Dentsply Sirona Essix A+ Kunststoff Gebrauchsanleitung

Essix A+® Plastic
INSTRUCTIONS FOR USE
INTENDED USE:
Essix A+® Plastic is thermoformed to fabricate intra-oral appliances such as bite planes, splints, and snoring appliances. Essix A+® Plastic is suitable for use
with non-bruxers.
INDICATIONS FOR USE:
Mouthguard and aligner materials are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards,
nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS:
Performance characteristics of dental plastic sheets include a good combination of strength, durability and clarity, resistant to cracking or breaking, easily
removeable from models and effortless to trim.
Clinical benefits of tooth whitening and aligner treatment may include overall improvement of tooth health and correction of malocclusion(s).
CONTRAINDICATIONS:
This product is contraindicated for patients with a history of allergic reactions to plastics.
WARNINGS:
Excessive heating time during thermoforming will cause plastic to over sag and potential for injury to operator.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
PRECAUTIONS:
Essix A+® Plastic is not recommended for bruxers.
Patients with a history of allergic reactions to plastics should not use this product.
Do not reuse plastic sheet. Once thermoformed it cannot be reused.
Thermoformed device is for Single Patient Use. Risks of reuse include infection and contamination (i.e. bacterial, viral).
Store plastic sheets in a cool, dry place.
ADVERSE REACTIONS:
Allergic reactions.
STEP BY STEP INSTRUCTIONS FOR USE WITH ESSIX VACUUM MACHINES:
1. Essix A+® Plastic has a protective film on both sides. REMOVE FILM FROM BOTH SIDES BEFORE THERMOFORMING.
2. All models should be trimmed to ¾" high. Full arch models should have the palate trimmed away.
3. IMPORTANT: Pre-heat the machine before using! Pre-heat the vacuum machine for at least 3 minutes or until the heating element is a solid orange
color. (Heating times may vary with current fluctuations or length of time the heating element has been left on.)
4. Spray the model with Trim-Rite® Release Agent to prevent the material from sticking to the model.
5. Place the plastic into the frame of the vacuum machine and the model on the base plate.
6. After pre-heating, swing the heating element over the plastic.
7. Observe the plastic as it heats.
8. Essix A+® Plastic should be heated until it sags approximately ½".
9. Move the heating element away from the plastic.
10. Turn on the vacuum and lower the plastic over the model.
11. Push the plastic into each undercut with the Essix Accentuator® Tool.
12. Immediately spray the plastic encased model with Essix Freeze Spray® Coolant. Not only does it cool the plastic, prohibiting further thinning, but it
"shrinks" the material around the cast, realizing a tighter fit.
13. Let vacuum continue to run until plastic is cool.
14. Trim and finish the appliance as desired.
*Heating time may vary depending upon machine. If plastic does not adapt to model, add heating time until adaptation occurs. If plastic "folds" when
thermoformed, reduce heating time until material does not fold.
For step-by-step instructions refer to owner's manual of thermo-forming machine used.
Thickness Vacuum Heat Time**
0.5mm (.020") 30 seconds
0.75mm (.030") 35 seconds
1.0mm (.040") 40 seconds
1.5mm (.060") 50 seconds
2.0mm (.080") 70 seconds
3.0mm (.120") 80 seconds
**after preheating element
SAFE DISPOSAL:
Unused plastic sheets can be recycled.
Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used
devices.
Manufacturer: Dentsply Sirona Orthodontics Inc.
7290 26th Court East Sarasota, FL 34243 USA
www.dentsplysirona.com/orthodontics-e-labeling
Biostar™ Code** Essix® SelectVac®
122 1:20
132 1:30
142 1:35
164 2:00
205 2:05
226 3:20
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
Drufomat
1:00
1:00
1:05
1:10
1:30
2:10
MKT-DFU0034-ML Rev. 01
Biostar and Drufomat are not trademarks of
Dentsply Sirona.
©2020 Dentsply Sirona
ENG
Issued 01-2020