Measurement Accuracy; Technical Data - Panasonic EW3036 Operating Instructions Manual

EW3036EU_25-45 05.2.17 7:55 PM ページ 44

Measurement accuracy

General
This blood pressure measurement device complies with the European
regulations (EU council directive 93/42/EEC dated June 14, 1993) and
bears the CE mark "CE 0197". The quality of the device has been verified
and it conforms to the following standards:
EN 1060-1 (Dec. 1995) Non-invasive blood pressure measuring
equipment
General requirement
EN 1060-3 (Sep. 1997) Non-invasive blood pressure measuring
equipment
Supplementary requirements for
electromechanical blood pressure measuring
systems
ANSI/AAMI SP10 (1992) Electronic or automated sphygmomanometers
Overall system efficacy
Auscultatory method as the reference standard
EN 60601-1-2 (Nov. 2001) Electromagnetic compatibility and safety for
medical electrical equipment
The CE mark serves to facilitate the free movement of goods between the
member countries of the EU.
Panasonic ensures accurate measurement
The seal confirms that each Diagnostec has been checked for
accurate measurement at the Matsushita plant. It is
recommended that the device be recalibrated every 3 years
starting with the year printed on the seal.
When the device has been repaired or the seal has been rendered illegible,
the accuracy of the device should be assumed to be inaccurate. In such
cases, it is recommended that the device be submitted for recalibration.
CALIBRATED UNTIL
2008
44

Technical data

Warning function
Method of measurement:
(oscillometric)
Measuring range:
Measuring accuracy:
Leakage of pneumatic system:
Inflation/deflation system:
Wrist circumference:
Batteries:
(Control sign for battery change)
Automatic switch-off:
Reference method for clinical trials: Auscultatory measurement
Weight:
Storage and transport conditions:
Operating conditions:
EW3036 was proven clinically by sequential comparison with auscultatory
measurement. The waiting period before EW3036 evaluation requires 1.5-2
minutes, and before auscultatory measurement of 0.5-1 minute.
EW 3036
Flashing figures on the display and
3 color LED
Intelligent measuring technology
(FUZZY LOGIC)
Pressure: 0–280 mmHg
The device is vented automatically at
pressures exceeding 280 mmHg and
an error message is shown.
Pulse: 30–160 beats per minute
Pressure ± 3 mmHg
Pulse rate: ± 5 %
≤ 6 mmHg/min
Automatic measurement during
inflation, and rapid deflation
12.5–22.0 cm (4 7/8–8 5/8 inches)
2#1.5 V alkaline (LR03/AAA/Micro)
Battery symbol appears when the
batteries have to be replaced.
Approx. 5 minutes after measurement
90 g (without batteries)
– 10˚C to + 60˚C, 10% to 95% RH
+ 10˚C to + 40˚C, 30% to 85% RH
45