Carestream Health 6950 Laser Imager User Manual AB3145

Carestream Health, Inc. Laser Imager AB3145

User Manual

Publication No. AB3145_en2014-06-09Safety Manual
All rights reserved. No part of this manual may be reproduced or copied in any form by any mean graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems without written permission.
AB3145_en | 2014-06-09 iContentsSafety and Related InformationSafety, Warnings, and Cautions....................................................................................................... 1Safety Labels ............................................................................................................................... 4System Labels .............................................................................................................................. 5Safety and Health Compliance ........................................................................................................ 8Safety Standards ......................................................................................................................... 8EMC Standards............................................................................................................................ 8EU Directives ............................................................................................................................. 16Publication History
AB3145_en | 2014-06-09 1Safety and Related InformationThe information contained herein is based on the experience and knowledge relating to the subject matter gained by the manufacturer prior to publication.No patent license is granted by this information.The manufacturer reserves the right to change this information without notice and makes no warranty, express or implied, with respect to this information. The manufacturer 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 the manufacturer’s negligence or other fault.For product specifications, see the User Manual.Safety, Warnings, and CautionsPlease read and understand all instructions before using this product.DANGERThis 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 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.• A power cord is provided with this equipment. All countries must use an agency-approved power cord with plug type suitable for the country of use. Contact a qualified dealer for help.• Do not operate equipment with the covers open.DANGERThis 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.
Safety, Warnings, and Cautions2AB3145_en | 2014-06-09DANGERThis 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.CautionThe operator must not touch or have contact simultaneously with the patient and the laser imaging system.CautionDo not use a cell phone within 2.0 m (6.6 ft) of a laser imager. This proximity includes any imager behind a wall adjacent to your location.CautionDo not use a microwave oven within 4.0 m (13.1 ft) 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.CautionDo 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.CautionThis equipment uses a DICOM network port, and is intended to connect to other medical devices over the network. It is not intended to be connected directly to other medical devices. Only qualified personnel may provide installation and service.CautionThis 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 G.CautionDo not substitute or modify any part of this equipment.
Safety, Warnings, and CautionsAB3145_en | 2014-06-09 3CautionThis 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.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.CautionChanges or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.CautionDo not use isopropyl alcohol to clean the exterior surfaces of the laser imager.CautionIn 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.CautionLithium batteries should only be replaced by an authorized service provider. 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. EPA’s 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 WarningThe equipment uses an invisible laser beam with a maximum power of 120 milliwatts. Laser radiation may be present when the machine operates without the rear cover installed. Covers with this label may only be removed by an authorized service provider. USE OF CONTROLS OR ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN, MAY RESULT IN EYE DAMAGE.
Safety, Warnings, and Cautions4AB3145_en | 2014-06-09Safety LabelsSafety labels are attached to the laser imager in compliance with international standards.English Text on LabelsSome names on the labels are shortened and left in English. Below is a key to understand the meanings of the shortened words on the labels: Symbol on label Definition Model Number Serial Number CAT Number Part Number Manufactured Date Manufactured By Operator must read the user documentation Consult instructions for use Attention! Consult accompanying documents
Safety, Warnings, and CautionsAB3145_en | 2014-06-09 5System LabelsLaser Radiation Warning Table 1: Laser specificationsHigh Voltage Warning This warning label indicates that high voltage is present under panels or enclosures where labels are attached. These panels may only be removed by an authorized service provider.1Class 3B invisible laser radiation. This label states: “When open and interlocks defeated, avoid exposure to the beam.”2Hazard symbolType Scanning (moving) laser beam emitting from a diodeWavelength 810 ±10 nanometersMaximum power 120 mWBeam divergence from Laser DiodeMinimum: 5 °, maximum: 32 °
Safety, Warnings, and Cautions6AB3145_en | 2014-06-09Back Panel and Agency StatementsFigure 1: Laser Imager Back PanelItem Label Description1 FCC compliance Describes compliance, if applicable for the country of installa-tion.2 Product States that the imager is a Laser Imaging Printer.
Safety, Warnings, and CautionsAB3145_en | 2014-06-09 7Hot and Sensitive Surface LabelsFigure 2: Drum labels: Hot Surface and Sensitive Surface (No Sharp Objects in this Vicinity)This label indicates that you must use care where the label is installed:• Hot surface! Take care to avoid possible burns.• Sensitive coating! Do not use abrasive or sharp objects around the drums.3 Agency labels and Class 1 Laser Safety•High voltage. Indicates that high voltage is present under panels where the label is attached. Only an autho-rized service provider should attempt access.•Static Sensitive Equipment. Identifies static-sensitive components. Connect a personal grounding strap to the appropriate ground before servicing this laser imager. These panels may only be removed by an authorized service provider.•Radio Frequency Energy. 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.•Class 1 Laser. Indicates that the laser imager complies with IEC requirements for Class 1 Laser systems.4 Grounding reliability States that grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.”5 Japanese import licenseAllows importation into Japan.6 Serial plate Shows the serial number and model number of the imager along with other important data items. 7 Power cord inlet Covers the power cord inlet when shipped from manufactur-ing. Shows the voltage at which the laser imager must be operated. The label is removed or moved during installation.8 Safety sign ISO 7010–M002Indicates that the operator must read the user documenta-tion.Item Label Description
Safety and Health Compliance8AB3145_en | 2014-06-09Safety 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 StandardsUnited States• 21 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 ProductsSection 10 - Laser Products• UL 60601-1:2003 - Medical Electrical Equipment. General Requirement for Safety.• ANSI/AAMI ES60601-1:2005 - Medical Electrical Equipment. Part 1: General requirements for basic safety and essential performance.CanadaCSA C22.2 NO 60601-1 CAN/CSA:2008 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.EuropeEN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.International• IEC 60601-1:1988 - Medical Electrical Equipment. General Requirement for Safety.• IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.• IEC 60825-1:2007 - Safety of laser products - Part 1: Equipment classification and requirements.EMC StandardsUnited States• 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
Safety and Health ComplianceAB3145_en | 2014-06-09 9provide reasonable protection against harmful interference in a commercial or light industrial installation.• FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices:Intentional Radiators. “FCC ID: U726950”RF Exposure Guidance: This equipment complies with FCC radiation exposure limitsset forth for an uncontrolled environment. This transmitter must not be co-located oroperating in conjunction with any other antenna or transmitter, except in accordancewith FCC multi-transmitter product procedures.Canada• CAN/CSA-C22.2 NO. 60601-1-2-08 Medical Electric Equipment - Part 1-2: Generalrequirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and Tests.• Intentional Radiation “IC: 7027A-6950”• This device complies with Industry Canada licence-exempt RSS standard(s). Operationis subject to the following two conditions: (1) this device may not cause interference,and (2) this device must accept any interference, including interference that maycause undesired operation of the device.• Le présent appareil est conforme aux CNR d'Industrie Canada applicables auxappareils radio exempts de licence. L'exploitation est autorisée aux deux conditionssuivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur del'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage estsusceptible d'en compromettre le fonctionnement.•Under Industry Canada regulations, this radio transmitter may only operate using anantenna of a type and maximum (or lesser) gain approved for the transmitter byIndustry Canada. To reduce potential radio interference to other users, the antennatype and its gain should be so chosen that the equivalent isotropically radiated power(e.i.r.p.) is not more than that necessary for successful communication.• Conformément à la réglementation d'Industrie Canada, le présent émetteur radiopeut fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur)approuvé pour l'émetteur par Industrie Canada.• This Class A digital apparatus complies with Canadian ICES-003 (A).• CET APPAREIL NUM ENRIQUE DE CLASSE A EST CONFORME A LA NORME NMB-003(A) DU CANADA.• This Class A digital apparatus meets all requirements of the CanadianInterference-Causing Equipment Regulations.EuropeEN60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.Rest of WorldIEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.•
Safety and Health Compliance10 AB3145_en | 2014-06-09Guidance and Manufacturer’s Declaration for Electromagnetic EmissionsThe system is intended for use in the electromagnetic environment specified below. The customer or user of the system should ensure that it is used in such an environment.Guidance and Manufacturer’s Declaration for Electromagnetic ImmunityThe system 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.Emissions Test Compliance Electromagnetic Environment— GuidanceRF emissions:• EN55011•CISPR 11Group 1 The system 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 equip-ment.RF emissions:• EN55011•CISPR 11Class A The system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies build-ings used for domestic purposes.Harmonics emissions:• EN61000-3-2• IEC 61000-3-2Class AThe system is suitable for use everywhere, including those establishments directly connected to the public low-voltage power supply network that supplies build-ings used for domestic purposes.Voltage fluctuations and flicker emissions:• EN61000-3-3• IEC 61000-3-3CompliesImmunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environ-ment— 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, con-crete, or ceramic tile. If floors are covered with synthetic material, the relative humid-ity 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/output lines±2 kV for power sup-ply lines±1 kV for input/out-put linesMains power quality should be that of a typical commer-cial or hospital environment.
Safety and Health ComplianceAB3145_en | 2014-06-09 11Surge:• 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 commer-cial 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 cycles70 % 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 commer-cial or hospital environment. If the user of the laser imager requires continued operation during power mains interrup-tions, it is recommended that the laser imager be powered from an uninterruptible power supply or a battery.Power frequency (50/60 Hz) magnetic field:• EN61000-4-8• IEC 61000-4-83 A/m 3 A/m Mains power quality should be that of a typical commer-cial or hospital environment.* UT is the a.c. mains voltage prior to application of the test levelImmunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environ-ment— Guidance
Safety and Health Compliance12 AB3145_en | 2014-06-09Guidance and Manufacturer’s Declaration for Electromagnetic ImmunityThe system 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.Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment— GuidanceConducted RFIEC 61000-4-63Vrms150 kHz–80 MHz3Vrms d=1.17√PRadiated RFIEC 61000-4-33v/m80 MHz–2.5 GHz3 v/m d = 1.17 √ P 80 MHz to 800 MHzd = 2.33 √ P 800 MHz to 2.5 GHzwhere 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 manufacturer.Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range†.Interference may occur in the vicinity of equipment marked with the following sym-bol: NoteAt 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.* Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, ama-teur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro-magnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the laser imager is used exceeds the applicable RF compliance level above, the 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 laser imager.† Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.
Safety and Health ComplianceAB3145_en | 2014-06-09 13Additional Guidance and Manufacturer’s Declaration–Electromagnetic Emissions/ImmunityElectromagnetic 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 document.Communications EquipmentPortable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment EMC performance.Replacement of Cables, Accessories, or TransducersThe use of cables, accessories or transducers other than those specified in this document with the exception of transducers or cables 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.Other EquipmentThe System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the System should be observed to verify normal operation in the configuration in which it will be used.Shielded LocationsThe System is fully compliant with the requirements of IEC 60601-1-2 without being located in a shielded room.
Safety and Health Compliance14 AB3145_en | 2014-06-09External Cables ListingDescription Length Shielded?Cable, Category 5E, Shielded RJ45 to RJ45, Patch Cord, 4 Pair2.1 m (7.0 ft) YesCord Assembly, Power, China 2.5 m (8.2 ft) NoCord Assembly, Power, Continental Europe Schuko 2.5 m (8.2 ft) NoCord Assembly, Power, India/South Africa 2.5 m (8.2 ft) NoCord Assembly, Power, North American 3.0 m (10.0 ft) NoCord Assembly. Power, UK, Fused 2.5 m (8.2 ft) No
Safety and Health ComplianceAB3145_en | 2014-06-09 15Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the SystemThe system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the system as recommended below, according to the maximum output of the communications equipment. Rated Maximum Output Power of Transmitter (P) Separation Distance (d) According to Frequency of TransmitterWatts Meters150 kHz–80 MHzd=1.17√P80 MHz–800 MHzd=1.17√P800 MHz–2.5 GHzd=2.33√P0.01 0.12 0.12 0.240.10 0.37 0.37 0.741.00 1.17 1.17 2.3310.003.703.707.37100.00 11.70 11.70 23.30For transmitters rated at a maximum output power not listed above, the recommended sepa-ration distance d in meters (m) can be estimated using the equation applicable to the fre-quency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NoteAt 80 MHz and 800 MHz, the separation distance for 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.
Safety and Health Compliance16 AB3145_en | 2014-06-09EU Directives• 93/42/EEC Title: Council Directive Concerning Medical Devices.• 1999/5/CE Title: Council Directive Concerning Radio Equipment and Telecommunications Terminal Equipment.Figure 3: Recycling LabelIn the European Union, this symbol indicates that when the last user wishes to discard this product, it must be sent to the appropriate facilities for recovery and recycling. Contact your local authorized representative for additional information.Authorized European Representative Carestream Health France1, rue Galilée93192 NOISY-LE-GRAND CEDEXFRANCEImporter for European UnionCarestream Health Netherlands B.V.Bramenberg 123755 BZ EemnesThe Netherlands
AB3145_en | 2014-06-09 17Publication HistoryRevision Date Reason for ChangeA 2014-04-30 First releaseB 2014-06-09 Draft, with additional FCC and RF guidance. Added cables listing.
Carestream Health150 Verona StreetRochester, NY 14608USA© Carestream Health, Inc., 2014Made in the USA.Pub. No. AB3145_enRev. B

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