User's Manual

Complied Standards List
FCC Statement
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.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to
radio communications. However, there is no guarantee that interference
will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and
on,the user is encouraged to try to correct the interference by one or more
of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.
FCC ID: OU9TMB1591-B
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 Medical electrical equipment - Part
1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
IEC60601-1-11:2010
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and
essential performance - Collateral
standard:Electromagnetic compatibility - Requirements
and tests
IEC 80601-2-30:2009+A1:2013 Medical electrical
equipment- Part 2-30: Particular requirements for the
basic safety and essential performance of automated
non-invasive sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 62366:2007+A1:2014
IEC 60601-1-6:2010+A1:2013 Medical electrical
equipment - Part 1 -6 : General requirements for basic
safety and essential performance - collateral standard :
Usability
ISO81060-2 Non-invasive sphygmomanometers —
Part 2: Clinical validation of automated
measurement type
COMPLIED STANDARDS LIST FCC STATEMENT
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