ASIGA 04504 DentaGUIDE Product Instruction Manual

: June 3, 2024
: ASIGA

ASIGA 04504 DentaGUIDE Product

Introduction

The following instructions for use are for dental professionals who use Asiga DentaGUIDE as a material for surgical guides. This instruction for use also provides information about safety and environmental aspects. In case more information is needed, contact the reseller.

Intended Use

Asiga DentaGUIDE is intended exclusively for professional dental work.
Asiga DentaGUIDE is a 3D print resin intended for the manufacturing of 3D printed dental surgical guides.
Asiga DentaGUIDE is not intended for long term use (longer than 30 days) within the oral cavity.
The surgical guides produced are suitable for all dental indications including dental implant surgical guides, crown and bridges applications.

Description, Indications & Effects

Asiga DentaGUIDE is intended be used in combination with DLP based 3D printers (i.e. Asiga Max Series or Asiga Pro Series) that support Asiga resins. Printer and resin must be optimized with respect to each other in order to produce complete and precise printed parts. If the printer and resin are not optimized with respect to each other this may have an adverse effect on the accuracy and physical quality of printed parts. DLP based 3D printers and post-curing lightboxes make use of a light source to polymerize the Asiga resin. Therefore, operators are advised to wear UV protective glasses when operating a 3D printer and/or lightbox. Differences in colour nuance may occur due to: production in batches; iadequate shaking and mixing of the original packaging before use; inadequate stirring in the DentaGUIDE resin before use; insufficient post-curing.

Contra-Indications

Asiga DentaGUIDE should not be used for any other purpose than as a 3D print resin for the manufacturing of dental surgical guides. Any deviation from this instruction for use may have an adverse effect on the chemical and physical quality of Asiga DentaGUIDE. In case of an allergic reaction, please contact a medical physician. Any serious incident that has occurred in relation to the device must be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Hazard & Precautions

Please refer to Asiga product safety data sheet for DentaGUIDE. For material SDS or technical assistance, contact your Asiga resellers or open a support ticket in your account online https://www.asiga.com/accounts/support/.

Processing & Post-Curing

Ensure the 3D printer is clean prior to use, including the imaging area and any optical surfaces. Ensure the material tray is clear of solid debris prior to commencing a print. The presence of solid particles in the resin may cause deformation or failure of the printed objects. Nitrile gloves should be worn at all times when handling Asiga liquid resins up until the finishing step. Avoid contact with skin. If contact with skin occurs, wash thoroughly with cold soapy water. If contact with eyes occur, remove any contact lenses and flush with cold water and seek immediate medical assistance.

Mixing Before Use

In Bottle: Agitate/shake bottle vigorously prior to pouring for at least one minute.
In Material Tray: Stir material with a soft spatula. Take care not to damage the film of the Material Tray.
This step is necessary to re-disperse the (possible) pigment sediment from the bottom of the vessel.
Colour deviation and print failures may occur if insufficiently mixed.

Fill Material Tray

Ensure the temperature of the resin is between 15 and 30°C / 59 and 86°F and prevent exposure to direct sunlight. Pour the resin into the material tray of the 3D printer.

Printer Settings

Asiga DentaGUIDE is optimised to build parts using light with 385nm wavelength. For Printer Settings, See manual or user guides of Asiga 3D Printers (Asiga Max Series or Asiga Pro Series). Ensure the film of the Material Tray is clear of any debris before starting the print. Ensure you are using the latest ini file. You can access the latest material ini file for this material in your Asiga account online here: https://www.asiga.com/accounts/#tab_material

Washing

Wash parts in IPA 98%+ pure (Isopropyl alcohol) in a well ventilated area. Best results are achieved when using a pre and post wash.

Using an ultrasonic cleaning device:
Pre-wash bath : 10 minutes.
Post-wash bath : 5 minutes.

Important : Ensure a dedicated bath is used for this material. Do not wash in baths that have previously been used for other materials. Allow parts to dry thoroughly before post-curing.

Post-Curing

After washing and drying, let the printed parts rest for at least 30 minutes to ensure that the printed parts are free of alcohol residue.
Place the printed parts in a UV curing unit “NK Optik Otoflash G171” for 2000 flashes.
Turn parts over and allow to cool for 5 minutes then repeat. Total: 8000 flashes (4 x 2000 flashes).

Post-curing is an UV-light treatment to ensure that DentaGUIDE printed parts obtain optimal polymer conversion. Through this the residual monomer is reduced to a minimum and the required mechanical properties are obtained. We advise use of the Asiga Flash post-curing box. Place parts inside the G171 Otoflash chamber on the support mesh, do not use a plastic tray inside the chamber. Inert gas is not required. Please see Asiga Flash Unit user guide.

Soaking

After post-curing, soak DentaGUIDE parts in fresh drinkable water for 60 minutes.

Autoclaving

DentaGUIDE parts may be optionally autoclaved after post-curing at 121 degrees Celsius.

Storage Conditions, Expiry Date & Transport

Store the resin in the original packaging at room temperature in a dry, cool and dark area. Close the packaging after each use. The expiry date of the product is mentioned on the product label along with the lot number. Store on printer for up to 4 weeks with hood closed or store in bottle for up to 24 months in a cool dark place. The product performance is no longer guaranteed once the expiry date is exceeded. Do not expose to UV-light. Standard transport conditions apply to this product. There are no restrictions for transport related to hazardous substances.

Waste Disposal

Asiga resin in its polymerized form is not environmentally harmful thus can be disposed of in general waste. Asiga resin in its liquid state should be treated as chemical waste. Special disposal requirements are applicable, check with your local, federal, or other regulatory agencies for disposal requirements.

Delivery Units

Asiga DentaGUIDE is available in 1 colour only : Clear, 1kg.

Manufactured by: ASIGA PTY LTD, UNIT 2, 19-21 BOURKE ROAD, ALEXANDRIA, NSW 2015, AUSTRALIA
AUSTRALIA HEAD OFFICE: +61 2 9690 2737 | EUROPE OFFICE: +49 361 5506 6866 | US TOLL FREE: +1 877-689 99 98 Instructions For Use: DentaGUIDE
Revision 7, Effective Date : 29th July 2022
SRN : AU-MF-000012099 – MDEL 17877
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