Gima 20751 Manualul proprietarului

Tip
Manualul proprietarului
MASCHERINA CHIRURGICA LAVABILE DI
TIPO II DOPPIO STRATO AD USO MEDICALE
TYPE II WASHABLE DOUBLE LAYERED
SURGICAL MASK FOR MEDICAL USE
MASQUE CHIRURGICAL LAVABLE À
DOUBLE COUCHE DE TYPE II À USAGE
MÉDICAL
TYP II WASCHBARE DOPPELLAGIGE
CHIRURGISCHE MASKE FÜR MEDIZINISCHE
ANWENDUNGEN
MASCARILLA FACIAL QUIRÚRGICA DE DOS
CAPAS TIPO II LAVABLE PARA USO MÉDICO
MÁSCARA CIRÚRGICA DE CAMADA DUPLA
LAVÁVEL TIPO II PARA USO MÉDICO
TYP II TVÄTTBART KIRURGMUNSKYDD
MED DUBBELT SKIKT FÖR MEDICINSK
ANVÄNDNING
ΠΛΕΝΟΜΕΝΗ ΧΕΙΡΟΥΡΓΙΚΗ ΜΑΣΚΑ
ΔΙΠΛΗΣ ΣΤΡΩΣΗΣ ΤΥΠΟΥ II ΓΙΑ ΙΑΤΡΙΚΗ
ΧΡΗΣΗ
DWUWARSTWOWA MASKA CHIRURGICZNA
MEDYCZNA MOŻLIWA DO PRANIA TYPU II
MASCĂ CHIRURGICALĂ DE UZ MEDICAL,
DE TIP II, LAVABILĂ, CU 2 STRATURI
PROFESSIONAL MEDICAL PRODUCTS
IT - La mascherina deve essere indossata come mo-
strato nella foto. Parte piccola sul naso, parte grande
sotto
GB - The mask must be worn as shown in the photo
Small part on the nose, large part below.
FR - Le masque doit être porté de la façon montrée
dans la photo : petite partie sur le nez, grande partie
en-dessous.
DE - Die Maske muss, wie in der Abbildung gezeigt,
getragen werden, d.h. der kleinere auf der Nase und
der größere Teil unten.
ES - La mascarilla se debe colocar tal y como muestra
la foto. Parte pequeña en la nariz, parte grande abajo.
PT - A máscara deve ser utilizada conforme mostra-
do na foto. Parte pequena sobre o nariz, parte grande
para baixo.
SE - Ansiktsmasken ska bäras som fotot visar. Mindre
del på näsan, större nedtill.
GR - Η μάσκα πρέπει να φοριέται όπως φαίνεται
στη φωτογραφία. Το μικρό τμήμα στη μύτη, το
μεγάλο τμήμα.
PL - Maseczka musi być noszona w sposób pokazany
na zdjęciu stronie. Mniejsza część na nosie, większa
część pod brodą.
RO - Masca trebuie purtată așa cum se observă în
fotograa. Partea mai îngustă pe nas, partea mai lată
dedesubt.
- SA
000001
Distribuito da / Disributed by / Distribué par / Vertrieben von
Distribuido por / Distribuído por / Distribueras av / Διανέμεται
από / Rozprowadzana przez / Distribuit de / :
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M20751-M-Rev.0-10.20
ENGLISH
1 - Product description and intended use
Washable mask, in 99% polyester and 1% carbon bre fab-
ric, designed to protect the nose and mouth.
2 - Classication
The BP2020V3TN series masks are classied as Type II,
according to the UNI EN 14683:2019 standard.
3 - Features
The device consists of a 99% polyester and 1% carbon bre
fabric layer and of a water-repellent outer layer; it is machine
washable up to 60°C (the fabric withstands up to 150°C) It is
not sterile.
PFE values:ParticleFiltrationefciency(%)0.3μm0.5
μm at 95%.
The fabric is NON-CYTOTOXIC according to tests carried
out on broblasts in compliance with the UNI EN ISO 10993-
5 standard.
BFE Filtration
BFE = 99.8% (from laboratory tests carried out in compli-
ance with the UNI EN 14683:2019 standard).
Biological load
UFC <30 UFC (from laboratory tests carried out in compli-
ance with the UNI EN 14683:2019 standard).
Air permeability (cm2/cm3/sec) ASTM E96 (Also known
as ISO - 11092 or Ret or Hohenstein test).
The result obtained on the BP2020 series masks is 7.5,
therefore good or very breathable.
4 - Instructions for use and warnings
Handle with clean and sanitised hands, making sure the
mask adheres well to the face, in the right position, i.e. with
the smallest part towards the nose, and the larger one over
the mouth and chin.
DO NOT MODIFY THE MASK; DO NOT CUT THE ELASTIC
BANDS; WEAR IT RIGHT WAY OUT (as shown in the gure).
Otherwise the mask loses its protective function.
5 -Washing
By hand or in the washing machine, with a detergent, up to
60°C. DO NOT BLEACH.
By complying with the instructions for use and maintenance,
the product maintains the same physical and technical fea-
tures up to approx. 100 washes.
6 -Disposal
Mask to be disposed of as SUW (unless it has been con-
taminated, in which case it must be disposed of as “special
waste”). The outer bag is disposed of as plastic.
Product code Lot number
Manufacturer Date of manufacture
Non-sterile Consult instructions
for use
Medical Device complies with Directive 93/42/EEC
20751 / BP2020V3TN FS
Vedere etichetta / See label / Voir l’étiquette
Siehe Etikett / Ver la etiqueta / Ver rótulo
Se etikett / Δείτε ετικέτα / Patrz etykieta
Consultați eticheta /
MYCROCLEAN ITALIA SRL
Via Carlo Porta, 14
20064 Gorgonzola - Italy
Made in Italy
Vedere etichetta / See label / Voir l’étiquette
Siehe Etikett / Ver la etiqueta / Ver rótulo
Se etikett / Δείτε ετικέτα / Patrz etykieta
Consultați eticheta /
UNI EN 14683:2019


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Gima 20751 Manualul proprietarului

Tip
Manualul proprietarului