Declaration Of Conformity; Intended Use; Restrictions On Use - Lowenstein Medical Protection Mask Gebrauchsanweisung

EN
11 Warranty
Löwenstein Medical Technology gives the purchaser
of a new original product and of a spare part fitted by
Löwenstein Medical Technology a limited manufac-
turer's warranty in accordance with the warranty
conditions applicable to the product in question and
in accordance 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 rec-
ommended in the instructions for use nor original
spare parts are used.
Product Warranty peri-
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 terms of the Medical Device Regu-
lations 2017/745. The unabridged text of the Decla-
ration of Conformity can be found on the
manufacturer's website
(www.loewensteinmedical.de).
In the EU: As a user and/or patient, you must report
any serious incident occurring in conjunction with the
product to the manufacturer and to the responsible
authority.
ods
1 Operation
English
Wear gloves while handling the mask.
See the figures for how to put on, adjust and remove
the mask:
Inserting particle filter
Putting on mask
Checking that mask seals properly and adjusting it
Removing mask
Disposing of particle filter and subjecting mask to
a hygiene treatment
1.1 Checking that mask seals
properly
1. Seal the filter area with your hand and breathe in
(see Figure ).
If the mask pulls towards your face, it is sealing
properly.
2. If air escapes (under the mask or into your eyes):
Correct the mask seal.
3. Tighten the headgear until the silicone seals
everywhere.
2 Introduction

2.1 Intended use

The mask protects the wearer from inhaling particles,
droplets, and aerosols and prevents them from being
transmitted to the environment.
Transmission of viruses and bacteria is prevented at a
filtration efficiency of > 99.9 %.
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: Skin allergies involving the face
2.3 Side effects
The following side effects may occur with use of the
mask:
Facial pressure marks, allergies, difficulty breathing
3 Safety
Risk of infection if particle filter is missing!
There is a risk of infection if the mask is not used in
accordance with the specified configuration.
 Before using the mask, check whether a particle
filter has been inserted in accordance with these
instructions for use (see "1 Operation", page
 Do not add or leave out any components.
Risk of leaking if mask does not seal properly!
If the mask does not seal properly or slips out of
place, protection is not effective and there is a risk of
infection.
 Wear the mask over your mouth and nose.
 Position the mask cushion over the mouth and
nose as per these instructions for use so that it
seals.
 Check that the mask seals properly
Checking that mask seals properly", page
 Position headgear correctly.
 Only use the mask and filter until the date quoted
on the packaging.
Risk of leaking due to facial hair!
If you have facial hair, hair falling into the face or
severely scarred skin, it is possible that the mask will
leak, creating a risk of infection.
 If you have a beard, check particularly carefully
that the mask is sealing properly.
 Tie up long hair.
Risk of infection if particle filter is reused!
Reusing the particle filter can lead to contamination
and infections.
 Dispose of the particle filter immediately after
use.
 Use particle filter for no more than one working
day (shift).
 If respiratory resistance is high, dispose of particle
filter and use a new one.
 Do not wash the particle filter.

3.1 Restrictions on use

You may not use the mask and enter or remain in a
contaminated area under the following circumstanc-
es:
• For protection against gases or vapors
• When sand-blasting, spray-painting or treating
asbestos
• In an explosive atmosphere
• If the ambient air contains less than 19.5 %
oxygen
• If you can smell or taste the harmful substance
• If harmful substances or their concentrations are
unknown or present an immediate hazard to life
or health.
1).
EN
(see "1.1
1).