Mobius AIRO Mobile CT System - Quality Testing; Chapter Overview; Contents

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MI-42-0001 Rev. 19 173

QUALITY TESTING: Chapter Overview

8 QUALITY TESTING

8.1 Chapter Overview

8.1.1 Contents

Topics Covered

Section See

st Object and Software 8.2

Testing Image Quality 8.3

Quality Check Reporting 8.4

Exposure Testing 8.5

Main Page

Table of Contents3
General Information13
Chapter Overview13
Contents13
Contact Data14
Contacting the Company14
User Manual15
System Described15
Symbols Used in this Manual15
Software Screens15
AIRO Mobile CT System16
Overview16
Pediatric Use Summary18
Overview of Components20
Transport Mode20
Scan Mode21
Legal Information22
Summary22
Training and Documentation23
Training23
Applications Training23
Documentation23
Safety25
Chapter Overview25
Contents25
Responsibilities26
After-Sale Operating and Safety Practices26
In Case of Emergency27
Overview27
CPR Mode29
Performing CPR on Patient in System29
Draping and Sterile Fields30
Operating Room Use30
Data Safety31
Protecting AIRO from Computer Viruses31
Radiation Safety32
General Radiation Safety Information32
Safety Features against Excessive Radiation33
Dose Notifications and Alerts33
Profile of Stray Radiation36
Protective Barriers38
Protection by Distance38
Assessing Patient Risk39
Reducing Risk from X-Ray Dose39
Laser Safety40
Reducing Risk from Incorrect Scan41
Reduce Risk of Skin Burns41
Mechanical Motion Safety42
Overview42
Patient Environment42
Safety Precautions in the Patient Environment43
Electrical Safety45
Overview45
Transportation Safety46
Overview46
Fire Safety48
Fire Extinguishers48
Power Failure49
In Case of Power Failure49
Restoring a Session50
Transport Mode51
Chapter Overview51
Contents51
Controls52
Pendant and Power52
Power Switches53
Power and Network Cables54
Transportation55
Turn on Power55
Logging in55
Starting from Parked Position57
Menu in Transport Mode61
Starting from Scan Mode62
Rotating and Latching the Ring in Transport or Scan Position63
Raising the System for Transport65
Transportation65
After Transport67
Setting up for Scan67
Lowering the System70
Unlocking and Rotating the Ring71
Setting the Orientation for Scanning72
Temporary Storage72
Powering down74
Set to Standby Mode74
Column and Table75
Transferring the Table77
Scanning79
Chapter Overview79
Contents79
System and Controls80
AIRO System80
Pendant Display81
Before Scanning82
Overview82
Choosing Scan Mode82
Connecting System85
Moving the Ring in Scan Mode87
Translating the Ring (Z-Axis)87
Prepare Scan Field of View88
Position and Diameter of Scan Field of View88
Remove Non-Essential Objects88
Remove Metal Objects88
Welcome Screen89
Welcome Screen and Functions89
Daily Warm up Scan91
Overview91
Preparing for Warm up Scan91
Performing Warm up Scan91
Menu in Scan Mode93
Typical Scan Sequence: New Scan94
New Scan94
Entering New Patient Data96
Select Existing Patient Data98
Entering Patient Data from Hospital Worklist99
Entering Patient Data from Navigation System101
Confirming Scan Direction103
Selecting Patient Type and Patient Category105
Selecting Exam Region, Protocol, and Scan Type108
Selecting Patient Orientation and Position112
Selecting 2D Scout Scan View113
Positioning with Lasers116
Setting 2D Scout Scan End Position118
Setting the 2D Start Position119
Verifying 2D Parameters and Scanning120
Selecting 3D Scan Region122
Selecting a Constant or Modulated Scan126
Move Ring to Start Position127
Verifying 3D Parameters and Scanning128
Summary of 3D Image Controls130
Main Image View131
Window/Level132
Image Controls133
Setting Slice Thickness134
Sending Scan to DICOM or USB135
Next Steps136
View an Existing Scan138
Emergency Scanning141
Taking Emergency Scans141
Editing Patient Data142
Editing or Adding Patient Data142
After Scanning144
Post-Scanning Steps144
Head Scanning145
Setup Patient145
Setup AIRO146
Maintenance149
Chapter Overview149
Contents149
Service Functions150
Service Functions Screen150
Hospital Service151
Option: Configure153
Option: Add New Phantom155
E-Stop Test156
Option: Using Custom Kv Settings in Manual or Single Shot Scans157
Option: Manual Scan158
Option: Single Shot Scan159
Quality Check Scans159
Option: Dose Check Report161
Brainlab Service162
Daily Gain Calibration164
Overview164
Preparing for Calibration164
Perform Gain Calibration165
Image Quality Assessment169
Cleaning, Disinfection, and Sterilization176
Cleanable Parts176
Sterilization179
Application of Mineral Oil to AIRO Base Rails180
Inspections181
Daily181
Preventative Maintenance182
Preventative Maintenance Is Required182
Temporary Disuse183
Disposal Instructions184
Disposal of System and Batteries184
Quality Testing185
Chapter Overview185
Contents185
Test Object and Software186
Description186
Testing Image Quality187
Testing Image Quality with the Phantom187
Scan a Phantom for Quality Testing187
Quality Check Reporting195
Examining Image Quality Report195
Exposure Testing207
Responsible Organization207
Measure and Verify CTDI207
Technical Description209
Chapter Overview209
Contents209
Introduction210
Obtaining more Information210
Warning Regarding Modifications210
Combining Accessories, Sub-Assemblies, and Compatible Equipment with AIRO210
Technical Description211
Brief Description and Operating Principle211
Significant Characteristics213
How the Device Functions213
Physical Characteristics214
Diagrams215
Pendant Specifications217
Operating Table Specifications219
Column Specifications219
Wireless Remote Controls for Columns219
Chargers219
Special Installation Requirements220
Overview220
Electrical Specifications221
Specifications221
X-Ray Specifications222
Generator (High Voltage Power Supply)222
X-Ray Source Assembly223
Battery System223
Performance Characteristics224
General Performance Characteristics224
Range, Accuracy, and Precision225
Environmental Requirements226
Safety Classifications227
List of Safety Classifications227
Replacing Fuses and Other Parts228
Replacing Parts228
Network/Data Coupling to Other Equipment229
Overview229
Regulatory Compliances and Approvals230
Summary of Standards Compliance230
General Electromagnetic Immunity231
Electromagnetic Emissions and Immunity231
RF Communications Equipment234
Overview234
Symbols235
Symbols Used235
Labels236
Labels Used236
Location of Certification and Safety Labels240
System Chassis Locations240
10 Ct User Information243
Chapter Overview243
Contents243
No Quick-Change X-Ray Tubes244
Dosage Factors and Image Quality245
Conditions of Operation245
Dose Information245
Statement of Maximum Deviations252
Imaging Performance Information252
Technical Statements254
Definitions of the Measurement Bases of the Technique Factors258
60601 Requirements: CT USERS258
Deterministic Effects260
Radiation Dose Levels260
Prevailing Radiation Dose260
Allowed Equipment261
Chapter Overview261
Contents261
Compatibility with Other Medical Devices and Software262
Medical Devices262
Medical Software262
Accessories List262
12 Troubleshooting265
Chapter Overview265
Contents265
Troubleshooting266
Problems and Suggested Actions266
Metal Artifacts in Scans271
Recognizing Metal Artifacts in CT Scans271
Rotation Sensor Error272
Verifying Scan Direction During Scan Setup272
Transport Failure273
Base Is Lifted but System will Not Move273
Cannot Raise System275
Malfunctions and Return Instructions279
Malfunctions279
Return Instructions279
13 Detachable pendant281
Chapter Overview281
Contents281
Detachable pendant and Holster282
Overview282
Maintenance with Detachable Pendants283
Connecting Detachable Pendants283
Disconnecting Detachable Pendants284
Technical Description for Detachable Pendants286
Detachable pendant Specifications286
Electromagnetic Emissions and Immunity with Detachable pendant288
Location of Certification and Safety Labels288
Index289

Mobius AIRO Mobile CT System - Quality Testing; Chapter Overview; Contents

Table of Contents