Page 2
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 Equipment EN60601-1
(General Safety Provisions), EN60601-2-30 (Particular Requirements for the Safety of Automatic
Cycling Indirect Blood Pressure Monitoring Equipment), EN60601-1-2 and EN55011 (Electromagnetic
Compatibility); European Standards pertaining to Non Invasive Blood Pressure Instruments EN1060-1
(General Requirements), EN1060-3 (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 Framework
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".
Constant exhaust This means "releasing the cuff air in a constant depressurization rate".
Exhaust velocity This means the rate of depressurizing the cuff air.
During a measurement
This means "a period between the start of cuff inflation and the
end of exhausting the air".
Interval This is called "block". A block consists of a start time and frequency.
bpm beats per minute.
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