Contact Information
For more information about our products, please visit www.transtekcorp.com.
you can get customer service, usual problems and customer download, Transtek
will serve you anytime.
Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
EC REP
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application
of risk management to medical devices
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of
medical devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 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
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
IEC 80601-2-30:2018 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2:
Clinical validation of intermittent automated measurement type
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
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Contact Information
COMPLIED STANDARDS LIST
FCC Statement
This device complies with Part 15 of the FCC Rules. Operation is subject to
the 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:
contains FCC ID
：
OU9TMB207401
-- 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.
