Braun VitalScan Plus BP 1650 Manual page 12

Clinical accuracy:
Inflation:
Deflation:
Power supply:
Operating temperature:
Storage temperature:
Humidity:
Cuff:
Clinical validation:
If device is not used within specified temperature and humidity ranges the technical
accuracy can not be ensured.
Type BF equipment
Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using cuff/stethoscope auscultation method, within
the limits prescribed by the American National Standard, Electronic or automated
sphygmomanometers.
Subject to change without notice.
This device conforms to the following standards:
DIN EN 60601-1: 3/96 «Medical electrical equipment» –
Part 1: General requirements for safety
DIN EN 1060-1: 12/95, AMD 1 09/02 «Non-invasive sphygmomanometers» –
Part 1: General requirements
DIN EN 1060-3: 9/97 «Non-invasive sphygmomanometers» –
Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems
12
According to AAMI-SP10 with auscultatory reference:
< 5 mmHg systematic offset
< 8 mmHg standard deviation
Automatic
Step valve
2 batteries, type LR 03 (AAA)
+ 10 °C to + 40 °C
– 20 °C to + 60 °C
Up to 85% RH
Suitable for wrist circumference of 13 to 21 cm
According to AAMI-SP10 with auscultatory reference.
(Please note that a validation against intra-arterial
measurements can lead to different results for devices
which are calibrated against auscultatory reference.)