Technical Specifications - Lowenstein Medical JOYCEone Mode D'emploi

EN
there is a gap between these parts.The exhaled air
can escape through this gap.
5 Cleaning and 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,
max. temperature 70 °C.
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 Hygiene treatment (clinical
sphere)
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 available on the manufacturer's
website. We will also send you this brochure on re-
quest.
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 tubes properly
leaking.
located.
8

Technical specifications

Product class to directive
93/42/EEC
X
Dimensions
96 mm x 115 mm x 83 mm
(W x H x D)
X
Weight
Therapy pressure range
Tube connection: tapered
X
connection to EN ISO 5356-1
Temperature range:
Operation +5 °C to + 40 °C
Transport and 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
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.
9 Pressure/flow curve
The characteristic pressure/flow curve shows the
leakage flow as a function of therapy pressure.
70
Remedy
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 these substances:
Mask cushion, forehead cushion,
spring of forehead support
Retaining ring (hard component)
IIa
Retaining ring (soft component)
Headgear clip
87 g
Forehead support, rotating sleeve,
mask body, elbow
4 hPa - 30 hPa
Ø 22 mm (male)
Headgear
No parts of the mask contain latex, PVC (polyvinyl
0.2 hPa
chloride) or DEHP (diethylhexyl phthalate).
0.9 hPa
11 Warranty
Löwenstein Medical Technology gives the customer a
18 dB(A)
limited manufacturer warranty on new original
26 dB(A)
Löwenstein Medical Technology products and any re-
3 dB(A)
placement part fitted by Löwenstein Medical
5 years
Technology in accordance with the warranty condi-
1
tions applicable to the product in question and in ac-
cordance with the warranty periods from date of
purchase as listed below. The warranty 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 Ham-
burg, Germany) hereby declares that the product
complies with the relevant regulations of Directive
8 12 16 20 24 28 32
93/42/EEC governing medical devices. The un-
abridged text of the Declaration of Conformity can be
found on the manufacturer's website.
SI (silicone)
PP (polypropylene)
TPE (thermoplastic
elastomer)
PA (polyamide), POM
(polyoxymethylene)
PA (polyamide)
EL (elastane), PES (poly-
ester), PU (polyure-
thane), UBL loop,
CO (cotton),
PA (polyamide)
EN
Product Warranty
periods
6 months