Carestream Health KODAK1500H KODAK 1500 Intraoral Camera - Handpiece User Manual 1500 Camera Safety Regulatory Guide

Carestream Health, Inc. KODAK 1500 Intraoral Camera - Handpiece 1500 Camera Safety Regulatory Guide

User Manual

8G8224-01KODAK 1500 Intraoral CameraSafety 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.All other trademarks and registered trademarks are the property of their respective holders.US Federal law restricts this device to sale by or on the order of a dentist.The Kodak 1500 intraoral camera is also marketed and sold as the STV Pro + intraoral camera.Manual Name: KODAK 1500 Intraoral Camera Safety and Regulatory GuidePart Number: 8G8224Revision Number: 01Print Date: August 2009Authorized Representative: Handpiece:FCC ID: U72KODAK1500HIC: 7027A-KODAK1500Docking StationFCC ID: U72KODAK1500IC: 7027A-KODAK 1500
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 1Safety and Regulatory InformationIndications for UseThe 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. There are two configurations for the camera: wired and wireless. The wired camera is composed of a camera, a docking station, and accessories. The wireless camera is composed of an additional charge station and accessories. Regulatory InformationThe KODAK 1500 intraoral camera complies with the following standards:•93/42/EEC European directive for medical devices including EN 60601-1-2 and collaterals•Electrical Safety and Electromagnetic Compatibility standards (IEC) (CEM)•Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
2Electromagnetic Compatibility PrecautionsMedical 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 DeclarationsGuidance and Manufacturer’s Declaration - Electromagnetic EmissionsThe KODAK 1500 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or user of the intraoral camera should assure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF EmissionsCISPR 11 Group 1The intraoral camera uses RF energy only for its internal function. Therefore, its RF emissions are low and are not likely to cause any interference in nearby electronic equipment.RF EmissionsCISPR 11 Class BThe intraoral camera is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonics EmissionsIEC 61000-3-2 Class AVoltageFluctuations/Flicker EmissionsIEC 61000-3-3Complies
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 3Guidance 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.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - GuidanceConducted RF IEC 61000-4-6Radiated RFIEC 61000-4-33 Vrms150 kHz to 80 MHz3 V/M80 MHz to 2.5GHz3 Vrms3 V/MPortable and mobile RF communications equipment should be used no closer to any part of the Kodak 1500 Intraoral camera, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distanced=1.17 ÖPd = 1.17 ÖP 80 MHz to 800 MHzd = 2.33 ÖP 800MHz to 2.5GHzwhere P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacture and is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
4Note 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.a Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the intraoral camera system is used exceeds the applicable RF compliance level above, the intraoral camera should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Kodak 1500 intraoral camera.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/M.Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 5EMC Standards InformationElectromagnetic 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.Immunity Test IEC 60601Test Level ComplianceLevel Electromagnetic Environment- GuidanceElectrostatic Discharge (ESD)IEC 61000-4-2+/- 6 kV contact+/- 8 kV air+/- 6 kV contact+/- 8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burstIEC 61000-4-4+/- 2 kV for power supply lines+/- 1 kV for input/output lines+/- 2 kV for power supply lines+/- 1 kV for input/output linesMains power quality should be that of a typical commercial or clinical environment.SurgeIEC 61000-4-5+/- 1 kV line to line+/- 2 kV line to earth+/- 1 kV line to line+/- 2 kV line to earthMains power quality should be that of a typical commercial or hospital environmentVoltage dips, short interruptions and voltage variations on power supply linesIEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycle40% UT(60% dip in UT) for 5 cycles70% UT (30% dip in UT) for25 cycles<5% UT (>95% dip in UT) for 5 sec. <5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70%UT (30% dip in UT) for25 cycles<5% UT (>95% dip in UT) for 5 sec. Mains power quality should be that of a typical commercial or hospital environment. Note: Most components in the intraoral camera are powered from an uninterruptible power supply.IEC 61000-4-11 is applicable only to the intraoral cameraPower frequency (50/60Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/mPower frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.Note: UT is the a.c. prior to application of the test level.
6Recommended Separation DistancesRecommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Intraoral Camera SystemThe Kodak 1500 intraoral camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the intraoral camera can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Kodak 1500 intraoral camera as recommended below, according to the maximum output of the communications equipment.Rated Maximum Output Power of TransmitterWattsSeparation Distance According to Frequency of Transmitter Meters150 kHz to 80 MHzd = 1.17 ÖP80 MHz to 800 MHzd = 1.17 ÖP800 MHz to 2.5 GHzd = 2.33 ÖP0.01 0.117 0.117 0.2330.1 0.37 0.37 0.7371 1.17 1.17 2.3310 3.7 3.7 7.36100 11.7 11.7 23.3For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note 1: At 80 MHz and 800 MHz, the separation distance for 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.
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 7EMC Standards for Intraoral CameraIEC 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. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Install the docking station in such a manner as to maintain a minimum of 20 cm (7.9 inches) separation distance between the radiating element(s) and all persons. This safety warning conforms to FCC radio frequency exposure limits.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two 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.Electromagnetic Interference and Electrostatic Discharge According to CISPR11:2003 + A1:2004 + A2:2006 Group 1, Class B.This Class A digital device complies with Canadian ICES-003.This device has been designed to operate with the antenna listed below, and having a maximum gain of 1.6 dB. Antennas not included in this list or having a gain greater than 1.6 dB are strictly prohibited for use with this device. The required antenna impedance is 50 ohms.
8Detachable antenna:Trade Name: LiteModel Name: CAR-ATR-086-008Safety InformationThe Kodak 1500 intraoral camera is a Type BF device. The corresponding symbol must be visible on the camera.Classification in accordance with IEC 60601-1Conforming Standards- SafetyCanada: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_9706.19-2000 Medical Electrical Equipment, Part 2: Particular requirements for safety -Section 2.18 Specification for endoscopic equipment. Environmental Requirements and Testing Methods of Medical Electrical Equipment.Europe:EN 60601-1 (1990) + A1: 1993 + A2: 1995 Medical Electrical Equipment, Part 1: General Requirements for Safety.Type BF Equipment
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 9EN 60825-1:2001 Safety of Laser products: Equipment classification, requirements and User’s GuideEN 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.USA:UL 60601-1:2003, UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety. Other Countries:IEC 60601-1:1988 + A1:1991+A2:1995 Medical electrical equipment; Part 1: General requirements for safety.IEC 60601-2-18:1996 Medical Electrical Equipment, Part 2: Particular requirements for safety -Section 2.18 Specification for endoscopic equipment.IEC 60825-1:2001 Safety of Laser products: Equipment classification, requirements and User's Guide.
10Communications EquipmentPortable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment EMC performance.The wireless version of the Kodak 1500 intraoral camera operates with a 802.11g protocol in a 2.4GHz frequency band. The radio output power is 20 mW (nominal).AccessoriesThe use of cables, adapters, or accessories other than those specified with the exception of those sold by the manufacturer of the equipment as replacement parts for internal components, may result in increased emissions or decreased immunity of the medical equipment. Changes or modifications not expressly approved by the party responsible �for compliance could void the user's authority to operate the equipmentOther EquipmentThe Kodak 1500 intraoral camera should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Kodak 1500 intraoral camera should be observed to verify normal operation in the configuration in which it will be used.Condition ClassificationType of protection against electrical shock: Class II EquipmentDegree of protection against electrical shock: Type BF applied partDegree of protection against ingress of water: Ordinary ProtectionFlammable anesthetics:Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide.Mode of operation Continuous operation
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 11CablingCautions for Safe Operation CAUTIONS•Before using the camera, check the outer surfaces of the camera and any accessories to ensure there are no rough surfaces, sharp edges, or protrusions which may cause a safety hazard.•Do not pull or twist the cable.•Do not drop the camera.•Never place the camera or accessories in a sterilizer or autoclave.Interface Max. Cable LengthShielded/ UnshieldedNumber of interfaces with identical electrical character-isticsCable ClassificationsAC Docking Station - Camera 2.5 m Unshielded 1 AC - DC AdapterDocking Station - Camera 2.5 m Shielded 1 Signal, DC Power (USB)Docking Station - Charge Station 2.5 m Unshielded 1 DC PowerDocking Station - Computer 1.5 m Shielded 1 SignalDocking Station - Monitor 1.5 m Shielded 1 SignalFootpedal - Docking Station 5.0 m Shielded 1 SignalDocking Station - S-Video Monitor 1.5 m Shielded 1 Signal
12•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.LabelsFigure 1 Charge StationFigure 2 Wired Camera
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 13Figure 3 Wireless CameraFigure 4 Camera Label WiredFigure 5 Camera Label Wireless
14Figure 6 Docking StationFigure 7 BatteryThis Class A digital device complies with Canadian ICES-003.Figure 8 Class A Apparatus
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 15Figure 9 FCC ID LabelIC: 7027A-KODAK1500
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