(ENGLISH) BLU-MOUSSE INSTRUCTIONS BLU-MOUSSE: a radiopaque, thixotropic (resists slumping), addition reaction silicone (polyvinyl siloxane) for use as a bite registration material. It can also be used as “putty” in (ENGLISH) a “putty/wash” impression technique, orINSTRUCTIONS as the preliminary impression in a double-arch tray BLU-MOUSSE technique. Available in either automixcartridges or tubes for hand mixing. Sets intra-orally in BLU-MOUSSE: a radiopaque, thixotropic (resists slumping), addition reaction silicone two (2) minutes. Compatible with other polyvinyls. (polyvinyl siloxane) for use as a bite registration material. It can also be used as “putty” in a “putty/wash” impression technique, or as the preliminary impression in a double-arch tray Contains Available no hazardous ingredients. May be 2% Glutaraldehyde technique. in either automixcartridges or disinfected tubes for handinmixing. Sets intra-orally solution. in two (2) minutes. Compatible with other polyvinyls. Working Time @ 23°C (OFF) 2 minutes Final Durometer 85 (Shore A) Contains no Intra-oral hazardous ingredients. May be 2disinfected Minimum Setting Time minutes in 2% Glutaraldehyde solution. Working Time @ 23°C (OFF) 2 minutes Minimum Intra-oral Setting Time 2 minutes INSTRUCTIONS (Automix Cartridges) Final Durometer 85 (Shore A) 1. Insert cartridge into impression gun, twist off sealing cap, express approximately 5mm INSTRUCTIONS (Automix (1/4”) of material to Cartridges) insure equal flow. If apertures are clogged, clear blockage with an 1. Insert cartridge intoproceeding. impression gun, twist off sealing cap, express approximately 5mm explorer before (1/4”) of material to insure equal flow. If apertures are clogged, clear blockage with an before proceeding. 2. explorer Securely attach mixing tip (1/4 turn) and squeeze trigger with moderate, even pressure to extrude mix. After material, tip attached as sealing cap until 2. Securely attach mixing tip extruding (1/4 turn) and squeeze leave triggermixing with moderate, even pressure use.mix. After extruding material, leave mixing tip attached as sealing cap until tonext extrude next use. INSTRUCTIONS (Tubes) INSTRUCTIONS (Tubes) 1. Dispense equal lengths of base and catalyst (1:1) onto a mixing pad. Altering the ratio 1. Dispense equalfinal lengths base for and 15-30 catalystseconds (1:1) ontowith a mixing Altering thearatio will impair set.ofMix cleanpad. spatula until uniform streakwill impair final set. Mix for 15-30 seconds with clean spatula until a uniform streakfree blue color is obtained. free blue color is obtained. IMPORTANT! Avoid trapping air bubbles mix. Close tubes immediately IMPORTANT! Avoid trapping air bubbles in mix. in Close tubes immediately after use. after use. Do color-coded caps. caps. Donot notinterchange interchange color-coded 3. with bitebite registration or impression 3. Proceed Proceed with registration or impression STORAGE AND USAGE STORAGE AND18°C USAGE 1. Store between and 24°C (64°F-75°F). Exposure to excess heat will shorten normal 1. shelf-life Store between 18°C and 24°C (64°F-75°F). Exposure to excess heat will shorten normal (12 months). Please read instructions Veuillez lire les instructions Por favor lea las instrucciones Please read instructions Bitte lesen Sie die Gebrauchsan Veuillez lire les instructions Si prega di leggere le istruzion Por favor lea las instrucciones Leia as instruções, por favor. Bitte lesen Sie die Gebrauchsanweisung Παρακαλούμε διαβάστε τις Si prega di leggere le istruzioni Læs venligst brugsvejledninge Leia as instruções, por favor. Deτις aanwijzingen lezen a.u.b. Παρακαλούμε διαβάστε οδηγίες Læs venligst brugsvejledningen Olkaa hyvä, lukekaa ohjeet De aanwijzingen lezen a.u.b. Vennligst les instruksjonene Olkaa hyvä, lukekaa ohjeet Se anvisningarna Vennligst les instruksjonene Se anvisningarna Storage Temperature Storage Temperature Température de stockage Température de stockageTemperatura de almacenamien Temperatura de almacenamiento Lagertempertur Lagertempertur Temperatura di immagazzinag Temperatura di immagazzinaggio Temperatura de armazenament Temperatura de armazenamento θερμοκρασία αποθήκευσης θερμοκρασία αποθήκευσης Obevaringstemperatur Obevaringstemperatur Bewaartemperatuur Bewaartemperatuur Varastolämpötila Varastolämpötila Lagringstemperatur Lagringstemperatur Förvaringstemperatur Förvaringstemperatur shelf-life (12 months). 2. For best results, use at normal room temperatures. To extend work/set times, use slightly material. Contamination by latex can interfere the setting reaction 2. chilled For best results, use at normal roomgloves temperatures. Towith extend work/set times, use slightly of polyvinyls. Polyvinyls are not compatible with polyether and polysulfide materials. chilled material. Contamination by latex gloves can interfere with the setting reaction Acrylic and methacrylate residues might inhibit setting of polyvinyls. Hard-setting Bluof polyvinyls. are not compatible with polyether and to polysulfide materials. Mousse will lock Polyvinyls into severe undercuts. Block them out. Advise laboratory cut the Acrylicfrom andmodels methacrylate residues might inhibit setting of polyvinyls. Hard-setting Blumaterial to avoid tooth breakage. Mousse will lock into severe undercuts. Block them out. Advise laboratory to cut the materialINFORMATION from models to avoid tooth breakage. ORDERING Stock No. S436 - Blu-Mousse Classic (2 minute set) Tubes, contains 1 tube base, 80ml, and 1 tube catalyst, 80ml. ORDERING INFORMATION Stock No. S438 - Blu-Mousse Classic (2 minute set) Automix Canridges, contains 2 - 50ml Stock No.plus S436 - Blu-Mousse Classic (2 minute set) Tubes, contains 1 tube base, 80ml, and cartridges mixing tips. 1 tubeNo. catalyst, 80ml. Stock S457 -Blu-Mousse Super-Fast (2 minute set) Automix Cartridges, contains 2 Stockcartridges No. S438 50ml plus- Blu-Mousse mixing tips. Classic (2 minute set) Automix Canridges, contains 2 - 50ml cartridges plus mixing tips. WARRANTY Stock No. S457 -Blu-Mousse Super-Fast (2 minute set) Automix Cartridges, contains 2 Parkell will replace, free of charge, any material found to be defective for a period of 1 year 50mldate cartridges plus mixing tips. from of manufacture if handled and stored properly. Parkell does not accept liability for any loss or damage, direct or consequential, from the use of or the inability to use the WARRANTY product described herein. The user shall determine the suitability of the product’s intended Parkell willuser replace, free of charge, any in material found to be defective a period of 1 year use, and the assumes all risk and liability connection therewith. There is nofor implied warranty connected with the sale of this merchandise. from date of manufacture if handled and stored properly. Parkell does not accept liability for any loss or damage, direct or consequential, from the use of or the inability to use the product described herein. The user shall determine the suitability of the product’s intended use, and the user assumes all risk and liability in connection therewith. There is no implied warranty connected with the sale of this merchandise. 300 Executive Drive, Edgewood, NY 11717 USA Phone: 631-249-1134 • 1-800-243-7446 300 Executive Drive, Edgewood, NY 11717 USA E-Mail: [email protected] • www.parkell.com Phone: 631-249-1134 • 1-800-243-7446 Made in U.S.A. E-Mail: [email protected] • www.parkell.com Made in U.S.A. European Authorized Representative (Not a dealer/distributor): EMERGO EUROPE European Authorized Representative Molenstraat 15, 2513 BH, (Not a dealer/distributor): The Hague, The Netherlands EUROPE Tel: +31 (0)70 345EMERGO 8570 Molenstraat 15, 2513 BH, Fax: +31 (0)70 346 7299 The Hague, The Netherlands Tel: +31 (0)70 345 8570 Fax: +31 (0)70 346 7299 A00059revH0812 A0005 Caution: Federal Law restricts this device to sale by or on the order of a properly licensed practitioner. Parkell, Inc. Blu-Mousse Occlusal Registration/Impression Material ® Device Description: A fast-setting vinyl polysiloxane material that has a light, fluffy consistency before setting, yet sets very hard (85 Shore A Durometer.) Intended use/indications: Occlusal registrations, transfer impressions, instant bite rims, edentulous impressions, double-arch tray impressions. Contraindications: Blu-Mousse sets almost as hard as plaster. Therefore, it should not be used wherever undercuts may cause locking of the impression. For example, Blu-Mousse is not generally recommended for dentate full-arch impressions...for periodontally involved teeth...for impressions that include pontics. Warning: Use of metal trays with Blu-Mousse (especially rim-locking designs) will make it extremely difficult to remove the tray if the material inadvertently locks into undercuts. Precautions: Caution: Block out undercuts before impressing. Caution: Blu-Mousse (like all vinyl polysiloxanes) will not set properly in the presence of latex, residue from polyether impression materials or the oxygen-inhibited layer on the surface of unfinished composite. Do not touch the material or the tooth with a gloved hand. HOW sUPPlIeD: Blu-Mousse Classic (2-minute set) Automix Cartridges - Two 50ml cartridges plus mixing tips (total - 136g) Tubes - 1 tube each of base and catalyst (total - 280g) Blu-Mousse superFast (30-second set) Automix Cartridges - Two 50ml cartridges plus mixing tips (total - 136g) See enclosed Instructions for use. A00227revC0911 Caution: Rx Only. Green-Mousse® Occlusal Registration/Impression Material Green-Mousse®: a radiopaque, thixotropic (resists slumping), addition reaction silicone (polyvinyl siloxane) for use as a monophase impression material or as the ‘wash’ for Blu-Mousse®. Available in automix cartridges only. Sets intra-orally in two (2) minutes. Compatible with other polyvinyls. Contains no hazardous ingredients. May be disinfected in 2% glutaraldehyde solution. Working Time @ 23ºC (73ºF): Minimum Intra-oral Setting Time: Final Durometer: 2 minutes 2 minutes 60 (Shore A) INSTRUCTIONS: 1. Insert cartridge into impression gun, twist off sealing cap, express approx. 5mm (1/4”) of material to insure equal flow. If apertures are clogged, clear blockage with an explorer before proceeding. 2. Securely attach mixing tip (1/4 turn) and squeeze trigger with moderate, even pressure to extrude mix. NOTE: If desired, an intra-oral tip (Stock No. S439IOT) may be affixed to the mixing tip. Check for firm attachment before proceeding. Intra-oral tips should not be used with filling trays. 3. After extruding material, leave mixing tip attached as sealing until next use. STORAGE AND USAGE: 1. Store between 18ºC and 24ºC (64ºF - 75ºF). Exposure to excess heat will shorten normal shelf-life. 2. For best results, use at normal room temperatures. To extend work/set times, use slightly chilled material. 3. Contamination by latex gloves can interfere with the setting reaction of polyvinyls. Polyvinyls are not compatible with polyether and polysulfide materials. Acrylic and methacrylate residues might inhibit setting of polyvinyls. ORDERING INFORMATION: WARRANTY: Stock No. S455—Green-Mousse automix cartridges only. Contains two 50ml Parkell willplus replace defective cartridges mixing tips. material. THIS WARRANTY IS IN LIEU OF ALL WARRANTIES OF MERCHANTABILITY, FITNESS FOR PURPOSE OR OTHERContinued WARRANTIES, EXPRESS OR IMPLIED. Parkell does not accept liability for any loss or damage, direct, consequential or otherwise, arising out of the use of or the WARRANTY: inability to use the product herein described. Before using, the user shall determine Parkell will replace defective material. THIS WARRANTY IS IN LIEU OF ALL the suitability of the product for its intended use and the user assumes all risk and WARRANTIES OF MERCHANTABILITY, FITNESS FOR PURPOSE OR OTHER liability whatsoever in connection herewith. Parkell’s Quality System is certified to WARRANTIES, EXPRESS OR IMPLIED. Parkell does not accept liability for any ISO 13485 and ISO 9001. loss or damage, direct, consequential or otherwise, arising out of the use of or the inability to use the product herein described. Before using, the user shall determine the suitability of the product for its intended use and the user assumes all risk and liability whatsoever in connection herewith. Parkell’s Quality System is certified to ISO 13485 and ISO 9001. European Authorized Representative (Not a dealer/distributor): EMERGO EUROPE Molenstraat 15, 2513 BH, The Hague, The Netherlands Tel: +31 (0)70 345 8570 • Fax: +31 (0)70 346 7299 European Authorized Representative (Not a dealer/distributor): EMERGO EUROPE Molenstraat 15, 2513 BH, The Hague, The Netherlands 300 Executive Drive, Edgewood, NY 11717 USA Tel: +31 (0)70 345 8570 • Fax: +31 (0)70 346 7299 1-800-243-7446 • (631) 249-1134 • Fax: (631) 249-1242 www.parkell.com • E-Mail: [email protected] 300 Executive Drive, Edgewood, NY 11717 USA 1-800-243-7446 • (631) 249-1134 • Fax: (631) 249-1242 www.parkell.com • E-Mail: [email protected] A00753rev*0414 A00753rev*0414 PARKELL, INC. 300 EXECUTIVE DRIVE EDGEWOOD, NY 11717 631-249-1134 MATERIAL SAFETY DATA SHEET 24-HOUR EMERGENCY TELEPHONE 1-800-535-5053 SECTION I - PRODUCT IDENTIFICATION PRODUCT NAME: BLU-MOUSSE CLASSIC & SUPER-FAST DOT HAZARD LABEL: NA UN NUMBER: PROPER SHIPPING NAME: NA DATE PREPARED: NFPA CODES: HEALTH - 0 STOCK NO’s: FLAMMABILITY - 0 S436, VAR. NA 01/31/12 03/18/14 REACTIVITY - 0 SECTION II - HAZARDOUS INGREDIENTS/IDENTITY INFORMATION HAZARDOUS COMPONENTS CAS NUMBER PEL TLV NO HAZARDOUS INGREDIENTS NA NA NA % SECTION III - PHYSICAL & CHEMICAL CHARACTERISTICS BOILING POINT: NA SPECIFIC GRAVITY (H2O = 1): >1.00 VAPOR PRESSURE: NA PERCENT VOLATILES: NA VAPOR DENSITY (Air = 1): NA EVAPORATION RATE (Butyl Acetate = 1): NA APPEARANCE AND ODOR: Light blue odorless paste. SECTION IV - FIRE AND EXPLOSION HAZARD DATA FLASH POINT (TCC): NA FLAMMABLE LIMIT (air, % by vol.) UPPER: NA LOWER: NA EXTINGUISHER MEDIA: Water, Carbon Dioxide, Dry chemical. SPECIAL FIRE FIGHTING PROCEDURES: None UNUSUAL FIRE & EXPLOSION HAZARDS: None SECTION V - REACTIVITY DATA (PHYSICAL HAZARDS) STABILITY: X CONDITIONS TO AVOID: STABLE Avoid high heat. INCOMPATIBILITY (Materials to avoid): HAZARDOUS DECOMPOSITION PRODUCTS: UNSTABLE Strong oxidizing agents, strong acids, & strong alkalies. None HAZARDOUS POLYMERIZATION: CONDITIONS TO AVOID: None MAY OCCUR X WILL NOT OCCUR SECTION VI - HEALTH HAZARD DATA PRIMARY ROUTE(S) OF ENTRY: EYES X SKIN INHALATION INGESTION HEALTH HAZARDS (Acute & Chronic): May cause eye irritation upon contact. SIGNS & SYMPTOMS OF EXPOSURE: NA CARCINOGENECITY: No NTP? No IARC MONOGRAPHS? No OSHA? A00131revK0314 MATERIAL SAFETY DATA SHEET (continued) PRODUCT NAME: BLU-MOUSSE CLASSIC & SUPER-FAST STOCK NO: S436/38/57 EMERGENCY AND FIRST AID PROCEDURES: INHALATION: NA EYES: In case of eye contact with uncured materials, flush eyes with water. SKIN: NA INGESTION: NA SECTION VII - SPECIAL PRECAUTIONS AND SPILL OR LEAK PROCEDURES PRECAUTIONS TO BE TAKEN IN HANDLING & STORAGE: Shelf life prolonged if stored at ambient (72°-74° F) temperature or below. OTHER PRECAUTIONS: None STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Wipe up area with absorbent material and dispose in metal container. Be careful because residue is slippery. WASTE DISPOSAL METHODS (Consult federal, state, and local regulations): Individual containers: dispose of as ordinary waste in accordance with local regulations. Case quantities: mix catalyst and base parts together, once they are fully cured you can dispose of in a sanitary landfill in accordance with local regulations. SECTION VII - SPECIAL PROTECTION INFORMATION/CONTROL MEASURES RESPIRATORY PROTECTION: None required. VENTILATION: None required. PROTECTIVE GLOVES: None required. EYE PROTECTION: None required, OTHER PROTECTIVE CLOTHING OR EQUIPMENT: None required. WORK/HYGIENIC PRACTICES: Wash hands before eating, drinking or smoking. The information accumulated herein is believed to be accurate but is not warranted to be whether originating with the company or not. Recipients are advised to confirm in advance of need that the information is current, applicable, and suitable to their circumstances. A00131revH0112 PARKELL, INC. 300 EXECUTIVE DRIVE EDGEWOOD, NY 11717 631-249-1134 MATERIAL SAFETY DATA SHEET 24-HOUR EMERGENCY TELEPHONE 1-800-535-5053 SECTION I - PRODUCT IDENTIFICATION PRODUCT NAME: GREEN-MOUSSE STOCK NO: S455 DOT HAZARD LABEL: NA UN NUMBER: NA PROPER SHIPPING NAME: NA DATE PREPARED: NFPA CODES: HEALTH - 0 FLAMMABILITY - 0 12/12/11 01/06/10 06/12/14 REACTIVITY - 0 SECTION II - HAZARDOUS INGREDIENTS/IDENTITY INFORMATION HAZARDOUS COMPONENTS CAS NUMBER PEL TLV NO HAZARDOUS INGREDIENTS NA NA NA % SECTION III - PHYSICAL & CHEMICAL CHARACTERISTICS BOILING POINT: NA SPECIFIC GRAVITY (H2O = 1): >1.00 VAPOR PRESSURE: NA PERCENT VOLATILES: NA VAPOR DENSITY (Air = 1): NA EVAPORATION RATE (Butyl Acetate = 1): NA APPEARANCE AND ODOR: Light blue odorless paste. SECTION IV - FIRE AND EXPLOSION HAZARD DATA FLASH POINT (TCC): NA FLAMMABLE LIMIT (air, % by vol.) UPPER: NA LOWER: NA EXTINGUISHER MEDIA: Water, Carbon Dioxide, Dry chemical. SPECIAL FIRE FIGHTING PROCEDURES: None UNUSUAL FIRE & EXPLOSION HAZARDS: None SECTION V - REACTIVITY DATA (PHYSICAL HAZARDS) STABILITY: X CONDITIONS TO AVOID: STABLE Avoid high heat. INCOMPATIBILITY (Materials to avoid): HAZARDOUS DECOMPOSITION PRODUCTS: UNSTABLE Strong oxidizing agents, strong acids, & strong alkalies. None HAZARDOUS POLYMERIZATION: CONDITIONS TO AVOID: None MAY OCCUR X WILL NOT OCCUR SECTION VI - HEALTH HAZARD DATA PRIMARY ROUTE(S) OF ENTRY: EYES X SKIN INHALATION INGESTION HEALTH HAZARDS (Acute & Chronic): May cause eye irritation upon contact. SIGNS & SYMPTOMS OF EXPOSURE: NA CARCINOGENECITY: No NTP? No IARC MONOGRAPHS? No OSHA? MATERIAL SAFETY DATA SHEET (continued) PRODUCT NAME: GREEN-MOUSSE STOCK NO: S455 EMERGENCY AND FIRST AID PROCEDURES: INHALATION: NA EYES: In case of eye contact with uncured materials, flush eyes with water. SKIN: NA INGESTION: NA SECTION VII - SPECIAL PRECAUTIONS AND SPILL OR LEAK PROCEDURES PRECAUTIONS TO BE TAKEN IN HANDLING & STORAGE: Shelf life prolonged if stored at ambient (72°-74° F) temperature or below. OTHER PRECAUTIONS: None STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED: Wipe up area with absorbent material and dispose in metal container. Be careful because residue is slippery. WASTE DISPOSAL METHODS (Consult federal, state, and local regulations): Individual containers: dispose of as ordinary waste in accordance with local regulations. Case quantities: mix catalyst and base parts together, once they are fully cured you can dispose of in a sanitary landfill in accordance with local regulations. SECTION VII - SPECIAL PROTECTION INFORMATION/CONTROL MEASURES RESPIRATORY PROTECTION: None required. VENTILATION: None required. PROTECTIVE GLOVES: None required. EYE PROTECTION: None required, OTHER PROTECTIVE CLOTHING OR EQUIPMENT: None required. WORK/HYGIENIC PRACTICES: Wash hands before eating, drinking or smoking. The information accumulated herein is believed to be accurate but is not warranted to be whether originating with the company or not. Recipients are advised to confirm in advance of need that the information is current, applicable, and suitable to their circumstances. A00133revH0614 A00133revG1211