Orthostore | orthodontic accessories
Instruction Manual for DB Lab models including: DBL4-101-1063, DBL4-84T-XXF, 4S04-1384, 4S04-1382, Iconic Splint, Iconic, Splint
– DB Orthodontics Limited
Old IFUs - Archived 21 August 2024 – DB Orthodontics Limited
File Info : application/pdf, 4 Pages, 181.54KB
DocumentDocumentInstructions For Use ICONIC SPLINT INTENDED USE · Iconic Splint is used in the manufacture of removable thermoformed dental appliances such as hard splints, drilling guides & mouthguards INDICATION · The dental appliances formed by Iconic Splint are indicated for use in patients requiring dental treatment. PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS · Performance characteristics of Iconic Splint include strength, durability, comfort, clarity, resistant to fracture, easy to process and finish. The clinical benefits of thermoformed appliances made from Iconic Splint are the correction and an overall improvement in dental related health. CONTRA-INDICATIONS · Patients with a history of allergic reactions to plastics should not use this product. WARNINGS · Iconic Splint is formed at extremely high temperatures; care must be taken when thermoforming. · When thermoforming never leave the machine unattended. · Excessive heating of Iconic Splint may result in the material cracking, fracturing, reduced patient wear time. · Any serious incident that has occurred in relation to the appliance should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. PRECAUTIONS · Iconic Splint should be stored between 5°C - 25°C, in a dry place. · Keep away from direct sunlight, if exposed for prolonged periods material could become prone to degradation and discolouration. · Iconic Splint should only be used as outlined in the indications of use, any use of Iconic Splint inconsistent with these indications of use is at the discretion and sole responsibility of the practitioner. · Patients with a history of allergic reactions to plastics should not use this product. · Iconic Splint does not contain Bisphenol A (BPA). ADVERSE REACTIONS · Allergic reactions. DIRECTIONS FOR USE 1) Iconic Splint is supplied with a heat resistant protective film on both surfaces of the blank. The clear film is thinner, the blue film is thicker. The user can decide if they require a thin or thick spacer film. For best clarity leave the film on the model contact surface during thermoforming. This will prevent the need to isolate the model, improving appliance aesthetics. This also creates a micro gap to the thermoformed appliance, preventing the need to block out minor undercuts. 2) The model used for thermoforming should be no more than 20mm (3/4") in height. 3) Remove the palate of full arch models. 4) Vacuum / Pressure form using a machine conventionally used for thermoforming. 5) Ensure Iconic Splint has cooled before removing material from model. For best results use Iconic Tricutter DBL4-101/1063. 6) Remove heat resistant film from Iconic Splint 7) Trim and finish appliance as required. For best results use Cool Tungsten Fine Bur (DBL4-84T/XXF) to trim edges, then Iconic Polishing Disk Coarse Brown (4S04-1384) 1st polish, 2nd polish with Medium Grey (4S04-1382). 8) Iconic Splint takes additions (chemical bond) cold cure ortho resin SUGGESTED HEATING TIMES Heating times may vary upon machine. If Iconic Splint does not adapt to model, add heating time until full adaptation occurs. If Iconic Splint "folds" when thermoformed, reduce heating time until this does not occur. When heating Iconic Splint, ensure the material does not sag more than 20mm. Thickness 2mm 3mm Iconic VF1 90 Sec Heat 120 Sec Heat Iconic PF1 90 Sec Heat / 45 Sec Cool 120 Sec Heat / 60 Sec Cool Biostar Code* 65 Sec (194) 80 Sec (227) Drufomat* 110 140 SAFE DISPOSAL · Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used devices. CARE ADVICE FOR YOUR APPLIANCE · Brush the top and bottom of the appliance with a soft toothbrush. · Do not brush using toothpaste as this will significantly reduce the life of the appliance. · Use cold water to wash the appliance. The appliance can also be cleaned with Retainer Brite or similar cleaning solution, rinse the appliance under cold water to ensure cleaning solution is not remaining prior to the appliance entering the mouth. · Hot water will distort the appliance. · Handle the appliance with care and store in a retainer box when not in mouth. · When removing the appliance apply equal pressure to all sides of the appliance - retainer retrievers recommended for this purpose. See Orthostore website www.orthostore.co.uk · If the appliance becomes too tight do not force it, call your Dentist. · Do not eat or drink when wearing the appliance, as acids in food and drink can considerably reduce the life of the appliance. Single use only Store in a cool dry place Instructions included DB Lab Supplies Ryefield Way, Silsden, West Yorkshire, BD20 0EF, United Kingdom 44 (0) 1535 656 999 | sales@dblabsupplies.co.uk www.dblabsupplies.co.uk IFU046 - Issue 1 - 09/05/2024