User's Manual

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.