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USER'S MANUAL
For use by qualified professionals only
This manual must be read thoroughly and understood prior to using
the Phasor™ Composite Heating System.
Inter-Med, Inc.
2200 South St.
Racine, WI 53404-2500 - U.S.A.
Tel.: +1-262-636-9755
Fax: +1-262-636-9760
Toll Free: +1-877-418-4782
www.vista-dental.com
Rx ONLY
408800
(Patent Pending)
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
408800-I-V-77-ENG (2)
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Summary of Contents for Vista phasor 408800
- Page 1 This manual must be read thoroughly and understood prior to using the Phasor™ Composite Heating System. Emergo Europe Inter-Med, Inc. 2200 South St. Prinsessegracht 20 Racine, WI 53404-2500 - U.S.A. 2514 AP The Hague Tel.: +1-262-636-9755 The Netherlands Fax: +1-262-636-9760 Rx ONLY Toll Free: +1-877-418-4782 408800-I-V-77-ENG (2) www.vista-dental.com...
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Page 2: Table Of Contents
Introduction ..........3 Welcome to Vista Dental’s PHASOR™ ......3 Contents of the PHASOR™... -
Page 3: Introduction
Materials remain highly sculptable, non-sticky, and easily shaped during manipulation. The Vista Dental Products website, www.vista-dental.com, also provides information on new products, accessories, and educational assistance for you and your professional staff. If you have any questions regarding the use of the PHASOR™, please call our customer service department Toll Free at... -
Page 4: Intended Use / Indications For Use
Unpacking the Container No special assistance is required to unpack and assemble the PHASOR™. If you have questions or concerns, please visit www.vista-dental.com or call Vista Dental Products at 877.418.4782 (Toll Free). Packaging should be inspected upon arrival for evidence of shipping damage. -
Page 5: Led Indicators
Programming / Flow Setting Device Activity Indicator Battery Level Indication LED Indicators The composite gun is designed to display the battery state via the battery level indicator: The LED light surrounding the ON/OFF button indicates current charge level (< 20% charged - Red, > 20% charged - Green). It is advised to charge the battery when the indication lights are Red. -
Page 6: Phasor™ Operation
CAUTION: Parts of the composite compule may become hot. Use caution and avoid touching the top of a hot composite compule. Composite & Setting Compatibility For a complete list of compatible compules and their ideal setting visit www.vista-dental.com/phasor OPTIMAL Setting Compatible Setting DO NOT USE COMPOSITE... -
Page 7: Selecting A Setting
Selecting a Setting Press & hold to enter programming mode. This is indicated by flashing yellow lights. Short press to toggle between settings. Press & hold to exit. Device will beep 3 times and shut off. Your setting is now memorized as default. Reference setting compatibility chart to determine the appropriate setting per composite brand. -
Page 8: Cleaning & Disinfection
Cleaning & Disinfection The device may be wiped down with a standard disinfectant wipe. Never spray disinfectant directly onto the device. CAUTION: Always use a protective barrier. Black nosecone is removable and autoclavable. Between uses, check the lens to ensure it is clean. A dirty lens will decrease performance. -
Page 9: Infection Control Measures
CAUTION: • DO NOT immerse the unit or unit parts in solutions. Use of solutions other than those recommended may damage plastic parts and will void product warranty. • DO NOT use abrasive material such as scouring powder, organic solvents, or solvent-based cleaning fluids. -
Page 10: Routine Maintenance
Routine Maintenance Between uses, check the lens to ensure it is clean. A dirty lens will decrease performance. 1. Insert the hex key provided into the trigger bolt. 2. Rotate counterclockwise and remove the trigger bolt once loose. 3. Slide the trigger and spring assembly apart from the device. - Page 11 4. Tilt the device forward to allow the plunger to slide forward and be removed from the device. 5. With the nosecone removed, clean the device with the provided brush. 6. Thoroughly clean the plunger space and LED lens to remove any composite residue.
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Page 12: Battery Removal & Replacement
Remove the old battery and replace with the new battery, ensuring that +/- indicators are properly aligned as indicated on the battery door. Troubleshooting Guide If the suggested solutions do not rectify the problem, please call Vista Dental 877.418.4782 (Toll Free). Problem Possible Solution Composite gun will not turn on 1. -
Page 13: Technical Data
Technical Data Technical Information Phasor™ Composite Gun Input: 100-240 VAC, 50-60 Hz Charger Nominal Consumption: 6W max Manufacturer: GlobeTek INC. Model: GTM46101-1005-USB Dimensions without blade or cable (LxWxH): 41mm x 71mm x 31.5mm Mass: 50g Classi cation: Protection class II, Battery: 3.6 V nominal, 3000mAh Li-ion, Handpiece 10.8 Wh... -
Page 14: Symbol Identification
Symbol Identification Description for additional symbols. Consult instructions Serial Number for use Temperature Manufacturer Limitation Manufacturing Date Humidity Limitation Class II Medical Pressure Limitation Electrical Equipment Type BF Patient Batch Code / Lot Number Applied Part European Keep Dry Representative Do not use if seal Part Number or packaging is... - Page 15 The PHASOR™ composite gun is a medical device which is subject to IEC 60601-1 (EN 60601-1) and EMC directives IEC 60601-1-2 (EN 60601-1-2) Edition 4.0, as well as the 93/42/EEC Medical Device Directive. The composite gun complies with the relevant EU regulations. The device has been shipped from the manufacturer in a safe and technically sound condition.
- Page 16 CAUTION • U.S. Federal law restricts the sale of this device by or on the order of a healthcare professional. Use of the device is restricted to qualified and trained personnel only in accordance with the operation instructions. The manufacturer assumes no liability for any damage arising from any other or improper use of this device.
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Page 17: Operating Conditions And Safety Consideration
Operating Conditions and Safety Consideration Heat Generation The PHASOR™ heated composite delivery system has been designed not to overheat to the point of discomfort or injury during standard operating durations. However, care should be taken to allow the product to completely cool between uses (approximately two-three minutes), to ensure overheating does not occur. -
Page 18: Vista Dental Products Terms And Conditions Of Warranty
(expressed or implied), liabilities or remedies for breach of warranty. Vista Dental Products shall not be liable for consequential or incidental damages. No person or distributor is authorized to modify the terms of this warranty. -
Page 19: Return Policy / Return Restocking Policy
Return Policy Vista Dental Products will accept for return previously purchased merchandise which is suitable for resale or was shipped in error by Vista Dental Products. Merchandise suitable for resale requires current labeling and unopened non-soiled packaging. All returns must have prior approval and must be shipped “prepaid” along with a return authorization form and a copy of the original invoice. -
Page 20: Appendix - Electromagnetic Compatibility
Appendix – Electromagnetic Compatibility and Electrical Safety Information The PHASOR™ heated composite delivery system is tested according to IEC 60601-1-2, Edition 4.0. Medical electrical devices are subject to particular preventive action according to EMC rules and must be installed and operated according to the EMC guidelines in the accompanying documents. - Page 21 Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance 70% UT 70% UT (30% dip in UT) for 25 (30% dip in UT) for 25 cycles cycles <5% UT <5% UT (>95% dip in UT) for 5 (>95% dip in UT) for 5 sec sec Power frequency Power frequency magnetic fields should be at (50/60Hz) magnetic 3 A/m 3 A/m levels characteristic of a typical location in a field IEC 61000-4-8 typical commercial or dental environment. Portable and mobile RF communications equipment should not be used closer to any part of Valiant, including cables, than PHASOR™ the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 3 Vrms d = 0.35 √P 61000-4-6 150 kHz to 80 MHz d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as Radiated RF 3 V/m determined by an electromagnetic site survey (a),...
- Page 22 Recommended Separation Distances Between Portable and Mobile RF communications equipment and the “Phasor™ Heated Composite Delivery System” The PHASOR™ heated composite delivery system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PHASOR™ heated composite delivery system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PHASOR™...
- Page 23 NOTES ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________...
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