EN
between these parts. The exhaled air can escape
through this gap.
4.4 Anti-asphyxia valve
Risk of asphyxia if anti-asphyxia valve not
working properly!
Residues may cause the valve to stick and lead to
CO
being re-inhaled.
2
Check before every use that the openings of the
anti-asphyxia valve are clear.
If the therapy device fails, the anti-asphyxia valve
opens so that the patient can breathe ambient air.
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.
Or: Put the mask parts in the dishwasher.
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
Mask cushion
Replace mask cushion.
amaged.
Therapy pres-
Check connectors,
sure is not
Patient circuit
check tubes properly
reached.
leaking.
located.
Anti-asphyxia valve
defective (only
Replace the mask.
vented).
X
X
X
8
Technical specifications
Product class to directive
93/42/EEC
Dimensions
(W x H x D)
Size S
Size M
Size L
Weight
Size S
Size M
Size L
Dead space
Remedy
Size S
Size M
Size L
Therapy pressure range
Tube connection: tapered
connection to
EN ISO 5356-1
vented
Temperature range:
).
Operation
Transport and storage
Flow resistance
at 50 l/min
at 100 l/min
Flow resistance, anti-as-
phyxia valve
Inspiration at 50 l/min:
Exhalation at 50 l/min:
Switching pressure
Anti-asphyxia valve
• Open:
• Close:
Quoted two-figure noise
emission value to
ISO 4871:
- Sound pressure level
- Sound power level
- Uncertainty factor
Service life
Standards applied
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
The characteristic pressure/flow curve shows the
IIa
leakage flow as a function of therapy pressure.
70
80
60
70
93 mm x 145 mm x 89 mm
50
95 mm x 160 mm x 90 mm
60
40
95 mm x 174 mm x 91 mm
50
30
40
93 g
20
30
97 g
10
20
102 g
0
10
4
0
0
5
180 ml
Output pressure at therapy device (hPa)
219 ml
244 ml
10 Materials
4 hPa - 25 hPa
Mask part
Mask cushion
Link
Ø 22 mm (male)
Headgear clip
+5 °C to + 40 °C
Rotating sleeve, mask body, elbow PA (polyamide)
-20 °C to +70 °C
Headgear
0.15 hPa
0.5 hPa
Emergency exhalation system:
Elbow, anti-asphyxia valve, valve
safety device
0.6 hPa
No parts of the mask contain latex, PVC (polyvinyl
0.8 hPa
chloride) or DEHP (diethylhexyl phthalate).
11 Warranty
0.5 hPa
2.2 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
19 dB(A)
the warranty conditions applicable to the product in
27 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
up to 12 months
manufacturer. We will also send you the warranty
EN ISO 17510-2:2009
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.
EN
8
12
16
20
24
28
32
10
15
20
25
30
35
40
Material
SI (silicone)
PA (polyamide)
PA (polyamide)
Elastane, polyester,
PU (polyurethane),
CO (cotton)
PA (polyamide),
SI (silicone),
PP (polypropylene)