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Renew Insert User Manual

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Open Here, Åbn her, Hier Önen, Abrir aquí, Avataan
tästä, Ouvrir ici, Aprire qui, Hier openen, Åpne her,
Öppna här
LARGE
Large, Stor, Groß, Grande, Suuri, Grand, Grande, Groot,
Stor, Stor
REGULAR
Regular, Normal, Normal, Normal, Tavallinen, Normal,
Normale, Normaal, Vanlig, Normalstor
STARTER
PACK
Starter Pack, Startpakke, Startpackung, Paquete
de iniciación, Aloituspakkaus, Kit de mise en route,
Confezione di prova, Startpakket, Startpakke, Startpaket
Manufacturer, Fabrikant, Hersteller, Fabricante,
Valmistaja, Fabricant, Produttore, Fabrikant, Produsent,
Tillverkare
Do not use if package is open or damaged, Må ikke
anvendes hvis pakningen er åbnet eller beskadiget,
Nicht verwenden, wenn Verpackung oen oder
beschädigt ist, No usar si el envase está abierto
o dañado, Ei saa käyttää, jos pakkaus on auki tai
vahingoittunut, Ne pas utiliser si l’emballage est ouvert
ou endommagé, Non utilizzare se la confezione è
stata aperta o danneggiata, Niet gebruiken indien de
verpakking geopend of beschadigd is, Ikke bruk hvis
pakningen er åpen eller skadet, Får inte användas om
förpackningen är öppnad eller skadad
EC REP
Authorized European Representative, Repræsentant,
Bevollmächtigter in Europa, Representante europeo
autorizado, Valtuutettu edustaja Euroopan unionissa,
Représentant européen autorisé, Rappresentante
autorizzato nella Comunità Europea, Gemachtigd
Europees vertegenwoordiger, Autorisert europeisk
representant, Representant i Europa
REF
Catalog Number/Model Number, Katalognummer/
Modelnummer, Katalognummer/Modellnummer, Número
de catálogo/Número de modelo, Luettelonumero/
mallinumero, Numéro de référence/Numéro de modèle,
Numero di catalogo/modello, Catalogusnummer/
modelnummer, Katalognummer/modellnummer,
Katalognummer/modellnummer
Refer to Instructions for Use, Se brugsanvisning,
Gebrauchsanweisung beachten, Consultar las
instrucciones de uso, Katso käyttöohjeita, Consulter
le mode d’emploi, Consultare le Istruzioni per l’uso,
Raadpleeg de gebruiksaanwijzing, Se bruksanvisningen,
Se bruksanvisningen
Do Not Reuse, Må ikke genbruges, Nicht
wiederverwenden, No reutilizar, Ei saa käyttää
uudelleen, Ne pas réutiliser, Non riutilizzare, Niet
hergebruiken, Ikke bruk på nytt, Får inte återanvändas
LOT
Lot Number / Batch Code, Serienummer,
Chargennummer / Chargencode, Número/código de
lote, Eränumero/eräkoodi, Numéro de lot/Code de lot,
Numero di lotto, Partijnummer/batchcode, Lotnummer/
partikode, Partinummer/partikod
(YYYY-MM-DD)
Expiration Date, Udløbsdato, Verfallsdatum, Fecha
de caducidad, Viimeinen käyttöpäivämäärä, Date de
péremption, Data di scadenza, Uiterste gebruiksdatum,
Utløpsdato, Utgångsdatum
NON
STERIL E
Non Sterile, Ikke steril, Nicht steril, No estéril, Ei steriili,
Non stérile, Non sterile, Niet steriel, Ikke steril, Osteril
CE Marking, CE-mærkning, CE-Kennzeichnung, Marca
CE, CE-merkintä, Marquage CE, Marchio CE, CE-
markering, CE-merking, CE-märkning
Dispose Properly, Disponer korrekt, Ordnungsgemäß
entsorgen, Desechar adecuadamente, Hävitettävä
asianmukaisesti, Éliminer correctement, Smaltire in
modo adeguato, Op correcte wijze afvoeren, Kasseres
på riktig vis, Kassera på rätt sätt
QTY
Quantity, Mængde, Anzahl, Cantidad, Määrä,
Quantiantité, Quantità, Aantal, Antall, Antal
PN
Part Number, Delnummer, Artikelnummer, Número
de parte, Osanumero, Numéro de référence,
Codice prodotto, Onderdeelnummer, Delenummer,
Artikelnummer
Recycle, Genbruge, Recycling, Reciclar, Kierrätettävä,
Recycler, Riciclabile, Recyclen, Resirkuler, Återvinn
Rx Only
US Only: Prescription Use, Kun USA: Receptanvendelse,
Nur in den USA: Verschreibungspflichtig, Solo EE UU:
Uso bajo prescripción, Vain Yhdysvallat: Reseptikäyttö,
États-Unis uniquement : sur ordonnance, Solo USA:
utilizzo dietro prescrizione, Alleen VS: Gebruik op
doktersvoorschrift, Kun USA: Reseptbelagt bruk, Endast
USA: Får endast användas på läkares ordination
US Only - CAUTION: Federal law restricts this device to
sale by or on the order of a physician.
Instructions For Use
Brugsanvisning
Gebrauchsanweisung
Indicaciones de uso
Käyttöohjeet
Mode d’emploi
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Renew Medical, Inc.
1065 E. Hillsdale Blvd
Suite 410
Foster City, CA 94404 USA
EMERGO EUROPE
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
EC REP
EC REP
REF
QTY
LOT
NON
STERILE
(YYYY-MM)
EC REP
REF
LOT
NON
STERILE
(YYYY-MM)
EC REP
REF
LOT
NON
STERILE
(YYYY-MM)
0344
© 2017 Renew Medical Inc.
LAB675 Rev A
USA: +1 888.987.2929
support@renew-medical.com
www.renew-medical.com
DE: +49 0800 7363933
kontakt@renew-medical.de
www.renew-medical.de
UK: +44 0800 542 0814
support@renew-medical.uk
www.renew-medical.uk
Question and Answer IconNeed help?

Do you have a question about the Renew Insert and is the answer not in the manual?

Renew Insert Specifications

General IconGeneral
BrandRenew
ModelInsert
CategoryMedical Equipment
LanguageEnglish

Summary

Sizing and Preparation

Product Sizing Options

Renew Inserts are available in two sizes: Regular and Large, catering to different user needs.

Preparation for Use

Instructions on preparing the Renew Insert and applicator prior to insertion, including hand washing.

Product Information and Safety

Indications for Use

Indicated for managing Accidental Bowel Leakage (ABL) due to bowel incontinence.

Product Description

Made of soft silicone, Renew Inserts are single-use, non-sterile, and available in two sizes.

Warnings and Precautions

Covers potential side effects, usage restrictions, and when to consult a doctor.

Clinical Study Results

Summarizes clinical findings on safety, effectiveness, and user satisfaction.

Risks and Adverse Events

Details potential risks, including mild adverse events and displacement occurrences.

Usage Guidance and FAQs

Insertion Positions

Guidance on various comfortable positions for inserting the Renew Insert.

Insertion and Removal

Step-by-step instructions for inserting the Renew Insert and its natural or manual removal.

Frequently Asked Questions

Answers common user queries regarding testing, comfort, placement, and wear time.