Carestream Health 5800 Laser Imager User Manual 2G0734

Carestream Health, Inc. Laser Imager 2G0734

Contents

Safety manual

Kodak DryView 5800 Laser ImagerSafety Manual
Carestream Health, Inc.150 Verona StreetRochester, New York 14608© Carestream Health, Inc., 2007DryView is a trademark of Carestream Health.Kodak is a trademark of Kodak used under license.Pub No. 2G0734Rev. ACatalog No. yyyyyyyy
June 7, 2007 2G0734 iTable of ContentsSafety and Related Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -5Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8EMC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9EU Directives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14CE Marking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14Please Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -15Imager Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
June 7, 2007 2G0734 1Safety and Related InformationSafety, Warnings, and CautionsPlease read and understand all instructions before using this product. RISK OF ELECTRIC SHOCK:This equipment is operated with hazardous voltage which can shock, burn, or cause death.•Remove wall plug before servicing equipment. Never pull on cord to remove from outlet. Grasp plug and pull to disconnect. Do not attempt to service or repair the laser imager yourself to avoid exposure to dangerous voltage, laser beam, or other danger. Always call an Authorized Service Provider of Carestream Health, Inc. products for any service or repair.•Do not operate equipment with a damaged power cord.•Do not use an extension cord to power this equipment.•Do not operate equipment with any of the safety interlocks overridden.•Position the power cord so it will not be tripped over or pulled.•Connect this equipment to a grounded wall outlet.•Three power cord sets are provided with this equipment:– power cord with plug for use in North America– power cord with plug for use in China– power cord with plug for use in EuropeAll other countries must use an Agency-approved power cord with plug type suitable for the country of use, or contact an authorized Carestream Health, Inc. dealer.DANGER: This equipment contains moving parts that may be accessible to the user. Loose clothing, jewelry or long hair may cause personal injury or damage to the equipment.•Do not operate equipment with the covers open.DANGER: This equipment is not contained in a sealed cabinet. Do not use this equipment in locations where it can come in contact with liquids, including body fluids.
2 2G0734 June 7, 2007Safety and Related InformationCAUTION:Do not use a cell phone within 2 meters of a laser imager. This proximity includes any imager behind a wall adjacent to your location.CAUTION:Do not use a microwave oven within 4 meters of a laser imager. Electromagnetic radiation from a microwave oven is only an issue if after the oven door is closed and latched, the seal does not maintain an electromagnetic tight fit between the oven door and oven main housing. Determining if the seal has an electromagnetic tight fit requires special detection equipment.CAUTION:Do not use in the presence of flammable anesthetics, oxygen, or nitrous oxide. This equipment does not have a gas-sealed electronics enclosure and could ignite any flammable or explosive gases present in its environment.CAUTION:This equipment uses a DICOM network port, and is intended to connect to other medical devices. It is not intended to be connected directly outside the building. Only an Authorized Service Provider of Carestream Health, Inc. products may perform installation and service maintenance.CAUTION:This device is NOT to be located within the patient environment. Therefore, the equipment must not be located closer than 1.83 meters from a patient bed or chair.1.83 m
Safety and Related InformationJune 7, 2007 2G0734 3CAUTION:This device should not be used in close contact with MRI devices, due to possible very high magnetic fields near an MRI unit. The magnetic field in the area where this equipment is installed must be less than 50 Gauss.CAUTION:Do not substitute or modify any part of this equipment without prior written approval of Carestream Health, Inc.CAUTION:Federal law prohibits dispensing without a prescription.CAUTION: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 User Guide and other User Documentation, 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.CAUTION:Changes or modifications not expressly approved by the party responsible for compliance could void the userís authority to operate the equipment.CAUTION:Do not use isopropyl alcohol to clean the exterior surfaces of the laser imager. Isopropyl alcohol can dissolve the exterior paint on the laser imager.CAUTION:In the U.S., exhausted filters are considered to be non-hazardous waste according to the US Environmental Protection Agency Resource Conservation Recovery Act (RCRA). Municipality owned and licensed solid waste management facilities are an appropriate disposal option. Contact your local or state solid waste authorities to determine if additional disposal requirements apply. In other regions, contact local or regional solid waste authorities for proper disposal guidance.
4 2G0734 June 7, 2007Safety and Related InformationCAUTION:Lithium batteries should only be replaced by an Authorized Service Provider of Carestream Health, Inc. products. The laser imager uses a lithium battery to power the clock and calendar circuitry. THERE IS A DANGER OF EXPLOSION IF THE BATTERY IS REPLACED INCORRECTLY. The battery must be replaced only with the same or equivalent type. The U.S. EPAís RCRA does not regulate disposal of this lithium battery. Users should discard spent batteries in municipal trash unless their community offers a battery collection program. In other regions, contact local or regional solid waste authorities for proper disposal guidance.LASER WARNING:The Equipment uses a 50-Milliwatt invisible laser. Laser radiation may be present when the machine operates without the rear cover installed. Covers with this lavbel may only be removed by an Authorized Service Provider of Carestream Health, Inc. products. USE OF CONTROLS OR OTHER ADJUSTMENTS, OR OTHER PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN, MAY RESULT IN EYE DAMAGE.
Safety and Related InformationJune 7, 2007 2G0734 5Safety Labels Safety labels are attached to the laser imager in compliance with international standards.This label shows the serial number and model number of the Imager along with other important data items.Laser Radiation Warning Labels1 Class 3B invisible laser radiation. This label states that, "When open and interlocks defeated, avoid exposure to the beam."2 Laser Hazard symbol. 7F3118.ECarestream Health, Inc.Rochester, NY 14608TM: DryView5800580005018F2800xxxxxxxAugust 2007, 2007 08100/120/200/220/240V12/12/7/7/7A50/60Hz311346 3JZTDryView Laser Imager ‚ ˚‰…⁄„ ‡ ˇæ ˙7F6587.A7F6587.A8F4187.A12
6 2G0734 June 7, 2007Safety and Related InformationAgency Statements1 Hazardous Voltage. This warning label indicates that high voltage is present under panels where the label is attached. Only an Authorized Service Provider of Carestream Health, Inc. products should attempt access.2 Static Sensitive Equipment. This label identifies static-sensi-tive components. Connect a personal grounding strap to appro-priate ground before servicing this laser imager. These panels may only be removed by an Authorized Service Provider of Carestream Health, Inc. products.3 Radio Frequency Energy. This label indicates that the laser imager can radiate radio frequency energy. If not installed and used in accordance with the instructions, the laser imager may cause harmful interference to radio communications.4 Class 1 Laser. This label indicates that the laser imager com-plies with IEC requirements for Class 1 systems.5 Japanese Import License. Japanese Import LicenceJapanese Import Licence12345
Safety and Related InformationJune 7, 2007 2G0734 7Hot Surface Labels1 Processor cover hot surface. This label indicates to use care near the processor drum to avoid possible burns.2 Processor heat shield hot surface. This label indicates to use care near the processor heat shield to avoid possible burns.2G0590.302G0589.3012
8 2G0734 June 7, 2007Safety and Related InformationSafety and Health ComplianceThis equipment has been tested for and complies with the following Safety and Emissions Standards. Certificates of Compliance and Declarations of Conformity have been issued as shown below.Safety United States21 CFR 1040.10 Class ICode of Federal Regulations Title 21 Food and DrugsChapter I Food and Drug Administration, Department of Health and Human ServicesVolume 8 - Parts 800 to 1299Subchapter J - Radiology HealthPart 1040 - Performance Standards for Light Emitting Products Section 10 - Laser ProductsFDA 21CFR 807 Premarket Notification 510(K): Regulatory Requirements For Medical Devices.UL 60950-1: Safety of Information Technology Equipment, including Electrical Business Equipment (Bi-National Standard).IEC 60601-1: Medical electrical equipment - Part 1: General require-ments for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19.IEC 60825-1: Safety of laser products - Part 1: Equipment classifica-tion, requirements and user’s guide.
Safety and Related InformationJune 7, 2007 2G0734 9CanadaEuropeRest of WorldEMC United StatesCAN/CSA - C22.2 NO 60950-1-03 Information Technology Equip-ment - Safety - Part 1: General Requirements. (Bi-National Standard, with UL 60950-1).IEC 60601-1: Medical electrical equipment - Part 1: General require-ments for safety, Clause 19.IEC 60825-1: Safety of laser products - Part 1: Equipment classifica-tion, requirements and user’s guide.EN60950-1: Safety of Information Technology Equipment, including Electrical Business Equipment (IEC 60950: 1991, Modified) (Includes Amendment A1, A2, A3, A4, and A11).EN60601-1: Medical electrical equipment - Part 1: General require-ments for safety, Clause 19.EN60825-1: Safety of laser products - Part 1: Equipment classifica-tion, requirements and user's guide.IEC 60950-1: Safety of information technology equipment.IEC 60601-1: Medical electrical equipment - Part 1: General require-ments for safety, Clause 19.IEC 60825-1: Safety of laser products - Part 1: Equipment classifica-tion, requirements and user's guide.FCC Rules and Regulations, Title 47, Part 15, Subpart B, Class A: Radio Frequency Devices: Unintentional Radiators.This equipment has been tested and been found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC rules. Those limits are designed to provide reasonable pro-tection against harmful interference in a residential installation.FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices: Intentional Radiators. FCC ID: U725800
10 2G0734 June 7, 2007Safety and Related InformationCanadaEurope and the Rest of World CAN/CSA-C108.6-M91, Class A: Limits and Methods of Mea-surement of Electromagnetic Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equip-ment.Intentional Radiation IC: 7027A-5800This Class A digital apparatus complies with Canadian ICES-003.CET APPAREIL NUM ENRIQUE DE CLASSE A EST CON-FORME A LA NORME NMB-003 DU CANADA.This Class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.Guidance and Manufacturerís Declaration for Electromagnetic EmissionsThe Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the Kodak DryView 5800 Laser Imager should ensure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment - GuidanceRF emissions:• EN55011• CISPR 11Group 1 The Kodak DryView 5800 Laser Imager uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissions:• EN55011• CISPR 11Class A The Kodak DryView 5800 Laser Imager is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonics emissions:• EN61000-3-2• IEC 61000-3-2Class A The Kodak DryView 5800 Laser Imager is suitable for use everywhere, including those establishments directly con-nected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Voltage fluctuations and flicker emissions:• EN61000-3-3• IEC 61000-3-3Complies The Kodak DryView 5800 Laser Imager is suitable for use everywhere, including those establishments directly con-nected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Safety and Related InformationJune 7, 2007 2G0734 11Guidance and Manufacturerís Declaration for Electromagnetic ImmunityThe Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the Laser Imager should ensure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - GuidanceElectrostatic dis-charge (ESD):• EN61000-4-2 • 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 cov-ered with synthetic material, the relative humidity should be at least 30%.Electrical fast tran-sient/burst:• EN61000-4-4 • IEC 61000-4-4± 2 kV for power supply lines ± 1 kV for input/out-put lines± 2 kV for power sup-ply lines ± 1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.Surge:• EN61000-4-5 • IEC 61000-4-5± 1 kV differential mode ± 2 kV common mode± 1 kV differential mode ± 2 kV common modeMains power quality should be that of a typical commercial or hospital environment.Voltage dips, short interruptions and voltage variations on power supply lines:• EN61000-4-11• IEC 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*) for 25 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 cycles 70% Ut* (30% dip in Ut*) for 25 cycles <5% Ut* (>95% dip in Ut*) for 5 sec.Mains power quality should be that of a typical commercial or hospital environment. If the user of the Kodak DryView 5800 Laser Imager requires continued opera-tion during power mains interrup-tions, it is recommended that the Kodak DryView 5800 Laser Imager be powered from an unin-terruptible power supply or a bat-tery.Power frequency (50/60 Hz) mag-netic field:• EN61000-4-8 • IEC 61000-4-83 A/m 3 A/m Mains power quality should be that of a typical commercial or hospital environment.NOTE: * Ut is the a.c. mains voltage prior to application of the test level.
12 2G0734 June 7, 2007Safety and Related InformationGuidance and Manufacturerís Declaration for Electromagnetic ImmunityThe Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the Kodak DryView 5800 Laser Imager should ensure that it is used in such an environment.Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - GuidancePortable and mobile RF communications equip-ment should be used no closer to any part of the Kodak DryView 5800 Laser Imager, including cables, than the recommended separation dis-tance calculated from the equation applicable to the frequency of the transmitter.Conducted RF 3 Vrms 3 VrmsIEC 61000-4-6 150 kHz to 80 MHzRadiated RF 3 v/m 3 v/m 80 MHz to 800 MHzIEC 61000-4-3 80 MHz to 2.5 GHz 800 MHz to 2.5 GHz d is the recommended separation distance in meters (m).P is the maximum output rating of the transmitter in watts (W) according to the transmitter manu-facturer. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b.Interference may occur in the vicinity of equip-ment marked with the following symbol: NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.a See Note 1 on next page.b See Note 2 on next page.d1.17 P=d1.17 P=d2.33 P=
Safety and Related InformationJune 7, 2007 2G0734 13Guidance and Manufacturerís Declaration for Electromagnetic ImmunityNote 1 Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) tele-phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broad-cast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be consid-ered. If the measured field strength in the location in which the Kodak DryView 5800 Laser Imager is used exceeds the applicable RF compliance level above, the Kodak DryView 5800 Laser Imager should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Kodak DryView 5800 Laser Imager.Note 2 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 v/m.Recommended separation distance between portable and mobile RF communications equipment and the Kodak DryView 5800 Laser ImagerThe Kodak DryView 5800 Laser Imager is intended for use in an electromagnetic environment in which radi-ated RF disturbances are controlled. The customer or the user of the Kodak DryView 5800 Laser Imager can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Kodak DryView 5800 Laser Imager as recommended below, according to the maximum output of the communications equipment.Rated maximum out-put power of transmit-ter (P) in Watts (W)Separation distance (d) according to frequency of transmitter in meters (m)150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.010.1110100For transmitters rated at a maximum output power not listed above, the recommended separation distance d 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.d1.17 P=d1.17 P=d2.33 P=
14 2G0734 June 7, 2007Safety and Related InformationEU Directives 93/42/EEC Title: Council Directive Concerning Medical Devices.99/05/EEC Title: Council Directive Concerning Radio and Telecommunications Terminal Equipment.73/23/EEC Title: Council Directive on the Harmonization of the Laws of Member States Relating to Electrical Equipment Designed for Use within Certain Voltage Limits.89/336/EEC Title: Council Directive on the Approximation of the Laws of the Member States Relating to Electromagnetic Compatibility.Recycling LabelIn the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to appropriate facilities for recovery and recycling. Contact your local Carestream Health, Inc. representative or refer to www.kodak.com/go/recycle for additional information on the collection and recovery programs available for this product.CE Marking Documents concerning the conformance of this product to Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices can be obtained from the Carestream Health, Inc. European Representative at:Carestream Health Deutschland GmbHHedelfinger Str. 6070327 Stuttgart, GermanyPhone: ++49 711 406 2993Fax: ++49 711 406 3513
Safety and Related InformationJune 7, 2007 2G0734 15Please Note The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health, Inc. reserves the right to change this information without notice and makes no warranty, express or implied, with respect to this information. Carestream Health, Inc. shall not be liable for any loss or damage, including consequential or special damages, resulting from the use of this information, even if loss or damage is caused by Carestream Health, Inc. negligence or other fault.Imager SpecificationsSee the Site Readiness for the Kodak DryView 5800 Laser Imager, 2G0735.
Carestream Health, Inc.150 Verona StreetRochester, New York 14608© Carestream Health, Inc., 2007DryView is a trademark of Carestream Health.Kodak is a trademark of Kodak used under license.Pub No. 2G0734Rev. ACatalog No. yyyyyyyy

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