HEINEN+LÖWENSTEIN JOYCEclinic FF Mode D'emploi page 6

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 single use only.
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 lo-
leaking.
cated.
8 Technical data
Product class to directive 93/
IIa
42/EEC
Dimensions (W x H x D)
Size S 100 mm x 140 mm x 105 mm
Size M 100 mm x 148 mm x 105 mm
Size L 100 mm x 160 mm x 105 mm
Weight
Size S 103 g
Size M 105 g
Size L 108 g
Therapy pressure range 0 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 210 ml
Size M 240 ml
Size L 290 ml
Unintended leaks:
4 - 20 hPa ≤ 4.0 l/min
20 - 50 hPa ≤ 6.0 l/min
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).
The right to make design modifications is reserved.
9 Warranty
The manufacturer Weinmann gives the customer a
limited manufacturer warranty on new original Wein-
mann products, and on any replacement part fitted
by Weinmann, in accordance with the warranty con-
ditions applicable to the product in question and in
accordance with the warranty periods from date of
purchase as listed below. The warranty conditions
can be downloaded from www.weinmann-medi-
cal.com on the Internet. 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, please contact
Heinen + Löwenstein.
Product Warranty peri-
ods
Masks including accessories 6 months
10 Declaration of conformity
The manufacturer Weinmann Geräte für Medizin
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 complete text of the
declaration of conformity can be obtained from
Heinen + Löwenstein.
11 Ordering information
Item, 1 per pack unit Item number
JOYCEclinic FF NV
Size S WM 26805HL0
Size M WM 26815HL0
Size L WM 26825HL0
JOYCEclinic FF vented (leak 2)
Size S WM 26840HL0
Size M WM 26850HL0
Size L WM 26860HL0
JOYCEclinic FF NV + AAV (leak 1)
Size S WM 26845HL0
Size M WM 26855HL0
Size L WM 26865HL0
JOYCEclinic FF headgear (5 pcs) WM 26835HL0
Item, 10 per pack unit Item number
JOYCEclinic FF NV
Size S WM 26857HL0
Size M WM 26858HL0
Size L WM 26859HL0
JOYCEclinic FF vented (leak 2)
Size S WM 26866HL0
Size M WM 26867HL0
Size L WM 26868HL0
JOYCEclinic FF NV + AAV (leak 1)
Size S WM 26869HL0
Size M WM 26870HL0
Size L WM 26871HL0
EN