Landauer microSTAR ii User manual

USER MANUAL
v1.3 | 12/16/2019

microSTAR®ii User Manual v1.3 ii
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This user manual is furnished under license only for the use and information of the licensee. It contains
confidential and proprietary information belonging to LANDAUER®.
As such, this user manual may not be reprinted or redistributed to any third party without the written
consent of LANDAUER®.
Use of the contents of this guide for any purpose other than that for which it was provided is
prohibited.
LANDAUER® does not warrant or guarantee the contents of this user manual.
LANDAUER®, nanoDot™, and microSTAR®ii are registered trademarks of LANDAUER® in the
United States and other countries. All other company, product, and service names and brands are the
trademarks or registered trademarks of their respective owners.
©2019 by LANDAUER®
All rights reserved.

microSTAR®ii User Manual v1.3 iii
Table of Contents
Chapter 1 Introduction & Background....................................................................................................1
1.1 Limitations of Product Scope..........................................................................................................2
1.1.1 Indications For Use ..................................................................................................................2
1.1.2 Manufacturer .............................................................................................................................2
1.2 Best Practices .....................................................................................................................................3
1.3 Conventions and Standards .............................................................................................................4
Chapter 2 System Overview ......................................................................................................................5
2.1 Hardware ............................................................................................................................................6
2.1.1 Reader.........................................................................................................................................6
2.1.2 Computer ...................................................................................................................................7
2.1.3 nanoDot™.................................................................................................................................7
2.2 Software............................................................................................................................................10
2.2.1 Main Functions .......................................................................................................................10
2.2.2 User Interface Overview........................................................................................................11
Chapter 3 System Operations..................................................................................................................14
3.1 Startup...............................................................................................................................................14
3.2 Shutdown..........................................................................................................................................16
3.2.1 Partial Shutdown.....................................................................................................................16
3.2.2 Full Shutdown .........................................................................................................................16
3.3 Positioning the nanoDot................................................................................................................16
3.4 Ejecting the nanoDot .....................................................................................................................17
Chapter 4 Configuration...........................................................................................................................18
4.1 General Configuration....................................................................................................................18
4.1.1 Dosimetry Category................................................................................................................18
4.1.2 Dosimetry Use Type...............................................................................................................19
4.1.3 Dose Reading Mode ...............................................................................................................19
4.1.4 Beam Use Mode......................................................................................................................19
4.1.5 Dose Unit.................................................................................................................................20

microSTAR®ii User Manual v1.3 iv
4.2 Advanced Configuration ................................................................................................................20
4.2.1 Configuring Organization Information ...............................................................................21
4.2.2 Configuring User Defined Fields .........................................................................................21
4.2.3 Setting the Reading Parameters ............................................................................................23
4.2.4 Changing Daily QC Limits ....................................................................................................23
4.2.5 System Compliance Checks...................................................................................................24
Chapter 5 Reader Quality Assurance......................................................................................................26
5.1 Reader Daily QC Tests...................................................................................................................27
5.2 Reader QC Tests .............................................................................................................................29
Chapter 6 Dosimeter Verification & Pre-Assignment.......................................................................32
6.1 General Background Using Reference Dosimeter .....................................................................33
6.2 Verify Dosimeters Using Individual Background Readings .....................................................36
Chapter 7 Dosimetry Reads.....................................................................................................................37
7.1 Generic Dosimetry..........................................................................................................................38
7.2 Patient Dosimetry ......................................................................................................................41
7.2.1 Radiation Therapy...................................................................................................................42
7.2.2 Diagnostic Imaging.................................................................................................................44
7.2.3 Patient Account Management...............................................................................................46
7.2.4 Dosimeter Assignment...........................................................................................................48
7.2.5 Modifying Results ...................................................................................................................50
Chapter 8 Reporting..................................................................................................................................51
8.1 Available Reports ............................................................................................................................51
8.1.1 Assignment Worklist ..............................................................................................................51
8.1.2 Calibration Data Export ........................................................................................................52
8.1.3 microSTARii Control Limit Test Report ............................................................................52
8.1.4 microSTARii Daily QC Test Report....................................................................................53
8.1.5 Sensitivity Assessment............................................................................................................53
8.1.6 Structured Dose Report.........................................................................................................54
8.2 Report Filtering ...............................................................................................................................56
8.2.1 General Information...............................................................................................................56
8.2.2 Icons .........................................................................................................................................56

microSTAR®ii User Manual v1.3 v
8.2.3 Advanced Filters .....................................................................................................................56
8.2.4 Data Template.........................................................................................................................57
Chapter 9 Advanced Operations.............................................................................................................59
9.1 Changing Read Type (Linear and Non-Linear) ..........................................................................59
9.2 Measurement Calibration ...............................................................................................................60
9.2.1 Calibration Considerations ....................................................................................................62
9.2.2 Performing a System Calibration..........................................................................................62
9.3 Simulated Calibrations....................................................................................................................64
9.4 Sensitivity Adjustment Factor Values ..........................................................................................65
9.4.1 Test Conditions.......................................................................................................................66
9.4.2 Sensitivity Assessment Test Calculations ............................................................................66
9.4.3 Running a Sensitivity Assessment ........................................................................................68
9.4.4 Saving a New SAF Value.......................................................................................................69
9.4.5Resetting SAF Value...............................................................................................................69
Chapter 10 System Administration ...........................................................................................................70
10.1 Profile Management (Security) ......................................................................................................70
10.1.1 Reviewing Profiles ..................................................................................................................70
10.1.2 Adding New Profiles..............................................................................................................71
10.1.3 Editing an Existing Profile ....................................................................................................71
10.2 User Access Management (Security) ............................................................................................72
10.2.1 Reviewing User Account .......................................................................................................72
10.2.2 Adding User Account.............................................................................................................72
10.2.3 Editing Existing User Account.............................................................................................73
10.2.4 Deleting a User Account........................................................................................................74
10.3 Adding a Reader ..............................................................................................................................74
10.4 System Backup.................................................................................................................................75
10.5 Database Management ...................................................................................................................77
Chapter 11 CLEANING PROCEDURES.............................................................................................79
11.1 Preparation: ......................................................................................................................................79
11.2 Cleaning the Drawer .......................................................................................................................80
11.3 Cleaning the Reader ........................................................................................................................81

microSTAR®ii User Manual v1.3 vi
Chapter 12 Troubleshooting......................................................................................................................83
12.1 Technical Support ...........................................................................................................................83
12.2 Event Logs .......................................................................................................................................84
12.2.1 Usage Information..................................................................................................................85
12.2.2 Exporting the Event Log.......................................................................................................85
12.3 System Version Information .........................................................................................................86
12.4 Hardware Issues ..............................................................................................................................86
12.5 Error Messages ................................................................................................................................89
12.6 Failed QC Tests...............................................................................................................................91
12.6.1 Reader Daily QC Tests Failure .............................................................................................91
12.6.2 Reader QC Tests Failure........................................................................................................92
12.7 Operations Issues............................................................................................................................92
Profile Permissions Listing................................................................................................94
Reader Daily Quality Control ...........................................................................................98
Standard Database Values .................................................................................................99
Glossary............................................................................................................................. 100
Stakeholder Approval....................................................Error! Bookmark not defined.

microSTAR®ii User Manual v1.3 1
CHAPTER 1 INTRODUCTION &
BACKGROUND
The microSTAR®ii Medical Dosimetry System is used as an independent secondary dose verification
system that performs comprehensive measurement readings of the nanoDot™ Optically-Stimulated
Luminescence (OSL) dosimeter. The system reads the dosimeter, performs analyses using calibration
parameters and customer-specific configurations, and provides in-depth reporting for review. The
system stores the data for reference and cumulative dosage records. It uses a compact Optical Engine
with a high-powered Light-Emitting Diode (LED) and Pulsed Optically-Stimulated Luminescence
(POSL) to provide a precise radiation dose measurement.
Figure 1-1: Optical Engine Components
This user manual contains detailed information for the microSTAR®ii Medical Dosimetry System,
including operation of both the reader and application software after installation and configuration is
complete. It includes useful information pertaining to quality assurance and compliance checks, system
configuration updates, measurement procedures, reporting, system administration, and
troubleshooting for the system.
Related documentation can be found at http://landauer.com/microstarii. This includes:
•microSTARii Installation & Configuration Guide for detailed instructions on how to
setup, configure, and test your system at installation.
•Frequently Asked Questions for information about the system design, operations, and term
definitions.
•microSTARii™ – A new system for medical dosimetry: Part I: Technology & Initial
Performance:a white paper that details the design and performance of the system.

microSTAR®ii User Manual v1.3 2
1.1 Limitations of Product Scope
The microSTAR®ii Medical Dosimetry System has been designed as a secondary dose verification
system. The system should only be employed as one of a number of tools in a program of quality
assurance for the primary dose verification systems being used. As such, the results obtained with the
microSTARii should not be used to guide patient care decisions. Instead, it may be used as a secondary
method to validate the prediction or assessment of radiation dose to patients resulting from
therapeutic or diagnostic procedures.
The nanoDot™ dosimeter used in the microSTARii Medical Dosimetry System is manufactured as a
single-use device ( ) only for use with patients. When used for calibration and quality control (QC),
the nanoDot dosimeter may be used in accordance with the recommended replacement schedule
detailed in Table 2 of Section 2.1.3. Due to the potential for changes in dosimeter performance with
accumulating life-time dose, LANDAUER® and its affiliates do not support reuse of the nanoDot
dosimeter for use with patients.
℞Only. Caution: Federal law restricts this device to sale by or on the order of a qualified medical
provider.
The user assumes full responsibility for implementing site-specific procedures to ensure correct
patient identification, HIPAA-compliant management of patient Personally Identifiable Information
(PII), dosimeter verification, and proper usage including: transport, handling, placement, and timely
readout. It is strongly recommended site-specific written Standard Operating Procedures be
implemented prior to the launch of a medical dosimetry program.
Customers who intentionally disregard these stated limitations of product scope assume full
responsibility for any negative consequences resulting from any such use.
Note: A known bug is preventing the Sensitivity Assessment feature (Section 9.4: Sensitivity
Adjustment Factor Values) from functioning properly at this time. LANDAUER® is working to
correct the issue. For questions related to this feature, please contact LANDAUER InLight®
customer service (Telephone: [phone], email: [e-mail]).
1.1.1 Indications For Use
The LANDAUER®microSTAR®ii Medical Dosimetry System provides an accurate, reliable, and
easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in
medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure
patient dose, the system is used to provide a secondary verification of radiation dose as a means of
Quality Control for the primary dose calculation method. The output of the microSTARii system is
not used to adjust the dose to the patient.
1.1.2 Manufacturer
LANDAUER at 2 Science Road in Glenwood, IL 60425.

microSTAR®ii User Manual v1.3 3
1.2 Best Practices
To achieve the best results using the microSTAR®ii Medical Dosimetry System, comply with the best
practice operating principles listed below. The contents of this manual provide the instructions and
guidance to support these standards.
Implement the microSTARii QA program and monitor reader performance trends. Do not
perform readings if the Daily QA test has failed.
Allow the reader to warm up for 60 minutes after it has been powered on prior to use. This
will allow the system to stabilize for improved performance.
Do not open the reader drawer during nanoDot analysis.
Do not remove the drawer from the reader during normal operations.
Set the nanoDot flat in the tray with the barcode facing up and in the upper-left corner of the
dosimeter. If the nanoDot is incorrectly positioned in the reader drawer the reader may be
significantly damaged. (See Figure 3-2 for correct nanoDot positioning.)
Verify the correct sensitivity is displayed when scanning nanoDot serial numbers prior to
reading. (See section 2.1.3 for more information.)
When reading nanoDots, note the form of the dose calculation formula on the Reading tab and
ensure that the values used in the calculation are correct.
Prior to analyzing a nanoDot, verify that the correct calibration name(s) appears in the Current
Calibration fields on the Reading tab.
Always use the average of 3-4 readings to calculate an average estimate of dose for medical
dosimetry applications to improve accuracy.
To minimize outside interference, which can affect measurement precision, do not place
reader near high Electromagnetic Field (EMF) generating equipment, such as CT machines.
Complete a system calibration annually as part of routine system maintenance.
Clean the reader and the drawer regularly to get rid of any debris generated after 1,000
open/close cycles of regular use (See Chapter 11 more for information).

microSTAR®ii User Manual v1.3 4
1.3 Conventions and Standards
The following symbol is used within this documentation to mark risks, warnings, and other
information.
Caution
This symbol denotes information that could affect the equipment operation or
cause issues with overall dosimetry operations.
Single Patient Use Only
This symbol indicates a device or product is intended for single patient use only.
Prevention of Personal Injury
To prevent eye damage and personal injury, please adhere to the following:
•Do not attempt to remove portions of the enclosure or otherwise
disassemble the reader. The Reader contains a high-
power LED, which
under specific conditions could cause damage to the eye. Please refer service
to an approved technician.
•Do not alter the Reader and use only as specified or the protection provided
by the Reader can be compromised.
•Use only a LANDAUER-approved power supply to power the Reader.
•Use the Reader indoors only.
•Do not use the Reader if it has been altered or is damaged.