Declaration Of Conformity; Intended Use; Side Effects; Product Description - Lowenstein Medical CARA Full Face Manual De Instrucciones

EN
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 regulations of Directive
93/42/EEC governing medical devices. The un-
abridged 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 CARA Full Face mask is used for treating sleep ap-
nea and for non-invasive and non-life-sustaining ven-
tilation of patients with respiratory insufficiency. It
serves as a connecting element between the patient
and the therapy device.
2.2 Contraindications
The mask may not be used in the following situations:
necessity for immediate intubation; loss of conscious-
ness, acute vomiting.
The mask may be used in the following situations only
with particular caution: pressure points and acute in-
juries to the facial skin; skin allergies involving the
face; deformities of the face or nasopharynx; acute
pain affecting the face; cough reflex restricted or ab-
sent; claustrophobia; acute nausea.
If you are not certain whether one of these situations
applies to you, please consult your attending physi-
cian or medical advisor. Please also observe the con-
traindications in the instructions for use of your
therapy 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.
Should such side effects occur, please contact your
attending physician or medical advisor.
3 Safety
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.
 Patients who are unable to take the mask off
themselves must be monitored by qualified nurs-
ing staff.
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.
Risk of injury from lack of cleaning!
The mask may show contamination, which can
possibly put the patient at risk.
 Clean the mask before using for the first time
(see section entitled "Hygiene treatment").
 Clean the mask regularly.
4

Product description

4.1 Overview
A diagram of the individual parts can be found on the
title page.
1. Headgear
2. Link
3. Elbow
4. Anti-asphyxia valve
5. Rotating sleeve
6. Mask body
7. Headgear clip
8. 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 pressure.

4.3 Exhalation system

The mask has an integrated exhalation system. The
link and mask body are shaped so that there is a gap
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