Lowenstein Medical JOYCE SilkGel Full Face Mode D'emploi page 5

EN
Mask part Material
POM
Headgear clip, rip-cord clip
(polyoxymethylene)
Forehead support, rotating sleeve PA (polyamide)
Elasthane, polyester, PU
(polyurethane), UBL
Headgear
loop, cotton, PA (poly-
amide)
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 JOYCE SilkGel Full Face mask is used for treating
sleep apnea and for non-invasive and non-life-sus-
taining ventilation of patients with respiratory insuffi-
ciency. It serves as a connecting element between the
patient and the therapy device. Use non-vented full
face masks only in combinations with therapy devices
that have an active 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
8. Pressure measurement port
9. Rotating sleeve
10. Mask body
11. Headgear clip
12. Mask cushion
13. Tube anchoring strap
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