SprintRay EU Splint Flex Instructions
- June 10, 2024
- SprintRay
Table of Contents
SprintRay EU Splint Flex Instructions
Indication
SprintRay EU Splint Flex is intended for the production of orthodontic and dental objects such as mouthguards, nightguards, snoring appliances, and splints.
Contraindication
SprintRay EU Splint Flex is contraindicated:
- if a patient is known to be allergic to any of the ingredients.
- for denture bases.
- for any application that is not part of the indication (see
above).
Requirements
Software: RayWare (CAD)
Hardware:
- Pro Desktop 3D (3D Printing)
- Pro Wash/Dry (Cleaning),
- ProCure (Post Curing)
SprintRay, Inc., 3577 North Figueroa St., Los Angeles, CA 90065
Material
SprintRay EU Splint Flex consists of functional (meth)acrylic resins.
Geometric Presetting
Minimum wall thickness: 1.5 mm
Material Parameters
Radiation depth is controllable through exposure time. 50 μm 100 μm
Manufacturing Process (fi g. 1-10)
-
Prepare data (RayWare).
-
Choose process parameters (build style, etc.).
-
Transfer prepared data to 3D printing device.
-
Prepare 3D printing – shake bottle.
-
Fill resin tank of 3D printing device.
-
Build the parts.
-
Clean parts (ProWash / Dry): 5 min. / 5 min.
-
Dry parts (ProWash / Dry): 3 min.
-
Post curing (ProCure): 20 min. / 60 °C.
-
Finish parts.
Finishing Processes
Polishing
Notice
According to the EU Medical Devices Regulation, users/patients are obliged to report serious events with a medical device to the manufacturer and to the competent authority of the country in which they occurred.
Caution: Polymerized resins are chemically resistant – avoid stains on clothing! Avoid any contact with skin and eyes! In case of accidental contact, rinse with adequate running water, consult a doctor if necessary. The lot number and the best before date areindicated on each packaging. In case of claims please always indicate the lot number of the product. Do not use the product after expiry of the best before date. Dispose of contents/container according to official regulations.
Hazard Statements
Causes skin irritation. May cause an allergic skin reaction. Causes serious eye irritation. May cause respiratory irritation. Harmful to aquatic life with long lasting effects.
These data come from measurements of a representative sample that was determined as part of our quality assurance.
According to internal design and requirements specifications.
Physical properties
SprintRay EU Splint Flex
- Shore hardness D
- Flexural strength
- Bending module
- Water absorption
- Solubility
- impact strength
- Elongation at break (ISO 37)
Ordering information
SprintRay EU Splint Flex
1 kg:
≤ 405 nm
REF: SRE-1001701
This side up
Temperature limit
CE mark
Warning
Do not use if package is
damaged
Consult instructions for use.
Keep away from sunlight
Rx only
QTY: 1EA
Medical Device
Use by date
Catalogue number
Lot number
Date of manufacture
Manufacturer:
pro3dure medical GmbH
Am Burgberg 13 · 58642 Iserlohn, Germany
Phone: +49 (0)2374 920050-0 · Fax +49 (0)2374 920050-50
info@pro3dure.com ·
www.pro3dure.com · Made in Germany
Distributor:
SprintRay Europe GmbH
Brunnenweg 11 · 64331 Weiterstadt · Germany