U72RVG00002WiFi and RFID 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 (with or without IPS) 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 (with or without IPS) 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 (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor. 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 User and Installation Guide Part Number: SM745 Revision Number: 02 Print Date: 06/2010 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 (with or without IPS) 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 (with or without IPS) Systems. 0086 Carestream Health, Inc. 150 Verona Street Rochester NY 14 608 EC REP KODAK RVG 6500 System_User & Installation Guide (SM745)_Ed02iii Contents Chapter 1 Conventions in This Guide Conventions in this Guide . . . . . . . . . . . . . . . . . . . 1 Chapter 2 KODAK RVG 6500 With or Without IPS System Packaging KODAK RVG 6500 With or Without IPS System 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 . . . . . . . . . . . . . . . . . . 9 KODAK Dental Imaging Software . . . . . . . . . . . . . . . 9 The RVG Acquisition Interface . . . . . . . . . . . . . . . .10 The IPS Aiming Ring Interface Overview . . . . . . . . . . . 12 IPS Aiming Ring Interface and RVG Sensor Display . . 12 IPS Aiming Ring Interface and RVG Sensor Centering .13 Chapter 5 Setting Up the KODAK RVG 6500 Systems KODAK RVG 6500 Systems Configuration Options. . . . . 15 Option 1: Single RVG Sensor / Single PC / Single Access Point Configuration . . . . . . . . . . . . . . . . 15 Option 2: Single RVG Sensor / Multi-PC / Single Access Point Configuration . . . . . . . . . . . . . . . . 15 Option 3: Multi-RVG Sensor / Multi-PC / Single Access Point Configuration . . . . . . . . . . . . . . . . 16 Option 4: Multi-RVG Sensor / Multi-PC / Multi-Access Point Configuration . . . . . . . . . . . . . . . . . . . . 16 WiFi Access Point Setup Configurations . . . . . . . . . . . 17 WiFi Access Point Wired Configuration Setup . . . . . 17 WiFi Access Point Wireless Configuring Setup . . . . . 17 iv Installing the KODAK Dental Imaging Software . . . . . . . 18 Starting the Configuration Setup . . . . . . . . . . . . . . . 23 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 With RFID Connecting an RVG Sensor to the Computer . . . . . . . . 31 Acquiring an Image with the RVG Sensor . . . . . . . . . . 32 Preparing the RVG Sensor . . . . . . . . . . . . . . . . 32 Preparing the X-Ray Generator . . . . . . . . . . . . . . 33 Launching the X-Ray . . . . . . . . . . . . . . . . . . . 35 Chapter 7 Acquiring an Image Without RFID Locking the RVG Sensor to the Computer . . . . . . . . . . 37 Locking a Single RVG Sensor to the Computer . . . . . 37 Locking Several Shared RVG Sensors to the Computer 38 Acquiring an Image with the RVG Sensor . . . . . . . . . . 40 Preparing the RVG Sensor . . . . . . . . . . . . . . . . 40 Preparing the X-Ray Generator . . . . . . . . . . . . . . 41 Launching the X-Ray . . . . . . . . . . . . . . . . . . . 43 Chapter 8 Troubleshooting Quick Trouble Shooting . . . . . . . . . . . . . . . . . . . . 45 Information Messages . . . . . . . . . . . . . . . . . . . . . 47 Quick Trouble Shooting for WiFi . . . . . . . . . . . . . . . 49 Chapter 9 Maintenance Daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 The RVG Sensor . . . . . . . . . . . . . . . . . . . . . 51 Cleaning and Disinfecting the RVG Sensor . . . . . 51 Cleaning the RVG Sensor Control Box . . . . . . . 52 Cleaning the Positioning Accessories . . . . . . . . . . 52 Monthly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Replacing the RVG Battery . . . . . . . . . . . . . . . . . . 53 Replacing the IPS Aiming Ring Battery. . . . . . . . . . . . 56 KODAK RVG 6500 System_User & Installation Guide (SM745)_Ed021 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 to yourself or others by following the safety instructions precisely. CAUTION: Alerts…

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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: 02 Print Date: 06/2010 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_Regulatory User Guide (SM737)_Ed02iii 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 RFID Technical Specification . . .22 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)_Ed021 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 Intelligent 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 without 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)_Ed023 •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 peri…

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Carestream Care streamHealthInc. 150 VeronaStreet Rochester,NY 14608 Date: September8 th , 2010 FCCID: U72RVG00002 We herebydeclarethat our devicewith the FCC ID abovedoes not have Ad-Hoc functionalityin non-USfrequencybands. Our operationis limitedto the followingfrequencies 802.llg Channell(24l2MHz)- Channel11 (2462MHz) Name:Mr. RonaldCain Title: EMC ComplianceEngineer Signature:1~,t/e~

CarestreamHealthInc. 150 VeronaStreet Rochester,NY 14608 September28 th ,2010 CarestreamHealthInc. 150 VeronaStreet Rochester,New York 14608USA To:FederalCommunicationsCommission 7435 OaklandMills Road Columbia,MD 21046-1609 Curtis-StrausLLC TCB One DistributionCenterCircle,#1 Littleton,MA 02702 Re: Letterof electricalWifi part Gentlemen: I, RonaldL. Cain,act on my behalfof CarestreamHealthwith respectto matters relatingspecificallyto the filing of an application,certifythat the 802.11(WiFi) radio in the devicewith FCC ID : U72RVG00002is electricallyidenticalto the radio in the devicewith FCC ID : U72RVG00001. Sincerelyyours, ~,~ Name:RonaldL. Cain, Title: EMC ComplianceEngineer ContactInformation:Phone(1) 585-627-8574 E-mail:[email protected]

IPS transmitter Sensor Hea d Control box: Cable Battery RVG8 power supply; IEC60601-1 Mains Wireless Wireless Access point Access point power supply; IEC 60950 Mains Wireless Battery Patient environment RFID Tags 13.56MHz Quartz: 24Mhz 25MHz 27.12MHz Oscillateur: 38.4MHz Owner interface RFID transceiver 13.56MHz WiFi 802.11b standard [2400 – 2483.5MHz] WiFi 802.11b standard[2400 – 2483.5MHz] Outside patient environment Mains Acquisition device; IEC 60950

CarestreamHealthInc. 150 VeronaStreet Rochester,NY 14608 September28 th ,2010 CarestreamHealthInc. 150 VeronaStreet Rochester,New York 14608USA To:FederalCommunicationsCommission 7435 OaklandMills Road Columbia,MD 21046-1609 Curtis-StrausLLC TCB One DistributionCenterCircle,#1 Littleton,MA 02702 Re:Confidentialityrequestfor a Low PowerCommunicationDevice FCCID:U72RVG00002 Gentlemen: This letteris to complywith 47 CFR0.457(d)(2)pertainingto confidential material.CARESREAMHealthrequeststhat the followingdocumentsregarding this submissionfor FCC 10 U72RVG00002be kept confidential: 1.Schematics: produceSchematics_RFID.pdf;sensor_head_schematics_card.pdf 2.OperationalDescription:KodakRV6500_Dentistpres_RFID.pdf The materialabovecontainstechnicaldata, whichwouldcustomarilybe guarded from competitors. Sincerelyyours, Signature: ~d<~ Name:RonaldL. Cain, Title: EMC ComplianceEngineer ContactInformation:Phone(1) 585-627-8574 E-mail:[email protected]

EXTERNAL PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG 6500 SYSTEM / KODAK RVG 6500 IPS RVG Ultimate + /RVG Ultimate + IPS FCC ID: U72RVG00002 IC : 7027A-RVG00002

KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed027 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 Model Number: Kodak RVG6500 FCC ID : U72RVG00002 IC : 7027A-RVG00002 * * IPS

INTERNAL PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG 6500 SYSTEM / KODAK RVG 6500 IPS RVG Ultimate + /RVG Ultimate + IPS FCC ID: U72RVG00002 IC : 7027A-RVG00002 WiFi Chipset WiFi antenna RFID antenna fixation RFID components location RFID Antenna

FCC ID: U72RVG00002 The device is in mobile exposure category (separation distance d > 20cm). It includes 2 radios that can transmit at the same time. Radio 1: WiFi (802.11g) Conducted output power: 16.30dBm Antenna gain: 1.5dBi Power density at 20cm: 0.012mW/cm2 Power density limit: 1 mW/cm2 Radio 2: RFID reader 13.56MHz EIRP: -47.2dBm (based on fundamental field strength conversion) Power density at 20cm: 0.000001mW/cm2 Power density limit: Per 1.1310 Table1, 180/f2 (f in MHz) 0.9789 mW/cm2 If [ Pd(1) / LPd(1) ] + [ Pd(2) / LPd(2) ] + ..... + [ Pd(n) / LPd(n) ] < 1, then device complies with FCC’s RF radiation exposure limit for general population for a mobile device. Where; Pd(n) = Power density of n th transmitter at 20cm LPd(n) = Power density limit for the n th transmitter 0.012/1 + 0.000001/0.9789 = 0.012 < 1 Therefore device complies with FCC’s RF radiation exposure limit for general population in mobile exposure category (separation distance d > 20cm).

TEST SET UP PHOTOGRAPHS WIRELESS SENSOR INTRA ORAL KODAK RVG 6500 SYSTEM / KODAK RVG 6500 IPS RVG Ultimate + /RVG Ultimate + IPS FCC ID: U72RVG00002 IC : 7027A-RVG00002 Power line conducted emission test Radiated emission test Temperature test

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