WXY-GLEDLR Series Transmitter

Installation and User’s Guide GLED-600 (Sagittal) GLED-800 (Crosshair) Table of Contents Introduction and Intended Use ....................................................................... 3 Definitions ....................................................................................................... 4 Safety Information .......................................................................................... 4 Storage and Transportation ........................................................................... 4 Environmental Limits ...................................................................................... 4 Location of Labels .......................................................................................... 5 Operator Controls .......................................................................................... 6 Pre-Installation ...........................................................................................7-11 Installation Requirements .............................................................................. 8 Typical Room Layout ......................................................................................9 Room Preparation .........................................................................................10 Installation ............................................................................................... 13-18 Side Optical Aligner Installation................................................................13-14 Second Side Aligner Installation .................................................................. 16 Installation on Angled Walls ......................................................................... 17 Ceiling Aligner Installation ............................................................................ 18 Sagittal Aligner Installation ........................................................................... 20 Remote Control ........................................................................................21-29 Optical Aligner Adjustments .................................................................... 30-32 Maintenance & Cleaning................................................................................32 Troubleshooting .......................................................................................33-34 Repair and Parts Information .................................................................. 35-37 Replacing the LED ....................................................................................... 35 Dismantling and Disposal ............................................................................ 36 Parts List ...................................................................................................... 37 Specifications ................................................................................................38 Technical Support ........................................................................................ 40 Product Warranty ......................................................................................... 40 NOTE: Installation Template was shipped with your patient positioning unit. For replacement template, please use Gammex part number: 007882 3 Dear Valued Customer Congratulations on your recent purchase of a Gammex Optical Alignment System! This optical alignment system product is the result of over 40 years of continuous quality improvement of alignment technologies. If, after carefully reading this manual, you have any questions, please contact our Sales and Service Department at 1-800-Gammex 1 or 1-800-426-6391. Introduction This Installation and User’s Guide includes the information you will need to safely and efficiently install, operate and maintain your medical alignment system. This guide is only intended for use with Gammex AccuChrom 3 models GLED-800 (Crosshair) and GLED–600 (Sagittal). Intended Use These optical alignment products are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. They are intended to be used in medical clinic or hospital settings by trained medical staff. The optical alignment products are not designed to be used around flammable anesthetics, which present a risk of explosion or fire. The optical alignment products are not intended to be used in a sterile or corrosive environment. No other uses are intended nor implied. 4 Storage and Transportation • Do not drop • Non-corrosive environment • Storage Temperature: -20 to +40° C (-4 to +104° F) • Storage Humidity: 0 to 85% relative humidity (no dew nor condensation) Environmental Limits: • Operating Temperature: +5 to +35° C (+41 to +95° F) • Operating Humidity: 0 to 85 % relative humidity (no dew nor condensation) • No flammable anesthetics • No corrosives General Safety Signal words are used according to international standards. The meanings of these signal words are: DANGER- Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. This signal word is to be limited to the most extreme situations. WARNING- Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION- Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. Permitted for property damage only accidents. Sagittal - Single vertical line projecting Crosshair - Crossed line projecting Iso-center - Center point where the X, Y and Z planes coincide. Indicates user to consult accompanying document This symbol indicates that when the end-user wishes to discard this product, it must be sent to a separate collection facility for recovery and recycling. Caution - Optical Radiation Risk of eye damage. Do not stare directly at light source. 5 Location of labels Safety labels are located i…

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FCC ID: WXY-GLED D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 January 6, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for Gammex Inc., an AccuChrom-3 Remote Control, Model Number: GLED-RC, with an FCC ID: WXY-GLED for Certification. This unit has been tested and complies to Part 15, Subpart C. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Section 15.231. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: 1/6/2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: WXY-GLED Pursuant to 47 CFR Section 0.459 Gammex Inc. understands that requests for non disclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459: • Block Diagram • Schematics • Description of Operation The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. Gammex Inc. understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

166 South Carter Street, Genoa City, WI 53128 Letter of Agency Date: January 6, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To Whom It May Concern: Please be advised that Gammex Inc. authorizes D.L.S. Electronic Systems, Inc. to act on their behalf, until otherwise notified, for applications submitted to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Signatory, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 FCC Labeling Requirements and Information Date: January 6, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: FCC Labeling Requirements FCC ID: WXY-GLED The following label information is required by the FCC Rules and Regulations for certified devices. Also attached, please find marketing information required by the FCC Rules and Regulations. Thank you for your attention to these matters. Sincerely, William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Modification Letter Date: January 6, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: WXY-GLED Please be advised that the following information is a list of modifications that will be included in the production process for the above-referenced equipment. Change 1: There were no modifications made during testing. Change 2: Change 3: Change 4: Change 5: Change 6: Change 7: Change 8: Change 9 Change 10: Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc. 166 South Carter Street, Genoa City, WI 53128 Manufacturer’s Letter Date: January 6, 2011 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: WXY-GLED To Whom It May Concern: Please be advised that the manufacturer will ensure that the above-referenced model will be manufactured in accordance with the FCC Rules and Regulations. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

Company: Gammex Inc. Model: GLED-RC Photo Description: Side 1 Company: Gammex Inc. Model: GLED-RC Photo Description: Side 2 Photo Description: Side 3 Company: Gammex Inc. Model: GLED-RC Photo Description: Side 4 Photo Description: Side 5 Company: Gammex Inc. Model: GLED-RC Photo Description: Side 6 Company: Gammex Inc. Model: GLED-RC Photo Description: Battery Cover Removed Company: Gammex Inc. Model: GLED-RC Photo Description: Batteries Removed

Gammex 1 REF 2 REF THIS DRAWING IS REFERENCE ONLY REFER TO BROTHER LABEL FILE 007934-00-01 FOR ACTUAL LABEL REV.DATEPCNREVISIONREV BYCHK BYAPPR BY 0112/03/101458JCORRECTED IC ID # AND ADDED IC TEXTSPDSAMDJS SPD MATERIAL White Brother Label SIZE A TOTAL SHEETS 2:1 SCALE DRAWING NO. ( PART-SHT-REV ) DATE DRAW BY PCN CHECK BY APPR BY STANDARD TOLERANCES UNLESS OTHERWISE NOTED INCHES X.X = .020 X.XX = .010 X.XXX = .005 = 1 THIRD ANGLE PROJECTION STANDARD UNITS TITLE AccuChrom This drawing and the ideas embodied herein represent the confidential and propietary intellectual property of Gammex and may be protected by copyrights, patents, trade secrets, know-how and other confidential or proprietary information. Reproduction or any use of this drawing is expressly prohibited without prior written permission of Gammex and then only on the condition that this notice be included in any such reproduction. N:\Prototype\AccuChrom3\PCN 1458 AccuChrom3\PCN 1458J\SW - Labels\ A B C 3 2 1 Label/ID IC 1 SAM 007934-00-01 05/19/10 1458H DJS

5 Location of labels Safety labels are located in two places on the Optical Aligner: 1) On the Optical Aligner back plate 2) Bottom outside of housing 3) Back of remote control Labels Optical Radiation Caution/Read Accompanying Material

Company: Gammex Inc. Model: GLED-RC Photo Description: Back Cover Removed Company: Gammex Inc. Model: GLED-RC Photo Description: Board Removed from Shell Company: Gammex Inc. Model: GLED-RC Photo Description: Close-up of Shell Company: Gammex Inc. Model: GLED-RC Photo Description: Board Side 1 Photo Description: Board Side 2

166 South Carter, Genoa City, WI 53128 Page 1 of 25 Company: Gammex, Inc. Model Tested: GLED-RC Report Number: 16630 Project Number: 4058 i. Cover Page Code of Federal Regulations 47 Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.231 Periodic operation in the band 40.66 - 40.70 MHz and above 70 MHz THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: AccuChrom-3 Remote Control Kind of Equipment: Standalone battery operated handheld transmitter Frequency Range: 433.92 MHz Test Configuration: Battery operated transmitter tested for intentional radiated emissions in three orthogonal planes. Model Number(s): GLED-RC Model(s) Tested: GLED-RC Serial Number(s): none (Test Sample) Date of Tests: November 15-19, 2010 Test Conducted For: Gammex, Inc. 7600 Discovery Drive Middleton, WI 53562-0327, USA NOTICE: “This test report relates only to the items tested and must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Description of Test Sample" page listed inside of this report. © Copyright 1983 - 2010 D.L.S. Electronic Systems, Inc. COPYRIGHT NOTICE This report must not be reproduced (except in full), without the approval of D.L.S. Electronic Systems, Inc. 166 South Carter, Genoa City, WI 53128 Page 2 of 25 Company: Gammex, Inc. Model Tested: GLED-RC Report Number: 16630 Project Number: 4058 ii. Signature Page SIGNAT URE PAGE Report By: Adam Alger Test Engineer Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager 166 South Carter, Genoa City, WI 53128 Page 3 of 25 Company: Gammex, Inc. Model Tested: GLED-RC Report Number: 16630 Project Number: 4058 iii. Table of Contents Table of Contents i. Cover Page .......................................................................................................................................1 ii. Signature Page .................................................................................................................................2 iii. Table of Contents .............................................................................................................................3 iv. NVLAP Certificate of Accreditation ...............................................................................................4 1.0 Summary of Test Report ..................................................................................................................5 2.0 Introduction ......................................................................................................................................5 3.0 Test Facilities ...................................................................................................................................5 4.0 Description of Test Sample ..............................................................................................................6 5.0 Test Equipment ................................................................................................................................7 6.0 Test Arrangements ...........................................................................................................................7 7.0 Test Conditions ................................................................................................................................8 8.0 Modifications Made To EUT For Compliance ................................................................................8 9.0 Additional Descriptions ...................................................................................................................8 10.0 Results ..............................................................................................................................................8 11.0 Conclusion .......................................................................................................................................8 Appendix A – Test Photos ...........................................................................................................................9 Appendix B – Measurement Data ..............................................................................................................13 1.0 Emission Bandwidth – 20 dB ................................................................................................... 13 2.0 Automatic Deactivation ............................................................................................................ 15 3.0 Field Strength of Emissions – Fundamental and Spurious ....................................................... 17 4.0 Duty Cycle Correction .............................................................................................................. 19 166 South Carter, Genoa City, WI 53128 Page 4 of 25 Company: Gammex, Inc. Model Tested: GLED-RC Report Number: 16630 Project Number: 4058 iv. NVLAP Certificate of Accreditation 166 South Carter, Genoa City, WI 53128 Page 5 of 25 Company: Gammex, Inc. Model Tested: GLED-RC Report Number: 16630 Project Number: 4058 1.0 Summary of Test Report It was determined that the Gamm ex, Inc. AccuChrom-3 Remote Control, Model GLED-RC, complies with the requirements of CFR 47 Part 15 Subpart C Section 15.231. Subpart C Section 15.231 Applicable Technical Requirements Tested: Section Description Procedure Note Compliant? 15.231(c) 20 dB Emission Bandwidth ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.231(a)(1) Automatic Deactivation ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.231(b) Field Strength of Emissions - Fundamental and Spurious - ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes 15.35(c) Duty Cycle Correction for Pulsed operation ANSI C63.4-2009 & ANSI C63.10-2009 1,2 Yes Note 1: Tested in 3 orthogonal planes. Note 2: Radiated emission measurement. 2.0 Introduction In November, 2010 the AccuChrom-3 Remote Control, Model GLED-RC, as provided from Gammex, Inc. was tested to the requirements of CFR 47 Part 15 Subpart…

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Company: Gammex Inc. Model: GLED-RC Photo Description: Radiated Emissions – x position Company: Gammex Inc. Model: GLED-RC Photo Description: Radiated Emissions – y position Company: Gammex Inc. Model: GLED-RC Photo Description: Radiated Emissions – z position Company: Gammex Inc. Model: GLED-RC Photo Description: Radiated Emissions Above 1 GHz