Device Description; Safety Instructions; Safety Regulations; Side-Effects - Weinmann JOYCE vented Manual De Instrucciones

1 Device description

English
Legend
(Description of individual parts: see
enclosed leaflet)
1
Headgear
2
Forehead cushion
3
Fine adjustment component of forehead
support
4
Coarse adjustment component of forehead
support
5
Forehead support
6
Headgear clips
7
Pressure measurement ports
8
Port cap
9
Rotating sleeve (non vented: blue coloured)
10 Elbow (non vented: blue coloured)
11 Retaining ring (non vented: blue coloured)
12 Mask frame
13 Mask cushion
Intended use
The nasal mask is an accessory and acts as a
seal between the patient and the therapy
device. It is used for the treatment of sleep
apnoea and for the non-invasive ventilation
of patients with ventilatory insufficiency.
Before use by the patient
Patients must be instructed in the use of the
mask by qualified personnel before therapy
begins.

2 Safety instructions

Safety regulations

Following the requirements of Richtlinie 93/
42 EWG please observe the following points:
• Please read these instructions for use very
carefully. They are a part of the product
and should be available at all times.
12
Device description
EN
• Use the mask only in the therapy pressure
ranges required for the individual variants:
– 4-30 hPa: JOYCE vented
JOYCE non vented
– 4-40 hPa: JOYCE vented 40 hPa
JOYCE non vented 40 hPa
JOYCE GEL vented
JOYCE GEL non vented
• If third-party items are used, functional fail-
ures may occur and fitness for use may be
restricted. Biocompatibility requirements may
also not be met. Please note that in such
cases, any claim under warranty and liability
will be voided if neither the accessories nor
genuine replacement parts recommended in
the instructions for use are used.
• Patients with limited spontaneous respira-
tion must be monitored at all times. The
appropriate negative pressure/leak alarm on
the ventilation device must be activated.
• Patients with obstructive and restrictive
lung diseases should be examined on an
individual basis during use of the JOYCE
masks (for example with regard to re-inha-
lation of CO ).
2
• Do not close the openings in this mask
except in situations described in these
instructions for use. Otherwise there is a
risk of re-inhaling CO
• Only put the nasal mask over your face for
a prolonged period when the therapy
device is switched on. Otherwise there is a
risk of re-inhaling CO
• Do not use a breathing hose that is electri-
cally conductive (exception: breathing
tubes which can be heated electrically).
• Follow the instructions in section 4
"Hygiene treatment" to avoid infection,
bacterial contamination and poor function-
ality of the mask.

Side-effects

The following side-effects may occur:
nasal congestion, dry nose, dry mouth in the
morning, sinus pressure, irritation of the
conjunctiva, irritating noises during
and of suffocation.
2
.
2