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Beschikbare talen
Beschikbare talen
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. This is caused by the gas inside the combination valve
cooling when high pressure gas is being reduced to a low pressure (Joule-Thomson effect).
EN
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 approximately -6 °C. A homogenous mixture is achieved if
the temperature has raised above 10°C and the cylinder is 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.
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:
According to the test results the device can be considered safe for static magnetic fields up to 3
Tesla, with a maximum local static magnetic field of 40 mT (400 Gauss) or a spatial field gradient
of |�� B|< 0.5 Tesla/meter.
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.
Note: In case of doubt regarding the use of the device as described by this Instructions for use,
contact the medical device provider or manufacturer.
Note: In case of doubt regarding the gas therapy or in case of any undesired change in health
condition, contact your healthcare professional.
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