GC 1-682 Exafast Putty 1-1 Pack Instruction Manual

GC 1-682 Exafast Putty 1-1 Pack

VINYL POLYSILOXANE IMPRESSION MATERIAL PUTTY-TYPE O
For use only by a dental professional in the recommended indications.

USES

Injection or Regular
Impression of Partial Denture| Putty-Wash Impression| Stock Tray| Putty + Regular or Injection

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| EXAFAST PUTTY TYPE O

PUTTY CONSISTENCY

---|---
Mixing Time (Sec.)| 30″
Total Working Time (Min., Sec)| 45″
Setting Time (Min., Sec)| 2’15”
Minimum Time in Mouth (Min., Sec.)| 2’15”
Recovery From Deformation (%)| 99.2
Maximum Strain in Compression (%)| 1.2
Linear Dimensional Change after 24 Hrs. (%)| < 0.2

DIRECTIONS FOR USE

1. Take equal volumes of Base and Catalyst. Knead quickly within 30 seconds with the fingertips until a uniform color is obtained.
2. Load the kneaded EXAFAST PUTTY into a tray and insert into mouth. When a wax spacer is not used, cover the surface of the EXAFAST PUTTY with a polyethylene sheet. Once the tray is seated, rock the tray back and forth to make space for the wash material.
3. Allow material to set and remove from the mouth.
4. Remove any areas of the impression that might interfere with reseating.
5.  Rinse and dry the impression. Make sure the impression is clean and dry prior to taking final impression.
6. Take detail impression.
7. The obtained impression should be cleaned, then disinfected, using a 2.5% or 3.4% glutaraldehyde or other appropriate disinfectant according to the manufacturer’s label recommendations.

CAUTION

1. When mixing EXAFAST PUTTY, care should be taken to avoid mixing or contact with the following materials. They may delay setting time:
   • The catalyst for condensation type silicone impression materials
   • Polysulfide impression materials
   • Eugenol materials
   • Sulfur • Latex • Oil • Acrylates Also avoid moisture and glycerol when mixing.
2. When kneading material, put on the plastic gloves provided or other polyethylene gloves. Do not use latex gloves as it may delay setting and cause rough surface.
3. The putty impression should be cleaned and dried completely before taking the final impression.
4. After use, each container should be closed with its original lid in order to prevent Base and Catalyst from contaminating each other.
5. Avoid the use of EXAFAST PUTTY with patients who have a history of hypersensitivity to silicone impression materials.
6. Caution must be used not to mix the putty using latex gloves.
7. EXAFS PUTTY can be silver-or copper-plated.
8. Care should be taken to avoid getting silicone mixtures on clothing. It is hard to remove.
9. 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.

PACKAGES

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: vigilance@gc.dental In this way you will contribute to improve the safety of this product. Last revised: 02/2021

References

• Country & Language Selector | GC Europe

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