Cutera GenesisPlus User manual

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GenesisPlus Operator Manual
D1151, REV C, 10/16
Operator Manual

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GenesisPlus Operator Manual
D1151, REV C, 10/16
This manual is copyrighted with all rights reserved. Under copyright laws, this manual may not
be copied in whole or in part or reproduced in any other media without the express written per-
mission of Cutera, Inc. Permitted copies must carry the same proprietary and copyright notices
as were affixed to the original. Under US federal law, copying includes translations into
another language.
Please note that while every effort has been made to ensure that the data given in this document
is accurate, the information, figures, illustrations, tables, specifications and schematics con-
tained herein are subject to change without notice.
Cutera is the registered trademark of Cutera, Inc.
©Cutera, Inc.
October 2016
Published in USA
D1151
Rev C
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
MDSS GmbH
Schiffgraben 41, D-30175
Hanover, Germany

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CONTENTS
OPERATION 1
Introduction 1
System Preparation 2
GenesisPlus System Components 3
System Console 4
Footswitch 4
Remote Interlock Plug 4
Handpiece 4
Connecting the System Components 5
Connecting the Footswitch 5
Inserting the Remote Interlock Plug 5
Connecting the Main Power Cable 5
System Basics 7
Turning On the System 7
Restarting the System 7
Turning Off the System 7
Emergency Off 8
Disconnecting the System 8
Moving the System 8
General System Functions 10
Genesis Control Screen 10
Warts Control Screen 11
System Status: STANDBY and READY Modes 12
Treatment, Aiming and Working Distance Beams 14
Memory Storage 16
Thermal Monitoring 17
Information & Adjustment Screen 19
Audible Tones 20
Audible Pulse Counter 21
Pop-up Screen 22
Displays and Indicators 23
User-selectable Parameters 24
Selecting the Fluence 24
Selecting the Pulse Width 25
Selecting the Repetition Rate (Genesis mode only) 26

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MAINTENANCE 27
Troubleshooting Guide 27
Error Code Guide 31
Annual System Maintenance 32
System Repair 32
Routine User Maintenance 32
Clean the External Surfaces of the System Console 33
Clean the System Touchscreen Display 33
Clean the External Surfaces of the Handpiece 33
Inspect and Clean the Handpiece Lenses 34
Inspect and Clean the Heat Exchanger Intake 36
Fill the Coolant Reservoir 37
Remote Interlock Pin Assignments 38
Electrical Utilities 39
Systems Designed for Use Outside of Europe 39
Systems Designed for Use in European Communities Under MDD 39
Removable or Lockable Wall Socket and Plug Configurations 40
Systems Designed for Use in European Communities Under MDD 40
System Specifications 41
Treatment Beam 41
Physical Parameters 41
Electrical Requirements 42
Environmental Requirements 42
Classifications 42
Eye Safety 42
Calibration Procedure 43
Equipment Required 43
Calibration Instructions 44
End of Life Disposal - Environmental Information 44
Warranty Information 44

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SAFETY AND REGULATORY 45
Introduction 45
Optical Hazard 45
Additional Ocular Protection 47
Additional Safety Considerations 48
Protecting Non-target Tissues 48
Electrical Hazard 48
Fire Hazard 49
Regulatory Compliance 49
Location of Controls 49
Key Lock Switch 49
Emergency Off Push-button 49
Laser Emission Indicator 49
Remote Interlock 50
Protective Housing 50
Laser Safety Shutter 50
Audible Emission Indicator 50
Manual Reset 50
Electronic Fault Detection Circuitry 50
Operational Training 51
Operational Safety 51
Location of Regulatory Compliance Labels 53
Electromagnetic Compatibility 55
CLINICAL APPLICATIONS 59
Indications for Use 59
Dermatology 59
Podiatry 59
Contraindications for Use 60
Precautions 60
Expected Transient Events and Possible Adverse Effects 61
Clinical Guidelines 61
Dermatology 62
Podiatry 63
Patient Information 63
APPENDIX A - LASER WARNING SIGN
APPENDIX B - SYMBOLS
APPENDIX C - BIBLIOGRAPHY
APPENDIX D - CUTERA DIRECT OFFICE LOCATIONS

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GenesisPlus Operator Manual
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Operation
Introduction
The Cutera GenesisPlus is an Nd:YAG (1064 nm) laser with a patented pulse structure
designed for safe and effective treatment on all skin types, including tanned skin. It is indicated
for use in the medical specialties of general and plastic surgery, dermatology, and podiatry,
among others. Indicated uses include, but are not limited to, the treatment of rosacea and poi-
kiloderma of Civatte, reduction of scars and wrinkles, removal of warts, and the temporary
increase of clear nail in patients with onychomycosis. The effects of the GenesisPlus laser for
rejuvenation are documented in multiple peer-review published studies where the result is
smoother skin with reduced erythema, decreased wrinkles, decreased pore size and an
improvement in overall skin quality.
Key benefits:
• Fast treatments – three times faster than alternative Nd:YAG lasers
• No recurring costs – one time purchase only
• Large spot for uniform coverage
• Integrated temperature feedback
• Safe for all skin types
• Year round application
• Comfortable treatment – no downtime and no need for anesthetic
GenesisPlus is a precision medical instrument. It has undergone extensive testing and with
proper handling is a useful and reliable clinical instrument. If you have any questions regard-
ing your system, contact your local Cutera representative.

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WARNING
Any laser device can generate highly concentrated light, which may
cause injury if improperly used. To protect patients and operating
personnel, this entire operator manual, including the Safety and
Regulatory section, should be carefully read and comprehended
before operation.
System Preparation
The GenesisPlus system is shipped directly from the factory to your site. Your local Cutera
representative will initially uncrate, inspect, set up and install the system to ensure that it is
working properly before use. In addition, Cutera provides in-service and training to ensure that
your staff is experienced with appropriate performance and safety considerations. Thereafter,
you or the staff at your facility will be performing the daily maintenance routines associated
with the system, as well as performing basic system safety checks. These procedures are
detailed later in this chapter and in the Maintenance section of this manual.
Most staff personnel prefer to inspect and perform a functional system check prior to sched-
uled cases. Doing so will ensure adequate time to troubleshoot problems or to contact your ser-
vice representative with the least amount of disruption to patients and schedules.

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GenesisPlus System Components
The GenesisPlus system consists of a system console, a laser handpiece, a handpiece cradle, a
touchscreen control panel and a footswitch. Other components necessary for operation, such as
a remote interlock plug and all electrical cables, are also included.
Footswitch
System console
Remote interlock plug
Laser handpiece
in handpiece cradle Touchscreen
control panel

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System Console
The system console houses the touchscreen control panel, the main power keyswitch, emer-
gency off switch, control electronics, the 1064 nm laser umbilical with handpiece, the laser
source with associated optics and power supply. The touchscreen control panel allows you to
select treatment settings.
NOTE
To ensure proper air circulation, the console must be positioned at
least 20 centimeters (8 inches) from walls, furniture or other equip-
ment.
Footswitch
The footswitch activates the treatment beam when the system is in READY mode.
Remote Interlock Plug
The system is equipped with a remote interlock plug which, when wired to an external door
switch, shuts down the system power if the treatment room door is opened or the interlock plug
is removed. To resume treatment, close the treatment room door or reinsert the remote inter-
lock plug, and restart the system using the keyswitch.
Use of an external door switch is optional; however, the remote interlock plug must be inserted
into the interlock receptacle at all times for proper operation.
NOTE
Refer to the Maintenance section of this operator manual for
instructions on connecting an external door switch to the remote
interlock plug.
Handpiece
The handpiece delivers laser energy from the system console to the treatment site. An inte-
grated temperature sensor and LED temperature indicators enable thermal monitoring of the
target tissue. A working distance beam ensures proper positioning of the handpiece when cen-
tered within the aiming beam.

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Connecting the System Components
Before connecting the GenesisPlus system components, inspect the individual components,
cables and electrical connections for any dirt, debris or damage. Check all electrical cables to
ensure they are not frayed or split. Inspect the handpiece, as instructed in the Maintenance sec-
tion of this operator manual.
WARNING
Always turn off the system before inspection of the handpiece.
Never look directly into the handpiece even when wearing protec-
tive eyewear. Never look directly into the laser beam or at scattered
light from metallic or other reflective surfaces. The 1064 nm
Nd:YAG laser beam can cause permanent eye damage.
NOTE
Do not touch the window on the handpiece; finger oils may damage
the coating.
Connecting the Footswitch
Plug the footswitch cable into the footswitch receptacle on the rear of the system con-
sole. If the footswitch is not properly connected when the system is turned on, a pop-up screen
with an animated illustration will be displayed on the touchscreen and the system cannot be
placed into READY mode. An illustration of the pop-up screen is displayed later in this chap-
ter.
Inserting the Remote Interlock Plug
Insert the remote interlock plug into the interlock receptacle on the rear of the system con-
sole. The remote interlock plug must be inserted into the interlock receptacle at all times,
whether or not an external door switch is used.
Connecting the Main Power Cable
1. Ensure that the system main power circuit breaker is OFF (down) and that the system key-
switch is in the O (OFF) position.
2. Insert the receptacle end of the power cable into the power cable receptacle on the system,
and insert the AC plug into the AC wall socket.

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3. Insert the main power cord plug into the appropriate wall socket and turn the main electri-
cal service ON. Ensure that the main power circuit breaker is in the up (ON) position.
Footswitch receptacle
Interlock receptacle
Main power circuit breaker
Power cable receptacle
Power cable wrap

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System Basics
Turning On the System
Insert the key in the keyswitch, turn to the (START) position, hold for a full second, and
release. Upon release, the key automatically springs back to the l (ON) position.
Keyswitch
The start-up screen (Cutera name) appears, and the system begins a self-test routine. After
approximately 10-15 seconds, the system emits an audible tone, the self-test message disap-
pears, and the touchscreen displays the Genesis Control Screen. If any fault conditions, advi-
sory messages or error codes appear in the pop-up display during self-test, refer to the
Troubleshooting section of this operator manual.
Restarting the System
To restart the system:
1. Turn the keyswitch to the O (OFF) position.
2. WAIT 5 SECONDS before turning the keyswitch to the (START) position. Release
the key. The system will go through its normal start-up sequence.
Turning Off the System
Under normal operating conditions, turn the keyswitch to the O (OFF) position.
NOTE
When the main power cable is connected to the electrical source,
some internal circuits remain energized. To de-energize all the
internal circuits, turn off the main power circuit breaker and discon-
nect the electrical service.

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Emergency Off
In an emergency, press the red Emergency OFF button to immediately turn off the system.
Emergency OFF button
Disconnecting the System
1. Turn the keyswitch to the O (OFF) position.
2. Set the main circuit breaker to the OFF position.
3. Remove the power plug from the electrical outlet and wrap the power cable around the
cable wrap.
4. Place the footswitch on the footswitch storage mount on the rear of the system console.
Coil the footswitch cable and store it inside the footswitch holder. Do not wrap the
footswitch cable around the power cable wrap.
Moving the System
1. Disconnect the system as described above.
WARNING
Water must be drained from the system if the system is stored in
temperatures below freezing. Freezing may result in damage to crit-
ical or delicate components.
2. Place the handpiece into the pouch attached to the system console.
3. Replace the vented filler cap with a sealed filler cap to prevent water from leaking.
4. Unlock the console wheels by disengaging the wheel locks.

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5. Move the system console to the desired site. Position the console at least 20 centimeters (8
inches) from walls, furniture or other equipment. Adequate space around the system con-
sole ensures proper air circulation.
CAUTION
Never use the handpiece or umbilical cord to move the system.
Moving the system using the handpiece or umbilical may irrepara-
bly damage the handpiece and/or the umbilical.
6. Lock each of the system console wheels by engaging each wheel lock.
Wheel locks
Filler cap

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General System Functions
Genesis Control Screen
After the successful completion of the self-test routine at system start-up, the Genesis Control
Screen displays. From the Genesis Control Screen, you can:
• select the fluence, pulse width and repetition rate (refer to the User-selectable
Parameters topic)
• adjust the aiming beam intensity and mode (refer to the Aiming Beam subtopic)
• store and recall frequently used treatment parameters (refer to the Memory Storage
subtopic)
• monitor the measured temperature of the target tissue (refer to the Thermal
Monitoring subtopic)
• select the system status (refer to the System Status: STANDBY and READY Modes
subtopic)
• view and reset the pulse counter (refer to the Displays and Indicators subtopic)
• go to the Warts Control Screen (refer to the Warts Control Screen subtopic)
• go to the Information & Adjustment Screen (refer to Information & Adjustment
Screen subtopic)
Genesis Control Screen (STANDBY mode)
READY button
Target tissue
temperature display
STANDBY button
Aiming beam
adjustment button
Memory storage
and recall buttons
Repetition rate
controls and display
Fluence controls
and display
Pulse width controls
and display
Info & Adjustment
Screen tab
Back button
Pulse counter display
and reset button

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Warts Control Screen
Press the (back) button on the Genesis Control Screen to access the Warts Control Screen.
From the Warts Control Screen, you can:
• select the fluence and pulse width (refer to the User-selectable Parameters subtopic)
• adjust the aiming beam intensity and mode (refer to the Aiming Beam subtopic)
• store and recall frequently used treatment parameters (refer to the Memory Storage
subtopic)
• select the system status (refer to the System Status: STANDBY and READY Modes
subtopic)
• view and reset the pulse counter (refer to the Displays and Indicators subtopic)
• go to the Genesis Control Screen (refer to the Genesis Control Screen subtopic)
• go to the Information & Adjustment Screen (refer to Information & Adjustment
Screen subtopic)
Warts Control Screen (STANDBY mode)
READY buttonSTANDBY button
Memory storage
and recall buttons
Pulse width controls
and display
Fluence controls
and display
Info & Adjustment
Screen tab
Back button
Aiming beam
adjustment button Pulse counter display
and reset button
CAUTION
Do not treat any indications other than warts from the Warts Con-
trol Screen.
NOTE
Press the (back) button to return to the Genesis Control Screen.

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System Status: STANDBY and READY Modes
The system automatically goes into STANDBY mode at system start-up. In STANDBY mode:
• the footswitch is disabled
• the internal safety shutter is closed
• the treatment, aiming and working distance beams are not available
• the temperature sensor and LED temperature indicators are functional
• the (standby) button and the borders around the treatment parameter displays are
highlighted in yellow
Press to go to
READY mode
To select READY mode, press the (ready) button.

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In READY mode:
• the footswitch is enabled
• the safety shutter is open
• the treatment, aiming and working distance beams are available
• the temperature sensor and LED temperature indicators are functional
• the (ready) button and the borders around the treatment parameter displays are
highlighted in green
Press to go to
STANDBY mode
To return to STANDBY mode, press the (standby) button.
When the system is in READY mode and the footswitch is depressed, treatment energy is dis-
charged from the handpiece, the system emits an audible tone and a yellow indicator next to
the (ready) button illuminates to indicate laser emission.
If the system is not used for more than three minutes, the system automatically goes into
STANDBY mode.
WARNING
Except during actual treatment, the system must always be in
STANDBY mode. Maintaining the system in STANDBY mode
prevents accidental treatment beam exposure if the footswitch is
inadvertently depressed.
WARNING
Verify that all persons in the treatment room are wearing the appro-
priate treatment beam safety eyewear before placing the system in
READY mode.

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Treatment, Aiming and Working Distance Beams
The GenesisPlus system produces three separate laser beams:
• a treatment beam
• an aiming beam
• a working distance beam
Aiming beam and
Temperature sensor
treatment beam (not visible)
Working distance beam
(not visible)
(optimal working distance)
Treatment Beam
The 1064 nm Nd:YAG treatment beam falls in the near infrared region of the electromagnetic
spectrum and is invisible to the human eye. Therefore, an aiming beam is provided to enable
accurate positioning of the treatment beam.
Aiming Beam
The aiming beam is a low power, visible laser beam that is coaxial with the invisible treatment
beam and is used to target the treatment area. All aiming beam functions are controlled from
the touchscreen display. There are four intensities in continuous and blink modes, as well as an
OFF mode. To adjust the intensity of the aiming beam:
1. Press the (aiming beam) button on the Genesis or Warts Control Screen.
2. Point the handpiece at the targeted treatment site.
3. Press the (aiming beam) button again to toggle through the modes and intensities.