Steris Prolystica 100 Pid Prion Inactivating Detergent Istruzioni per l'uso

Marca
Steris
Modello
Prolystica 100 Pid Prion Inactivating Detergent
Tipo
Istruzioni per l'uso
STERIS Corporation
1P12-T6ECI Prolystica100 10 L
Products/Prolystica 100/ Design
Date Started : 06/06/23
06/14/23
10:07 AM
LB
DANGER
CONTIENT : contient de l’hydroxyde de potassium et de l’éthylènediaminetétraacétate
de tétrasodium. Nocif en cas d’ingestion. Provoque des brûlures de la peau et des
lésions oculaires graves. Provoque des lésions oculaires graves. Ne pas respirer les poussières ni
les brouillards. Se laver soigneusement après manipulation. Ne pas manger, boire ou fumer en
manipulant ce produit. Porter des gants de protection/des vêtements de protection/un équipement
de protection des yeux/du visage. EN CAS D’INGESTION: rincer la bouche. NE PAS faire vomir.
EN CAS DE CONTACT AVEC LA PEAU (ou les cheveux): enlever immédiatement les vêtements
contaminés. Rincer la peau à l’eau/se doucher. EN CAS DE CONTACT AVEC LES YEUX: rincer avec
précaution à l’eau pendant plusieurs minutes. Enlever les lentilles de contact si la victime en porte
et si elles peuvent être facilement enlevées. Continuer à rincer. Laver les vêtements contaminés
avant réutilisation. EN CAS D’INHALATION: transporter la victime à l’extérieur et la maintenir au
repos dans une position où elle peut confortablement respirer. Appeler immédiatement un CENTRE
ANTIPOISON ou un médecin en cas de malaise. (Montrer l’étiquette dans la mesure du possible).
Tout incident grave survenu en rapport avec ce dispositif médical doit être signalé au fabricant
et aux autorités compétentes du pays dans lequel l’incident s’est produit. Réservé à l’usage des
établissements industriels et des collectivités. Ne convient pas à l’usage domestique ou à la
vente au détail. Pour tout renseignement supplémentaire, consulter la fiche signalétique.
Produit fabriqué aux Etats-Unis.
PERICOLO
CONTIENE: Idrossido di potassio, etilendiamminotetraacetato di tetrasodio. Nocivo se
ingerito. Provoca gravi ustioni cutanee e gravi lesioni oculari. Provoca gravi lesioni oculari.
Non respirare la polvere o i vapori. Lavarsi accuratamente dopo l’uso. Non mangiare, né bere, né
fumare durante l’uso. Indossare guanti/indumenti protettivi/protezione occhi/viso. IN CASO DI
INGESTIONE: Sciacquare la bocca. NON provocare il vomito. IN CASO DI CONTATTO CON LA PELLE (o
con i capelli): Togliersi di dosso immediatamente tutti gli indumenti contaminati. Sciacquare la pelle/
fare una doccia. IN CASO DI CONTATTO CON GLI OCCHI: Sciacquare accuratamente per parecchi minuti.
Togliere le eventuali lenti a contatto se è agevole farlo. Continuare a sciacquare. Lavare gli indumenti
contaminati prima di indossarli nuovamente. IN CASO DI INALAZIONE: Trasportare l’infortunato
all’aria aperta e mantenerlo a riposo in posizione che favorisca la respirazione. In caso di malessere,
contattare immediatamente un CENTRO ANTIVELENI o un medico (se possibile, mostrare l’etichetta).
Eventuali incidenti gravi vericatisi in relazione a questo dispositivo medico devono essere segnalati
al produttore e all’autorità competente nel Paese in cui si è vericato l’incidente. Esclusivamente per
uso industriale e istituzionale. Non per uso domestico o al dettaglio. Per ulteriori informazioni,
consultare la scheda contenente i dati sulla sicurezza. Prodotto realizzato negli USA.
GEFAHR
ENTHÄLT: Kaliumhydroxid, Tetranatriumethylendiamintetraacetat. Gesundheitsschädlich
bei Verschlucken. Verursacht schwere Verätzungen der Haut und schwere Augenschäden.
Staub oder Nebel nicht einatmen. Nach Gebrauch gründlich waschen. Bei Gebrauch nicht essen,
trinken oder rauchen. Schutzhandschuhe/Schutzkleidung/Augenschutz/Gesichtsschutz tragen.
BEI VERSCHLUCKEN: Mund ausspülen. KEIN Erbrechen herbeiführen. BEI KONTAKT MIT DER
HAUT (oder dem Haar): Alle beschmutzten, getränkten Kleidungsstücke sofort ausziehen.
Haut mit Wasser abwaschen/duschen. BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang
behutsam mit Wasser spülen. Vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter
spülen. Kontaminierte Kleidung vor erneutem Tragen waschen. BEI EINATMEN: An die frische
Luft bringen und in einer Position ruhigstellen, die das Atmen erleichtert. Bei Unwohlsein sofort
GIFTINFORMATIONSZENTRUM oder Arzt anrufen (wenn möglich, dieses Etikett vorzeigen).
Schwerwiegende Vorfälle, die im Zusammenhang mit diesem Medizinprodukt aufgetreten sind, sollten
dem Hersteller und der zuständigen Behörde des Landes, in dem der Vorfall aufgetreten ist, gemeldet
werden. Nur zur Verwendung in der Industrie und in Anstalten. Nicht für den Hausgebrauch
oder für den Einzelhandel. Siehe Sicherheitsdatenblatt für zusätzlichen Informationen.
Produkt hergestellt in den USA.
PELIGRO
CONTIENE: Hidróxido de potasio y etilendiaminatetraacetato tetrasódico. Nocivo en caso de
ingestión. Provoca quemaduras graves en la piel y lesiones oculares graves. Provoca lesiones
oculares graves. No respirar el polvo o la niebla. Lavarse concienzudamente tras la manipulación. No
comer, beber ni fumar durante su utilización. Llevar guantes, prendas, gafas y máscara de protección.
EN CASO DE INGESTIÓN: Enjuagarse la boca. NO provocar el vómito. EN CASO DE CONTACTO CON
LA PIEL (o el pelo): Quitarse inmediatamente las prendas contaminadas. Aclararse la piel con agua o
ducharse. EN CASO DE CONTACTO CON LOS OJOS: Aclarar cuidadosamente con agua durante varios
minutos. Quitar las lentes de contacto, si lleva y resulta fácil. Seguir aclarando. Lavar las prendas
contaminadas antes de volver a usarlas. EN CASO DE INHALACIÓN: Transportar a la víctima al exterior
y mantenerla en reposo en una posición confortable para respirar. Llame inmediatamente a un CENTRO
DE INFORMACIÓN TOXICOLÓGICA o a un médico en caso de malestar (si es posible, muestre la etiqueta).
Si se producen accidentes graves en relación con este dispositivo médico, deberán comunicarse al
fabricante y a la autoridad competente del país en el que se hayan producido. Solo para uso industrial
e institucional. No para uso doméstico ni al por menor. Consulte la hoja de información de
seguridad para obtener información adicional. Producto fabricado en EE. UU.
TEHLİKE
İÇERİR: Potasyum hdrokst, tetrasodyum etlen damn tetraasetat çerr. Yutulması
halnde zararlıdır. Cdd clt yanıklarına ve göz hasarına yol açar. Cdd göz hasarına yol
açar. Tozunu veya buharını solumayın. Temas ettkten sonra yce yıkayın. Bu ürünü kullanırken
hçbr ey yemeyn, çmeyn ve sgara çmeyn. Koruyucu eldven/koruyucu kıyafet/göz koruyucu/
yüz koruyucu kullanın. YUTULMASI HALİNDE: Ağzınızı çalkalayın. Kusmaya ZORLAMAYIN. CİLDE
(veya saça) TEMAS HALİNDE: Krlenm tüm gyslernz hemen çıkarın. Cldnz suyla durulayın/
du alın. GÖZLE TEMASI HALİNDE: Brkaç dakka boyunca suyla dkkatl br eklde yıkayın. Kontakt
lensnz varsa ve kolay çıkarablyorsanız, çıkarın. Gözlernz yıkamaya devam edn. Krlenm
gyslernz yenden kullanmadan önce yıkayın. SOLUNMASI HALİNDE: Maruz kalan ky açık
havaya çıkarın ve rahat nefes alableceğ pozsyonda olmasını sağlayın. Kendnz y hssetmyorsanız
hemen ZEHİR DANIMA MERKEZİNİ veya doktoru/hekm arayın (mümkünse etket göstern).
Bu tıbb chazla lkl olarak meydana gelen cdd olaylar üretcye ve olayın gerçekletğ ülkedek
yetkl makama rapor edlmeldr. Yalnızca Endüstryel ve Kurumsal kullanım çndr. Ev
kullanımı veya perakende kulanım çn değldr. Ek blg çn Güvenlk Ver Sayfasına bakın.
ABD’de Üretlm Ürün.
PROLYSTICA 100 Prion Inactivating Detergent (PPID) solution
FIELD OF APPLICATION: PROLYSTICA 100 Prion Inactivating
Detergent (PPID) solution can be used for manual or automated
surface cleaning in conjunction with a validated steam sterilization
methodology to reduce the risk of prion contamination on medical device
surfaces.
INSTRUCTIONS FOR USE: Medical instruments must remain wet after
use by employing Pre-Klenz™ instrument transport gel or other similar
products, in order to keep the contamination from setting. Follow
all instructions and current national and institutional practices when
handling contaminated medical devices. Here is a partial list of these
practices: Use personal protective equipment such as gowns, face
protection shields and gloves. Avoid inhaling aerosols; cleaning medical
devices with another chemical product before employing the PPID
solution is not recommended. It is recommended to use PROLYSTICA
100 Prion Inactivating Detergent (PPID) solution with tap water from
a source that is in accordance with quality standards or softened water;
if this type of water is unavailable, consult your support agent or your
STERIS Sales Representative for assistance. DO NOT use with rigid or
flexible endoscopic devices. Consult the data on compatible materials
in order to ensure the compatibility of instruments with highly alkaline
solutions. Medical instruments may be treated using manual or automatic
processes, such as described below.
Manual Soaking:
1. Place the contaminated medical devices in a container that can hold
enough water for the instruments to be completely submerged by at
least 5centimeters.
2. The temperature of the water must be above 43°C.
a. For routine cleaning, dilute the solution to 0.2 - 0.4% in water.
Allow the instruments to soak for 4 minutes at a temperature
above 43°C.
b. For high-risk applications (high-risk procedures or materials
where the inactivation of non-conventional transmission agents
is required, according to Standard Protocol for Prions), dilute to
a 0.8% solution in water. Allow the instruments to soak for 7 to 8
minutes at a temperature above 43°C.
3. After soaking is complete, drain the solution, rinse the instruments and
continue processing medical devices in accordance with the facility’s
washing and standard terminal sterilization procedures.
CAUTION: Do not reuse the PPID solution.
Automatic Washers: PROLYSTICA 100 Prion Inactivating
Detergent (PPID) solution is compatible with STERIS brand
automatic washers and others. When using other equipment
brands, check with the manufacturer regarding the compatibility
of the solution with their equipment. Automatic washer cycles are
programmed to perform various processes. For any questions
concerning reprogramming your model of automatic washer in order
to use the PPID solution, consult your STERIS sales representative
or support agent. CAUTION: Do not reuse PPID solutions. The
automatic cleaning cycles for medical instruments using PPID
solutions must comply with the following criteria:
Routine Application High-Risk Applications
Exposure and Washing Phases Exposure and Washing Phases
Duration: 4minutes minimum Duration: 7 to 8 minutes
Temperature: Controlled, above 43°C Temperature: Above 43°C
PPID concentration: 0.2 to 0.4% v/v PPID concentration: 0.8% v/v
High-Risk Applications: When inactivation of non-conventional
transmission agents is required, in accordance with the Standard
Protocol for Prions.
Rinsing/Drying Phases: Follow the current cycle parameters.
Terminal Sterilization Phase: Follow standard terminal sterilization
practices for the specific instruments treated.
DANGER
CONTAINS: Potassium Hydroxide and Tetrasodium
Ethylenediaminetetraacetic acid. Harmful if swallowed. Causes severe
skin burns and eye damage. Causes serious eye damage. Do not
breath dusts or mists. Wash thoroughly after handling. Do not eat,
drink or smoke when using this product. Wear protective gloves /
protective clothing / eye protection / face protection. IF SWALLOWED:
Rinse mouth. Do NOT induce vomiting. IF ON SKIN (or hair): Take
off immediately all contaminated clothing. Rinse skin with water /
shower. IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
Wash contaminated clothing before reuse. IF INHALED: Remove
person to fresh air and keep comfortable for breathing. Immediately
call a POISON CENTER, doctor or physician if you feel unwell (show
the label where possible). For industrial and institutional use only.
Serious incidents that have occurred in relation to this medical device
should be reported to the manufacturer and competent authority in
the country where the incident occurred. Not for home or
retail use. See Safety Data Sheet for additional information.
LYSTICA
PRION INACTIVATING
DETERGENT
PROLYSTICA™
100
100
1P12T6EC 10 L
REF
™
PMS 527 C PURPLE COLOR BAND
PMS 279 BLUE HEXAWAVE
PMS 2707 LIGHT BLUE LYSTICA
PMS 186 RED HAZARD DIAMONDS
REST BLACK
7"
7 "
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es
DO NOT PRINT SPOT RED TEMPLATE
1P12-T6ECI(F)(623) 63694 Product Made in U.S.A.
7"
7 "
1P12-T6ECI(B)(623) 63695 Product Made in U.S.A.
FRONT LABEL BACK LABEL
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STERIS Ireland Limited
IDA Business and Technology Park
Tullamore n County Offaly
R35 X865 n Ireland
24 Hr. Emergency No. +44 (0) 1895 622639
STERIS Corporation n 7501 Page Avenue
St. Louis, MO 63133 n USA
800-548-4873 n www.steris.com
STERIS GmbH
c/o BDO AG
Längfeldweg 116A
CH-2504 Biel-Bienne
Switzerland
STERIS Solutions Limited
Chancery House Rayns Way
Watermead Business Park
Leicester LE7 1PF UK
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Steris Prolystica 100 Pid Prion Inactivating Detergent Istruzioni per l'uso

Marca
Steris
Modello
Prolystica 100 Pid Prion Inactivating Detergent
Tipo
Istruzioni per l'uso
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