Intended Use; Side Effects; Product Description; Compatible Devices - Lowenstein Medical JOYCEone Manual De Instrucciones

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1 Operation
The following figures show you how to adjust, apply,
remove, dismantle and assemble the mask:
Putting on the mask
Adjusting the mask
Removing the mask
Dismantling the mask
Assembling the mask
2 Introduction

2.1 Intended use

The JOYCEone mask is used for treating sleep apnea
and for non-invasive and non-life-sustaining ventila-
tion of patients with respiratory insufficiency. It serves
as a connecting element between the patient and the
therapy device.
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, flush of the
facial skin, pressure marks on the face, claustropho-
bia, anxiety, deformities of the face or nasopharynx,
intake of medication which may induce vomiting, the
necessity for immediate intubation. Please also ob-
serve the contraindications in the instructions for use
of your therapy device.

2.3 Side effects

Nasal congestion, dry nose, dry mouth in the morn-
ing, feeling of pressure in the sinuses, irritated con-
junctiva, skin rashes, pressure marks on the face,
irritating noises when breathing.
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.
 Avoid naked flames.
Risk of injury from re-inhaling CO !
2
If the mask is used incorrectly, CO may be
2
re-inhaled.
 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!
Anesthetic gas may escape through the exhalation
valve and put third parties at risk.
 Never use the mask during anesthesia.
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. Rotating sleeve
7. Mask body
8. Headgear clip
9. Mask cushion

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 ad-
justed by a physician or specialist dealer so that actual
pressure in the mask corresponds to therapy pressure.
4.3 Exhalation system
The mask has 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.
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