A&D WM:PD4000136 Ambulatory Blood Pressure Monitor - Manual (Page 4)

Page 2
Compliance Before use
Before use
Compliance
Compliance with European Directive
93/42 EEC for Medical Products
The device conforms to the following requirements: European Directive 93/42 EEC for
Medical Products; Medical Products Act; European Standards for Electrical Medical Equip-
ment EN 60601-1 (General Safety Provisions), EN 60601-2-30 (Particular Requirements for
the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment) , EN 60601-
1-2 and EN 55011 (Electromagnetic Compatibility); European Standards pertaining to Non
Invasive Blood Pressure Instruments EN 1060-1 (General Requirements), EN 1060-3
(Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems).
The above is evidenced by the CE mark of conformity accompanied by the reference number
of a designated authority. This device is designed for adults only.
Compliance with FCC Rules
Please note that this equipment generates, uses and can radiate radio frequency energy.
This equipment has been tested and has been found to comply with the limits of a Class A
computing device pursuant to Subpart J of Part 15 of FCC rules. These rules are designed
to provide reasonable protection against interference when this equipment is operated in a
commercial environment. If this unit is operated in a residential area it might cause some
interference and under these circumstances the user would be required to take, at his own
expense, whatever measures are necessary to eliminate the interference. (FCC: Federal
Communications Commission in the U.S.A.)
Compliance with the Australian EMC Frame
work
The device conforms to the following requirements: EMC Emission standard for
industrial, Scientific & Medical equipment AS/ NZS 2064-1997, EMC Generic Immunity
standard AS/ NZS 4252. 1-1994. The above is evidenced by the C-Tick label.
Definitions
SYS Systolic Blood Pressure
DIA Diastolic Blood Pressure
DSD The Difference between Systolic Blood Pressure and Diastolic
Blood Pressure.
Exhaust This means "releasing the cuff air as soon as possible".
Exhaust velocity This means the rate of depressurizing the cuff air.
Measurement cycle This means "a period between the start of cuff inflation and the
end of exhausting the air".
Interval This is called a "block". A block consists of a start time and
frequency.
bpm beats per minute.