NDD EasyOne Pro Operator's Manual page 131

Specifications and bibliography
Age range for patients For spirometry
For DLCO
Voltage
Power consumption
(device)
Appliance class
Instrument
classification
IP Code
Storage conditions Temperature
Humidity
Atmospheric
pressure
Operating conditions Temperature
Humidity
Atmospheric
pressure
Gas specification DLCO gas
specification
Certifications and
standards
EU
US
Associations
and institutes
Life time
 Specifications for EasyOne Pro/LAB
Operator's Manual V5.0 • EasyOne Pro/LAB Rev. 05
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
>4 years
>6 years
100 V to 240 V AC, 50 or 60 Hz
Up to 80 VA
Class I
Type BF applied part
IP20
-20°C to +50°C (-4°F to +122°F)
5% to 95% (non-condensing)
500 hPa to 1060 hPa
5°C to 40°C (41°F to 104°F)
15% to 95% (non-condensing)
700 hPa to 1060 hPa
10% helium, accuracy ±10%
0.3% carbon monoxide, accuracy ±10%
18% to 25% oxygen,
balance nitrogen
IEC 60601-1 Medical electrical equipment. General requirements for basic
safety and essential performance
IEC 60601-1-2 Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral standard. Electromagnetic
compatibility. Requirements and tests
IEC 62304 Medical device software – Software life cycle processes
IEC 62366 Medical devices. Application of usability engineering to medical
devices
ISO 9001 Quality management systems — Requirements
ISO 13485 Medical devices — Quality management systems — Requirements
for regulatory purposes
ISO 14971 Medical devices. Application of risk management to medical
devices
ISO 26782 Anesthetic and respiratory equipment. Spirometers intended for
the measurement of time forced expired volumes in humans
ISO 23747 Anesthetic and respiratory equipment. Peak expiratory flow meters
for the assessment of pulmonary function in spontaneously breathing
humans
CE marked, EC declaration of conformity, see on the ndd website under
"Certificates"
FDA 510(k) market clearance
ATS/ERS 2005, NIOSH, OSHA
7 years
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