RBQAS0670Diomed RFID Module type AS/0670

Page 1 of 1 Author: C.E. Daily, Diomed Limited. 15 July 2005 AS/0670 Module User Manual Introduction The AS0670 Module is a RFID transceiver used to identify accessories attached to Diomed Lasers. It must only be fitted by Diomed Ltd in Diomed Lasers, and in accordance with this guide. General Requirements Power Supply: 5V dc +/- 0.25V, 50mA The mains input to the power supply must be filtered and comply with the requirements of EN60601.1.2 Screening: A ground plane and de-coupling capacitors on the PCB ensures that no additional screening is required around the module. There should be no enclosure screening directly in front of the antenna coil or the field will not radiate outside of the Laser. Frequency The operating frequency must be checked after installation in the Diomed Laser and if necessary fine tuned to 125kHz +/- 1kHz using the trimmer capacitor on the module. Antenna: This is a fixed coil soldered to the PCB and must be installed in the vertical plane to ensure compliance. Signal Cable Maximum length: 0.7m Cable type: 6 way ribbon cable 7/36 AWG, 1.27mm pitch. Connector type: MMT 6way male (e.g. Farnell part no. 149-068) Labelling The outside of the Laser must be labelled in accordance with FCC and Industry Canada rules. Operator Manual The Laser’s Operator Manual must contain the EMC warnings in accordance with FCC and Industry Canada rules. Signal Requirements Name Function Vin high Vin low Vout high Vout low CFE Data In 3.0min 0.8Vmax - - Output Data Out - - 2.4V min 0.5Vmax /OE Output Enable 2.4V min 0.5Vmax - - Connections Connector (J1) Pin Name Function 1 P5V +5V 2 0V 0V 3 0V 0V 4 CFE Data In 5 Output Data Out 6 /OE Output Enable

Section Version Welcome B.2 Safety & Warning B.2 Operating Instructions B.2 Procedures B.2 Technical Information B.2 Guarantee B.2 Manufactured in the United Kingdom by DIOMED Limited DIOMED is a Registered Trademark of DIOMED Ltd.
2005 DIOMED Ltd. DIOMED DELTA 15/30 DIODE LASER OPERATOR MANUAL Version B.2 July 2005 MAN/26/0068 DELTA 15/30 DELTA 15/30 Operator Manual Page 1.2 Version B.2 SECTION 1 WELCOME Thank you for purchasing a DIOMED laser. This is a high quality medical instrument that will give many years of service if used and cared for according to the instructions in this operator manual. Before going any further it is important that the Product Information on page 1.4 is completed at installation. The Guarantee Registration Certificate and Guarantee Form in section 5 must also be filled in and the form returned to DIOMED to complete the registration process. INTRODUCTION This manual describes the operation of the DIOMED DELTA 15 and the DIOMED DELTA 30, (referred to as DIOMED DELTA 15/30 in this manual). These lasers are to be used only by experienced, trained operators familiar with laser procedures. Before using this instrument for the first time, read the Safety & Warnings section and the Operating Instructions. The operator must become familiar with all the controls before commencing any therapy. DIOMED DELTA 15 The DIOMED DELTA15 is a diode laser capable of delivering up to 15W of continuous wave radiation via an optical fiber, or 119J/cm² of pulsed radiation via a spot handpiece, coupled to the laser aperture. The DIOMED DELTA 15 incorporates a Class IV GaAlAs (Gallium Aluminium Arsenide) diode lasers with a wavelength of 810nm (±20nm). The DIOMED DELTA 15 incorporates a visible Class IIIa diode laser aiming beam with a wavelength of 635-660nm and a maximum power output of 5mW. DIOMED DELTA 30 The DIOMED DELTA 30 is a diode laser capable of delivering up to 30W of continuous wave radiation via an optical fiber, or 400J/cm² of pulsed radiation via a spot handpiece, coupled to the laser aperture. The DIOMED DELTA 30 incorporates Class IV GaAlAs (Gallium Aluminium Arsenide) diode lasers with a wavelength of 810nm (±20nm). The DIOMED DELTA 30 incorporates a visible Class IIIa diode laser aiming beam with a wavelength of 635-660nm and a maximum power output of 5mW. DELTA 15/30 DELTA 15/30 Operator Manual Page 1.3 Version B.2 DESCRIPTION OF THE DIOMED DELTA 15/30 The DIOMED DELTA 15/30 has been designed for use with the DIOMED range of procedure kits, such as those for EVLT (EndoVenous Laser Treatment). It can also be used with a wide range of standard fibers and accessories, further details of which are in section 4 of this manual. The DIOMED DELTA 15/30 consists of three main components: • The main enclosure houses the laser module containing the optics, heatsink, microprocessor- based control electronics and power supplies • The footswitch to activate the laser output when in READY mode • The fiber or handpiece for delivering the laser radiation to the tissue Key features of the DIOMED DELTA 15/30 include: • 15W or 30W power output • Compact & portable • Intuitive user interface • Automatic procedure recognition when used with fibers and accessories conforming to the DIOMED FRS fiber system • Minimal maintenance & service • Internal power calibration meter (optional on DIOMED DELTA 15) ABOUT THIS MANUAL This manual is broken down into five main sections as described below. The contents of each one are detailed at the beginning of the appropriate section. 1 Welcome 2 Safety & Warnings Explains the general warnings and precautions that must be followed to ensure that the DIOMED DELTA 15/30 is used in a safe manner. 3 Operating Instructions Detailed instructions on how to install and operate the DIOMED DELTA 15/30 laser. 4 Procedures Specific information about DIOMED fibers and procedure kits, equipped with FRS. 5 Technical Information This section explains all the maintenance procedures that can be performed by the user. 6 Guarantee Contains the DIOMED guarantee policy and your guarantee certificate. Ensure that the accompanying form is returned to DIOMED and that the certificate is kept in a safe place. DELTA 15/30 DELTA 15/30 Operator Manual Page 1.4 Version B.2 PRODUCT INFORMATION Laser Serial Number ............................................................................................................................... Software Version .................................................................................................................................... (Note: This information is shown on the screen displayed at start-up.) Date Installed ......................................................................................................................................... Installed by .............................................................................................................................................. Signed .................................................................................................................................................... Print Name ............................................................................................................................................. Organisation ........................................................................................................................................... For service, parts or repair, contact your local DIOMED representative: DELTA 15/30 DELTA 15/30 Operator Manual Page 2.1 Version B.2 SECTION 2 SAFETY & WARNINGS CONTENTS Section 2 SAFETY & WARNINGS ....................................................................................................... 1 Contents .................................................................................................................................................1 Symbols used in this manual................................................................................................…

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Osc RF Field RFID IC AS/0670 Module Diomed Laser User Interface ( AS/0667) RFID Tag Ribbon Cable +5V O/P 0V EN CFE AS/0670 Block Diagram 05 May 2005 Coil Read channel Diomed Ltd.

I 0 Diomed Delta Laser Serial Number: 000000 Date of Manufacture: Sept 2005 100-240V500VA 50-60Hz 2 x T6.3A H 250V 0086 IOIOI Made in the United Kingdom by:Diomed Ltd.Building 2000, Beach Drive,Cambridge Research Park,Waterbeach,Cambridge CB5 9TEDistributed in the USA byDiomed Inc, MA 01810 This product complies with21 CFR 1040.10 and 1040.11, UL60601-1,EN60601-1, 60601-2-22, 60825-1 IP21 This device contains an intentional radiator part numberThis product 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.This device complies with Canadian RSS-210 AS/0670 FCC ID: RBQAS0670Canada IC: 4690A-AS0670 GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED ‘HOSPITAL ONLY’ OR ‘HOSPITAL GRADE’ 90 mm 4 4 .5 m m Artwork and Location of FCC / IC label on rear panel of Diomed Delta lasers. Diomed Ltd13 July 2005. FCC / IC Label is chemical and solvent resistant polyester and attached with a permanent adhesive.

|---------- ( Cambridge Ltd. ) ----------| Testing EMCEMC Consultancy EMC Training or : 01223 241140 (accounts) 23, Headington Drive, Cambridge. CB1 9HE Tel : 01954 251974 (test site) Fax : 01954 251907 email: [email protected] web : www.dbtechnology.co.uk REPORT ON ELECTROMAGNETIC COMPATIBILITY TESTS Performed at: TWENTY PENCE TEST SITE Twenty Pence Road, Cottenham, Cambridge U.K. CB4 8PS on Diomed Ltd RFID Module AS/0670 dated 1st July 2005 Document History C.A.D.B.Update stds detail & correct units labels2, 9-1215/07/052 Initial release01/07/051 Approved by Revised by Description of modifications Affected page(s) DateIssue Based on report template: v031111 1 of 16 Page: Test Report T1584 Test No: FCC ID: RBQAS0670 R2052 2 Report No: Issue No: This report shall not be reproduced except in full, without the written approval of: dB Technology (Cambridge) Ltd. Equipment Under Test (EUT):RFID Module AS/0670 Test Commissioned by:Diomed Ltd Building 2000, Beach Drive Cambridge Research Park Waterbeach Cambridge CB5 9TE Representative:Andy Howe Test Started:13th June 2005 Test Completed:21st June 2005 Test Engineer:Peter Barlow Date of Report:1st July 2005 Report: Written by:Peter BarlowChecked by:Derek Barlow Signature:Signature: Date:1st July 2005Date:1st July 2005 dB Technology can only report on the specific unit(s) tested at its site. The responsibility for extrapolating this data to a product line lies solely with the manufacturer. Test Standards Applied CFR 47 : 2004Code of Federal Regulations: Pt 15 Subpart C - Radio Frequency Devices - Intentional Radiators Emissions Test Results Summary CFR 47 : 2004PASS TestPortMethodLimitPASS/FAILNotes Conductedac powerANSI C63.4:2003CISPR22(B)PASSCISPR22(B) Emissions conducted Radiated ANSI C63.4:2003FCC Pt 15 Subpt CPASS CISPR22(B) Emissions radiated specs_fccv040903 2 of 16 Page: Test Report T1584 Test No: FCC ID: RBQAS0670 R2052 2 Report No: Issue No: This report shall not be reproduced except in full, without the written approval of: dB Technology (Cambridge) Ltd. Contents 16 PLOT 6 Magnetic Emissions - 150kHz to 30MHz - RFID Module inside enclosure .................. 15 PLOT 5 Magnetic Emissions - 9kHz to 150kHz - RFID Module inside enclosure .................... 14 PLOT 4 Magnetic Emissions - 150kHz to 30MHz - RFID Module outside enclosure ................. 13 PLOT 3 Magnetic Emissions - 9kHz to 150kHz - RFID module outside enclosure ................... 12 PLOT 2 Conducted Emissions - Live Line - 115V ............................................. 11 PLOT 1 Conducted Emissions - Neutral Line - 115V .......................................... 104.2 Magnetic Field Emissions Results - Module outside of enclosure............................. 94.1 Conducted Emissions (Power) - Results................................................... 8 4 Test Results ............................................................................. 83.2 Radiated Emissions <30MHz............................................................. 83.1 Conducted Emissions - ac power......................................................... 8 3 Test Methods ............................................................................ 7 2 Test Equipment .......................................................................... 6 Photograph 2 Arrangement of EUT and Peripherals for RFID Emissions ........................... 6 Photograph 1 Arrangement of EUT and Peripherals for Conducted Emissions ....................... 5 Figure 1 General Arrangement of EUT and Peripherals ......................................... 51.4 EUT Operating Modes................................................................... 41.3 Modifications to EUT and Peripherals...................................................... 41.2 Details of Interconnecting Cables......................................................... 41.1 General................................................................................ 4 1 EUT Details ............................................................................. 3 of 16 Page: Test Report T1584 Test No: FCC ID: RBQAS0670 R2052 2 Report No: Issue No: This report shall not be reproduced except in full, without the written approval of: dB Technology (Cambridge) Ltd. 1 EUT Details 1.1 General The EUT was a Diomed AS/0670 RFID module. The module is intended to be fitted to Diomed laser products. Its purpose is to identify the type of optical peripheral device connected to the laser by reading information from a tag. The AS/0670 module is an intentional transmitter operating at a nominal frequency of 120kHz to 125kHz. This report only covers the RFID module - not the laser device as a whole. Radiated emissions from the intentional transmitter were measured with the module fitted inside a laser unit (the Diomed Reel 2) and also outside of the laser unit as it is intended that this RFID module should be approved for fitting to a range of products and it was required to ascertain that the RFID module still complied when not subject to any shielding from the main instrument enclosure. Conducted emissions were measured on the power leads of the Diomed Reel 2 with the RFID module fitted. Details of the EUT and associated peripherals used during the tests are listed below. Figure 1 shows the interconnections between the EUT and peripherals. ItemManufacturerModelDescriptionSerial No:FCC ID 1DiomedAS/0670RF ID modulePilot 01RBQAS0670 2Diomed LtdReel 2Medical Diode LaserPilot 1N/A 1.2 Details of Interconnecting Cables The following table lists details of the cables connected to the EUT. FromToCable TypeLengthNotes EUTMainsStandard IEC1.5m EUT (Interlock)FloatingBraid Screened3m EUT (handswitch)HandswitchBraid Screened3m 1.3 Modifications to EUT and Peripherals Details of any modifications that were required to achieve compliance are listed below. The modification numbers are referred to in the results sections as appropriate. ModDetailsImplemented for No: 0 As received for testin…

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