Technical Information - Deaflux DEAS Instrucciones De Uso

4 EN
INTENDED USE
Humidification chamber with autofeed system for invasive (patients that have bypassed airways) and non-invasive ventilation
for patients being treated in hospital or home environment. Can be used with the humidifiers listed on the label. The device
meets the biocompatibility requirements set forth for a short-term use (fewer than 30 days) in accordance with Directive
93/42/EEC and subsequent amendments.

TECHNICAL INFORMATION

Maximum peak flow: 180 l/min for 30 secs
Maximum Operating pressure: <8,826 kPa (90 cmH
Resistance to flow: @30L/min: 0,1 hPa (cmH
@60L/min: 0,3 hPa (cmH
WARNINGS
- DO NOT use the chamber if it has been
dropped.
- Use only sterile water, USP water for
inhalation or equivalent.
- Before starting ventilation, make sure
the water level is not above the black
maximum fill line.
- DO NOT fill the chamber above the
black maximum fill line to prevent liquid
entering the breathing circuit and then
the patient's airways.
- Make sure you periodically check the
water level in the humidification cham-
ber. The humidification chamber is fitted
with a coloured ring-shaped float mem-
ber that facilitates visual identification of
water level.
- Replace the device immediately should
the water level exceed the maximum
level marked by the black line and if the
connections become unsafe.
- Before connecting the respiratory hu-
midification system to the patient, check
its tightness with a test lung following
the manufacturer's instructions. Make
sure that there are no leaks or block-
ages.
- DO NOT begin ventilation before the
chamber is filled. Always check tem-
perature before connecting the circuit
to the patient. Certain conditions will
temporarily reduce the compressible
volume: starting the ventilator before the
chamber is filled or tilting the chamber
during operating.
- DO NOT use the humidification cham-
ber with flows higher than 180 l/min
or circuits with internal diameter lower
than 11 mm. Flows higher than 180 l/
min or high flow speeds due to circuits
with an internal diameter lower than 11
mm, may cause water spilling inside the
breathing circuit and eventually inside
the patient's airways and then the pa-
tient's airways. Visually check that there
is no water leakage when setting the
ventilation parameters.
- When using CPAP neonatal nasal gen-
erators, pressures higher than 90 cmH
may be reached inside the breathing
circuit, which prevent water from flow-
ing. For water to be able to flow, use a
pressure infusion bag, checking that
the liquid level does not rise above the
chamber's black safety line. Pressures
above 180 cmH O may cause the cham-
2
ber to break.
- Ensure that the chamber is always posi-
tioned lower than the patient, so that any
O)
2
O)
2
O)
2
condensed water does not drain back
towards the patient.
- DO NOT drain any condensed water
backwards towards the humidifier as
this can cause infections.
- Ensure that the humidifier is not tilted.
This could cause water to enter the
breathing circuit.
- DO NOT touch the heating plate or the
base of the chamber. The exposed sur-
faces of metal can be hot and cause
burns on contact.
- Single-use device to be used on a sin-
gle patient. Reuse may cause cross-
infections.
- The maximum duration of use is 7
days; thus replace the device regularly.
Use proper sticker indicating the day of
the week the product is due for replace-
ment. Prolonged use of the device after
the recommended replacement time
may cause it to malfunction and com-
promise safety.
- DO NOT soak, wash, sterilize or reuse
this product. Avoid contact with chemi-
cal substances, cleaning products or
sanitisers. These substances may dam-
age the device and cause the product to
malfunction.
- Do not use the humidification cham-
ber during the transport of patients as
undulating and sudden movements and
the airflow of the ventilator could cause
water to spill out of the breathing circuit
chamber, which may reach the patient's
airways.
- Take notice of all alarms generated by
the equipment connected.
- Non-conductive product. This product
is not suitable for use with inflammable
anaesthetic agents.
- When chamber is not in use, empty the
chamber and disconnect it from the ster-
ile water flacon or bag.
- This device should be used only by
qualified and/or trained personnel. It is
recommended to thoroughly acquaint
the instructions for use prior to use this
device.
O
- Open the packaging, checking that it is
2
complete and free from foreign bodies.
Do not use the device if the package is
damaged. Any damage or opening in
the package may affect sterility and/or
device performance. In this case do not
use the device concerned.
STORAGE AND DISPOSAL
The device should be stored respecting
the instructions given by the symbols
AUTOFEED HUMIDIFICATION CHAMBER
Compliance: 0.4 ml/hPa
Compressible Volume: 217 ml
Gas leakage: < 10 ml/min
on the packaging. After use, the device
must be treated and / or disposed of as
hazardous medical waste according to
local regulations in force.
RESPONSIBILITY
DEAS devices guarantee top quality and
products which are in compliance with
the standard in force for safe use. DEAS
will not be responsible for any conse-
quences resulting from incorrect choice
of model or size or use other than that
indicated. If you notice that the device's
features or performance have dete-
riorated or are malfunctioning and/or
there are serious problems, inform DEAS
straight away. If this happens, we will
need you to send the device concerned
along with appropriate photos, placed in
the original packaging so the batch can
be traced.
DIRECT TECHNICAL ASSISTANCE
If you are unsure about interpreting this
instruction leaflet or if you would like any
additional technical information, contact
the DEAS customer services directly at
the address indicated overleaf.