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Appendix G

Electromagnetic Compatibility

CAUTION:

Medical Electrical Equipment needs special precautions

regarding Electromagnetic Compatibility (EMC) and needs to be

installed and put into service according to the EMC information

provided in the following tables.

Portable and mobile Radio Frequency (RF) communications equipment can affect Medical Electrical

Equipment.

Accessories: Medical grade power cord, maximum length 10ft (2.44 meters) (BIOLASE part number

2000204).

Footswitch: includes shielded, coiled Footswitch cable, Footswitch, 5 conducting wires. (BIOLASE part

number 6200150)

Waterlase iPlus User Manual

WARNING:

The use of accesories, other than those specified,

except those supplied or sold by BIOLASE as replacement parts for

internal or external components, may result in increased

EMISSIONS or decreased IMMUNITY of the model Waterlase

iPlus.

Summary of Contents for Waterlase iPlus

Page 1: ...User Manual...

Page 2: ...PAGE INTENTIONALLY LEFT BLANK...

Page 3: ...n Statement 10 Eyewear 10 Training 10 Anesthesia 10 Treatment Technique and Settings 11 Hard Tissue Procedures 11 Soft Tissue Procedures 11 Curettage Procedures 11 Fluid Entrapment and Air Embolism 11...

Page 4: ...the Handpiece to the Fiber Cable 28 4 Waterlase iPlus User Manual 5 EQUIPMENT DESCRIPTION 15 System Parts List 15 General 15 Main Laser Console Elements 15 Control Panel 15 Energy Monitor 16 Front and...

Page 5: ...er Screens 38 System Flow Chart 39 9 CLINICAL APPLICATION 40 Introduction 40 Hard Tissue Cutting 40 Soft Tissue Cutting 41 Laser Parameters 42 10 CLEANING AND STERILIZATION 45 Handpiece and Tip Cleani...

Page 6: ...Tip Types 64 Tip Ferrule Colors 64 Tip Settings Waterlase iPlus Gold Handpieces 64 Z Glass Tips 64 Sapphire Tips 65 APPENDIX D TIP INSPECTION 66 Tip Inspection Instructions 66 Tip Cleaning Instructio...

Page 7: ...with water for cooling and hydration or without water for coagulation A flexible Fiber Cable connects at one end to the laser and at the other to a Handpiece that delivers laser energy to the target t...

Page 8: ...eous tissues bone Osteotomy LASER PERIODONTAL PROCEDURES Full thickness flap Partial thickness flap Split thickness flap Laser soft tissue curettage Laser removal of diseased infected inflamed and nec...

Page 9: ...ctomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscesses Laser soft tissue...

Page 10: ...ons imprinted on the frame of the glasses to ensure they offer the required protection for the specific laser wavelength Prior to use inspect eyewear for pitting a cracking Replace if damaged do not u...

Page 11: ...ties or channels such as the crevice resulting from the extraction of a molar Also for example avoid working through soft tissues adjacent to the roots of molars especially the third inferior molars w...

Page 12: ...as such as pockets cavities or channels where critical structures i e nerves vessels could be damaged Do not proceed with using the laser if visibility is limited in these areas CLINICAL CONDITIONS Us...

Page 13: ...enerated by vaporization of virally or bacterially infected tissue during procedures done with the laser and minimal or no water spray Ensure that all appropriate protective equipment including high s...

Page 14: ...Tip diameter range Turbo Tip focal diameter range Output divergence Mode Aiming Beam Nominal Ocular Hazard Distance NOHD Maximum Permissible Exposure MPE 11 x 19 x 33 in 28 x 48 x 84cm 11 x 19 x 40 in...

Page 15: ...he main laser console is controlled through a touch screen control panel See section 8 Operating Instructions for details and instructions Safety Features All control functions accessed through the Co...

Page 16: ...sport of the laser from operatory to operatory Press down on the front tabs on the wheels to lock the console Lift up the tabs to release the locking mechanism EMERGENCY STOP The red button located on...

Page 17: ...laser radiation To use it properly requires a normally closed pair of contacts to be connected to pins 1 and 5 of the connector These contacts should have no voltage associated with them and should op...

Page 18: ...Fiber Delivery System Touch Screen Control Panel Front Handle Telescopic Fiber Support Arm Handpiece Emergency Stop Switch Locking Wheels front only WATER BOTTLE RELEASE A push button release on the t...

Page 19: ...he laser console it supports the Delivery System Fiber Cable and extends to bear its weight when the Handpiece is pulled forward extension releases when the Handpiece is let go and the arm is in a ver...

Page 20: ...Fiber Cable HANDPIECE HOLDER Cradles the Handpiece when it is not in use FIBER CABLE A component of the delivery system contains the optical Fiber Cable together with the illumination waveguides air...

Page 21: ...may still exist SAFETY INSTRUCTIONS Follow these safety instructions before and during treatments 1 Remove or cover all highly reflective items in the treatment area if possible 2 Do not operate in t...

Page 22: ...exposure and high voltage may exist NOTE Please direct any safety questions to the local BIOLASE representative or call BIOLASE at 888 424 6527 or BIOLASE Service at 800 321 6717 US only SAFETY CLASSI...

Page 23: ...e of 4kV COMPRESSED AIR SUPPLY 80 120 psi 5 5 8 2 bar ENVIRONMENTAL REQUIREMENTS TEMPERATURE 15 30 C HUMIDITY 20 80 non condensing AIR SUPPLY Connections for an air supply must be available in each op...

Page 24: ...follow the instructions below 1 Open the back panel door by turning two thumb screws counter clockwise and pull back gently Fig 7 1 WARNING Be careful when opening the door Make sure it opens easily a...

Page 25: ...water filter assembly Do not touch the white filter material to prevent contamination and potential damage 5 Use the funnel supplied to fill the bottle with distilled or de ionized water up to full Fi...

Page 26: ...support arm Fig 3 1 NOTE It may help to drape the Fiber Cable around the user s neck for ease of handling as they prepare it for installation 2 Remove the Fiber Cable from its packaging Fig 7 14 3 Rem...

Page 27: ...ig 7 17 7 18 WARNING DO NOT APPLY FORCE when installing the Fiber Cable Applying force may damage the laser head components 8 Secure the retainer ring by turning it clockwise until it is snug Fig 7 19...

Page 28: ...Handpiece from the Handpiece box 2 Remove the rear plug from the Handpiece by pulling place the plug in the Handpiece box to store 3 Remove the protective cover from the shaft of the Fiber Cable by pu...

Page 29: ...the target tissue WARNING Never touch the input proximal end of the Tip If the input surface is contaminated it may damage the Tip Handpiece and Fiber Cable Hold the Tip only by the plastic ferrule an...

Page 30: ...the tool used for the Gold Handpiece DOES NOT work with Turbo Tips Refer to the Turbo Handpiece instructions for use for more information Fig 7 28 Fig 7 29 Fig 7 30 Fig 7 31 Fig 7 32 30 Waterlase iPl...

Page 31: ...not glowing red and no error message is displayed on the screen 8 The system will begin its startup process as the software is loaded about 45 seconds 9 Attach the Handpiece to the Fiber Cable Shaft...

Page 32: ...ion USER INTERFACE GENERAL NAVIGATION INTRODUCTION The Graphical User Interface GUI is the main part of the system control It communicates with the user through the interactive touch screen display an...

Page 33: ...NICAL APPLICATIONS Once a procedure category is selected the system goes to a Clinical Applications Menu which offers the clinical applications within the selected category that have been tested and c...

Page 34: ...The Handpiece recommended for the current procedure step appears at the bottom of the screen However the Handpiece can be changed by taking the following steps 1 Press the image of the Handpiece that...

Page 35: ...ers can be changed at any time in Ready or Standby modes After adjusting these settings press the Back or Laser button at the bottom of the display to return to the Procedure screen Spray Spray settin...

Page 36: ...Waterlase iPlus User Manual locked lock symbol confirming that the settings have been changed back to facotry pre set values Factory recommended settings and modified settings can be saved as one of t...

Page 37: ...dpiece within a range 0 to 9 Fig 8 10 SERVICE leads to the Service Menu CUSTOM SETTINGS Parameters may be adjusted without any limitations and without any relation to any procedure in the Advanced scr...

Page 38: ...t Air ON Press again and the system returns to the Advanced screen Settings leads to the Settings screen OTHER SCREENS Help i icon found on every screen accesses an Information Recommendations Screen...

Page 39: ...tings Advanced Class I Class II Class III IV V Gingival Recontouring Frenectomy Biopsy Root Canal Therapy Pulpotomy Apicoectomy Steps 1 4 Steps 5 7 Pocket Therapy Closed Pocket Therapy Open Osseous Cr...

Page 40: ...oth present stop firing the laser and move the Handpiece Tip to the targeted tissue site Press on the Footswitch to fire the laser and begin cutting tissue 5 Use high speed suction as necessary to kee...

Page 41: ...e tip along the tissue surface The incision will be noticed immediately after laser activation NOTE Bleeding is controlled through a reduction in water The most effective hemostasis is achieved when t...

Page 42: ...it increases tissue temperature reducing bleeding If uncertain which parameters are best for a chosen procedure please refer to the suggested settings on the device or make the appropriate adjustments...

Page 43: ...use on crowns that are made from porcelain fused to high noble metals PFM 1 From the Home Menu select Settings 2 Press the Purge Prime icon on the Settings screen then select Prime press and hold Pri...

Page 44: ...n to treat in 1 minute cycles attempt to remove the restoration with a mechanical instrument after each cycle if the crown is still bonded to the underlying tooth repeat up to no more than a cumulativ...

Page 45: ...h the Tip still installed and leave wrapped for a minimum of 10 minutes 6 Unwrap the Handpiece and Tip Using a soft bristled brush dipped in the cleaning solution gently brush around the Tip ferrule c...

Page 46: ...ee cloth making sure to remove any soil debris that may have accumulated in the crevice between the laser tip and the Handpiece 12 Once removed from the Handpiece single use Tips must be disposed of i...

Page 47: ...as Cavicide or a similar quaternary ammonium compound product containing 20 alcohol or less and follow the manufacturer s instructions Avoid getting any liquid or debris near the laser head DO NOT AU...

Page 48: ...of the Fiber Delivery System NOTE If the plastic Tip ferrule is continuously getting damaged at the input end the mirror should be checked and cleaned and mirror alignment should be checked 48 Waterl...

Page 49: ...ated above 2 Mirror can be contaminated or damaged Fig 11 7 3 A contaminated mirror can be cleaned with a cotton swab moistened with optical grade acetone or alcohol as follows Fig 11 8 Place the wet...

Page 50: ...dpiece head with a long cotton swab moistened with acetone or alcohol 7 Install the new or cleaned mirror and check for proper alignment Fig 11 5 11 6 1 Point the Handpiece towards a white surface The...

Page 51: ...D VPDOO SLQ SXVK WKH WDE RI WKH 3URWHFWLYH LQGRZ KROGHU LJ 3XOO RXW WKH 3URWHFWLYH LQGRZ IURP WKH PHWDO EHDULQJ Lg 11 14 PPHGLDWHO LQVHUW WKH QHZ 3URWHFWLYH LQGRZ E DOLJQLQJ WKH WDE WR WKH UHFWDQJXODU...

Page 52: ...cutting ef ciency Properly following the operating and maintenance instructions of this User Manual will increase the delivery system s lifetime LASER CONSOLE The Laser Console contains electronic and...

Page 53: ...ibration is to be performed annually The Service Engineer will write the date of installation and subsequent power calibration dates in the table provided below INSTALLATION AND CALIBRATION DATES Inst...

Page 54: ...y Mode Release the Footswitch Check connector Switch to Ready mode 15 28 Interlock is open Interlock is open Check Interlock Check Remote Interlock connector at back panel 17 Shut Down temperature con...

Page 55: ...mps or objects on the ground Do not roll the Laser Console outside of the of ce building across a road or over any other rough surface Do not place the Laser Console into a pick up truck van or other...

Page 56: ...E OF MANUFACTURE REFER TO INSTRUCTION MANUAL Location Back panel TYPE BF APPLIED PART Location Distal end of Fiber Cable one side DUTY CYCLE Location Distal end of Fiber Cable opposite side PRODUCT ID...

Page 57: ...ng Dangerous voltage Only visible during service Locations Top cover of laser head directly above the High Voltage input PFN Board Capacitor Front Capacitor Bracket CERTIFICATION This device complies...

Page 58: ...Inside Laser Console left ELECTRICAL SHOCK RATINGS Type BF Applied Part Location Next to E1 ground terminal inside Laser Console REMOTE INTERLOCK LABEL Input for Remote Interlock Connector which when...

Page 59: ...ion Back Panel AIR LABEL Indicates minimum and maximum air pressure Location Wall Back Panel KEYSWITCH LABEL Turns laser on and off when key inserted Location Back Panel WEEE WASTE ELECTRICAL AND ELEC...

Page 60: ...60 C TEMPERATURE TEMPERATURE LIMITATIONS 106kPa 50kPa ATMOSPHERIC PRESSURE ATMOSPHERIC PRESSURE LIMITATIONS 90 10 RELATIVE HUMIDITY NON CONDENSING HUMIDITY LIMITATIONS HANDLE WITH CARE KEEP DRY THIS...

Page 61: ...61 Appendix A Labels Keyswitch Label Electrical Rating Label Footswitch Label Remote Label ETL Listing Air Intake Waterlase iPlus User Manual Identification Calibration...

Page 62: ...Appendix A Labels Laser Explanatory Label Laser Aperture Label 62 Waterlase iPlus User Manual...

Page 63: ...old Handpiece 6201037 6201102 6201126 Turbo Handpiece 6201133 7200106 MD Gold Mirror Replacement Kit 3200105 Waterlase Mirror Removal Tool 2200706 Waterlase iPlus Display Covers 7200407 Turbo Tip Hold...

Page 64: ...old Handpiece Tissue Types Calibration Factor Maximum Power W RFT2 200 21 25 0 55 4 0 Root Canal MZ3 320 9 14 20 25 28 0 85 4 0 Root Canal Soft Tissue RFT3 17 21 Root Canal MZ5 500 3 6 9 14 0 95 4 0 A...

Page 65: ...Types Calibration Factor Maximum Power W MX5 Red 500 1 00 Hard Tissues MX7 Green 700 1 00 No Limit MX9 White 900 1 00 No Limit MX11 Black 1 100 1 00 No Limit TURBO TIPS No Limit Hard Tissues Hard Tiss...

Page 66: ...the Tip test holder into the test adapter with the distal or laser emitting end of the Tip toward the microscope 3 Slide the adapter over the microscope to move the Tip surface toward the focal point...

Page 67: ...ng beam or the BIOLASE Tip Inspection Kit Fig D 1 Fig D 2 Fig D 3 Waterlase iPlus User Manual 1 Before using the Tip inspect Tip surfaces for any damage or debris using loupes or a magnifier Clean or...

Page 68: ...pidPrep Gold MZ10 10 00 20 H 70 90 MZ8 8 00 20 H 70 90 MZ6 5 00 20 H 50 80 MZ5 4 00 20 H 40 60 MT4 2 50 20 H 40 60 MGG6 5 00 20 H 50 80 MC6 5 00 20 H 50 80 MS75 7 25 20 H 50 80 Turbo MX11 10 00 20 H 7...

Page 69: ...apidPrep Gold MZ10 10 00 20 H 70 90 MZ8 8 00 20 H 70 90 MZ6 5 00 20 H 50 80 MZ5 4 00 20 H 30 60 MT4 2 50 20 H 40 60 MGG6 5 00 20 H 50 80 MC6 5 00 20 H 50 80 MS75 7 25 20 H 50 80 Turbo MX11 10 00 20 H...

Page 70: ...H 40 60 MX5 1 25 15 H 40 60 RapidPrep Gold MZ8 5 25 20 H 50 80 MZ6 3 25 20 H 50 60 MZ5 2 50 20 H 50 60 MT4 1 75 20 H 50 60 MGG6 3 25 20 H 50 80 MC6 3 25 20 H 50 80 MS75 4 75 20 H 50 80 MS75 4 75 20 H...

Page 71: ...2 25 50 H 10 10 MC3 2 50 H 10 10 Frenectomy Rapid Cut Gold MZ6 2 75 75 H 30 20 MT4 2 5 75 H 30 20 MC3 2 75 75 H 30 20 Smooth Cut Gold MZ6 3 5 50 S 20 20 MT4 2 5 50 S 20 20 MC3 3 5 50 S 20 20 Tissue Pl...

Page 72: ...ing Laser Not Used Clean Shape Gold RFT2 1 25 50 H 25 35 RFT3 2 25 50 H 25 35 Disinfection Gold RFT2 0 75 20 H OFF 10 RFT3 1 5 20 H OFF 10 Pulpotomy Access Gold MZ10 8 20 H 70 90 MZ8 6 20 H 70 90 MZ6...

Page 73: ...0 H 50 20 MGG6 2 100 H 50 20 MZ6 2 100 H 50 20 PERIO Pocket Therapy Closed Inner Epithelium Removal Gold RFPT5 1 5 30 H 50 40 Calculus Removal Gold RFPT5 3 5 75 H 40 20 Outer Epithelium Removal Gold R...

Page 74: ...Z6 2 5 30 H 55 30 MGG6 2 5 30 H 55 30 MS75 3 5 30 H 65 40 MZ8 4 30 H 65 40 Bone Plasty Gold MZ6 2 5 50 H 40 20 MGG6 2 5 50 H 40 20 MC3 2 5 50 H 40 20 MZ8 4 50 H 40 20 Tissue Plasty Gold MZ6 2 25 50 H...

Page 75: ...Gold MZ6 2 5 30 H 80 70 MZ5 2 5 30 H 80 70 Final Sulcular Debridement Gold RFPT5 1 5 30 H 10 10 RFPT8 1 5 30 H 10 10 REPAIRTM IMPLANT PROTOCOL REPAIR Implant Protocol Outer Pocket De epithelial izati...

Page 76: ...30 H 5 20 MGG6 0 5 30 H 5 20 MZ5 0 5 30 H 5 20 Dry Gold MZ6 0 5 30 S OFF 20 MGG6 0 5 30 S OFF 20 MZ5 0 5 30 S OFF 20 Laser Bandage Laser bandage is a term generally used to describe using the Waterla...

Page 77: ...pment can affect Medical Electrical Equipment Accessories Medical grade power cord maximum length 10ft 2 44 meters BIOLASE part number 2000204 Footswitch includes shielded coiled Footswitch cable Foot...

Page 78: ...Appendix G Electromagnetic Compatibility 78 Waterlase iPlus User Manual...

Page 79: ...79 Appendix G Electromagnetic Compatibility Waterlase iPlus User Manual...

Page 80: ...Appendix G Electromagnetic Compatibility 80 Waterlase iPlus User Manual...

Page 81: ...PAGE INTENTIONALLY LEFT BLANK...

Page 82: ...ntries All other trademarks are property of their registered owners Subject to change without notice 5200158 Rev H biolase com NORTH AMERICA BIOLASE INC 4 Cromwell Irvine CA 92618 Telephone 888 424 65...

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