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: OU9TMB1597BN
ISO 14971:2007 Medical devices - Application of risk
management to medical devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
IEC 60601-1-2:2014 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 62304:2006/AC: 2008 Medical device software -
Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO 15223-1:2012 Medical devices - Symbols to be
used with medical device labels, labelling and information
to be supplied - Part 1 General requirements
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
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and essential
performance - collateral standard : Usability
ISO 81060-2:2009 Non-invasive
sphygmomanometers - Part 2: Clinical validation of
automated measurement type
MODIFICATION: Any changes or modifications not expressly approved
by the grantee of this device could void the user’s authority to operate the
device.
28 29
COMPLIED STANDARDS LIST FCC STATEMENT