U724900DRYVIEW Chroma Imaging System

CARESTREAM DRYVIEW CHROMA Imaging System Preliminary Safety Manual H210_0843AC Pub No. 9G4259_en Rev. 30 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2011 CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc. i Table of Contents Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1 Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4 English Text on Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4 Labels - Locations and Details - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4 Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 EMC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 EU Directives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11 CE Marking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11 Please Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12 Imager Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12 Publication History - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12 2011-03-019G4259_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 imager yourself to avoid exposure to dangerous voltage or other danger. Always call a qualified 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. •One power cord set is provided with this equipment. You must use an Agency-approved power cord with a plug type suitable for the country of use. 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. 29G4259_en2011-03-01 Safety and Related Information CAUTION: Double pole/neutral fusing. CAUTION: Do not use a cell phone within 2 m of this device. This proximity includes any imager behind a wall adjacent to your location. CAUTION: Do not use a microwave oven within 4 m of this device. 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 perform installation and service. CAUTION: This device is NOT to be located within the patient environment. Therefore, the equipment must not be located closer than 1.83 m from a patient bed or chair. 1.83 m Safety and Related Information 2011-03-019G4259_en3 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 without prior written approval of Carestream Health, Inc. 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. 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 device. CAUTION: Lithium batteries should only be replaced by a qualified service provider. The device uses…

Text truncated - open the document above for the full version.

CARESTREAM DRYVIEW CHROMA Imaging System Preliminary User’s Guide H210_0843AC Carestream Health, Inc. 150 Verona Street Rochester, New York 14608 © Carestream Health, Inc., 2011 Pub No. 9G4260_en Rev. 30 i Table of Contents Overview CHROMA Imager at your site ............................................................................................................................ 1-1 Intended Use .................................................................................................................................................... 1-1 Imager Features ............................................................................................................................................... 1-2 Film and paper sizes .................................................................................................................................. 1-2 Network interfaces ..................................................................................................................................... 1-2 Film throughput ......................................................................................................................................... 1-2 Power management features ...................................................................................................................... 1-2 Configuring and monitoring the system (using the Web Portal).................................................................. 1-2 Enhancing serviceability with remote monitoring ....................................................................................... 1-3 How the Imaging System works ........................................................................................................................ 1-4 System Components ......................................................................................................................................... 1-4 DICOM Interface ........................................................................................................................................ 1-4 Imager ....................................................................................................................................................... 1-5 Rear / Spindle ............................................................................................................................................ 1-6 Control Panel ............................................................................................................................................. 1-7 Screen view ................................................................................................................................................ 1-9 Using the Web Portal to access additional functionality .................................................................................. 1-12 Accessing the Web Portal ......................................................................................................................... 1-12 Agency Compliance ........................................................................................................................................ 1-13 User Guide Conventions ................................................................................................................................. 1-13 Working with Ink and Media Working with media (film or paper) ................................................................................................................ 2-1 Loading the media...................................................................................................................................... 2-1 Changing the media size in the imager ............................................................................................................. 2-9 Working with ink ........................................................................................................................................... 2-11 Extending the life of ink cartridges during periods of inactivity or low use ............................................... 2-11 Checking ink levels .................................................................................................................................. 2-12 Replacing ink cartridges .......................................................................................................................... 2-13 Replacing the maintenance tanks ............................................................................................................. 2-15 Settings, Maintenance and Troubleshooting Overview .......................................................................................................................................................... 3-1 Changing the date and time .............................................................................................................................. 3-2 ii Changing configuration items........................................................................................................................... 3-2 Entering maintenance mode ...................................................................................................................... 3-2 Exiting from maintenance mode ................................................................................................................ 3-2 Imager language ........................................................................................................................................ 3-2 Units of measurement ................................................................................................................................ 3-3 Temperature units ..................................................................................................................................... 3-3 Auto cleaning ..........................................................................................................................…

Text truncated - open the document above for the full version.

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 Chroma Laser Imager Model No: DRYVIEW Chroma Imaging System FCC ID: U724900 FRN: 0016195265 IC: 7027A-4900 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 15.209 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: 20 May 2011

Requestfor Confidentiality Date: 5/2/2011 Subject:ConfidentialityRequestfor: U724900 Pursuantto FCC 47 CRF 0.457(d)and 0.459 and IC RSP-IOO,Section10, the applicantrequeststhat a part of the subjectFCC applicationbe held confidential. D Permanent*1 X Permanent DPermanent D Permanent X Permanent Type of ConfidentialityRequested DShort TermX Permanent D Short Term D Short Term D Short Term D Short Term D Short Term D Short Term DShort Term D Short TermD Permanent* *Note:(InsertExplanationas Necessary) Exhibit Block Diagrams ExternalPhotos InternalPhotos OperationDescriptionlTheoryof 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. SinCerelY~!l/) By:r~4.(;~MCComplianceEngineer RonaldL. Cain 1 _ 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 a potted device would be: "The EUT is FULLYpotted using a non-removableepoxy based material.Removalof pottingmaterialcauses irreparable damageto internalcircuitry.See photographsexhibitsthat outlinethe device before and afterpotting." 2 _ Please refer to htur//atcb.com/publicdocs/Memo-Short-Term-Vs-Standard-Confidentiality.pdffor completedetails.

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

Top Bottom Front Back Right Side Left Side

FCC / IC Label COMPANY NAME AND MODEL NUMBER Label Location Close-up showing model number Close-up showing Company name

FCC / IC Label COMPANY NAME AND MODEL NUMBER Label Location

Chroma RF-Tag Enclosure Inside Imager Chroma RF-Tag Enclosure Inside Imager – Alternate View Chroma RF-Tag Board Enclosure Chroma RF-Tag Board in Enclosure Chroma RF-Tag Board Components Side Chroma RF-Tag Board Components Side – Closer View Chroma RF-Tag Board Coupler Side

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 Chroma Imaging System MODEL NUMBER(S) TESTED DRYVIEW Chroma Imaging System SERIAL NUMBER(S) TESTED MP2E001273 PRODUCT DESCRIPTION Imaging system with a 13.56 MHz RFID TEST REPORT NUMBER WC1100177.2 Rev A TEST DATE(S) 28 January – 15 February and 10 March 2011 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: 30 March 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. WC1100177.2 Rev A Date of issue: 30 March 2011 Product Name DRYVIEW Chroma Imaging System Model(s) Tested DRYVIEW Chroma Imaging System Serial No(s) Tested MP2E001273 Product Description Imaging system with a 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 WC11000177.2 Rev A1 of 44 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 44 10 March 2011 Initial Release A 44 30 March 2011 Correcting Test Report Number from WC110177.2 to WC1100177.2. Test Report WC11000177.2 Rev A2 of 44 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 - 8 Occupied Bandwidth RSS-Gen 4.6.1 9 - 11 Conducted limits - AC Power Lines 15.207(a), IC RSS-Gen 7.2.4 12 - 26 Test area diagram 27 Test-setup Photos 28 - 32 Equipment Under Test Information 33 General Remarks, Deviations, Summary 34 Appendix A Carestream Health Incorporated EMC Test Plan, PART #: 8J5350 VERSION # 0.1 35 - 44 Test Report WC11000177.2 Rev A3 of 44 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: : 22°C Atmospheric pressure : 98kPa Relative Humidity : 18% 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 WC11000177.2 Rev A4 of 44 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, IC 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 5.0 dBμV/m* or 1.78 μV/m at 30 meters at 13.56 MH…

Text truncated - open the document above for the full version.

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 WC11000177.2 Rev A27 of 44 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 WC11000177.2 Rev A28 of 44 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 WC11000177.2 Rev A29 of 44 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 WC11000177.2 Rev A30 of 44 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 WC11000177.2 Rev A31 of 44 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): 99% Occupied bandwidth Test Report WC11000177.2 Rev A32 of 44