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16. RULES FOR REFERENCE
Device standard:
Electromagnetic
compatibility:
Clinical test:
In compliance with the specifications in the EU 93/42/CEE directive for Class IIa medical
products.
17. TECHNICAL SPECIFICATIONS
Storage temperature:
Humidity:
Working temperature:
Screen:
Method of measurement:
Measurement interval:
SYS / DIA:
Beat:
Tensometer pressure
indication limits:
Measurement resolution:
Power supply:
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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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
This device complies with the European standard specifications
EN 60601-1-2
The clinical function test was conducted in Germany, in accordance
with the DIN 58130 / 1997 N6 (sequential) procedure.
–5 ºC to +50 °C
15 - 85% maximum relative humidity
10 ºC to 40 °C
Liquid crystal display
Oscillometric
30 to 280 mmHg ± 3 mmHg
40 to 200 beats per minute ± 5% of the reading
From 0 to 299 mmHg. As from 300 mmHg, "HI" is displayed.
1 mmHg
4 x LR 06 type (AA) 1.5V batteries (supplied with the device).
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