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9. Headgear clip

10. Quick-release cord

11. Rotating joint adapter (for JOYCEclinic FF vented

only, not shown)

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

If the therapy device fails, the anti-asphyxia valve
opens so that the patient can breathe ambient air.

Hygiene treatment

The mask is intended for a single patient and a maxi-
mum usage period of 7 days. A change of patient is
not permitted.
Clean the mask with an isopropyl alcohol wipe (70 %
by vol.) before using it for the first time and if it is
lightly soiled.

Disposal

Dispose of the mask in accordance with hospital
regulations.

Troubleshooting

Technical data

Risk of asphyxia if anti-asphyxia valve not
working properly!

Residues may cause the valve to stick and lead to
CO

being re-inhaled.



Check before every use that the openings of the
anti-asphyxia valve are clear.

Fault Cause

Remedy

Pain from
pressure on
the face.

Mask too tight.

Loosen headgear
slightly.

Draft in the

eye.

Mask too loose.

Tighten headgear
slightly.

Mask does not fit.

Use mask of different
size.

Therapy pres-
sure is not
reached.

Mask not correctly
adjusted.

Re-adjust mask (see
Figure ).

Patient circuit
leaking.

Check connectors,
check tubes properly
located.

Product class to directive

93/42/EEC

IIa

Dimensions (W x H x D)
Size S
Size M
Size L

100 mm x 145 mm x 110 mm
100 mm x 155 mm x 110 mm
100 mm x 165 mm x 110 mm

Weight
Size S
Size M
Size L

110 g
113 g
117 g

Therapy pressure range

4 hPa - 50 hPa

Tube connection: tapered
connector to EN ISO 5356-1

Ø 22 mm (female)

Temperature range:
Operation
Transport and storage

5 °C to

40 °C

20 °C to

70 °C

Flow resistance, vented
at 50 l/min
at 100 l/min
Flow resistance, non-vented
at 50 l/min
at 100 l/min
Flow resistance, non-vented
+ AAV
at 50 l/min
at 100 l/min

0.04 hPa
0.19 hPa

0.04 hPa
0.11 hPa

0.05 hPa
0.19 hPa

Flow resistance, anti-
asphyxia valve
Inspiration at 50 l/min:
Exhalation at 50 l/min:

0.8 hPa
0.5 hPa

Materials

Only use the mask after consulting your physician if
you are allergic to any of these substances:

No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).

10 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
Technology in accordance with the warranty condi-
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.

11 Declaration of conformity

The manufacturer Löwenstein Medical Technology
GmbH + Co. KG (Kronsaalsweg 40, 22525
Hamburg, Germany) hereby declares that the product
complies with the relevant regulations of Directive
93/42/EEC governing medical devices. The un-
abridged text of the Declaration of Conformity can be
found on the manufacturer's website.

12 Ordering information

Switching pressure
Anti-asphyxia valve
• Open:
• Close:

1.2 hPa
1.4 hPa

Geometrical dead space:
Size S
Size M
Size L

225 ml
255 ml
305 ml

Service life

5 years

Useful life

Up to 7 days

Mask part

Material

Mask cushion, forehead cushion