BELLA VITA BVDABPMTRKA User manual

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.

Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
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
Caution: These notes must be
observed to prevent any damage
to the device.
Manufactured by: Guangdong Transtek Medical Electronics Co.,Ltd
(Zone A, No.105 Dongli Road Torch Development District, Zhongshan, Guangdong 528437 China)
Sold in Australia by Kogan Australia Pty Ltd,
(GPO Box 2679 Melbourne VIC 3001)
ARTG Number: ARTG 286504

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

2~3cm
START
STOP

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

START
STOP

press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
SYS
DIA
<120
<80
120-129
80-84
130-139
85-89
140-159
90-99
160-179
100-109
≥180
≥110
Level
Blood
Pressure (mm Hg)
Optimal Normal High-normal Mild Moderate Severe

List
1.Digital Upper Arm Blood Pressure
Monitor BVDABPMTRKA
4.User manual
3. 4×AAA batteries
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.)
START
STOP

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

Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical
investigation
Usability
Software life-cycle
processes
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers
EN 60601-1-6: 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
EN 62304:2006/AC: 2008 Medical device software - Software
life cycle processes
EN ISO 14971:2012 Medical devices - Application of risk
management to medical devices
EN 980:2008 Symbols for use in the labelling of medical
devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement
type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part
3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
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 safety and essential
performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in
the home healthcare environment
IEC 80601-2-30:2009 Medical electrical equipment - Part
2-30: Particular requirements for the basic safety and
essential performance of automated noninvasive
sphygmomanometers