Introduction; Compliance - G-Lab MD1500 Instruction Manual

INTRODUCTION

Thank you for purchasing the G.LAB MD1500/MD1520/MD1590
Wrist 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 Wrist Blood Pressure Monitor WBPM15 Series is
for use by medical professional or at home. The WBPM15 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 wrist 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
sphygmomanometers
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.
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