TS9-DVS-R-100Dosimetry Verification System

DVS ® DOSE VERIFICATION SYSTEM Operators Manual Caution: Federal Law restricts the use of this device to sale by or on the order of a physician. 934-00553-00.book Page i Friday, June 16, 2006 8:07 AM DVS Dose Verification System ii © 2006 Sicel Technologies ® , Inc. All rights reserved. Sicel Technologies ® is a registered trademark of Sicel Technologies, Inc. DVS ® is a product and registered trademark of Sicel Technologies ® , Inc. Part Number: 934-00553-00 rev. 05 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. This product is covered by one or more issued or pending U.S. patents including one or more of the following: U.S. Patent Nos. 6,047,214; 6,345,203; 6,263,247; 6,402,689; 6,963,770; 6,963,771; 7,010,340, and 7,011,814. DVS DVS-R-100 FCCID TS9-DVS-R-100 934-00553-00.book Page ii Friday, June 16, 2006 8:07 AM Table of Contents TABLE OF CONTENTS 1Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 1.2Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 1.3Contraindications, Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . .2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 1.4Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 1.5Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 1.6Statement of Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Changes or Modifications to the System . . . . . . . . . . . . . . . . . . . . . . . . . .9 1.7User Equipment Requirements (Not Supplied) . . . . . . . . . . . . . . . . . . . . . .9 2Dose Verification System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.1DVS Dosimeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 2.2DVS Reader System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 2.3DVS Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 2.4Bar Code Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 2.5DVS Insertion Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 3Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3.1DVS Software Installation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Corequisite Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Windows Administrator Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 3.2Installing the DVS Plan and Review Software . . . . . . . . . . . . . . . . . . . . . .15 3.3Installing the DVS Dosimetry Database Server . . . . . . . . . . . . . . . . . . . . .21 3.4Configuring the DVS Software After Installation . . . . . . . . . . . . . . . . . . .25 Setting up the Database Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 Editing the Admin User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 Entering Institution Information and System Options . . . . . . . . . . . . . .29 3.5Setting Up the DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 Choose a Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Make the Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Power on the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Connect to the DVS Dosimetry Database . . . . . . . . . . . . . . . . . . . . . . . . .31 4Quick Start Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 4.1Step 1 - Test Dosimeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 4.2Step 2 – Implant Dosimeters and Record Implant Information . . . . . . . .34 4.3Step 3 – Enter Patient Information Into the Plan and Review Software .35 4.4Step 4 – Measure Radiation Pre-dose and Post-dose Values Using The DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37 934-00553-00.book Page i Friday, June 16, 2006 8:07 AM DVS Dose Verification System ii 5Using the Plan and Review Software . . . . . . . . . . . . . . . . . . . . . . . . . . 38 5.1Logging into the DVS Plan and Review Software . . . . . . . . . . . . . . . . . . . 38 5.2DVS Main Menu Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 5.3Working With Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Adding, Editing, and Viewing Patients . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Entering Patient, Dosimeter, and Plan Information . . . . . . . . . . . . . . . . 41 Entering Patient and Physician Information . . . . . . . . . . . . . . . . . . . . . . 41 Entering Plans . . . . …

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DVS Dose Verification System 36 Figure 28 — CT Scout and Transverse Images 1. Login to the Plan and Review Software. 2. Click Patient Information. 3. Click Add. 4. In the Patient Data Entry dialog box, enter the patient information: a. Enter the patient number. b. Enter the patient’s name. c. Enter the physician’s name (this is generally the attending radiation oncologist). 5. Click Add Dosimeter to assign the implanted dosimeters to the patient. a. Scan the dosimeter’s bar code. The bar code contains the dosimeter’s serial number and calibration information. Sensitive Volume Antenna “Flare” End Sensitive Volume Point Dose Location 934-00553-00.book Page 36 Friday, June 16, 2006 8:07 AM DVS Dose Verification System 37 Quick Start Instructions b. Enter the implant location for each dosimeter from the transfer labels. 6. Click Add Plan and add the patient’s plan information: a. Enter the name of each plan, and the number of fractions for each plan. b. Enter the predicted dose at each dosimeter (point dose) from the planning CTs. Note that this must be in cGy (not MU). The dose fractions usually range from 150-250 cGy. Values outside this range result in the following error message: This predicted dose is outside the typical range of 150 to 250 cGy. Are you sure you want to use this value? Note: After implantation, additional plans may be added, such as a boost plan. 4.4 Step 4 – Measure Radiation Pre-dose and Post-dose Values Using The DVS Reader 1. Login to the Reader. 2. Press Scan patient. 3. Select the patient from the list and press Next. 4. Select the current plan and fraction for the patient and press Next. 5. Read the dosimeters’ pre-dose values. a. Hold the Reader Wand up to the patient. b. Press then release the button on the Reader Wand. c. Hold the Reader Wand near the patient’s treatment area until the Reader scans and reads all the dosimeters. 6. Proceed with radiation therapy. 7. Press Next on the reader to display the POST-Dose Reading screen. 8. Read the dosimeters’ post-dose values within 10 minutes of treatment: a. Hold the Reader Wand up to the patient. b. Press then release the button on the Reader Wand. c. Hold the Reader Wand near the patient’s treatment area until the Reader scans and reads all the dosimeters again. 934-00553-00.book Page 37 Friday, June 16, 2006 8:07 AM DVS Dose Verification System 38 9. Press Next and enter any notes related to the therapy on the Treatment Notes screen. 10. Press Save to save the readings to the Dosimetry Database. 5USING THE PLAN AND REVIEW SOFTWARE The Plan and Review Software is used to: •Enter patient, dosimeter, and plan information •Review results from the patient’s dosimeters •Maintain the authorized user list •Setup system options 5.1 Logging into the DVS Plan and Review Software To log into the Plan and Review Software: 1. Click the DVS Plan and Review icon on the Desktop or select Start>Programs>DVS>DVS Plan and Review. The DVS Login dialog box appears (Figure 29). Figure 29 — DVS Login 2. Enter the Login Name and Password that were assigned to you by the DVS Administrator. 3. Click OK. 5.2 DVS Main Menu Overview The DVS Main Menu contains five buttons as shown in Figure 30: •Patient Information – Enter or edit patient, dosimeter, and plan information (see section 5.3 Working With Patient Information on page 39) 934-00553-00.book Page 38 Friday, June 16, 2006 8:07 AM DVS Dose Verification System 39 Using the Plan and Review Software •Patient Results – View charts and reports for the patient’s dosimeter results (section 4 Quick Start Instructions on page 33) •Administration – Maintain the list of authorized users, and set DVS options (see section 5.5 DVS System Administration on page 53) •Exit DVS – Exit the Plan and Review Software •About... – Show software version and copyright information Note: Depending on the user’s authorization level, some of these buttons may be disabled. For more information, see Adding and Editing DVS Users on page 53. Figure 30 — DVS Main Menu 5.3 Working With Patient Information From the DVS Main Menu, click Patient Information to perform the following tasks: •Adding, Editing and Viewing Patients •Entering Patient, Dosimeter, and Plan Information •Entering Patient and Physician Information •Entering Plans •Entering Dosimeters •Changing or Deleting Dosimeters •Working with Measurement Fractions and Skipped Fractions •Changing Information for a Fraction 934-00553-00.book Page 39 Friday, June 16, 2006 8:07 AM DVS Dose Verification System 40 Adding, Editing, and Viewing Patients To add, edit or view patients, click Patient Information on the DVS Main Menu. The Patient Selection for Editing window appears (Figure 31). Figure 31 — Patient Selection for Editing By default, the patient list displays only the patients that are marked to be shown in the DVS Reader. This makes it easier to manage a large list of patients. To list all the patients in the Dosimetry Database, select the Show all patients check box. From this window, you can perform the following tasks: •To add a new patient, click Add. The Patient Data Entry window appears. You can enter the new patient’s information using this window. •To delete a patient from the list, select the patient in the list and click Delete. Patients who have dosimeters with measurements cannot be deleted. To remove a patient from the list, clear the Patient shown on Reader check box in the Patient Data Entry window. •To edit a patient’s information, select the patient in the list and click View/Edit. The Patient Data Entry window appears. You can enter the new patient’s information using this window. •To return to the Main Menu, click Done. For more information about the Patient Data Entry window, see Entering Patient, Dosimeter, and Plan Information on page 41. 934-00553-00.book Page 40 Friday, June 16, 2006 8:07 AM DVS Dose Verification System 41 Using the Plan and Review Software Entering Patient, Dosimeter, and Plan Information To edit patient, dosimeter, an…

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Dose Verification System (DVS) Sicel Technologies, Inc. Block Diagram – FCC Submission Transmitter Receiver Base Station 120VAC Wand Panel PC Panel PC Power Supply Wand Power Supply TX Antenna RX Antenna Controller Power RS232 Dosimeter I/O (database)

TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 1 of 6 Figure 1 – Overall View of EUT Base Unit Wand Sensors TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 2 of 6 Figure 2 – Photo of Support Equipment Database Server DSL Router TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 3 of 6 Figure 3 – Photo of Base Unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 4 of 6 Figure 4 – Photo of Base Unit (Rear) TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 5 of 6 Figure 5 – Photo of Wand (top view) TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT EXTERNAL Page 6 of 6 Figure 6 – Photo of Wand (bottom view) and dosimeters.

Label location for the DVS Reader Base Station Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560

TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 1 of 41 Figure 1 – Internal view of base Unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 2 of 41 Figure 2 – Internal view of Base unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 3 of 41 Figure 3 – Internal view of Base unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 4 of 41 Figure 4 – Internal view of Base unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 5 of 41 Figure 5 – Internal view of Base unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 6 of 41 Figure 6 – Internal view of Base unit TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 7 of 41 Figure 7 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 8 of 41 Figure 8 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 9 of 41 Figure 9 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 10 of 41 Figure 10 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 11 of 41 Figure 11 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 12 of 41 Figure 12 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 13 of 41 Figure 13 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 14 of 41 Figure 14 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 15 of 41 Figure 15 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 16 of 41 Figure 16 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 17 of 41 Figure 17 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 18 of 41 Figure 18 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 19 of 41 Figure 19 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 20 of 41 Figure 20 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 21 of 41 Figure 21 – Panel PC TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 22 of 41 Figure 22 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 23 of 41 Figure 23 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 24 of 41 Figure 24 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 25 of 41 Figure 25 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 26 of 41 Figure 26 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 27 of 41 Figure 27 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 28 of 41 Figure 28 – View of Power Supplies TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 29 of 41 Figure 29 – Internal view of wand TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 27596 Tel: (919) 554-3668, Fax: (919) 554-3542 PHOTOS PRODUCT INTERNAL Page 30 of 41 Figure 30 – Close up view of wand circuit board TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youn…

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SICEL TECHNOLOGIES, INC. -Confidential Document 1 of 3 Operational Description – FOR FCC Filing FCCID: TS9-DVS-R-100 Dose Verification System (DVS) Sicel Technologies, Inc. 1 Overview The DVS System is made up of three primary components: The Reader System, the Implantable Dosimeter, and the Database. The Reader System is comprised of two main components: The Wand and the Base Station. This Document will briefly describe the operation of the DVS Reader System and its interaction with the dosimeter and database. 2 Reader System A block diagram of the DVS System is shown below: Fig 1 – Block Diagram of System 2.1 Base Station Power comes into the unit through an IEC-power entry module that contains an EMI filter, a switch and two fuses. The power is routed to two separate medical grade power supplies; one dedicated for the panel PC (+12V/5V) and one for the DVS Wand (+15V). The Panel PC has a 300MHZ processor. The Panel PC’s I/O connects through the back panel as follows: Base Station Wand Dosimeter Database Location SICEL TECHNOLOGIES, INC. -Confidential Document 2 of 3 ∑ USB connection- for use by field service personnel (not used in normal operation) ∑ Ethernet connection – for ethernet connectivity to a centralized dosimetry database (DVS data records and storage). ∑ The Wand Connector- contains a 3-wire RS232 serial connection for communications with the Wand. The RS232 communications is configured at 9600 Baud. This connector also has the +15V and power return (ground) for the Wand’s electronics. ∑ The IEC power entry module is connected to the safety ground on the metal I/O panel. ∑ Both power supplies’ inputs and output are referenced to the chassis ground point, also on the back I/O panel. 2.2 Wand The DVS Wand Connects to the Base Station through the Wand Connector on the back panel of the Base Station. The Wand’s retractile cord is a 5 conductor shielded cable with the shield referenced to chassis ground on the base station. The Wand side of the shield is not grounded. The Wand contains the transmitter board assembly (three circuit boards) which communicates with the dosimeters (through the electromagnetic field energy) and the base station (through the Wand cable). The transmitter draws approximately 1.4Amps DC from the +15V supply. The transmitter is a self-resonant topology that operates at ~133kHz (nominal). The series Inductor-Capacitor (LC tank) transmitter operates at ~3A RMS with about 650VAC (peak) while transmitting. The Transmitter is referenced to the Power return which is referenced to chassis ground through the Wand Cable. During addressing (or interrogation) of a dosimeter, the Transmitter will modulate an address request for a specific dosimeter. Any dosimeters in the presence of the electromagnetic field will power up but will only respond upon proper addressing. When a dosimeter is properly addressed, it will perform the requested channel calculation (each dosimeter has four channels of data) and modulate the data back to the Wand using Manchester encoded frequency shift keying (FSK). The FSK data signal is centered around 20.5kHz. The Wand’s 133 kHz transmitter provides both the energy to power the dosimeter(s) as well as the carrier frequency for the FSK data signal. The Wand’s receiver decodes the data received and sends it to a microcontroller for conversion to RS232 data format. The microcontroller then sends the data to the RS232 transceiver which sends the data to the panel PC for interpretation. Results are then stored in the database. SICEL TECHNOLOGIES, INC. -Confidential Document 3 of 3 2.3 Operation The Clinical Operator accesses a patient’s profile through the touch screen on the Panel PC. The panel PC communicates with the remote database to access the patient’s information. Once loaded, the Clinical Operator will prepare to read a patient’s dosimeter(s). The Operator presses the Wand button which turns on the transmitter. The transmitter then modulates an interrogation pattern requesting information from a specific dosimeter. This dosimeter performs a calculation and transmits the data back to the Wand. The Wand receiver decodes the data and sends it to the panel PC thru the RS232 connection (Wand cable). The Panel PC then sends the data to the database. The patient’s profile details the number of dosimeters to interrogate and the Reader will continue to address each dosimeter as requested by the Panel PC.

Report Number: 30562169.003 Page 1 of 34 EUT: Dosimetry Verification System (DVS) Reader Model: DVS-R-100 33_EME/I 01/29/2001 FCCID TS9-DVS-R-100 Emissions & Immunity Test Report EUT Name: Dosimetry Verification System (DVS) Reader EUT Model: DVS-R-100 CFR Title 47 - Part 15, ANSI C64.3:2005 Prepared for: Brendan McSoley Sicel Technologies 3800 Gateway Centre Blvd., Ste. 308 Morrisville, NC 27560 Tel: 919-465-2236 Fax: 999-465-0153 Prepared by: TUV Rheinland of North America 762 Park Avenue Youngsville, NC 27596 Tel: (919) 554-3668 Fax: (919) 554-3542 http://www.tuv.com/ Report/Issue Date: 27 July 2006 Report Number: 30562169.003 Statement of Compliance Report Number: 30562169.003 Page 2 of 34 EUT: Dosimetry Verification System (DVS) Reader Model: DVS-R-100 33_EME/I 01/29/2001 Manufacturer: Sicel Technologies 3800 Gateway Centre Blvd., Ste. 308 Morrisville, NC 27560 919-465-2236 Requester / Applicant: Brendan McSoley Name of Equipment: Model No. Dosimetry Verification System (DVS) Reader DVS-R-100 Type of Equipment: Medical Class of Equipment: Intentional Radiator Application of Regulations: CFR Title 47 - Part 15, ANSI C64.3:2005 Test Dates: 24 October 2005 to 11 November 2005 Guidance Documents: Emissions: FCC 47 CFR Part 15 - Subpart C Test Methods: Emissions: FCC §§15.209(a), 15.209(d), FCC §15.207(a), FCC §15.31(e), FCC §15.215(c), The electromagnetic compatibility test and documented data described in this report has been performed and recorded by TUV Rheinland of North America, in accordance with the standards and procedures listed herein. As the responsible authorized agent of the EMC laboratory, I hereby declare that a sample of one, of the equipment described above, has been shown to be compliant with the EMC requirements of the stated regulations and standards based on these results. If any special accessories and/or modifications were required for compliance, they are listed in the Executive Summary of this report. This report must not be used to claim product endorsement by NVLAP or any agency of the U.S. Government. This report contains data that are not covered by NVLAP accreditation. This report shall not be reproduced except in full, without the written authorization of the laboratory. 27 July 2006 27 July 2006 Test Engineer Date NVLAP Signatory Date FCC Industry Canada 200094-0 90552 and 100881 IC3755 Table of Contents Report Number: 30562169.003 Page 3 of 34 EUT: Dosimetry Verification System (DVS) Reader Model: DVS-R-100 33_EME/I 01/29/2001 1 EXECUTIVE SUMMARY................................................................................................................. 4 1.1 SCOPE............................................................................................................................................ 4 1.2 PURPOSE........................................................................................................................................ 4 1.3 SUMMARY OF TEST RESULTS........................................................................................................ 4 1.4 SPECIAL ACCESSORIES.................................................................................................................. 4 1.5 EQUIPMENT MODIFICATIONS........................................................................................................ 4 2 LABORATORY INFORMATION ................................................................................................... 5 2.1 ACCREDITATIONS & ENDORSEMENTS.......................................................................................... 5 2.2 TEST FACILITIES............................................................................................................................ 6 2.3 MEASUREMENT UNCERTAINTY..................................................................................................... 6 2.4 CALIBRATION TRACEABILITY....................................................................................................... 7 3 PRODUCT INFORMATION ............................................................................................................8 3.1 PRODUCT DESCRIPTION................................................................................................................ 8 3.2 EQUIPMENT CONFIGURATION....................................................................................................... 8 3.3 OPERATION MODE........................................................................................................................ 8 4 EMISSIONS ........................................................................................................................................ 9 4.1 RADIATED EMISSIONS................................................................................................................... 9 4.2 CONDUCTED EMISSIONS............................................................................................................. 17 4.3 FREQUENCY STABILITY.............................................................................................................. 23 4.4 BANDWIDTH................................................................................................................................27 5 TEST EQUIPMENT USE LIST ...................................................................................................... 29 5.1 LAB TEST EQUIPMENT................................................................................................................ 29 6 EMC TEST PLAN ............................................................................................................................ 30 6.1 TEST PLAN................................................................................................................................... 30 TUV Rheinland of North America FCC ID: TS9-DVS-R-100 762 Park Ave., Youngsville, NC 2…

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