Leader BP3MS1-3B, Instruction Manual

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10. Standards
Device standard
: Device corresponds to the requirements
of the standard for non-invasive blood
pressure monitors:
AAMI / ANSI / IEC 80601-2-30
IEC 60601-1, IEC 60601-1-2, IEC 60601-11
Bluetooth® system to V4.0,FCC Part
15C
Electromagnetic compatibility:
Device fulfills the stipulations of the
International standard IEC 60601-1-2
IP20 Classification
: Protected against solid foreign particles
with a diameter of more than 12.5 mm,
no protection against water.
Keep Dry.
Clinical testing:
Testing per the ESH Protocol and ISO
81060-2:2013 was conducted on blood
pressure units using the same
measurement technology.
Expected Service Life:
Monitor: 5 years
Cuff: 2 years.
Do NOT use this device close to strong electromagnetic fields such as mobile
telephones or radio installations. Keep a distance from such devices when
using this unit.
Please note:
According to international standards, your monitor should be
checked for accuracy every 2 years.
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