OmniPro-InViDos Users Guide 1.3c July 2018

Notice This User's Guide is an integral part of OmniPro-InViDos and should always be kept at hand. Observance of the manual instructions is required for proper performance and correct operation of OmniPro-InViDos. OmniPro-InViDos and its accessories must not be used for any other purpose than described in the accompanying documentation (intended use). Violation will result in loss of warranty. IBA Dosimetry does not accept liability for injury to personnel or damage to equipment that may result from misuse of this equipment, failure to observe the hazard notices contained in this manual, or failure to observe local health and safety regulations. IBA Dosimetry shall under no circumstances be liable for incidental or coincidental damage arising from use of the equipment described in this document. No part of the accompanying documentation may be translated or reproduced without written permission of IBA Dosimetry, unless reproduction is carried out for the sole purpose to be used by several people in the same department. The user must treat the accompanying documentation like any other copyrighted material. Especially, if part of the accompanying documentation is provided in electronic form, these files shall not be modified in any way. IBA Dosimetry and its suppliers retain title and all ownership rights to the accompanying documentation (either in electronic or printed form).

IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck Germany

Phone: +49 9128 607-0 Fax:

+49 9128 607-10

www.iba-dosimetry.com

Last update: 2018-07-23 Documentation ID: P-05-010-510-001 11 © 2018 IBA Dosimetry GmbH, Schwarzenbruck

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Table of Contents 1. 1.1. 1.2. 1.3. 1.4. 1.4.1. 1.4.2. 1.4.3. 1.4.4. 1.4.5. 1.4.6. 1.5. 1.5.1. 1.5.2. 1.5.3.

2. 2.1. 2.2. 2.3. 2.3.1. 2.3.2. 2.4. 2.5. 2.6. 2.7. 2.8. 2.9. 2.9.1. 2.10. 2.11. 2.12.

3. 3.1.

Introduction

1

Intended use Non-Intended use Intended Users Product Description Data Storage Measurement Analysis Reports Calibration External Databases Product Documentation User’s Guide On-line On-line Help Associated Documentation

1 1 1 2 2 3 3 3 4 4 4 5 5 5

Health and Safety Information

7

General Operator Power Connection Protective Ground Line Voltage Equipment Operation Calibration Service and Maintenance Responsibility Safety Labels Electrometer – emX Rating Labels Accessories Regulatory Requirements

7 7 8 8 8 8 9 10 10 10 11 11 11 11 12

System Description

13

Equipment Database

13

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3.1.1. 3.1.2. 3.1.3. 3.1.4. 3.1.5. 3.1.6. 3.2. 3.2.1. 3.2.2. 3.3. 3.4. 3.5. 3.5.1. 3.5.2. 3.5.3. 3.5.4. 3.5.5. 3.6. 3.6.1. 3.6.2. 3.6.3. 3.6.4. 3.6.5. 3.6.6. 3.6.7. 3.6.8. 3.7. 3.7.1. 3.7.2. 3.8. 3.9. 3.9.1. 3.9.2.

4. 4.1. 4.2. 4.2.1. 4.2.2. 4.2.3. 4.2.4.

Local Storage Patient Database Treatments, Fractions, Fields, and Positions Read-only Patients Search Templates Calibration Accuracy Detector Sensitivity Temperature Correction Leakage Measurement Corrections SDD/SSD Correction Configuration Correction Additional Corrections Multiplicity Sharing Correction Factors Measurement Electrometer Reset Before Measurement Dose Display Action level / Alarm Low Perturbation Detector Portal Imaging Device Beam-off Detection Missing Detector Detection Tumor Dose Calculation Treatment Planning System Dose Interpolation Accumulated Total Dose Biological Effect Cumulative Radiation Effect / Nominal Standard Dose Linear Quadratic Model

13 13 13 14 14 14 14 14 15 15 15 15 15 16 16 17 17 18 18 18 18 18 19 20 20 20 21 21 21 22 22 22 23

Technical Specifications

25

Standard equipment Electrometer DPD-12 (emX) Power Supply Connections Electrometer Specification Design

25 25 25 25 26 26

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4.2.5. 4.2.6. 4.2.7. 4.2.8. 4.3. 4.3.1. 4.3.2. 4.3.3.

5. 5.1. 5.1.1. 5.2. 5.2.1. 5.2.2. 5.2.3. 5.2.4. 5.2.5. 5.2.6. 5.2.7. 5.2.8. 5.2.9. 5.2.10. 5.3.

6. 6.1. 6.2. 6.2.1. 6.2.2. 6.2.3. 6.2.4. 6.2.5.

7. 7.1. 7.2. 7.3. 7.4. 7.5. 7.5.1. 7.5.2.

Environmental Requirements, Operation Environmental Requirements, Storage Dimensions and Material Detector Connection Measurement Characteristics Dose Measurement Dose Accuracy Calibration

26 26 27 27 27 27 27 28

Detectors and Accessories

29

General Common characteristics Detectors for External Beam Photon Detectors, External Beam Electron Detectors, External Beam Operational characteristics EDP-53G EDP-103G EDP-153G EDP-203G EDP-HL3G EDD-23G EDD-53G Detector Supports

29 29 30 30 30 30 31 32 33 34 35 36 37 38

Software Installation

40

Computer Requirements Installation Database Location Registration Installation Troubleshooting Un-installation Re-installation

40 40 40 41 41 42 42

Hardware Installation

43

DPD-12PC (emX) Electrometer DPD-510 Electrometer DPD-3 Electrometer Extension Cable Detector Supports Standard Detector Support Detector Supports with Automatic Retraction of the Cord (Option)

43 43 44 44 45 45 45

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7.6. 7.6.1. 7.6.2. 7.7. 7.8.

8. 8.1. 8.2. 8.3. 8.3.1. 8.3.2. 8.3.3. 8.4. 8.5. 8.5.1. 8.5.2. 8.5.3. 8.6. 8.7. 8.8. 8.9. 8.10. 8.10.1. 8.11.

9. 9.1. 9.2. 9.3. 9.4. 9.4.1. 9.4.2. 9.5. 9.6. 9.7. 9.8. 9.9. 9.10. 9.11. 9.11.1.

Hardware Connection Extension Cable Detectors Power Cord Communication Cable

46 46 46 46 47

Definitions and Settings

49

Define Users Define a Radiation Device Define an Electrometer DPD-3 DPD-510 DPD-12 (emX) Define a Detector Set up a Correction Group First Level Second Level (Optional) Third Level (Optional) Perform a Sensitivity Calibration Perform a Correction Calibration Replace a Broken Detector Add a New Patient Import Patient Data from a Verification System Import a New Patient Open an Existing Patient

49 50 51 52 53 53 54 55 55 56 56 57 58 60 60 62 62 63

Measurements

66

Start a Patient Measurement Synchronize Measurement with a Verification System Automatically Detect Beam Off Identify the Detectors in Use Manual Identification Automatic Identification Measure Dose with a Low Perturbation Detector Estimate Dose via Daily QA Measurements Enter Dose Manually Calculate Dose at the Prescription Point Add Fractions Move a Patient to an Alternative Accelerator Display Measured Dose Single Fraction

66 67 68 68 69 69 70 72 73 74 75 75 76 76

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9.11.2. 9.11.3. 9.11.4. 9.12. 9.13. 9.14. 9.14.1. 9.14.2.

10. 10.1. 10.2. 10.3. 10.3.1. 10.3.2. 10.4. 10.4.1. 10.4.2. 10.4.3. 10.4.4. 10.5. 10.5.1. 10.5.2. 10.5.3. 10.6. 10.6.1. 10.6.2. 10.6.3. 10.6.4. 10.7. 10.7.1. 10.7.2. 10.7.3. 10.7.4. 10.7.5. 10.7.6.

11. 11.1. 11.2.

12.

All Fractions Accumulated Dose Multiple Patients Use the Biological Effect Print Reports Schedule Measurements Create a Patient Specific Schedule In Vivo Schedule

76 77 78 78 79 79 80 80

Verification System Link

81

Patient set-up Treatment Synchronization Patient Scheduling Patient Specific Schedule Common Schedule VISIR Installation Patient Setup Treatment Synchronization Dose Export LANTIS / Multi-ACCESS (Option) Installation Patient Setup Treatment Synchronization MOSAIQ (Option) Preparing the data to be exported into OmniPro-InViDos Patient Setup Treatment Synchronization Dose Export VARiS/ARIA (Option) Setting up the Interface Import Patient Data The Measurement Console Dose Export Enable Dose Export Dose Export Settings

81 81 81 82 82 82 82 84 84 84 85 85 86 87 87 87 89 89 90 90 90 91 91 92 92 92

Standard Detector Support

95

General Mounting of the Standard Detector Support

95 95

Advanced Detector Support (Option)

97

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12.1. 12.2. 12.3. 12.4. 12.4.1. 12.4.2. 12.4.3. 12.4.4. 12.4.5. 12.5. 12.5.1. 12.5.2.

13. 13.1. 13.2. 13.3. 13.3.1. 13.3.2. 13.3.3. 13.4.

14. 14.1. 14.2. 14.2.1. 14.2.2. 14.3. 14.4. 14.4.1. 14.4.2. 14.4.3. 14.4.4. 14.4.5. 14.4.6.

15. 15.1. 15.2. 15.3.

General Intended Use Detectors and BNC Connectors Mounting of the Detector Support Removing the Cover Mounting of the Counter Weights Mounting of the Detector Cables Mounting of the Security Clamps Mounting the Cover Mounting of the Console Mounting of the Detector Support onto the Console Advanced Detector Support, Drawings

97 97 97 97 97 98 99 102 102 102 103 103

Mobile Detector Support (Option)

111

Supported Detectors Handling Mounting Removing the Cover Mounting of the Cable and the Detector Connectors Mounting of the Detector Cables Instructions for Use

112 112 113 113 115 116 121

Maintenance

123

Electrometers Detectors Inspection Cleaning Calibration Databases ODBC Moving the Database Connecting to another Database Compression Repair Backup

123 123 123 123 124 124 124 125 125 125 125 125

Technical Support

127

Contact for Technical Support Reporting Complaints Returning Device for Repair

127 127 127

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1. Introduction 1.1.

Intended use

The intended use of the InViDos system is independent patient specific dosimetry, verifying that the dose to the patient is delivered as planned utilizing electrometers, detectors, and EPID (Electronic Portal Imaging Devices). The InViDos system is intended to be used by physicists, therapists, clinicians, and other personnel in a radiotherapy clinic performing treatment of cancer utilizing ionizing radiation.

1.2.

Non-Intended use

In vivo dosimetry measurements shall never be used for the adjustment of the dose delivery (modifying a plan calculation or a treatment unit performance). IBA Dosimetry recommends to follow internationally acknowledged recommendations and guidelines concerning diode in vivo dosimetry for patients receiving external beam radiation therapy1,2 Please ensure sure that the diode detector is used only in those energies for which the detector is intended to be used and has been calibrated.

1.3.

Intended Users

The myQA system is to be used by the personnel with the following expertise: Area

Expertise

Installation

Experts

Operation, start-up and shutdown

Experts and trained personnel

Maintenance

Experts

Troubleshooting

Experts

Trained personnel: Any personnel who have received a training for using this medical device as described in this User’s Guide by the expert or other trained personnel. Experts: Assigned person by IBA Dosimetry who received a specific training for this medical device as described in this User’s Guide.

1 “Diode in Vivo Dosimetry for Patients Receiving External Beam Radiation Therapy”. AAPM Report No

87. Report of Task Group 62 of the Radiation Therapy Committee. American Association of Physicists, 2005. 2 Practical Guidelines for the Implementation of in Vivo Dosimetry with Diodes in External Radiotherapy

with Photon Beams (Entrance Dose). Dominique P. Huyskens, European Society for Radiotherapy and Oncology, 2001.

mniPro-InViDos User’s guide | Introduction | 1

1.4.

Product Description

The InViDos system is a patient dosimetry management system that combines traditional in vivo dosimetry techniques with verification systems and electronic portal imaging (EPI). The system provides the tools to complement verification of geometric parameters with the important feedback of delivered dose. Thus, the InViDos system helps the physician in delivering accurate dose according to the treatment plan. To run OmniPro-InViDos, it is recommended that your computer fulfills the following requirements: ■ 2 GHz processor ■ 1 GB of RAM ■ 120 GB hard disk ■ Serial port, RS-232, for electrometer communication ■ Graphics card supporting 16-bit colors and 1024 x 768 pixels ■ Windows 7 (Enterprise or Professional, 64-bits), 2000 SP4, or XP SP2, US English version ■ Microsoft Data Access Components (MDAC), version 2.7 or later ■ OpenGL drivers The software communicates with the following electrometers from IBA Dosimetry: ■ DPD-3

3 channels

■ DPD-510

5 or 10 channels

■ DPD-12 (emX)

12 or 24 channels, one or two units (master/slave)

Omni-Pro InViDos simplifies the use of patient dosimetry by ■ giving the user an overview of the calibration ■ providing tools to perform the calibration in an efficient way and automatically selecting correction factors for each field ■ providing tools to help improving the accuracy of radiation treatment ■ providing book-keeping data for traceability. More information about the electrometers can be found in the respective operation manuals (see 1.5.3 Associated Documentation).

1.4.1.

Data Storage

Patient Data All data describing the in vivo measurement and its result is saved in a patient database. Keeping complete historical records of the measurements and not only the measured dose is the key to make InViDos a real in vivo verification tool.

Equipment The available equipment used for treatment and measurement is easily accessed in a database. A database located on a network server keeps patient data and records easily available even if the treatment room is changed.

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1.4.2.

Measurement

Measurement Modes The most common way to do a measurement is to simply mount a semiconductor detector at the point of interest (e.g. on skin at beam entrance). Doing so for many fractions may cause field perturbance. Therefore OmniPro-InViDos allows indirect measurements via low perturbance semiconductor detectors and electronic portal imaging systems (EPID).

Display Modes During measurement there is a real-time display showing Dose, Dose rate, Dose difference, or Dose ratio (8.3.3 Dose display, p.67). The above is valid for semiconductor detectors only. Non real-time detectors like TLD and electronic portal imaging devices will only show blanked fields.

Alarm The alarm is visual and audible. It is triggered when the dose reaches the expected value plus a predefined action level. The default action level is valid for the whole system, but specific levels can be set for individual detector and detector positions.

Verification Systems A link to a verification system simplifies and automates a lot the patient setup and measurement. No information needs to be entered twice and OmniPro-InViDos may run unattended during the measurement.

1.4.3.

Analysis

Dose at Prescription Point Dose is normally not measured in the tumor itself but rather on, or close to, the patient’s skin. The dose at the prescription point (in the tumor) can be calculated by interpolating between entrance and exit doses or by using information from a treatment planning system.

Accumulated Dose Since all measurements are saved in a database, the dose can be accumulated for the whole treatment, which makes it possible to observe accumulated deviations etc. If in vivo is not applied to all fractions, OmniPro-InViDos can calculate the dose for fractions without measured dose.

Biological Effect The biological effect is calculated for both the planned treatment and the completed treatments. The effect of alternative plans for the remaining treatment is compared.

1.4.4.

Reports

Reports can be printed with optional graphics showing measured dose or biological effect.

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1.4.5.

Calibration

Detector Sensitivity Semiconductor detectors will change sensitivity when exposed to radiation. OmniPro-InViDos assists in calibrating the detectors at regular intervals to maintain the high accuracy.

Temperature Correction The measured dose is automatically adjusted for differences in temperature between patient measurement and calibration.

General Corrections Additional calibrations and corrections are required for improved accuracy. This will affect parameters like SSD, field size and wedge etc. Advanced tools are available to reduce the amount of work required for calibrations and corrections.

1.4.6.

External Databases

OmniPro-InViDos provides interfaces to the following TPS databases: ■ VISIR (Nucletron) ■ LANTIS (Siemens) ■ Multi-ACCESS (Impac Medical Systems) ■ MOSAIQ (Impac Medical Systems) ■ VARiS / ARIA (Varian Medical Systems)

1.5.

Product Documentation

OmniPro-InViDos User’s Guide IM PO RT ANT N O T IC E PICTURES AND SCREENSHOTS All numbers and selections displayed in pictures and screenshots are only examples and no recommendations for settings or entries. ■ The functions of the devices, hardware display, button texts; and functions and names of the dialogs in the SW are indicated by bold font. Examples: Calibration, Save. ■ References to chapter and section headings and captions of tables and figures in this manual are indicated by italic font. Examples: Equipment Setup, Technical Specifications. ■ A green arrow bullet ( bullets (■).

) list is used for a list of actions in a procedure; other lists use orange square

■ All numbers and selections displayed in images are examples. Values and settings cannot be regarded as references. ■ Throughout this manual, hazardous situations or operations are identified by DANGER, WARNING, CAUTION and NOTICE. They are indicated by specific signs and colors, and described below:

4 | Introduction | OmniPro-InViDos User’s guide

Sign

Meaning DANGER indicates a hazardous situation, which, if not avoided, will result in death or serious injury of the operator or patient. WARNING indicates a hazardous situation, which, if not avoided, could result in death or serious injury of the operator or patient. CAUTION, used with a safety alert symbol, indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury of the operator or patient. CAUTION without the safety alert symbol, used to address issues related to possible hardware damage. IMPORTANT NOTICE used to address operational issues not related to personal injury or hardware damages.

1.5.1.

User’s Guide On-line

OmniPro-InViDos User’s Guide can also be accessed on-line when you have installed the software on your PC. To get access to the on-line User’s Guide, start the Help system by clicking on the Help icon from the Windows Program Manager, or from the OmniPro-InViDos software.

1.5.2.

On-line Help

Menu commands and dialog boxes are described. Click the Help button in a dialog box, or press <F1> on the keyboard for context help. Select Contents in the Help menu to open Contents in the help-file.

1.5.3.

Associated Documentation

■ DPD-3 Operation Manual, DBB000 90000 04 ■ DPD-12pc Operation Manual, DBC100 90001 01 ■ DPD-510 Operation Manual, DBA000 90010 00 ■ Mobile Detector Support User’s Guide, P-Mobile Detector Support-510-001

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2. Health and Safety Information 2.1.

General IM PO RT ANT N O T IC E ALL PERSONNEL MUST READ THIS CHAPTER All personnel must read this chapter and be fully aware of its contents before commencing installation work, and before operating or servicing OmniProInViDos. If the InViDos system is used in a way not specified in this User’s Guide, the protection provided by the equipment may be reduced. IM PO RT ANT N O T IC E INFORMATION FOR USERS IN USA This is a prescription device, and federal law restricts this device to sale by or on the order of a health care practitioner.

The InViDos system has been designed to ensure that, provided the equipment is operated properly, the health and safety of hospital personnel and patients is maintained at all times. However, it should be fully understood that there are a number of dangerous and potentially lethal hazards associated with electrical equipment and radiation therapy. The purpose of this chapter is to identify the hazards associated with the equipment. This information is presented by displaying all safety and rating labels, which are attached to the equipment, and by providing instructions to avoid the associated hazards. The instructions are presented as a series of Warning and Caution notices (see section Notice, p.i).

2.2.

Operator

The InViDos system should only be used by people who ■ are aware of, and understand, the limitations of the device in measurement of radiation output. ■ have knowledge about safety procedures to be observed when working with radiation sources such as Cobalt-60 machines or linear accelerators. ■ are aware of safety precautions required to avoid possible injury when using electrical/electronic equipment. Before using the chamber for measurements, the operator must verify the general functionality, safety, and duly condition of the system.

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2.3.

Power Connection

2.3.1.

Protective Ground W AR NI NG PROTECTIVE GROUND All electrometers must be connected to a mains power outlet with protective ground.

2.3.2.

Line Voltage W AR NI NG LINE VOLTAGE SETTINGS Before using the electrometer, check that the line voltage settings are in accordance with the local mains voltage.

2.4.

Equipment W AR NI NG EARTH CONNECTION Avoid metallic contact between any part of the InViDos system and the treatment couch. C AUT IO N EXTENSION CABLE IBA Dosimetry will not be responsible for the performance of the InViDos system if other cables and connectors than specified are used to extend the supplied cables. W AR N ING DETECTORS IBA Dosimetry will not be responsible for the performance of the InViDos system if: ▪ other detectors than specified in this manual are used ▪ selection of detector type does not follow the recommendation ▪ detector are positioned in the beam in a different way than during calibration ▪ detectors are used with incorrect correction factors ▪ IBA Dosimetry will not be responsible for the patient safety if ▪ other detectors than specified are used ▪ the insulation is damaged. The insulation should be better than 4 kV.

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C AUT IO N DO NOT USE THE DAMAGED DEVICE Do not use any damaged device for measurements. W AR NI NG DETECTOR SUPPORT The counterweights in the detector supports are made of lead. Always use protection gloves during installation of detector support and new detectors.

2.5.

Operation W AR NI NG WAM-UP TIME To allow the electrometer to reach a stable operating temperature, turn it on at least 20 minutes prior to measurement. W AR NI NG ALARM SETTINGS Verify alarm settings before starting a measurement. W AR NI NG DISCREPANCY BETWEEN MEASURED AND PLANNED DOSE There can be a discrepancy between measured and planned dose due to the need for estimation of equivalent field size, or due to inaccurate correction of an asymmetric field. W AR NI NG DETECTOR POSITIONING It is important that a detector is positioned according to the plan. After the treatment, check that the positions of the detectors are still correct. W AR N ING SATURATION When the display indicates saturation, the displayed dose is not correct. W AR NI NG POWER FAILURE Power failure might cause an error in the dose measurement. W AR NI NG ERROR HANDLING ROUTINE It is important that a routine / checklist is established, for identifying possible error conditions in case of unexpected measured dose levels.

mniPro-InViDos User’s guide | Health and Safety Information | 9

2.6.

Calibration W AR NI NG CALIBRATION CONDITIONS During calibration it is important that the system is correctly setup, according to the specified conditions. W AR NI NG WARM-UP TIME BEFORE CALIBRATION To get best result in calibration, turn the electrometer on at least 1 hour before starting the measurement.

2.7.

Service and Maintenance W AR NI NG AUTHORIZED SERVICE ONLY Only service engineers who have been trained on the service of the system, and who are authorized by IBA Dosimetry, may open any of the electrometers. W AR NI NG DATABASE BACK-UP Ensure that back-ups of the OmniPro-InViDos databases are made regularly. W AR NI NG THIRD PART DATABASES Although the ODBC / SQL interface makes it technically possible to access the databases from other third party programs than those described in this User’s Guide, IBA Dosimetry will not be responsible for any consequences of such an action.

2.8.

Responsibility

IBA Dosimetry accepts responsibility for the safety, reliability, and performance of the InViDos system only under the following conditions: ■ Assembly operations, extensions, or repairs are carried out by personnel authorized by IBA Dosimetry. ■ The electrical installation of the relevant room complies with the IEC requirements. ■ The equipment is used in accordance with the operation manual.

10 | Health and Safety Information | OmniPro-InViDos User’s guide

2.9. 2.9.1.

Safety Labels Electrometer – emX

Attention, consult accompanying documents.

Type BF Equipment - Equipment providing a particular degree of protection against electric shock, particularly regarding: ■ Allowable leakage current. ■ Reliability of the protective earth connection (if present). ■ Applied part isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault conditions is not exceeded when a voltage equal to 1.1 times the highest rated mains voltage is applied between the applied part and earth.

2.10. Rating Labels

0124

Typical rating label for the electrometers and detectors.

2.11. Accessories AC C E S SO RI E S AN D S P AR E P ART S No other accessories and spare parts than those provided or approved by the manufacturer must be used, otherwise operator safety, specified measuring accuracy, and interference free operation cannot be guaranteed. Violation of this prescription will result in loss of warranty. IBA Dosimetry cannot be held liable for any damages resulting from the use of accessories or consumables that are not provided or approved by the manufacturer.

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