parkell S432S Dental Impression Material Mach-2 Die-Silicone Starter Set Fast Instruction Manual

parkell S432S Dental Impression Material Mach-2 Die-Silicone Starter Set Fast

Explanation of Symbols Used

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• Professional use only

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• Follow instructions for use

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• Temperature limit

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• Store product tightly sealed away from direct sunlight.

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• Use-by date (expiration)

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• Batch code

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• Catalogue / stock number

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• Unique Device Identifier

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• Medical Device

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• Package contents

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• Do not use if package is damaged

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• Single use only

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• Manufacturer

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• Translation

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• 50 ml Split Cartridge

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• Mixing Tip

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• Intraoral Tip

Description

Parkell’s MACH-2® Die Silicone / Dental Impression Material is fast setting, highly fowable (ultra-low viscosity) and highly accurate once fully set. Set material has a fnal durometer over 90 (Shore A) which makes it hard but slightly fexible. MACH-2 is classifed as an addition-reaction silicone, also known as an A-Silicone, a polyvinyl siloxane (PVS), or a vinyl polysiloxane (VPS). It is packaged in a dual-barrel, split cartridge that utilizes the DS-50 (1:1, 2:1) dispensing gun. Indications for U

Indications for Use

MACH-2 is indicated to produce extremely accurate, dies and models that can be used when either fabricating or repairing dental restorations and prosthesis which may include; permanent indirect resin inlays, onlays and veneers, provisional restorations, resin and fiber-reinforced splints, bleaching trays, repair of removable prosthetic and orthodontic appliances. Additional Use: As the wash impression material inside a high-viscosity VPS tray matrix.

Important Clinical Information

• Mach-2 SETS VERY QUICKLY, ESPECIALLY AT MOUTH TEMPERATURE. Clinicians should allocate enough time to complete the task, along with extra time for any delays.
• We recommend that Mach-2 be used with tray or basing materials with a short setting time of 2 minutes or less. Such products include Parkell’s Blu-Mousse® (SuperFast or Classic), Green-Mousse®, Quick CinchTM Medium (“Cinch 90”) or Quick CinchTM Heavy. This will assure that the tray and wash materials bond well to each other, and complete their set at approximately the same time. Remember to always wait for the slower material to be set before pulling a model or an impression.

Properties of Mach-2 Vinyl Polysiloxane Material

Working Time (at room temp 23º C / 73º F)| 60 – 80 Seconds| NOTE: Working & settings times are dependent on room temperature, age of material and storage conditions.
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Setting Time (at mouth temp 37º C / 98.6º F)| 4 Minutes
Final Durometer (Shore A)| 90+

Storage and General Use Instructions for Mach-2

1. Mach-2 should be stored between 18º C (64º F) and 24º C (75º F). Exposure to excess heat will shorten shelf life. For best results, use at normal room temperature. To extend work/set times, the materials may be slightly chilled, which will also reduce fowability
2. Avoid contact between Mach-2 and all latex or sulfur-containing products, including latex rubber gloves or rubber dams, and hemostatic agents with sulfates (e.g. Aluminum Sulfate, Ferric Subsulfate). If teeth or gingiva are contaminated with these products, scrub with a 5% hydrogen peroxide solution on gauze, and follow with a copious water rinse before impressioning. Chloride hemostatic agents are acceptable substitutes that do not inhibit VPS setting.
3. Vinyl polysiloxanes like Mach-2 are not compatible with polysulfdes or polyethers.
4. Acrylic or methacrylate residue from bonding agents or restorative resins can inhibit the setting of Mach-2. Remove the uncured outer layer of such products before impressioning. Avoid making temporaries inside fnal impressions.
5. Set materials may be disinfected using glutaraldehyde or most other standard dental surface disinfectants.
6. Allergic reactions may occur in susceptible individuals. Flush affected tissues with copious water and consult a physician.
7. Mach-2 VPS will work with equivalent VPS products from many other high quality manufacturers.

Double-Bleeding Cartridges is Essential Every Time!

Mach-2 VPS possesses very high accuracy as a result of its extremely low viscosity. This loose consistency means that it must be very well mixed each time it is used. To accomplish this, we strongly recommend that “The Double Bleed Technique” be used every time the product is dispensed. Load and lock the Mach-2 cartridge onto a DS-50 (1:1, 2:1) dispensing gun.

1. Twist off and discard the sealing cap or previously-used mixing tip. Do not reuse.
2. FIRST BLEED: Bleed about ¼ inch of Mach-2 from the two cartridge orifces onto a mixing pad, ensuring that material is visible at the end of both holes afterward.
3. Wipe the ends clean with a tissue, avoiding cross contamination.
4. Attach a yellow-hubbed mixing tip to the cartridge and lock tight with a ¼ turn.
5. Affx a yellow intraoral tip to the end of the mixer. For increased fow, you may cut off 1 mm of the intraoral tip. Verify that the cut end is round and open.
6. SECOND BLEED: Bleed a small, pea-sized amount of Mach-2 thru the intraoral tip onto a mixing pad, and immediately dispense the material from the cartridge.
7. When complete, keep the tip immersed in the Mach-2 material and slowly withdraw it while material is still being expressed. This will ensure that air is not trapped in the mixed material.
8. Leave the mixing tip on the cartridge as a sealing cap. Disinfect the cartridge and tip with a germicidal wipe or disinfectant moistened paper towel. Store horizontally until the next use.
9. Mach-2 models may be used immediately after set for restoration fabrication. Mach-2 impressions should be poured after a 60-minute waiting time, to assure no distortion in the stone model. Properly stored impressions may be poured up to 30 days later.

Suggested Impression Techniques for Mach-2

• Single Step / Dual Body Method (Wet-Wet or Simultaneous), where unset medium body or heavy body VPS is placed over unset Mach-2 that has been syringed over the teeth. The materials set together.
• Double Step / Dual Body Method (Dry-Wet or Tray-Wash Method), where a prefab or custom tray flled with medium body or heavy body VPS is used to make a primary impression on the teeth and allowed to fully set. After the prepping is complete, the initial impression material is relieved, cleaned, dried and a second impression is made in the frst one, using the Mach-2 as a wash to accurately reproduce detail.
• Laminar Flow Impression Technique, where Mach-2 material is injected into a previously taken, properly vented, closed-mouth, preliminary impression made from a rigid VPS such as Parkell’s BluMousse. The resulting impressions are strong and extremely accurate, with excellent reproduction of the patient’s bite.
• NOTE: The frst stage (tray) impression should not be used as a matrix for a bis-acryl temporary, if a second stage (wash) impression is planned. The residual, uncured slick layer from the bis-acryl will interfere with the bond between the tray and wash materials, causing them to separate upon removal.

Impression Procedure Using Mach-2 as a Wash

1. Using two separate impression guns, load a Mach-2 cartridge onto one, and the appropriate tray viscosity VPS cartridge onto the other. Twist off and discard the sealing caps. Bleed about ¼” of material from the orifces, ensuring that it is visible at both holes. Wipe the ends clean, avoiding cross-contamination.
2. Attach a yellow-hubbed mixing tip to the Mach-2 cartridge and lock tight ¼ turn. Affx a yellow intraoral tip to the end of the mixer. For increased fow, cut off 1 mm of the intraoral tip. Verify that the hole at the end is round and open.
3. Attach a pink or teal-colored mixing tip to the tray material cartridge, lock tight ¼ turn, and load the tray.
4. Quickly remove the retraction cord, and rinse and dry the tooth.
5. Bleed a small amount of Mach-2 thru the intraoral tip outside of the mouth, and immediately syringe it into the gingival sulcus and over all the desired teeth, keeping the tip immersed in impression material to avoid air entrapment.
6. Place loaded impression tray over teeth, and wait for tray material to set. Remove impression with a quick, frm motion.
7. Leave mixing tips on cartridges as sealing caps. Disinfect the cartridges and store them horizontally until the next use.
8. Wait one hour after removal from the mouth before pouring the impressions in dental stone. Properly stored impressions may be poured up to 30 days later.

Instructions for Using Mach-2 as a Wash in the Laminar Impression

Technique

1. Take a preliminary impression with Blu-Mousse Classic or SuperFast with a double-arch tray.

2. Load a Mach-2 cartridge onto the cartridge gun, and affx a yellow mixing tip and a yellow intraoral tip. For increased fow, cut off 1 mm of the intraoral tip. Verify that the hole at the end is round and open.

3. Drill 1/8” holes in the buccal of the preliminary impression, mesial and distal to the prepared tooth, at the gingival papilla. They should be large enough to accommodate the cut end of the intraoral tip.
   Replace the tray in the patient’s mouth and have them fully bite down into their tightest bite.

4. Bleed a small amount of Mach-2 thru the intraoral tip outside of the mouth on a mixing pad, and immediately proceed to the next step.

5. Inject Mach-2 in the mesial hole and continue injecting with a steady trigger pressure until the material exits the distal hole. Keep expressing until the escaping Mach-2 is clean and free of any blood or debris.

6. Allow the Mach-2 to set completely before removal. Test by using a fnger nail on the excess that escaped from the vent hole.

Instructions for Using Mach-2 for Die/Model Fabrication

1. For the intraoral impression, use either a hydrocolloid impression material, or a high-quality alginate such as Parkell’s Triphasix™ (hS400).
   Choose the appropriate sized perforated metal or plastic quadrant impression tray, and make sure to place the correct tray adhesive in it.

2. Syringe the alginate into the preparation as you would for a VPS crown and bridge impression.
   Cover the syringed alginate with the tray completely flled with alginate. Wait the appropriate interval and remove the tray in a frm, quick motion.
   Inspect for accuracy. If the alginate impression is acceptable, spray it with a liquid surfactant.

3. If VPS is used as the impression material, it MUST be thoroughly coated with a separating medium AFTER IT HAS BEEN REMOVED FROM THE MOUTH. This will prevent copolymerization with the Mach-2. Such media include Handler’s SPL-88 (use 3-5 coats, allowing it to dry between coats), or Miller-Stephenson Chemical Company’s MS122-AD PTFE (“Tefon”) Release Agent (spray entire impression lightly). Follow their directions for use. Failure to use a separating medium will make separation of the model from the impression impossible.

4. Load a Mach-2 cartridge onto an impression gun, remove sealing cap and express 5 mm (¼”) onto mixing pad to ensure free fow of base and catalyst. Securely attach a yellow base mixing tip to the cartridge, and a yellow intraoral tip to the mixing tip. For increased fow, cut off 1 mm of the intraoral tip. Verify that the hole at the end is round and open.

5. Load a Blu-Mousse SuperFast cartridge onto another impression gun, remove and discard sealing cap and express 5 mm (¼”) onto mixing pad to ensure free fow of base and catalyst. Securely attach a pink base mixing tip to the cartridge.

6. Bleed a small amount of Mach-2 thru the intraoral tip outside of the mouth on a mixing pad, and immediately proceed to the next step.

7. Express Mach-2 into the impression and allow it to fow across the occlusal surfaces. Keep the tip immersed in the Mach-2 so as not to trap air in the material. A lab plaster vibrator may be used to maximize model accuracy. Express enough material to fll the crowns of impressed teeth to the desired level.

8. Express the Blu-Mousse SuperFast directly over the poured Mach-2 to completely fll the rest of the impression. Express additional Blu-Mousse into a plastic base former and invert this onto the impression so that two Blu-Mousse layers fuse.
   Allow 2 minutes for complete setting.

9. Separate the impression from the poured model.
   Separation from an alginate or hydrocolloid impression is easy. However, if VPS material was used, the model may resist removal. To separate them, remove all set VPS impression material that has expressed around the tray border or through tray perforations. Cut the plastic tray with a separating disc and remove it from the impression, and peel the impression from the model.

10. Make sure to fully remove the separating medium from the model using an alcohol gauze before proceeding to the next step.

11. To create a removable die model:
    a. Leave the model in the plastic base former for now. Create individual dies by carefully cutting through interproximals with a single-edge razor blade. Cut through the model to the top of the base former, without cutting through it.
    b. Remove the cut model from the base former, grasp the model frmly, and snap apart the remaining uncut portion. This will form a rough edge that will assure accurate re-assembly of the model in the base former. This is important for proper interproximal and occlusal contact, and for proper contour of the restoration.
    c. Trim dies if desired with a scalpel, and use any preferred restorative material to fashion a restoration. If desired, a light cured restoration may be post-cured along with the Mach-2 / Blu-Mousse SuperFast working model in a thermostatically-controlled oven (e.g., toaster oven). Post-curing enhances the physical properties of composites and may be accomplished by placing the restoration into an oven and raising the temperature to about 120° C (250° F) and holding there for 10 minutes. DO NOT PLACE PLASTIC BASE FORMERS INTO THE OVEN—THEY WILL MELT!
    d. Final occlusal adjustments and polish of the composite restoration(s) should be accomplished intraorally AFTER it has been cemented with an appropriate shade composite luting resin.

Tips for Dental Practitioners

The following information should help dental practitioners reduce the risk of cross-contamination between patients when using “disposable multiple-use dental dispensers” (referred to as “these items” below).

• Apply disposable barrier sleeves/wraps over these items before use with each patient.
• Use new, uncontaminated gloves when handling these items.
• Utilize dental assistants to dispense material from these items for the dentist.
• Avoid contact between these items and the patient’s orofacial tissues.
• Do not reuse or reprocess these items with chemical wipes or disinfectants if they become contaminated.
• Do not attempt to sterilize these items, or immerse them in high-level chemical disinfectants, as this may damage them or the material contained within them.

Warranty and Terms of Use

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

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

• Dental Tools, Devices and Materials
• Dental Instruments, Devices and Materials

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