Lowenstein Medical JOYCEone Mode D'emploi page 6

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.
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
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.
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 Adjust headgear
pressure on tight. so that it is looser.
the face
Draft in the Full face mask Adjust headgear
eye fits too so that it is tighter.
loosely.
Mask does not Contact your spe-
fit. cialist dealer.
Therapy pres- Mask is not Re-adjust mask.
sure is not correctly ad-
reached. justed.
Mask cushion Replace mask
is damaged. cushion.
Circuit is dam- Check circuit and
aged. the correct fit of
circuit.
7 Technical data
Dimensions in mm
(W x H x D) 96 x 115 x 83
Weight 87 g
Dead space 90 ml
Tube connection: Tapered Ø 22 mm (male)
connection to EN ISO 5356-1
Flow resistance
at 50 l/min 0.2 hPa
at 100 l/min 0.9 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
Sound power level
Uncertainty factor
Temperature:
Operation
Transport and storage
Standards applied
Product class to MDR (EU)
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).
Headgear CO (cotton), EL (elastane), PA
(polyamide), P (polyester), PU
(polyurethane)
Headgear clip PA (polyamide), POM (poly-
oxymethylene)
Forehead support PA (polyamide)
Spring of forehead SI (silicone)
support
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)
1
EN
9 Characteristic pressure/flow
curve
70
19 dB(A)
27 dB(A) 60
3 dB(A)
50
40
+5 °C to + 40 °C
-20 °C to +70 °C 30
EN ISO 17510: 2020
20
IIa
10
0
0 5 10
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
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