Technical Specifications - Lowenstein Medical JOYCE SilkGel Manual De Instrucciones

EN
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 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 (except for mask
cushion and forehead cushion), clean thor-
oughly 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.
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).
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
Therapy pressure range
Tube connection: tapered
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
Remedy
Flow resistance non vented
at 50 l/min
at 100 l/min
Quoted two-figure noise emis-
sion value to ISO 4871:
- Sound pressure level
- Sound power level
- Uncertainty factor
Useful life
).
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.
9 Pressure/flow curve
The characteristic pressure/flow curve shows the leak-
age flow as a function of therapy pressure.
JOYCE SilkGel
IIa
100 100
90 90
80 80
86 mm x 121 mm x 63 mm
70 70
86 mm x 125 mm x 67 mm
60 60
86 mm x 126 mm x 70 mm
50 50
40
30
134 g
20
137 g
10
139 g
0
0 5
4 hPa - 40 hPa
Output pressure at therapy device (hPa)
Ø 22 mm (male)
10 Materials
Ø 22 mm (female)
Ø 4 mm
Only use the mask after consulting your physician if
you are allergic to any of the following substances:
+5 °C to + 40 °C
Mask part
-20 °C to +70 °C
Mask cushion, forehead cushion
0.06 hPa
Plug for pressure measurement
0.24 hPa
port
0.11 hPa
0.51 hPa Retaining ring
Mask body, elbow
15 dB(A)
23 dB(A)
Headgear clip
3 dB(A)
Forehead support, rotating sleeve PA (polyamide)
5 years
1
up to 12 months
Headgear
EN ISO 17510-2:2009
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).
11 Warranty
Löwenstein Medical Technology gives the customer a
limited manufacturer warranty on new original
Löwenstein Medical Technology products and any re-
placement part fitted by Löwenstein Medical Tech-
nology in accordance with the warranty conditions
applicable to the product in question and in accor-
dance with the warranty periods from date of pur-
chase as listed below. The warranty conditions are
available on the website of the manufacturer. We will
also send you the warranty conditions on request.
EN
JOYCE SilkGel
JOYCE SilkGel non vented
10 15 20 25 30 35 40
Material
SI (Silicone), SI (silicone
gel)
SI (Silicone)
TPE (thermoplastic
elastomer),
PP (polypropylene)
PC (polycarbonate),
PA (polyamide)
POM (polyoxymethylene)
EL (elasthane), PES
(polyester), PU (polyure-
thane), PA (polyamide),
CO (cotton)