SprintRay IFU-002 Surgical 3 Platform Instruction Manual

: June 1, 2024
: SprintRay

Table of Contents

Indications for Use
Contraindications
Device Description
Printing and Hardware Parameters
Warning and Precautions
Storage
Fabrication of Device
Polishing (optional)
Sterilization
Additional Help & Support
Contact Information
Manufacturer information
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

Instructions For Use
SprintRay Surgical Guide 3 Resin
IFU-002_6
DCO# 1419
Effective Date: 12/08/2023

Indications for Use

The Sprint Ray Surgical Guide 3 is a light-curable polymerizable resin intended to be used for fabrication of surgical guides. This material is an alternative to traditional surgical guide material.

Contraindications

Sprint Ray Surgical Guide 3 is contraindicated when:

a patient is known to be allergic to any of the ingredients
there is direct intraoral contact with resin that is not fully cured
it is used for any purpose other than its indications for use

Device Description

Surgical Guide 3 is an alternative to traditional surgical guide making material that is intended exclusively for professional dental work.

Printing and Hardware Parameters

These device specifications have been validated using the following manufacturing products.
Any products or processes not specified in this document are outside of the device specifications.

a. CAD File: CAD file of treatment device in STL file format
b. Printer: Sprint Ray Pro or Pro S DLP 3D printer

55 or 95 micron XY resolution
c. Software: Ray Ware Desktop or Ray Ware Cloud
STL file import
Manual/automatic orientation

d. Printing Parameters

Intaglio surface facing away from build platform
100 micron layer thickness
Default support structures

e. Wash Device: Sprint Ray Pro Wash S or Sprint Ray Pro Wash/Dry

91% or higher IPA
Standard preprogrammed wash cycle

f. Cure Device: Sprint Ray Procure 2 or Pro Cure

Use manufacturer recommended curing times

Warning and Precautions

Sprint Ray Surgical Guide 3 is non-toxic in processed, cured form, and is classified as a biocompatible material. In uncured form, Surgical Guide 3 is classified as a sensitizer. When washing with solvent or grinding the device, do so in a well-ventilated area with proper protective equipment.

Skin Contact: May cause skin irritation. If unprocessed resin contacts skin, wash thoroughly with soap and water. May cause an allergic skin reaction. If skin sensitization occurs, stop using. If dermatitis or other symptoms persist, seek medical assistance.
Inhalation: High vapor concentration may cause headache, irritation of eyes and/or respiratory system. If exposed to a high concentration of vapor or mist, move to fresh air. Use oxygen or artificial respiration as required.
Eye Contact: Wash the contacted area thoroughly with soap and water.
Ingestion: Contact your regional poison control center immediately.

Storage

Material Reuse: The remaining resin in the resin tank can be reused. You may use a filter to ensure the resin is free from any cured particles to avoid print failures. The remaining material in the tank can be poured back into the resin bottle upon filtration. This process can be repeated until the material in the bottle is fully consumed. Please note that in the case of reuse, the resin must be filtered and poured back into the same bottle.
Store Surgical Guide 3 at 15-25°C (60-77°F) and avoid direct sunlight
Keep the bottle closed and/or the tank lid securely attached when not in use
Before disposal, completely polymerize
Do not use Surgical Guide 3 after the expiration date printed on the bottle

Do not use expired resin; biocompatibility and print stability may be compromised if expired photo initiators do not activate properly.

Fabrication of Device

Designing
The device is designed in STL file format by a dental design service or dental CAD software using digital anatomical data from the patient. This STL file is delivered to the clinician for fabrication.
3D Printing
Sign in to Ray Ware Cloud and select the appliance type; the algorithm will automatically orient and add supports. Select this material and use 100 micron layer thickness. Queue the job to your printer.
Shake the resin bottle thoroughly for one minute, then pour into the resin tank up to at least the min fill line. From the printer touchscreen, navigate to the printer queue. Start the print job.
Part and Support Removal
After your device has been printed, remove it from the print platform using the provided Print Removal Tool. Remove all supports using a flush cutter or round diamond disc. Cut as close as possible to the device to minimize the smoothening and finishing procedure.
Washing and Drying
Use ≥91% IPA to wash the device using the Sprint Ray Pro Wash S or Sprint Ray Pro Wash/Dry:

Standard cleaning cycle

Dry the part completely before post-curing.

Post Curing
Use one of the following post-curing equipment from Sprint Ray to cure the device and select the preprogrammed profile for Surgical Guide 3:

Pro Cure 2 (preprogrammed material profile)
Pro Cure (20 min at 50°C)
The printed guide may have a yellowish color after post curing. It will turn to clear during sterilization.

Finishing
Use A Scotch-Brite/Fuzzies Wheel with a lab handpiece to smoothen the surface.

Polishing (optional)

Use pumice and a muslin wheel to remove minor scratches from the surface of the appliance, then use a polishing compound and muslin wheel to polish. Wash and clean the device with a brush using soap and warm water.

Sterilization

Insert the surgical guide sleeves into the drill holes and autoclave for 5 minutes at 134°C.

Additional Help & Support

We are here to support you throughout the implementation period of your new technology. Our experienced support technicians are available M – F from 6 AM – 5 PM PT at 800-914-8004.