parkell Cinch Vinyl Polysiloxane Impression Materials Instructions

parkell Cinch Vinyl Polysiloxane Impression Materials Instructions

Rx Only—product is intended for use by a licensed dental professional. For Safety Data Sheet (SDS) go to www.parkell.com.

Description

Parkell’s Cinch® dental impression materials are addition-reaction silicones. (a.k.a. PVS, VPS.) Important physical properties include dimensional accuracy, high tear strength, resistance to permanent deformation and being hydrophilic. Additional properties: “Quick pour formulation” for making models 15 minutes after impression pulled from the mouth. Scannable.

Cinch materials are available in light, medium and heavy body viscosities, each of which comes in both a regular (4 minute) and fast (90 second) set.
Dispensing options include dual barrel cartridges for gun dispensing, tubes for hand mixing, and super cartridges

IMPORTANT—FOR BEST RESULTS

• To ensure complete set when taking single stage, multiple viscosity impressions, do not mix regular set and quick set Cinch materials.
• For maximum retention of the material to the tray, always use a VPS tray adhesive (hS446) with perforated, solid, and triple trays.
• Material should extrude easily through the appropriately sized mixer: DO NOT USE EXCESSIVE FORCE. Excessive pressure may result in cartridge rupture and/or dispensing gun breakage.
• Stated worktimes and set-times are estimates, and may vary based upon storage, temperature, humidity, age of product, and when the cartridge was first opened.
• Do not use after expiration date.

Indications for Use

Cinch impression materials are indicated for all dental impression techniques.

Storage and General Use Instructions

• All Cinch products should be stored between 2° C (36° F) and 25° C (77° F). Exposure to excess heat will shorten shelf life and result in possible malfunction of the product.
• Avoid contact between Cinch materials and latex or sulfur-containing products, including latex gloves, rubber dams, and hemostatic agents with sulfates (e.g., Aluminum Sulfate, Ferric Subsulfate). If teeth or gingiva are contaminated with these products, they must be thoroughly removed with copious amounts of water before impressioning. Chloride containing hemostatic agents are acceptable substitutes.
• Vinyl polysiloxanes (VPS) are not compatible with polysulfdes or polyethers. DO NOT USE THEM TOGETHER.
• Acrylic or methacrylate residues from bonding agents and restorative resins can inhibit impression setting. Completely remove this uncured layer from the surface of the prep and surrounding soft tissue prior to impressioning.
• The set materials may be disinfected using glutaraldehyde or most other standard dental surface disinfectant products.
• Allergic reactions may occur in susceptible individuals. Flush affected tissues with copious water and consult a physician.

Impression Techniques

• Single Step / Dual Body Method—A
  combination of heavy, medium, and light body materials with the same work and set-time are dispensed and allowed to set simultaneously.

• Double Step / Dual Body Method—A
  preliminary impression (either pre or post prepping) is taken. Once fully set, the inner lining of this impression is relieved, and a second impression is taken using the preliminary impression as a custom tray.

• Monophase Impression—A
  material of a single viscosity (usually medium body) is used alone for impressioning. Technique of choice when using Cinch Medium materials (Cinch-90/ Cinch Platinum) as an alginate substitute.

IMPORTANT: For double-step, dual-body impressions DO NOT use the preliminary impression as a matrix for bis-acryl temporary fabrication. The bis-acryl resin will contaminate the surface of the preliminary impression and prevent the second stage wash impression material from adhering to it.

Impression Procedure (Gun Dispensed Cartridge)

1.  Depending on technique, prepare one or two cartridges by inserting and locking the cartridge(s) into an impression gun marked DS-50/1:1, 2:1. Remove the shipping cap, but do not discard as you will be using it later to recap and reseal the cartridge. Bleed about ¼″ of material from the orifces, ensuring that it is visible at both holes.

2. Attach an appropriately colored mixer to the cartridge, and if placing the material intraorally a compatible intraoral tip on the end of the mixer.
   Mixer Compatibility Guidelines:

   • Heavy Body: Blue/Green Base Mixing Tip
     (hS496).

   • Medium Body: Blue/Green (hS496) or Pink
     Base Tip (hS445).

   • Light Body: Pink Base Tip (hS445);
     Intraoral Tip Compatibility Guidelines:

   • For Pink Base Mixer use White Intraoral Tip (hS439IOT).

3. Clean rinse and dry the entire area being inpressioned being sure to remove all residual traces of retraction materials and any other contaminants that may inhibit the setting of the material.

4. Bleed a small amount of material thru the mixer(s) outside of the mouth, and immediately begin loading the impression tray. Once fully loaded, syringe intraorally into the sulcus around the prep and all other desired areas, keeping the tip immersed in impression material to avoid air entrapment.

5. Place the loaded impression tray over the teeth and hold in position until fully set. Once fully set, remove with a quick, frm motion (See chart on back for work and set times).

6. Mixers that were used intraorally should be removed from the cartridge and discarded. These cartridges should be resealed with the original sealing cap. To prevent cross contamination of the base and catalyst, the original cap should be cleaned of residual material before resealing. For mixers that were not used intraorally, the mixer can be left on the cartridge as a sealing cap.

Stone Model Pouring Guidelines:

• Minimum: 15 minutes after removal from the mouth.
• Maximum: Up to 30 days when impression properly stored and maintained.

Impression Procedure for Cinch Platinum in Tubes

1. Dispense equal lengths of base and catalyst (1:1) onto a mixing pad. DO NOT Alter the mix ratio. It will impair fnal set.
2. Recap tubes immediately, making sure not to inter-change the color-coded caps.
3. Mix by hand for 30-45 seconds with clean spatula until color is uniform and streak-free, with no air bubbles.
4. Load tray and syringe and proceed to follow standard impression procedure.

How to use Cinch in the 380 ml Super-Cartridge

1. With the Super-Cartridge seated on a flat surface and the nozzles aimed up, hold the cartridge with one hand and bend the tab on the cap upward.

2. While holding the cartridge with one hand, remove the cap.

3. Turn the retraction knob on the machine clockwise to completely retract the pistons.

4. Insert the cartridge into the mixer (Pentamix, Pentamix II or Mixstar) according to the mixer instructions. While holding the knob to keep the mixer pistons in the most-retracted position, insert the nozzle-end of the cartridge first, then seat the barrels.

5. Turn the retraction knob counter-clockwise so the plungers engage the cartridge plugs.

6. Bleed the cartridge before each use according to the mixer instructions to assure that the material is flowing properly.
   Note: When cleaning of the expressed impression material, wipe the nozzles vertically (not horizontally) to avoid cross contamination of the nozzles.

7. Install a mixing tip: Orient the tip so the large orifice on the tip will be inserted into the large orifice on the cartridge. Take care that the hex recess on the tip is aligned with the mixer’s drive shaft. (Do not substitute mixing tips. A tip not specifically made for this cartridge may appear to ft, yet leak badly when used.)

8. Lock the mixing tip in position by slipping the yellow locking cap over the mixing tip and turning clockwise.

9. Dispense the Cinch material.

10. Immediately after filling the tray, relieve pressure on the plungers by turning the sideknob clockwise to disengage the plungers.

11. Leave the used mixing tip on the cartridge until ready for the next impression.

12. To change tips immediately before next use: Remove yellow ring by turning counterclockwise. Remove mixing tip. Bleed cartridge (Step 6). Affix new tip (Step 7). Lock in place with yellow ring (Step 8).

13. To change cartridges, remove the yellow locking ring from the old cartridge by turning counterclockwise. Turn the machine’s retraction knob as far clockwise as possible to completely disengage the plungers. Remove the cartridge.

Tips for Dental Practitioners for Cross-Contamination Control

The following information should help dental practitioners reduce the risk of cross-contamination between patients when using multiple-use dental dispensers: apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient; use new, uncontaminated gloves when handling multiple-use dental dispensers; utilize dental assistants to dispense material for the dentist when appropriate; avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth; do not reuse the multiple-use dental dispenser if it becomes contaminated; do not immerse multipleuse dental dispensers in a high level chemical disinfectant, as this may damage the dispenser and the material contained in the device; do not sterilize multiple-use dental dispensers, as this may damage the material contained in the device.

The cartridge and dispensing gun can be cleaned of debris with an EPA- registered low-level to intermediate-level hospital disinfectant. The used mixing tip should be discarded, and the original cap should be reattached to the cartridge to re-seal until next use. Utilize the surface disinfecting protocol of the disinfectant manufacturer. Consult www.CDC.gov for the most recent version of the “Guidelines for Infection Control in Dental Health-Care Settings”.

Warranty and Terms of Use

For full Warranty and Terms of Use information, please go to www.parkell.com. Safety Data Sheets (SDS) are available at www.parkell.com. Parkell’s Quality System is certifed to ISO 13485.

Properties of Cinch Materials

Cinch Medium Body

Cinch 90| Cinch Platinum
60 seconds| 3 minutes
90 seconds| 4 minutes
45 (Shore A)| 55 (Shore A) in cartridge, 60 (Shore A) in tubes
RFE S453S (Pink base mixing tip RFE S445)| RFE S454S (Pink base mixing tip hS445)
| RFE S466 (mixing tip is RFE S472)
| RFE S435
RFE S439IOT| REF S439IOT
Cinch Heavy Body

Quick Cinch Heavy| Cinch Automix Putty
60 seconds| 3 minutes
90 seconds| 4 minutes
72 (Shore A)| 72 (Shore A)
RFE S463S (Blue-Green base mixing tip
RFE S496)| RFE S456S (Blue-Green base mixing tip RFE S496)

Each Cinch Impression Material Kit contains the proper mixing tips or tube squeezers for that product. VPS Adhesive (hS446), the DS-50 Mixing Gun (hS343), replacement mixing tips and intra-oral tips are available separately from Parkell or many dental dealers.

Explanation of Symbols Use

| Professional use only
---|---
| Follow instructions for use
| Temperature limit
| Store product tightly sealed away from direct sunlight.
| Use-by date (expiration)
| Batch code
| Catalogue / stock number
| Unique Device Identifier
| Medical Device
| Package contents
| Importer
| Do not use if package is damaged
| Single use only
| Manufacturer

| Translation
| 50 ml Mixing Tip
| Intraoral Tip
| 50ml Cartridge / Paste
| 380 ml Super-Cartridge / Paste
| 380 ml Super-Cartridge Collar / Locking Cap
| 380 ml Super-Cartridge Tip
| Base/Catalyst Tube / Paste

Parkell, Inc.,
300 Executive Dr., Edgewood, NY 11717 USA 800-243-7446 • www.parkell.com

UKRP: Topdental (Products) Ltd,
12 Ryefeld Way, Silsden, West Yorkshire BD20, 0EF England UK

mt‑g medical translation GmbH & Co KG
Stuttgarter Straße 155 • D-89075 Ulm

References

• Centers for Disease Control and Prevention | CDC
• Dental Instruments, Devices and Materials

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