auris Monarch Platform - Label Locations

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300-002547-00 rev7 15

Label Locations

The following figures show the system labels and their locations. The Monarch

System UDI is located on the tower.

Cart

Main Page

Table of Contents12
Monarch Platform Device Overview18
System Overview19
- Pre-Procedural Planning19
- Monarch Cart19
- Monarch Tower23
- Monarch Bronchoscope System25
- Working Channel Instruments26
- Accessories26
Classifications27
Monarch Platform Labels28
- Label Locations31
Technical Specifications32
- Physical Dimensions, Weight, and Power Requirements32
Declaration of Emissions33
Declaration of Immunity35
Original Documentation38
Recommended CT Scan and Reconstruction Parameters40
Monarch Pre-Op Planning Application User Interface42
- Patient List42
- Planning45
- Manual Path48
Before You Can Plan49
Create a Plan49
- Identify a Target51
Export a Patient Case53
Perform an Unplanned Case54
Import a Patient Case54
Software Information56
Suggested Bronchoscopy Suite Configuration56
Prepare the Bronchoscopy Suite57
Prepare the Patient57
Prepare the Monarch Bronchoscope System59
Monarch Tower System Setup Guidance60
- Monarch Controller60
- Fluidics System61
- Camera62
- Navigation62
Monarch Cart System Setup Guidance64
- Unstow Cart64
- Load the Monarch Bronchoscope System67
Overview70
Functional Descriptions of Monarch Components70
- Monarch Bronchoscope and Monarch Bronchoscope Sheath70
- Monarch Controller71
Working Channel Instruments73
- Biopsy Instruments73
Monarch Navigation Application User Interface74
- Top Navigation Bar76
- Primary Area76
- Scrolling Area77
- CT Area78
- Full Screen Mode79
- Menu System79
- Navigation Views81
- Configuring View Screens91
- Quick Action Button93
Procedural Steps or Actions94
- Scope Insertion94
- Navigation Initialization95
- Monarch Bronchoscope Advancement95
Perform Biopsy96
- Monarch Controller96
Post-Procedure97
- Retraction97
Prepare the Patient for Discharge100
- Remove the Monarch Bronchoscope System100
- Remove Monarch Navigation Patient Sensors100
- Remove the Bronchoscope Patient Introducer100
Remove and Clean Equipment100
- Disassemble and Clean the Monarch Bronchoscope System100
- Clean Monarch Navigation Patient Sensors101
- Disassemble and Clean the Monarch Navigation Field Generator102
- Disassemble and Clean Bronchoscope Patient Introducer Mount102
- Clean and Store the Monarch Cart102
- Clean the Monarch Tower and Store the Monarch Platform102
Servicing103
- Preventative Maintenance103
- Configuration103
- Maintenance103
User Administration108
- User Types108
- Add New User108
- Change User Password109
- Disable Existing User110
System Security111
- Virus Protection111
- Patient Data Security111
Networking111
- Firewall111
- Internet Connectivity111
Fault Messages and Troubleshooting114
- Emergency Removal114
- E-Stop Recovery114
- Joystick Articulations Not Matching Directionally114
- Controller Does Not Appear Functional114
- Field Generator or Patient Introducer Mount Clamps Do Not Tighten115
- Monarch Platform will Not Turn on115
- Tower and Cart Do Not Turn on Simultaneously115
- Video (Start Screen) Does Not Appear on Tower and Cart Monitor after System Turns on116
- Loss of Video on Tower or Cart Touchscreen (During Procedure)116
- Navigation Patient Sensors Not Detected During Setup116
- CT Scan or Pre-Planned Case Cannot be Uploaded to Tower117
- Keyboard on Planning Laptop Is Unresponsive117
- Planning Laptop will Not Turn on117
- Unable to Log on to Physician User Account on Tower or Planning Laptop117
- Unable to Log on to Admin User Account on Tower or Planning Laptop117
Errors and Messages119
System Messages120

auris Monarch Platform - Label Locations

Table of Contents