8G8224-01 KODAK 1500 Intraoral Camera Safety and Regulatory Guide
Notice ©Carestream Health, Inc., 2009. The information in this document is subject to change. Neither Carestream Health nor any of its subsidiaries shall be liable for errors contained herein or for incidental damages in conjunction with the furnishing, performance, or use of this material. No part of this publication may be reproduced with the permission of Carestream Health, Inc. Carestream is a trademark of Carestream Health, Inc. The Kodak trademark and trade dress are used under license from Kodak.
Safety and Regulatory Information Indications for Use The KODAK 1500 intraoral camera is designed for use by health professionals in viewing and capturing intraoral or extraoral color images for the purpose of: • Enabling practitioners to view and magnify all regions of the oral cavity to assess overall dental health. • Assisting communications with the patient by providing a view of treatment areas before and after a procedure. • Providing images for documentation in patient records.
Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided in this documentation. Other equipment can interfere with communications with the intraoral camera, even if the equipment complies with CISPR emissions requirements.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The KODAK 1500 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or the user of the intraoral camera should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued) Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
EMC Standards Information Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-2:2001+A1:2004 The KODAK 1500 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or the user of the intraoral camera should assure that it is used in such an environment.
Recommended Separation Distances Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Intraoral Camera System The Kodak 1500 intraoral camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
EMC Standards for Intraoral Camera IEC 60601-1-2:2001 + A1:2004 EMC requirements and tests, Medical Electrical Equipment including CISPR11:2003 +A1: 2004 + A2:2006 Group 1, Class B. NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
Detachable antenna: Trade Name: Lite Model Name: CAR-ATR-086-008 Safety Information The Kodak 1500 intraoral camera is a Type BF device. The corresponding symbol must be visible on the camera. Type BF Equipment Classification in accordance with IEC 60601-1 Conforming Standards- Safety Canada: CSA-C22.2 #601.1-M90 (R2005) - Medical Electrical Equipment: General Requirements for Safety. China: GB 9706.1-2007 Medical Electrical Equipment, Part 1: General Requirements for Safety. GB_9706.
EN 60825-1:2001 Safety of Laser products: Equipment classification, requirements and User’s Guide EN 60601-2-18:1997 Medical electrical equipment, Part 2: Particular requirements for safety -Section 2.18 Specification for endoscopic equipment. 93/42/EEC MDD (Medical Device Directive)-Europe Only. ISO13485: 2003 Quality Systems-Medical Devices-Particular requirements for the application of IS09001.
Condition Classification Type of protection against electrical shock: Class II Equipment Degree of protection against electrical shock: Type BF applied part Degree of protection against ingress of water: Ordinary Protection Flammable anesthetics: Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide.
Cabling Interface Max. Cable Length Number of interfaces with Shielded/ identical Unshielded electrical character-i stics Cable Classifications AC Docking Station - Camera 2.5 m Unshielded 1 AC - DC Adapter Docking Station Camera 2.5 m Shielded 1 Signal, DC Power (USB) Docking Station Charge Station 2.5 m Unshielded 1 DC Power Docking Station Computer 1.5 m Shielded 1 Signal Docking Station Monitor 1.5 m Shielded 1 Signal Footpedal Docking Station 5.
• Do not expose the camera to water spray or submerge it in water. • Do not expose the camera to high vibrations. • Do not replace the USB cable that is provided with the Kodak 1500 intraoral camera with any other USB cable. • Do not replace the power adaptor that is provided with the Kodak 1500 intraoral camera with any other power adaptor. Substitutes may not provide the required electric shock protection.
Figure 3 Wireless Camera Figure 4 Camera Label Wired Figure 5 Camera Label Wireless KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 13
Figure 6 Docking Station Figure 7 Battery This Class A digital device complies with Canadian ICES-003.
IC: 7027A-KODAK1500 Figure 9 FCC ID Label KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 15
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