Lowenstein Medical JOYCEone Mode D'emploi page 5

with the warranty periods from date of purchase
listed below. The warranty conditions are available
on the manufacturer's website. We will also send you
the warranty conditions on request.
Please bear in mind that any claim under warranty
and liability shall be void if neither the accessories
recommended in the instructions for use nor original
spare parts are used.
In the event of a claim under warranty, contact your
specialist dealer.
Product Warranty periods
Masks including accessories 6 months
12 Declaration of Conformity
The manufacturer Löwenstein Medical Technology
GmbH + Co. KG (Kronsaalsweg 40, 22525 Hamburg,
Germany) hereby declares that the product complies
with the relevant provisions of the Medical Device
Regulations (EU) 2017/745. The unabridged text of
the Declaration of Conformity can be found on the
manufacturer's website.
In the EU: As a user and/or patient, you must report
any serious incidents occurring in conjunction with
the product to the manufacturer and to the responsi-
ble authority.
EN
1 Operation
The figures show the following steps for operating
the mask:
Putting on the mask
Adjusting the mask
Removing the mask
Dismantling the mask
Assembling the mask
For blind and partially-sighted users
An electronic version of the instructions for use is
also available on the manufacturer's website.
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 must not be used for patients weighing <
30 kg.
The mask may not be used in the following situa-
tions: Necessity for immediate intubation, loss of
consciousness, acute vomiting.
The mask may be used in the following situations
only with particular caution: pressure points and
acute injuries to the facial skin, skin allergies in the
facial area, facial or nasopharyngeal deformities,
acute pain in the facial area, cough reflex restricted
or absent, claustrophobia, acute nausea.
Mask is not suitable for use with a nebulizer or as an
anesthetic mask.
If you are not certain whether one of these situations
applies to you, consult your healthcare professional.
Please observe the contraindications in the instruc-
tions for use of your device.
2.3 Side effects
The following side effects may occur with use of the
mask: 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.
If these side effects occur, contact your healthcare
professional.
2.4 Clinical benefit
Transfers the therapeutic efficacy of the therapy de-
vice to the patient.
EN
3 Safety
WARNING! Unusually hazardous situation. If
you ignore the following instructions, severe,
irreversible or fatal injuries may result.
Risk of injury due to damaged mask parts or
those under strain!
Perform a visual inspection before every use and
⇒
after every cleaning operation. Replace mask
parts if necessary.
Note useful life (see section entitled "Technical
⇒
data").
Risk of injury from re-inhaling CO !
2
Only use the mask when therapy is in progress.
⇒
Only use the mask within the quoted therapy
⇒
pressure range.
Patients unable to remove the mask themselves
⇒
must be monitored by a nurse.
Do not close off exhalation systems.
⇒
Risk of injury due to the use of oxygen!
Oxygen can accumulate in clothing, bed linen, and
hair. Supplying oxygen without a safety device can
lead to fire.
Use an oxygen safety valve.
⇒
Follow the instructions for use for the oxygen
⇒
supply system.
Do not smoke.
⇒
Avoid naked flames.
⇒
Ventilate the room well.
⇒
Keep mask free from oil and grease.
⇒
Observe the safety instructions in the instruc-
⇒
tions for use of the device.
Risk of injury due to insufficient supply to the
patient!
Activate low pressure/leakage alarms on device.
⇒
Use the correct mask size and check that it fits
⇒
tightly.
Risk of injury from inadequate cleaning!
Clean mask parts before using for the first time
⇒
(see section entitled "Cleaning and reprocess-
ing").
Clean the mask regularly.
⇒
In case of a change of patient in the clinical envi-
⇒
ronment: Follow the document Mask reprocess-
ing instructions (see section entitled "Reprocess-
ing").
CAUTION! Hazardous situation. If you ignore
these instructions, mild or moderate injuries
may result.