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4.3 Exhalation system
The mask has an integrated exhalation system. The
forehead support and mask body are shaped so that
there is a gap between these parts. The exhaled air
can escape through this gap.
5
Hygiene treatment
Risk of injury from inadequate cleaning!
Residues may congest the mask, impair the
integrated exhalation system and jeopardize therapy
success.
For patients with a compromised immune system
or particular background of illness, disinfect
mask components daily following consultation
with the physician.
5.1 Clean mask
1. Dismantle mask (see Figure
).
2. Clean mask in accordance with the table below:
Action
Wash mask components with warm water
and a mild detergent.
When washing mask parts, clean thoroughly
with a cloth or a soft brush.
Wash headgear by hand.
3. Rinse all parts with clear water.
4. Allow all parts to air-dry.
5. Perform a visual inspection.
6. If necessary: replace damaged parts.
7. Re-assemble mask (see Figure
).
r
Discolorations of mask components do not impair
the functionality of the mask.
5.2 Change of patient
In the clinical sphere only: You must subject the mask
to a hygiene treatment in the event of a change of
patient. Information on the hygiene treatment with a
change of patient can be found in a brochure avail-
able on the manufacturer's website. We will also send
you this brochure on request.
6
Disposal
You can dispose of all parts in domestic waste.
7
Troubleshooting
Fault
Cause
Pain from
Loosen headgear
pressure on
Mask too tight.
slightly.
the face.
Tighten headgear
Mask too loose.
slightly.
Draft in the
eye.
Contact your specialist
Mask does not fit.
dealer.
Mask not correctly
Re-adjust mask (see
adjusted.
Figure
Therapy pres-
Mask cushion
Replace mask cushion.
sure is not
amaged.
reached.
Check connectors,
Patient circuit
check tube properly
leaking.
located.
8
Technical specifications
Product class to directive 93/
42/EEC
Dimensions
(W x H x D)
X
Size XS
72 mm x 112 mm x 70 mm
Size S/M
72 mm x 117 mm x 70 mm
X
Size M/L
72 mm x 118 mm x 70 mm
X
Weight
Size XS
Size S/M
Size M/L
Therapy pressure range
Tube connection: tapered
connection to EN ISO 5356-1
Temperature range:
Operation
Transport and storage
Flow resistance
at 50 l/min
at 100 l/min
Quoted two-figure noise emis-
sion value to ISO 4871:
- Sound pressure level
- Sound power level
- Uncertainty factor
Service life
Useful life
Standards applied
EN ISO 17510-2:2009
1
The mask materials deteriorate if exposed to e.g. ag-
gressive detergents. In individual cases it may be nec-
essary to replace mask parts sooner.
The right to make design modifications is reserved.
9
Pressure/flow curve
Remedy
The characteristic pressure/flow curve shows the
leakage flow as a function of therapy pressure.
70
60
50
40
30
).
20
10
0
4
Output pressure at therapy device (hPa)
10 Materials
Only use the mask after consulting your physician if
you are allergic to any of the following substances:
IIa
Mask cushion
Forehead support, rotating sleeve,
mask body, elbow, headgear clip
Headgear
58 g
No parts of the mask contain latex, PVC (polyvinyl
59 g
chloride) or DEHP (diethylhexyl phthalate).
60 g
4 hPa - 30 hPa
11 Warranty
Ø 22 mm (male)
Löwenstein Medical gives the customer a limited
manufacturer warranty on new original
+5 °C to + 40 °C
Löwenstein Medical products and any replacement
-20 °C to +70 °C
part fitted by Löwenstein Medical in accordance with
the warranty conditions applicable to the product in
question and in accordance with the warranty peri-
0.2 hPa
ods from date of purchase as listed below. The war-
0.9 hPa
ranty conditions are available on the website of the
manufacturer. We will also send you the warranty
conditions on request.
18 dB(A)
Please bear in mind that any claim to warranty and li-
26 dB(A)
ability shall be void if neither the accessories recom-
3 dB(A)
mended in the instructions for use nor genuine
5 years
replacement parts are used.
1
up to 12 months
In the event of a claim under warranty, contact your
specialist dealer.
Masks including accessories
12 Declaration of conformity
The manufacturer Löwenstein Medical Technology
GmbH + Co. KG (Kronsaalsweg 40, 22525
y
Hamburg, Germany) hereby declares that the product
complies with the relevant regulations of Directive
93/42/EEC governing medical devices. The un-
abridged text of the Declaration of Conformity can be
found on the manufacturer's website.
8
12
16
20
24
28
32
Silicone
PA (polyamide)
Elastane, polyester,
PU (polyurethane),
UBL loop, cotton
EN
Product
Warranty
periods
6 months
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