Device Description; Safety Instructions; Safety Regulations - Weinmann JOYCE Device Description And Instructions For Use

1 Device description

Legend
(Description of individual parts: see
enclosed leaflet)
1 Headgear JOYCE
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 (NV: matt finish)
10 Elbow (NV: matt finish)
11 Retaining ring (NV: matt finish)
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 Directive 93/42
ECC please observe the following points:
10
Device description
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strap
•Please read these instructions for use very
carefully. They are a part of the product and
should be available at all times.
•Use the mask only with therapy pressures
between 4 and 30 hPa or between 4 and
40 hPa (other models JOYCE
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JOYCE NV 40 hPa).
•Malfunctions and a lack of biocompatibility
may result if third-party articles are used.
Please bear in mind that in these cases any
warranty entitlement and liability shall lapse
where the accessories recommended in the
instructions for use or original spare parts are
not utilized.
•Patients with limited spontaneous respiration
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
(for example with regard to re-inhalation 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
2
•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 .
2
•Do not use a breathing hose that is
electrically conductive.
•Follow the instructions in section 4 "Cleaning
and disinfecting instructions" to avoid
infection, bacterial contamination and poor
functionality 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 exhalation,
pressure sores on the face, reddening of the
skin.
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40 hPa /
and of suffocation.
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