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DIN 58130, NIBP – clinical investigation
US standard:
ANSI / AAMI SP10, NIBP – requirements
Electromagn. compatibility:
Device fulfills the stipulations of the European
standard EN 60601-1-2
Clinical testing:
Clinical performance testingwas carried out in
Germany according to the DIN 58130 / 1997
procedure N6 (sequential).
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have
been fulfilled.
TECHNICAL SPECIFICATIONS
Weight:
1.11 lbs (503 g) with batteries
Size:
4.6 (W) x 6.9 (L) x 3.0 (H) inches
Storage temperature:
-4˚F to 122˚C (–20˚C to +50°C)
Humidity:
15 to 90% relative humidity maximum
Operation temperature:
50˚F to 104˚F (10˚C to 40°C)
Display:
LCD-Display (Liquid Crystal Display)
Measuring method:
oscillometric
Pressure sensor:
capacitive
Measuring range:
SYS/DIA:
30 to 280 mmHg
Pulse:
40 to 200 beats per minute
Cuff pressure display range:
0–299 mmHg
Memory:
Automatically stores 2 x 30 measurements
Measuring resolution:
1 mmHg
Accuracy:
Pressure within ± 3 mmHg
Pulse ± 5 % of the reading
Power source:
DC 6V/600mA
a) Size AA, 1.5 V
b) AC adaptor 6 V DC 600 mA (included)
Accessories:
cuff type M for arm circumference 8.6 in – 12.5
in (22–32 cm) or
cuff type L for arm circumference 12.5 in – 16.5
in (32–42 cm)
Reference to standards:
EN 1060-1 /-3, NIBP - requirements
DIN 58130, NIBP - clinical investigations
ANSI / AAMI SP10, NIBP – requirements
Detailed user information about our thermometers and blood pressure monitors as
well as services can be found
at www.timexhealthcare.com.
Manufactured and Distributed under license by:
MEDport, LLC.
23 Acorn Street, Providence, RI 02903
1-800-422-0360
e-mail: info@medportllc.com
www.timexhealthcare.com
Made in China
TIMEX is a trademark of Timex Corporation.
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