Related Manuals for BELLA VITA BVDWBPMTRKA
Summary of Contents for BELLA VITA BVDWBPMTRKA
- Page 3 The Blood Pressure Monitor is digital LCD monitors intended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13.5cm to 21.5 cm ( about 5 ″-8 ″ ). It is intended for adult indoor use only. Sold in Australia by Kogan Australia Pty Ltd, (GPO Box 2679 Melbourne VIC 3001) ARTG Number: ARTG 286504...
- Page 4 Symbol for “THE OPERATION Symbol for “TYPE BF APPLIED GUIDE MUST BE READ” PARTS” Symbol for “ENVIRONMENT Caution: These notes must be PROTECTION - Electrical waste observed to prevent any damage products should not be disposed of to the device. with household waste.
- Page 5 wrist wrist The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃. ３...
- Page 6 SYMBOL DESCRIPTION EXPLANATION High blood pressure Systolic pressure Diastolic pressure Low blood pressure Pulse display Pulse in beats per minute Motion may result in an inaccurate Motion indicator measurement. Low battery Batteries are low and need to be replaced Measurement unit of the blood pressure (1kPa=7.5mmHg) Measurement unit of the blood pressure mmHg...
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Page 7: Lcd Display
SYSTOLIC PRESSURE LCD DISPLAY MEMORY BUTTON DIASTOLIC PRESSURE GRADE SET BUTTON TIME PULSE RATE START/STOP BUTTON CUFF (Type BF applied part) List 1) Wrist Blood Pressure Monitor BVDWBPMTRKA 2) 2×AAA batteries 3) User manual BATTERY COMPARTMENT ５... - Page 8 ６...
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- Page 13 After confirming the meausrement unit, the LCD will display all the settings you have done one by one and then shut off,...
- Page 17 When the monitor is off, press“MEM”button to show the latest measurement record. DOWN Date and time will display alternately. The corresponding The corresponding date is 5th January. time is 10:38.
- Page 21 Systolic Diastolic blood entering blood discharging vein artery press relax Level Blood Severe Optimal Normal Mild Moderate High-normal Pressure (mmHg) 120~129 130~139 140~159 160~179 <120 >180 80~84 85~89 90~99 100~109 <80 >110...
- Page 24 wrist...
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Page 25: Device Classification
Pressure: 5℃-40℃within±0.4kPa(3mmHg) Pulse value:±5% operation Device classification Internally Powered ME Equipment... - Page 26 Risk management EN ISO 14971:2012 Medical devices - Application of risk management to medical devices Labeling EN 980:2008 Symbols for use in the labelling of medical devices User manual EN 1041:2008 Information supplied by the manufacturer of medical devices EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and General Requirements essential performance EN 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety...
- Page 27 1) * This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment. 2) * Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit.
- Page 28 Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
- Page 29 Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level...
- Page 30 <5% U Mains power quality should be that of a typical (>95% dip in U commercial or hospital Voltage dips, for 0.5 cycle environment. If the user of short interruptions the device requires 40% U and voltage continued operation during (60% dip in U variations on power mains interruptions,...
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Page 31: Test Level
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test IEC 60601 Compliance... - Page 32 3 Vrms Field strengths from fixed RF Conducted RF 150 kHz to Not applicable transmitters, as determined by an IEC 61000-4-6 80 MHz electromagnetic site survey, should be less than the compliance level in each Radiated RF 3 V/m 3 V/m frequency range.
- Page 33 Table 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
- Page 34 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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