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adeptmedical.com | 

| adeptmedicaltraining.com

Intended Purpose

STARBoard: 

To support a supine patient’s arm, 

facilitating hyperextension for radial access.

Extension Tray: 

To provide a transitional work 

surface from the radial access site to trolley.

IR Shield: 

To provide scatter radiation 

protection.

Intended User/Training Requirement

Intended to be used by trained medical 

professionals.

Patient Target Group

Adult male or female patient requiring 

diagnostic imaging and image guided therapy.

Contraindications

 

Not to be used with patients over 135Kg.

 

Not for paediatric use.

Warnings and Cautions

 

Ensure IFU is read prior to use.

 

Ensure preparatory Cleaning is 

conducted.

 

Ensure Preparatory Product Check is 

conducted.

 

Do not use with patients over 135Kg.  

 

To provide restraint for restless patient 

(refer to page 6).

 

Not for paediatric use.

Incident Reporting Guidelines

For product complaints and incidents, please 

complete form on

|

 Information

adeptmedical.co.nz

/repairs

Cleaning

Refer to Disinfection Instructions.

Product Checks

 

No exposed Carbon Fibre.

 

No break in Carbon Fibre surface.

 

No visible damage or sharp edges, e.g. cracks.

STARBoard

 

Ensure all pivoting joints can rotate with the 

appropriate amount of friction and adjust if 

necessary. (refer to page 5).

 

Correct placement (Refer to page 5).

 

Patient can access the handle to grip (refer to 

page 6).

IR Shield

 

Ensure correct daggerboard placement 

(refer to page 7)

 

Ensure the X-Ray Shield is correctly placed in 

the daggerboard (refer to page 7)

Arm Support Pad

 

No visible damage or tearing.

!

EN

Warnings

 

Insufficient cleaning may compromise 

disinfection process and lead to transmission 

of pathogens.

 

Do not use any disinfectant products or 

abrasive/corrosive agents which are not on 

the approved cleaners list.

 

Always read manufacturer’s instructions 

and consult the manufacturers MSDS for 

cleaning and disinfectant products.

 

Do not use any cleaning procedure which 

exceeds 65°C/149°F.

 

Some disinfectants may cause slight 

discolouration to the soft blue material used 

on some components within the product 

range. This will not affect the strength and 

the product will remain fit for purpose.

Limitations on Processing

Discontinue use if:

 

Any cracks, breakages, or tears are present.

 

Any exposed carbon fibre is visible.

|

 Disinfection

|

 Initial Checks & Cleaning

EN

Initial treatment at the point of use

It is important to clean the product once it 

is removed from the packaging and after 

each procedure. Ensure all areas including 

joints, clips, sockets, brackets and levers are 

thoroughly cleaned after use to remove all 

contaminant build-up that may be present 

following a procedure.

Preparation before cleaning

Extension Tray: 

Detach the Extension Tray 

from the STARBoard.

STARBoard:

 Remove STARBoard from 

beneath the mattress.

Arm Support  Pad:

 Remove Arm Support Pad 

from STARBoard.

IR Shield: 

Remove from Daggerboard.

Daggerboard:

 Remove from beneath the 

mattress.

|

 Disinfection Instructions

Cleaning: Manual

 

If any visible residue is present, rinse 

under water, but avoid submerging the 

device. 

 

A soft bristle brush can be used.

 

Ensure the device is completely dried 

prior to disinfection.

!

!

?

adeptmedicaltraining.com

/productcleaning/IR-System

Disinfection

Refer to the Approved Cleaners List (following 

page) for selection of an appropriate 

disinfecting agent.

STARBoard

With a cloth dampened by an approved 

disinfectant, wipe all surfaces, Armrest, Handle, 

Wrist Pivot, and adjust device to wipe entire 

Slider Arm. 

Extension Tray

Wipe all surfaces and the bracket area with a 

cloth dampened by an approved disinfectant.

IR Shield

With a cloth dampened by an approved 

disinfectant, wipe all surfaces including inside 

the slot on the Daggerboard.

Arm Support Pad

With a cloth dampened by an approved 

disinfectant, wipe all surfaces.

12

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Summary of Contents for AM0180

Page 1: ...2021 B EC Representative Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Manufacturer Adept Medical Ltd 2 6 McDonald St Morningside Auckland 1025 New Zealand INSTRUCTIONS FOR USE Instrucciones de uso Mode d emploi Istruzioni per l uso Gebrauchsanweisung Gebruiksaanwijzing ...

Page 2: ...Lista de productos de limpieza aprobados Eliminación Essential Information EN Information Initial Checks Cleaning Disinfection Disinfection Instructions Approved Cleaners List Disposal Essentiële informatie NL Informatie Eerste controles en reiniging Desinfectie Instructies voor desinfectie Lijst van goedgekeurde schoonmaakmiddelen Afval Informations essentielles FR Informations Contrôles initiaux...

Page 3: ...uebe las juntas de fricción y ajústelas si es necesario Contrôlez les articulations à friction et réglez les si nécessaire Controllare l attrito delle articolazioni e se necessario regolare Reibverbindungen prüfen und ggf einstellen Controleer frictieverbindingen en stel ze indien nodig af Tighten Apretar Serrer Serraggio Festziehen Vastdraaien Aflojar Desserrer Allentamento Lösen Losdraaien Loose...

Page 4: ...hésive facultatif Fissaggio con nastro opzionale Fixieren Optional Vastplakken optioneel Hand Positioning Options Opciones de posicionamiento de las manos Options de positionnement de la main Opzioni di posizionamento delle mani Optionen für die Handpositionierung Opties voor handpositie 3 D E X Ray Shield Daggerboard 1 2 6 7 ...

Page 5: ... Ersatzteile Reserveonderdelen STARBoard Component Codes A1 A2 Plastic Slider M3332 Armrest M3003 Washer Arm Rest M3331 Hex Bolt M5108 Slider Arm M3051 18 mm 3 1 2 4 5 STARBoard Códigos de componentes de STARBoard Codes des composants du STARBoard Codici dei componenti di STARBoard STARBoard Komponentencodes STARBoard onderdeelcodes Maintenance instructions adeptmedicaltraining com product mainten...

Page 6: ...rale e longitudinale 15 lateral und longitudinal 15 lateraal en longitudinaal Table Surface Superficie de la mesa Surface de la table Superficie del tavolo Tischoberfläche Tafeloppervlak Flat Plana Plane Piatto Flach Vlak Información básica Informations essentielles Informazioni essenziali Grundlegende Informationen Essentiële informatie Información básica ES Información Comprobaciones iniciales y...

Page 7: ...er s instructions and consult the manufacturers MSDS for cleaning and disinfectant products Do not use any cleaning procedure which exceeds 65 C 149 F Some disinfectants may cause slight discolouration to the soft blue material used on some components within the product range This will not affect the strength and the product will remain fit for purpose Limitations on Processing Discontinue use if ...

Page 8: ...reported immediately to The Competent Authority of the applicable Member State The Manufacturer using the Serious Incident Reporting Form found on the Adept Medical Website Serious Incidents Form Approved Disinfectant by Brands Approved Active Disinfectant Ingredients Acid Based 10 Malic Acid CAS 6915 15 7 6 Sulfamic acid CAS 5329 14 6 Alcohol Based 5 2 Butoxyethanol CAS 111 76 2 10 Butyldiglycol ...

Page 9: ... a la transmisión de patógenos No utilice productos desinfectantes ni agentes abrasivos corrosivos que no estén en la lista de productos de limpieza aprobados Lea siempre las instrucciones del fabricante y consulte las fichas de datos seguridad del fabricante MSDS para obtener información sobre los productos de limpieza y desinfectantes No utilice ningún procedimiento de limpieza que supere los 65...

Page 10: ... dispositivo debe notificarse inmediatamente a La autoridad competente del Estado miembro correspondiente El fabricante que utiliza el formulario de notificación de incidentes graves que se encuentra en el sitio web de Adept Medical Formulario de incidentes graves Desinfectantes aprobados por marcas Ingredientes de los desinfectantes activos aprobados Base ácida 10 de ácido málico CAS 6915 15 7 6 ...

Page 11: ...t peut compromettre le processus de désinfection et conduire à la transmission d agents pathogènes N utilisez pas de produits désinfectants ni d agents abrasifs ou corrosifs qui ne figurent pas sur la liste des produits de nettoyage approuvés Lisez toujours la notice d utilisation et consultez les FDS des fabricants des produits de nettoyage et de désinfection N utilisez pas de procédé de nettoyag...

Page 12: ...tion Incidents graves Tout incident grave survenu en lien avec le dispositif doit être immédiatement signalé A l autorité compétente de l état membre concerné Au fabricant en utilisant le formulaire de signalement d incident grave disponible sur le site Web d Adept Medical Formulaire de signalement d incident grave Désinfectants approuvés par marques Ingrédients désinfectants actifs approuvés À ba...

Page 13: ...di agenti patogeni Non usare prodotti disinfettanti o agenti abrasivi corrosivi non indicati nell elenco dei detergenti approvati Quando si usano prodotti detergenti e disinfettanti leggere sempre le istruzioni del produttore e consultare la scheda dei dati di sicurezza MSDS Non usare procedure di pulizia che prevedono temperature superiori a 65 C 149 F Alcuni disinfettanti possono causare un legg...

Page 14: ...acido Acido malico 10 CAS 6915 15 7 Acido solfammico 6 CAS 5329 14 6 A base di alcol 2 Butossietanolo 5 CAS 111 76 2 Butildiglicole 10 CAS 112 34 5 Alcol isopropilico 70 Propan 2 olo CAS 67 63 0 Tridecanolo 10 CAS 69011 36 5 Alcol C12 14 etossilato 10 CAS 68439 50 9 Etanolo denaturato 70 CAS 64 17 5 A base di solfato PHMB poliesametilene biguanide 0 1 CAS 27083 27 8 Perossimonosolfato di potassio ...

Page 15: ...en Sie immer die Anweisungen des Herstellers und beachten Sie das Sicherheitsdatenblatt des Herstellers der verwendeten Reinigungs und Desinfektionsmitteln Verwenden Sie keine Reinigungsverfahren die eine Temperatur von 65 C überschreiten Einige Desinfektionsmittel können eine leichte Verfärbung des weichen blauen Materials verursa chen das bei einigen Komponenten innerhalb der Produktreihe verwen...

Page 16: ...er schwerwiegende Vorfall der im Zusammenhang mit dem Gerät auftritt sollte sofort gemeldet werden an Die zuständige Behörde des jeweiligen Mitgliedstaates Dem Hersteller über das Meldeformular für schwerwiegende Vorfälle das auf der Adept Medical Website zu finden ist Meldeformular für schwerwiegende Vorfälle Zugelassenes Desinfektionsmittel nach Marken Zugelassene Desinfektionsmittelwirkstoffe A...

Page 17: ...taan Lees altijd de instructies en raadpleeg het veiligheidsinformatieblad van de fabrikant voor schoonmaak en desinfectiemiddelen Gebruik geen reinigingsprocedure met een temperatuur die hoger is dan 65 C Sommige desinfectiemiddelen kunnen een lichte verkleuring veroorzaken van het zachtblauwe materiaal dat op sommige onderdelen van het productassortiment wordt gebruikt Dit zal geen invloed hebbe...

Page 18: ...lpmiddel moet onmiddellijk worden gemeld aan De bevoegde autoriteit van de toepasselijke lidstaat De fabrikant via het formulier voor het melden van ernstige incidenten dat u op de website van Adept Medical vindt Formulier voor ernstige incidenten Goedgekeurd desinfectiemiddel per merk Goedgekeurde actieve desinfectiemiddelen Op zuurbasis 10 appelzuur CAS 6915 15 7 6 sulfaminezuur CAS 5329 14 6 Op...

Page 19: ... ce dispositif Per indicazioni visive e dettagliate su questo dispositivo accedere alla piattaforma Adept Medical Training Besuchen Sie die Adept Medical Schulungsplattform fur detaillierte visuelle Anweisungen zu diesem Produkt Bezoek het Adept Medical Training Platform voor uitgebreide visuele instructies voor dit hulpmiddel Visite la plataforma de formación Adept Medical para obtener instruccio...

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