T652160000Symphony Staining System

Ventana Medical Systems SYMPHONY System Operator Manual FCC COMPLIANCE INFORMATION SYMPHONY SYSTEM FCC COMPLIANCE This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. WARNING! Changes or modifications not expressly approved by Ventana Medical Systems, Inc could void the user's authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ƒ Reorient or relocate the receiving antenna. ƒ Increase the separation between the equipment and receiver. ƒ Connect the equipment into an outlet on a circuit different from that which the receiver is connected. ƒ Consult the dealer or an experienced radio/TV technician for help.

S S y y m m p p h h o o n n y y O O p p e e r r a a t t o o r r M M a a n n u u a a l l SYMPHONY TM Operator Manual A User’s Guide to Installing, Configuring, Operating, and Troubleshooting the SYMPHONY System Part Number 1488600 Revision A Ventana Medical Systems Copyright © 2006 Ventana Medical Systems, Inc., 1910 Innovation Park Drive, Tucson, Arizona 85755 All rights reserved. Ventana Medical Systems’ technical documentation and its product(s) described herein are protected by one or more U.S. copyrights, patents, foreign patents, or pending applications. No part of this publication may be reproduced or transmitted into any human or computer language in any form, or by any means stored in a retrieval system, transmitted, redistributed, translated or disclosed to third parties, or de-compiled in any way including, but not limited to, photocopy, photograph, electronic, mechanical, magnetic or manual means without the expressed written permission of Ventana Medical Systems, Inc., or its licensors, if any. All copies of this publication, so authorized, shall include the full text of this copyright notice. Civilian Agencies Restricted Rights: Use, reproduction or disclosure is subject to restrictions set forth in subparagraph (a) through (d) of the Commercial Computer Software Restricted Rights clause at 52.227-19, as applicable, and the limitations set forth in Ventana Medical Systems’ standard license agreements for software and technical documentation. U.S. Government Users Restricted Rights: Use, duplication, or disclosure by the Government is subject to restrictions set forth in FAR 52.227.19(c)(2) or subparagraph (c)(1)(ii) of the Rights in Technical Data and Computer Software clause at DFARS 252.227-7013 and/or in similar or successor clauses in the FAR or the DOD or NASA FAR Supplement. Unpublished rights reserved under the copyright laws of the United States. Ventana Medical Systems products are licensed products and are protected by one or more U.S. or foreign patents or pending applications. The product licenses convey the right to use only those specific products, components, modules, features and/or functions specified in the license agreement or contract. This publication may mention or reference products, components, modules, features and/or functions that are not part of the base product, package of products, or particular license agreement. The customer is not entitled to the receipt of, or use of, any other products, components, modules, features and/or functions that may be referenced in any documentation provided to customer unless the appropriate license fees are paid and an appropriate license agreement is duly executed. Ventana Medical Systems' obligations with respect to its products and services are governed solely by the contracts and/or agreements under which they are provided. This publication is furnished for informational use only and should not be construed as a commitment by Ventana Medical Systems, Inc. The information contained in this publication could include inaccuracies, obsolete information, or typographical errors. Every effort has been made to make this publication as complete and accurate as possible, but it is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Ventana Medical Systems may make improvements and/or changes in the program(s), product(s), and/or applications described in this publication at any time and without notice and, as such, information published in this document may be or may become obsolete. The trademarks or registered trademarks of Ventana Medical Systems are listed in the chapter of this manual that covers Intellectual Property. Third-party products, services, or company names referenced in this document may be trademarked or copyrighted by their respective owners, and are for identification purposes only. Copyrights, trademarks and license agreements shall be governed and construed in accordance with the laws of the State of Arizona and the Federal Arbitration Act, and shall benefit Ventana Medical Systems, its successors, and assigns. Ventana Medical Systems SYMPHONY System Operator Manual Page 1 Table of Contents PREFACE ........................................................................................................................................ 7 SAFETY INFORMATION .............................................................................................................9 SYMPHONY SYSTEM SAFETY COMPLIANCE................................................................................................... 9 SAFETY TRAINING........................................................................................................................................... 9 REAGENT HANDLING..................................................................................................................................... 10 SAFETY LABELS............................................................................................................................................. 11 Caution: Hot Surface—Do Not Touch............................................................................................... 11 Caution: Refer to Accompanying Documents................................................................................. 11 Caution: Laser....................................................................................................................................... 11 Caution: Risk of Electric Shock......................................................................................................... 11 INTRODUCING THE SYMPHONY PROCESS™ AND SOLUTIONS..................................... 13 SYMPHONY INSTRUMENT AND OPERATION OVERVIEW ............................................... 17 SYSTEM OPERATION..............................................................…

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Northwest EMC TCB Compliance Opinion Rev. 9/15/03 VENT0023 Information about the Applicant Company Name Ventana Medical Systems, Inc. Grantee Bill Richards Address 1910 E. Innovation Park Drive City, State, Zip Tucson, AZ 85737 Job Number vent0023 Model Symphony Staining System FCC ID T652160000 Agent Northwest EMC, Inc. Approval Type Original Equipment Class DXT Part 15, Low Power Transceiver, Rx Verified Rule Part 15.225 Overview This radio is installed in the Ventanna Symphony system, which is a high volume tissue slide staining system. It utilizes RFID technology with a module manufactured by Secura Key, A Division of Soundcraft. The radio transmits at 13.56MHz at a low output power. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature 5/24/2006 Dave Tolman, TCB Committee

NORTHWEST EMC, INC. 22975 NW Evergreen Parkway, Suite 400 Hillsboro, OR 97124 May 8, 2006 Dear Application Examiner: On behalf of Ventana Medical Systems, Inc., Northwest EMC Inc is submitting this application for the certification of the Symphony (TM) Slide Staining System, FCC ID: T652160000. The Symphony system is a high volume tissue slide staining system. It utilizes RFID technology with a module manufactured by Secura Key, A Division of Soundcraft. The radio transmits at 13.56MHz at a low output power. The RF functionality is per ISO/IEC 15693 protocols. The radio is part of the Symphony system which will be permanently installed in a hospital laboratory setting. The device will be connected to a dedicated facility power line. The radio utilizes a four different PCB etch antennas. This configuration satisfies the requirements of 47 CFR 15.203. The technical reports and exhibits demonstrate compliance with FCC rules 47 CFR 15.225. Your efforts in reviewing this application are greatly appreciated. Best regards, Northwest EMC, Inc.

NORTHWEST EMC Internal Photos PSA 2006.03.02 NORTHWEST EMC Internal Photos PSA 2006.03.02 NORTHWEST EMC Internal Photos PSA 2006.03.02

Date: May 4, 2006 To: Whom it may concern Subject: TCB Certification of Ventana Medical Systems, Inc model Symphony instrument Antenna information Information regarding the Symphony instrument antenna(s) is as follows: a. The Symphony employs four antennas which are internal to the system and are not accessible to the operator. b. The device is not a Part 15.247 transmitter c. Four PC board antennas are contained within the system as follows: i. Assy, PCB, Limonene Antenna, Ventana Medical Systems, Inc P/N 2142400 ii. Assy, PCB, Coverslipper Antenna, Ventana Medical Systems, Inc P/N 2137500 iii. Assy, PCB, Reagent Drawer Board A, Ventana Medical Systems, Inc P/N 2137000 iv. Assy, PCB, Reagent Drawer Board B, Ventana Medical Systems, Inc P/N 2217100 Bill Richards Electrical Engineering Fellow Ventana Medical Systems, Inc Ventana Medical Systems, Inc. 1910 Innovation Park Drive Tucson, Arizona 85737 Telephone: 520-887-2155 Toll Free: 800-227-2155 www.ventanamed.com Ventana Symphony Mult iplexed RFID Antennas May 10, 2006 W. Richards, Ventana Medical Systems, Inc. RFID Transceiver P/N 2142400 P/N 2137500 P/N 2137000P/N 2137000 P/N 2217100 Assy, PCB, Reagent Drawer Board A, V entana Medical Systems, Inc P/N 2137000 Six antennas, two boards per system, gain = unity. Assy, PCB, Reagent Drawer Board B, V entana Medical Systems, Inc P/N 2217100 Four antennas, one board per system, gain = unity. Assy, PCB, Coverslipper Antenna, Vent ana Medical Systems, Inc P/N 2137500 Two antennas, one board per system, gain = unity. Assy, PCB, Limonene Antenna, Vent ana Medical Systems, Inc P/N 2142400 One Antenna, one board per system, gain = unity.

Ventana Medical Systems, Inc. Symphony Slide Staining System RFID March 15, 2006 Report No. VENT0023 Report Prepared By www.nwemc.com 1-888-EMI-CERT © 2006 Northwest EMC, Inc 22975 NW Evergreen Parkway Suite 400 Hillsboro, Oregon 97124 Certificate of Test Issue Date: March 15, 2006 Ventana Medical Systems, Inc. Model: Symphony Slide Staining System RFID Emissions Test Description Specification Test Method Pass Fail Radiated Spurious Emissions FCC 15.209(a):2005-9 ANSI C63.4:2003 Conducted Emissions FCC 15.107 Class B:2005-10 ANSI C63.4:2003 Field Strength of Fundamental FCC 15.225(a) Field Strength of Fundamental:2005-9 ANSI C63.4:2003 Frequency Stability FCC 15.225(c) Frequency Stability:2005-9 ANSI C63.4:2003 Modifications made to the product See the Modifications section of this report Test Facility The measurement facilities used to collect the data is located at: Northwest EMC, Inc. 22975 NW Evergreen Parkway, Suite 400; Hillsboro, OR 97124 Phone: (503) 844-4066 Fax: 844-3826 Northwest EMC, Inc. 41 Tesla; Irvine, CA 91618 Phone: (949) 861-8918 Fax: 861-8923 These site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada. Approved By: Dean Ghizzone, President This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested, the specific description is noted in each of the individual sections of the test report supporting this certificate of test. Northwest EMC Revision History Revision 05/05/03 Revision Number Description Date Page Number 00 None Northwest EMC Accreditations and Authorizations Revision 03/18/05 FCC: Accredited by NVLAP for performance of FCC radio, digital, and ISM device testing. Our Open Area Test Sites, certification chambers, and conducted measurement facilities have been fully described in reports filed with the FCC and accepted by the FCC in letters maintained in our files. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by the FCC as a Telecommunications Certification Body (TCB). This allows Northwest EMC to certify transmitters to FCC specifications in accordance with 47 CFR 2.960 and 2.962. NVLAP: Northwest EMC, Inc. is accredited under the United States Department of Commerce, National Institute of Standards and Technology, and National Voluntary Laboratory Accreditation Program for satisfactory compliance with the requirements of ISO/IEC 17025 for Testing Laboratories. The NVLAP accreditation encompasses Electromagnetic Compatibility Testing in accordance with the European Union EMC Directive 89/336/EEC, ANSI C63.4, MIL- STD 461E, DO-160D and SAE J1113. Additionally, Northwest EMC is accredited by NVLAP to perform radio testing in accordance with the European Union R&TTE Directive 1999/5/EEC, the requirements of FCC, and the RSS radio standards for Industry Canada. NVLAP LAB CODE 200629-0 NVLAP LAB CODE 200630-0 NVLAP LAB CODE 200676-0 Industry Canada: Accredited by NVLAP for performance of Industry Canada RSS and ICES testing. Our Open Area Test Sites and certification chambers comply with RSS 212, Issue 1 (Provisional) and have been filed with Industry Canada and accepted. Northwest EMC has been accredited by ANSI to ISO / IEC Guide 65 as a product certifier. We have been designated by NIST and recognized by Industry Canada as a Certification Body (CB) per the APEC Mutual Recognition Arrangement (MRA). This allows Northwest EMC to certify transmitters to Industry Canada technical requirements. CAB: Designated by NIST and validated by the European Commission as a Conformity Assessment Body (CAB) to conduct tests and approve products to the EMC directive and transmitters to the R&TTE directive, as described in the U.S. - EU Mutual Recognition Agreement. TÜV Product Service: Included in TUV Product Service Group's Listing of Recognized Laboratories. It qualifies in connection with the TUV Certification after Recognition of Agent's Testing Program for the product categories and/or standards shown in TUV's current Listing of CARAT Laboratories, available from TUV. A certificate was issued to represent that this laboratory continues to meet TUV's CARAT Program requirements. Certificate No. USA0401C. TÜV Rheinland: Authorized to carryout EMC tests by order and under supervision of TÜV Rheinland. This authorization is based on "Conditions for EMC-Subcontractors" of November 1992. Northwest EMC Accreditations and Authorizations Revision 03/18/05 NEMKO: Assessed and accredited by NEMKO (Norwegian testing and certification body) for European emissions and immunity testing. As a result of NEMKO's laboratory assessment, they will accept test results from Northwest EMC, Inc. for product certification (Authorization No. ELA 119). Technology International: Assessed in accordance with ISO Guide 25 defining the general international requirements for the competence of calibration and testing laboratories and with ITI assessment criteria LACO196. Based upon that assessment, Interference Technology International, Ltd., has granted approval for specifications implementing the EU Directive on EMC (89/336/EEC and amendments). The scope of the approval was provided on a Schedule of Assessment supplied with the certificate and is available upon request. Australia/New Zealand: The National Association of Testing Authorities (NATA), Australia has been appointed by the ACA as an accreditation body to accredit test laboratories and competent bodies for EMC standards. Accredited test reports or assessments by competent bodies must carry the NATA …

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NORTHWEST EMC FIELD STRENGTH OF FUNDAMENTAL XMit 2006.03.01 NORTHWEST EMC FIELD STRENGTH OF FUNDAMENTAL XMit 2006.03.01 NORTHWEST EMC FIELD STRENGTH OF FUNDAMENTAL XMit 2006.03.01 NORTHWEST EMC FIELD STRENGTH OF FUNDAMENTAL XMit 2006.03.01 NORTHWEST EMC FREQUENCY STABILITY XMit 2006.03.01 NORTHWEST EMC FREQUENCY STABILITY XMit 2006.03.01 NORTHWEST EMC OCCUPIED BANDWIDTH XMit 2006.03.01 NORTHWEST EMC RADIATED SPURIOUS EMISSIONS XMit 2006.03.01