Premier Removalon-I Cleaner Instruction Manual

Removalon®-I Instrument Cleaner
Instruction Manual

INSTRUCTIONS FOR USE 

Intended Use:
It is intended to dissolve carboxylate, glass ionomer and zinc phosphate cements easily, quickly, and safely from instruments, ortho bands, crowns, bridges, veneers, glass slabs, inlays, etc.

Device Description:

Premier® Removalon®-I am a water-activated instrument cleaner who removes set blocks of cement from dental instruments. Removalon® -I dry pack is a concentrated powder, which quickly dissolves forming a safe and effective solution.

Contraindications:
Do not use Removalon®-I under the following conditions:

• If the container or cap is found broken/damaged.
• The container is not able to extend fully.

PRECAUTIONS:

• Single-use only, Disposable.
• Do not mix with other detergents or contaminants.
• Keep product stored only in the original container.
• Avoid over dilution.
• Extend the container and be recommended to fill it with warm tap water.
• Wash exposed skin and hands thoroughly after handling.

WARNINGS:

• Remove contact lenses, if exposed.
• EYES – Rinse with large volumes of water for 15 minutes. If irritation persists, seek medical attention.
• SKIN – Rinse with large volumes of water.
• INGESTION – Drink large volumes of water. Contact physician promptly.

Adverse Events:

• IF SWALLOWED –
  » Harmful, may cause nausea and vomiting.
  » May be irritating to mouth and throat.
  » May cause allergic type reaction.
• May cause skin irritation, eye damage, and allergic skin reactions.
  If a serious incident has occurred in relation to the device, please report the incident to the Manufacturer and/or competent authority of the Member State where the device was used.

Contents and Setup:

Materials:
Citric Acid Anhydrous Granular formulation, environmentally friendly and biodegradable.

DIRECTIONS FOR USE:

• Pop flip-top cap or lid to open position.
• Hold bottle-up right and away from the face to avoid potential dust inhalation. Pull up to height.
• Unscrew the cap and fill it with warm tap water to here.
• Shake well for 15-20 seconds.

Without Ultrasonic Machine:

• Pour Removalon®-I into metal, glass, or plastic containers to a depth, which will cover the areas of the instruments to be cleaned.
• Place instruments, etc. into Removalon-I and allow to soak.
• The length of time required for dissolution depends on the degree of setting and the thickness of the cement. The average time is 15 minutes.
• Prolonged immersion will cause surface discoloration. Remove after 15 minutes.

With Ultrasonic Machine:

• Fill the beaker or bath receptacle with Removalon-I.
• Immerse those instruments to be cleaned, certain that areas containing cement are covered with Removalon-I.
• The average time for cement dissolution is 5 minutes.
• After removal from Removalon-I solution rinse instruments with water.
• If Removal on-I comes in contact with skin, wash thoroughly with water.
• Removal on-I can be reused; the used solution should be discarded when a sufficient amount of debris accumulated.

Storage:
Store in a cool, dry place away from direct sunlight.

Shelf Life:
The product does not have a shelf life.

Disposal:
After use, dispose of as biohazardous medical waste in accordance with facility or institutional guidelines/procedures.

For Further Information:

To obtain SDS or IFU, visit premierdentalco.com or call Premier at 610-239-6000.

Inspired solutions for daily dentistry
Manufacturer:
Premier® Dental Products Company
1710 Romano Drive,
Plymouth Meeting, PA 19462 U.S.A.
888-670-6100 • 610-239-6000
premierdentalco.com ∙ Made in the U.S.A.
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germanypremierdentalco.com/promise
IFU# 90115-2 0421097 Rev0 PDF