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INTRODUCTION
Thank you for purchasing the G.LAB MD2000/MD2010/MD2040/
MD2050/MD2001/MD2011/MD2041/MD2051/MD2090 Blood
Pressure Monitor.
The device is easy-to-use and good for home users and healthcare
professionals. It applies non-invasive oscillometric method which
can measure your blood pressure and pulse rate quickly and easily,
and it saves the data automatically to let you review the average and
measured data at any time.
Indication for use
Digital Automatic Blood Pressure Monitor BPM20 Series is for use
by medical professional or home user. The BPM20 Series is
intended to measure the systolic and diastolic blood pressure, and
pulse rate of an adult individual by using a non-invasive technique,
in which an inflatable cuff is wrapped around the upper arm of an
individual. The inflatable cuff circumference is limited to 17cm –
44cm via 3 different size of cuffs. The 3 different cuff sizes are 17 –
22cm, 22 – 32cm and 32 – 44cm. For Bluetooth capable models,
the measurement result can be transmitted to pre-approved mobile
devices.
COMPLIANCE
This device conforms to European Medical Device Directive
93/42/EEC.
This device complies with:
• EN ISO 81060 standard relating to non-invasive sphygmomanom-
eters
Part 1: Requirements and test methods for non-automated
measurement types and EN 1060 standard relating to non-invasive
sphygmomanometers.
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems.
• EN 60601 standard relating to medical electrical equipment
Part 1-2: General requirements for basic safety and essential
performance and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and tests.
• EN 1060-4:2004 standard relating to non-invasive sphygmoma-
nometers
Part 4: Test procedures to determine the overall system accuracy
of automated non-invasive sphygmomanometers.
• ISO 81060-2:2013 standard relating to non-Invasive sphygmoma-
nometers
Part 2: Clinical validation of automated measurement type.
• IEC 80601-2-30:2009+A1:2013 standard relating to medical
electrical equipment
Part 2-30: Particular requirements for the basic safety and
essential performance of automated type non-invasive
sphygmomanometers.
Содержание MD2000
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