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16. RULES FOR REFERENCE

Device standard:

This device complies with the European standard requirements for

 

non-invasive arterial pressure control instruments

 

EN1060-1 / 12:95

 

EN1060-3 / 09:97

 

DIN 58130, NIBP – clinical research

 

ANSI / AAMI SP10, NIBP – requirements

 

 

Electromagnetic

This device complies with the European standard specifications

compatibility:

EN 60601-1-2

 

 

Clinical test:

The clinical function test was conducted in Germany, in accordance

 

with the DIN 58130 / 1997 N6 (sequential) procedure.

 

 

In compliance with the specifications in the EU 93/42/CEE directive for Class IIa medical products.

17. TECHNICAL SPECIFICATIONS

Storage temperature:

–5 ºC to +50 °C

 

 

 

Humidity:

15 - 85% maximum relative humidity

 

 

 

Working temperature:

10 ºC to 40 °C

 

 

 

Screen:

Liquid crystal display

 

 

 

Method of measurement:

Oscillometric

 

 

 

Measurement interval:

 

 

SYS / DIA:

30 to 280 mmHg ± 3 mmHg

Beat:

40 to 200 beats per minute ± 5% of the reading

Tensometer pressure

 

 

indication limits:

From 0 to 299 mmHg. As from 300 mmHg, "HI" is displayed.

 

 

 

Measurement resolution:

1 mmHg

 

 

 

Power supply:

4 x LR 06 type (AA) 1.5V batteries (supplied with the device).

 

 

 

18. WASTE ELIMINATION

The materials used in the packaging, product and accessories can be

recycled. Correct separation of waste materials will allow recyclable materials

to be re-used.

When the appliance is no longer useful, you should cut its cord to put it out of action and dispose of it using a suitable waste elimination procedure. For

further information on this matter, consult your local authorities.

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Fagor America ts8-10 manuel dutilisation Rules for Reference, Technical Specifications, Waste Elimination