Operation; Hygienic Preparation - Weinmann JOYCEone Instructions For Use Manual

1 Introduction
1.1 Intended use
The JOYCEone nasal masks are used for treating sleep
apnea and for non-invasive and non-life-sustaining
ventilation of patients with respiratory insufficiency. It
serves as a connecting element between the patient
and the therapy device.
1.2 Contraindications
In the case that any of the following symptoms are
present the mask may not be used, or only with
particular caution:
erosions and ulcerations, skin allergies, flush of the
facial skin, pressure marks on the face,
claustrophobia, anxiety, deformities of the face or
nasopharynx, intake of medication which may induce
vomiting, the necessity for immediate intubation.
Please also observe the contraindications in the
instructions for use of your therapy device.
1.3 Side effects
Nasal congestion, dry nose, morning xerostomia (dry
mouth), feeling of pressure in the sinuses, irritated
conjunctiva, skin rashes, pressure marks in the face,
irritating noises when breathing
2 Safety
Read these instructions for use carefully. They are a
constituent part of the mask and must be available at
all times. In accordance with Directive 93/42/EEC,
observe the points below.
Risk of injury from the supply of oxygen!
Oxygen can deposit in clothing, bed linen, and hair.
In conjunction with smoking, naked flames, or
electrical equipment, it can cause fires and
explosions.
 Do not smoke.
 Avoid naked flames.
 Do not use electrically conductive tubes (excep-
tion: breathing tubes which can be heated elec-
trically).
Risk of injury from re-inhaling CO !
2
If the mask is used incorrectly, CO may be re-inhaled.
2
 Do not close the openings of the mask.
 Only apply the mask for a prolonged 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 cannot
take it off themselves.
 Monitor patients with obstructive and restrictive
lung diseases individually when using JOYCEone
masks.
Risk of injury from slipping of the mask!
If the mask slips or falls off, the therapy is ineffective.
 Monitor patients with restricted spontaneous res-
piration.
 Activate low pressure/leakage alarms on the ther-
apy device.
 Monitor patients with obstructive and restrictive
lung diseases individually.
Patient endangerment through application of
mask during anesthesia!
If the nasal mask is used during anesthesia, the
anesthetic gas supplied can escape through the
mouth and endanger the patient.
 Do not use nasal mask during anesthesia.
2.1 General information
• Use of third-party products may lead to functional
failures and restricted fitness of purpose.
Biocompatibility may also be compromised.
Please note that in these cases, any claim under
warranty and liability will be void if neither the
accessories nor original replacement parts
recommended in the instructions are used.
• To prevent infection, bacterial contamination, or
functional impairments, follow the instructions in
the section "Hygiene preparation".
3 Product description
3.1 Overview
Illustrations of the individual components can be
found on the front cover.
Key
1. Headgear
2. Forehead cushion
3. Forehead support
4. Retaining ring
5. Elbow
6. Plug for pressure measurement port
7. Pressure measurement port
8. Rotating sleeve
9. Mask body
10. Headgear clip
11. Mask cushion
3.2 Compatible devices
The mask can be used with all therapy devices which
are not for life-sustaining treatment of patients with
sleep apnea or ventilatory insufficiency.
With some combinations of devices, the actual
pressure in the mask will not correspond to the
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 the actual pressure in the
mask corresponds to therapy pressure.
3.3 Exhalation system
The mask has an integrated exhalation system. The
retaining ring and mask body are shaped in such a
way that a gap forms between these parts. The
exhaled air can escape through this gap.
3.4 Pressure measurement port
The mask has a pressure measurement port which
can be used for measuring pressure or supplying
oxygen. If you are not using this, close it with the plug
for pressure measurement port to reach therapy
pressure.
4

Operation

The following figures show you how to assemble,
apply, remove, adjust, and dismantle the mask:
Figure 1: Assembling the mask
Figure 2: Applying the mask
Figure 3: Adjusting the mask
Figure 4: Removing the mask
Figure 5: Dismantling the mask
5

Hygienic preparation

Risk of injury from inadequate cleaning!
Residues may congest the mask, impair the
integrated exhalation system, and jeopardize
therapy success.
 For patients with a compromised immune system
or particular background of illness, disinfect
mask components daily following consultation
with the physician.
 Thoroughly clean the contact surfaces between
the elbow and the rotating sleeve.
5.1 Cleaning the mask
1. Dismantle the mask (see figure 5).
2. Clean mask in accordance with the table below:
Action
Wash mask components with warm
X
water and a mild detergent.
When washing mask parts (exception:
mask cushion and forehead cushion),
clean thoroughly with a cloth or a soft
brush.
Wash headgear by hand.
3. Rinse all parts with clear water.
Material damage due to abrasion!
Rubbing the mask cushion and forehead cushion
can damage the coating.
 Do not rub the mask cushion and forehead cush-
ion dry.
4. Allow all parts to air-dry.
5. Perform a visual inspection.
6. Replace damaged parts if necessary.
7. Assemble the mask (see figure 1).
Discolorations of mask components do
not impair the functionality of the mask.
5.2 Change of patient
You must subject the mask to a hygienic preparation
in the event of a change of patient. For information
on hygienic preparation in the event of a change of
patient, please refer to our Internet brochure at
www.weinmann.de. If you do not have Internet
access, please contact Weinmann.
6 Disposal
You can dispose of all parts in domestic waste.
X
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