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STORAGE AND TRANSPORT
OPERATING CONDITIONS
CONDITIONS
-20* / +65** °C
-40 / +65 °C
*Note: For inner tightness of the shut-off valve, during transport and storage of the combination
EN
valve mounted on a cylinder, the valid lower temperature limit is -40°C.
In case of the combination valve storage temperature drops below -20°C do not use
the combination valve until its temperature reaches at least -20°C.
For the combination valves designed to be used with mixture of gases O
+N
O, the lowest
2
2
operating temperature is +5°C. In normal use of the combination valve, frosting can appear on
the combination valve surface, which is caused by the gas inside the combination valve when
high pressure in the combination valve cooling when high pressure gas is being reduced to
low pressure (Joule-Thomson effect). Check that all patient associated equipment connected
to the combination valve is via a hose of at least 2 metres length.
O
+N
O mixtures are temperature sensitive. N
O begins to separate out from the mixture
2
2
2
if the temperature falls below about -6°C. A homogenous mixture is again obtained when
the temperature has raised above 10°C and the cylinder was agitated. Before use, to ensure it
is properly mixed, cylinders should be stored horizontally for 24 hours at a temperature above
10°C. If this is not practicable, before use the cylinders must be maintained at a temperature
above 10°C for at least 2 hours and then completely inverted three times or placed in warm
water at body temperature for 5 minutes and then completely inverted three times.
In case the ambient valve temperature drops below -10°C or rises above +40°C, the battery is
being self-discharged, and therefore the lifetime is shortened.
** If the valve is used in the reach of a patient, the ambient temperature must not exceed 40°C.
When used in home care, the acclimatization time after a change of conditions from storage
(or transport) to operational must be at least 1 hour.
MAGNETIC RESONANCE (MR) CONDITIONAL REQUIREMENTS:
GCE medical combination valve itself is MR conditional. It means that this medical device can
be safely used in an MR environment meeting the following conditions:
Closer operating contitions in chapter 5.1.1.5 E-GAUGE in MR environment.
Note: GCE cannot guarantee the MR conditional status of the whole gas package.
4. PERSONNEL INSTRUCTIONS
The medical device provider must ensure that all personnel handling the medical device are
provided with the operating instructions & performance data. Gas source is not an integrated
part of the medical device.
4.1. INTENDED USER
The intended user is any person, i. e. Healthcare professional or lay user*, who has read and
understood the instructions for use and is able to operate the device correctly.
*The device is intended for lay users whose ability to operate the device is approved by the
healthcare professional who prescribed the gas therapy.
If a training is considered necessary, it should be provided by the provider of the gas package
(gas cylinder + integrated combination valve + associated equipment (cannula, breathing mask).
The device shall be installed by a filling station and delivered to the end-user as ready to use
the device.
Do not use the medical device without proper familiarization with the medical device and its
safe operation as defined in this Instructions for use. Be aware of particular information and
knowledge required for the gas in use.
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