Sicel Technologies DVS-R-100 Dosimetry Verification System User Manual 934 00553 00

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Users Manual Part I

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2. Users Manual Part II

Users Manual Part I

DVS® DOSE VERIFICATION SYSTEM Operators ManualCaution: 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 Systemii© 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. 05This 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-100FCCID TS9-DVS-R-100 934-00553-00.book Page ii Friday, June 16, 2006 8:07 AM

Table of ContentsTABLE OF CONTENTS1 Welcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21.3 Contraindications, Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . .2Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71.4 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71.5 Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81.6 Statement of Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Changes or Modifications to the System . . . . . . . . . . . . . . . . . . . . . . . . . .91.7 User Equipment Requirements (Not Supplied) . . . . . . . . . . . . . . . . . . . . . .92 Dose Verification System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 102.1 DVS Dosimeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102.2 DVS Reader System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112.3 DVS Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122.4 Bar Code Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132.5 DVS Insertion Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133 Installation and Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.1 DVS Software Installation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Corequisite Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Windows Administrator Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153.2 Installing the DVS Plan and Review Software . . . . . . . . . . . . . . . . . . . . . .153.3 Installing the DVS Dosimetry Database Server . . . . . . . . . . . . . . . . . . . . .213.4 Configuring the DVS Software After Installation . . . . . . . . . . . . . . . . . . .25Setting up the Database Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Editing the Admin User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Entering Institution Information and System Options . . . . . . . . . . . . . .293.5 Setting Up the DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Choose a Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Make the Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Power on the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Connect to the DVS Dosimetry Database . . . . . . . . . . . . . . . . . . . . . . . . .314 Quick Start Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.1 Step 1 - Test Dosimeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .344.2 Step 2 – Implant Dosimeters and Record Implant Information . . . . . . . .344.3 Step 3 – Enter Patient Information Into the Plan and Review Software .354.4 Step 4 – Measure Radiation Pre-dose and Post-dose Values Using The DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37934-00553-00.book Page i Friday, June 16, 2006 8:07 AM

DVS Dose Verification Systemii5 Using the Plan and Review Software . . . . . . . . . . . . . . . . . . . . . . . . . . 385.1 Logging into the DVS Plan and Review Software . . . . . . . . . . . . . . . . . . . 385.2 DVS Main Menu Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385.3 Working With Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Adding, Editing, and Viewing Patients . . . . . . . . . . . . . . . . . . . . . . . . . . 40Entering Patient, Dosimeter, and Plan Information . . . . . . . . . . . . . . . . 41Entering Patient and Physician Information . . . . . . . . . . . . . . . . . . . . . . 41Entering Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Entering Dosimeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Changing or Deleting Dosimeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Working with Measurement Fractions and Skipped Fractions . . . . . . . . 45Deleting a Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Inserting Skipped Fractions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Changing Information for a Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475.4 Viewing Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Displaying a List of Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Viewing Results Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Viewing Results Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515.5 DVS System Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Adding and Editing DVS Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Changing Institutional Information and System Options . . . . . . . . . . . 55Changing the Database Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Backing up and Restoring the DVS Database . . . . . . . . . . . . . . . . . . . . . 576 Using the DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 586.1 Power On the DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 586.2 Login to the DVS Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 606.3 Test a Dosimeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 616.4 Scan a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Select a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Select a Plan/Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Take a PRE-Dose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Dose the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Take a POST-Dose Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Enter Treatment Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687 Imaging and Therapeutic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . 698 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 708.1 Troubleshooting the DVS Server System Software Setup . . . . . . . . . . . . 708.2 DVS Reader Not Operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 708.3 Unable to Obtain a Pre-Dose or Post-Dose Reading . . . . . . . . . . . . . . . . 708.4 DVS Reader Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 708.5 Plan and Review Software Error Messages . . . . . . . . . . . . . . . . . . . . . . . 749 Maintenance and Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . 799.1 Dosimeter Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 799.2 Disinfecting the Reader Wand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79934-00553-00.book Page ii Friday, June 16, 2006 8:07 AM

DVS Dose Verification SystemiiiTable of Contents9.3 Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7910 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80934-00553-00.book Page iii Friday, June 16, 2006 8:07 AM

DVS Dose Verification Systemiv934-00553-00.book Page iv Friday, June 16, 2006 8:07 AM

Welcome1WELCOMEThe Dose Verification System Operators Manual includes information about the setup and use of the DVS® (Dose Verification System). The intended users of this manual are radiation oncologists, medical physicists, dosimetrists, radiation therapists, and other personnel that may be assisting in the setup and use of DVS.This manual is organized into the following sections:Section 1 Welcome – provides a brief overview of the product, a list of indications, contraindications, cautions and warnings, and summaries of the conventions, symbols and terms used in the Operators Manual and the device.Section 2 Dose Verification System Overview – provides a detailed description of the components of DVS and how it is used.Section 3 Installation and Setup – provides instructions for installing and configuring the DVS Software and setting up the DVS Reader.Section 4 Quick Start Instructions – provides an overview of the workflow for testing, implanting, and scanning the DVS dosimeters.Section 5 Using the Plan and Review Software – provides the instructions for using the Plan and Review Software to enter patient, dosimeter, and plan information and review patient results.Section 6 Using the DVS Reader – provides the instructions for using the DVS Reader to test dosimeters and scan patients.Section 7 Imaging and Therapeutic Compatibility – provides a chart describing the interactions of an implanted dosimeter with various imaging and therapeutic modalities.Section 8 Troubleshooting – provides guidance if you encounter issues or errors while using DVS.Section 9 Maintenance and Technical Support – provides information on maintaining DVS and getting technical support.Section 10 Specifications – provides the technical specification for the DVS system.934-00553-00.book Page 1 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System21.1 Product DescriptionDVS provides an oncologist with information about the actual radiation dose delivered to a patient’s tissues and organs, and it provides charts and statistics for comparing the actual dose to the prescribed dose. DVS uses an implantable dosimeter and an external reading system to determine the absorbed dose near a tumor within a patient. DVS provides the oncologist with dose information that may be used in conjunction with other clinical information to make decisions regarding treatment plans or to identify the need for further investigation. 1.2 Intended UseDVS is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.1.3 Contraindications, Warnings, Cautions, and NotesThe following section explains the contraindications, warnings, cautions and notes for DVS. The terms Warning, Caution, and Note have specific meanings throughout this manual:• A Warning advises against actions or situations that could result in personal injury or death.• A Caution advises against actions or situations that could damage equipment or produce inaccurate or invalid data.• A Note provides useful information regarding the operation or function of the system.Contraindications•DVS may not be used in patients who are already implanted with other electronic devices such as pacemakers or insulin pumps. The impact of the potential electronic interference is unknown.•Not calibrated for use in electron beam therapy or brachytherapy. The DVS Dosimeter is pre-calibrated for external beam photon therapy in the energy range of 6-18 MV and daily fraction range of 150-250 cGy. 934-00553-00.book Page 2 Friday, June 16, 2006 8:07 AM$

DVS Dose Verification System3Welcome• Do not use for patients receiving microwave mediated therapy.• Do not use in blood or central nervous system.• Do not allow patients with a DVS Dosimeter to receive the following treatments: shortwave diathermy, microwave diathermy, or therapeutic ultrasound. These could result in serious injury.Warnings• Electric Shock Hazard – Do not remove the covers of the Reader or Reader Wand assemblies. The DVS Reader and Reader Wand contain no user serviceable internal parts. Contact technical support for return information.• Electric Shock Hazard – The Dose Verification System is grounded with a three-conductor cable and three-prong plug. Insert the power cable only into a properly grounded three-contact outlet.• Only use the manufacturer-supplied power cord. • Replace fuse only with same type and rating: 250V 5 AMP, Type T or 250V 5 AMP, Type 3AG. Failure to replace the fuse with the same type and rating may pose a fire hazard. • The DVS system is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen, or nitrous oxide.• Be sure that the cables do not pose a trip hazard.The DVS system is not intended to specify adjustments to dose.Dose measurement data obtained using the DVS system should be used in conjunction with existing planning and delivery tools to verify delivered dose rather than as a stand alone tool for determining dose adjustments.934-00553-00.book Page 3 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System4• The Reader Wand is not for use in direct contact with the patient – especially near wounds. Contact with gowns or other clothing is acceptable. The Reader Wand is not intended to be sterile. Disinfect the Reader Wand after direct skin contact using isopropyl alcohol-based disinfectants.• Do not use in a wet environment – could cause electrocution.• Only qualified personnel should attempt to implant the dosimeter.• The DVS Insertion Tool is extremely sharp. Using medical imaging, note critical structures in the pre-determined implant area. Avoid inserting the radiation dosimeter near critical structures such as veins and arteries.• Store dosimeters in a cool dry environment. • Do not use product if there is evidence of sterile packaging damage, expiration, or contamination of the dosimeter or insertion tool – inspect for damage or breaches of the packaging prior to use. • The dosimeter and insertion tool are single-use devices – do not attempt to re-use.• Do not use locking forceps, a hemostat, or a similar locking instrument to handle the radiation dosimeter; may cause mechanical damage to the glass.Cautions • Proper use of this system depends on careful reading of all instructions and labels.• Do not use cellular phones or hand held two-way radios in close proximity to the DVS Reader.• Keep CRTs at least 3 feet from the DVS Reader to prevent the DVS Reader from interfering with the CRT image.934-00553-00.book Page 4 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System5Welcome• Turn OFF the system power before connecting or disconnecting any system components or accessories. Connecting components with power applied may cause damage to the connectors or connecting circuitry.• If the dosimeter is tested prior to implantation, (1) do not remove the dosimeter from its package as this will compromise sterility and (2) do not place the dosimeters near metal.• Do not use a dosimeter near implanted metal objects. Read range may be compromised.• Enter the predicted dose in cGy, not monitor units. Entry in monitor units will cause a false error in the planned vs. actual dose report.• The DVS Reader Wand should not be used within 1-2 feet of large metal objects. Using the Reader Wand close to large metal objects has the potential to reduce the read range of the Reader Wand. • Do not conduct the pre-dose or post-dose reading while the patient is on a metal table. If the treatment table is metal, conduct the pre-dose reading before the patient is placed on the table and the post-dose reading after the patient is removed from the table. A metal table or other metal objects will interfere with the functioning of the DVS Reader Wand.• Take the post-dose reading within 10 minutes after the end of therapy. Readings taken beyond 10 minutes decrease dose accuracy.• The presence of dosimeters causes MR image artifacts. If an MRI scan is required in the vicinity of the area in which dosimeters will be implanted, it is recommended that the scan be performed prior to dosimeter implantation. Subsequent imaging of the affected area may require removal of the dosimeters.• There are three considerations with regard to implantable devices and MR imaging: localized heating, movement due 934-00553-00.book Page 5 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System6to interaction with the magnetic field, and image distortion or flare. Non-clinical testing has demonstrated that the DVS Dosimeter (device size: 2.1 mm diameter by 20 mm length) is MR Conditional. It can be scanned safely under the following conditions:• Static magnetic field of 1.5 Tesla or less• Spatial gradient field of 250 Gauss/cm or less• Maximum whole-body-averaged specific absorption rate (SAR) of 3.5 W/kg for 15 minutes of scanningIn non-clinical testing, the DVS dosimeter produced a temperature rise of less than 1.8°C at a maximum whole body averaged specific absorption rate (SAR) of 3.5 W/kg for 15 minutes of MR scanning in a 1.5 Tesla MR . system: Symphony Siemens Medical Solutions.MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the DVS dosimeter (following ASTM standard F2119-01 the largest artifact area in the device long axis: T1 weighted spin echo, 16.6 cm2; gradient echo, 31.1 cm2). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.It is recommended that where MRI is deemed medically necessary that MRI be performed prior to implantation of the dosimeter. Where subsequent MRI is deemed medically necessary in the vicinity of the dosimeter, the dosimeter may require removal.• Do not implant the dosimeter deeper than 12 cm or less than 3 cm from the surface of the skin. Implanting deeper than 12 cm may result in the inability of the Reader to communicate with the implanted dosimeter. Implanting at least 3 cm deep ensures adequate build-up and minimizes potential for mechanical damage.• Do not store dosimeters near stray radiation.• Implant dosimeters approximately parallel to the long axis of the body.934-00553-00.book Page 6 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System7WelcomeNotes The dosimeter is factory calibrated and does not require calibration during use.1.4 SymbolsSYMBOL DESCRIPTIONIndicates the Presence of a DANGEROUS VOLTAGE within the enclosure. This voltage may constitute the risk of an electric shock if the device is connected to a service outlet. Indicates an attention to users to consult accompanying documents (Operators Manual) for more information on the device.Indicates that the Dose Verification System is a Type B Applied Part.Protective earth (ground) – Indicates the point where the safety ground wire connects inside the Reader assembly.Indicates the ON position of the AC power switch.Indicates the OFF position of the AC power switch.Indicates that the parts should be protected from heat and radioactive sources.Indicates that the DVS Dosimeter is ethylene-oxide sterilized.Indicates the DVS Dosimeter or Insertion Tool is for single use only.Indicates the Lot number of the DVS Dosimeter or Insertion Tool. The ID includes the date of manufacture and a 4-digit code.Indicates the sterilization expiration date of the DVS Dosimeter (DDMMYY) or Insertion Tool (YYYY-MM).934-00553-00.book Page 7 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System81.5 Glossary of TermsBase Station – The main part of the DVS Reader, which contains the touch-screen display for operating the Reader.cGy – Centi-Gray (hundredths of a Gray (Gy)) unit of radiationCT – Computed TomographyDosimetry Database – The database used by the DVS system for storing patient, dosimeter, planning, and result information.Fraction – One radiation treatment session. A treatment plan is made of one or more fractions.Isodose Curve – The plot of the radiation dose plan showing lines of equal radiation dose in cGy.Insertion Tool – Used for percutaneous and intraoperative implant procedures. MRI – Magnetic Resonance ImagingPlan – A set of fractions where the dose delivered for each fraction is the same.Predicted Dose – The dose, in cGy, expected at a dosimeter for a treatment session.ManufacturerCatalog NumberDo not use if package is damaged.Do not re-sterilizeSerial NumberFragileConsult Instructions for UseSYMBOL DESCRIPTION934-00553-00.book Page 8 Friday, June 16, 2006 8:07 AM$

DVS Dose Verification System9WelcomeReader – The DVS Reader system, which is composed of the Base Station and the Reader Wand.Reader Wand – The hand-held part of the DVS Reader that contains the electronics to read the dose measurement from a dosimeter.1.6 Statement of ComplianceDVS has been tested and complies with the following safety standards:• UL 60601-1• CSA C22.2 No. 601-M90• Medical Directive 93/42/EEC• FCC Part CFR 15Note: 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 instruction manual, 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.Changes or Modifications to the SystemChanges or modifications to the DVS system not expressly approved by Sicel Technologies could void the user's authority to operate the equipment.1.7 User Equipment Requirements (Not Supplied)The following equipment and software are required to use DVS:• Personal Computer with LAN or network access for DVS Dosimetry Database• Operating System Requirements:• Windows XP Pro or later version934-00553-00.book Page 9 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System102DOSE VERIFICATION SYSTEM OVERVIEWThe Dose Verification System consists of five components: • DVS Dosimeter• DVS Insertion Tool • DVS Reader• DVS Software (Plan and Review Software and Dosimetry Database)• Bar Code Scanner The implantable dosimeter measures in vivo dose from external beam, photon radiation therapy. The dosimeter uses a semiconductor device called a MOSFET (metal oxide semiconductor field effect transistor) to measure radiation. Radiation within the human therapeutic dose range causes a shift in the threshold voltage of the MOSFET. By measuring the threshold voltage before and after radiation dose therapy, the dose fraction can be calculated. Cumulative dose can be calculated by tabulating the radiation dose measured at each fraction.To measure absorbed dose, a pre-dose and post-dose reading must be taken. The pre-dose reading is taken before the radiation treatment and the post-dose reading is taken after the radiation treatment. The pre-dose and post-dose threshold voltage readings are then used to calculate the daily dose fraction that is reported for each treatment session. The daily fractional dose values are stored in the Dosimetry Database and are added together to calculate a cumulative dose. The dosimeter is powered by the Reader Wand utilizing electromagnetic energy and does not contain a battery. The dosimeter derives all power from the Reader-generated electromagnetic field. The dosimeter modulates the electromagnetic field to send the digitized threshold voltage readings back to the Reader.2.1 DVS DosimeterThe dosimeter is powered telemetrically and measures the radiation using two MOSFETs. The MOSFETs are hermetically sealed in a biocompatible glass capsule. The dosimeter is covered by a polyester surgical mesh for handling, suturing, or fixating the dosimeter in vivo. The dosimeter is subsequently sterilized with 934-00553-00.book Page 10 Friday, June 16, 2006 8:07 AM$

DVS Dose Verification System11Dose Verification System Overviewethylene oxide. In the tissue, the dosimeter provides a radio-opaque image that registers on a dose planning computed tomography (CT). The measured dose data can be compared with the prescribed dose plan.Figure 1 — DVS DosimeterEach dosimeter is factory calibrated by correlating to a NIST-traceable ion chamber. The calibration information for each dosimeter is included in a bar code on pre-printed calibration labels.Dosimeters are provided in sterile packages. The expiration date printed on the dosimeter package is the date when the dosimeter is no longer considered sterile. Electrical functionality of the dosimeter is not affected by the sterility expiration.2.2 DVS Reader SystemThe DVS Reader system is used to take the pre-dose and post-dose readings from the dosimeter during each treatment session. The DVS Reader system consists of a Reader Wand and a Base Station (Figure 2). The Base Station includes a touch screen to view instructions and enter data. The Reader Wand sits in the cradle of the Base Station and is removed for reading a patient’s radiation dose. The highlighted end of the Reader Wand under the LED indicators is the active reading area. The DVS Reader can be used on a table top or on a pole mounted to the wall. The pole should be 1.25” in diameter and able to support 25 pounds.934-00553-00.book Page 11 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System12Figure 2 — DVS Reader2.3 DVS SoftwareThe DVS Software consists of Plan and Review Software and a Dosimetry Database. The Plan And Review Software is used to enter patient treatment information and to access patient data for viewing and reporting. The Dosimetry Database is a centralized database to which the Plan and Review Software and the DVS Reader connect through a local area network (LAN) connection. All patient information and dosimeter measurements are stored in the database. A bar code scanner is used to enter calibration information for the dosimeter. Up to 25 users can simultaneously access the database.934-00553-00.book Page 12 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System13Dose Verification System Overview2.4 Bar Code ScannerThe bar code scanner is used to read the dosimeter serial number and calibration values from a 2D bar code into the Dosimetry Database. The 2D bar code is packaged with each dosimeter so it is easy to scan the calibration values into the DVS system. The bar code scanner does not require any external power.2.5 DVS Insertion ToolThe Insertion Tool is an 11 (eleven) gauge needle similar in design to a bone biopsy needle. It is used for percutaneous and intraoperative implant procedures and consists of a cannula, trocar, and plunger. Figure 3 — Insertion Tool934-00553-00.book Page 13 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System143INSTALLATION AND SETUPThe Dose Verification System has three main components that you need to setup:• DVS Plan and Review Software• DVS Dosimetry Database Server• DVS ReaderThis section contains the following steps for installing and setting up the DVS Software and Reader:• DVS Software Installation Overview• Installing the DVS Plan and Review Software• Installing the DVS Dosimetry Database Server• Configuring the DVS Software after Installation• Setting up the DVS Reader3.1 DVS Software Installation OverviewThe DVS Software has two parts: the DVS Plan and Review Software (client), and the DVS Dosimetry Database (server). You can install the DVS Dosimetry Database on the same computer as the Plan and Review Software or you can install it on a separate computer on a network. For example, you can install the DVS Dosimetry Database Server on a computer in the server room and then install the Plan and Review Software on a workstation or laptop in a central location. You can install the Plan and Review Software on multiple computers and connect to the one database server. For administrative purposes, a version of the Plan and Review Software needs to be installed on the same computer as the DVS Dosimetry Database Server.System Requirements• Plan and Review Software – must be installed on computers running Windows XP with a minimum of 200 MB of disk space.• Dosimetry Database – must be installed on a computer running Windows XP Pro with a recommended minimum of 5 GB of disk space. The Windows XP Firewall must be turned off on the computer where the Dosimetry Database is installed.934-00553-00.book Page 14 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System15Installation and SetupCorequisite SoftwareThe two parts of the DVS Software each have several corequisite software components that are installed with the DVS Software:DVS Plan and Review Software• Microsoft .NET Framework (.NET) • Microsoft Data Access Components (MDAC)DVS Dosimetry Database Server - This uses Microsoft SQL Server.• Microsoft .NET Framework (.NET) • Microsoft Data Access Components (MDAC)• Microsoft SQL Server Desktop Engine (MSDE)• Microsoft Internet Information Services Web Server (IIS)• Microsoft SQL Server CE Tools (CE Tools)Windows Administrator LoginTo install the DVS Software, you must be logged into the computer with Administrator privileges. Check with your system administrator for instructions on setting up a user ID with Administrator privileges.3.2 Installing the DVS Plan and Review SoftwareThe DVS Plan and Review Software is installed on a laptop or workstation connected to your network. It is the interface for accessing the patient and dosimeter information stored in the DVS Dosimetry Database. To install the DVS Plan and Review Software, perform the following steps:1. Place the DVS Software Installation CD into the CD-ROM drive. The installation program should start automatically. If it doesn’t, browse to the CD-ROM drive using Windows Explorer and double-click setup.exe.Shortly after inserting the DVS Software Installation CD, a command window appears. The installation program automatically verifies the files on the CD-ROM.934-00553-00.book Page 15 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System16Figure 4 — CD File CheckingIf the verification process ends with a failure message, press any key to exit the program, and contact Technical Support.Figure 5 — CD File Checking FailedIf all files are verified, the DVS Plan and Review Setup Wizard opens and displays the Welcome panel.2. On the Welcome panel, click Next. You can click the Next and Back buttons on the setup wizard to move forward or backward 934-00553-00.book Page 16 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System17Installation and Setupthrough the setup panels. You can click Cancel to exit the setup wizard without making any changes to your computer.Figure 6 — Welcome3. On the Server Setup Option panel, select the Server Setup check box if you want to install the DVS Dosimetry Database on the computer. If selected, the DVS System Server Setup program installs the database after the Plan and Review Software installation finishes. If you want to install only the Plan and Review Software, clear this check box. Figure 7 — Server Setup Option934-00553-00.book Page 17 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System184. Click Next to display the Select Installation Folder panel. By default, the setup wizard installs the Plan and Review Software in the C:\Program Files\DVS\DVS Plan and Review folder. To change the location where the Plan and Review Software is installed, click Browse to select a new location using the Open dialog box. Figure 8 — Select Installation Folder5. Select Everyone or Just Me to indicate whether everyone who logs into this computer can use the Plan and Review Software or just users logged in with the current user ID.6. Click Next to display the Confirm Installation panel. If you want to change any of the setup information you entered into the setup wizard, click Back to change the information. 7. When you are ready to start installing the software, click Next.934-00553-00.book Page 18 Friday, June 16, 2006 8:07 AM$

DVS Dose Verification System19Installation and SetupFigure 9 — Confirm Installation PanelThe next panel that appears displays a progress bar for the installation program. If you need to stop the installation before it finishes, click Cancel. Figure 10 — Installing DVS Plan and Review SoftwareIf the installation program encounters any errors during installation, the installation is aborted and an error message appears. If an error occurs, fix the problem and restart the installation program. The following issues may prevent the software from installing and result in an error message:934-00553-00.book Page 19 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System20• Low disk space – reinstall the software in a location where you have enough disk space. The Plan and Review Software requires at least 200 MB of disk space.• Inadequate write permissions. – Make sure the user ID you used to log into the computer has Administrator privileges. The user ID needs the rights to install applications and modify the application folders. • Corrupted files on the installation CD—Contact Technical Support.8. When the DVS Plan and Review Software installation finishes, the Installation Complete panel appears. Click Close to exit the setup wizard. If the Server Setup checkbox was selected, the DVS System Server Setup starts. See section 3.3 Installing the DVS Dosimetry Database Server on page 21.Figure 11 — Installation CompleteIf you already installed the DVS Dosimetry Database Server or installed it with the DVS Plan and Review Software, perform the steps in Configuring the DVS Software after Installation. If the DVS Dosimetry Database Server has not been setup, see section 3.3 Installing the DVS Dosimetry Database Server on page 21.934-00553-00.book Page 20 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System21Installation and Setup3.3 Installing the DVS Dosimetry Database Server The DVS Dosimetry Database stores the client and dosimeter measurement data. It is accessed using the DVS Plan and Review Software. Even if you plan to use the Plan and Review Software on a separate computer, you need to install the Plan and Review Software on the same computer as the DVS Dosimetry Database Server. To install the DVS Dosimetry Database Server and the Dosimetry Database, perform the following steps:1. On the computer where you want to install the DVS Dosimetry Database Server, perform the steps for Installing the DVS Plan and Review Software on page 15. Be sure to select the Server Setup check box on the Server Setup Option panel in the DVS Plan and Review Setup Wizard. 2. When the DVS Plan and Review Setup Wizard completes, the DVS Server System Software Setup window appears. If the DVS Server System Software Setup window does not appear, rerun the installation program and make sure you selected the Server Setup check box on the Server Setup Option panel.Figure 12 — DVS Server System Software Setup3. Click Setup Server Components. Several windows appear while SQL Server Desktop Engine installs.4. If the setup program determines that you need to install Microsoft Internet Information Services Web Server (IIS), the following dialog box appears. Click Yes . 934-00553-00.book Page 21 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System225. For the IIS installation, the following dialog box appears to alert you that the setup program might need system files from the Windows XP Operating System Installation CD if they are not found on the computer. Click Yes . 6. When the IIS installation completes, the following dialog box appears. Click OK to start the SQL Server CE Tools Setup Wizard.7. Click Next on the first panel of the SQL Server CE Tools Setup Wizard.934-00553-00.book Page 22 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System23Installation and SetupFigure 13 — Welcome8. On the License Agreement panel, select I Agree and click Next.Figure 14 — License Agreement Panel9. On the Specify a Destination Folder panel, click Next.934-00553-00.book Page 23 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System24Figure 15 — Specify a Destination Folder10. On the Start the Installation panel, click Next.Figure 16 — Start the InstallationWhen the SQL Server CE Tools Setup Wizard begins, the setup program displays a number of windows as it completes the installation. When the setup program completes, the DVS Server System Software Setup window displays ALL SERVER COMPONENTS FULLY INSTALLED in the last line of Component Status window.934-00553-00.book Page 24 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System25Installation and SetupFigure 17 — All Server Components Fully Installed11. Click close (X) to exit the setup program.3.4 Configuring the DVS Software After InstallationAfter you have installed the DVS Plan and Review Software and the DVS Dosimetry Database, you need to configure the DVS system. Configuration steps include the following:• Setting up the Database Connection (only required if the Plan and Review Software is installed on a different computer than the database server)• Editing the Admin User• Entering Institution Information and PreferencesSetting up the Database ConnectionIf you installed the Plan and Review Software on a different computer than the DVS Dosimetry Database Server, you must set up the connection to the database. If the Plan and Review Software is only installed on the same computer as the DVS Dosimetry Database Server, skip this section and perform the steps in Editing the Admin User and Entering Institution Information and Preferences.On the computer (or computers) where the Plan and Review Software is installed without the database server, perform the following steps:934-00553-00.book Page 25 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System261. Click the DVS Plan and Review icon on the Desktop or select Start>Programs>DVS>DVS Plan and Review. After a 30 second pause, the following error dialog box appears.2. Click No. The DVS Administration window appears.Figure 18 — DVS Administration3. Click the Database tab.4. Enter the name of the SQL Server instance with the DVS Dosimetry Database in the Database Server field. For example:<servername>\DVSBy default, the Database Server field is set to .\DVS which indicates that the DVS Database is installed locally on the same computer as the Plan and Review Software.5. Click Done. The DVS Login dialog box appears. 934-00553-00.book Page 26 Friday, June 16, 2006 8:07 AM$

DVS Dose Verification System27Installation and SetupEditing the Admin UserBy default, an Admin login name with no password is setup in the DVS system so that you can login to the DVS Software initially. After installation, you should login using the Admin login and set the Admin user password, user information, and authorizations.To edit the Admin user, perform the following steps:1. Click the DVS Plan and Review icon on the Desktop or select Start>Programs>DVS>DVS Plan and Review. The DVS Main Menu and DVS Login dialog box appears.Figure 19 — DVS Login2. In the Login field, enter Admin (case sensitive) and leave the Password field blank.3. Click OK. The DVS Main Menu for the DVS Plan and Review Software appears.934-00553-00.book Page 27 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System28Figure 20 — DVS Main Menu4. Click Administration to display the DVS Administration window.Figure 21 — DVS Administration5. Click the Users tab. 6. Select the Admin user from the User List and click Edit. 934-00553-00.book Page 28 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System29Installation and SetupFigure 22 — User Data Entry7. In the User Data Entry dialog box, edit the user information, password, and authorizations.• Password - must be numeric (0-9) and at least 4 digits long. Be sure to set a secure password for the default Admin user.• Authorizations – select the tasks you want the user to be able to perform. The Admin user should only have Administrator authorization. Administrator authorizations let the user access the Administration dialog box.8. When you are finished editing the user, click OK to close the dialog box and return to the Users tab.9. Click Done. Entering Institution Information and System OptionsTo enter institution information and set the options for DVS, perform the following steps:1. Click the DVS Plan and Review icon on the Desktop or select Start>Programs>DVS>DVS Plan and Review. The DVS Main Menu and DVS Login dialog box appears.2. In the DVS Login dialog box, enter the Admin login name and password.3. Click OK. The DVS Main Menu for the DVS Plan and Review Software appears.4. Click Administration.5. Click the Options tab.934-00553-00.book Page 29 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System30Figure 23 — Options6. Enter the Institution Name and Address.7. Enter the time in minutes after which you want the DVS Reader to automatically logout. To disable automatic logout, set the value to 0 (zero). 8. Select how you want to display measured doses on the DVS Reader Notes screen:• None• Percent Error• Absolute Dose9. Click Done when finished.3.5 Setting Up the DVS ReaderTo set up the DVS reader perform the following steps:• Choose a Location• Make the Connections• Power on the Reader• Connect to the DVS Dosimetry Database934-00553-00.book Page 30 Friday, June 16, 2006 8:07 AM

DVS Dose Verification System31Installation and SetupChoose a LocationFind a location for the DVS Reader in or near the treatment room. The DVS Reader can be placed on a counter top or attached to a pole mounted to the wall. The pole should be 1.25” in diameter and able to support 25 pounds.Choose a place that is:• Near an electrical outlet• Near a local area network (LAN) connection•Not in the radiation path of the linear acceleratorMake the ConnectionsThere are three connections that you must make:• Reader Wand - Connect the Reader Wand cable to the back of the Reader Base Station. Turn the connector 1/4-turn to lock it in place.• Ethernet Cable - Connect the Ethernet cable to the back of the base station and then to a LAN connection in the room.• Power cord - Connect the power cord to the back of the base station and then to the wall outlet.Note: The USB connection on the back of the Base Station is for field service.Power on the ReaderTo power on the Reader, use the switch on the back of the base station near the power cord. Connect to the DVS Dosimetry DatabaseAfter powering on the reader, you need to setup the connection to the DVS Dosimetry Database. 1. Contact Sicel Technical Support, and get the Administrator password-of-the-day.2. Power on the DVS Reader. The Power On screen appears briefly.934-00553-00.book Page 31 Friday, June 16, 2006 8:07 AM

$DVS Dose Verification System32Figure 24 — Power On3. On the Initializing DVS Reader screen, press Login as Administrator.Figure 25 — Initializing DVS Reader4. Select the Administrator user in the users list.5. Enter the password-of-the-day received from Technical Support.6. On the Reader Administrator screen, enter the name of the server computer in the IIS Server field. This is typically the same as the name of the server entered in the Database Server field, but without the \DVS instance name. 934-00553-00.book Page 32 Friday, June 16, 2006 8:07 AM$

$DVS Dose Verification System33Quick Start InstructionsFigure 26 — Administration7. In the Database Server field, enter the server name and SQL server instance . For example:<server>\DVSwhere <server> is the name of the database server computer.8. Select the local time zone from the drop-down list box.9. (Optional) Select the Automatically Adjust for Daylight Saving Time check box. The date and time is automatically set when the DVS Reader connects to the DVS Dosimetry Database Server.10. Press Save.11. Wait for the Initializing DVS Reader screen to appear and then turn off the power to the DVS Reader.12. Power on the DVS Reader.4QUICK START INSTRUCTIONSThis section provides an overview of the workflow for using the DVS system:• Step 1 – Test Dosimeters (optional)• Step 2 – Implant Dosimeter and Record Implant Information• Step 3 – Enter Patient Information into the Plan and Review Software934-00553-00.book Page 33 Friday, June 16, 2006 8:07 AM$

Sicel Technologies DVS-R-100 Dosimetry Verification System User Manual 934 00553 00

Sicel Technologies, Inc. Dosimetry Verification System 934 00553 00

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