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4.3 Exhalation system
vented variants
Vented variants (transparent elbow and rotating
sleeve) have an integrated exhalation system. The re-
taining ring and mask body are shaped so that there
is a gap between these parts. The exhaled air can es-
cape through this gap.
Non-vented variants
Non-vented variants (blue retaining ring and elbow)
do not have an exhalation system. If you are using the
non-vented variant with an external exhalation valve,
please see the associated instructions for use.
4.4 Pressure measurement port
The mask has a pressure measurement port, which
can be used for measuring pressure or supplying oxy-
gen. If you are not using the connection, close it with
the seal for pressure measurement to reach therapy
pressure.
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 (except for mask
cushion and forehead cushion), clean thor-
oughly 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
Mask cushion
Replace mask cushion.
amaged.
Therapy pres-
Check connectors,
Patient circuit
sure is not
check tubes properly
leaking.
reached.
located.
Close pressure mea-
Air escapes at pres-
surement port with
sure measurement
plug (included in scope
port.
of supply).
8
Technical specifications
Product class to directive 93/42/EEC
X
Dimensions
(W x H x D)
Weight
X
Therapy pressure range
Tube connection: tapered
X
connection to EN ISO 5356-1
vented
non vented
Pressure measurement port
).
Temperature range:
Operation
Storage
Flow resistance vented
at 50 l/min
at 100 l/min
Flow resistance non vented
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
Standards applied
1
The mask materials deteriorate if exposed to e.g. ag-
gressive detergents. In individual cases it may be nec-
Remedy
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 leak-
age flow as a function of therapy pressure.
JOYCE SilkGel
).
100
100
90
90
80
80
70
70
60
60
50
50
40
30
20
10
0
0
5
Output pressure at therapy device (hPa)
IIa
10 Materials
80 mm x 130 mm
x 90 mm
Mask part
85 g
Mask cushion, forehead cushion
4 hPa - 40 hPa
Plug for pressure measurement port Silicone
Ø 22 mm (male)
Retaining ring
Ø 22 mm (female)
Ø 4 mm
Mask body, elbow
+5 °C to + 40 °C
Headgear clip
-20 °C to +70 °C
Forehead support, rotating sleeve
0,02 hPa
0,26 hPa
Headgear
0,09 hPa
0,37 hPa
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).
15 dB(A)
23 dB(A)
11 Warranty
3 dB(A)
1
Löwenstein Medical gives the customer a limited
up to 12 months
manufacturer warranty on new original
EN ISO 17510-2:2009
Löwenstein Medical products and any replacement
part fitted by Löwenstein Medical in accordance with
the warranty conditions applicable to the product in
question and in accordance with the warranty peri-
ods from date of purchase as listed below. The war-
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.
JOYCE SilkGel
Masks including accessories
12 Declaration of conformity
JOYCE SilkGel non vented
The manufacturer
Löwenstein Medical Technology GmbH + Co. KG
10
15
20
25
30
35
40
(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.
Material
Silicone, silicone gel,
silicone coating
TPE (thermoplastic
elastomer), PP (polypro-
pylene)
PC (polycarbonate), PA
(polyamide)
EN
Mask part
Material
POM
(polyoxymethylene)
PA (polyamide)
Elasthane, polyester, PU
(polyurethane), UBL
loop, cotton, PA (poly-
amide)
Product
Warranty
periods
6 months
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