Inhoudsopgave
Advertenties
Beschikbare talen
Beschikbare talen
Risk of injury due to allergies!
Be aware of the materials used in the mask (see
⇒
section entitled "Materials"). Only use a mask fol-
lowing consultation with a healthcare profes-
sional. .
When selecting the detergent, consider potential
⇒
allergies.
4
Product description
A diagram of the individual parts can be found on
the title page.
Compatible devices
In some device combinations, the actual pressure
does not correspond to the therapy pressure dis-
played by the device. Have the device adjusted by a
healthcare professional so that the actual pressure
in the mask corresponds to the therapy pressure.
This adjustment should be made with the type of
mask that will be used during therapy.
Exhalation system
The mask has an integrated exhalation system. The
exhaled air escapes through a gap.
1 Headgear
6
Rotating sleeve
2 Forehead cushion
7
Mask body
3 Forehead support
8
Headgear clip
4 Retaining ring
9
Mask cushion
5 Elbow
10
5
Cleaning and reprocessing
5.1 Clean mask
1. Wash your hands before starting cleaning.
2. Dismantle mask (see Figure
).
3. Clean the mask by hand (max. 30 °C, 1 ml mild
detergent to 1 l water) in accordance with the fol-
lowing table:
Mask part
Frequency Action
All mask
Daily
Soak and wash for 15
parts
minutes and clean for 3
minutes using a soft
cleaning brush.
Headgear
Weekly
Wash for 15 minutes.
All parts can be washed in a dishwasher once a
week (max. 70 °C, mild detergent, max. pro-
gram length 90 minutes, top basket, separate
rinse).
4. Rinse all parts with clean water.
5. Allow all parts to air-dry.
EN
6. Carry out a visual inspection for cracks and de-
formations. Replace damaged parts. Discol-
oration is harmless.
7. Re-assemble mask (see Figure
).
5.2 Reprocessing (clinical environment)
In the event of a change of patient, follow the in-
structions in the document entitled Information on
reprocessing. The document can be found on the
manufacturer's website. We will send you this docu-
ment on request.
5.3 Disposal
Dispose of the mask in domestic waste. In the clinical
environment: Dispose of the mask in accordance
with hospital regulations.
6
Troubleshooting
Fault
Cause
Action
Pain due to
Mask too
Loosen headgear.
pressure on
tight.
the face
Draft in the
Mask too
Tighten headgear.
eye
loose.
Mask does not
Contact your spe-
fit.
cialist dealer.
Therapy pres-
Mask not cor-
Re-adjust mask.
sure not
rectly ad-
reached.
justed.
Mask cushion
Replace mask
damaged.
cushion.
Patient circuit
Check circuit and
damaged.
correct fit of cir-
cuit.
7
Technical data
Dimensions in mm
(W x H x D)
Size S
100 x 100 x 80
Size M
105 x 110 x 80
Size L
110 x 120 x 80
Weight
Size S
94 g
Size M
97 g
Size L
98 g
Dead space
Size S
100 ml
Size M
105 ml
Size L
115 ml
Tube connection: Tapered
Ø 22 mm (male)
connection to EN ISO 5356-1
Flow resistance
at 50 l/min
0.3 hPa
at 100 l/min
1.0 hPa
Service life
5 years
Useful life
Up to 12 months
Therapy pressure
4 hPa - 30 hPa
Quoted two-figure noise emis-
sion value according to ISO
4871:
Sound pressure level
17 dB(A)
Sound power level
25 dB(A)
Uncertainty factor
3 dB(A)
Temperature:
Operation
+5 °C to + 40 °C
Transport and storage
-20 °C to +70 °C
Standards applied
EN ISO 17510: 2020
Product class to MDR (EU)
IIa
2017/745
1
Useful life depends on cleaning and on the cleaning
agents used, on the amount of time worn daily, on
therapy pressure, and on individual secretion of
sweat. The use of the second mask cushion (option-
ally included) will not extend the useful life.
8
Materials
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate). If you are
allergic to any of the materials listed, only use the
mask after consulting a healthcare professional.
Headgear
CO (cotton), EL (elastane), P
(polyester), PU (polyurethane)
Headgear clip
PA (polyamide), POM (poly-
oxymethylene)
Forehead support
PA (polyamide)
Forehead cushion
SI (silicone)
Retaining ring
PP (polypropylene)
(hard component)
Retaining ring (soft
TPE (thermoplastic elastomer)
component)
Mask body
PA (polyamide)
Mask cushion
SI (silicone)
Elbow
PA (polyamide)
Rotating sleeve
PA (polyamide)
EN
9
Characteristic pressure/flow
curve
60,0
50,0
40,0
1
30,0
20,0
10,0
0,0
0
5
10
15
20
Therapy pressure (hPa)
10 Markings and symbols
The following markings and symbols may be applied
to the device, accessories or packaging.
Symbol Description
Manufacturer and, if necessary, date of
manufacture
Unique device identifier (unique product
code for medical devices)
Order number
Indicates the product is a medical device
Follow the instructions for use
Permitted temperature range for trans-
port and storage
Use by date
Keep out of sunlight
Lot number
CE symbol (confirms that the product
conforms to the applicable European di-
rectives/regulations)
11 Warranty
Löwenstein Medical Technology gives the purchaser
of a new original Löwenstein Medical Technology
product and of a spare part fitted by Löwenstein
Medical Technology a limited manufacturer warranty
in accordance with the warranty conditions applica-
ble to the product in question and in accordance
25
30
Advertenties
Inhoudsopgave
