EID-2 Optical Impression Device Operation Manual iTero Mobile Cart Publication SD08300-A Revision 1.05 December 26, 2006 Optical Impression System for Computer Assisted Design and Manufacturing
(510K exempt under 21 CFR 872.3661) DIGITAL IMPRESSION DEVICE EID-2 Optical Impression Device Operation Manual COPYRIGHT Copyright by Cadent. 1995-2006. All rights reserved. The hardware and software described in this document are supplied under a Sales and Services Agreement and may be used only in accordance with the terms of that agreement. The information contained in this document is subject to change without notice. No part of this document may be reproduced, photocopied, stored in a retrieval system, or transmitted in any manner (electronic or mechanical) for any purpose other than the customers normal usage, without the prior written permission of Cadent. TRADEMARKS Cadent, OrthoCAD, iTero, EID-1, EID-1 Optical Impression Device, EID2, EID-2 Optical Impression Device, OrthoCAD iQ, OrthoCAD Set-Up, OrthoCAD Bracket Placement and OrthoCAD Bracket Placement Video System are trademarks or registered trademarks of Cadent. Any other trademarks and registered trademarks appearing in this manual are the property of their respective owners. CONTACT US Cadent, Inc. 640 Gotham Parkway Carlstadt NJ, 07072-2405 USA Phone:
Fax:
Email:
www.cadent.biz
(201) 842-0800
(201) 842-0850 info@cadent.biz 2 Publication SD08300-A (Rev. 1.05) Operation Manual SYMBOLS EID-2 Optical Impression Device Caution! - Wherever this symbol appears on the equipment, it is recommended to refer to the instructions in this Operators Guide. Applied part type B. Any device on which this symbol appears is electric isolation type B. CLASS 1 LASER COMPLIANCE This product complies with 21 CFR 1040.10 and EN 60825-1. MEDICAL SAFETY COMPLIANCE This equipment complies with the medical safety standard UL 60601. FCC Compliance This device complies with part 15 of FCC Rules, and operation is subject to the following two conditions:
1) This device may not cause harmful interference. 2) This device must accept any interference received, including interference that may cause undesired operation. FCC Warning Modifications to the equipment that are not expressly approved by the manufacturer may void your authority to operate the equipment under FCC Rules. December 26, 2006 3 EID-2 Optical Impression Device Operation Manual WARNINGS POWER An internal battery backup unit will supply AC power to the system in the event of a power shortage. Therefore, power is present in the internal hardware components even when the system is unplugged from the wall. To ensure that power is removed from all components, follow these instructions:
Close all files and applications. Press the front POWER switch to shutdown the system. Unplug power cable from the wall socket. Press the MAIN POWER SHUT OFF switch on the back of the cart (see page 14). To restore power, press the MAIN POWER SHUT OFF switch again and the system will beep to indicate return of power. According to Department of Transportation (DOT) regulations, the system must be shipped with internal battery leads disconnected. Please note that battery leads should be disconnected and reconnected by authorized Cadent technicians only. Power is supplied to the system via an isolation transformer. WIRELESS LAN The EID-2 system comes equipped with a Wireless LAN unit. Using standard wired communications will violate the AC mains power isolation. SCANNER The scanner emits red laser light for performing a tooth scan (660 nm Class 1). Normal usage of the scanner does not present any danger to the eye. However, you should refrain from shining the light directly into the patients eyes. The scanner also emits colored lights for performing a colored scan. This light does not present any danger to the eyes. Avoid stepping or rolling over the scanner cable. The scanner head contains fragile parts and should always be handled with care. Be sure to read Disinfecting Scanner and Replacing Disposable Sleeve on page 11 before beginning to scan patient cases. GENERAL Be careful not to block any of the air vents on the cart (see page 14). Refrain from opening any closed components. Except for the replacement of batteries in the mouse and foot pedal, all closed components should be serviced by authorized Cadent technicians only. The EID-2 system is intended for indoor usage only and should not be exposed to direct sunlight. Due to its weight, the EID-2 system should be lifted and loaded by two or more persons. 4 Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Table of Contents Chapter 1: Introduction .......................................................................................................... 7 Overview ................................................................................................................................ 7 The Digital Crown Production Process ................................................................................... 7 About the iTero Service .......................................................................................................... 8 Chapter 2: Operating Instructions ......................................................................................... 9 First Time Usage .................................................................................................................... 9 Booting System ...................................................................................................................... 9 Shutting Down System ........................................................................................................... 9 Unplugging System for Short Intervals.................................................................................... 9 Automatic Shutdown............................................................................................................... 9 Using the iTero Software .......................................................................................................10 Using the Handheld Scanner.................................................................................................10 Disinfecting Scanner and Replacing Disposable Sleeve........................................................11 Using the Foot Pedal Unit......................................................................................................12 Chapter 3: Cart Features .......................................................................................................13 Front View of Cart .................................................................................................................13 Back View of Cart..................................................................................................................14 Main Power Shut Off For Shipping or Storage.......................................................................14 Restoring Power after Shipping or Storage............................................................................14 Cleaning Monitor ...................................................................................................................15 Locking Wheels .....................................................................................................................16 Appendix A: Hardware Specifications..................................................................................17 December 26, 2006 5 EID-2 Optical Impression Device Operation Manual 6 This page is intentionally blank. Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Chapter 1: Introduction Overview The EID-2 functions as a digital impression system for scanning preparation teeth in the doctors office and uploading the digital files to Cadent for further processing and CNC crown production. This Operators Guide explains how to operate the EID-2 system, and also describes the systems hardware components and features. Chapter 1:
Introduction Overview of the iTero digital crown production process. Chapter 2:
Operating Instructions Chapter 3:
Cart Features Appendix A:
Hardware Specifications Essential instructions for working with the EID-2 system. Description of the external EID-2 hardware components. List of hardware specifications. The Digital Crown Production Process Below are listed the major steps involved in Cadents iTero Service for digital crown production. STEP 1: Prepare Tooth and Perform Digital Scan Perform tooth preparation in conventional fashion. Then use the EID-2 system to perform a high-resolution digital scan of the tooth. Upon completion of the scanning process, place a temporary crown on the patient tooth. STEP 2: Upload Case to Cadent Upload the case to Cadent for processing based on your choice of materials and color. Cadent receives the case, performs crown design, and then sends the case to the lab technician for viewing and editing. STEP 3: Lab Review The lab technician receives the case, performs any desired changes to crown design, and sends the updated case back to Cadent for production. (If necessary, one or more additional rounds of changes may be performed between Cadent and the lab before proceeding to step 4.) STEP 4: Cadent Production Cadent receives the case from the technician, performs a final check, and then sends the case to CNC production. STEP 5: Crown Shipped to Dentist for Fitting The finished crown is delivered by courier to the doctor's office. The temporary crown can then be removed from patient tooth and the permanent crown fastened in place. December 26, 2006 7 EID-2 Optical Impression Device Operation Manual About the iTero Service Cadents iTero service has introduced to the dental industry a breakthrough technology in the field of digital crown production. The iTero technology makes it possible to perform an intra-oral digital scan in the office and to produce a precise crown based on the digitally acquired data. iTero provides important advantages over existing crown-production methods, including powder-free color scanning, greater crown-production accuracy, and immediate feedback during the scanning process. Refer to our website at www.cadent.biz to learn more about how the iTero Service can save time and money for your practice. 8 Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Chapter 2: Operating Instructions This chapter describes the essential operating instructions for working with the EID-2 system. First Time Usage For first-time usage it is essential to boot the EID-2 system at least 24 hours prior to the first case scanning to ensure that the battery backup unit is fully charged. This 24-hour charge is also required in cases when the battery backup unit has been emptied (for example, if the system was unattended during a power out). Following the 24-hour charge period, its recommended to leave the system running during all office hours to allow background file transfer with Cadent. Booting System
(1) Press the front POWER switch.
(2) Green POWER LED goes on, PC boots, and MS Windows appears. NOTE: If the green POWER LED does not go on, refer to Restoring Power after Shipping or Storage on page 14. Shutting Down System
(1) Close all files and applications
(2) Press the front POWER switch.
(3) MS Windows shuts down, PC turns off, and green POWER LED goes off. Unplugging System for Short Intervals Follow these instructions if you need to unplug the system for 10 minutes or less for relocation:
(1) Save current case in iTero software.
(2) Attach foot pedal to front of cart.
(3) Hang scanner cable on cart hook.
(4) Unlock wheels.
(5) Unplug power cable from the wall socket. The system will begin to beep.
(6) Move system to its new location and plug into wall socket. The system will stop beeping.
(7) Lock wheels.
(8) Resume work where you left off. Automatic Shutdown When the cart is unplugged or a power outage occurs, a warning beep will begin. If the system is left unplugged for several minutes, warning messages will appear on the screen and will also be heard through the speakers. As the minutes pass, the status of the battery backup unit will be displayed on the screen. When the battery backup unit is nearly empty (after about 10 minutes), the system will be automatically shut down. After an automatic shutdown, it may be necessary to press the front POWER switch once to wake up the system. December 26, 2006 9 EID-2 Optical Impression Device Operation Manual Using the iTero Software Once the EID-2 system is up and running, you can use the following iTero applications. The iTero OFFICE application is used for performing 3D color scans of the preparation teeth. The mouse and foot pedals can be used to respond to screen questions during the scanning process. For more information, press F1 to activate the iTero OFFICE help. The iTero Case Manager works interactively with iTero OFFICE and handles file communications between the doctors office and the Cadent Center. For more information, press F1 to activate the iTero Case Manager help. The Cadent support icon enables Cadent technical support to provide remote training and support. Using the Handheld Scanner The handheld scanner is used to scan 3D images of the prepared teeth, while the scan images are displayed interactively on the screen. TOP VIEW OF HANDHELD SCANNER BOTTOM VIEW OF HANDHELD SCANNER Disposable Sleeve 10 Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Disinfecting Scanner and Replacing Disposable Sleeve To avoid cross contamination between patients, the scanner must be disinfected and the disposable plastic sleeve must be replaced. First use disinfectant wipes to clean the scanner arm, cradle, keyboard and mouse. Then proceed with the steps below in order to replace the disposable sleeve. STEP 1 Press firmly on both sides of the disposable sleeve to release. STEP 2 Pull the disposable sleeve slowly off the scanner arm and discard. STEP 3 Note that as the sleeve is removed, the optical lens is automatically covered over by a small metal plate. At this time you may slide on a new sleeve for the next patient. WARNING !!
When removing the sleeve, be careful not to touch the optical lens directly with your fingers. Touching it may cause damage to the optical lens. December 26, 2006 11 EID-2 Optical Impression Device Operation Manual Using the Foot Pedal Unit USING THE PEDALS The foot pedal unit contains two pedals for activating the scanning sequence and responding to screen questions. The colors of the two foot pedals match the Pedals dialog in the iTero OFFICE application (right is green, left is red). LED INDICATOR Pressing either foot pedal turns on the green LED. The battery needs to be replaced if any of the following events occur:
Pressing a foot pedal causes the LED to blink (or the LED doesnt light up at all). Pressing a foot pedal causes no response within the iTero software. LED Indicator A warning appears requesting that the battery be replaced. REPLACING BATTERY To change the battery, follow the instructions below. 12 Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Chapter 3: Cart Features This chapter describes the external hardware components of the EID-2 system. Front View of Cart Flat LCD monitor can be swiveled freely in any direction. Optical scanner for capturing teeth images. Note that the handheld scanner may be placed in scanner cradle in either direction (right-to-left or left-to-right). POWER switch for performing boot and shutdown. Wireless optical mouse. Built-in keyboard. Hook for holding scanner cable off the floor. Foot pedal holders. Lockable wheels. Wireless foot pedals for responding to screen questions during scan process. December 26, 2006 13 EID-2 Optical Impression Device Operation Manual Back View of Cart Air Vent
(do not block) Air Vent
(do not block) Main AC Power Cable Main Power Shut Off For Shipping or Storage When you need to unplug the cart for an extended period of time, perform these steps:
(1) Close all files and applications.
(2) Press the front POWER switch to shut down system.
(3) Unplug power cable from the wall socket.
(4) Press the MAIN POWER SHUT OFF switch on the back of the cart to remove power from all internal components. Restoring Power after Shipping or Storage To restore power, press the MAIN POWER SHUT OFF switch once and the system will beep to indicate return of power. If the battery backup unit is empty (for example, if the system was unattended during a power out), a 24-hour recharge period is required to restore full capacity. 14 Publication SD08300-A (Rev. 1.05) Operation Manual EID-2 Optical Impression Device Cleaning Monitor
(1) Shut down the system using the front POWER switch to ensure that no power is being supplied to monitor.
(2) Lightly dampen a clean white cotton cloth with water and wipe monitor clean.
(3) Dry the monitor immediately using a clean white cotton cloth.
(4) If further cleaning is necessary, use a clean cloth to wipe off the monitor with a small amount of alcohol. Do not use liquid cleaners, chemicals or aerosol sprays to clean monitor. Do not use abrasive cleaning materials such as newspaper or plastics. Monitor Controls December 26, 2006 15 EID-2 Optical Impression Device Operation Manual Locking Wheels Each of the four wheels can be locked or unlocked individually. LOCK WHEEL Step down on lever to lock wheel. Raise lever to unlock wheel. Publication SD08300-A (Rev. 1.05) UNLOCK WHEEL 16 Operation Manual EID-2 Optical Impression Device Appendix A: Hardware Specifications ITEM Monitor Handheld Scanner Battery Backup Unit Wireless LAN Foot Pedal Battery Mouse Mouse Battery DESCRIPTION LCD 19 monitor meets FCC and safety approval (UL, CSA, TUV) and operates at 1280x1024 resolution. Emits red laser light for performing tooth scan (660 nm Class 1). Also emits colored lights for performing a colored scan. APC Back-UPS ES 725 Broadband DWL-G122 Wireless USB Adapter produced by D-LINK. The DWL-G122 provides 2.4 GHz communications using the 802.11g standard for wireless connectivity. 3V Lithium coin battery (type CR2450 or CR2477). Optical wireless mouse. A screen message will appear when the mouse battery needs to be replaced. Use 1.5V alkaline LR6 battery (size AA). Operating Power Operating Temperature 18to 30C 115V / 4.5A / 60Hz 64.4 to 86F 0to 50C 32to 122F 30-90%
Storage Temperature Humidity Dimensions
(including wheels but not including monitor) Weight
(including all components) Height: 75.2 cm / 29.33 inches Width: 67.0 cm / 26.13 inches Depth: 40.0 cm / 15.60 inches 187.4 lbs 85 kg December 26, 2006 17