Lowenstein Medical JOYCEone Manual De Instrucciones página 5

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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 gen-
uine 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.
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 link between the patient and the ventila-
tor.
2.2 Contraindications
The mask must not be used on patients weighing <
30 kg.
The mask must not be used in the following situa-
tions: Immediate intubation required, loss of con-
sciousness, acute vomiting.
The mask may be used in the following situations
only with particular caution: Pressure points and
acute injuries to the skin of the face; skin allergies in-
volving the face; deformities of the face or nasophar-
ynx; acute pain affecting the face; cough reflex re-
stricted or absent; claustrophobia; acute nausea.
If you are not sure whether one of these situations
applies to you, consult your healthcare professional.
Observe the contraindications in the instructions 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 ventilator to
the patient
3 Safety
Risk of injury due to damaged mask parts or
those under strain!
Perform a visual inspection before every use and
⇒
after every cleaning operation.
Note useful life (see section entitled "Technical
⇒
Data").
Replace mask parts if necessary.
⇒
Risk of injury due to the use of oxygen!
Oxygen can become deposited in clothing, bedlinen,
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.
Set up oxygen sources at a distance > 1 m from
⇒
the device.
Do not smoke.
⇒
Avoid naked flames.
⇒
Ventilate the room well.
⇒
Keep mask free from oil and grease.
⇒
Risk of injury due to patient receiving inade-
quate supply!
Activate low pressure/leakage alarms on the
⇒
ventilator.
Use the appropriate mask size and check that it
⇒
is securely in position.
Monitor patients with restricted spontaneous
⇒
breathing.
Risk of injury from re-inhalation of 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 escape of anesthetic gas
or atomization of drugs!
Do not use the mask during anesthesia.
⇒
Do not use the mask to atomize drugs.
⇒
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.
⇒
When selecting a detergent, consider potential
⇒
allergies.
On change of patient in a hospital environment:
⇒
Comply with the document entitled Information
on reprocessing (see section entitled "Repro-
cessing").
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