The Blood Pressure Monitor is digital upper arm monitors intended for use in measuring blood pressure and heartbeat rate with upper arm circumference

Transcription

1 The Blood Pressure Monitor is digital upper arm monitors intended for use in measuring blood pressure and heartbeat rate with upper arm circumference ranging from 22cm to 32 cm ( about 83/4-121/2 ).It is intended for adult indoor use only.

2 Sold in Australia by Kogan Australia Pty Ltd, (GPO Box 2679 Melbourne VIC 3001) ARTG Number: ARTG Manufactured by: Guangdong Transtek Medical Electronics Co.,Ltd (Zone A, No.105 Dongli Road Torch Development District, Zhongshan, Guangdong China) 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 ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice Symbol for MANUFACTURE DATE SN Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT

3 SYMBOL kpa mmhg DESCRIPTION EXPLANATION Systolic pressure High blood pressure Diastolic pressure Low blood pressure Pulse display Pulse in beats per minute Deflation symbol The cuff is deflating. Memory Indicate it is in the memory mode and which group of memory it is. kpa Measurement Unit of the blood pressure mmhg Measurement Unit of the blood pressure Low battery Batteries are low and need to be replaced Irregular heartbeat Blood pressure monitor is detecting an irregular heartbeat during measurement. Heartbeat Blood pressure monitor is detecting a heartbeat during measurement. Blood pressure level indicator Indicate the blood pressure level Current Time Year/Month/Day, Hour/Minute CUFF BATTERY COMPARTMENT AIR HOSE AIR CONNECTOR PLUG MEMORY BUTTON SET BUTTON START/STOP BUTTON LCD DISPLAY

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6 S TA R T S TO P 2~3cm

7 START STOP START STOP UP DOWN Date and time will display alternately. The corresponding date is January 1st. The corresponding time is P.M. 10:08.

8 START STOP

9 Systolic Diastolic press relax blood discharging artery Level blood entering vein Optimal Normal High-normal Mild Moderate Severe SYS < DIA < Blood Pressure (mm Hg)

10 S TA R T S TO P List 1.Digital Upper Arm Blood Pressure Monitor BVDABPMTRKA 2.Cuff (Type BF applied part) (22cm~32cm) (Please use authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.) 3. 4 AAA batteries 4.User manual

11 operation part Device Classification Battery Powered Mode: Internally Powered ME Equipment

12 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 Electromagnetic compatibility Performance requirements Clinical investigation EN :2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN :2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC :2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers EN :2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:electromagnetic compatibility - Requirements and tests EN ISO :2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type EN :1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems EN :2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers Usability EN : 2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability EN 62366: 2008 Medical devices - Application of usability engineering to medical devices Software life-cycle processes EN 62304:2006/AC: 2008 life cycle processes Medical device software - Software