Compatible Devices; Change Of Patient; Troubleshooting - Lowenstein Medical JOYCEclinic Full Face Manual De Instrucciones

EN

4.2 Compatible devices

With many combinations of device, actual pressure in
the mask will not correspond to prescribed therapy
pressure, even if the therapy device is displaying the
correct pressure. Have the combination of devices
adjusted by a physician or specialist dealer so that
actual pressure in the mask corresponds to therapy
pressure.
4.3 Exhalation system
Vented variants
Vented variants (transparent retaining ring and
elbow) have an integrated exhalation system. The
retaining ring and mask body are shaped so that
there is a gap between these parts. The exhaled air
can escape through this gap.
Non-vented variants
Non-vented variants (blue retaining ring) do not have
an exhalation system. Only use non-vented full-face
masks in combination with therapy devices which
have an active exhalation valve and have alarms und
safety systems for any device failure. If you are using
the non-vented variant with an external exhalation
valve, please see the associated instructions for use.
4.4 Anti-asphyxia valve
Risk of asphyxia if anti-asphyxia valve not
working properly!
Residues may cause the valve to stick and lead to
CO being re-inhaled.
2
⇒ Check before every use that the openings of the
anti-asphyxia valve are clear.
If the therapy device fails, the anti-asphyxia valve
opens so that the patient can breathe ambient air.
5 Hygiene treatment
The mask is intended for single use only and should
not be disinfected or cleaned after use on the patient.
If the mask becomes slightly soiled, we recommend
cleaning it with a cloth wetted with isopropyl alcohol
(70 % v/v).

5.1 Change of patient

The mask is intended for a single patient and a
maximum usage period of 7 days.
6 Disposal
Dispose of the mask in accordance with hospital
regulations.
7

Troubleshooting

Fault Cause Remedy
Pain from
Loosen headgear
pressure on Mask too tight.
slightly.
the face.
Tighten headgear
Mask too loose.
slightly.
Draft in the
eye.
Use mask of different
Mask does not fit.
size.
Mask not correctly Re-adjust mask (see
adjusted. Figure ).
Therapy pres-
sure is not
Check connectors,
Patient circuit
reached.
check tubes properly
leaking.
located.
8 Technical data
Product class to directive
IIa
93/42/EEC
Dimensions (W x H x D)
Size S 100 mm x 145 mm x 110 mm
Size M 100 mm x 155 mm x 110 mm
Size L 100 mm x 165 mm x 110 mm
Weight
Size S 110 g
Size M 113 g
Size L 117 g
Therapy pressure range 4 hPa - 50 hPa
Tube connection: tapered
Ø 22 mm (female)
connector to EN ISO 5356-1
Temperature range:
operation +5 °C to + 40 °C
storage: -20 °C to +70 °C
Flow resistance, vented
at 50 l/min 0.03 hPa
at 100 l/min 0.1 hPa
Flow resistance, non-vented
at 50 l/min 0.08 hPa
at 100 l/min 0.32 hPa
Flow resistance, anti-
asphyxia valve
Inspiration at 50 l/min: 0.5 hPa
Exhalation at 50 l/min: 0.5 hPa
Switching pressure
Anti-asphyxia valve
• Open: 1 hPa
• Close: 2 hPa
Geometrical dead space:
Size S 225 ml
Size M 255 ml
Size L 305 ml
The right to make design modifications is reserved.
9 Materials
Mask part Material
Mask cushion, forehead cushion Silicone
Mask body Tritan (HTC)
Retaining ring Polypropylene (PP)
Elbow Polycarbonate (PC)
Polyoxymethylene
Headgear clip
(POM)
Polyoxymethylene
Quick-release cord (POM), cotton,
polyurethane (PU)
Elastane, polyester,
polyurethane (PU),
Headgear
UBL loop, cotton,
polyamide (PA)
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).
10 Warranty
Löwenstein Medical gives the customer a limited
manufacturer warranty on new original
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.
Product Warranty
periods
Masks including accessories 6 months
11 Declaration of conformity
The manufacturer
Löwenstein Medical Technology GmbH + Co. KG
(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.
12 Ordering information
Item, 1 per pack unit Item number
JOYCEclinic NV
Size S WM 26805
Size M WM 26815
Size L WM 26825
JOYCEclinic vented (leak 2)
Size S WM 26840
Size M WM 26850
Size L WM 26860
JOYCEclinic NV + AAV (leak 1)
Size S WM 26845
Size M WM 26855
Size L WM 26865
JOYCEclinic headgear (5 pcs) WM 26835
Item, 10 per pack unit Item number
JOYCEclinic NV
Size S WM 26857
Size M WM 26858
Size L WM 26859
JOYCEclinic vented (leak 2)
Size S WM 26866
Size M WM 26867
Size L WM 26868
JOYCEclinic NV + AAV (leak 1)
Size S WM 26869
Size M WM 26870
Size L WM 26871
EN