Lowenstein Medical JOYCEclinic Full Face, Instructions For Use Manual

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1 Operation
Use the template on the title page (see Figure
)
of
these instructions for use to select the correct mask
size. See the following figures for how to put on,
adjust and remove the mask:
Putting on the mask
Adjusting the mask
Removing the mask
2 Introduction
2.1 Intended use
The JOYCEclinic full-face mask is used as a connect-
ing element between the patient and the therapy de-
vice for non-invasive positive pressure respiratory
therapy in hospitals/clinics. It is for a single patient
with respiratory insufficiency (> 30 kg) who is breath-
ing spontaneously and who may be subjected to non-
invasive ventilation with pressure support. The mask
may only be used in combination with therapy devic-
es which have the appropriate alarms and safety sys-
tems in case the device fails.
Use JOYCEclinic NV only in combination with therapy
devices which have an active exhalation valve.
2.2 Contraindications
The mask may not be used, or may be used only with
particular caution, if any of the following symptoms
are present:
erosions and ulcerations, skin allergies, rashes on the
face, pressure marks on the face, claustrophobia,
anxiety, deformities of the face or nasopharynx,
taking of medication which may induce vomiting, the
necessity for immediate intubation, pronounced
reflux, dysfunctional cough reflex. Please also observe
the contraindications in the instructions for use for
your therapy device.
2.3 Side effects
Nasal congestion, dry nose, dry mouth in the
morning, feeling of pressure in the sinuses, irritated
conjunctiva, skin rashes, pressure marks on the face,
irritating noises when breathing. Masks may cause
teeth, gums or jaw to ache.
3 Safety
Risk of injury from the supply of oxygen!
Oxygen can become deposited in clothing, bedlinen
and hair. In conjunction with smoking, naked flames
or electrical equipment, it can cause fires and
explosions.
 Do not smoke.
 No naked flame.
Risk of injury from re-inhaling CO
2
!
If the mask is used incorrectly, CO
2
may be
re-inhaled.
 Vented variant only: do not close off the
exhalation system of the mask.
 Only put on the mask for an extended period if
the therapy device is running.
 Only use the mask within the quoted therapy
pressure range.
 Do not use the mask on patients who are unable
to take it off themselves.
Risk of injury if the mask slips!
If the mask slips or falls off, the therapy is ineffective.
 Monitor patients with restricted spontaneous
respiration.
 Activate low pressure/leakage alarms on the
therapy device.
Risk of injury from anesthetic gases!
Aesthetic gas may escape through the exhalation
valve and put third parties at risk.
 Never use the mask during anesthesia.
Risk of injury from lack of cleaning!
The mask may show contamination which may put
the patient at risk.
 Clean the mask before using for the first time
(see section entitled "Hygiene treatment").
 Clean mask regularly.
4 Product description
4.1 Overview
A diagram of the individual parts can be found on the
title page.
1. Headgear
2. Forehead cushion
3. Forehead support
4. Retaining ring
5. Elbow
6. Anti-asphyxia valve
7. Mask body
8. Mask cushion
WM 6811
0i 05/
2021
EN
EN EN