Smart One Oxi
English
Rev.1.8
User Manual
Page 30 of 35
SYMBOL
DESCRIPTION
Temperature limits: indicates the temperature limits to which the medical device
can be safely exposed
Humidity limitation: indicates the range of humidity to which the medical device
can be safely exposed
Pressure limitation: indicates the range of pressure to which the medical device
can be safely exposed
SMART ONE
OXI
complies with the Essential Requirements of Directive 93/42/EEC on
Medical Devices. This is based on CE Certificate no. MED 9826 issued by Kiwa Cermet,
notified Organism no. 0476.
13.
TECHNICAL SPECIFICATIONS
Peak Expiratory Flow
PEF (l/min)
Maximum Expiratory Volume in 1st
second
FEV1 (l)
Mean saturation percentage of
oxygen in the blood during the test
SpO2 (%)
Average heart rate during the test
BPM (heartbeats per minute)
Measuring system
Bi-directional turbine (rotary blade)
Spirometry principle of
measurement
Infrared interruption
Oximetry principle of
measurement
Reflective LED sensor, with double wavelength
Max. peak flow
PEF 960 l/min (16 l/s)
Volume max
FEV1 10l
Volume accuracy (ATS 2019)
The greater value between
2.5% and
0.05 l
Peak flow accuracy
The greater value between
10% and
20 l/min
(
0.33 l/s)
Dynamic resistance at 12 L/s
<0.5 cm H
2
O/L/s
SpO2 measurement range
70%-100%
