1、Safety ManualCarestream Health, Inc.150 Verona StreetRochester, New York 14608 Carestream Health, Inc., 2011Pub No. 9G3888_enRev. ATable of ContentsSafety and Related InformationSafety, Warnings, and Cautions . 1-1Safety Labels. 1-4Safety and Health Compliance . 1-8Safety. 1-8EMC 1-9EU Directives 1-
2、14CE Marking. 1-14Please Note 1-15Imager Specifications . 1-15Publication History. 1-15iSafety 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 ca
3、n 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 a
4、uthorized 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. Con
5、nect 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
6、 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
7、 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.2011-03-17 9G3888_en 1Safety and Related InformationCAUTION:Do not use a microwave oven within 4 m of a laser imager. Electromagnetic radiation from a
8、 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
9、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 devi
10、ces. 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 w
11、here 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
12、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 U
13、ser 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.2 9G3888_en 2011-03-17Safet
14、y and Related InformationCAUTION:Changes or modifications not expressly approved by the party responsible for compliance could void the users 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 fil
15、ters 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 de
16、termine 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 cal
17、endar 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. EPAs RCRA does not regulate disposal of this lithium battery. Users should discard spent batteries in municipal trash unless their comm
18、unity 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 withou
19、t 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.2011-03-17 9G3888_en 3Safety and Related InformationSafety Labels Safety
20、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
21、 NumberManufactured DateManufactured By4 9G3888_en 2011-03-17Safety and Related InformationLabelsThis 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
22、 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 7F3118.ECarestream Health, Inc.Rochester, NY 14608TM: DryViewDryView 6800680005017F23016551576August 2007, 2007 08
23、100/120/200/220/240V12/12/7/7/7A50/60Hz311346 3JZTDryView Laser Imager 1 Class 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 nanometersMaximu
24、m power 120 milliwattsBeam divergence from Laser DiodeMinimum: 5 degrees, maximum: 32 degrees2011-03-17 9G3888_en 5by an Authorized Service Provider.Safety and Related InformationLaser Imager Back PanelAgency Statements31326541 Product Label. This label states that the imager is a Laser Imaging Prin
25、ter.2 Agency 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 str
26、ap 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 ima
27、ger may cause harmful interference to radio communications.Class 1 Laser. Indicates that the laser imager complies with IEC requirements for Class 1 Laser systems.3 Grounding Reliability. This label states that grounding reliability can only be achieved when the equipment is connected to an equivale
28、nt receptacle marked “Hospital Only” or “Hospital Grade.”4 Japanese Import License5 FCC Compliance. Provides FCC ID and Industry Canada; describes compliance. NOTE: This label is not applicable for the 5700C Laser Imager. 6 Power Cord Inlet. Covers the power cord inlet when shipped from manufacturin
29、g. Shows the voltage at which the laser imager must be operated. The label is removed or moved during installation.6 9G3888_en 2011-03-17Safety and Related InformationHot Surface LabelsThis label indicates that you must use care where the label is installed to avoid possible burns.2011-03-17 9G3888_
30、en 7Safety 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
31、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
32、 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 users guide.CAN/CSA - C22.2 NO 60601-1 Ed. 2 - Medical ele
33、ctrical equipment - Part 1: General requirements for safety.IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1: Equipment classification, requirements and users guide.EN60601-1 Ed. 2 - Medical electrical equipment - Part 1: General requirements for safety.EN60825-1 Ed. 2 (2007): Safety of l
34、aser products - Part 1: Equipment classification, requirements and users 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 users guide.8 9G3888_en 20
35、11-03-17Safety and Related InformationEMC 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 purs
36、uant 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-
37、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 CONF
38、ORME 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
39、 and Tests.IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests.2011-03-17 9G3888_en 9Safety and Related InformationEurope and the Rest of WorldGuidance and Manufacturers Declaration for
40、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: EN5501
41、1 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 othe
42、r 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 t
43、he 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 pow
44、er supply network that supplies buildings used for domestic purposes.10 9G3888_en 2011-03-17Safety and Related InformationGuidance and Manufacturers Declaration for Electromagnetic ImmunityThe Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user o
45、f 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): EN61000-4-2IEC 61000-4-26 kV contact8 kV air6 kV contact8 kV airFloors should be wood, concrete, or ceramic
46、tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burst: EN61000-4-4IEC 61000-4-42 kV for power supply lines1 kV for input/output lines2 kV for power supply lines1 kV for input/output linesMains power quality should be that of
47、 a typical commercial or hospital environment.Surge: EN61000-4-5IEC 61000-4-51 kV differential mode2 kV common mode1 kV differential mode2 kV common modeMains power quality should be that of a typical commercial or hospital environment.Voltage dips, short interruptions and voltage variations on powe
48、r supply lines: EN61000-4-11IEC 61000-4-1195% dip in Ut*) for 0.5 cycle40% U * (60% dip in U *) for 5 cycles70% U * (30% dip in U *) for 25 cycles95% dip in U *) for 5 sec.95% dip in U *) for 0.5 cycle40% U * (60% dip in U *) for 5 cycles70% U * (30% dip in U *) for 25 cycles95% dip in U *) for 5 se
49、c.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: EN61000-4-8IEC 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.2011-03-17 9G3888_en 11Safety and Related Informatio
