Lowenstein Medical JOYCEone Manual De Instrucciones página 6

EN
For patients with a compromised immune sys-
⇒
tem or particular background of illness, disinfect
mask parts daily following consultation with the
healthcare professional.
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, actual pressure does
not correspond to the therapy pressure displayed by
the device. Have the device adjusted by a healthcare
professional so that actual pressure in the mask cor-
responds to therapy pressure. This setting should be
made using the type of mask 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. Wash mask by hand (max. 30 °C, 1 ml mild deter-
gent in 1 l water) in accordance with the table be-
low:
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.
6. Perform a visual inspection for cracks and defor-
mation. Replace damaged parts. Discoloration is
not a problem.
7. 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 the 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) 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 deter-
gents used, on the amount of time worn daily, on
therapy pressure, and on individual secretion of
sweat. Using the second mask cushion (included as
an option) does not extend useful life.
8 Materials
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate). In the
event of allergies to the materials listed, only use the
mask following agreement with the healthcare pro-
fessional.
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
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
Unique device identifier (uniform product
code for medical devices)
Order number
Indicates the product is a medical device
Lot number
Manufacturer and, if necessary, date of
manufacture
Follow the instructions for use
CE symbol (confirms that the product
conforms to the applicable European di-
rectives/regulations)
Permitted temperature range for trans-
port and storage
Use by date
Keep out of sunlight
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
EN
15 20 25 30 35