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INTRODUCTION
Thank you for purchasing the G.LAB MD1100/MD1120/MD1130/
MD1150/MD1180 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 BPM11 Series is for use
by medical professional or at home. The BPM11 Series is intended
to measure the systolic and diastolic blood pressure, and pulse rate
(heartbeat rate) of an individual by using a non-invasive technique,
in which an inflatable cuff is wrapped around the upper arm of an
individual.
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.
Summary of Contents for MD1100
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