NDD EasyOne Air Operator's Manual page 90

Specifications and bibliography
Instrument
classification
Mode of operation
Wireless connection Type
Modulation
QoS
Frequency band
Transmit power
Receive sensitivity
Contains
transmitter module
Storage and transport Temperature
conditions
Relative humidity
Atmospheric
pressure
Battery
Operating conditions Temperature
Relative humidity
Atmospheric
pressure
Certifications and International
standards standards
EU
US
Associations and
institutes
Life time
 Specifications for EasyOne Air
Operator's Manual V03 • EasyOne Air • EasyOne Connect
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
Type BF applied part (the surface of the EasyOne Air enclosure)
Powered internally with a lithium-ion battery
Short usage time, less than 10 minutes
Not intended to be used in the presence of oxygen-rich environments
Continuous operation
Bluetooth: v2.1 + EDR, v3.0 + HS, v4.0
Bluetooth: GFSK, DQPSK, 8DPSK
WMM and WMM Power Save Support
Bluetooth: 2.402 GHz to 2.480 GHz
Bluetooth: 15 dBm (class-1)
Bluetooth: -94dBm
FCC ID: XF6-RS9113SB
IC ID: 8407A-RS9113SB
-20°C to 50°C (-4°F to 122°F)
5% to 90%
500 hPa to 1060 hPa
removed battery
0°C to 40°C (32°F to 104°F)
At 40°C (104°F) room temperature, the surface temperature of the applied
part of EasyOne Air can reach up to 44.7°C (112.5°F).
5% to 90%
700 hPa to 1060 hPa
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 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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