Yahorng BP-700W Instruction Manual page 3

* COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
* IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007);
* EN 60601-1: 2006 Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
* ANSI/AAMI ES60601-1: 2005:
Medical Electrical Equipment-Part1: General requirement for basic safety and essential
performance
* EN1060-1: 1995 with Amendment A2: 2009:Non-invasive sphygmomanometer
Part 1: General requirements
* EN1060-3: 1997 with Amendment A2: 2009: Non-invasive sphygmomanometers,
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring
systems
* EN55011: 2007 + A2: 2007;
* EN60601-1-2: 2007 / AC 2010: Medical electrical equipment: Part 1-2:
General requirements for basic safety and essential performance
* EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine
the overall system accuracy of automated non-invasive sphygmomanometers.
* FCC 47 CFR PART 18: Electromagnetic Compatibility
* EN ISO 13485:2003 /AC:2009 & ENISO1497:2009
* EN ISO 10993-1:2009 Biological evaluation of medical devices
* ANSI/AAMI SP10:2002/(R)2008 -Manual, electronic, or automated sphygmomanometers
* ANSI/AAMI/ISO 81060-2:2009 Non-invasive sphygmomanometers -
Gederal Communications Commission (FCC) Statement
15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for compliance
could void the user's authority to operate the equipment.
15.105(b)
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.
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 of the device.
FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
End users must follow the specific operating instructions for satisfying RF exposure compliance.
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