Braun bp1600, BP 1650 manual Which are calibrated against auscultatory reference

Clinical accuracy: According to AAMI-SP10 with auscultatory reference:

<5 mmHg systematic offset

<8 mmHg standard deviation

Inflation:Automatic

Deflation:	Step valve
Power supply:	2 batteries, type LR 03 (AAA)
Operating temperature:	+ 10 °C to + 40 °C
Storage temperature:	– 20 °C to + 60 °C
Humidity:	Up to 85% RH
Cuff:	Suitable for wrist circumference of 13 to 21 cm
Clinical validation:	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.)

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

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