Warranty; Declaration Of Conformity; Operation - Lowenstein Medical JOYCEeasy Gebrauchsanweisung

EN
Mask part Material
Elastane, polyester,
PU (polyurethane),
Headgear
UBL loop, cotton
PA (polyamide),
TPE (thermoplastic
Anti-asphyxia valve elastomer), PP
(polypropylene)
POM, polyester, PA
Quick-release cord
(polyamide)
No parts of the mask contain latex, PVC (polyvinyl
chloride) or DEHP (diethylhexyl phthalate).

11 Warranty

Löwenstein Medical gives the customer a limited
manufacturer warranty on new original
Löwenstein Medical products and any replacement
part fitted by Löwenstein Medical in accordance with
the warranty conditions applicable to the product in
question and in accordance with the warranty peri-
ods from date of purchase as listed below. The war-
ranty conditions are available on the website of the
manufacturer. We will also send you the warranty
conditions on request.
Please bear in mind that any claim to warranty and li-
ability shall be void if neither the accessories recom-
mended in the instructions for use nor genuine
replacement 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) here-
by declares that the product complies with the rele-
vant regulations of Directive 93/42/EEC governing
medical devices. The unabridged text of the
Declaration of Conformity can be found on the
manufacturer's website.
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 JOYCEeasy Full Face / JOYCEeasy next Full Face
mask is used for treating sleep apnea and for non-in-
vasive and non-life-sustaining ventilation of patients
with respiratory insufficiency. It serves as a connect-
ing element between the patient and the therapy de-
vice. Use non-vented full face masks only in
combinations with therapy devices that have an ac-
tive 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, 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. Anti-asphyxia valve (only vented)
7. Pressure measurement port seal (only vented)
8. Pressure measurement port (only vented)
9. Rotating sleeve (only vented)
10. Mask body
11. Headgear clip
12. 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 pres-
sure.
EN