GC AMERICA GCA-137288 ExaFast NDS Vinyl Polysiloxane Instruction Manual

C AMERICA GCA-137288 ExaFast NDS Vinyl Polysiloxane

EXAFAST™ NDS

HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIAL
For use only by a dental professional in the recommended indications.

RECOMMENDED INDICATIONS AND USES

Cavity Impression of| Impression Technique| Tray Type| Recommended Consistencies|
---|---|---|---|---
Facing, Inlay, Onlay, etc.|
Single Mix Single Impression|

Stock or Custom Tray

| Monophase|
| Double Mix Single Impression| Monophase or Heavy + Injection or Regular|
Impression of| Double Mix Double Impression| Putty + Injection or Regular|
Crown or Bridge|
Double Mix Single Impression| Monophase or Heavy + Injection or Regular|
| Putty-Wash Impression| Putty + Injection or Regular|

Impression of Partial Denture

| Single Mix Single Impression| Stock or Custom Tray| Monophase|
Putty-Wash Impression| Stock Tray| Putty + Regular or Injection|
Impression of Full Denture| Single Mix Single Impression| Stock or Custom Tray| Monophase|

CONTRAINDICATIONS

In rare cases, the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a physician.

PHYSICAL PROPERTIES (Average )

Test Items

| Injection Type 3: Light-Bodied Consistency| Regular Type 2: Med.-Bodied Consistency| Monophase Type 2: Med.-Bodied Consistency| Heavy Type 1:

Heavy-Bodied Consistency

---|---|---|---|---
Total Working Time (Min., Sec.)| 1’00”| 1’15”| 1’20”| 1’15”
Setting Time (Min., Sec.)| 1’45”| 2’15”| 2’15”| 2’30”
Minimum Time in Mouth (Min., Sec.)| 1’30”| 1’30”| 1’30”| 1’30”
Recovery From Deformation (%)| 99.7| 99.5| 99.3| 99.3
Maximum Strain in Compression (%)| ≤7.0| ≤4.8| ≤3.2| ≤3.3
Linear Dimensional Change after 24 hrs (%)|

≤0.2

|

≤0.2

|

≤0.2

|

≤0.2

Test conditions : Temperature (74˚F/23˚C 4˚F/2˚C) Relative humidity (50 5%) (ISO 4823:1992(E))

NEW CARTRIDGE LOADING AND DISPENSING

1. Lift the release lever of the CARTRIDGE
   DISPENSER 2 referred to as the dispenser hereafter) and pull the piston plunger all the way back into the dispenser. Lift the cartridge holder of the dispenser and load the cartridge, ensuring that the V-shaped notch on the flange of the cartridge is facing down. Push the cartridge holder down to hold the cartridge firmly in place.

2. Remove the cartridge cap by rotating 1/4 turn anti-clockwise. Tilt the cap downward and peel it away from the cartridge. Gently squeeze the dispenser handle to extrude a small amount of material from the two openings at the end of cartridge. Make sure that base and catalyst come out evenly.

3.  Align the V-shaped notch on the rim of mixing tip to the V-shaped notch between the cartridge barrels. Push firmly to attach the mixing tip. Then rotate the colored collar of the mixing tip 1/4 turn clockwise to the end of the cartridge. The dispenser is now ready for use.

4. Squeeze the handle several times to extrude the material. After use, do not remove the mixing tip as this will become the storage cap until next use. When replacing the mixing tip, rotate the collar on the mixing tip 1/4 turn anti-clockwise to align the V-shaped notch on the cartridge. Tilt the mixing tip downward and peel it away from the cartridge.

5. Remove and replace the old mixing tip immediately prior to next use. Before attaching a new tip, gently extrude a small amount of material to ensure that base and catalyst are flowing evenly from both openings. If the materials should fail to extrude, remove any hardened materials from the end of the cartridge.

6. To replace the cartridge, lift the release lever and retract the piston plunger fully. Remove the empty cartridge by lifting the cartridge holder and load a new one into the dispenser.

DIRECTIONS FOR USE

1. Attach an intraoral tip to the mixing tip or load material into a syringe.
2. Inject the mixture onto the prepared teeth.
3. Load the tray with the appropriate material (putty, monophase, heavy body or regular depending on technique being used).
4. Seat the loaded tray in the mouth within specified working times.
5. Wait for set (1’30” minutes in the mouth).
6. The obtained impression should be cleaned, then disinfected, utilizing a 2.5% or 3.4%glutaraldehyde, or another appropriate disinfectant, according to the manufacturer’s label recommendations.
7. Remove the impression and pour a model immediately (if desired). The maximum time for pouring the model is 14 days.

CAUTION

1. When extruding EXAFAST NDS, care should be taken to avoid mixing or contact with the following materials. They may delay or prevent setting:
   • The catalyst for condensation type silicone impression materials
   • Polysulfide impression materials • Latex
   • Oil
   • Sulfur • Acrylates Also avoid moisture and glycerol when extruding.
2. Fast set material may not be preferred for full arch multiple (more than 3) unit impressions where quick setting time could interfere with accuracy. Higher temperatures accelerate set; refrigeration retards set.
3. Avoid use of EXAFAST NDS with patients who have a history of hypersensitivity to silicone impression materials.
4. EXAFS NDS can be silver-or copper-plated.
5. Care should be taken to avoid getting material on clothing. It is hard to remove.
6. Personal protective equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.

STORAGE

Recommended for optimal performance, store at room temperature (74°F/23°C) @50% Relative Humidity.
CLEANING AND DISINFECTING
MULTI-USE DELIVERY SYSTEMS: To avoid cross-contamination between patients this device requires mid-level disinfection. Immediately after use inspect device and label for deterioration. Discard device if damaged.
DO NOT IMMERSE. Thoroughly clean device to prevent drying and accumulation of contaminants. Disinfect with a mid-level registered healthcare-grade infection control product according to regional/national guidelines.
Some products referenced in the present IFU may be classified as hazardous according to GHS. Always familiarize yourself with the safety data sheets available at:
http://www.gceurope.com
or for The Americas:
http://www.gcamerica.com
They can also be obtained from your supplier.
UNDESIRED EFFECTS – REPORTING:
If you become aware of any kind of undesired effect, reaction or similar events experienced by use of this product, including those not listed in this instruction for use, please report them directly through the relevant vigilance system, by selecting the proper authority of your country accessible through the following link: https://ec.europa.eu/growth/sectors/medical devices/contacts_en as well as to our internal vigilance system:
[email protected]
In this way you will contribute to improve the safety of this product.
Last revised: 02/2021
MANUFACTURED by GC CORPORATION
76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japan
Tel: +81-3-3965-1221
RESPONSIBLE MANUFACTURER IN CANADA:
GC AMERICA INC.
3737 West 127th Street, Alsip IL 60803 U.S.A.
DISTRIBUTED by GC AMERICA INC.
3737 West 127th Street, Alsip IL 60803 U.S.A.
Tel: +1-708-597-0900
www.gcamerica.com

References

• Country & Language Selector | GC Europe

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>