U725700DRYVIEW 5700 Laser Imager

User’s Guide Carestream Health, Inc. 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2011 Pub No. 9G3886_en Rev. A i Table of Contents 1 Overview Major internal assemblies ............................................................................................................................... 1-2 How the laser imager works ............................................................................................................................ 1-3 Film sizes ........................................................................................................................................................ 1-4 Automatic image quality and processing .......................................................................................................... 1-4 Configuring and monitoring the system (using the Web Portal) ....................................................................... 1-4 Enhancing serviceability with remote monitoring ............................................................................................ 1-5 Agency compliance ......................................................................................................................................... 1-5 User guide conventions ................................................................................................................................... 1-5 2 Basic Operating Tasks Understanding the display screen .................................................................................................................... 2-2 Turning the power on and off .......................................................................................................................... 2-3 Working with film cartridges ........................................................................................................................... 2-5 Deleting pending jobs ..................................................................................................................................... 2-8 Making a test print .......................................................................................................................................... 2-8 Calibrating the laser imager for the installed film ............................................................................................ 2-9 Opening or removing a cover .......................................................................................................................... 2-9 Using the Web Portal to access additional functionality ................................................................................. 2-10 3 Maintenance and Troubleshooting Overview: Status and error messages and codes .............................................................................................. 3-1 Preventive maintenance ................................................................................................................................... 3-2 Error indicators on the display screen ............................................................................................................ 3-4 Using the Web Portal to gain more information on errors .............................................................................. 3-5 Subsystem error codes and messages .............................................................................................................. 3-5 Condition codes .............................................................................................................................................. 3-9 Correcting film jams ...................................................................................................................................... 3-14 Display Screen is not functional .................................................................................................................... 3-18 Calling for support ........................................................................................................................................ 3-18 4 Film Technical Information General description ......................................................................................................................................... 4-1 ii 5 Specifications Equipment Specifications ................................................................................................................................ 5-1 Operating Space Requirements ....................................................................................................................... 5-1 Environmental Requirements .......................................................................................................................... 5-1 Environmental Effects ..................................................................................................................................... 5-2 Power Requirements ....................................................................................................................................... 5-2 Network Requirements ................................................................................................................................... 5-2 Overview 2011-03-319G3886_en1-1 1Overview The Laser Imaging System is a continuous-tone laser imager with an internal photothermographic film processor. Heat, rather than photo chemicals, is used to develop the film. This easy-to-use and reliable laser imager provides high quality prints. Use the prints from this system for: • Diagnostic purposes to determine patient treatments • Referral, sharing, or educational purposes The system receives and prints from image sources such as medical electrical equipment (modalities) and workstations over the network. You can send print jobs simultaneously from multiple image sources. The open design lets you connect to modalities of all types and vendors. IMPORTANT: Install the printing system in a secure location to …

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Safety Manual Carestream Health, Inc. 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2011 Pub No. 9G3888_en Rev. A i Table of Contents Safety and Related Information Safety, Warnings, and Cautions .................................................................................................1-1 Safety Labels ......................................................................................................................... 1-4 Safety and Health Compliance...................................................................................................1-8 Safety..................................................................................................................................... 1-8 EMC ...................................................................................................................................... 1-9 EU Directives ...................................................................................................................... 1-14 CE Marking ......................................................................................................................... 1-14 Please Note .......................................................................................................................... 1-15 Imager Specifications ............................................................................................................... 1-15 Publication History ................................................................................................................... 1-15 2011-03-179G3888_en1 Safety and Related Information Safety, Warnings, and Cautions Please 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. 29G3888_en2011-03-17 Safety and Related Information CAUTION: 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 Information 2011-03-179G3888_en3 CAUTION: 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 imag…

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TÜV America Inc. Phone: (651) 638-0297 19333 Wild Mountain Road Fax: (651) 638-0298 Taylor Falls, MN 55084 E-mail: [email protected] www.TUVamerica.com Management Service • Product Service • Industry Service • Automotive • BABT TÜV America Inc. is a subsidiary of TÜV SÜD Group. TÜV SÜD AMERICA INC 19333 WILD MOUNTAIN ROAD TAYLORS FALLS, MINNESOTA 55084-1786 ENGINEERING STATEMENT For Certification of Carestream Health Inc DRYVIEW 5700 Laser Imager Model No: DRYVIEW 5700 Laser Imaging System FCC ID: U725700 FRN: 0016195265 IC: 7027A-5700 I am an Electromagnetic Compatibility Engineer for TÜV SÜD AMERICA INC, Taylors Falls, Minnesota. My education and experience are a matter of record with the Federal Communications Commission. TÜV SÜD AMERICA INC has been authorized by Ronald Cain, EMC Compliance Engineer, of Carestream Health Inc, to make Certification measurements of the above mentioned equipment. I attest that all testing done under my supervision was done in accordance with, and that the EUT fulfills the requirements of, the Federal Communications Commission's CFR 47 Part 209 and Industry Canada's RSS-210 Issue 8. Joel T. Schneider Senior Engineer Minnesota Wild River Lab TÜV SUD America Product Service Tel: 651 604 4582 Fax: 651 638 0298 [email protected] Dated: 04 May 2011

Carestrea Authorityto Act as Agent Date:4/20/11 AmericanCertificationBody,Inc. 6731 WhittierAvenue Suite ClIO McLean,VA 22101 To WhomIt May Concern: TUV SUD Americais authorizedto act on our behalf,until otherwisenotified,for applicationsto AmericanCertificationBody,Inc. (ACB). We certifythat we are not subjectto denialof federalbenefits,that includesFCC benefits,pursuantto Section5301 of the Anti-DrugAbuseAct of 1988,21U.S.C.862. Further,no party, as definedin 47 CFR 1.2002(b), to the applicationis subjectto denialof federalbenefits,that includesFCC benefits. Thankyou, AgencyAgreementExpirationDate:12/31/2011 By: ~Le:- (Signature) RonaldL. Cain (Print name) Title:EMC ComplianceEngineer On behalfof:CarestreamHealthInc. (CompanyName) Telephone:585-627-8321 091010-5

Carestream Requestfor Confidentiality Date: 4/20/2011 Subject:ConfidentialityRequestfor: U725700 Pursuantto FCC 47 CRF 0.457(d)and 0.459 and IC RSP-I00,Section10,the applicantrequeststhat a part of the subjectFCC applicationbe held confidential. o Permanent*1 X Permanent oPermanent oPermanent X Permanent Type of ConfidentialityRequested o Short TermX Permanent o Short Term oShort Term oShort Term oShort Term oShort Term oShort Term o Short Term oShort Term0Permanent* *Note:(InsertExplanationas Necessary) Exhibit Block Diagrams ExternalPhotos InternalPhotos OperationDescription/Theoryof Operation Parts List & Placement/BOM Tune-UpProcedure Schematics Test Setup Photos User'sManual CarestreamHealthInc. has spent substantialeffort in developingthis productand it is one of the first of its kind in industry.Havingthe subjectinformationeasily availableto "competition"wouldnegatethe advantagethey have achievedby developingthis product.Not protectingthe detailsof the designwill result in financialhardship. PermanentConfidentiality: The applicantrequeststhe exhibitslisted above as permanentlyconfidentialbe permanentlywithheldfrom public reviewdue to materialsthat containtrade secretsand proprietaryinformationnot customarilyreleasedto the public. Short-TermConfidentiality: The applicantrequeststhe exhibitsselectedabove as short term confidentialbe withheldfrom publicview for a periodof (specifynumberof days not to exceed180i_days from the date of the Grant of Equipment Authorizationand prior to marketing.This is to avoid prematurereleaseof sensitiveinformationprior to marketing or releaseof the productto the public.Applicantis also aware that they are responsibleto notify ACB in the event informationregardingthe productor the productis made availableto the public.ACB will then releasethe documentslisted above for publicdisclosurepursuantto FCC PublicNoticeDA 04-1705. NOTEfor IndustryCanadaApplications: The applicantunderstandsthat until such time that IC distinguishesbetweenShort Term and Permanent Confidentiality,either type of markedexhibitabove will simplybe markedConfidentialwhen submittedto IC. Sin=lY~ By:~~:EMCComplianceEngineer RonaldL. Cain I _The asteriskeditems (*) requirefurtherjustificationbefore permanentconfidentialitywill be allowed.These also currently requirereviewby the FCC under their Permit-But-Askpolicy before the grant is issued and can delay completionof an application.Furtherjustificationshouldbe added to the note above.One such examplefor apotted device would be: "The EUT isFULLYpotted using a non-removableepoxy based material.Removalof pottingmaterialcausesirreparable damageto internalcircuitry.Seephotographsexhibitsthat outlinethe device before and after potting." 2 _ Please refer to http://atcb.com/publicdocs/Memo-Short-Term-Vs-Standard-Confidentiality.pdffor completedetails. 091010- 5

Top View Bottom View Front View Back View Left Side Right Side

FCC & IC ID and label statement Data plate showing model number & company name DRYVIEW 5700 Label placement

MCS Board Front MCS Board Front – alternate view MCS Board Front - Rear Two pin connector on MCS to RF-Tag Antenna. RF-Tag Antenna Board Front RF-Tag Antenna Board Rear RF-Tag Antenna Components RF-Tag Antenna Components - Closeup RF-Tag Antenna Inside 5700 RF-Tag Board from left outside

TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 TEST RESULT SUMMARY FCC Part 15 Subpart C Section 15.207 FCC Part 15 Subpart C Section 15.209 IC RSS-210 Issue 8 IC RSS-Gen Issue 3 MANUFACTURER'S NAME Carestream Health Incorporated 150 Verona Street Rochester NY 14608 PRODUCT NAME DRYVIEW 5700 Laser Imaging System MODEL NUMBER(S) TESTED DRYVIEW 5700 Laser Imaging System SERIAL NUMBER(S) TESTED EM7 PRODUCT DESCRIPTION Laser Imager with a 13.56 MHz RFID TEST REPORT NUMBER WC1008566.3 TEST DATE(S) 10-13 December 2010 TÜV SÜD America Inc, as an independent testing laboratory, declares that the equipment tested as specified above conforms to the applicable EMC requirements of FCC Part 15 Subpart C Sections 15.207 “Conducted Limits” and 15.209 “Radiated emission limits; general requirements” and IC RSS-210 “Low-power License-exempt Radiocommunication Devices (All Frequency Bands): Category I Equipment” and IC RSS-Gen “General Requirements and Information for the Certification of Radiocommunication Equipment”. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical characteristics. Any modifications necessary for compliance made during testing on the above mentioned date(s) must be implemented in all production units for compliance to be maintained. Date: 24 January 2011 Location: Taylors Falls MN Greg S Jakubowski Joel T Schneider USA Senior EMC Technician Senior EMC Engineer Not Transferable TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 EMC TEST REPORT Test Report No. WC1008566.3 Date of issue: 24 January 2011 Product Name DRYVIEW 5700 Laser Imaging System Model(s) Tested DRYVIEW 5700 Laser Imaging System Serial No(s) Tested EM7 Product Description Laser Imager with 13.56 MHz RFID Manufacturer Carestream Health Incorporated 150 Verona Street Rochester NY 14608 Test Result „ Positive † Negative TÜV SÜD America Inc reports apply only to the specific samples tested under stated test conditions. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. TÜV SÜD America Inc shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD America Inc issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. This report shall not be used by the client to claim product endorsement by NVLAP, NIST, or any agency of the US government. TÜV SÜD America Inc and its professional staff hold government and professional organization certifications and are members of AAMI, ACIL, AEA, ANSI, IEEE, NARTE, and VCCI. Test Report WC1008566.31 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 REVISION RECORD REVISION TOTAL NUMBER OF PAGES DATE DESCRIPTION 31 24 January 2011 Initial Release Test Report WC1008566.32 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 D I R E C T O R Y Contents Revision Record 2 Directory 3 Test Regulations 4 Environmental Conditions 4 Power Supply 4 Test Equipment Traceability 4 Test Information General Field Strength Limits 0.009 – 30 MHz FCC 15.209(a), (c), IC RSS-210 2.5, RSS- GEN 7.2.5 5 Radiated Emissions 30 - 8000 MHz 15.209(c) & (f) , IC RSS-210 2.5 6 - 9 Occupied Bandwidth RSS-Gen 4.6.1 10 - 12 Conducted limits - AC Power Lines 15.207(a), IC RSS-Gen 7.2.4 13 - 14 Test area diagram 15 Test-setup Photos 16 - 19 Equipment Under Test Information 20 General Remarks, Deviations, Summary 21 Appendix A Carestream Health Incorporated EMC Test Plan, Document Part Number #: 8J5343 22 - 31 Test Report WC1008566.33 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 EMC TEST REGULATIONS: The tests were performed according to the following regulations: FCC Part 15 Subpart C Section 15.207 Paragraph (a) FCC Part 15 Subpart C Section 15.209 Paragraphs (a), (c), (f) IC RSS-210 Issue 8 Section 2.5 IC RSS-Gen Issue 3 Sections 4.6.1, 7.2.5 ENVIRONMENTAL CONDITIONS IN THE LAB Actual Temperature: : 21-23°C Atmospheric pressure : 98-100kPa Relative Humidity : 5-8% POWER SUPPLY UTILIZED Power supply system : 110 V / 60 Hz TEST EQUIPMENT All measurement instrumentation is traceable to the National Institute of Standards and Technology and is calibrated according to internal procedure. MEASUREMENT UNCERTAINTY The test system for conducted emissions is defined as the LISN, tuned receiver or spectrum analyzer, and coaxial cable. The test system has a measurement uncertainty of ±1.8 dB. The test system for radiated emissions is defined as the antenna, the pre-amplifier, the spectrum analyzer and the coaxial cable. The test system has a measurement uncertainty of ±4.8 dB. The equipment comprising the test systems is calibrated on an annual basis SIGN EXPLANATIONS † - not applicable „ - applicable Test Report WC1008566.34 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 General field strength limits 0.009 – 30 MHz FCC 15.209(a), FCC 15.209(c), IC RSS-210 2.5, RSS-Gen 7.2.5 Test summary The requirements are: „ - MET † - NOT MET Testing was performed in accordance with the test procedure of ANSI C63.4 2003, clause 8.2.2. Maximum field strength of the fundamental is -3.8 dBμV/m* or 0.646 μV/m at 30 meters at 13.56 MHz. Minimum margin of compliance of the fundamental is 33 dB. Maximum field strength of spurious emissions is -36 dBμV/m* or 0.015 μV…

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TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 TEST SETUP FOR EMISSIONS TESTING WILD RIVER LAB Large Test Site Notes: 1. Items shown in dotted lines are located on the floor below the test area. It is 5 meters vertically from the ground floor to the test area. 2. 50 Hz, 60 Hz, and 400 Hz are power panels for alternating current. 3. The antenna may be positioned horizontally 3, 10 or 30 meters from the center of the turntable. 4. The circle is a 6.7 meter diameter turntable. 5. A ground plane is in the plane of this sheet. 6. The test sample is shown in the azimuthal position representing zero degrees. EUT 0 90270 180 60 Hz 50 Hz 400 Hz Shielded Enclosure ANTENNA Test Report WC1008566.315 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 Test-setup photo(s): General Field Strength Limits 0.009 – 30 MHz Test Report WC1008566.316 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 Test-setup photo(s): Radiated Emissions 30 - 8000 MHz Test Report WC1008566.317 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 Test-setup photo(s): Radiated Emissions 30 - 8000 MHz Test Report WC1008566.318 of 31 TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 Test-setup photo(s): Conducted Emissions, AC lines, 150 kHz - 30 MHz Test Report WC1008566.319 of 31