Iridex Cyclo G6 User manual

User Guide: Cyclo G6 Laser with Sweep Management Software, PN 88199 Rev A
User Guide
Cyclo G6® Laser with Sweep Management Software
for MicroPulse® Transscleral Laser Therapy
Provides information on procedure-specific screens,
audible tones, and summary of patient treatment parameters

2 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
Table of Contents
1. Introduction .............................................................................................................. 1
1.1 Purpose of the User Guide ............................................................................................................ 1
1.2 Intended Use and Indications for Use ......................................................................................... 1
1.3 Contents of the Sweep Management Software Upgrade ......................................................... 1
2. Overview of Procedure-Specific Screens ................................................................. 2
2.1 Set-up Screens ................................................................................................................................ 2
2.1.1 Standby Screen & Treatment Parameter Fields ............................................................. 2
2.1.2 MicroPulse-Related Programmable Screens ................................................................... 3
2.1.2.1 Duty Cycle Settings ...................................................................................... 3
2.1.2.2 Preset Screen ............................................................................................... 3
2.2 Treat Screen .................................................................................................................................... 4
2.3 Post-Treatment Screen ("Treatment Summary" Screen) .......................................................... 4
3. Audible Tones ........................................................................................................... 7
4. Operation .................................................................................................................. 8
4.1 Setting Parameters ......................................................................................................................... 8
4.1.1 Load Default Parameter Options ...................................................................................... 8
4.1.2 Press the "Tx Summary" icon to reset treatment summary values to zero ................ 9
4.1.3 Review/Modify Treatment Parameters ........................................................................... 9
4.2 Delivering Treatment ................................................................................................................... 11
4.2.1 Advance to Next Segment ............................................................................................... 13
4.3 Viewing and Documenting Patient Treatment Information ................................................... 14
5. Troubleshooting ..................................................................................................... 15
6. Contact Information ............................................................................................... 15
!

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 1
1. Introduction
1.1 Purpose of the User Guide
This User Guide is intended to provide information specific to the Cyclo G6® Sweep Management
Software Upgrade for MicroPulse® Transscleral Laser Therapy (TLT) delivered with the MicroPulse
P3® Delivery Device (also referred to as “MicroPulse P3 Probe”).
This User Guide will describe and explain the operation of the graphical user interface screens and
treatment parameter fields specific to the software upgrade. The User Guide will not provide
information that is common to both the standard software and the software upgrade. For complete
instructions for use, refer to the Cyclo G6 Laser System Operator Manual and MicroPulse P3
Delivery Device Instructions for Use (IFU).
NOTE: This User Guide is intended to be used in conjunction with the Cyclo G6 Laser System Operator
Manual and the MicroPulse P3 Delivery Device IFU.
1.2 Intended Use and Indications for Use
This software upgrade is intended to facilitate console and probe use when performing
MicroPulse TLT by providing procedure-specific screens, audible tones, and a summary of patient
treatment parameters.
Please refer to the Cyclo G6 Laser System Operator Manual and the MicroPulse P3 Delivery Device
IFU for complete description of Intended Use and Indications for Use.
1.3 Contents of the Sweep Management Software Upgrade
This software upgrade includes Set-up Screens, a Treat Screen, and a Post-Treatment Screen that
are specific to the MicroPulse TLT procedure. These separate procedure-specific screens allow the
user to navigate the loading and programming of parameters during setup, monitor delivery during
treatment, and then view a summary of treatment information used for the patient.
Additionally, the software upgrade provides audible tones to help the physician match the desired
sweep speed velocity while sweeping the MicroPulse P3 Probe over a given segment (i.e., quadrant
or hemisphere).

2 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
2. Overview of Procedure-Specific Screens
The Cyclo G6 Sweep Management Software upgrade for MicroPulse TLT differs from the standard
software provided with the Cyclo G6 laser system, in that the upgrade provides procedure-specific
Set-Up Screens, a Treatment Screen, and a Post-Treatment Screen, in addition to audible tones.
The following sections only describe screens and fields specific to the software upgrade. This user
guide does not describe screens or fields that are common to both the software upgrade and the
standard software. Please refer to the Cyclo G6 Laser System Operator Manual and the MicroPulse
P3 Delivery Device IFU for information on the general operation and maintenance of the Cyclo G6
laser console and MicroPulse P3 Probe, including a description of the screens that are common to
both the software upgrade and the standard software.
2.1 Set-up Screens
2.1.1 Standby Screen & Treatment Parameter Fields
The Standby Screen is used to enter the treatment parameters for MicroPulse TLT.
The screen includes two user programmable fields: "Duration/Sweep" (i.e., sweep velocity) and
"Sweep/Segment" (i.e., number of sweeps per segment), and a treatment summary (“Tx Summary”)
icon that are not included in the standard software.
The two user programmable fields are "Duration/Sweep" (i.e., sweep velocity) and
"Sweep/Segment" (i.e., number of sweeps per segment). These are two MicroPulse TLT treatment
variables that have been underreported in the literature. Documenting these treatment variables
will help users analyze their MicroPulse TLT treatment outcomes, and adjust parameters as needed
to achieve the desired clinical outcome for each patient.
When the Tx Summary icon is pressed, the Treatment Summary Screen will appear. The Treatment
Summary Screen offers the user the opportunity to document treatment information in the
patient’s record. No personal or identifying patient information is saved to the software.
See Table 1: Overview of Sweep Management Software Upgrade Screens

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 3
2.1.2 MicroPulse-Related Programmable Screens
The MicroPulse Duty Cycle Settings and the MicroPulse Preset Screen in the software upgrade differ
from the standard software provided with the Cyclo G6 laser, as shown below.
2.1.2.1 Duty Cycle Settings
Standard Software
Software Upgrade
Default Selections
5%, 10%, 15%
5%, 15%, 31.3%
NOTE: There is no change to the manual adjustment of duty cycles, and there is no change to the range of
MicroPulse durations and intervals.
MicroPulse Duty Cycle Settings
as shown in the Software Upgrade
2.1.2.2 Preset Screen
Standard Software
Software Upgrade
Programmable Fields
Total Duration
Duration/Sweep
Sweeps/Segment
MicroPulse Preset Screen
as shown in the Software Upgrade

4 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
2.2 Treat Screen
The Treat Screen is displayed when the user presses the Standby/Treat button to enter Treat Mode.
There are no programmable fields on the Treat Screen.
The Treat Screen allows the user to track the progress of a treatment segment (i.e., quadrant or
hemisphere). The following information is displayed:
1. Total Sweeps per Segment
2. Current Sweep
3. Sweep Duration Remaining
4. Total Segment Duration
5. Total Seconds Remaining
6. Power
Once a treatment segment is completed, the
"Next Segment" button
automatically replaces the
stopwatch. The field caption next to the button, reads "Segment Completed." To deliver treatment
to the next segment (i.e., quadrant or hemisphere), press the “Next Segment” button to reset the
“Sweep Duration Remaining” the “Current Sweep,” and the “Total Seconds Remaining” fields to
their starting values.
See Table 1: Overview of Software Upgrade Screens, Treat Screen
2.3 Post-Treatment Screen (“Treatment Summary” Screen)
The Treatment Summary Screen is accessible by selecting the “Tx Summary” icon on the Standby
Screen. There are no programmable fields on the Treatment Summary Screen.
The Treatment Summary Screen allows the user to view a summary of treatment information used
for the patient, including:
1. Total Segments
2. Total Duration
3. Total Sweeps
4. Procedure Duration/Sweep, Power, and Sweeps/Segment
Cumulative values should be reset between treatments. Resets can be performed either before or
after each MicroPulse TLT treatment.
The Treatment Summary Screen provides MicroPulse TLT treatment data that the user may record
in the patient’s file. Alternatively, the user may take a picture of the Treatment Summary screen, to
place in the patient’s file. No personal or identifying patient information is saved to the software.

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 5
Table 1: Overview of Sweep Management Software Upgrade Screens
Software Upgrade Screens
Description
Standby Screen
The Standby Screen is used to enter the following
treatment parameters* for MicroPulse TLT:
• Duration/Sweep
• Power
• Sweeps/Segment
The Standby Screen gives access to the Options
menu, Presets menu, MicroPulse duty cycle settings,
aiming beam settings, and Treatment Summary
Screen.
* The MicroPulse duty cycle defaults at 31.3% when a
MicroPulse P3 Probe is connected to the Cyclo G6 laser.

6 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
Treat Screen
The Treat Screen displays the following fields:
• Power
Its value is automatically transferred from the
“Power” field on the Standby Screen.
• Sweep Duration Remaining (Stopwatch)
o Its value is automatically transferred from
the “Duration/Sweep” field on the Standby
Screen.
o The Sweep Duration Remaining field tracks
the progress of a single sweep and
automatically resets after each sweep.
• Total Sweeps per Segment
Its value is automatically transferred from the
“Sweeps/Segment” field on the Standby Screen.
• Current Sweep
The current sweep automatically advances after
each completed sweep.
• Total Segment Duration
Its value is automatically calculated as the
product of the Duration/Sweep and
Sweeps/Segment fields.
• Total Seconds Remaining
Automatically counts down the total seconds
remaining for the segment.
The
Next Segment button
appears over the Sweep
Duration Remaining stopwatch when a user
completes treatment of a segment.
To treat the next segment, press the “Next
Segment” button to reset the “Sweep Duration
Remaining,” the “Current Sweep,” and the “Total
Seconds Remaining” fields to their starting values.
The Next Segment
button appears over the
stopwatch when a user
completes treatment of
a segment.
To treat the next
segment, press the Next
Segment button to reset
the Sweep Duration
Remaining stopwatch,
the Current Sweep and
the Total Seconds
Remaining fields to their
starting values. The
stopwatch reappears.

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 7
Treatment Summary Screen
The Treatment Summary Screen displays a summary
of the MicroPulse TLT treatment delivered,
including:
• Total Segments
• Total Duration in seconds
• Total Number of Sweeps
• Duration per Sweep
• Treatment Power
• Number of Sweeps per Segment
The Total Segments, Total Duration, and Total
Number of Sweeps are cumulative until the Reset
and Close button is selected. Prior to a new
MicroPulse TLT treatment, view the Treatment
Summary Screen to confirm that these values have
been reset to zero.
No personal or identifying patient information is
saved to the software.
3. Audible Tones
To help the physician match the desired sweep speed velocity while sweeping the MicroPulse P3
Probe back and forth over a given segment (i.e., quadrant or hemisphere), a single tone is
automatically played at the halfway point of a sweep, and a double tone of the same sound is
played at the start of the next sweep.
The volume of the tone can be adjusted in the Options menu, accessible from the Standby Screen.

8 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
4. Operation
The following operation descriptions are specific to the software upgrade. Please refer to the
Cyclo G6 Laser System Operator Manual and the MicroPulse P3 Delivery Device IFU for a complete
description of Intended Use and Indications for Use.
4.1 Setting Parameters
4.1.1 Load Default Parameter Options
After setting up the Cyclo G6 laser, turning on the laser, and connecting the MicroPulse P3 Probe, a
Load Defaults pop-up window appears with the options to load or to cancel default treatment values.
The Load Defaults pop-up window in the software upgrade replaces the Total Duration field in the
standard software with the Duration/Sweep and the Sweeps/Segment fields.
The product of the Duration/Sweep and Sweeps/Segment fields automatically calculates the total
duration per segment. The total duration per segment is displayed in the Treat Screen.
1
Parameter Display
Default parameters, excluding Power, for the connected device.
2
Cancel
Press to cancel changes and return to the Standby Screen to retain
prior parameters.
3
OK
Press to load the default parameters and go to the Standby Screen.
After pressing either “Cancel” or “OK,” a pop-up screen will appear for the user to acknowledge eye
safety requirements as shown below. Select “OK” to acknowledge eye safety requirements and go
to the Standby Screen.
Eye Safety Requirements Pop-up Window
1
2
3
Load Defaults for MicroPulse P3 Device Pop-up Window

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 9
4.1.2 Press the “Tx Summary” icon to reset treatment summary values to zero
Select the “Tx Summary” icon in the Standby Screen to access the Treatment Summary Screen. In
the Treatment Summary Screen, select the “Reset and Close” button. It will reset the total segment,
total sweeps, and total duration values to zero.
4.1.3 Review/Modify Treatment Parameters
In the Standby Screen, review your desired treatment parameters for MicroPulse Duty Cycle,
Duration/Sweep, Power, and Sweeps/Segment fields, and modify as needed. To modify parameters,
either adjust the values manually or select a Preset to load user-programmed treatment
parameters.
Standby Screen
1
Displays eye safety filter status and the connected delivery device.
2
Press to go to the Options Screen.
3
Press to go to the Presets Screen.
4
Press to adjust MicroPulse settings.
5
Displays the selected MicroPulse duty cycle.
1
2
3
5
4
6
10
11
9
8
7

10 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
6
Duration/Sweep field
Values range from 5 seconds to 40 seconds in 5-second increments.
Use the left control knob to enter the duration (velocity) per sweep in the
“Duration/Sweep” field. The value will be transferred to the “Sweep Duration
Remaining” field (stopwatch countdown timer) in the Treat screen.
7
Power field
Values range from 50 mW to 3,000 mW in 10-mW increments.
Use the center control knob to enter the laser power setting (mW). The value will be
transferred to the “Power” field in the Treat Screen.
8
Sweep/Segment field
Values range from 1 sweep to 10 sweeps in 1-sweep increments.
Use the right control knob to enter the number of sweeps per segment in the
“Sweeps/Segment” field. The value will be transferred to the “Total Sweeps per
Segment” field in the Treat Screen.
9
Displays the selected Illumination and Aiming Beam settings.
10
Displays the current laser mode:
Ready: The laser is ready and will fire when you press the footswitch.
Standby: The laser is disengaged.
Treat: The laser is firing (the footswitch has been pressed).
11
Press to open the Treatment Summary Screen.

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 11
4.2 Delivering Treatment
Note: Before delivering treatment, please refer to the Cyclo G6 Laser System Operator Manual and
the MicroPulse P3 Delivery Device IFU for delivery instructions, including safety, warnings, and
cautions.
1. Press the Treat/Standby button to go to the Treat Screen.
Treat Screen
1
Displays eye safety filter status and the connected delivery device.
2
The Sweep Duration Remaining stopwatch tracks the progress of a single sweep and
automatically resets after each sweep.
The starting value is transferred from the value entered in the “Duration/Sweep” field
in the Standby Screen.
At the completion of a treatment segment, the Next Segment button will appear over
the stopwatch. Press the Next Segment button to reset the “Sweep Duration
Remaining” the “Current Sweep” and the “Total Seconds Remaining” fields to their
starting values.
3
Displays the current sweep being performed.
4
Displays the “Total Sweeps per Segment” programmed in the Sweeps/Segment field in
the Standby Screen.
5
Displays the number of seconds remaining in the segment.
2
5
6
4
3
1
7
8

12 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
6
Displays the “Total Segment Duration” calculated as the product of the
Duration/Sweep and Sweeps/Segment fields programmed in the Standby Screen.
7
Displays the selected laser power setting (mW) programmed in the Standby Screen.
8
Displays the current laser mode:
Ready: The laser is ready and will fire when you press the footswitch.
Standby: The laser is disengaged.
Treat: The laser is firing (the footswitch has been pressed).
2. Press the footswitch to activate the laser according to the instructions in the Cyclo G6 Laser
System Operator Manual. If you need to interrupt the treatment, release the footswitch.

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 13
4.2.1 Advance to Next Segment
1. When a user completes treatment of a segment (i.e., quadrant or hemisphere), the stopwatch
changes into a "Next Segment" button.
2. To treat the next segment, press the Next Segment button to reset the "Sweep Duration
Remaining," the "Current Sweep," and the "Total Seconds Remaining" fields to their starting values.
3. When all the desired segments have been treated, select the Treat/Standby button to return to
the Standby Screen.
Next Segment Button
1
Press the Next Segment button to reset the "Sweep Duration Remaining", the "Current
Sweep," and the "Total Seconds Remaining" fields to their starting values prior to
treating the next segment.
If the Next Segment button is pressed before the completion of a segment, a confirmation window
will appear to confirm the reset.
1
Press to close the window and complete the treatment segment.
2
Press to reset the timer for a new segment.
1
1
2

14 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
4.3 Viewing and Documenting Patient Treatment Information
1. At the end of the MicroPulse TLT treatment
a. Press the "Tx Summary" icon on the Standby Screen to access the Treatment
Summary Screen.
b. Manually document the treatment information in the patient’s record, or take a photo of
the Treatment Summary Screen to place in the patient’s record. No personal or identifying
patient information is saved to the software.
2. After documentation, select "Reset and Close" to reset the Total Segment, Total Duration
and Total Sweeps values to zero in preparation for the next MicroPulse TLT treatment.
Treatment Summary Screen
1
Press to close the screen and retain the treatment summary values. The screen closes
and returns to the Standby screen.
2
Press to clear the Total Duration, Total Sweeps, and Total Segments fields. Treatment
parameters are not affected. The screen closes and returns to the Standby Screen.
1
2
Procedure Started On:

User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B 15
5. Troubleshooting
Error Message
Error Code
Error Message
Cause
User Action
W00002
User is aware of eye
safety requirement.
Laser probe is
connected.
Press OK.
NOTE: Reference your Cyclo G6 Laser System Operator Manual for guidance on all other
troubleshooting and system error messages.
6. Contact Information
Iridex Corporation
1212 Terra Bella Avenue
Mountain View, California 94043-1824 USA
Telephone: [phone]
[phone] (US only)
Fax: [phone]
Technical Support: [phone]
[email protected]
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
2797
Before delivering treatment, please refer to the “Cyclo
G6 Laser System Operator Manual,” and the “MicroPulse
P3 Delivery Device Instructions for Use” for delivery
instructions, including safety, warnings, and cautions.

16 User Guide: Sweep Management Software Upgrade for MicroPulse TLT, PN 88199-EN Rev B
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© 2022 Iridex Corporation. All rights reserved. PN 88199-EN Rev B 02.2022