4
STANDARDS
In addition to the standards stated in the Instruction Manual:
• This medical device is compliant with medical device and non-invasive
blood pressure monitor standards IEC 60601-1, IEC 60601-1-2, IEC
60601-1-11, and AAMI/ANSI/IEC 80601-2-30, and
• Electromagnetic standards IEC 60601—1-2 along with FCC Part 15, and
• Clinical Testing per standard ISO 81060-2:2013 was conducted on blood
pressure device using the same measurement technology.
Please note: According to international standards, your monitor should be
checked for accuracy every 2 years.
TYPE
IP20 Protected against solid foreign particles with a diameter of more than
12.5 mm, no protection against water. Keep Dry.
Type BF Applied Part
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestic waste.
Expected Life
Monitor: 5 Years
Cuff: 2 Years
BHS
The B.H.S. (British Hypertension Society) clinical protocol was used to measure
the accuracy of this product. Blood pressure units using the same measurement
technology are graded “AA” for systolic/diastolic accuracy by independent
investigators using the BHS protocol. This is the highest grading available for
blood pressure monitors. Please see bhsoc.org for more information. (Uses the
same algorithm as B.H.S. graded “AA” model number 3BT0-1)
FCC
This device complies with part 15 of the FCC Rules. Operation is subject to
the following
two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation. Changes or
modifications to the product are not approved by Microlife USA and could
void the user's authority to operate the equipment under FCC jurisdiction.
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