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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 51/3″-81/2″ ). 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 Manufactured by: Guangdong Transtek Medical Electronics Co.,Ltd (Zone A, No.
SN Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “TYPE BF APPLIED PARTS” Caution: These notes must be observed to prevent any damage to the device. Symbol for “MANUFACTURE DATE” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist.
wrist wrist The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃.
SYMBOL DESCRIPTION EXPLANATION Systolic pressure High blood pressure Diastolic pressure Low blood pressure Pulse display Pulse in beats per minute Motion indicator Motion may result in an inaccurate 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 (1mmHg=0.133kPa) Blood pressure monitor is detecting an Irregular heartbeat irregular heartbeat during measurement.
SYSTOLIC PRESSURE LCD DISPLAY MEMORY BUTTON DIASTOLIC PRESSURE GRADE SET BUTTON PULSE RATE TIME 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
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After confirming the meausrement unit, the LCD will display all the settings you have done one by one and then shut off, 11
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When the monitor is off, press“MEM”button to show the latest measurement record. UP DOWN Date and time will display alternately. The corresponding date is 5th January. 15 The corresponding time is 10:38.
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Systolic Diastolic press relax blood discharging artery Level Blood Pressure (mmHg) blood entering vein Optimal Normal High-normal Mild Moderate Severe SYS <120 120~129 130~139 140~159 160~179 >180 DIA <80 80~84 85~89 90~99 100~109 >110 19
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Pressure: 5℃-40℃within±0.
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 General Requirements for Safety EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic sa
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. This may result in incorrect operation of the unit.
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.
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.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT for 0.5 cycle ) 40% UT (60% dip in UT for 5 cycles ) 70% UT (30% dip in UT for 25 cycles ) <5% U T (>95% dip in UT for 5 s Not applicable ) Power frequency (50/60Hz) magnetic field 3A/m 3A/m IEC 61000-4-8 NOTE Mains power quality should be that of a typical commercial or hospital environment.
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.
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 NOTE 1 NOTE 2 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Not applicable 3 V/m Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations.
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.
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. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
