Carestream Health 5700 DRYVIEW 5700 Laser Imager User Manual 9G3888 en A

Carestream Health, Inc. DRYVIEW 5700 Laser Imager 9G3888 en A

Contents

User Manual 2

Safety Manual
Carestream Health, Inc.150 Verona StreetRochester, New York 14608© Carestream Health, Inc., 2011Pub No. 9G3888_enRev. A
iTable of Contents Safety and Related InformationSafety, Warnings, and Cautions ................................................................................................. 1-1Safety Labels......................................................................................................................... 1-4Safety and Health Compliance ................................................................................................... 1-8Safety..................................................................................................................................... 1-8EMC ...................................................................................................................................... 1-9EU Directives ...................................................................................................................... 1-14CE Marking......................................................................................................................... 1-14Please Note.......................................................................................................................... 1-15Imager Specifications ............................................................................................................... 1-15Publication History................................................................................................................... 1-15
2011-03-17 9G3888_en 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 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.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.CAUTION:Do not use a cell phone within 2 m of a laser imager. This proximity includes any imager behind a wall adjacent to your location.
2 9G3888_en 2011-03-17Safety and Related InformationCAUTION:Do not use a microwave oven within 4 m 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 qualified personnel may provide installation and service. CAUTION: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 G.CAUTION:Do not substitute or modify any part of this equipment.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.
Safety and Related Information2011-03-17 9G3888_en 3CAUTION:Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.CAUTION:Do not use isopropyl alcohol to clean the exterior surfaces of 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. CAUTION:Lithium 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 WARNING:The 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.
4 9G3888_en 2011-03-17Safety and Related InformationSafety Labels Safety labels are attached to the laser imager in compliance with international standards.English Text on Labels Some 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 DefinitionModel NumberSerial NumberCAT NumberManufactured DateManufactured By
Safety and Related Information2011-03-17 9G3888_en 5LabelsThis label shows the serial number and model number of the laser imager along with other important data items. (The label shown above is an example serial plate label.)Laser Radiation Warning LabelsLaser SpecificationsHigh Voltage Warning LabelThis 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.7F3118.ECarestream Health, Inc.Rochester, NY 14608TM: DryViewDryView 6800680005017F23016551576August 2007, 2007 08100/120/200/220/240V12/12/7/7/7A50/60Hz311346 3JZTDryView Laser Imager 1Class 3B invisible laser radiation. This label states: “When open and interlocks defeated, avoid exposure to the beam.”2 Hazard symbolType Scanning (moving) laser beam emitting from a diodeWavelength 810 +/- 10 nanometersMaximum power 120 milliwattsBeam divergence from Laser DiodeMinimum: 5 degrees, maximum: 32 degrees
6 9G3888_en 2011-03-17Safety and Related InformationLaser Imager Back PanelAgency Statements31326541Product Label. This label states that the imager is a Laser Imaging Printer.2Agency Symbols and Class 1 Laser Safety. High voltage. Indicates that high voltage is present under panels where the label is attached. Only an Authorized 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.3Grounding Reliability. This label states that grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.”4Japanese Import License5FCC Compliance. Provides FCC ID and Industry Canada; describes compliance. NOTE: This label is not applicable for the 5700C Laser Imager. 6Power Cord Inlet. Covers the power cord inlet when shipped from manufacturing. Shows the voltage at which the laser imager must be operated. The label is removed or moved during installation.
Safety and Related Information2011-03-17 9G3888_en 7Hot Surface LabelsThis label indicates that you must use care where the label is installed to avoid possible burns.
8 9G3888_en 2011-03-17Safety 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 StatesCanadaEuropeRest of WorldFDA 21CFR 807 Subpart E - Premarket Notification Procedures.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 ProductsUL 60601-1: Medical electrical equipment - Part 1: General requirements for safety.IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification, requirements and user’s guide.CAN/CSA - C22.2 NO 60601-1 Ed. 2 - Medical electrical equipment - Part 1: General requirements for safety.IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification, requirements and user’s guide.EN60601-1 Ed. 2 - Medical electrical equipment - Part 1: General requirements for safety.EN60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification, requirements and user's guide.IEC 60601-1 Ed. 2 - Medical electrical equipment - Part 1: General requirements for safety.IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
Safety and Related Information2011-03-17 9G3888_en 9EMC United StatesCanadaEuropeRest of WorldFCC 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 protection against harmful interference in a residential installation.FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices: Intentional Radiators. “FCC ID: U725700”CAN/CSA-C22.2 NO. 60601-1-2-08 Medical Electric Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.Intentional Radiation “IC: 7027A-5700”This Class A digital apparatus complies with Canadian ICES-003.CET APPAREIL NUM ENRIQUE DE CLASSE A EST CONFORME A LA NORME NMB-003 DU CANADA.This Class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.EN60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.
10 9G3888_en 2011-03-17Safety and Related InformationEurope and the Rest of WorldGuidance and Manufacturer’s Declaration for Electromagnetic EmissionsThe Laser Imaging 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 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 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 Laser Imager is suitable for use everywhere, including those establishments directly connected 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 Laser Imager is suitable for use everywhere, including those establishments directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Safety and Related Information2011-03-17 9G3888_en 11Guidance and Manufacturer’s Declaration for Electromagnetic ImmunityThe 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 LevelCompliance Level Electromagnetic Environment - GuidanceElectrostatic discharge (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 covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burst:• EN61000-4-4•IEC 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 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% U * (>95% dip in Ut*) for 0.5 cycle40% U * (60% dip in U *) for 5 cycles70% U * (30% dip in U *) for 25 cycles<5% U * (>95% dip in U *) for 5 sec.<5% U * (>95% dip in U *) for 0.5 cycle40% U * (60% dip in U *) for 5 cycles70% U * (30% dip in U *) for 25 cycles<5% U * (>95% dip in U *) for 5 sec.Mains power quality should be that of a typical commercial or hospital environment. If the user of the Laser Imager requires continued operation during power mains interruptions, 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 commercial or hospital environment.* U is the a.c. mains voltage prior to application of the test level.
12 9G3888_en 2011-03-17Safety and Related InformationGuidance and Manufacturer’s Declaration for Electromagnetic ImmunityThe 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 LevelCompliance Level Electromagnetic Environment - GuidancePortable and mobile RF communications equipment should be used no closer to any part of the Laser Imager, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Conducted RFIEC 61000-4-63 Vrms150 kHz–80 MHz3 VrmsRadiated RFIEC 61000-4-33 v/m80 MHz–2.5 GHz3 v/m 80 MHz–800 MHz800 MHz–2.5 GHzd 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 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: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.aSee NOTE 1 on the top of the next page.bSee NOTE 2 on the top of the next page.d1.17 P=d1.17 P=d2.33 P=
Safety and Related Information2011-03-17 9G3888_en 13Note 1 Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast 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 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.Note 2 Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.Recommended separation distance between portable and mobile RF communications equipment and the Laser ImagerThe Laser Imager is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Laser Imager can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Laser Imager as recommended below, according to the maximum output of the communications equipment.Rated maximum output power of transmitter (P)in Watts (W)Separation distance (d) according to frequency of transmitter in meters (m)150 kHz–80 MHz 80 MHz–800 MHz 800 MHz–2.5 GHz0.010.1110100For 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.Guidance and Manufacturer’s Declaration for Electromagnetic Immunityd1.17 P=d1.17 P=d2.33 P=
14 9G3888_en 2011-03-17Safety and Related InformationEU Directives 93/42/EEC Title: Council Directive Concerning Medical Devices.1999/5/CE Title: Council Directive Concerning Radio Equipment and Telecommunications Terminal Equipment.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.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 France1, rue Galilée93192 NOISY-LE-GRAND CEDEXFrance
Safety and Related Information2011-03-17 9G3888_en 15Please Note The 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.SpecificationsSee the User’s Guide.Publication HistoryRevision Date Reason for ChangeA2011-03-17 First release

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