Related Manuals for Kodak RVG 6500 IPS System
Summary of Contents for Kodak RVG 6500 IPS System
- Page 1 KODAK RVG 6500 System and KODAK RVG 6500 IPS System Safety, Regulatory & Technical Specification User Guide...
- Page 2 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.
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Page 3: Table Of Contents
Specification ...22 KODAK RVG 6500 With or Without IPS System Environmental Requirements ...23 KODAK RVG 6500 System_Safety, Regulatory & Technical Specifica-... -
Page 5: Indications For Use
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. -
Page 6: 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... - Page 7 • 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. KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B...
- Page 8 The visual access of the acquired image for the patient encourages communication. • The KODAK RVG 6500 systems must run on a computer with a keyboard. • The KODAK RVG 6500 systems must run on a computer with a...
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Page 9: Hygiene And Disinfection
Do not use chemical autoclave for the toothbrush holders and avoid direct contact with the metallic part of the autoclave. • To prevent cross-contamination, use a new hygienic barrier for each new patient.. KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B... -
Page 10: Marking And Labeling Symbols
Marking and Labeling Symbols Type BF device symbol complying with the IEC 60601-1 standard In the EEC, this symbol indicates: DO NOT discard this product in a trash receptacle; use an appropriate recovery and recycling facility. Contact your local sales representative for additional information on the collection and recovery programs available for this product... -
Page 11: Label Locations
Label Locations The following Figures illustrate the label locations of the KODAK RVG 6500 Systems. Figure 1 KODAK RVG 6500 Control Box Label FCC ID: U72RVG00001 IC ID : 7027A-RVG00001 Model Number : Kodak RVG6500 FCC ID : U72RVG00001 IC ID... -
Page 12: Kodak Rvg 6500 With Or Without Ips System Battery Specification
KODAK RVG 6500 with or without IPS System battery. The KODAK RVG 6500 with or without IPS System provides a medical battery charge. You can purchase additional battery separately (for battery replacement, see Chapter “Maintenance” section “Replacing the RVG Battery”). -
Page 13: General Regulatory Information
Information supplied by the manufacturer of medical EN 1041 devices Medical device software - Software life cycle EN 62304/IEC 62304 processes Biological evaluation of medical devices - Part 1 : EN 10993-1 Evaluation and testing KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B... - Page 14 Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). • KODAK RVG 6500 with or without IPS System must be installed and put into service according to the EMC information provided in this document. 10 Chapter 2 Regulatory Information...
- Page 15 KODAK RVG 6500 with or without IPS System. • The KODAK RVG 6500 with or without IPS System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the KODAK RVG 6500 with or without IPS System should be observed to verify normal operation in the configuration in which it will be used.
- Page 16 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The KODAK RVG 6500 with or without IPS System is intended for use in the electromagnetic environment specified below. The customer or the user of the KODAK RVG 6500 with or without IPS System should assure that it is used in such an environment.
- Page 17 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The KODAK RVG 6500 with or without IPS System is intended for use in the electromagnetic environment specified below. The customer or the user of the KODAK RVG 6500 with or without IPS System should assure that it is used in such an environment.
- Page 18 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The KODAK RVG 6500 with or without IPS System is intended for use in the electromagnetic environment specified below. The customer or the user of the KODAK RVG 6500 with or without IPS System should assure that it is used in such an environment.
- Page 19 The KODAK RVG 6500 with or without IPS System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KODAK RVG 6500 with or without IPS System can help prevent electromagnetic interference by maintaining a minimum distance between portable...
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Page 20: Regulations
Antenna Requirement 47 CFR Section 15.203 This device KODAK RVG 6500 System and KODAK RVG 6500 IPS System complies with Part 15 of the FCC Rules. Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. -
Page 21: Ic Requirements For Canada
équivalente (p.i.r.e.) ne soit pas supérieure au niveau requis pour l'obtention d'une communication satisfaisante. Cet appareil numérique de la classe B respecte toutes les exigences du règlement sur le matériel brouilleur du Canada. KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B... -
Page 22: Declaration Of Conformity With The R-Tte Directives
Declaration of Conformity with the R-TTE Directives 18 Chapter 2 Regulatory Information... -
Page 23: Factory
Carestream health, Inc. 150 Verona Street Rochester, New York - USA 14608 Model KODAK RVG 6500 System KODAK RVG 6500 IPS System KODAK RVG 6500 With or Without IPS System Technical Specifications KODAK RVG 6500 KODAK RVG 6500 IPS Components System System... - Page 24 (Continued) KODAK RVG 6500 KODAK RVG 6500 IPS Components System System 〈 〈 Sensor active Size 0: 16.6 x 22.2 mm Size 1: 22.2 x 29.6 mm 〈 〈 surface Size 1: 22.2 x 29.6 mm Size 2: 26.6 x 35.5 mm 〈...
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Page 25: Minimum Computer System Requirement
Wireless adapter PCMCIA or PCI) DVD-ROM drive is required to CD/DVD drive install the product. We strongly recommend a daily Removable/portable, external hard Backup media backup of x-ray disk drive. images and patient records. KODAK RVG 6500 System_Regulatory User Guide (SM737)_Ed01B... -
Page 26: Wifi Network Technical Specification
Number of channels 13 for Europe • 14 for Japan Maximum Power 20 mW The KODAK RVG 6500 / KODAK RVG 6500 IPS client acts as a DHCP. Client IP Address DHCP server is embedded within the Access Point. Data Size (maximum) One 5.4 MByte file... -
Page 27: Kodak Rvg 6500 With Or Without Ips System Environmental Requirements
KODAK RVG 6500 With or Without IPS System Environmental Requirements Ambient Operating Conditions Temperatures 0 ~ 45 °C Relative humidity 45% ~ 85% Atmospheric pressure 700 ~ 1060 hpa Storage Conditions Temperatures -20 ~ 60 °C Relative humidity 45 ~ 85%... - Page 28 24 Chapter 3 Technical Specifications...