Landauer microSTAR ii User manual

USER MANUAL
v1.3 | 12/16/2019

microSTAR®ii User Manual v1.3 ii
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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.

microSTAR®ii User Manual v1.3 5
CHAPTER 2 SYSTEM OVERVIEW
Figure 2-1: Full microSTAR®ii System
The microSTAR®ii Medical Dosimetry System includes both hardware and software components.
The hardware is used to scan and read the nanoDot™ dosimeter. The software provides the tools
necessary to manage the reader, view stored measurement data, generate reports, manage patient
assignment, and manage inventory. This section provides an overview of the hardware components
and software interface.
Note: For detailed hardware and software setup instructions and configuration, see the microSTARii
Installation & Configuration Guide.

microSTAR®ii User Manual v1.3 6
2.1 Hardware
The microSTARii Medical Dosimetry System consists of the microSTARii reader, a laptop or all-in-
one computer with installed software, and associated peripherals (including a mouse, keyboard, and
barcode scanner).
2.1.1 Reader
The microSTARii reader includes a drawer and two LED indicators. The indicators show if the reader
is powered on and it is performing a readout.
Figure 2-2: Reader Front
The microSTARii reader drawer is used to hold the nanoDot dosimeter and correctly position its
active OSL element for readout. To ensure that the reader drawer operates correctly, the nanoDot
dosimeter must be properly positioned within the recessed well. (See section 3.3 for more information
on positioning a nanoDot.)
Figure 2-3: Reader Drawer

microSTAR®ii User Manual v1.3 7
CAUTION:Under normal operating conditions, the reader drawer should not be removed from the
reader. Under special conditions (e.g., maintenance or troubleshooting), the drawer can be removed.
The drawer can only be removed while the power is turned OFF to avoid potential damage to the
optical engine. The reader drawer must be fully inserted before connecting the reader to a power
source and turning the reader ON.
The back of the reader includes a power connector socket, a power button, a USB port, and an
identification label with the reader serial number and other hardware information.
Figure 2-4: Reader Back
2.1.2 Computer
LANDAUER will supply the computer hardware (all-in-one or laptop) required for use with this
system. The computer provided should be used in conjunction with the microSTARii reader. It will
run a Windows Operating System and will be loaded with the microSTARii application and supporting
programs.
2.1.3 nanoDot™
The microSTARii Medical Dosimetry System is used to read nanoDot OSL dosimeters. The
dosimeters come in sealed, labelled plastic packages that protect against contamination. It is
recommended unused dosimeters remain stored in shipment packaging.
When it is time to perform a readout (for pre-verification or dose) the dosimeter is removed from the
pouch and set in the recessed well in the reader drawer. The active element is highlighted in the
crosshair circle in Figure 2-5 below.

microSTAR®ii User Manual v1.3 8
Figure 2-5: nanoDot Dosimeter
CAUTION:If the nanoDot is incorrectly positioned in the reader drawer (e.g., not set in completely
or put in with barcode facing down) the reader may be significantly damaged. (See Figure 3-2 for
correct nanoDot positioning.)
The nanoDot label includes the following information:
•Barcode used to scan the dosimeter information into the system. (Left in Figure 2-5.)
•Serial number used to track and manually enter dosimeter information into the system. (Right
in Figure 2-5.)
•Relative sensitivity is included as part of the serial number. Sensitivity can be determined by
taking the first three digits in the serial number and dividing it by 100. In example in Figure
2-5, the serial number is DN091042837, thus making the sensitivity 0.91.
Two types of nanoDot dosimeters are available for purchase:
•Unscreened (General) nanoDots use a general sensitivity based on the average readings for
the OSL material. These devices have an accuracy of ±10% in sensitivity determination. These
dosimeters area also referred to as General nanoDots.
•Screened (Patient) nanoDots are individually tested to ensure a high accuracy in sensitivity
determination (± 5.5%). These are recommended for therapy and other applications that
require more precise measurements. These dosimeters are also referred to as patient
nanoDots.
Screened nanoDots can also be used to set performance baselines and validate operational
performance, including the following:
•Calibration dosimeters (calsets) are used to create the calibration factor(s) used for dose
calculation (Section 9.1).
•Quality Control (QC) dosimeters are read to verify the accuracy of the calibration and
resulting computed dose. (Used in Chapter 5 best practices and general calibration

microSTAR®ii User Manual v1.3 9
troubleshooting in Chapter 12.) These dosimeters can be used for the Daily QC Check (see
Section 5.1), in additional to other QC methodologies.
Note: The nanoDot is intended to be used in combination with an existing system performance
monitoring methodology. The nanoDot is not intended for independent use as an occupational or
standalone dosimeter.
The nominal dose levels for the 80 kVp and Cs-137 (662 keV) NIST-traceable LANDAUER
Calibration, QC, and Consistency Sets are summarized in the following table. The actual dose level is
listed on the LANDAUER Calibration Certificate issued with the set.
NOTE: Calibration and QC sets for other energies are available as non-standard sets.
THERAPY:662 keV(GAMMA) DIAGNOSTIC:80 kVp (X-RAY)
Application: QA only (Therapy Users will perform on-
site clinical calibrations using their own LINAC and
clinical geometry).
Application: QA + uses where the exposure conditions
emulate the application exposure conditions.
Calibration Set QC Set Consistency Calibration Set QC Set Consistency
Low Dose in cGy (Linear Range) Low Dose in cGy (Linear Range)
Unexposed Unexposed - Unexposed Unexposed -
1.0 - - 0.5 0.5 -
5.0 5.0 - 3.0 3.0 -
10.0 10.0 - - - -
High Dose in cGy (Linear Range) High Dose in cGy (Linear Range)
50.0 50.0 - 50.0 50.0 -
100.0 100.0 100.0 100.0 100.0 100.0
200.0 200.0 - - - -
Table 1: Calibration and QC Dosimeter Set Energies
All dosimeters for use with patients are single use only ( ). However, dosimeters used for QC
and Calibration purposes may be read multiple times in accordance with the replacement frequency
listed in the table below, based on depletion per use.
D
EPLETION
R
ATE
R
EPLACEMENT
F
REQUENCY
Weak Beam 0.2% Every six months or after 10 uses (whichever comes
first)
Strong Beam 2.0% Every three months or after five uses (whichever
comes first)
Table 2: Replacement Recommendations for QC and Calibration Dosimeters ONLY

microSTAR®ii User Manual v1.3 10
2.2 Software
The microSTARii Medical Dosimetry System includes:
1. Embedded software within the reader (firmware)
2. Reader device driver that controls the reader (sending commands or data to and from the
reader firmware)
3. Software application used to operate the reader, manage data, and report dosimetry results
4. SQL database to store reader data
2.2.1 Main Functions
The software supports the following main functions:
•Quality Assurance
The system supports both quality assurance of the system and the dosimeters used.
•Dosimeter Tracking (Patient Assignment)
Dosimeters can be assigned to a patient to record information including: track dose, usage
cycle, and location used.
•Intrinsic and Dosimetry Measurements
Measurements are initiated through the software. The system is calibrated and reads are
configured based on usage and application.
•Reporting
A robust reporting set supports analysis, trending, and compliance reporting.

microSTAR®ii User Manual v1.3 11
2.2.2 User Interface Overview
The user interface includes view buttons at the top of the window and session status information at
the bottom of the window. Figure 2-6 outlines key areas on the user interface.
Figure 2-6: User Interface Overview
L
ABEL
D
ESCRIPTION
1 Button to minimize the application window to Microsoft taskbar
2 Button to maximize window to full computer screen or restore the
window to its previous size
3 Button to exit the software application
4 Reader Connection Status (Connected or Disconnected)
5 Username of the Logged In User
6 Name of the Connected Reader (the reader
name assigned at
installation)
7 Current Beam Use Mode (Automatic vs. Forced Weak)
8 Current Date
9 Current Time

microSTAR®ii User Manual v1.3 12
The user interface has eleven main user screens. The screens are visible based on permissions level
and profile assigned. (For a full listing of profile permission and permissions for default profiles, see
Appendix A: Profile Permissions Listing.)
S
CREEN
S
HORT
D
ESCRIPTION
About
microSTARii
system information: user software version, the SQL
database version, the reader device driver version, the connected
reader’s firmware version, the computer name, and Unique Identifier
for the software installed at each facility.
Backups Database
management for creating backups, restoring backup files,
and database resets.
Calibration
Reader calibration factor(s) used in the dose calculation formula
shown on the Reading tab. The calibration dosimeters are read on this
screen as part of the system calibration.
Configuration
Basic operating parameters for the reader and customizable software
configuration.
This tab includes operations configuration, such as
Dosimetry Category, Dosimetry Use Type, Dose Reading Mode,
Beam Use Mode, and Dose U
nit. It also includes advanced
configuration, such as compliance settings, field options, and QC
limits.
Data Full reporting of all measurement data collected through reads.
Dosimeter Assignment Listing of patient information and associated dosimeter(s). New
assignments and assignment updates can be made on this tab.
Event Log A log of software activities used to troubleshoot issues or log usage
patterns.
QA
Quality Control tests used to evaluate the reader’s stability, verify the
reader is operating correctly prior to clinical use, and determine the
background measurements prior to patient
assignment and clinical
use.
Reading
Main interface used to initiate a reading for both Patient and Generic
dosimetry. It includes fields needed to associate additional data with
the readout and check on the Daily QC status.
Security User account management and profile configuration.

microSTAR®ii User Manual v1.3 13
S
CREEN
S
HORT
D
ESCRIPTION
Sensitivity Assessment
The toolset used to assess a population of nanoDots, validate the
accuracy of labeled sensitivity, complete on-
screen and structured
sensitivity assessment reporting, and input a sensitivity correction
using a Sensitivity Adjustment Factor (SAF).

microSTAR®ii User Manual v1.3 14
CHAPTER 3 SYSTEM OPERATIONS
3.1 Startup
The microSTARii Medical Dosimetry System startup sequence is outlined in the following flowchart.
Figure 3-1: Startup Sequence
STEP 1: Verify Connections
Check the physical connections from the reader to the computer. Ensure they match
the setup instructions in the installation guide.
STEP 2: Turn on the Reader
Press the power button on the back of the device (Figure 2-4) to turn the reader on.
When the reader is fully powered, the LED indicator on the front will be illuminated
(Figure 2-2).
NOTE: The reader should be turned on at least 60 minutes prior to use.
STEP 3: Turn on the Computer
Turn on the computer according to the manufacturer’s instructions for the model of
computer that came with your reader.