The Comite Europeen de Normalisation recently proposed a new standard
for 'the particular requirements of oxygen monitors for medical use'.
The feasibility of this proposed standard was tested in respect of (I)
accuracy of alarm activation (2) accuracy of oxygen display value dur
ing both continuous and cyclical gas flows (3) rise time during rapid
changes in oxygen concentration in the following 12 analysers: Datex C
apnomac II and Servomex 570A (paramagnetic); Bruel & Kjaer 1304 (magne
toacoustic); Criticare Poet II, Multinex, Drager Oxydig, Drager PM 803
0, Megamed 046A (part of the Megamed 700 ventilator), Ohmeda 5120, Spa
celabs Multigas, Teledyne TED 200 (galvanic); Kontron OM 810 (polarogr
aphic). All the analysers tested displayed an oxygen reading, which wa
s within +/-3 vol% of the actual oxygen concentrations of the test gas
es (15, 21, 40, 60 and 100 vol%). A cyclical pressure of between - 1.5
to + 8kPa did not affect the measured oxygen concentration as display
ed by the Bruel & Kjaer 1304, Datex Capnomac II and Servomex 570A anal
ysers. The remainder, however, showed, depending on their measuring pr
inciple, a display error of between -1 and +6 vol%. After exposure to
high pressure all the oximeters functioned normally. Some of the teste
d devices showed more than 2% of deviation between their alarm activat
ion and the preset alarm limits. Only the Kontron OM 810, the Megamed
046A and the Spacelabs Multigas monitors satisfied the requirements at
all the rested oxygen concentrations. The time required by the oxygen
analyser to display the rise from 29 to 92 vol% after a sudden change
of concentration from 21 to 100 uol% O-2 is defined as 'rise time' an
d must not, according to the Comite Europeen de Normalisation standard
proposal, exceed the manufacturers' specification by more than a fact
or of 1.15. The Bruel & Kjaer and Poet II monitors did not comply with
this requirement, although their rise times were among the shortest.
We conclude that the recommended standards concerning occuracy are gen
erally met during continuous gas flow. Some of the monitors tested fai
led to meet the required standard during cyclical flows and in the acc
uracy of their alarm response. These small deviations are,however, not
likely to be clinically relevant.