO 12 Irregular Heartbeat Detector 13 Memory Function 13 Error Codes 15 Troubleshooting 16 Cleaning and Disinfecting 17 Technical Specification 18 EMC Tables 19 Explanation of Symbols 21 ...

Страница 3: ...ng measurement an indicated symbol will appear with measuring readings This device is designed only for adults Type of Use Reuse Multiple patient multiple use Intended User The Arm type blood pressure monitor is intended or both professional and consumer and the patient is the intended operator Patient selection criteria Handicapped persons and children are the exception of handicapped persons and...

Страница 4: ...physiologic condition Details of what the operator should do if unexpected readings are obtained An explanation of the need to avoid compression or restriction of the connection tubing 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 Do not use the cuff on people who have un...

Страница 5: ... the cuff placement 6 Keep the monitor stable during measurement to achieve an accurate reading Remain still do not talk during the measurement 7 Record your daily blood pressure and pulse readings on a chart 8 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 9 Wait a minimum of 15 minutes between r...

Страница 6: ...ation events please contact manufacturer or local representative for further information and assistance Avoid the sensor degrading it is needed calibrate the device every 2 year Do not use in this case e g Device for use in an ambulance or helicopter For use in the professional environment This product is suitable for use in the home healthcare environment The performance of the device can be affe...

Страница 7: ...5 Product Identification 1 Display 2 Date and Time Set button 3 Start Stop button Power key 4 MEMORY Recall button M key 5 Air socket 6 Cuff connector 7 Cuff 8 Cuff tube ...

Страница 8: ...of LCD Display Low battery indicator WHO indicator Date Time Irregular Heartbeat Symbol Average measurement Symbol Memory Symbol Memory Set Heartbeat Symbol Pulse rate Release air Systolic Pressure Diastolic Pressure ...

Страница 9: ...suring to match the indicated polarity symbols Always use new batteries 3 Replace the battery cover CAUTION Risk of explosion if battery is replaced by an incorrect type Dispose of used batteries according to the instructions NOTE Battery operated 1 Please properly dispose of the batteries away from small children and heat Avoid the children accidentally swallow the battery 2 It is recommended to ...

Страница 10: ...utton to enter Date and Time setting procedure and the Year value will begin to flash 2 Press the MEMORY Recall button to advance the display to the desired year press Power button to confirm the year 3 Next the month will blink Repeat steps 2 to set the month and date then hours then minutes 4 After setting the minutes the unit will automatically exit out of the date time setting mode and briefly...

Страница 11: ...cuff placement 2 Be seated at a table or desk with your feet flat on the floor 3 The cuff should not be plugged into the monitor until after the cuff is applied to your arm Note Blood pressure naturally varies from one arm to the other therefore measure your blood pressure on the same arm to ensure comparability of the two readings 4 Position the cuff on a solid surface with the tubing facing up a...

Страница 12: ... to tighten the cuff Wrap and secure the cuff making sure in place as shown 9 The cuff should fit comfortably yet snugly around your arm You should be able to insert one finger easily between your arm and the cuff Note If you are not comfortable with applying your cuff please seek the assistance of another member of your household or work with your physician to practice the cuff application Incorr...

Страница 13: ...r left hand 1 Press the Power key to turn the power on After full display is shown the values for the last reading will appear on the display If there is no measurement the unit displays the value 0 2 After the self test the blood pressure monitor starts to measure The cuff will automatically begin to inflate with the display showing the increasing pressure in the cuff 3 As the pressure increases ...

Страница 14: ...r key to turn the unit off and conserve energy and battery life The unit will automatically shut off approximately 2 minutes World Health Organization WHO 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 alw...

Страница 15: ...ars frequently Memory Function Recalling Measurements in Memory You can recall up to 60 measurements per memory bank plus an average of the last 3 stored measurements in memory to share with your physician or trained healthcare professional 1 Press and release the MEMORY Recall Button The unit will first display the average of the last 3 stored measurements 2 Continue to press the MEMORY Recall Bu...

Страница 16: ... of readings exceeds 60 the oldest data will be replaced with the new record 5 Press the Power button to turn the monitor OFF at any time during review of the stored measurements Clearing Measurements from Memory From power display off press and hold down the MEMORY Recall Button until the display shows CLr This indicates that all measurements have been erased ...

Страница 17: ...ened properly Re apply the cuff and take a measurement again Err 02 Inaccurate reading Rest a while relax and retry again Err 03 Inflation or deflation fail during the measurement The Arm cuff is not fastened properly Re apply the cuff and take a measurement again Err Memory error Take off batteries to reboot the device then take another measurement Low batteries Replace all batteries with new one...

Страница 18: ...all batteries with new ones Suspicious blood pressure results Perhaps the cuff was improperly positioned Adjust patient and Arm cuff to measure Blood pressure naturally varies throughout the day Rest a while relax and measure again Suspicious heart rate results Bodily movement during device use Refrain from moving during measurement Measurement shortly after exercise or exposure to the outdoors Do...

Страница 19: ...t use any detergents or solvents Never hold the instrument under water as otherwise liquid can penetrate and damage the instrument Never place any heavy objects on the instrument Please note For home use device disinfection 75 Ethanol or Isopropyl alcohol available in the phWristacy can be used receipt requested ...

Страница 20: ...ironment 10 C 40 C 85 relative air humidity non condensing 700 1060 hPa ambient pressure Storage Transportation environment 20 to 50 C 85 relative air humidity non condensing 700 1060 hPa ambient pressure Power Source 4 x 1 5V LR6 AA alkaline Weight approx 275g exclude batteries 5 Dimensions approx 113mm x 140mm x 57mm L x W x H Cuff circumference M L Size approx 22 42 cm 9 17 ...

Страница 21: ...considered and applied The equipment is suitable for use in the mentioned environments when directly connected to the Public Mains Network b The test is not applicable in this environment 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 Electro...

Страница 22: ...ncy magnetic fields IEC 61000 4 8 30 A m c 50 Hz or 60 Hz 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 c This test level assumes a minimum dis...

Страница 23: ...on Number of the Notified Body This denotes the compliance of Regulation EU 2017 745 Medical Device Manufacturer Authorized representative in the European Community Date of manufacture YYYY MM DD or YYYY MM Batch code YYMMWWWW Serial number YYMWWWXXXXX Keep dry Temperature limit ...

Страница 24: ...hority 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 the concentration of 0 1 weight by...

Страница 25: ...r 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 You are legally required to dispose of the batteries Importer Distributor Model Number Country of Manufacturer Unique Device Identifier BPM63P 22052AV 2022 04 22 ...

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