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Mobius AIRO Mobile CT System - User Manual
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MI-42-0001 Rev. 19
AIRO
Mobile CT System
USER MANUAL
®
Copyright © 2020, Mobius Imaging LLC. All rights reserved.
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2
Table of Contents
Main Page
Table of Contents
3
General Information
13
Chapter Overview
13
Contents
13
Contact Data
14
Contacting the Company
14
User Manual
15
System Described
15
Symbols Used in this Manual
15
Software Screens
15
AIRO Mobile CT System
16
Overview
16
Pediatric Use Summary
18
Overview of Components
20
Transport Mode
20
Scan Mode
21
Legal Information
22
Summary
22
Training and Documentation
23
Training
23
Applications Training
23
Documentation
23
Safety
25
Chapter Overview
25
Contents
25
Responsibilities
26
After-Sale Operating and Safety Practices
26
In Case of Emergency
27
Overview
27
CPR Mode
29
Performing CPR on Patient in System
29
Draping and Sterile Fields
30
Operating Room Use
30
Data Safety
31
Protecting AIRO from Computer Viruses
31
Radiation Safety
32
General Radiation Safety Information
32
Safety Features against Excessive Radiation
33
Dose Notifications and Alerts
33
Profile of Stray Radiation
36
Protective Barriers
38
Protection by Distance
38
Assessing Patient Risk
39
Reducing Risk from X-Ray Dose
39
Laser Safety
40
Reducing Risk from Incorrect Scan
41
Reduce Risk of Skin Burns
41
Mechanical Motion Safety
42
Overview
42
Patient Environment
42
Safety Precautions in the Patient Environment
43
Electrical Safety
45
Overview
45
Transportation Safety
46
Overview
46
Fire Safety
48
Fire Extinguishers
48
Power Failure
49
In Case of Power Failure
49
Restoring a Session
50
Transport Mode
51
Chapter Overview
51
Contents
51
Controls
52
Pendant and Power
52
Power Switches
53
Power and Network Cables
54
Transportation
55
Turn on Power
55
Logging in
55
Starting from Parked Position
57
Menu in Transport Mode
61
Starting from Scan Mode
62
Rotating and Latching the Ring in Transport or Scan Position
63
Raising the System for Transport
65
Transportation
65
After Transport
67
Setting up for Scan
67
Lowering the System
70
Unlocking and Rotating the Ring
71
Setting the Orientation for Scanning
72
Temporary Storage
72
Powering down
74
Set to Standby Mode
74
Column and Table
75
Transferring the Table
77
Scanning
79
Chapter Overview
79
Contents
79
System and Controls
80
AIRO System
80
Pendant Display
81
Before Scanning
82
Overview
82
Choosing Scan Mode
82
Connecting System
85
Moving the Ring in Scan Mode
87
Translating the Ring (Z-Axis)
87
Prepare Scan Field of View
88
Position and Diameter of Scan Field of View
88
Remove Non-Essential Objects
88
Remove Metal Objects
88
Welcome Screen
89
Welcome Screen and Functions
89
Daily Warm up Scan
91
Overview
91
Preparing for Warm up Scan
91
Performing Warm up Scan
91
Menu in Scan Mode
93
Typical Scan Sequence: New Scan
94
New Scan
94
Entering New Patient Data
96
Select Existing Patient Data
98
Entering Patient Data from Hospital Worklist
99
Entering Patient Data from Navigation System
101
Confirming Scan Direction
103
Selecting Patient Type and Patient Category
105
Selecting Exam Region, Protocol, and Scan Type
108
Selecting Patient Orientation and Position
112
Selecting 2D Scout Scan View
113
Positioning with Lasers
116
Setting 2D Scout Scan End Position
118
Setting the 2D Start Position
119
Verifying 2D Parameters and Scanning
120
Selecting 3D Scan Region
122
Selecting a Constant or Modulated Scan
126
Move Ring to Start Position
127
Verifying 3D Parameters and Scanning
128
Summary of 3D Image Controls
130
Main Image View
131
Window/Level
132
Image Controls
133
Setting Slice Thickness
134
Sending Scan to DICOM or USB
135
Next Steps
136
View an Existing Scan
138
Emergency Scanning
141
Taking Emergency Scans
141
Editing Patient Data
142
Editing or Adding Patient Data
142
After Scanning
144
Post-Scanning Steps
144
Head Scanning
145
Setup Patient
145
Setup AIRO
146
Maintenance
149
Chapter Overview
149
Contents
149
Service Functions
150
Service Functions Screen
150
Hospital Service
151
Option: Configure
153
Option: Add New Phantom
155
E-Stop Test
156
Option: Using Custom Kv Settings in Manual or Single Shot Scans
157
Option: Manual Scan
158
Option: Single Shot Scan
159
Quality Check Scans
159
Option: Dose Check Report
161
Brainlab Service
162
Daily Gain Calibration
164
Overview
164
Preparing for Calibration
164
Perform Gain Calibration
165
Image Quality Assessment
169
Cleaning, Disinfection, and Sterilization
176
Cleanable Parts
176
Sterilization
179
Application of Mineral Oil to AIRO Base Rails
180
Inspections
181
Daily
181
Preventative Maintenance
182
Preventative Maintenance Is Required
182
Temporary Disuse
183
Disposal Instructions
184
Disposal of System and Batteries
184
Quality Testing
185
Chapter Overview
185
Contents
185
Test Object and Software
186
Description
186
Testing Image Quality
187
Testing Image Quality with the Phantom
187
Scan a Phantom for Quality Testing
187
Quality Check Reporting
195
Examining Image Quality Report
195
Exposure Testing
207
Responsible Organization
207
Measure and Verify CTDI
207
Technical Description
209
Chapter Overview
209
Contents
209
Introduction
210
Obtaining more Information
210
Warning Regarding Modifications
210
Combining Accessories, Sub-Assemblies, and Compatible Equipment with AIRO
210
Technical Description
211
Brief Description and Operating Principle
211
Significant Characteristics
213
How the Device Functions
213
Physical Characteristics
214
Diagrams
215
Pendant Specifications
217
Operating Table Specifications
219
Column Specifications
219
Wireless Remote Controls for Columns
219
Chargers
219
Special Installation Requirements
220
Overview
220
Electrical Specifications
221
Specifications
221
X-Ray Specifications
222
Generator (High Voltage Power Supply)
222
X-Ray Source Assembly
223
Battery System
223
Performance Characteristics
224
General Performance Characteristics
224
Range, Accuracy, and Precision
225
Environmental Requirements
226
Safety Classifications
227
List of Safety Classifications
227
Replacing Fuses and Other Parts
228
Replacing Parts
228
Network/Data Coupling to Other Equipment
229
Overview
229
Regulatory Compliances and Approvals
230
Summary of Standards Compliance
230
General Electromagnetic Immunity
231
Electromagnetic Emissions and Immunity
231
RF Communications Equipment
234
Overview
234
Symbols
235
Symbols Used
235
Labels
236
Labels Used
236
Location of Certification and Safety Labels
240
System Chassis Locations
240
10 Ct User Information
243
Chapter Overview
243
Contents
243
No Quick-Change X-Ray Tubes
244
Dosage Factors and Image Quality
245
Conditions of Operation
245
Dose Information
245
Statement of Maximum Deviations
252
Imaging Performance Information
252
Technical Statements
254
Definitions of the Measurement Bases of the Technique Factors
258
60601 Requirements: CT USERS
258
Deterministic Effects
260
Radiation Dose Levels
260
Prevailing Radiation Dose
260
Allowed Equipment
261
Chapter Overview
261
Contents
261
Compatibility with Other Medical Devices and Software
262
Medical Devices
262
Medical Software
262
Accessories List
262
12 Troubleshooting
265
Chapter Overview
265
Contents
265
Troubleshooting
266
Problems and Suggested Actions
266
Metal Artifacts in Scans
271
Recognizing Metal Artifacts in CT Scans
271
Rotation Sensor Error
272
Verifying Scan Direction During Scan Setup
272
Transport Failure
273
Base Is Lifted but System will Not Move
273
Cannot Raise System
275
Malfunctions and Return Instructions
279
Malfunctions
279
Return Instructions
279
13 Detachable pendant
281
Chapter Overview
281
Contents
281
Detachable pendant and Holster
282
Overview
282
Maintenance with Detachable Pendants
283
Connecting Detachable Pendants
283
Disconnecting Detachable Pendants
284
Technical Description for Detachable Pendants
286
Detachable pendant Specifications
286
Electromagnetic Emissions and Immunity with Detachable pendant
288
Location of Certification and Safety Labels
288
Index
289
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Mobius AIRO Mobile CT System Specifications
General
Brand
Mobius
Model
AIRO Mobile CT System
Category
Medical Equipment
Language
English
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