FCC ID: TS9-DVS-R-200 Low Frequency RFID

DVS installation manual Technology Installation and Set-up Guide DVS System Installation and Setup Guide 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. in the United States. SmartMarker is a registered trademark of Sicel Technologies, Inc. in the United States. Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, North Carolina, 27560 USA Part Number: 934-00553-02 rev. 04 Model #: DVS-R-200 FCCID: TS9-DVS-R-200 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. Note: For Qualified Service Personnel Only. 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. Page 2 of 44 DVS System Installation and Setup Guide Table of Contents 1 2.2 2.1.1 2.1.2 2.1.3 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 Introduction ............................................................................................................................... 4 Warnings and Cautions .................................................................................................. 4 Notes .............................................................................................................................. 6 Symbols .......................................................................................................................... 6 Glossary of Terms .......................................................................................................... 7 Statement of Compliance ............................................................................................... 7 Essential Performance ................................................................................................... 8 Electromagnetic Compatibility/Immunity ........................................................................ 8 Changes or Modifications to the System ..................................................................... 12 Equipment Supplied ..................................................................................................... 13 User Equipment Requirements (Not Supplied) ............................................................ 13 2 DVS Installation Overview ...................................................................................................... 14 System Requirements .............................................................................................. 14 Data Security ........................................................................................................... 14 Contacting Customer Support ................................................................................. 15 How to Use this Manual ............................................................................................... 15 3 Network Configuration Checklist ............................................................................................ 16 3.1.1 Network Configuration ............................................................................................. 16 Installing the DVS Plan and Review Software ....................................................................... 17 4 4.1.1 Installation Errors ..................................................................................................... 21 Post-Installation Configuration Notes ...................................................................... 21 4.1.2 Setting up Database Connection .................................................................... 21 Editing the Admin User ................................................................................. 22 Entering Institution Information and System Options ...................................... 25 Installing the .NET Framework ..................................................................................... 26 Upgrading the .NET Framework .................................................................................. 28 4.3.1 Option 1 Microsoft Windows Update (Recommended) ........................................ 28 4.3.2 Option 2 Download and Install .............................................................................. 28 Windows Firewall ......................................................................................................... 29 4.4.1 Service Pack 1 or Earlier ......................................................................................... 30 Service Pack 2 ......................................................................................................... 30 4.4.2 Installing the DVS Dosimetry Database Software .................................................................. 32 5.1.1 Installation Errors ..................................................................................................... 37 5.1.2 Backing up the DVS Dosimetry Database ............................................................... 37 Installing the DVS Reader ...................................................................................................... 38 Unpack the Reader Components ................................................................................. 38 Choose a Location ....................................................................................................... 38 Make the Connections ................................................................................................. 38 Barcode Scanner Connections .................................................................................... 38 Power on the Reader ................................................................................................... 39 Connecting to the DVS Dosimetry Database ............................................................... 39 Configuring DVS Reader for Static IP Addressing ....................................................... 42 7 System Specifications ............................................................................................................ 43 8 Technical Support and Product Service ................................................................................. 44 6.1 6.2 6.3 6.4 6.5 6.6 6.7 4.1.2.1 4.1.2.2 4.1.2.3 4.2 4.3 4.4 5 6 Page 3 of 44 DVS System Installation and Setup Guide 1 Introduction The Dose Verification System consists of three main components that need to be set up. These are as follows:

DVS Plan and Review Software DVS Dosimetry Database Server DVS Reader System This guide contains information on the installation and configuration of these components. It will be broken up into the following steps:

DVS Software Installation Overview Network Configuration Checklist Installing the DVS Plan and Review Software Installing the DVS Dosimetry Database Server Installing the DVS Reader System 1.1 Warnings and Cautions See Dosimeter Instructions for Use and Reader Operator Manual. The following section explains the 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. Warnings 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. Electric Shock Hazard Do not remove the covers of the Reader or Reader Wand assemblies. Do not open the case or touch the internal parts. The DVS Reader and Reader Wand contain no user serviceable internal parts. Contact the local representative for technical support and 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. Electric Shock Hazard Do not use in wet environment. May result in electrocution. Page 4 of 44 DVS System Installation and Setup Guide Only use the manufacturer-supplied power cord, data cables, or other accessories. The use of accessories other than those supplied by the manufacturer with or as replacement parts for the DVS system may result in increased emissions or decreased immunity of the equipment or system.. Replace fuse only with same type and rating: 2 AMP 250V, Time-Lag Fuse, Failure to replace the fuse with the same type and rating may pose a fire hazard. The DVS equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation. 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 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. Clean the Reader Wand after direct skin contact using isopropyl alcohol-based disinfectants. 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. Cautions Do not use cellular phones or hand held two-way radios in close proximity to the DVS Proper use of this system depends on careful reading of all instructions and labels. Reader. Keep CRTs at least 3 feet from the DVS Reader to prevent the DVS Reader from interfering with the CRT image. Also, interference from CRTs may result in reduced read range. 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. Do not store dosimeters near stray radiation. 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. Page 5 of 44 DVS System Installation and Setup Guide 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. 1.2 Notes The dosimeter is factory calibrated and does not require calibration during use. 1.3 Symbols SYMBOL DESCRIPTION Indicates an attention to users to consult accompanying documents (Dosimeter Instructions for Use) for more information on the device. Type B Equipment Protective earth (ground) ON OFF Manufacturer Date of Manufacture (YYYY-MM-DD or YYYY-

MM) Catalog Number Do not use if package is damaged. Serial Number Fragile, handle with care. Page 6 of 44 DVS System Installation and Setup Guide Consult Instructions for Use. Temperature Limitation Keep dry. Non-ionizing radiation 1.4 Glossary of Terms Base 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 radiation CT Computed Tomography Dosimetry 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. Plan Dosimetric representation of a prescribed radiation treatment course. Predicted Dose The dose, in cGy, expected at a dosimeter for a treatment session. Reader 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. 1.5 Statement of Compliance DVS has been tested and complies with the following standards:

CSA C22.2 No. 601-1-M90 RTT&E Directive, 1999/5/EC 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 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. IEC/EN/UL 60601-1-2 FCC 47 CFR Part 15 - Subpart C instruction manual, may cause harmful IEC/EN/UL 60601-1 interference the Page 7 of 44 DVS System Installation and Setup Guide 1.6 Essential Performance The Essential Performance of the DVS System is:

Interpretation (dose calibration algorithm) of dosimeter data for accurate dose response storage/display error free data transmission (dosimeter to database) mechanical integrity during normal use for protection from electrical hazards maintenance of the integrity of the protective earth connection 1.7 Electromagnetic Compatibility/Immunity Notes:

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Portable and mobile RF (radiofrequency) communications equipment can affect medical electrical equipment. The use of accessories and cables other than those specified, with the exception of parts sold by the manufacturer of the equipment or system as replacement parts, may result in increased emissions or decreased immunity of the equipment or system. The DVS equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. In the event operation of the DVS System is suspected of adverse electromagnetic effects on other equipment, please contact Sicel technical support for further assistance. Page 8 of 44 DVS System Installation and Setup Guide Guidance and Manufacturers Declaration Electromagnetic Emissions The DVS-R-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the DVS-R-200 should assure that it is used in such and environment. Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 CISPR 11 The DVS-R-200 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions Class A Harmonic emissions Class A Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies The DVS-R-200 is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the DVS-R-200 or shielding the location. IEC 60601-1-2 Table 1 Page 9 of 44 DVS System Installation and Setup Guide Guidance and Manufacturers Declaration Electromagnetic Immunity The DVS-R-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the DVS-R-200 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2

+6 kV contact

+8 kV air

+6 kV contact

+8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

+2 kV for power supply lines

+1 kV for input/output lines

+2 kV for power supply lines

+1 kV for input/output lines Mains powered quality should be that of a typical commercial or hospital environment. Electrical fast transient/burst IEC 61000-4-4 Surge IEC- 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 3 A/m Power frequency

(50/60 Hz) magnetic field IEC 610000-4-8

+1 kV line(s) to line(s)

+2 kV line(s) to earth

<5 % UT

(>95 % dip in UT ) for 0,5 cycle 40 % UT

(60 % dip in UT ) for 5 cycles 70 % UT

(30 % dip in UT ) for 25 cycles

<5 % UT

(>95 % dip in UT ) for 5 sec

+1 kV line(s) to line(s)

+2 kV line(s) to earth

<5 % UT

(>95 % dip in UT ) for 0,5 cycle 40 % UT

(60 % dip in UT ) for 5 cycles 70 % UT

(30 % dip in UT ) for 25 cycles

<5 % UT

(>95 % dip in UT ) for 5 sec 3 A/m Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the DVS-R-200 requires continued operation during power mains interruptions, it is recommended that the DVS-R-200 be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at level characteristics of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. IEC 60601-1-2 Table 2 Page 10 of 44 DVS System Installation and Setup Guide Guidance and Manufacturers Declaration Electromagnetic Immunity The DVS-R-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the DVS-R-200 should assure that it is used in such and environment. Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz

[3] V

[3] V/m Portable and mobile RF communications equipment should be used no closer to any part of the DVS System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distances d d d

5.3 3 P

5.3 3 P 80 MHZ to 800 MHz 7 3 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitter, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the DVS-R-200 is used exceeds the applicable RF compliance level above, the DVS-R-200 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DVS-R-200. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. IEC 60601-1-2 Table 4 Page 11 of 44 DVS System Installation and Setup Guide Recommended separation distances between portable and mobile RF communications equipment and the DVS Dose Verification System (DVS-R-200). The DVS-R-200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DVS-R-200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DVS-R-200 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d

5.3 3 P d

5.3 3 P d

7 3 P 0,01 0,1 1 10 100 0.12 0.37 1.17 3.69 11.67 0.12 0.37 1.17 3.69 11.67 0.23 0.74 2.33 7.38 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1.8 Changes or Modifications to the System Changes or modifications to the DVS system not expressly approved by Sicel Technologies could void the user's authority to operate the equipment. IEC 60601-1-2 Table 6 Page 12 of 44 DVS System Installation and Setup Guide 1.9 Equipment Supplied Reader Base Station Reader Wand Power Cord -(see Specifications section for appropriate power cord information) Ethernet cord Bar code scanner 1.10 User Equipment Requirements (Not Supplied) The following equipment and software are required to use DVS:

Operating System Requirements:

Personal Computer with LAN or network access for DVS Dosimetry Database

Windows XP Professional, Windows Vista Business, or later The equipment must be certified for the Application and in accordance with National, State, or Local codes. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical services department or your local representative. Page 13 of 44 DVS System Installation and Setup Guide 2 DVS Installation Overview The DVS Software has three parts, the DVS Plan and Review Software (client), and the DVS Dosimetry Database (server), and the DVS Reader configuration. The DVS Dosimetry Database software can be installed on the same computer as the DVS Plan and Review Software or it can be installed on a separate computer on a network (e.g. The DVS Dosimetry Database Server can be installed on a computer or server in a server room or other remote location, and the DVS Plan and Review Software can be installed on several workstations or laptops elsewhere on the clients network). The DVS Plan and Review Software can be installed on multiple computers and connect to a single database server. For administrative purposes, a version of the Plan and Review Software should be installed on the same computer as the DVS Dosimetry Database Server. 2.1.1 System Requirements The DVS Plan and Review and Database Server Software must be installed on machines with the following minimum requirements. Windows XP, Service Pack 1 or later recommended o The DVS Dosimetry Database Server software must be installed on Windows XP Professional machines as it needs access to the Internet Information Server (IIS) functionality that is not installed as part of Windows XP Home Edition. 5 GB (Giga-bytes) free space o min. 200 MB (Mega-bytes) of disk space for the Plan and Review software o min. 4 GB (Giga-bytes) disk space for the DVS Dosimetry Database Server software The Windows XP Firewall should be turned off on the machine where the DVS Dosimetry Database is installed. The following components will be installed during installation. Microsoft Internet Information Services Web Server (IIS) (DVS Dosimetry Database only) Microsoft .NET Framework (.NET) v1.1 SP1 Microsoft Data Access Components (MDAC) v2.7 or newer Microsoft SQL Server 2000 Desktop Engine (MSDE) Release A (SP3a) (DVS Dosimetry Database only) Microsoft SQL Server CE 2.0 Tools (CE Tools) (DVS Dosimetry Database only) 2.1.2 Data Security Database access between the DVS Reader and the DVS Dosimetry Database occurs over a network using Microsofts SQL Server CE and Remote Data Access methods. Database accesses from the DVS Reader are sent using HTTP to the IIS Server on the Database computer which then passes the request to the Database. Neither of these methods is inherently encrypted, and the ability to enable SSL or other internet encryption schemes on the DVS Reader is not supported. Therefore, it is recommended that the DVS Dosimetry Database computer and associated DVS Readers be contained within the same facility unless other measures can be implemented to guarantee data security. Page 14 of 44 DVS System Installation and Setup Guide 2.1.3 Contacting Customer Support For Technical Support, contact Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC Telephone: 1-888-DVS-6697 (1-888-387-6697) E-mail:

27560 helpdesk@siceltech.com 2.2 How to Use this Manual If the intention is to set up the system for the first time or to perform a full clean install (i.e. the database, Plan and Review software, configure the readers), then the installation should proceed as follows:

Install the Plan and Review Software as described in Section 4. Install the DVS Dosimetry Database as described in Section 5 1. 2. 3. Run the Post-Installation Software Configuration instructions from Section 4.1.2. 4. Configure the DVS Reader(s) as instructed in Section 6. If, instead, only the DVS Plan and Review Software is to be installed on machines other than the one where the DVS Dosimetry Database is located, the installation consists of the following:

Install the Plan and Review Software as described in Section 4 1. 2. Run the Post-Installation Software Configuration instructions from Section 4.1.2. Lastly, if additional DVS Readers are being added to an existing installation, simply execute the instructions found in Section 6. Page 15 of 44 DVS System Installation and Setup Guide 3 Network Configuration Checklist The following information is required before attempting to install the DVS Software as this information may be needed during the installation and later configuration of the software. If the information is unknown, consult the clients IT Department. 3.1.1 Network Configuration YES NO Does the network use DHCP to assign IP Addresses?

If Yes, then the following information is required for the computer containing the DVS Dosimetry Database installation:

Database Computer Name:

___________________________ The computer name is identified using the following procedure on the computer where the Database will be installed:

1. Press the Start menu button 2. Right-Click on the My Computer icon and select Properties 3. Select the Computer Name tab 4. The first part of the Full Computer Name entry is the Database Computer Name to use

(e.g. if the entry lists thispc.domain.com, the Database Computer Name would be thispc). If No, then network uses Static IP Addresses, and the following information is required for the network and the computers where the DVS Database will be installed:

Database Computer Static IP Address:

Subnet Mask (usually 255.255.255.0):

Default Gateway:

Primary DNS Server:

Static IP Address for Base Station:

(optional) Alternate DNS Server:

____.____.____.____ ____.____.____.____ ____.____.____.____ ____.____.____.____ ____.____.____.____ ____.____.____.____ Most of this information can be determined using the following procedure:

1. Press the Start menu button, and select Control Panel 2. When the Control Panel window opens, if the link on the left-hand side of the window says Switch to Classic View, press it to switch into Classic View. 3. Double-Click on the Network Connections icon. 4. Right-Click on the Local Area Connection or whichever connection is active and select 5. From the This connection uses the following items list, select Internet Protocol (TCP/IP) Properties and then press the Properties button 6. Record the information displayed. Page 16 of 44 DVS System Installation and Setup Guide 4 Installing the DVS Plan and Review Software The DVS Plan and Review Software is installed on a computer 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. Login to the machine using account with Administrative privileges. 2. If not already done, disable the Windows Firewall. For instruction on how to do this, see Section 4.4. 3. Place the DVS Software Installation CD into the CD-ROM drive. The installation program should start automatically. a. If it does not automatically start, 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. Figure 1 - CD File Checking If the verification process ends with a failure message, press any key to exit the program, and contact Technical Support, otherwise, the installation starts. Figure 2 - CD File Checking Failed Page 17 of 44 DVS System Installation and Setup Guide 4. If the .NET Framework is not installed, then the following message will appear. In this case, execute the procedures in Section 4.2. When completed, execute the procedure in this section once more from the beginning. Figure 3 - .NET Framework NOT Installed 5. If the .NET Framework is installed, but is not at least version 1.1.4322, then the following message will appear. In this case, execute the procedure in Section 4.3. When completed, execute the procedure in this section once more from the beginning. Figure 4 - .NET Framework Version Incorrect 6. On the Welcome panel, click Next >. The Next > and < Back buttons can be used to move forward or backward through the setup applications panels. Clicking Cancel will exit the setup wizard without making any changes to your computer. Figure 5 - Welcome Panel 7. On the Server Setup Option panel, select the Server Setup check box if you want to install the DVS Dosimetry Database on the computer. a. If selected, the DVS System Server Setup program installs the database after the Plan and Review Software installation finishes. Page 18 of 44 DVS System Installation and Setup Guide b. If this check box is cleared, only the Plan and Review Software will be installed. Figure 6 - Server Setup Option Panel 8. 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 software will be installed, click Browse and select a new location using the Open dialog box that appears. Figure 7 - Select Installation Folder Panel 9. Select the Everyone or Just Me option to indicate whether this software will be available to everyone who logs into this computer or only the account used to install the Plan and Review Software. 10. 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. 11. When you are ready to start installing the software, click Next. Page 19 of 44 DVS System Installation and Setup Guide Figure 8 - Confirm Installation Panel 12. The 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 9 - Installing DVS Plan and Review Progress Panel 13. When the DVS Plan and Review Software installation finishes, the Installation Complete panel appears. Click Close to exit the setup wizard. a. b. If the Server Setup check box was selected, then the DVS Server System Software Setup application will launch (see Section 5) before continuing. If the Windows Service Pack Version selected is SP1 or earlier, even when the Server Setup check box is selected, no further installation software will launch after the Plan and Review software is installed. i. In this case, the installation software can be launched manually by double-clicking the DVS Server Setup icon found in the Administrative folder on the desktop (see Section 5) before continuing. Page 20 of 44 DVS System Installation and Setup Guide Figure 10 - Installation Complete Panel 4.1.1 Installation Errors If 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:

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. 4.1.2 Post-Installation Configuration Notes After installing the DVS Plan and Review software, and assuming the DVS Dosimetry Database Server software is also installed, do the following to ensure that the software is installed and configured properly. 1. Launch the DVS Plan and Review software by double clicking on the Plan and Review 2. icon on the desktop. If an Incorrect Version error for the .NET Framework appears, press OK and then execute the procedure in Section 4.3 to upgrade the .NET Framework. When completed, try to launch the software once more before continuing. 4.1.2.1 Setting up Database Connection If the Plan and Review Software is installed on a computer other than the machine where the DVS Dosimetry Database Server is installed, or an error message like the one shown in Figure 11 appears, then do the following:

1. Launch the DVS Plan and Review Application by double clicking on the DVS Plan and Review icon. a. This is accessible inside the Administrative folder on the desktop or from Start ->

All Programs -> DVS -> DVS Plan and Review. Page 21 of 44 DVS System Installation and Setup Guide 2. If the following error dialog box appears (after an approximate 30 second timeout), click No and then skip to Step 5. Figure 11 - Plan and Review Database Detection Error 3. Login as the Admin user (the default password, if not changed, is blank) 4. Select the Database tab so the screen looks like the one below. Figure 12 - Plan and Review Database Configuration Tab 5. Make sure the Database server entry is set to the database computer name from the Network Configuration checklist plus \DVS (e.g. DBSERVER\DVS) a. By default, the value is set to .\DVS which implies the locally installed instance of the DVS Dosimetry Database. 6. Make sure the Catalog name entry is set to DVS 7. Press the Done button. 8. Press the Exit DVS button to close the application. 4.1.2.2 Editing the Admin User By default, the Admin login, which is for administrative access, has a blank password. It is highly recommended that this password be changed. To change the password, do the following:

1. Launch the DVS Plan and Review Application by double clicking on the DVS Plan and Review icon. a. This is accessible inside the Administrative folder on the desktop or from Start ->

All Programs -> DVS -> DVS Plan and Review. Page 22 of 44 DVS System Installation and Setup Guide 2. Enter Admin (case sensitive) in the Login Name text box, and leave the Password text box blank. 3. Click OK. The login dialog box will disappear and the DVS Main Menu will be showing. Figure 13 - Plan and Review Login Dialog Box Figure 14 - Plan and Review Main Menu 4. Press the Administration button to display the DVS Administration window. 5. Click the Users tab, and in the Users List that appears, select the Admin user. 6. Press the Edit button to bring up the DVS User Data Entry dialog box. Page 23 of 44 DVS System Installation and Setup Guide Figure 15 - Plan and Review Administration Users Tab Figure 16 - DVS User Data Entry Dialog Box 7. In the DVS User Data Entry dialog box, edit the user information, password, and authorizations. a. Password - must be numeric (0-9) and at least 4 digits long. Be sure to set a secure password for the default Admin user. b. Authorizations select the tasks you want the user to be able to perform. The Admin user should only have at least Administrator authorization. Administrator authorizations let the user access the Administration dialog box. 8. When finished editing the Admin user, press the OK button to close the dialog box and return to the Users tab. 9. Press the Done button. Page 24 of 44 DVS System Installation and Setup Guide 4.1.2.3 Entering Institution Information and System Options To enter the Institution information and/or set options for the DVS system, do the following:

1. If not already running, launch the DVS Plan and Review Application by double clicking on the DVS Plan and Review icon. a. This is accessible inside the Administrative folder on the desktop or from Start ->

All Programs -> DVS -> DVS Plan and Review. b. Enter Admin (case sensitive) in the Login Name text box c. Enter the Admin users password in the Password text box (blank by default). d. Press the OK button. The login dialog box will disappear and the DVS Main Menu will be showing. 2. Press the Administration button, and then select the Options tab. Figure 17 - Plan and Review Administration Options Tab 3. Edit the information on this screen (e.g. Institution Name, Address). 4. Enter the time in minutes after which you want the DVS Reader to automatically logout. a. To disable automatic logout, set the value to 0 (zero). 5. Select how you want to display measured doses on the DVS Reader Notes screen. The choices are as follows:

a. None b. Percent Error c. Absolute Dose 6. Press the Done button when finished to commit the changes. Page 25 of 44 DVS System Installation and Setup Guide 4.2 Installing the .NET Framework If, during the installation, the application detects that the .NET Framework needs to be installed, it will display a dialog message like the one shown below. To install the .NET Framework, do the following:

Figure 18 - .NET Framework Installation Request 1. Press the Yes button. This will cause another dialog box to appear asking whether to install the Microsoft .NET Framework 1.1 Package. Figure 19 - .NET Framework Installation Confirmation 2. Press the Yes button. This will cause the .NET Framework v1.1 Setup application to be launched using the included installation file(s) on the CD. The following screen will then appear. Note: The .NET Framework version included on the CD (v1.1.4322) does not include the .NET Framework v1.1 Service Pack 1 patch that is required. Figure 20 - .NET Framework v1.1 Setup License Agreement Screen Page 26 of 44 DVS System Installation and Setup Guide 3. Select I agree and then press the Install button to begin the installation. The installation process will take a few minutes. Figure 21 - .NET Framework v1.1 Setup Installation Screen 4. When finished, the following message will be displayed. Press the OK button to close the installation screen. Figure 22 - .NET Framework Installation Complete 5. The following dialog message from the DVS software installation may still be displayed. If so, then perform the procedure in Section 4.3. Figure 23 - Installer Detects Correct Version of .NET Framework NOT Installed Page 27 of 44 DVS System Installation and Setup Guide 4.3 Upgrading the .NET Framework If the message box as shown in Figure 4 is displayed, the version of the installed .NET Framework is not the version required for the Plan and Review software to function properly. There are actually two options to acquire the required version of the .NET Framework:

4.3.1 Option 1 Microsoft Windows Update (Recommended) Microsofts Windows Update is the most automatic way to retrieve and install updates for the operating system installation. To use the Microsoft Windows Update utility, do the following:

1. Press the No button on the dialog message shown in Figure 4. 2. Run the Windows Update utility included with every Windows XP installation a. This can be launched by pressing the Start button, selecting All Programs, and then clicking on the Windows Update icon. b. A Web Browser will launch. 3. After the Windows Update page is loaded, two buttons will be visible in the main section of the page. Press the Custom button to start the updates detection process. a. Pressing the Express button is also valid, but in this case, Steps 4 through 6 can be skipped. 4. When the list of updates appears, find and select the update named Microsoft NET Framework 1.1. Service Pack 1 (i.e. Make sure the items check-box is checked). 5. Press the Review and install updates link 6. After the summary page loads, press the Install Updates button. 7. After the update is installed, the computer will request a reboot. Reboot the computer. 4.3.2 Option 2 Download and Install 1. Press the No button on the dialog message shown in Figure 4. 2. Make sure the Plan & Review CD-ROM is still in the CD-ROM drive. Open the CD-ROM folder. In the CD-ROM folder, double-click on the file "NDP1.1sp1-KB867460-X86.exe". The following window will appear. 3. Figure 24 - .NET Framework v1.1 SP1 Installation Confirmation 4. Press the OK button. The License Agreement screen will appear (see Figure 25). Page 28 of 44 DVS System Installation and Setup Guide Figure 25 - .NET Framework v1.1 SP1 Setup License Agreement Screen 5. Press the I accept button to commence the installation. 6. The installation will commence and when complete, the following dialog box will be shown. Press OK to complete the installation. Figure 26 - .NET Framework v1.1 SP1 Installation Complete 7. The following message will appear. Do the following:

a. Remove the CD from the CD-Drive. b. Press the Yes button to reboot the system Figure 27 - Reboot Required 8. When the reboot operation is complete, re-insert the CD to restart the installation. 4.4 Windows Firewall On the computer on which the DVS Dosimetry Database software is to be installed, the Windows Firewall (a feature built-in to Windows XP) should be disabled. Depending on the Service Pack level of the Windows XP installation, this can be done in different ways. Page 29 of 44 DVS System Installation and Setup Guide 4.4.1 Service Pack 1 or Earlier The Windows Firewall in Service Pack 1 or earlier versions of Windows XP can be customized for each network connection that is setup. In order to disable the Windows Firewall, do the following:

1. Press the Start menu button, and then select Control Panel 2. When the Control Panel window appears, check the left-hand side of the window. a. If a link that says Switch to Classic View exists, press it to switch into classic view. 3. Double-Click on the Network Connections icon. 4. Right-Click on the Local Area Connection or whichever connection is active and select Properties 5. Press the Advanced tab and make sure the check-box is cleared. Figure 28 - Windows XP SP1 Firewall Configuration 6. Close the Connection Properties dialog box and then close the Control Panel window. 4.4.2 Service Pack 2 Starting with Windows XP Service Pack 2, the Windows Firewall is a system service and is accessible directly from the Windows Control Panel. In order to disable the Windows Firewall, do the following:

1. Press the Start menu button, and select Control Panel 2. When the Control Panel window appears, check the left-hand side of the window. a. If a link that says Switch to Classic View exists, press it to switch into classic view. 3. Double-Click on the Windows Firewall icon to launch the Windows Firewall utility Page 30 of 44 DVS System Installation and Setup Guide Figure 29 - Windows Firewall Utility 4. Make sure that the Off option is selected in the General tab to indicate that the Windows Firewall is turned OFF. 5. Close the Windows Firewall utility and then close the Control Panel window. Page 31 of 44 DVS System Installation and Setup Guide 5 Installing the DVS Dosimetry Database Software Note: The DVS Dosimetry Database stores the client and dosimeter measurement data. It is accessed using the DVS Plan and Review software. Even if the Plan and Review software is installed on other computers, it is recommended that the Plan and Review software also be installed on the same computer as the DVS Dosimetry Database Server. SP1 SP2 None Select the Windows XP Service Pack Version for the machines where the DVS Dosimetry Database will be installed. I the Server Setup checkbox was selected during the CD installation, the DVS Dosimetry Database and its associated software will be installed. The process of installing the DVS Dosimetry Database involves the installation or configuration of the following items, and should be handled automatically by the installation program. Create a Microsoft SQL Server 2000 Desktop Engine (MSDE) instance called DVS which will be the actual database engine. Install or configure the Microsoft SQL Server CE 2.0 Tools to allow access to the newly created MSDE instance. Install or configure the machines Internet Information Services (IIS) application to provide access for remote devices like the DVS Reader to gain access to the DVS Dosimetry Database via Remote Data Access (RDA) Components. o These components use HTTP access through the local web server (IIS) to communicate with the database. Configure or seed the database with the default configuration items for a new DVS Dosimetry Database installation. To install the DVS Dosimetry Database Server and the Dosimetry Database, perform the following steps:

1. Before going forward, verify that the Windows Firewall is disabled (see Section 4.4 if unsure). 2. On the computer where the DVS Dosimetry Database Server is to be installed, perform the steps for Installing the DVS Plan and Review Software first (see Section 4). a. Be sure to select the Server Setup check box on the Server Setup Option panel in the DVS Plan and Review Setup Wizard. 3. When the DVS Plan and Review Setup Wizard completes, the DVS Server System Software Setup window appears. a. If the window does not appear, then launch the DVS Server System Software Setup application by opening the Administrative folder on the desktop and then double-click on the DVS Server Setup icon. Note: For installations on Windows XP SP1 and earlier, the DVS Server System Software Setup may NOT automatically launch after a Plan and Review installation. Page 32 of 44 DVS System Installation and Setup Guide Figure 30 - DVS Server System Software Setup Application Main Window 4. Click the Setup Server Components button. Several windows may appear while MSDE Database Engine installs. 5. Once completed, the application checks to see if the Microsoft Internet Information Services Web Server (IIS) is installed or not. a. b. If IIS is already installed, then the installation will skip to Step 7. If not, the following dialog box appears. Click Yes. Figure 31 - IIS Installation Message 6. During IIS installation, the following dialog box may appear to indicate the setup application may need system files from the Windows XP Professional Operating System Installation CD if they are not found on the computer. Click Yes to continue. a. If the Windows XP Professional CD Auto-Launch Window appears (see Figure 33), press the Exit button as the configuration should be handled automatically. Figure 32 - IIS Installation CD Needed Message Page 33 of 44 DVS System Installation and Setup Guide Figure 33 - Windows XP Professional CD Auto-Launch Window 7. When the IIS installation is complete, the following dialog box appears. Click OK to start the SQL Server CE Tools Setup Wizard. Figure 34 SQL Server CE Tools Pre-Installation Message Figure 35 - SQL Server CE Tools Setup Wizard Page 34 of 44 DVS System Installation and Setup Guide 8. Click Next to continue with the installation. 9. The License Agreement panel should appear. Select the I Agree option and then press the Next button. Figure 36 - License Agreement Panel 10. On the Specify a Destination Folder panel, it is recommended (though not required) that the default locations be kept, so click the Next button. Figure 37 - Specify a Destination Folder Panel 11. On the Start the Installation panel, click Next. a. When the SQL Server CE Tools Setup Wizard begins, the setup program displays a number of windows as it installs the software and configures the database. Page 35 of 44 b. DVS System Installation and Setup Guide If a message box showing When the SQL Server CE Connectivity Management screen is displayed, please double-click on Create a Virtual Directory and allow the wizard to complete. appears, press the OK button. Figure 38 - Start the Installation Panel 12. 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. a. Regardless of the Windows XP Service Pack level of the machine where the software is installed, if IIS has to be installed, the DVS Server System Software Setup will issue an OSQL error like the one shown below. To correct this, run the procedure in Section 5.1.1 before proceeding to the next step. Figure 39 - OSQL Exception Error Page 36 of 44 DVS System Installation and Setup Guide Figure 40 - Setup Complete 13. Click the Close (X) button to exit the setup program. 5.1.1 Installation Errors If the DVS Server System Software Setup application continues to fail for an extended period of time or an error message box appears with a title OSQL Failed and message of Failed on exception. The system cannot find the file specified., do the following to correct the problem. 1. Stop the Installation by pressing the Stop button in the DVS Server System Software Setup applications main window. 2. Close the DVS Server System Software Setup application by pressing the Close (X) button. 3. From the Administrative folder on the desktop, double-click on the DVS Server Setup icon to re-launch the DVS Server System Software Setup application. 4. Press the Setup Server Components button to complete the installation. a. In most cases, this is where the Database will be configured so a Command Prompt window will appear during this configuration. 5. When the installation is completed, the All SERVER COMPONENTS FULLY INSTALLED message should appear in the Component Status window. a. If it doesnt, contact Technical Support for more assistance (see Section 2.1.3). 5.1.2 Backing up the DVS Dosimetry Database There are two ways to perform backups of the DVS Dosimetry Database. 1. Manually - Consult Backing up and Restoring the DVS Database in Section 5.5 of the DVS Operator Manual (Part Number 934-00553-00). 2. Automatically - Information on setting up and performing these operations can be obtained from technical support (see Section 2.1.3) and requesting document number 934-00552-04. Page 37 of 44 DVS System Installation and Setup Guide 6 Installing the DVS Reader To set up the DVS Reader so that it can properly communicate with the DVS Dosimetry database, the following steps need to be performed:

Unpack the Reader Components Choose a Location Make the Connections Power on the Reader Connect to the DVS Dosimetry Database 6.1 Unpack the Reader Components Carefully remove the Reader Components from the shipping cartons. Confirm the following components have been provided:

Reader Wand Reader Base Station Power Cord, Hospital Grade, 10 feet or 3 meters Ethernet Cable, CAT 5e FTP, Shielded, 3 meters Bar Code Scanner 6.2 Choose a Location Find 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 wall-mounted pole. If the DVS Reader is attached to a pole, the pole should be 1.25 in diameter and able to support at least 25 pounds. It is important to consider the following when choosing a location for the DVS Reader. Near an electrical outlet Near a local area network (LAN) connection Not in the radiation path of the linear accelerator 6.3 Make the Connections There are three physical connections that must be made for the DVS Reader to properly operate:

1. Reader Wand -Connect the Reader Wand cable to the back of the Reader Base Station. Turn the connector until it is securely in place. 2. Ethernet Cable - Connect the Ethernet cable to the back of the base station and then to a LAN connection in the room. 3. Power cord - Connect the power cord to the back of the base Note: There is also a USB connection on the back of the Base Station used for field service and/or future upgrades. 6.4 Barcode Scanner Connections Connect one end of the USB cable into the end of the barcode scanner. Press the cord in firmly to assure a proper connection. Plug the opposite end of the cable into a USB port on a computer containing the DVS Plan and Review software application. Page 38 of 44 DVS System Installation and Setup Guide To test the barcode scanner, depress the trigger. A red line should appear. If the redline doesnt appear, check the connection between the cable and barcode scanner. 6.5 Power on the Reader To power on the Reader, use the switch on the back of the base station near the power cord. It may take a few seconds before anything appears on the screen while the DVS Reader boots up. 6.6 Connecting to the DVS Dosimetry Database Each time the DVS Reader is booted, it starts its own initialization process (see the screenshots below) before it launches into the main application. Figure 41 - DVS Reader Initialization Screen Figure 42 - Main Application Initialization Screen In order to configure the application so that it can properly connect to the DVS Dosimetry Database, the application must be configured within its Administration options screen. To do this, do the following:

Page 39 of 44 DVS System Installation and Setup Guide 1. Obtain the Administrative Login Password of the Day from Technical Support (see Section 2.1.3). 2. After booting the DVS Reader, when the Initializing DVS Reader screen appears, press the Login as Administrator button. a. If you fail to press this button before it disappears (roughly 3 seconds), wait for the Cannot access the Dosimetry Database. message box to appear, press the OK button and the application will start its re-initialization process and the Login as Administrator button will re-appear. 3. When the Login screen appears, select Administrator from the users. 4. Press the Password text box, and then using the on-screen key-pad that appears, enter the Password of the Day and then press the Enter button. 5. When the key-pad disappears, press the Scan Patient button to log in as the Administrator. The Administration screen will appear. 6. 7. 8. Figure 43 - Administrative Options Screen In the Database Server field, enter the IIS Server value you just entered followed by the SQL server instance name for the DVS Dosimetry Database, which is usually \DVS. a. For example, if the DVS Dosimetry Database is installed on a machine called DBSERVER, then the Database Server value entered would need to be DBSERVER\DVS. In the IIS Server text box, use the on-screen keyboard that appears when the text box is touched to enter the Computer Name of the machine where the DVS Dosimetry Database is installed (if unsure, check the Network Configuration Checklist, Section 3). If you are using Anonymous Access (default), leave the Use Anonymous Access checkbox checked, otherwise, do the following:

a. Un-check the Use Anonymous Access checkbox. The Username and Password text fields will become enabled (white). b. Select the Username text field and using the on-screen keyboard, enter the Web Access username to use. Press Enter to commit the changes, or Cancel to undo them. c. Select the Password text field and using the on-screen keyboard, enter the Web Access password to use. Press Enter to commit the changes, or Cancel to undo them. 9. Select the Local Time Zone from the drop-down list box. 10. (optional) Select the Automatically Adjust for Daylight Saving Time check box. Page 40 of 44 DVS System Installation and Setup Guide a. The date and time are automatically set when the DVS Reader connects to the DVS Dosimetry Database Server. 11. Press the Save button to commit the changes made. 12. Wait for the Initializing DVS Reader screen to appear and then turn off the DVS Reader. 13. Turn ON the DVS Reader. Yes No If No, then execute the process in Section 6.7, and when complete, restart this section. Otherwise, configuration is complete. Does the network use DHCP to assign IP Addresses? If unsure, check the Network Configuration Checklist (see Section 3). Page 41 of 44 DVS System Installation and Setup Guide 6.7 Configuring DVS Reader for Static IP Addressing In cases where the network connecting the DVS Reader to the DVS Dosimetry Database uses static IP Addressing, the DVS Reader must be configured to support this. When in the Administrator screen, do the following. If not in the Administrator screen, execute Steps 1 through 5 in Section 6.6. 1. Connect a USB Keyboard using the USB Port on the back of the DVS Reader. 2. When the Administration screen appears, press Ctrl + Alt + Delete on the attached USB keyboard. 3. When the Windows Taskbar appears, either press the End Task button on the touch screen or press the Tab button twice on the USB keyboard and then press the Enter button on the keyboard to exit the DVS Reader Application. 4. On the error box that appears, press the Quit button on the touch screen to close it. The Windows desktop should now be showing. 5. Press the Start menu button, then Settings, and then Network and Dial-Up 6. Double-Click on the PCI-RTL81392 connection (or which-ever is currently enabled). The configuration options dialog will appear. Connections. Figure 44 - DVS Reader Network Connection Settings Dialog 7. On the IP Address tab, enter the information as gathered from the Network Configuration Checklist (Static IP Address for the Base Station, Subnet Mask, Default Gateway) in Section 3. 8. Press the Name Servers tab and enter the Primary and Alternate DNS Server values (if known) as gathered from the Network Configuration Checklist. 9. Press OK to close the configuration options dialog. 10. Turn Off the DVS Reader. 11. Turn On the DVS Reader. Page 42 of 44 DVS System Installation and Setup Guide 7 System Specifications Parameter Rating Time to Read Dosimeter Up to 10 minutes following radiation therapy. Optimal read time is 2 to 3 minutes following irradiation. Power RF Frequency Transmission Effective Radiated Power

(ERP) Inputs/Outputs Power Cord 10ft (3.05m) maximum length Operating Conditions Storage and Transport Conditions Fuse Classification Mode of Operation 110-240V~, 50-60 Hz 1A @ 120V~ , 0.5A @ 240V~

133 kHz Backscatter modulation 12.1 dBm (16.2mW) 1-Ethernet port 1-Wand Cable Assembly Connection 1-USB Connection (For Field Service Use Only) US & Canada Hospital Grade cordset 10A/120V/60Hz with NEMA 5-

15 plug & IEC 60320 C13 connector UK, Ireland, Cyprus, & Malta International style cable 10A/230V/50Hz with BS 1363 plug & IEC60320 C13 connector France, Spain, Belgium, Czech Republic, & Slovakia International style cable 10A/230V/50Hz with CEE7/7 plug and IEC 60320 C13 connector Italy International style cable 10A/230V/50Hz with CEI 23-16/VII plug

& IEC60320 C13 connector Denmark International style cable 10A/230V/50Hz with Afsnit 107-2-

D1 plug & IEC 60320 C13 connector Switzerland International style cable 10A/230V/50Hz with SEV1011 plug & IEC60320 C13 connector Remaining members of the European Union International style cable 10A/230V/50Hz with CEE7/7 plug & IEC 60320 C13 connector Please contact Technical Support with any questions regarding power cords Temperature: 10C to 40C (50F to 104F). Humidity at 10% to 95%, non-condensing Pressure: 700 hPa-1060 hPa System not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Temperature: -18C to 55C Humidity at 10% to 95%, non-condensing Pressure: 700 hPa-1060 hPa Type T2AL250V ; 5x20mm or 3AG- X 1 Class I equipment, Type B Applied Part IPX0 Continuous Operation Page 43 of 44 DVS System Installation and Setup Guide 8 Technical Support and Product Service For technical support or to request product servicing, contact the local representative or , Sicel Technologies, Inc. Telephone: 1-888-DVS-6697 (1-888-387-6697) / Outside the US: 1-919-465-2236, ext. 361 E-mail: helpdesk@siceltech.com Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560 USA Page 44 of 44 Manufactured by: Sicel Technologies, Inc. 3800 Gateway Centre Blvd, Suite 308 Morrisville, NC 27560 Toll-free tech support (US): 1-888-DVS-6697 Fax: (919) 465-0153 www.dvssmartmarker.com

DVS operator manual Technology DVS DOSE VERIFICATION SYSTEM Operator Manual Caution: Federal Law restricts the use of this device to sale by or on the order of a physician. DVS Dose Verification System 20062007 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. in the United States. SmartMarker is a registered trademark of Sicel Technologies, Inc. in the United States. Part Number: 934-00553-00 rev. 08 Model #: DVS-R-200 FCCID: TS9-DVS-R-200 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Warning: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the DVS-R-

200 or shielding the location. Note: For Qualified Service Personnel Only. 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. T a b l e o f C o n t e n t s TABLE OF CONTENTS 1 Welcome ................................................................................... 1 1.1 Product Description ..................................................................... 2 1.2 Intended Use ................................................................................ 2 1.3 Contraindications, Warnings, Cautions, and Notes ..................... 2 Contraindications .................................................................. 3 Warnings .............................................................................. 3 Cautions ................................................................................ 4 Notes ..................................................................................... 5 1.4 Symbols ....................................................................................... 5 1.5 Glossary of Terms ....................................................................... 7 1.6 Statement of Compliance ............................................................. 7 Changes or Modifications to the System .............................. 8 1.7 Essential Performance ................................................................. 8 1.7 Equipment Supplied .................................................................... 8 1.8 User Equipment Requirements (Not Supplied) ............................. 9 2 Dose Verification System Overview ...................................... 10 2.1 DVS Dosimeter ......................................................................... 11 2.2 DVS Reader System .................................................................. 12 2.3 DVS Software ............................................................................ 13 2.4 Bar Code Scanner ...................................................................... 13 2.5 DVS Insertion Tool ................................................................... 13 3 System Configuration ............................................................. 14 3.1 Configuring the DVS Software After Installation ..................... 14 Setting up the Database Connection ................................... 14 Editing the Admin User ...................................................... 16 Entering Institution Information and System Options ........ 19 3.2 Setting Up the DVS Reader ....................................................... 20 Choose a Location .............................................................. 20 Make the Connections ........................................................ 20 Barcode Scanner Connections ............................................ 21 Power on the Reader ........................................................... 21 Connect to the DVS Dosimetry Database .......................... 21 4 Quick Start Instructions .......................................................... 25 4.1 Step 1 - Test Dosimeters ............................................................ 25 4.2 Step 2 Implant Dosimeters and Record Implant Information . 26 4.3 Step 3 Enter Patient Information Into the Plan and Review Software ............................................................................................ 27 4.4 Step 4 Measure Radiation Pre-dose and Post-dose Values Using The DVS Reader .................................................................... 29 DVS Dose Verification System 5 Using the Plan and Review Software...................................... 31 5.1 Logging into the DVS Plan and Review Software .................... 31 5.2 DVS Main Menu Overview ....................................................... 32 5.3 Working With Patient Information ............................................ 33 Adding, Editing, and Viewing Patients .............................. 33 Entering Patient, Dosimeter, and Plan Information ............ 34 Entering Patient and Physician Information ....................... 35 Entering Dosimeters ........................................................... 36 Entering Plans ..................................................................... 39 Changing or Deleting Dosimeters ...................................... 39 Working with Measurement Fractions and Skipped Fractions ............................................................................. 41 Deleting a Fraction ............................................................. 42 Inserting Skipped Fractions ................................................ 42 Changing Information for a Fraction .................................. 43 5.4 Viewing Patient Results ............................................................. 44 Displaying a List of Patient Results ................................... 44 Viewing Results Charts ...................................................... 45 Viewing Results Reports .................................................... 48 5.5 DVS System Administration ..................................................... 50 Adding and Editing DVS Users .......................................... 50 Changing Institutional Information and System Options ... 52 Changing the Database Connections .................................. 53 Backing up and Restoring the DVS Database .................... 54 6 Using the DVS Reader ............................................................ 56 6.1 Power On the DVS Reader and Power Off ................................ 56 6.2 Log in to the DVS Reader ......................................................... 57 6.3 Test a Dosimeter ........................................................................ 59 6.4 Scan a Patient ............................................................................ 62 Select a Patient ................................................................... 62 Select a Plan/Fraction ......................................................... 63 Take a PRE-Dose Reading ................................................. 64 Dose the Patient .................................................................. 66 Take a POST-Dose Reading ............................................... 67 Enter Treatment Notes ........................................................ 68 7 Troubleshooting ...................................................................... 70 7.1 Troubleshooting the DVS Server System Software Setup ......... 70 7.2 DVS Reader Not Operational .................................................... 70 7.3 Unable to Obtain a Pre-Dose or Post-Dose Reading ................. 70 7.4 DVS Reader Error Messages ..................................................... 71 7.5 Plan and Review Software Error Messages ............................... 75 ii T a b l e o f C o n t e n t s DVS Dose Verification System 8 Maintenance and Technical Support ....................................... 81 8.1 Reader Maintenance .................................................................. 81 8.2 Database Maintenance ............................................................... 81 8.3 Dosimeter Maintenance ............................................................. 81 8.4 Cleaning the Reader Wand and Reader Base Station ................ 81 8.5 Technical Support and Product Service ..................................... 82 8.6 Disposal and Recycling ............................................................. 83 9 Specifications .......................................................................... 84 iii DVS Dose Verification System iv W e l c o m e 1 WELCOME The Dose Verification System Operator 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, cautions and warnings, and summaries of the conventions, symbols and terms used in the Operator 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 System Configuration 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 Troubleshooting provides guidance if you encounter issues or errors while using DVS. Section 8 Maintenance and Technical Support provides information on maintaining DVS and getting technical support. Section 9 Specifications provides the technical specification for the DVS system. 1 DVS Dose Verification System 1.1 Product Description DVS provides an oncologist with information about the actual radiation dose delivered to a patients 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. The DVS Dosimeter is able to be visualized and used as a radio-opaque treatment area marker in IGRT (Image Guided Radiation Therapy) using ultrasound, kV planar images, kV CBCT (Cone Beam Computed Tomography), and MV CT/CBCT. 1.2 Intended Use DVS 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 Notes See Dosimeter Instructions for Use. The following section explains the 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. 2 DVS Dose Verification System Contraindications W e l c o m e The Reader Wand may not be used on patients who are already implanted with other electronic devices such as pacemakers, or insulin pumps. The impact of the potential electronic interference is unknown. Do not allow patients with a DVS Dosimeter to receive the following treatments: shortwave diathermy, microwave or therapeutic ultrasound. These could result in serious injury. Warnings 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. Electric Shock Hazard Do not remove the covers of the Reader or Reader Wand assemblies. Do not open the case or touch the internal parts. The DVS Reader and Reader Wand contain no user serviceable internal parts. Contact the local representative for technical support and 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. Electric Shock Hazard Do not use in wet environment. May result in electrocution. Only use the manufacturer-supplied power cord. Replace fuse only with same type and rating: 2 AMP, 250V Time-Lag Fuse. Failure to replace the fuse with the same type and rating may pose a fire hazard. 3 DVS Dose Verification System 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 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. Clean the Reader Wand after direct skin contact using isopropyl alcohol-

based disinfectants. 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. Interference from the CRTs may result in reduced read range. 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. Do not store dosimeters near stray radiation. 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. 4 W e l c o m e DVS Dose Verification System 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. 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. Notes The dosimeter is factory calibrated and does not require calibration during use. 1.4 Symbols SYMBOL DESCRIPTION Indicates an attention to users to consult accompanying documents (Dosimeter Instructions for Use) for more information on the device. Type B Equipment 5 DVS Dose Verification System Protective earth (ground) ON OFF Manufacturer Date of Manufacture (YYYY-MM-DD or YYYY-MM) Catalog Number Do not use if package is damaged. Serial Number Fragile, handle with care. Consult Instructions for Use. Temperature Limitation Keep dry. Non-ionizing radiation 6 W e l c o m e DVS Dose Verification System 1.5 Glossary of Terms Base 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 radiation CT Computed Tomography Dosimetry 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. Plan Dosimetric representation of a prescribed radiation treatment course. Predicted Dose The dose, in cGy, expected at a dosimeter for a treatment session. Reader 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 Compliance IEC/EN/UL 60601-1 DVS has been tested and complies with the following standards:

CSA C22.2 No. 601-1-M90 FCC 47 CFR Part 15 - Subpart C RTT&E Directive, 1999/5/EC IEC/EN/UL 60601-1-2 7 DVS Dose Verification System Note: 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 the users own expense. Changes or Modifications to the System Changes or modifications to the DVS system not expressly approved by Sicel Technologies could void the user's authority to operate the equipment. 1.7 Essential Performance The Essential Performance of the DVS System is:

Interpretation (dose calibration algorithm) of dosimeter data for accurate dose response storage/display error free data transmission (dosimeter to database) mechanical integrity during normal use for protection from maintenance of the integrity of the protective earth con-

electrical hazards nection 1.7 Equipment Supplied Reader Base Station Reader Wand Ethernet cord 8 DVS Dose Verification System Power cord - (see Specifications section for appropriate power cord information) Bar Code Scanner W e l c o m e 1.8 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 Professional, Windows Vista Business, or later The equipment must be certified for the Application and in accordance with National, State, or Local codes. Accessory equipment connected to the analog and digital interfac-

es must be certified according to the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is there-

fore responsible that the system complies with the requirements of IEC 60601-1-1. If in doubt, consult the technical services depart-

ment or your local representative. 9 DVS Dose Verification System 2 DOSE VERIFICATION SYSTEM OVERVIEW The 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 photon beam 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. 10 DVS Dose Verification System 2.1 DVS Dosimeter The 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 ethylene oxide. In the tissue, the dosimeter provides a radio-

opaque image that registers on a dose planning computed tomography (CT) scan. The measured dose data can be compared with the prescribed dose plan. D o s e V e r i f i c a t i o n S y s t e m O v e r v i e w Figure 1 DVS Dosimeter Each 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. 11 2.2 DVS Reader System DVS Dose Verification System The 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 DVS Reader). 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 patients 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. Figure 2 DVS Reader 12 D o s e V e r i f i c a t i o n S y s t e m O v e r v i e w DVS Dose Verification System 2.3 DVS Software The 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. 2.4 Bar Code Scanner The 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 Tool The 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 Tool 13 DVS Dose Verification System 3 SYSTEM CONFIGURATION The Dose Verification System has three main components that you need to setup:

DVS Plan and Review Software DVS Dosimetry Database Server DVS Reader Refer to the Installation and Set Up Guide, 934-00553-02, for installing and setting up the DVS Software and Reader. 3.1 Configuring the DVS Software After Installation After 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 Preferences Setting up the Database Connection If 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:

14 DVS Dose Verification System 1. Double click the DVS Plan and Review icon on the Desktop or select Start>Programs>DVS>DVS Plan and Review. This application will launch and attempt to connect to the DVS database. If it cannot connect after a 30 second pause, the following error dialog box appears. S y s t e m C o n f i g u r a t i o n 2. Click No. The DVS Administration window appears. Figure 4 DVS Administration 3. 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>\DVS 15 DVS Dose Verification System By 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. If the DVS Database is located elsewhere on a different computer, the name of that computer will be <servername>. 5. Click Done. If the application connects successfully, the DVS Login dialog box appears. If the application connection is unsuccessful, the error dialog box appears and steps 2-5 should be repeated with the correct information. Editing the Admin User By default, an Admin login name with no password is setup in the DVS system so that you can log in 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. Double 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 5 DVS Login 2. In the Login field, enter Admin (case sensitive) and leave the Password field blank. 16 DVS Dose Verification System 3. Click OK. The DVS Main Menu for the DVS Plan and Review Software appears. S y s t e m C o n f i g u r a t i o n Figure 6 DVS Main Menu 4. Click Administration to display the DVS Administration window. Figure 7 DVS Administration 5. Click the Users tab. 17 DVS Dose Verification System 6. Select the Admin user from the User List and click Edit. Figure 8 User Data Entry 7. 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. 18 DVS Dose Verification System Entering Institution Information and System Options To enter institution information and set the options for DVS, perform the following steps:

1. Double 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. S y s t e m C o n f i g u r a t i o n 4. Click Administration. 5. Click the Options tab. Figure 9 Options 6. 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). 19 DVS Dose Verification System 8. Select how you want to display measured doses on the DVS Reader Notes screen:

None Percent Error Absolute Dose 9. Click Done when finished. 3.2 Setting Up the DVS Reader To set up the DVS Reader, perform the following steps:

Choose a Location Make the Connections Power on the Reader Connect to the DVS Dosimetry Database Choose a Location Find 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 accelerator Make the Connections DVS Reader Base Station Connections are three connections to the Reader Base Station 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. 20 DVS Dose Verification System S y s t e m C o n f i g u r a t i o n 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. Barcode Scanner Connections Connect one end of the USB cable into the end of the barcode scanner. Press the cord in firmly to assure a proper connection. Plug the opposite end of the cable into a USB port on a computer containing the DVS Plan and Review software application. To test the barcode scanner, depress the trigger. A red line should appear. If the redline doesnt appear, check the connection between the cable and barcode scanner. Power on the Reader To power on the Reader, use the switch on the back of the base station near the power cord. The Power On screen may take one to two minutes to appear. Connect to the DVS Dosimetry Database After powering on the Reader, you need to set up the connection to the DVS Dosimetry Database. 1. Contact Sicel technical support, and get the Administrator password-of-the-day. 21 DVS Dose Verification System Figure 10 Power On 2. On the Initializing DVS Reader screen, press Login as Administrator. Figure 11 Initializing DVS Reader 3. Select Administrator in the user list. 4. Press the Password field to display the numeric keypad. Enter the password-of-the-day received from technical support. Press Enter. 22 DVS Dose Verification System 5. On the Database Server field, enter the server name and SQL server instance. For example:

<server>\DVS where <server> is the name of the database server computer. S y s t e m C o n f i g u r a t i o n Figure 12 Administration 6. In the Reader Administration 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. 7. (Optional) Determine whether Anonymous Access should be used to communicate with the DVS database. If Anonymous Access is used, verify that the checkbox is checked (default). If Anonymous Access is not required, uncheck the checkbox for web server access. Enter the username and password in the fields provided by using the onscreen keypad. 8. Select the local time zone from the drop-down list box. 9. (Optional) Select the Automatically Adjust for Daylight Savings Time check box. The date and time is automatically set when the DVS Reader connects to the DVS Dosimetry Database Server. 10. Press Save. 23 DVS Dose Verification System 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. 24 Q u i c k S t a r t I n s t r u c t i o n s DVS Dose Verification System 4 QUICK START INSTRUCTIONS This section provides an overview of the workflow for using the DVS system:

Step 1 Test Dosimeters (recommended) Step 2 Implant Dosimeter and Record Implant Information Step 3 Enter Patient Information into the Plan and Review Software Step 4 Measure Radiation Pre-Dose and Post-Dose Values Using the DVS Reader 4.1 Step 1 - Test Dosimeters Using the DVS Reader, you can test dosimeters before sending them to surgery. This assures that the dosimeters are working properly. This step is encouraged but not required. Important: Do not remove the dosimeters from the package because this will compromise sterility. Dosimeters can be scanned through the package. Check the expiration date on the outer package to ensure sterility. 1. Log in to the DVS Reader. 2. Press Test Dosimeter on the Reader Login screen. 3. Hold the Reader Wand near the dosimeter. 25 DVS Dose Verification System 4. Press and release the button on the Reader Wand to scan the dosimeter. Below the status bar, the DVS Reader displays one of the following messages:

Dosimeter <number> was found the dosimeter is functional. No dosimeter found the dosimeter could not be located. Attempt to read again. Dosimeter xxxxxx found. MOSFET is not functional there is a problem with the dosimeter. Contact the local representative for technical support. 5. Press Logout to exit. 4.2 Step 2 Implant Dosimeters and Record Implant Information Verify that the DVS Dosimeter and insertion tool package sterility have not been compromised, are not expired, and that the items have not been contaminated prior to implantation. At surgery, specify the implant location of each dosimeter on the transfer labels provided. The transfer label information aids the dosimetrist in identifying the dosimeters on a CT scan. For each dosimeter, retain one transfer label in the surgical records and return the other to Radiation Oncology. 26 DVS Dose Verification System 4.3 Step 3 Enter Patient Information Into the Plan and Review Software Using the Plan and Review Software, enter the patients demographic information and dose planning information. Ensure that the predicted dose at the dosimeter was obtained by measuring the point dose 1.3 mm from the end of the capsule opposite the antenna (Figure 13 DVS Dosimeter Sensitive Volume). Use a CT scout film or radiograph to determine dosimeter orientation within the patient (Figure 14 CT Scout and Transverse Images). Q u i c k S t a r t I n s t r u c t i o n s Figure 13 DVS Dosimeter Sensitive Volume 27 DVS Dose Verification System Figure 14 CT Scout and Transverse Images 1. Log in 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 patients name. c. Enter the physicians name (this is generally the attending radiation oncologist). 28 Q u i c k S t a r t I n s t r u c t i o n s DVS Dose Verification System 5. Click Add Dosimeter to assign the implanted dosimeters to the patient. a. Scan the dosimeters bar code. The bar code contains the dosimeters serial number and calibration information. b. Enter the implant location for each dosimeter from the transfer labels. 6. Click Add Plan and add the patients 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). Verify the dose fraction range for the dosimeter from the dosimeters Instruction for Use, specifications section. Values outside this range will result in an error message:

This predicted dose is outside the typical range of xxx to xxx cGY. Are you sure you want to use this value?

Note: Additional plans may be added at any time. 4.4 Step 4 Measure Radiation Pre-dose and Post-dose Values Us-

ing The DVS Reader 1. Log in 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 patients treatment area until the Reader scans and reads all the dosimeters. 6. Proceed with radiation therapy. 29 DVS Dose Verification System 7. Press Next on the Reader to display the POST-Dose Reading screen. 8. Read the dosimeters post-dose values within 10 minutes of the completion 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 patients treatment area until the Reader scans and reads all the dosimeters again. 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. 30 DVS Dose Verification System 5 USING THE PLAN AND REVIEW SOFTWARE The Plan and Review Software is used to:

Enter patient, dosimeter, and plan information Review results from the patients dosimeters Maintain the authorized user list Setup system options 5.1 Logging into the DVS Plan and Review Software To log in to 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 15 DVS Login). U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 15 DVS Login 2. Enter the Login Name and Password that were assigned to you by the DVS Administrator. 3. Click OK. 31 DVS Dose Verification System 5.2 DVS Main Menu Overview The DVS Main Menu contains five buttons as shown in Figure 16 DVS Main Menu:

Patient Information Enter or edit patient, dosimeter, and plan information (see Working With Patient Information) Patient Results View charts and reports for the patients dosimeter results (see Quick Start Instructions) Administration Maintain the list of authorized users, and set DVS options (see DVS System Administration) Exit DVS Exit the Plan and Review Software About Show software version and copyright information Note: Depending on the users authorization level, some of these buttons may be disabled. For more information, see Adding and Editing DVS Users. Figure 16 DVS Main Menu 32 DVS Dose Verification System 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 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 17 Patient Selection for Editing). U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 17 Patient Selection for Editing 33 DVS Dose Verification System 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. If a patient has been entered, but neither a plan nor dosimeters have been added to the patient record, then the patient is not active and will not be listed. 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 patients 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 patients information, select the patient in the list and click View/Edit. The Patient Data Entry window appears. You can enter the new patients 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. Entering Patient, Dosimeter, and Plan Information To edit patient, dosimeter, and plan information, click Add or View/Edit on the Patient Selection for Editing window to display the Patient Data Entry window (Figure 18 Patient Data Entry). 34 DVS Dose Verification System U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 18 Patient Data Entry From the Patient Data Entry window, you can perform the following tasks:

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 Entering Patient and Physician Information The top of the Patient Data Entry window has the following fields for entering patient demographic information:

Patient number (required) This must contain a unique patient number or identifier Patient shown on Reader Select this check box to display the patient on the Select Patient screen on the DVS Reader. For patients that are no longer active, clear this check box. Entry date (read-only) Displays the date the patient was entered. 35 DVS Dose Verification System Last name (required) Enter the patients last name First name Enter the patients first name. Middle name Enter the patients middle name Physician Select a physician from the list. If you want to add a new physician, select Add Physician from the top of the list. The Physician Data Entry dialog box appears (Figure 19 Physician Data Entry). Enter the physicians name and unique physician number. The physician number and last name are required fields. If there is not a unique number that identifies the physician, enter their name or other identifier. Figure 19 Physician Data Entry When finished making changes, click Save to save the data entered in this window and its dialog boxes. Click Cancel to discard all changes made for the current patient. Entering Dosimeters Dosimeters assigned to the patient are shown in the planning table on the Patient Data Entry window. To add a new dosimeter:

1. Click Add Dosimeter. A dialog box for entering the dosimeters bar coded calibration values appears (Figure 20 Dosimeter Barcode). 36 DVS Dose Verification System U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 20 Dosimeter Barcode 2. Use the bar code scanner to read the 2D bar code on the dosimeters transfer label:

a. Hold the bar code scanner at a slight angle to the transfer label. b. Be sure the scanners light field completely covers the bar code from left-to-right. c. Slowly scan the bar code from top-to-bottom or bottom-to-

top until an audible beep is heard and numeric values are displayed in the dialog box. 37 DVS Dose Verification System 3. When completed, click OK. The Dosimeter Data Entry dialog box appears (Figure 21 Dosimeter Data Entry). Figure 21 Dosimeter Data Entry 4. Refer to the dosimeter transfer label and enter information about the dosimeter:

Dosimeter ID (Read-only) Displays the serial number of the dosimeter. Location Select a location name for the dosimeter from the pull-down menu. If you want to create a new location, just type it into this field. Implant date (Optional) Select the implant date of the dosimeter. The default is todays date. Surgeon (Optional) Enter the surgeons name. Notes (Optional) Enter notes about the dosimeter Dosimeter used by Reader To have the DVS Reader scan for this dosimeter, select this check box. To prevent the Reader from scanning for this dosimeter, clear this check box. 38 U s i n g t h e P l a n a n d R e v i e w S o f t w a r e DVS Dose Verification System 5. Click OK to save the dosimeter information. The planning table is updated with a new column for the dosimeter. The Location that was entered in the Dosimeter Data Entry dialog box appears in the new columns heading. Entering Plans Use the planning table on the Patient Data Entry window to enter the patients plan information. Each row in the planning table contains a plan for the patient. Each plan is made of a series of treatment fractions each at the same dose level. To add a new plan:

1. Click Add Plan and edit the new row that appears. 2. Set the following items for each plan:

Plan name The name to use for the plan First fraction The number of the first fraction. This is typically 1, but can is any number greater than zero, and less than or equal to the Last fraction. Last fraction The number of the last fraction. This must be greater than or equal to the First fraction. If dosimeters have been assigned to the patient, additional columns appear in the table, one for each dosimeter. For more information about assigning dosimeters to a patient, see Entering Dosimeters. To delete a plan:

1. Select the row to delete. 2. Click Delete Plan. Changing or Deleting Dosimeters Dosimeters assigned to the patient are shown in the planning table on the Patient Data Entry dialog box. To edit dosimeter information 1. Put the cursor in the Dosimeters column. 39 DVS Dose Verification System 2. Click Edit Dosimeter. The Dosimeter Data Entry dialog box appears (Figure 21 Dosimeter Data Entry). 3. Change the information in this dialog box. 4. Click OK to save the information. 40 DVS Dose Verification System To delete a dosimeter:

1. Put the cursor in the Dosimeters column. 2. Click Delete Dosimeter. Note: Dosimeters with measurements cannot be deleted. Click Edit Dosimeter to display the Dosimeter Data Entry dialog box. Clear the Dosimeter used by Reader check box. Working with Measurement Fractions and Skipped Fractions As measurements are collected from a patients dosimeters, you can make changes to the information collected on the DVS Readers Treatment Notes screen, and you can add, edit, or delete skipped fractions. On the Patient Data Entry window, click View Fractions to display the Fractions & Measurements windows. This window lists the planned fractions and the measurements made for each fraction (Figure 22 Fractions & Measurements). U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 22 Fractions & Measurements The columns in the Fractions & Measurements window are defined as follows:

Plan name The plans name from the planning table. 41 DVS Dose Verification System Plan fraction The plans fraction number. Date The measurement date. Status The measurement status for the plan and fraction:

Ready A normal measurement was taken. Skipped No measurement was taken, but treatment was given. Deleted The measurement is marked as deleted; it is not associated with a plan and fraction.

[Blank] No measurement or treatment has been performed yet. Port film (MU) The number of monitor units from port films taken during the measurement. Notes? Whether any notes check boxes were selected for the measurement. Yes means there are notes. Blank means there are no notes. Deleting a Fraction To mark a measurement fraction as deleted so it is not associated with a plan and fraction, perform the following steps:

1. Select the measurement. 2. Click Delete. The measurement is not actually deleted, but will not be used to calculate total dose administered. To restore a deleted measurement:

1. Select the fraction. 2. Click Undelete. Inserting Skipped Fractions Skipped fractions are used to record when treatment was given, but pre- and/or post-dose readings were not recorded. If a skipped fraction is used, the predicted dose is substituted automatically for the measured dose to approximate the cumulative dose. The dose appears in brackets [ ]. 42 U s i n g t h e P l a n a n d R e v i e w S o f t w a r e DVS Dose Verification System To insert a skipped fraction:

1. Select the row with the plan and fraction that was missed. 2. Click Insert Skip. This associates a skipped fraction with the selected plan and fraction. To remove a skipped fraction:

1. Select the row with the skipped fraction. 2. Click Delete. Changing Information for a Fraction From the Fractions & Measurements window, you can change the notes or the port film monitor units for a fraction:

1. Select the fraction to edit. 2. Click Edit to display the Measurement Data Entry dialog box (Figure 23 Measurement Data Entry). Figure 23 Measurement Data Entry 3. Edit the following information in the Measurement Data Entry dialog box:

Plan name (read-only) The plan name of the selected fraction Fraction # (read-only) The plans fraction number 43 DVS Dose Verification System Date & Time (read-only, except for Skipped fractions) The date and time of the measurement. For Skipped fractions, this can be changed; however, the date and time must stay between the fraction before and after the current fraction. This is needed to keep the measurement fractions in the proper order. Port Film (MU) The number of monitor units from Port films taken during this measurement Notes This group-box contains check boxes that record the notes entered by the user 4. Click OK to save the changes made in this dialog box. To discard the changes, click Cancel. 5.4 Viewing Patient Results From the Main Menu, click Patient Results to perform the following tasks:

Displaying a List of Patient Results Viewing Results Charts Viewing Results Reports Displaying a List of Patient Results To view patient results, click Patient Results on the DVS Main Menu. The Patient Selection for Results window appears (Figure 24 Patient Selection for Results). 44 DVS Dose Verification System U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 24 Patient Selection for Results 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 view a chart showing the dose measurements from a patients dosimeters, select the patient and click View Chart to display the Results Chart screen. For more information, see Viewing Results Charts. To view a report showing the dose measurements from a patients dosimeters, select the patient and click View Report to display the Results Report screen. For more information, see Viewing Results Reports. To return to the Main Menu, click Done. Viewing Results Charts The Results Chart window summarizes a patients dosimeter measurements. There are two charts and a statistics table shown for each dosimeter (Figure 25 Results Charts and Figure 26 Statistics Table). 45 DVS Dose Verification System Figure 25 Results Charts Figure 26 Statistics Table 46 U s i n g t h e P l a n a n d R e v i e w S o f t w a r e DVS Dose Verification System Dosimeter results are displayed in a tab labeled with the dosimeter location. The first chart is the Relative Dose Chart. This shows the difference between each measured dose and its predicted dose as a percentage. The value shown for each bar is the measured dose relative to the predicted dose. The second chart is the Absolute Dose Chart. This shows the measured doses (in cGy) as gold bars, and the predicted doses as blue lines. Each plan is shown as a separate blue line. In the charts, the brown bars identify measurements where either a port film was taken or notes were entered by the user. For each of the charts, the mouse can be positioned over a bar to show more information about the measurement:

The value of the measurement The date of the measurement Who made the measurement The monitor units from port films that were taken Any notes selected during the measurement process No bars are shown for skipped fractions or fractions where a dosimeter value could not be read. Positioning the mouse over these empty spaces will show if it was a skipped fraction or a measurement error. The Statistics Table shows summary statistics for each of the patients plans. The columns are as follows:

Plan name The name of the plan Fractions planned The number of fractions in the plan Fractions used The number of dose fractions administered so far Total predicted dose (cGy) The expected dose administered for the number of fractions displayed in the Fractions used column 47 DVS Dose Verification System Total measured dose (cGy) The measured dose for the number of fractions displayed in the Fractions used column. For skipped fractions or fractions with measurement errors, the predicted dose is used instead. Relative standard deviation (%) The standard deviation of the measurements divided by the average of the measurements. For skipped fractions or fractions with measurement errors, the predicted dose is used instead. To print the charts for a patient, click Print. One page is printed for each dosimeter. Viewing Results Reports The Results Report window summarizes a patients dosimeter measurements in a report format (Figure 27 Results Report). Figure 27 Results Report 48 U s i n g t h e P l a n a n d R e v i e w S o f t w a r e DVS Dose Verification System The report is similar to the Fractions & Measurements screen

(see Working with Measurement Fractions and Skipped Fractions). However, the report also shows the dose values from each dosimeter. The measurement for each dosimeter is shown in a separate table. The columns in the tables are as follows:

Plan name The plans name from the planning table. Fract # The plans fraction number. Date The measurement date. Status The measurement status for the plan and fraction. It is one of:

[Blank] A normal measurement was taken. Skipped No measurement was taken, but treatment was given. Deleted The measurement is marked as deleted; it is not associated with a plan and fraction. Error An error occurred when taking the measurement from this dosimeter. Predicted dose (cGy) The dose from the planning table. Measured dose (cGy) The measured dose. Dose error (%) The difference between the Measured dose and the Predicted dose, divided by the Predicted dose. Port film (MU) The number of monitor units from port films taken during the measurement. Notes? Whether any notes check boxes were selected for the measurement. Yes means there are notes. Blank means there are no notes. The size of the displayed report can be changed with the Zoom selection. This does not affect the printed report. To display the next page of the report, click >>. To display the previous page, click <<. To print the report, click Print. 49 DVS Dose Verification System 5.5 DVS System Administration From the Main Menu, click Administration to display the Administration screen. This screen contains three tabs:

Users This tab contains the list of authorized users. Options This tab contains options for the DVS system. Database This tab contains the database connection information. From these tabs, you can perform the following tasks:

Adding and Editing DVS Users Changing Institutional Information and System Options Changing the Database Connections Backing up and Restoring the DVS Database Adding and Editing DVS Users The Users tab displays the list of authorized users (Figure 28 Users). Figure 28 Users 50 DVS Dose Verification System Each person who uses the DVS Plan and Review Software and the DVS Reader, must have a login name and password. To add a new user, click Add. This displays the User Data Entry window

(Figure 29 User Data Entry). The fields in this window are as follows:

Active user Select this check box to let the user log in. Clear this check box to disable this user. User number (Required) Enter a unique user number or identifier. U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Last name (Required) Enter the users last name. First name Enter the users first name. Middle name Enter the users middle name. Login name (Required) Enter the users login name for the Plan and Review Software. Password (Required) Enter the users numeric password. The password must be a minimum of 4 digits and a maximum of 8 digits. Verify password (Required) Enter the users password for verification. Entry date (Read-only) Date is entered automatically when the user is added. Can use Reader Select this check box to allow the user to log in and use the DVS Reader. Clear this check box to prevent this user from appearing in the user list on the Reader. View Patient data Select this check box to allow the user to select the Patient Information button and view the screens that it contains. Clear this check box to disable the Patient Information button for this user. Edit Patient data Select this check box to allow the user to edit patient information. If this check box is selected, then the View Patient Data check box is selected also. Clear this check box to prevent the user from changing any patient information. 51 DVS Dose Verification System Create reports Select this check box to allow the user to select the Patient Results button and view the charts and reports. Clear this check box to disable the Patient Results button. Administrator Select this check box to allow the user to select the Administrator button and perform administrative functions. Clear this check box to disable the Administrator button. Figure 29 User Data Entry To edit an existing user, select the user in the list and click Edit. This displays the User Data Entry window with the users information. To return to the Main Menu, click Done. Changing Institutional Information and System Options The Options tab contains information that is typically setup once when the DVS system is installed (Figure 30 Options). 52 DVS Dose Verification System U s i n g t h e P l a n a n d R e v i e w S o f t w a r e Figure 30 Options The Options tab contains the following fields:

Institutions name The name of the institution to print on the charts and reports Address The address printed on the charts and report On Reader, time for automatic logout This is the number of minutes of idle time to allow before automatically logging out of the DVS Reader How to show the measured dose on the Readers Notes Screen The user can choose from three options to the dose on the Reader:

None Do not show the measured dose on the Reader Percent error Show the measure dose as a percentage relative to the predicted dose Absolute dose Show the measured dose in cGy Changing the Database Connections The Database tab contains the connection information to the Dosimetry Database. Contact your DVS administrator to get the settings for this tab (Figure 31 Database). 53 DVS Dose Verification System Figure 31 Database Backing up and Restoring the DVS Database To back up or restore the DVS Database, 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 Main Menu of the DVS Plan and Review Software appears. 4. Click Administration. 5. Click the Database tab. 54 DVS Dose Verification System 6. To back up the database:

a. Click Backup Database. b. In the Backup DVS Database dialog box, select a location to save the backup file. c. Click Save. The database backup file is saved using the current date and time in the file name. For example: DVS DB Backup 20Apr2006 15.20.32.bak d. When the database is successfully backed up, a message box appears. Click OK. 7. To restore a database:

a. Click Restore Database. b. In the Restore DVS Database dialog box, select the backup file you want to restore. DVS Database files are saved using the current date and time in the file name. For example: DVS DB Backup 20Apr2006 15.20.32.bak c. Click Open. 8. Click Done. U s i n g t h e P l a n a n d R e v i e w S o f t w a r e 55 DVS Dose Verification System 6 USING THE DVS READER Use the DVS Reader to perform the following tasks:

Power on the DVS Reader and Power off the Reader Log in to the DVS Reader Test a Dosimeter Select a Patient Select a Plan/Fraction Take a Pre-Dose Reading Take a Post-Dose Reading Enter Treatment Notes In order to use the DVS Reader, the patient, dosimeter, and plan information must have been entered using the Plan and Review Software. 6.1 Power On the DVS Reader and Power Off 1. Power on the Reader. The Power On screen appears briefly. Figure 32 Power On 56 DVS Dose Verification System The Initializing DVS Reader screen appears indicating that the Reader is starting up (Figure 33 Initializing DVS Reader). U s i n g t h e D V S R e a d e r Figure 33 Initializing DVS Reader The Reader performs tests to verify the connection to the Dosimetry Database, software compatibility, and that the Reader Wand is functioning. If you need to set up the DVS Dosimetry Database, you can log in using the Administrator Login screen by clicking Login as Administrator. You need to get the Administrator password-of-

the-day from technical support. All other users should wait until initialization is complete and the DVS Reader Login appears. Note: If there are any errors, see Troubleshooting for a resolution. To power off the Reader, turn the power switch OFF 2. 3. To remove power from the System, unplug the power cord. 6.2 Log in to the DVS Reader To log in to the DVS Reader, perform the following steps:

1. Select a username from the list (Figure 34 Reader Login ). 57 DVS Dose Verification System Figure 34 Reader Login Tap the Password field and a numeric keypad appears. Figure 35 Keypad 2. Enter the password using the touch-screen keypad and then press Enter on the keypad. 3. Choose whether you want to test a dosimeter or scan a patient:

Press Test Dosimeter to test a dosimeters functionality before implantation. 58 DVS Dose Verification System Press Scan Patient to begin the process of reading a patients dose. 6.3 Test a Dosimeter Dosimeters may be tested prior to implant to assure functionality or to verify dosimeters that have already been implanted. The dosimeter may be tested by either entering the dosimeters serial number and scanning using the Reader Wand, or by simply scanning using the Reader Wand without entering a serial number. U s i n g t h e D V S R e a d e r Figure 36 Test Dosimeter If there are two or more dosimeters in the read range, then you need to enter each dosimeters serial number one at a time. If you do not enter a dosimeters serial number, then only one dosimeter is allowed in the read range volume. If there is only one dosimeter in the read range, make sure the Dosimeter to test field is blank so the Reader searches for any dosimeter. To read a dosimeter without knowing its serial number, leave the Dosimeter to test field blank (Figure 36 Test Dosimeter ), then hold the dosimeter near the Reader Wand and press the button on the Reader Wand. The Reader searches for any available dosimeters within the read range. 59 DVS Dose Verification System To scan for a specific dosimeter, tap the Dosimeter to test field and a numeric keypad appears. Enter the dosimeter number in the field and press Enter. Next, hold the dosimeter near the Reader Wand and press the button on the Reader Wand. Number 1: If the dosimeter is functional, a message appears indicating that the dosimeter was found. For example:

Dosimeter 27650 was found. Figure 37 Dosimeter Found Number 2: If the dosimeter could not be read, an error message appears:

No Dosimeter found. 60 DVS Dose Verification System U s i n g t h e D V S R e a d e r Figure 38 No Dosimeter Found Number 3: If the dosimeter is not functional, a message appears:

Dosimeter xxxxxx found. MOSFET is not functional. Figure 39 Dosimeter Not Functional When finished testing, press Logout and the Reader returns to the Login Screen. 61 6.4 Scan a Patient DVS Dose Verification System To scan a patient, log in to the DVS Reader and press Scan Patient. The scan patient screens are set up like a wizard. You can move forward and backward through the series of screens by pressing Next or Back. The workflow for scanning a patient is as follows:

Select a Patient Select a Plan/Fraction Take a PRE-Dose Reading Dose the Patient Take a POST-Dose Reading Enter Treatment Notes Select a Patient To select a patient:

1. Press Scan Patient on the Login Screen. The Select Patient screen appears (Figure 40 Select Patient ). Patient names appear in alphabetical order. To find a patient, tap the up and down arrows on the right side of the screen to move between pages of patients. Figure 40 Select Patient 62 DVS Dose Verification System 2. Select the patient to be scanned by pressing the patients name on the touch screen, then press Next. Press Logout and the system returns to the Login Screen. Select a Plan/Fraction After a patient is selected and the patient data is retrieved from the database, the Select Plan screen appears for the selected patient

(Figure 41 Select Plan ). Important: Always verify that the correct patient is being treated by verifying the name at the top of the screen. U s i n g t h e D V S R e a d e r Figure 41 Select Plan The Select Plan/Fraction screen displays the current plan, treatment fraction, and previous dose measurements. If more than one plan was set up for the patient, you can select a new plan by tapping the Plan pull-down menu and selecting the new plan. If the fraction needs to be changed, press the button or the + button to decrease or increase the fraction number. You can also tap the Fraction field and enter the fraction number using the keypad. Note: You cannot use a fraction that is not part of the patients plan, use a fraction that has been skipped, or re-use a fraction that already has measurements. 63 DVS Dose Verification System If the selected plan and fraction number is advanced beyond the initial value, then the following message appears:

Are you sure you wish to add Skip Fraction(s)?

This is a reminder that one or more skipped fractions will be added to the Dosimetry Database. These skipped fractions serve as markers that measurements were not made for some of the planned fractions. Press the OK button to accept the skipped fractions. Press the Cancel button to return to the Select Plan screen and choose another plan or fraction. Later, the skipped fractions can be edited using the Plan and Review Software. For information about skipped fractions in the Plan and Review Software, see Working with Measurement Fractions and Skipped Fractions. When the correct plan and fraction are selected, press Next to go to the PRE-Dose screen. To cancel the treatment at this point, press Back and to return to the Select Patient screen where you can press Logout. Take a PRE-Dose Reading The PRE-Dose screen is used to scan the patients dosimeters before being treated (Figure 42 PRE-Dose ). If the plan and fraction are correct, position the Reader Wand next to the patient where the dosimeters are implanted. Press and release the button on the Reader Wand to activate the Reader Wand. 64 DVS Dose Verification System U s i n g t h e D V S R e a d e r Figure 42 PRE-Dose As the Reader Wand begins scanning for dosimeters, the blue light on the Reader Wand is on and steady, indicating that it is searching for dosimeters. When the Reader Wand detects a dosimeter, the blue and green lights on the Reader Wand will flash briefly. On the PRE-Dose screen, the following message appears next to each dosimeter as it is read:

ScanningXX%

where XX% is the percentage of the data from the dosimeter that has been read. When each dosimeter has been completely read, the Status for the dosimeter changes to Complete. When all of the dosimeters have been found, the light on the Reader Wand stops blinking. Press Next to go on to POST-Dose screen. All Dosimeters Not Read If all dosimeters were not read during the pre-dose operation, the following message appears:

Not all dosimeters have been read. Do you want to continue?

65 DVS Dose Verification System Figure 43 Dosimeters Not Read Press OK to skip the dosimeters that were not read and go on to POST-Dose screen. However, if no dosimeters have been read

(none are Complete), the Treatment Notes screen appears instead of the POST-Dose screen. Press Cancel to cancel the operation and stay on the PRE-Dose screen. Discard Readings If you want to discard the readings just made, press Back and the following message appears:

Do you want to discard these Pre-dose readings?

Press OK to discard the pre-dose readings and return to the Select Plan screen. Press Cancel to cancel the operation and stay on the PRE-Dose screen. Dose the Patient When the pre-dose operation is complete, the patient is ready for radiotherapy. Treat the patient as usual. Within ten (10) minutes of completing radiation therapy, scan the patient again to obtain a post-dose reading (Optimal post-dose reading is 2.5 minutes following irradiation). 66 DVS Dose Verification System Take a POST-Dose Reading The POST-Dose screen is used to scan the patients dosimeters after being treated (Figure 44 POST-Dose ). U s i n g t h e D V S R e a d e r Figure 44 POST-Dose Position the Reader Wand next to the patient where the dosimeters are implanted. Press the button on the Reader Wand to activate the Reader Wand. As the Reader Wand begins scanning for the dosimeters, the lights on the Reader Wand blink indicating that it is looking for the dosimeters. On the POST-Dose screen, the following message appears:

ScanningXX%

When each dosimeter has been completely read, the Status for the dosimeter changes to Complete. When all of the dosimeters have been found, the light on the Reader Wand stops blinking. Press Next to display the Treatment Notes screen. 67 DVS Dose Verification System All Dosimeters Not Read If all dosimeters were not read during the post-dose operation, the following message appears:

Not all dosimeters have been read. Do you want to continue?

Press OK to skip the dosimeters that were not read and go on to the Treatment Notes screen. Press Cancel to cancel the operation and stay on the POST-Dose screen. Discard Readings If you want to discard the readings just made, press the Back button and the following message appears:

Do you want to discard these Post-dose readings?

Press OK to discard the post-dose readings and return to the PRE-

Dose screen. Press Cancel to cancel the operation and stay on the POST-Dose screen. Enter Treatment Notes Use the Treatment Notes screen to record information about the treatment session (Figure 45 Treatment Notes ). Figure 45 Treatment Notes 68 DVS Dose Verification System Select any of the check boxes in this screen, or enter the number of monitor units (MU) from a port film that the patient received. To enter the number of monitor units, tap the Port Film field to display the keypad. The port films monitor units will not be incorporated into the calculated daily or cumulative dose. When you have completed this screen, press Save. A dialog box asks if you want to save the results. Press OK to save the results, or Cancel to stay on the Treatment Notes screen. After the data is saved, the Select Patient screen appears again, so you can start scanning the next patient. U s i n g t h e D V S R e a d e r 69 DVS Dose Verification System 7 TROUBLESHOOTING This section provides a list of common issues and error messages and the steps you can take to resolve them. Troubleshooting the DVS Server System Software Setup DVS Reader not operational Unable to obtain a pre-dose or post-dose reading DVS Reader error messages Plan and Review Software error messages 7.1 Troubleshooting the DVS Server System Software Setup If the window below appears more than two or three times while installing the DVS Dosimetry Database Server, close it and click Stop on the DVS Server System Software Setup window. Click Setup Server Components to restart the setup program. If this problem continues, remove ALL components from system, reboot the computer, and restart the setup program. 7.2 DVS Reader Not Operational Check that the power cord is fully seated in the electrical outlet and in the back of the Reader Base Station. 7.3 Unable to Obtain a Pre-Dose or Post-Dose Reading 1. Check that the Reader Wand is connected to the Base Station. 2. Make sure metal objects are clear of the patient and Reader Wand. 3. Re-position the Reader Wand to another area near the implanted Dosimeters. 4. Hold the Reader steady over the area with the implanted Dosimeters. 70 DVS Dose Verification System 7.4 DVS Reader Error Messages The error messages displayed by the Reader are listed in this section in alphabetical order. Cannot access the Dosimetry Database. Please check connections, or contact your IT Department, then press OK to try again. T r o u b l e s h o o t i n g If you encounter this error, perform the following troubleshooting steps:

Make sure the LAN (local area network) cable is firmly connected to the Reader. Make sure that the Windows XP Firewall is turned OFF on the database server computer or create an exception to allow access to the computer over Port 80 (HTTP). Make sure the computer with the Dosimetry Database is running and is connected to the LAN. Contact the IT Department to make sure they did not change the setup of the Dosimetry Database. To have the Reader try the operation again, press the OK button. If the problem remains, turn off the Reader then wait 15 seconds and turn it on again. Try the operation again. If the problem remains, contact the local representative for technical support. Cannot communicate with the Wand. Please refer to the trouble-shooting guide, and then press OK to try again. If you encounter this error, make sure that the Reader Wands green power-on light is lit. If it is not, then make sure the Wand cable is firmly connected to the back of the Base Station. 71 DVS Dose Verification System To have the Reader try the operation again, press the OK button. If the problem remains, turn off the Reader then wait 15 seconds and turn it on again. Try the operation again. If the problem remains, contact the local representative for technical support. The data for this Patient is invalid. Please select another patient. This message means that the patients data was likely changed without using the DVS Software. Contact your DVS Administrator to resolve this problem. The Dosimetry Database has changed. Contact technical support. This message means that the Dosimetry Database was likely changed without using the DVS Software. Contact the local representative for technical support to resolve this problem. The dosimetry database is not compatible with this Reader. Please correct and press OK to try again. Verify that all software upgrades needed for the Reader, the Dosimetry Database, and the Plan and Review Software have been implemented. Then press the OK button to try this operation again. This patient has no more Fractions. Please verify that the Plans are correct. This message means that all the planned fractions for this patient have been used. That is, each planned fraction has dosimeter measurement data. 72 T r o u b l e s h o o t i n g DVS Dose Verification System To collect more dosimeter measurements, more fractions must be added to the patients Planning Table (see Entering Plans). This Plan & Fraction # cannot be found. Please select another. This message means that the selected plan and fraction number are not in the patients Planning Table. You can either select another plan and fraction # that is in the Planning Table, or add more fractions to the patients Planning Table (see Entering Plans). This Plan & Fraction # has already been used. Please select another. This message means that the selected plan and fraction number have dosimeter measurement data already. You can either select another plan and fraction number that is in the Planning Table, or add more fractions to the patients Planning Table (see Entering Plans). Wand field current <current> A is outside the acceptable range. Place the Wand in its Base, then press OK to try again. If you encounter this error, perform the following troubleshooting steps:

Check the connection of the Reader Wand cable to the back of the Base Station. Make sure the Reader Wand is not near any metal objects. It is recommended that the Wand is placed in the Base Station during initialization. To have the Reader try the operation again, press the OK button. 73 DVS Dose Verification System If the problem remains, turn off the Reader then wait 15 seconds and turn it on again. Try the operation again. If the problem remains, contact the local representative for technical support. Wand not operating properly. Place the Wand in its Base, then press OK to try again. If you encounter this error, perform the following troubleshooting steps:

Check the connection of the Reader Wand cable to the back of the Base Station. Make sure the Reader Wand is not near any metal objects. It is recommended that the Reader Wand is placed in the Base Station during initialization. To have the Reader try the operation again, press the OK button. If the problem remains, turn off the Reader then wait 15 seconds and turn it on again. Try the operation again. If the problem remains, contact the local representative for technical support. Wand resonant frequency <freq> kHz is outside the acceptable range. Place the Wand in its Base, then press OK to try again. If you encounter this error, perform the following troubleshooting steps:

Check the connection of the Reader Wand cable to the back of the Base Station. Make sure the Reader Wand is not near any metal objects. It is recommended that the Reader Wand is placed in the Base Station during initialization. To have the Reader try the operation again, press the OK button. 74 DVS Dose Verification System If the problem remains, turn off the Reader then wait 15 seconds and turn it on again. Try the operation again. If the problem remains, contact the local representative for technical support. 7.5 Plan and Review Software Error Messages T r o u b l e s h o o t i n g The error messages displayed by the Plan and Review Software are listed in this section in alphabetical order. A Patient cannot have more than 8 Dosimeters. The limit on the number of dosimeters assigned to a patient is eight. Delete a dosimeter to add a new one. A Patient cannot have more than 8 plans. The limit on the number of plans for a patient is eight. Delete a plan to add a new one. Barcode misread. Please scan the Dosimeter barcode again. The verification check of the dosimeter checksum data failed. Try to read the dosimeters bar code again. Cannot access the database. Do you want to attempt to connect again?

This message may appear when the Plan and Review Software starts and a connection to the Dosimetry Database cannot be made. To try to connect again, press the Yes button. If the problem continues, perform the following steps:

Make sure the LAN (local area network) cable is firmly connected to the Reader. Make sure the computer with the Dosimetry Database is running and is connected to the LAN. 75 DVS Dose Verification System Contact the IT Department to make sure they did not change the setup of the Dosimetry Database. To try the operation again, press the OK button. If the problem remains, contact your DVS Administrator or the IT Department. Cannot access the database. Please check connections, or contact your I.T. Department, then press OK to try again. If you encounter this error, perform the following steps:

Make sure the LAN (local area network) cable is firmly connected to the Reader. Make sure the computer with the Dosimetry Database is running and is connected to the LAN. Contact the IT Department to make sure they did not change the setup of the Dosimetry Database. To try the operation again, press the OK button. If the problem remains, contact your DVS Administrator or the IT Department. Cannot delete a patient with Dosimeter measurements. Patients who have dosimeters with measurements cannot be deleted. Instead, open the Patient Data Entry window for the patient and clear the Patient shown on Reader check box (see Entering Patient, Dosimeter, and Plan Information). Cannot delete this Dosimeter because it has measurement data. Dosimeters with measurements cannot be deleted. Instead, open the Dosimeter Data Entry dialog box for the dosimeter and clear the Dosimeter used by Reader check box (see Entering Dosimeters). 76 T r o u b l e s h o o t i n g DVS Dose Verification System Cannot insert a Skipped measurement here. A skipped fraction cannot be within two minutes of the most recent fraction. Try to add the skipped fraction between two other factions in the list. Cannot save Database settings to the registry. This message means that you do not have permission to write to the registry on the computer. Contact your system administrator to correct this problem. Checksum error reading <table>. This data cannot be loaded. This message means that the Dosimetry Database was changed without using the DVS Software. Contact your DVS Administrator to resolve this problem. In plan <plan>, the Last fraction # cannot be less than the First fraction #. The last fraction number must be greater than or equal to the first fraction number. Make the last fraction number greater to correct this problem. Login name <login name> is already assigned to User <user name>. Please correct before saving this Users data. The Login name entered is already used by another person. Enter a different Login name for this user. More than 100 Patients cannot be shown on the Reader. Please reduce the number of Patients shown on the Reader before adding more Patients. At most, 100 patients at a time can be shown on the DVS Reader. The patients shown on the Reader are those with the Patient shown on Reader check box selected. 77 DVS Dose Verification System To correct this problem, clear the Patient shown on Reader check box for inactive patients. Password fields do not match. Please enter Passwords again. When setting up a new user, the fields Password and Verify password must be the same. Type the same password into these two fields again and press OK. Password must be at least 4 digits long. Make sure the users numeric password is at least four digits and no greater than eight digits. Patient number <patient num> is already assigned to patient

<patient>. Please correct before saving this patients data. The Patient number entered is already used by another patient. Enter a different Patient number for this patient. Physician number <physician num> is already assigned to Physician <physician>. Please correct before saving this Physicians data. The Physician number entered is already used by another physician. Enter a different Physician number for this physician. Plan/Fraction <plan name, fraction #> is duplicated. Please correct before saving the plans. In the Planning Table, the displayed plan and fraction # are listed more than once. Remove this duplication from the Planning Table. 78 T r o u b l e s h o o t i n g DVS Dose Verification System The dosimetry database is not compatible with this software. Verify that all software upgrades needed for the Reader, the Dosimetry Database, and the Plan and Review Software have been implemented. Then press the OK button to try this operation again. There are <x> more measurements than planned fractions for this Patient. Please adjust the plans/fractions so that all the measurements will have a planned fraction. This message means that there are not enough planned fractions for all the measurements made so far. Each dosimeter measurement needs to have a planned fraction that it is associated with. Adjust the number of fractions in the Planning Table to correct this problem. There cannot be more than 99 total fractions. Please correct before saving the plans. There are more than 99 planned fractions in the Planning Table. Reduce the number of fractions to correct this problem. There is nothing to view because no measurements have been made from this Patients Dosimeters. The Fractions & Measurement window cannot be used until at least one dosimeter measurement has been taken for the patient. This Dosimeter is already assigned to patient <patient name>. Please use another Dosimeter. Each dosimeter can only be assigned to one patient. The dosimeter scanned is already assigned to another patient. Either delete the dosimeter from the other patient or select another dosimeter for this patient. 79 DVS Dose Verification System This record was updated by someone else during this editing session. Please reload this data and make the changes again. This message means that someone else changed the same data

(for example, patient or user) that you were editing. Press the Cancel button to discard your changes, and then make the changes again. Since this patient has either no plans or no dosimeters, he/she will not be shown on the DVS Reader. In order to scan a patients dosimeters using the DVS Reader, there must be both plans and dosimeters assigned to the patient. If one or the other of these is not assigned yet, the patient cannot be used by the Reader. This message is a notice that the Plan and Review Software will clear the Patient shown on Reader check box, so the patient will not appear in the Readers patient list. User number <user num> is already assigned to User <user name>. Please correct before saving this Users data. The user number entered is already being used by another person. Enter a different user number for this person. 80 DVS Dose Verification System 8 MAINTENANCE AND TECHNICAL SUPPORT 8.1 Reader Maintenance The Reader does not require any routine user maintenance or preventive maintenance for components or the system other than cleaning. Prior to use, inspect the Reader for damage such as frayed power cords or visible damage of external surfaces. 8.2 Database Maintenance Refer to document 934-00553-04 Archiving the DVS Dosimetry Database. 8.3 Dosimeter Maintenance DO NOT SEND DOSIMETERS TO A RE-PROCESSING FACILITY FOR RE-STERILIZATION OR RE-STERILIZE USING A HOSPITAL OR LABORATORY STERILIZER. 8.4 Cleaning the Reader Wand and Reader Base Station M a i n t e n a n c e a n d T e c h n i c a l S u p p o r t Turn off all power to the Reader and its components prior to cleaning. If the Reader Wand or Base Station is in direct contact with skin or bodily fluids, clean by wiping the contact surface with a standard isopropyl alcohol-based disinfectant. More frequent cleaning is not required otherwise. 81 DVS Dose Verification System 8.5 Technical Support and Product Service For technical support or to request product servicing, contact the local representative or Sicel Technologies, Inc. Telephone: 1-888-DVS-6697 (1-888-387-6697) / Outside the US: 1-919-465-2236, ext. 361 E-mail: helpdesk@siceltech.com Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560 USA 82 DVS Dose Verification System 8.6 Disposal and Recycling When the product has reached the end of its useful life, contact the local representative for information concerning recycling or disposal per local, state, county, or country directives. M a i n t e n a n c e a n d T e c h n i c a l S u p p o r t 83 DVS Dose Verification System 9 SPECIFICATIONS Parameter Rating Time to Read Dosimeter Up to 10 minutes following radiation therapy. Optimal read time is 2 to 3 minutes following irradiation. Power 110V-240V~, 50-60 Hz 1A @ 120V~ , 0.5A @ 240V~

RF Frequency Transmission Effective Radiated Power

(ERP) 133 kHz Backscatter modulation 12.1 dBm (16.2mW) Inputs/Outputs 1-Ethernet port 1-Wand Cable Assembly Connection 1-USB Connection (For Field Service Use Only) Power Cord 10ft (3.05m) maximum length US & Canada Hospital Grade cordset 10A/120V/60Hz with NEMA 5-

15 plug & IEC 60320 C13 connector UK, Ireland, Cyprus, & Malta International style cable 10A/230V/50Hz with BS 1363 plug & IEC60320 C13 connector France, Spain, Belgium, Czech Republic, & Slovakia International style cable 10A/230V/50Hz with CEE7/7 plug and IEC 60320 C13 connector Italy International style cable 10A/230V/50Hz with CEI 23-16/VII plug

& IEC60320 C13 connector Denmark International style cable 10A/230V/50Hz with Afsnit 107-2-

D1 plug & IEC 60320 C13 connector Switzerland International style cable 10A/230V/50Hz with SEV1011 plug & IEC60320 C13 connector Remaining members of the European Union International style cable 10A/230V/50Hz with CEE7/7 plug & IEC 60320 C13 connector Please contact Technical Support with any questions regarding power cords Operating Conditions Temperature: 10C to 40C (50F to 104F). Humidity at 10% to 95%, non-condensing Pressure: 700 hPa 1060 hPa 84 DVS Dose Verification System System not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Storage and Transport Conditions Temperature: -18C to 55C Humidity at 10% to 95%, non-condensing Pressure: 700 hPa - 1060 hPa Fuse Classification Type T2AL250V ; 5x20mm or 3AG- X 1 Class I equipment, Type B Applied Part IPX0 Mode of Operation Continuous Operation S p e c i f i c a t i o n s 85 Manufactured by: Sicel Technologies, Inc. 3800 Gateway Centre Blvd, Suite 308 Morrisville, NC 27560 Toll-free tech support (US): 1-888-DVS-6697 Fax: (919) 465-0153 www.dvssmartmarker.com