Product Description; Technical Specifications - Lowenstein Medical Protection Mask Gebrauchsanweisung

EN
4

Product description

4.1 Overview
A diagram of the individual parts can be found on the
title page.
1. Filter insert
2. Particle filter
3. Filter holder
4. Mask cushion
5. Fastening clip
6. Headgear
4.2 Markings and symbols on the
mask and on the packaging
Symbol Description
CE symbol (confirms that the product
conforms to the applicable European
regulations)
Permitted humidity range for transport
and storage
Permitted temperature range for
transport and storage
Consult instructions for use
Lot number
Manufacturer and if necessary date of
manufacture
Use by date
Order number
Unique device identifier
Indicates the product is a medical device
5 Hygiene treatment
Disinfect or sterilize mask (maximum 30 cycles) after
every use (no later than when changing shift).
r
When using detergents and disinfectants, follow
the manufacturer's instructions.
1. Dispose of particle filter immediately after use (no
later than when changing shift) (see Figure
2. Initially wash mask parts in hot water and a mild
detergent.
3. Rinse all parts with clean water.
4. Subject mask and headgear to a hygiene
treatment in line with the table below:
Disinfection Sterilization
Immerse mask parts in
®
• Sekusept Aktiv solution at a
concentration of 2 %
Alternatively
®
• Gigasept FF (new) at a When sterilizing with a
concentration of 7 % certified thermal steril-
for 15 minutes. ization system, observe
Ensure that there are no air bub- the following time/tem-
bles on any of the mask parts. perature combinations:
Alternatively 134 °C - 7 minutes
When disinfecting using a certified (Range of efficacy in a
thermal disinfecting system, ob- Robert Koch Institute
serve the following time/tempera- program: A/B)
ture combinations:
94 °C for 5 minutes
(Range of efficacy in Robert Koch
Institute program: A/B)
Rinse off all parts with clean water
(at least drinking water quality,
sterile distilled water or fully
demineralized water).
In the domestic environment
Put the mask (without the particle filter) in a large saucepan
with plenty of water. Ensure that the mask is floating com-
pletely freely in the water bath to stop it melting on the
bottom of the pan.
Bring the water to the boil and boil for at least 15 minutes.
Pour off the water and remove the mask with tongs.
5. Leave all parts to air-dry in an environment
containing no harmful substances.
6. Perform a visual inspection (see "6 Visual
inspection", page 2).
7. Store the mask in its original packaging or a
sealable bag in a dry, dust-free place away from
heat and out of direct sunlight in a temperature
range of -20 °C to +70 °C.
Store mask in a leaktight container outside the
contaminated areas.
r
Discolored mask parts do not impair the
functionality of the mask.
).
5.1 Composition of disinfectants
The following information is based on the
disinfectant list from VAH.
Active ingredi-
ent basis
®
gigasept FF Aldehyde, alde-
(new) hyde derivatives
®
Sekusept Peroxide
Aktiv compounds
5.2 Change of user
Following disinfection or sterilization, the mask is in-
tended for use by the same user or a different one.
Insert a new particle filter before use (see Figure
6 Visual inspection
Perform a visual inspection before using the mask for
the first time and after every hygiene treatment.
1. Check mask for cleaning residues. If necessary,
rinse off with clean water.
2. Check mask and headgear for external damage
(cracks, holes etc.).
If damaged: Do not use mask. Check particle
filter for damage.
If damaged: Use a different particle filter.
3. Check that markings on the mask are legible.
4. Check that mask is complete.
7 Disposal
You can dispose of all parts in domestic waste.
8

Technical specifications

Product class to (EU)
Medical Device Regula-
tions 2017/745
Dimensions
(W x H x D)
Weight
Temperature range:
Operation
Individual active
Transport and storage
ingredients
Permitted humidity:
Contains as active in-
Transport and storage
gredient a reaction
product of DMO-THF;
Useful life
this corresponds to
succindialdehyde, 2,5-
Service life
dimethoxytetrahydro-
Mask
furan, ethanol,
methanol, and water
Particle filter (unused)
Contains as active in-
gredient a reaction
9 Materials
product of peracetic
acid which corre-
Only use the mask after consulting your physician if
sponds to sodium per-
you are allergic to any of these substances:
carbonate, non-ionic
Mask part
surfactants, and
phosphonates.
Filter insert, filter holder
Headgear, mask cushion
Fastening clip
Particle filter
).
All parts of the mask are free from latex, PVC (poly-
vinyl chloride), bisphenol-A and DEHP (diethylhexyl
phthalate).
10 Scope of delivery
Product
Mask
Particle filter (10 pcs)
EN
I
89 mm x 105 mm x 70 mm
93 g
+5 °C to +40 °C
-20 °C to +70 °C
5 % to 95 % relative humidity
Up to 8 hours (one shift)
or change particle filter sooner if
respiratory resistance is too high
30 cleaning cycles or 5 years
from manufacture
5 years
Material
PA (polyamide)
SI (silicone)
POM
(polyoxymethylene)
PP (polypropylene)
Article number
LMT 26685
LMT 26694