U725950Film Printer for Medical Images using 13.56 MHz Transmitter RFID

Publication No. AA2204_en 2012-07-27 Preliminary User Manual SHORT TERM CONFIDENTIAL All 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 AA2204_en | 2012-07-27i Contents 1 Overview How the Imager Works ................................................................................................................. 1-4 Print Sequence ......................................................................................................................... 1-4 Film Sizes ........................................................................................................................................ 1-5 Mammography Imaging ............................................................................................................... 1-5 Automatic Image Quality and Processing .................................................................................... 1-6 Configure and Monitor the System (Using the Web Portal) ....................................................... 1-6 Enhanced Serviceability with Remote Monitoring ...................................................................... 1-6 Agency Compliance ....................................................................................................................... 1-6 User Guide Conventions ................................................................................................................ 1-7 2 Basic Operating Tasks The Display Screen ......................................................................................................................... 2-2 Imager Power ................................................................................................................................. 2-5 Power Switch Location ............................................................................................................ 2-5 Start the Imager ....................................................................................................................... 2-5 Emergency Shutdown or Power Loss ..................................................................................... 2-6 Restart the Imager ................................................................................................................... 2-6 View the Film Cartridge Information ...........................................................................................2-7 Replace an Empty Film Cartridge ................................................................................................. 2-9 Load a Different Film Size to Match a Print Request ................................................................ 2-10 Delete All Pending Jobs .............................................................................................................. 2-11 Calibrate the Imager for the Loaded Film ................................................................................. 2-12 Automatic vs. Manual Calibration ........................................................................................ 2-12 Make a Test Print ......................................................................................................................... 2-13 SMPTE Image Prints ............................................................................................................... 2-13 Mammography Test Prints .................................................................................................... 2-14 Open or Remove a Cover ............................................................................................................ 2-15 Access More Functionality with the Web Portal ........................................................................ 2-16 Access the Web Portal ........................................................................................................... 2-16 3 Maintenance and Troubleshooting Overview: Status and Error Messages and Codes ........................................................................ 3-2 Preventive Maintenance ............................................................................................................... 3-3 About the Charcoal Filter ........................................................................................................ 3-3 Replace the Filter ..................................................................................................................... 3-4 550 Code and Maintenance Symbol ....................................................................................... 3-5 SHORT TERM CONFIDENTIAL iiAA2204_en | 2012-07-27 Error Indicators on the Display Screen .........................................................................................3-6 Recognize and Handle a Calibration Error ............................................................................ 3-6 Handle a Required Restart ......................................................................................................3-7 Recognize and Handle a Film Jam .......................................................................................... 3-8 Using the Web Portal to Gain More Information on Errors ....................................................... 3-9 Subsystem Error Codes and Messages ........................................................................................ 3-10 DICOM (Digital Imaging and Communications in Medicine) .............................................. 3-10 Printer ..................................................................................................................................... 3-10 Film Cartridge ........................................................................................................................ 3-11 Job Manager .....................................................…

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

Publication No. AA2205_en 2012-07-27 Preliminary Safety Manual SHORT TERM CONFIDENTIAL 1–2AA2205_en | 2012-07-27 All 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 | 2012-07-27i Contents 1 Safety and Related Information Safety, Warnings, and Cautions .................................................................................................... 2 Safety Labels ............................................................................................................................ 5 System Labels ........................................................................................................................... 5 Safety and Health Compliance ..................................................................................................... 9 Safety Standards ...................................................................................................................... 9 EMC Standards ....................................................................................................................... 10 EU Directives .......................................................................................................................... 15 C E Marking ............................................................................................................................. 15 Publication History SHORT TERM CONFIDENTIAL SHORT TERM CONFIDENTIAL Safety and Related Information AA2205_en | 2012-07-27 1 1Safety and Related Information 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. For product specifications, see the User Manual. SHORT TERM CONFIDENTIAL Safety and Related Information 2AA2205_en | 2012-07-27 Safety, Warnings, and Cautions Please read and understand all instructions before using this product. DANGER 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, 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. 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. 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 an imager. This proximity includes any imager behind a wall adjacent to your location. Caution Do 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 Information AA2205_en | 2012-07-27 3 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. Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authori…

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

TÜV SÜD 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 TÜV SÜD AMERICA INC 19333 WILD MOUNTAIN ROAD TAYLORS FALLS, MINNESOTA 55084-1786 ENGINEERING STATEMENT For Certification of CARESTREAM HEALTH INC DRYVIEW 5950 Imaging System Model No: DRYVIEW 5950 Imaging System FCC ID: U725950 FRN: 0016195265 IC: 7027A-5950 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, 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 15.207, 15.209 and Industry Canada's RSS-210 Issue 8. Joel T. Schneider Senior Engineer Minnesota Wild River Lab TÜV SÜD America Product Service Tel: 651 604 4582 Fax: 651 638 0298 [email protected] Dated: 21 August 2012

Carestream Date 15/08/1012 BABTFCB ForsythHouse, ChurchfieldRoad, Walton-on-Thames, Surrey, KT122TD Dear Sir or Madam, We, CarestreamHealthInc. 150 VeronaSt, Rochester,NY 14608,hereby authorizeJoel Schneider,SeniorEMC Engineer,TUV-SUDAmericaInc., 19333Wild MountainRoad,TaylorsFalls,MN USA 55084-1786,to act as our agentin all mattersrelatingto applicationsfor equipmentauthorization,includingthe signingof all documentsrelatingto thesematters. This authorizationexpireson December31,2012. Sincerely, jlJ.IJ _I /)"--- ~/~C-~ CompanyOfficer: TelephoneNumber: Email: RonaldCain 585.627.8321 [email protected]

External Photos Front View SHORT TERM CONFIDENTIAL Rear View SHORT TERM CONFIDENTIAL Top View SHORT TERM CONFIDENTIAL Bottom View SHORT TERM CONFIDENTIAL Right Side View SHORT TERM CONFIDENTIAL Left Side View SHORT TERM CONFIDENTIAL

Rear view of DRYVIEW 5950 Laser Imaging System Showing label placement Placement of label with label statement FCC ID and IC ID. See page 2 for close- up of this label Placement of label with Model Number & company name. See page 3 for close- up of this label 1 0.5 0.26 5950 ERIC VRAA 2012-08-06 2012-08-06 AA3758 A B C D 1234 D C B A 1234 MM (INCH) 25.4 MM = 1 INCH TOLERANCES EXCEPT AS NOTED MM 0 ± .0 ± .00 ± ANGLES ± MATERIAL FINISH INCHES .0 ± .00 ± .000± DATE DATE DRFT ENG INTERPRET PER ASME Y14.5M-1994 THIRD ANGLE PROJECTION TITLE MODEL FSCM NO. SIZE DRAWING NO. DO NOT SCALE DRAWING REV SHT 11 OF DRA WING NO. OAKDALE, MN CARESTREAM HEALTH, INC. 0.5 SEENOTES SEENOTES AA3758 ERIC VRAA A LABEL- FCC STATEMENT, 5950 COMPLIES WITH 21 CFR 1040.10 AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE NO. 50, DATED JUNE 24, 2007 U725950 7027A-5950 French Can. ARTWORK FORAA3758 REV. A DIELINE F ORAA3758 REV. A AA3758.A 73 47.4 PMS White PMS Black DIE LINE LABELNOTES: COLORS ARE INDICATED AS PANTONE (PMS) VALUES, PROCESS COLORS MAY BE USED WITH PRIOR WRITTEN APPROVAL, SIGNATURE, AND PRINTED SAMPLES. NOTES: 1.MATERIAL: ITEM 1: 0.254 MM HIGH GLOSS POLYCARBONATE MANUFACTURER'S PART NUMBER: LEXAN 8010 COLOR: OPTICALLY CLEAR RAW MATERIALMANUFACTURER MUSTBE: SABIC INNOVATIVE PLASTICS WWW.GEPLASTICS.COM ITEM 2: ACRYLIC ADHESIVE WITH RELEASE LINER MANUFACTURER'S PART NUMBER: 3M 468MP RAW MATERIALMANUFACTURER MUSTBE: 3M INDUSTRIALADHESIVES AND TAPE WWW.3M.COM 2.LABELTO BE MADE PER ELECTRONIC ARTWORK SUPPLIED BY CARESTREAM HEALTH INC. 3. SUPPLIER ARTWORK TO BE APPROVED BYCARESTREAM HEALTH INC. OAKDALE ENGINEERING PRIOR TO PRINTING. 4.INSPECTION REQUIREMENTS, IF SHOWN ON DRAWING: A INDICATES PRIMARY INSPECTION DIMENSION. B. GEOMETRIC TOLERANCES ARE PRIMARY INSPECTION ATTRIBUTES. C. REFERENCE DIMENSIONS ARE ENCLOSED IN PARENTHESES ( ). DO NOT INSPECTREFERENCE DIMENSIONS. 5. SUPPLIER MUSTUSE ULRECOGNIZED PRINTING PROCESS PER UL STANDARD 969 (MARKING AND LABELING SYSTEMS [PGDQ2]). 6. CERTIFICATION OF COMPLIANCE: SUPPLIER MUSTINDICATE COMPLIANCE TO ULSTANDARD 969 AND THE FOLLOWING MUSTBE INCLUDED WITH SHIPMENT: A. ITEM 1 SUPPLIER'S NAME AND/OR TRADEMARK. B. D. CARESTREAM HEALTH INC. PART NUMBER AND REVISION. E . DATE OF PRODUCTION. F . PURCHASE ORDER NUMBER AND QUANTITY. G . LOTNUMBER. ITEM 1 MATERIAL GRADE DESIGNATION C. UL FILE NUMBER OF APPROVED PGDQ2 LABEL MANUFACTURER. REV ECO REVISION RECORD DESCRIPTION DESIGNERDATE ERIC VRAA ECN001174A 2012-08-06RELEASE TO PRODUCTION. 1.5 radius 4 places THIS IS AN UNPUBLISHED WORK THAT IS CARESTREAM HEALTH, INCORPORATED. RESTRICTED INFORMATION. DISCLOSURE, USE OR REPRODUCTION WITHOUT THE WRITTEN AUTHORIZATION OF CARESTREAM HEALTH, INCORPORATED IS PROHIBITED. IF PUBLICATION OCCURS, THE FOLLOWING NOTICE APPLIES: COPYRIGHT (c) 2012, CARESTREAM HEALTH, INCORPORATED. ALL RIGHTS RESERVED. ALTERNATE: GENERAL ELECTRIC LEXAN 8B35, 0.254 MIL, MATTE VELVET, POLYCARBONATE ALTERNATE: 467MP 201 2 7F3118.P Carestream Health, Inc. Rochester, NY 14608 150 Verona Street 200 - 240 ~ 4 50/60 1033869 59130050 9J2001 UL60601-1 锐珂（上海）医疗器材有限公司 上海市浦东新区金桥出口加工区川桥路1510号 第四、七幢通用厂房 邮编201206 YZB/5120-24A Medical Equipment DRYVIEW 5950 Laser Imaging System 1240342 2012 Month-yyyy / yymmdd 5950 Made in China by Rayco for B

Internal Photos Board Front View SHORT TERM CONFIDENTIAL Board Front – Inverted View SHORT TERM CONFIDENTIAL Board Rear SHORT TERM CONFIDENTIAL

RF Antenna Board Front View RF Antenna Board Rear View RF Tag Antenna Components RF Tag Antenna Components Alternate View RF Tag Antenna Inside DRYVIEW 5950 Top View RF Tag Antenna Inside DRYVIEW 5950 Bottom View

TÜV SÜD 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 16 August 2012 BABT FCB Forsyth House, Churchfield Road, Walton-on-Thames, Surrey, KT12 2TD RE: Declaration of Compliance to RF Exposure Limits for Humans Carestream Dryview 5950 RF Exposure Statement 1. Standard Applicable According to 1.1307 (b)(1) and IC RSS-102, systems operating under the provisions of this section shall be operated in a manner that ensures that the public is not exposed to radio frequency energy levels in excess of the published guidelines. This is a mobile device operating at 13.56 MHz range. 2. Measurement Result: This is a mobile device and the ERP is 5.7 x 10 -10 W. This is lower than low threshold 60/f GHz mW (4424 mW), d<2.5 cm, general population category. The SAR measurement is not necessary. 2.5.1 Exemption from Routine Evaluation Limits – SAR Evaluation SAR evaluation is required if the separation distance between the user and the radiating element of the device is less than or equal to 20 cm, except when the device operates as follows:  from 3 kHz up to 1 GHz inclusively, and with output power (i.e. the higher of the conducted or equivalent isotropically radiated power (e.i.r.p.) source-based, time- averaged output power) that is less than or equal to 200 mW for general public use and 1000 mW for controlled use; Joel T. Schneider Senior Engineer Minnesota Wild River Lab TÜV SÜD America Tel: 651 604 4582 Fax: 651 638 0298 [email protected]

TÜV SÜD AMERICA INC 19333 Wild Mountain Road Taylors Falls MN 55084 Tel: (651) 638-0297 Fax: (651) 638-0298 Rev. 113006 TEST REPORT FCC Part 15 Subpart C Section 15.207, 15.107 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 5950 Laser Imaging System MODEL NUMBER(S) TESTED DRYVIEW 5950 Laser Imaging System SERIAL NUMBER(S) TESTED EM7 PRODUCT DESCRIPTION Laser Imaging System TEST REPORT NUMBER WC1204476.1 TEST DATE(S) 10 July - 14 August 2012 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 Licence-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: 16 August 2012 Location: Taylors Falls MN Joel T Schneider Robert J Behringer USA Senior EMC Engineer EMC Engineer Not Transferable FCC ID: U725950 IC ID: 7027A-5950 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. WC1204476.1 Date of issue: 16 August 2012 Product Name DRYVIEW 5950 Laser Imaging System Model(s) Tested DRYVIEW 5950 Laser Imaging System Serial No(s) Tested EM7 Product Description Laser Imaging System Manufacturer Carestream Health Incorporated 150 Verona Street Oakdale MN 55128-344 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 WC1204476.11 of 25 FCC ID: U725950 IC ID: 7027A-5950 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 25 16 August 2012 Initial Release Test Report WC1204476.12 of 25 FCC ID: U725950 IC ID: 7027A-5950 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 - 1000 MHz FCC 15.209(c), (f). IC RSS-210 2.5 6 - 7 Occupied Bandwidth RSS-Gen 4.6.1 8 - 10 Conducted limits - AC Power Lines 15.207(a), 15.107(b), IC RSS-Gen 7.2.4 11 - 12 Test-setup Photos 13 - 15 Equipment Under Test Information 16 General Remarks, Deviations, Summary 17 Appendix A Carestream Health Incorporated EMC Test Plan, Document Part Number #: 9J5174 18 - 25 Test Report WC1204476.13 of 25 FCC ID: U725950 IC ID: 7027A-5950 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 §15.209 FCC Part 15 Subpart C Section 15.207 Paragraph (a) IC RSS-210 Issue 8 IC RSS-Gen Issue 3 ENVIRONMENTAL CONDITIONS IN THE LAB Actual Temperature: : 21-23°C Atmospheric pressure : 99kPa Relative Humidity : 62-63% POWER SUPPLY UTILIZED Power supply system : 60 Hz – 110/220 VAC 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. All measurement instrumentation is traceable to the National Institute of Standards and Technology and is calibrated according to internal procedure. SIGN EXPLANATIONS  - not applicable  - applicable Test Report WC1204476.14 of 25 FCC ID: U725950 IC ID: 7027A-5950 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 2009, clause 8.2.2. Maximum field strength of the fundamental is 15 dBV/m* or 5.62 V/m at 30 meters at …

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 photo(s): Test Report WC1204476.113 of 25 FCC ID: U725950 IC ID: 7027A-5950 SHORT TERM CONFIDENTIAL 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): Test Report WC1204476.114 of 25 FCC ID: U725950 IC ID: 7027A-5950 SHORT TERM CONFIDENTIAL 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): Test Report WC1204476.115 of 25 FCC ID: U725950 IC ID: 7027A-5950 SHORT TERM CONFIDENTIAL