OmniPro-InViDos Users Guide 1.3c July 2018.pdf
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OmniPro-InViDos Version 1.3c
User’s Guide
Page 3
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
mniPro-InViDos User’s guide | Notice | i
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ii | Notice | OmniPro-InViDos User’s guide
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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
Technical Specifications
Standard equipment
Electrometer DPD-12 (emX)
Power Supply
Connections
Electrometer Specification
Design
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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)
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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
Definitions and Settings
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
Measurements
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
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57
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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
Verification System Link
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
Standard Detector Support
General
Mounting of the Standard Detector Support
Advanced Detector Support (Option)
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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
Mobile Detector Support (Option)
Supported Detectors
Handling
Mounting
Removing the Cover
Mounting of the Cable and the Detector Connectors
Mounting of the Detector Cables
Instructions for Use
Maintenance
Electrometers
Detectors
Inspection
Cleaning
Calibration
Databases
ODBC
Moving the Database
Connecting to another Database
Compression
Repair
Backup
Technical Support
Contact for Technical Support
Reporting Complaints
Returning Device for Repair
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102
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103
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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.
“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.
1
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
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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.
2 | Introduction | OmniPro-InViDos User’s guide
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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.
mniPro-InViDos User’s guide | Introduction | 3
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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
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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
mniPro-InViDos User’s guide | Introduction | 5
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6 | Introduction | OmniPro-InViDos User’s guide
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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.
mniPro-InViDos User’s guide | Health and Safety Information | 7
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2.3.
2.3.1.
Power Connection
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.
8 | Health and Safety Information | OmniPro-InViDos User’s guide
Page 19
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
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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.
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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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2.12. Regulatory Requirements
The InViDos system fulfills the requirements of the following European directive and standards:
The Medical Device Directive 93/42 EEC (Annex II, Class IIb)
EN 60601-1
Safety requirements for Medical electrical systems
EN 60601-2
Electromagnetic compatibility – requirements and
tests
EN 60601-2-9
Particular requirements for the safety of patient
contact dosimetry used in radiotherapy with
electrically connected radiation detectors
The InViDos system is also in accordance with the US Medical Device Regulation, CFR Title 21.
The quality assurance system at IBA Dosimetry GmbH is certified according to ISO 13485.
0124
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3. System Description
3.1.
Equipment Database
OmniPro-InViDos uses a database to store information about the equipment being used, e.g. radiation
devices, electrometers, and detectors. Although not required, it is strongly recommended that a single
database be used for the whole clinic. Equipment can then be defined and edited from any computer on
the network.
Radiation devices are described with their options, such as energies, wedges, applicators etc.
Electrometers contribute with their name and type only. The detector settings include type, temperature
dependence, electrometer connection, etc. Finally the database also contains calibration information,
such as detector sensitivity, and different correction factors.
3.1.1.
Local Storage
Some equipment-related information has to be saved locally, on each computer. Typical examples are
serial port configurations for electrometers, or local settings for verification systems. Instead of a
conventional database, the Windows registry is used.
3.1.2.
Patient Database
OmniPro-InViDos uses a database to save data from all in vivo measurements on a patient. Among the
data stored are radiation device settings, detector information, calibration factors, etc. Thus a more or
less complete picture of the conditions when the dose was given is stored.
As for the equipment database, it is not required that the patient database can be accessed from
several computers via a network, but it is strongly recommended. It makes it possible to move patients
between treatment rooms (i.e. radiation devices), and also to initially define patients off-line on any
computer on the network.
3.1.3.
Treatments, Fractions, Fields, and Positions
Each patient may have one or more treatments defined. Once a treatment has started, the number of
fields may not be changed. For each treatment fraction, all fields are exposed and may be measured by
OmniPro-InViDos. More than one treatment can sometimes be active at the same time. OmniProInViDos must treat a boost field, not given at every fraction, as a separate treatment.
For each field a number of measurement positions are defined. Normally the same detector is used in
the same position during the whole treatment. Even though the position is unique, it is possible to swap
the detectors. Thus a patient can be moved between treatment rooms, with different sets of detectors.
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Most of the information is stored per fraction, in order to reflect any changes during the treatment
period.
3.1.4.
Read-only Patients
With a common database for several users, there is a risk that data will be overwritten by accident.
Assume that the same patient is opened and edited on two computers at the same time. The changes
first saved will be lost when the second copy of the same patient is saved. For this reason OmniProInViDos logs all open patients, and will prevent a second copy of the same patient to be opened, unless
in read-only mode. Changes to a read-only patient, including measurements, can only be saved if all
patient information is stored as a completely new patient.
3.1.5.
Search
Each patient is saved with a unique, user selected, identifier. It is possible to search the database for a
specific patient even if the identifier is (partly) unknown or forgotten. Given the beginning of either the
identifier or the patient’s last name, OmniPro-InViDos will try to find a match in the database.
3.1.6.
Templates
The patient database also contains templates for quick and easy setup of new patients. A template may
contain all information required for a measurement, including radiation device settings and detectors.
Any “normal” patient can be used when creating a template for other new patients.
3.2.
3.2.1.
Calibration
Accuracy
The accuracy in in-vivo measurements depends very much on the selected calibrations and corrections.
A higher accuracy requires more time and effort in preparation. OmniPro-InViDos allows the user to
choose the ambition level, and also offers some tools to make the calibration work easier.
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3.2.2.
Detector Sensitivity
Semiconductor detectors will change sensitivity when exposed to radiation. Therefore it is necessary to
calibrate the detector sensitivity at regular intervals. The time between re-calibrations depends on the
desired accuracy, the accumulated detector dose, and the radiation type and energy. The optimal
frequency must be defined based on experience.
The sensitivity factor is a combination of detector sensitivity and electrometer characteristics. Because
of this, a detector can only be used when connected to the electrometer channel where it was once
calibrated.
3.3.
Temperature Correction
The signal from a semiconductor detector depends on the temperature. Therefore the calibrated
sensitivity factor is only valid for one temperature. However, a detector’s temperature dependence is
fairly predictable. By comparing the estimated temperature in the position of the detector (e.g. skin 32
°C mask 25 °C, fixture 22 °C, between skin and couch 37°C) with the temperature at calibration, a
correction factor can be applied. Note that a temperature correction is always applied to the measured
dose.
3.4.
Leakage Measurement
Even without radiation, a signal can be recorded from the detector. It is sometimes referred to a dark
current, due to leakage in either detector or electrometer. This leakage signal is normally very small, but
if a long time passes after an electrometer reset it will contribute to the final measured dose.
The leakage drift and offset should be measured in conjunction to a detector sensitivity calibration, but
can be performed at any time.
3.5.
Corrections
W AR NI NG
LIMITATION OF 300 SINGLE CORRECTION FACTORS
The database can handle only 300 correction factors. Do not generate more than
300 single correction factors. Use the multiplicity functionality in combination to
increase the amount of correction factors based on the measured single factors.
3.5.1.
SDD/SSD Correction
When in vivo dosimetry is used for teletherapy, the detector is often not placed on the patient’s skin, but
rather slightly up-streams the beam, for measurement of the entrance dose. The reasons can be a
bolus, a fixture, irradiation through the table top, etc. The measured dose will in these cases be higher
than if the detector was placed on the skin.
When the SDD (source detector distance) is different from the SSD (source skin distance), the
measured dose is automatically corrected with the factor SDD2 / SSD2. Note that the correction is also
used if SDD > SSD.
If a bolus is used, it is better to let the SSD define the distance to the bolus instead of the skin. The
calibration point will then be at the depth from the bolus surface, and no special handling will therefore
be required.
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Among the additional corrections, described later in this chapter, there is a correction factor for the air
gap. This factor does not include the SDD/SSD correction, but rather the deviation from the SDD/SSD
correction (e.g. due to the lack of scattering).
3.5.2.
Configuration Correction
The corrections described in the previous sections are all required by OmniPro-InViDos. In most
situations this minimum level is sufficient to detect any major deviations during treatment. The next,
optional, level includes corrections for different energies and detector placements, and gives an
increased accuracy with only a small additional effort.
During detector sensitivity calibration, a reference setting is used, defining the radiation device, energy,
and detector placement (e.g. entrance, exit, off-axis etc). Each additional combination of these three
parameters will have a separate correction factor.
These correction factors must be calibrated once, but they remain constant over a very long time. The
maintenance is very limited, since no regular re-calibrations are necessary.
3.5.3.
Additional Corrections
It is possible to further increase the accuracy by, optionally, adding more correction factors. Instead of
having only one single factor for each combination of radiation device, energy, and placement,
corrections can be added for different SSD:s, field sizes, wedges, etc.
Each factor is calibrated for a unique combination of the selected parameters (SSD, field size, wedge
etc). When the correction is applied, the factor with parameters matching the current radiation device
settings will be used.
Some of the corrections allow linear interpolation. Here we find SSD, field size, off-axis distance, fieldedge distance, direction, and air gap. For example, a set of SSD:s is selected for calibration, and later
correction will be also performed for distances in-between.
Field size is another type of exception, where calibration is done on quadratic fields only, but the final
correction includes rectangular fields as well. The factor for a rectangular field is calculated as:
FactorRect AB FactorQuad A FactorQuad B
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