U72RVG00001WiFi Control Box

KODAK RVG 6500 System and KODAK RVG 6500 IPS System User & Installation Guide Notice The User & Installation Guide for the KODAK RVG 6500 System includes information on the installation of the device as well as its usage. We recommend that you thoroughly familiarize yourself with this Guide in order to make the most effective use of your system. The KODAK RVG 6500 System, wireless digital intra-oral X-ray system, is intended to produce an image of the dental area at the direction of dentists, oral surgeons and orthodontists for x-ray imaging of the dento-maxillo-facial area. The KODAK RVG 6500 IPS System, in addition, provides the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor. All rights reserved. iPhone®, iPod® are trademarks or registered trademarks of Apple Inc. No part of this Guide may be reproduced without the express permission of Carestream Health, Inc. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician. This document is originally written in English. Manual Name: KODAK RVG 6500 System User and Installation Guide Part Number: SM728 Revision Number: 01 Print Date: 10/2009 In this Guide, all trademarks and registered trademarks are the property of their respective holders. The Brand names and logos reproduced in this Guide are copyright. KODAK is a trademark of KODAK used under Licence. KODAK RVG 6500 System, complies with Directive 93/42/CEE relating to medical equipment. Manufacturer Authorized Representative in the European Community TROPHY 4, Rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France WARNING: We recommend that you consult the “Safety, Regulatory and the Technical Specification User Guide” before using the KODAK RVG 6500 Systems. 0086 Carestream Health, Inc. 150 Verona Street Rochester NY 14 608 EC REP KODAK RVG 6500 System_User & Installation Guide (SM728)_Ed01iii Contents Chapter 1 Conventions in This Guide Conventions in this Guide . . . . . . . . . . . . . . . . . . . 1 Chapter 2 KODAK RVG 6500 Systems Packaging KODAK RVG 6500 Systems Description. . . . . . . . . . . 3 Packaging of KODAK RVG 6500 System . . . . . . . . . . 3 Packaging of KODAK RVG 6500 IPS System . . . . . . . . 3 Opening the Boxes . . . . . . . . . . . . . . . . . . . . . . 3 Chapter 3 KODAK RVG 6500 Systems Overview KODAK RVG 6500 Systems Overview . . . . . . . . . . . . 5 RVG Functional Components Overview . . . . . . . . . . . 6 WiFi Access Point Functional Components Overview . . . . 7 Chapter 4 Imaging Software Overview Computer System Requirements . . . . . . . . . . . . . . . 9 General Software Overview . . . . . . . . . . . . . . . . . . 10 KODAK Dental Imaging Software . . . . . . . . . . . . . . .10 The RVG Acquisition Interface . . . . . . . . . . . . . . . .11 The IPS Aiming Ring Interface Overview . . . . . . . . . . . 13 IPS Aiming Ring Interface and RVG Sensor Display . . 13 IPS Aiming Ring Interface and RVG Sensor Centering .14 The RVG Mobile Application Overview . . . . . . . . . . . .15 Chapter 5 Setting Up the KODAK RVG 6500 Systems WiFi Access Point Setup Configurations . . . . . . . . . . . 17 WiFi Access Point Wired Configuration Setup . . . . . 17 WiFi AP Wireless Configuring Setup . . . . . . . . . . . 18 Installing the KODAK Dental Imaging Software . . . . . . .19 Registering the KDIS Licence . . . . . . . . . . . . . . . . .25 Mounting the RVG Holders . . . . . . . . . . . . . . . . . . 26 Mounting the IPS Aiming Ring on the X-Ray Generator . . . 27 Chapter 6 Acquiring an Image Locking the RVG Sensor to the Computer . . . . . . . . . .31 Locking a Single RVG Sensor to the Computer . . . . .31 Locking Several Shared RVG Sensors to the Computer . . . . . . . . . . . . . . . . . . . . . . . . . 32 Acquiring an Image with the RVG Sensor . . . . . . . . . .34 Preparing the RVG Sensor . . . . . . . . . . . . . . . .34 Preparing the X-Ray Generator . . . . . . . . . . . . . . 35 iv Launching the X-Ray . . . . . . . . . . . . . . . . . . . 37 Chapter 7 RVG Mobile Application The RVG Mobile Application Overview . . . . . . . . . . . . 39 Downloading the RVG Mobile Application . . . . . . . . . . 42 If iPhone/iPod Touch is Connected to the Internet . . . 42 If iPhone/iPod Touch is not Connected to the Internet . 43 Connecting The Device to the WiFi Access Point . . . . . . 44 Configuring the Preference Settings . . . . . . . . . . . . . 45 Locking the RVG Sensor to the Apple Device . . . . . . . . 48 Accessing the Sensor List Window . . . . . . . . . . . 48 Locking a Single RVG Sensor to the Apple Device . . . 48 Locking Several Shared RVG Sensors to the Apple Device . . . . . . . . . . . . . . . . . . . . . . . 49 Finding or Creating a Patient File . . . . . . . . . . . . . . . 51 Acquiring an Image with the RVG Mobile Application . . . . 52 Preparing the RVG Sensor . . . . . . . . . . . . . . . . 52 Preparing the X-Ray Generator. . . . . . . . . . . . . . 53 Launching the X-Ray . . . . . . . . . . . . . . . . . . . 54 Chapter 8 Troubleshooting Quick Trouble Shooting . . . . . . . . . . . . . . . . . . . . 59 Information Messages . . . . . . . . . . . . . . . . . . . . . 61 Chapter 9 Maintenance Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 The RVG Sensor . . . . . . . . . . . . . . . . . . . . . 63 Cleaning and Disinfecting the RVG Sensor . . . . . 63 Cleaning the RVG Sensor Control Box . . . . . . . 64 Cleaning the Positioning Accessories . . . . . . . . . . 64 Monthly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Replacing the RVG Battery . . . . . . . . . . . . . . . . . . 65 Replacing the IPS Aiming Ring Battery. . . . . . . . . . . . 68 KODAK RVG 6500 System_User & Installation Guide (SM728)_Ed011 1 Conventions in This Guide Conventions in this Guide The following special messages emphasize information or indicate potential risk to personnel or equipment: WARNING: Warns you to avoid injury t…

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KODAK RVG 6500 System and KODAK RVG 6500 IPS System Safety, Regulatory & Technical Specification User Guide Notice The Regulatory Information & Technical Specifications User Guide for the KODAK RVG 6500 System and KODAK RVG 6500 IPS System includes information on the safety instructions, regulatory information and the technical specifications of the device. We recommend that you thoroughly familiarize yourself with this Guide in order to make the most effective use of your system. The information contained in this Guide may be subject to modification without notice, justification or notification to the persons concerned. No part of this Guide may be reproduced without the express permission of Carestream Health, Inc. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician. This document is originally written in English. Manual Name: KODAK RVG 6500 System and KODAK RVG 6500 IPS System Safety, Regulatory and Technical Specifications User Guide Part Number: SM737 Revision Number: 01B Print Date: 04/2010 The Brand names and logos reproduced in this Guide are copyright KODAK is a trademark of KODAK used under Licence. KODAK RVG 6500 System, complies with Directive 93/42/CEE relating to medical equipment. Manufacturer Authorized Representative in the European Community TROPHY 4, Rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France 0086 Carestream Health, Inc. 150 Verona Street Rochester NY 14 608 EC REP KODAK RVG 6500 System_Safety, Regulatory & Technical Specifica- Contents Chapter 1 Safety Information Indications for Use . . . . . . . . 1 Conventions in this Guide . . . . . 1 Warning and Safety Instructions . . 2 Hygiene and Disinfection . . . . . 5 Marking and Labeling Symbols . . 6 Label Locations . . . . . . . . . . 7 KODAK RVG 6500 With or Without IPS System Battery Specification . 8 Chapter 2 Regulatory Information General Regulatory Information . . 9 Compliance with International Regulations . . . . . . . . . . . .16 FCC Requirements for USA . . . .16 IC Requirements for Canada. . . .17 Declaration of Conformity with the R-TTE Directives . . . . . . . . .18 Chapter 3 Te c h n i c a l Specifications Factory . . . . . . . . . . . . . .19 Manufacturer: . . . . . . . . . . .19 Model. . . . . . . . . . . . . . .19 KODAK RVG 6500 With or Without IPS System Technical Specifications . . . . . . . . . . .19 Minimum Computer System Requirement . . . . . . . . . . .21 WiFi Network Technical Specification . . . . . . . . . . .22 KODAK RVG 6500 With or Without IPS System Environmental Requirements . . . . . . . . . . .23 iv KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B 1 Safety Information Indications for Use The KODAK RVG 6500 System, wireless digital intra-oral X-ray system, is intended to produce an image of the dental area at the direction of health care professionals of dento- maxillo-facial region of the human anatomy. The KODAK RVG 6500 IPS System, in addition, provides the Intelligent Positioning System to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor. Conventions in this Guide The KODAK RVG 6500 Systems is composed of the KODAK RVG 6500 System and the KODAK RVG 6500 Intellegient Positioning System (IPS) System. The following special messages emphasize information or indicate potential risk to personnel or equipment. WARNING: Warns you to avoid injury to yourself or others by following the safety instructions precisely. Important: Alerts you to a condition that might cause problems. Tip: Provides extra information and hints. 2Chapter 1 Safety Information Warning and Safety Instructions WARNINGS Device: •Read and understand this Safety Information before using the KODAK RVG 6500 with or withour IPS System. •This device complies with FCC and Industry Canada RF radiation exposure limits set forth for general population (uncontrolled exposure). This device must be installed to provide a separation distance of at least 20cm from all persons and must not be collocated or operating in conjunction with any other antenna or transmitter. •You are responsible for the operation and maintenance of this device. Only legally qualified persons can operate this device. When necessary, have a trained authorized service technician carry out inspection and maintenance operations. •Install this device in an X-ray room that complies with current installation standards. From this location, you must be able to maintain visual or audio communication with the patient and be able to access the Acquisition interface module during exposure. •DO NOT operate the device if there is the threat of an earthquake. Following an earthquake, ensure that the device is operating satisfactorily before using it again. Failure to observe this precaution may expose patients to hazards. •X-ray equipment is hazardous to patients and the operator if you do not observe the exposure safety factors and operating instructions. •DO NOT place objects within the field of operation of the device. •Connect this equipment ONLY to a mains power supply with protective ground to avoid any risk of electric shock. •To dispose of the device or its components, contact a service technician. •No modification of this equipment is allowed. Note: Emphasizes important information. KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B 3 •DO NOT use this device in conjunction with oxygen-rich environments. This device is not intended for use with flammable anesthetics or flammable agents. •Using accessories other than those specified in this document with the exception of those sold by Carestream Health may result in a lower level of security for the entire system. 4Chapter 1 Safety Information Computer: •DO NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient in the unit. Leave at least 1.5 m distance between the patient and the unit. The computer and the peripheral equipment must conform…

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HEALTH CorestrearnInc 150 VeronaStreet Rochester,NY 14608 November30, 2009 Curtis-StrausLLC '527 GreatRoad Littleton,MA 01460 USA Re: HConfidentiality Hrequest H FCC ID: U72RVG00001 Gentlemen, CarestreamHealthInc. requests,pursuantto 47CFR0.459,postgrant confidentialityfor portionsof the materialcontainedin this application. The followingdocumentregardingthis submissionfor FCC ID: U72RVG00001 shall be kept confidential: Schematics:ProducCSchematics.pdf, SensocHead_schematic_card.pdf, Wi-FLSchematics.pdf Operationaldescription: OperationaLdescription-KodakRVG6500.pdf.pdf Block diagrams:Block_Diag2-GDCC.pdf,Block_Diag3-DSP.pdf Specifically,theseexhibitscontaininformationrelatingto circuitfunctionand complexitythat couldbe of benefitto competitors.The materialcontainstrade secretsand confidentialinformationthat CarestreamHealthInc. doesnot customarilyreleaseto the publicand whichis otherwisenot generallyavailableto the public. Regards, RonaldL. Cain EMC ComplianceEngineer

CorestreomHealth,inc, 150 VeronoStreet Rochester,NY 14608 Date: Aprilli h ,2010 FCC ID: U72RVGOOOOI We herebydeclarethat our devicewith the FCC ID abovedoes not have Ad-Hoc functionalityin non-USfrequencybands. Our operationis limitedto the followingfrequencies 802.11g Name:Mr. RonaldCain Channell(24l2MHz)- Channel11(2462MHz) Title:EMC ComplianceEngineer Signature:"1~df{~

EXTERNAL PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG6500 System and KODAK RVG6500 IPS System FCC ID: U72RVG00001 IC : 7027A-RVG00001 General view sensor Front side back side Power supply Power supply charger label General view of the power supply

6Chapter 1 Safety Information Label Locations The following Figures illustrate the label locations of the KODAK RVG 6500 Systems. Figure 1KODAK RVG 6500 Control Box Label Figure 2KODAK RVG 6500 Labels Figure 3KODAK RVG 6500 IPS Aiming Ring Label FCC ID: U72RVG00001 IC ID : 7027A-RVG00001 Model Number: Kodak RVG6500 FCC ID : U72RVG00001 IC : 7027A-RVG00001 ** IPS IFFCC ID: XVHRVG00001 IC ID : 8683A-RVG00001

INTERNAL PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG6500 System and KODAK RVG6500 IPS System FCC ID: U72RVG00001 IC : 7027A-RVG00001 Antenna

Prediction of MPE limit at a given distance Equation from page 18 of OET Bulletin 65, Edition 97-01 where:S = power density P = power input to the antenna G = power gain of the antenna in the direction of interest relative to an isotropic radiator R = distance to the center of radiation of the antenna Maximum peak output power at the antenna terminal:16.30 (dBm) Maximum peak output power at the antenna terminal:42.65795188 (mW) Antenna gain(typical):1.5 (dBi) Maximum antenna gain:1.412537545 (numeric) Prediction distance:20 (cm) Prediction frequency:2450 (MHz) MPE limit for uncontrolled exposure at prediction frequency:1 (mW/cm^2) Power density at prediction frequency:0.011988 (mW/cm^2) 2 4R PG S

Therefore, device complies with FCC and Industry Canada RF radiation exposure limits for general population as a mobile device (d > 20cm).

TESTS SET UP PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG6500 System and KODAK RVG6500 IPS System FCC ID: U72RVG00001 IC : 7027A-RVG00001 Radiated emission test Power line conducted emission test