A&D Ambulatory Blood Pressure Monitor instruction manual Before use, Compliance, Definitions

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.

Compliance Page 2 Before use