Carestream Health 5950 Film Printer for Medical Images using 13.56 MHz Transmitter RFID User Manual 5950 Safety

Carestream Health, Inc. Film Printer for Medical Images using 13.56 MHz Transmitter RFID 5950 Safety

Contents

User Manual II

Publication No. AA2205_en2012-07-27Preliminary Safety ManualSHORT TERM CONFIDENTIAL
1–2 AA2205_en | 2012-07-27All 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.SHORT TERM CONFIDENTIAL
AA2205_en | 2012-07-27 iContents1 Safety and Related InformationSafety, Warnings, and Cautions .................................................................................................... 2Safety Labels ............................................................................................................................ 5System Labels ........................................................................................................................... 5Safety and Health Compliance ..................................................................................................... 9Safety Standards ...................................................................................................................... 9EMC Standards ....................................................................................................................... 10EU Directives .......................................................................................................................... 15CE Marking ............................................................................................................................. 15Publication HistorySHORT TERM CONFIDENTIAL
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Safety and Related InformationAA2205_en | 2012-07-27 11Safety 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.SHORT TERM CONFIDENTIAL
Safety and Related Information2AA2205_en | 2012-07-27Safety, 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 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.DANGERThis 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.CautionDo not use a cell phone within 2 m of an imager. This proximity includes any imager behind a wall adjacent to your location.CautionDo not use a microwave oven within 4 m of an 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.SHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 3CautionDo 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. It is not intended to be connected directly outside the building. 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.CautionFederal law prohibits dispensing without a prescription.CautionThis 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.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 imager. SHORT TERM CONFIDENTIAL
Safety and Related Information4AA2205_en | 2012-07-27CautionIn 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 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.ImportantInstall the printing system in a secure location to protect patient privacy rights if required by local regulations.SHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 5Safety LabelsSafety labels are attached to the 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: System LabelsSerial Number and Model Number This label shows the serial number and model number of the imager along with other important data items. (The label shown above is an example serial plate label.)Symbol on label DefinitionModel NumberSerial NumberCAT NumberManufactured DateManufactured BySHORT TERM CONFIDENTIAL
Safety and Related Information6AA2205_en | 2012-07-27Laser Radiation WarningTable 1: Laser specificationsHigh Voltage WarningThis 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 degrees, maximum: 32 degreesSHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 7Back Panel and Agency StatementsFigure 1: Laser Imager Back Panel 3143625Item Label Description1 FCC compliance Provides FCC ID and Industry Canada, describes compliance.2 Product States that the imager is a Laser Imaging Printer.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 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 imager. These panels may only be removed by an Authorized Service Provider.•Radio Frequency Energy. Indicates that the imager can radiate radio frequency energy. If not installed and used in accordance with the instructions, the imager may cause harmful interference to radio communications.•Class 1 Laser. Indicates that the imager complies with IEC requirements for Class 1 Laser systems.4 Grounding reliabilityStates that grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.”SHORT TERM CONFIDENTIAL
Safety and Related Information8AA2205_en | 2012-07-27Hot SurfaceFigure 2: Hot Surface Labels This label indicates that you must use care where the label is installed to avoid possible burns.4 Japanese import licenseAllows importation into Japan.6 Power cord inlet Covers the power cord inlet when shipped from manufacturing. Shows the voltage at which the imager must be operated. The label is removed or moved during installation.Item Label DescriptionSHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 9Safety 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 I Code 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• ANSI/AAMI ES60601-1 (2005+C1+A2)• UL 60601-1 Ed. 2 (1998): 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.Canada• CAN/CSA - C22.2 NO 60601-1 (2008): 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.Europe• EN60601-1 Ed. 3 (2006): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.• EN60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification, requirements and user's guide.Rest of World• IEC 60601-1 Ed. 2 (1998) - Medical electrical equipment - Part 1: General requirements for safety.• IEC 60601-1 Ed. 3 (2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.• IEC 60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification, requirements and user's guide.SHORT TERM CONFIDENTIAL
Safety and Related Information10 AA2205_en | 2012-07-27EMC 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 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: U725950”Canada• 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-5950”• 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.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.SHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 11Guidance 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 system 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 equipment.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 buildings 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 buildings used for domestic purposes.Voltage fluctuations and flicker emissions:• EN61000-3-3• IEC 61000-3-3CompliesImmunity Test IEC 60601 Test Level Compliance 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.SHORT TERM CONFIDENTIAL
Safety and Related Information12 AA2205_en | 2012-07-27Surge:• 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 % Uτ1 (>95 % dip in Uτ) for 0.5 cycle40 % Uτ (60 % dip in Uτ) for 5 cycles70 % Uτ (30 % dip in Uτ) for 25 cycles<5 % Uτ (>95 % dip in Uτ) for 5 sec.<5 % Uτ (>95 % dip in Uτ) for 0.5 cycle40 % Uτ (60 % dip in Uτ) for 5 cycles70 % Uτ (30 % dip in Uτ) for 25 cycles<5 % Uτ (>95 % dip in Uτ) for 5 sec.Mains power quality should be that of a typical commercial or hospital environment. If the user of the Imager requires continued operation during power mains interruptions, it is recommended that the 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.1. Uτ is the a.c. mains voltage prior to application of the test levelImmunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment— GuidanceSHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 13Guidance and Manufacturer’s Declaration for Electromagnetic ImmunityThe 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.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 TestIEC 60601 Test LevelCompliance Level Electromagnetic Environment—GuidanceConducted RFIEC 61000-4-63 Vrms150 kHz–80 MHz3 Vrms d = 1.17 √ PRadiated RFIEC 61000-4-33 v/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 survey1, should be less than the compliance level in each frequency range2.Interference may occur in the vicinity of equipment marked with the following symbol: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.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.2. Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.SHORT TERM CONFIDENTIAL
Safety and Related Information14 AA2205_en | 2012-07-27Recommended 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 MHz d = 1.17 √ P80 MHz–800 MHz d = 1.17 √ P800 MHz–2.5 GHz d = 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 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.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.SHORT TERM CONFIDENTIAL
Safety and Related InformationAA2205_en | 2012-07-27 15EU Directives• 93/42/EEC Title: Council Directive Concerning Medical Devices• 1999/5/CE Title: Council Directive Concerning Radio Equipment and Telecommunications Terminal EquipmentFigure 3: Recycling Label In 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 MarkingDocuments 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 France 1, rue Galilée 93192 NOISY-LE-GRAND CEDEX FRANCESHORT TERM CONFIDENTIAL
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Publication HistoryAA2205_en | 2012-07-27 17Publication HistoryRevision Date Reason for ChangeA 2012-07-27 Preliminary - for Gate 2 (preliminary) reviewSHORT TERM CONFIDENTIAL
Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 United States© Carestream Health, Inc., 2012Printed in China.CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc.Pub No. AA2205_en Rev A (preliminary)SHORT TERM CONFIDENTIAL

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