Keystone keyprint KeyOrtho IBT Bedienungsanleitung Seite 2

KeyOrtho IBT
Indications for Use: KeyPrint
is a biocompatible photopolymer resin intended
for the fabrication of indirect bonding trays used
during orthodontic bracket placement.
Product Description: KeyPrint
a liquid photopolymer resin designed for additive
manufacturing in vat Polymerization DLP printers
utilizing wavelengths between 385nm–405nm.
Characterized by its flexibility, elongation at
break, and adhesive release from dental cement,
KeyOrtho IBT™ is a material designed for 3D
printing of Indirect Bonding Trays.
The user should review all applicable product
labeling, including Instructions for Use, user
manuals, and associated labeling for any
component(s) used in conjunction with KeyOrtho
IBT™. Strict adherence to all
label requirements and validated printer and
post cure settings is critical in assuring a safe,
biocompatible and effective printed appliance.
Contraindications: Contains acrylate monomers
and oligomers, which, although rare, may cause
an allergic reaction in individuals sensitive to
acrylic containing products.
CAUTION: US Federal law restricts this
device to sale by or on the order of a
dental professional.
Warnings & Precautions
1. Review the product Safety Data Sheet (SDS)
before use.
2. To ensure a safe and effective final device,
Keystone Industries recommends using dedicated
accessories for KeyOrtho IBT™, including resin
tank, build platform, and washing station. For full
biocompatibility, the dedicated accessories must
not mix with any other resins.
3. Clean the printer build plate and vat tray
before using a different batch of KeyOrtho
IBT™. DO NOT mix different batches of the
same product.
4. Do not use any devices or components that
are not validated in collaboration with Keystone
Industries.
5. As per the SDS, wear proper personal
protective equipment when handling KeyPrint®
resins and uncured printed parts.
6. When pouring the resin, be careful not
to splash.
7. Store in a cool, dry place 15°C-30°C
(59°F-86°F) and away from light. Cap the bottle
when not in use.
8. Keystone recommends against reclaiming
the resin material without filtering. In the unlikely
event of print failure, filter the liquid resin through
a mesh screen with pore sizing <200 microns. It
is a good practice to filter the resin vat periodically
to prevent print failures.
9. To achieve proper consistency of the resin
and prevent bubbles, thoroughly mix 1 hour
before use.
10. Allow the resin to reach ambient
temperature (20-25°C/68-77°F)
before printing.
11. Limit the total wash time with Isopropanol
(IPA) to no more than 5 minutes to prevent
adverse effects on final physical properties.
Compatible Equipment: To ensure
the biocompatibility of the final device,
Keystone Industries collaborates with printer
manufacturers to provide validated printer
and post-cure settings. Visit Keystone Industries'
website for a list of completed a
nd in-process validations.
TM
3D PRINTING RESINS | FOR PROFESSIONAL USE ONLY
KeyOrtho IBT
® ™
KeyOrtho IBT is
® ™
KeyOrtho IBT™ is compatible with DLP
Printers utilizing UV wavelengths between
385nm-405nm and post-cure units using UV
wavelengths of 250nm-390nm.
Processing Printed Parts
1. Pour the liquid material in the reservoir of the
printer. Follow the Printers' instructions for use.
2. Print the part according to your printers'
Instructions for Use. Keystone Industries
recommends nesting the print files on the build
plate in a flat orientation, aligning the trays' non-
intaglio surface to be in contact with the build
plate.
3. Remove printed parts from the build plate.
Directions for cleaning/ post-cure of
printed part(s)
1. Stage 1 Cleaning: Place printed part(s) in
an Isopropanol (IPA) bath with at least 97% IPA.
Use this bath as the first wash of any part coming
from the printer. Remove excess liquid resin from
the printed part(s). Run fingers over the surface,
using swishing or vibrating motions with the part
submerged in the IPA bath.
2. Stage 2 Cleaning: Transfer the part(s) into
a Stage 2 IPA bath. To achieve optimal final print
quality, use fresh IPA with a lower concentration
of contaminants. A soft bristle brush or cotton
swab dipped in IPA can help remove excess resin.
3. Dry Part(s):Use compressed air to dry
part(s), looking for glossy spots of residual liquid
resin. If residual resin remains, repeat steps 1-3
as needed.
4. Post Cure: KeyOrtho IBT™ requires post-
cure to reach optimal physical properties and
biocompatibility. After cleaning, place the part(s) in a
validated post-cure box, ensuring the part is placed
flat to prevent warping. Cure time will depend on
the wavelength and intensity of light used.
One validated method of post-curing is:
Otoflash G171: Set the post-cure box to 1000
flashes per side without nitrogen
See Keystone's website for validated post-cure
box settings.
Allow part to cool completely before removing
from the cure-box to prevent surface defects
or warping.
The finished medical device resulting from
following these directions/validated workflows
is safe, biocompatible, and effective for its
intended use.
Clinical Use Instructions: An Indirect Bonding
Tray fabricated with KeyPrint® KeyOrtho IBT™
is a customized single-patient, single-use oral
appliance that should be disposed of after it is
used to place orthodontic brackets.
Disposal Considerations: KeyPrint® KeyOrtho
IBT™ is not an environmental hazard in its final,
fully cured state. Dispose of unused and non-
recyclable liquid resin materials in accordance
with federal, state, and
local regulations.
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