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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.
Mask too
Tighten headgear
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 tubes properly
leaking.
located.
8
Technical specifications
Product class to direc-
X
tive 93/42/EEC
Dimensions
X
(W x H x D)
Size S
100 mm x 100 mm x 80 mm
X
Size M
105 mm x 110 mm x 80 mm
Size L
110 mm x 120 mm x 80 mm
Weight
Size S
Size M
Size L
Therapy pressure range
4 hPa - 30 hPa
Tube connection: ta-
pered connection to EN
Ø 22 mm (male)
ISO 5356-1
Temperature range:
Operation
+5 °C to + 40 °C
Storage
-20 °C to +70 °C
Flow resistance
at 50 l/min
at 100 l/min
Quoted two-figure noise
emission value to ISO
4871:
- Sound pressure level
- Sound power level
- Uncertainty factor
Service life
up to 12 months
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.
Remedy
The right to make design modifications is reserved.
9
Pressure/flow curve
The characteristic pressure/flow curve shows the
leakage flow as a function of therapy pressure.
70
).
60
50
40
30
20
10
0
4
8
Output pressure at therapy device (hPa)
IIa
10 Materials
Mask cushion, forehead cushion
Retaining ring (hard component)
Retaining ring (soft component)
72 g
Headgear clip
75 g
Forehead support, rotating sleeve,
78 g
mask body, elbow
Headgear
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).
11 Warranty
0.16 hPa
0.64 hPa
Löwenstein Medical gives the customer a limited
manufacturer warranty on new original
Löwenstein Medical products and any replacement
part fitted by Löwenstein Medical in accordance with
16 dB(A)
the warranty conditions applicable to the product in
24 dB(A)
question and in accordance with the warranty peri-
3 dB(A)
ods from date of purchase as listed below. The war-
1
ranty conditions are available on the website of the
manufacturer. We will also send you the warranty
conditions on request.
Please bear in mind that any claim to warranty and li-
ability shall be void if neither the accessories recom-
mended in the instructions for use nor genuine
replacement parts are used.
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 Hamburg, Germany) here-
by declares that the product complies with the rele-
vant regulations of Directive 93/42/EEC governing
medical devices. The unabridged text of the
Declaration of Conformity can be found on the
manufacturer's website.
12
16
20
24
28
32
36
40
44
Silicone
PP (polypropylene)
TPE (thermoplastic
elastomer)
PA (polyamide), POM
(polyoxymethylene)
PA (polyamide),
PC (polycarbonate)
Elastane, polyester,
PU (polyurethane),
UBL loop, cotton,
PA (polyamide)
EN
Product
Warranty
periods
6 months
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