LUMENIS Array LaserLink User manual

Delivery Device
Operator Manual

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 permission of Lumenis, Inc.
Permitted copies must carry the same proprietary and copyright notices as
were affixed to the original. Under the law, copying includes translation
into another language.
Please note that while every effort has been made to ensure that the
information in this document is accurate, the instructions, photos, figures,
illustrations, tables, specifications, and schematics contained herein are
subject to change without notice.
Lumenis, the Lumenis Logo, and Novus are registered trademarks of
Lumenis, Inc.
Array, LaserLink, SureSpot, Varia, Spectra, and Vision One are
trademarks of Lumenis, Inc.
Manufactured by:
1870 S Milestone Dr
Salt Lake City, UT 84104 USA
Lumenis (Germany) GmbH
Heinrich-Hertz-Strasse 3
63303 Dreieich, Germany
+49.6103.8335.0
© 2016 Lumenis, Inc.
Published in USA
UM-1098750, Rev. B
Lumenis ECO: ECO-0007078
Effective Date: July 2016

Operation ●3
Contents
Operation ................................................................................................. 6
Introduction..................................................................................................7
Array LaserLink Components.....................................................................8
Array LaserLink Module.................................................................................8
Console..........................................................................................................8
Touchscreen Display......................................................................................8
Remote Touchpad .........................................................................................8
3D Mouse ......................................................................................................8
Array LaserLink Installation......................................................................10
Connecting an Eye Safety Filter...................................................................13
Installing Observation Equipment.................................................................13
Array LaserLink Operation........................................................................14
The Treatment Screen ...............................................................................15
Touchpad....................................................................................................16
3D mouse....................................................................................................17
Setting Treatment Parameters ..................................................................18
Selecting the Shape.....................................................................................18
Titrating........................................................................................................19
Frame Mode ................................................................................................19
Rotating a Shape.........................................................................................20
Micromanipulation........................................................................................21
....................................................................................................................21
Adjusting the Spacing between Spots..........................................................22
Setting the Laser Power...............................................................................23
Setting the Spot Size....................................................................................25
About Spot Size and Fluence.......................................................................26

4 ●Operation
Setting the Aiming Beam Intensity...............................................................27
Setting the Duration.....................................................................................27
Setting the Interval.......................................................................................28
Setting the Treatment Beam Wavelength ....................................................28
Resetting the Shot Counter..........................................................................29
Selecting the Fundus Lens ..........................................................................30
Selecting the Laser Status...........................................................................31
Setting System Options ............................................................................32
Options Form 1............................................................................................32
Setting the Date & Time...............................................................................32
Setting Time Format....................................................................................32
Setting Date Format.....................................................................................33
Adjusting Date & Time.................................................................................33
Setting the Speaker Volume........................................................................33
Standby Backlight and Ready Backlight.......................................................33
Options Form 2............................................................................................34
Controlling Sound........................................................................................34
Displaying Fluence ......................................................................................34
Resetting Rotation and Micromanipulation...................................................34
Enabling the On-Retina Text........................................................................34
Options Form 3............................................................................................35
Enable Manipulation....................................................................................35
Enable Spacing ...........................................................................................35
Enable Next Pattern.....................................................................................35
Enable Number of Spots..............................................................................35
Enable Rotation...........................................................................................35
Saving and Retrieving Treatment Presets ...............................................36
The Preset Panel.........................................................................................36
Saving a Preset...........................................................................................36
Recalling a Preset........................................................................................37
Updating a Preset........................................................................................37
Exporting and Printing Reports................................................................38
Using the Report Panel................................................................................39
Preoperative Instructions..........................................................................42
Intraoperative Instructions........................................................................42
Postoperative Instructions........................................................................44

Operation ●5
Maintenance........................................................................................... 45
Troubleshooting Guide..............................................................................46
Error Messages..........................................................................................50
User Maintenance ......................................................................................51
Inspecting the Delivery Device Components................................................51
Clean the External Surface of the Delivery Device.......................................51
Annual Maintenance ....................................................................................51
Changing the Console Fuses....................................................................52
Electromagnetic Compatibility..................................................................53
Essential Performance ..............................................................................53
Specifications.............................................................................................54
Warranty Information.................................................................................56
Safety and Regulatory........................................................................... 57
Introduction................................................................................................58
Laser Safety Eyewear................................................................................59
Additional Ocular Protection.........................................................................61
Additional Safety Considerations..................................................................62
Electrical Hazards........................................................................................62
Regulatory Compliance.............................................................................63
Eye Safety Filter...........................................................................................63
Location of Controls.....................................................................................63
Location of Regulatory and other System Labels.........................................63
Indications for Use................................................................................ 67
Indications for Use.....................................................................................68
Contraindications in Ophthalmology.............................................................70
Retinal Pigmentation....................................................................................70
Potential Side Effects or Complications........................................................71
Clinical References......................................................................................72
Appendix 1............................................................................................. 75
EMC Guidance and Manufacturer’s Declarations.........................................75
Appendix 2............................................................................................. 81
Specifications for Patterns, Spacing, and Spot Size.....................................81

6 ●Operation
Operation

Operation ●7
Introduction
This manual describes the connection and operation of the Lumenis Array
LaserLink delivery device. The Array LaserLink delivery device adapts to a
Slit Lamp for use as a therapeutic laser delivery system, utilizing a scanning
pattern generator to deliver predefined patterns of treatment. It is intended
for use by an Ophthalmologist within a clinic or surgeon’s office environment
on patients regardless of age, gender, weight, or race. As the Lumenis
Array LaserLink is for professional use only the device qualifies for
exemption per 21 CFR 801 Subpart D.
CAUTION –Federal law restricts this device to sale by or on the
order of a physician.
When attached to a compatible Lumenis photocoagulator, treatment
parameters such as power, spot size, pattern shape, and wavelength are
configurable with the included touchscreen interface and remote
touchpad\3D mouse.
Your local Lumenis Representative initially unpacks, inspects, sets up, and
installs the Array to ensure that it is working properly. In addition, Lumenis
provides in-service training to ensure that your surgical staff is experienced
in the performance and safety considerations of the device.
CAUTION - Do not attempt to operate the system until a qualified
Lumenis Representative has installed and checked it for proper
operation.
Thereafter, you, or the nursing staff at your facility, will perform the daily
maintenance routines associated with this device as directed in the
maintenance section of this manual.
Lumenis laser systems and delivery devices are precision medical
instruments. They have undergone extensive testing and with proper
handling are useful and reliable clinical instruments. If you have questions
regarding your laser or delivery device, contact your local Lumenis
Representative.
WARNING - Lasers generate a highly concentrated beam of light
which may cause injury if improperly used. To protect the patient
and operating personnel, the entire laser and your delivery device
operator manuals, including all Safety and Regulatory sections,
should be carefully read and comprehended before operation.

8 ●Operation
Array LaserLink Components
The Array is comprised of the following components:
a scanning Array LaserLink Module
a Console
a Touchscreen Display
a Remote Touchpad or 3D mouse (depending on customer
selection and region regulatory approvals)
Optional co-observation devices are also available. System connections and
controls are described in the following pages.
Array LaserLink Module
The Array LaserLink module attaches to the Slit Lamp and delivers the
treatment beam to the target tissue.
Console
The console houses the control electronics and power supply, and
integrates the Array LaserLink module with the laser system.
Touchscreen Display
Use the touchscreen display to adjust laser treatment settings, such as laser
mode, energy, and aiming beam intensity. It can be positioned on either
side of the Slit Lamp, and duplicates the functions of the laser’s remote
control so that you can verify the laser treatment parameters without moving
back from the Slit Lamp binoculars.
Remote Touchpad
Use the touchpad to micromanipulate the position of the aiming and
treatment beams, adjust laser power, spot size, the number of spots, and
several other pattern parameters.
3D Mouse
Use the 3D mouse to micromanipulate the position of the aiming and
treatment beams, adjust laser power and the number of spots.

Operation ●9
Fig. 1 Doctor and patient positioning
Fig. 2 Array LaserLink Components (3D Mouse not displayed)
Array
Module
Array Console
Touchscreen
Display
Remote Touchpad
Eye Safety
Filter (not part of
the Array, but
required for safe
operation)

10 ●Operation
Array LaserLink Installation
The Array LaserLink delivery device must be installed by a Lumenis-certified
technician, and is only compatible with specific Lumenis laser systems:
Novus Spectra™ Laser System (K022327*)
Novus Spectra™ Dual Port Laser System (K022327*)
Vision One™ Laser System (K111213*)
*Premarket FDA Clearance numbers
WARNING - The Array LaserLink shall only be connected to defined
laser systems. Connecting to anything else will result in a non-
functioning delivery device.
The Array LaserLink consists of the four components which are shown in
Fig. 2 on the previous page.
The touch screen and touch pad\3D mouse are mounted by a qualified
service technician at a location chosen by the user.
The array module (head) is attached to a Slit Lamp by the technician using
the adjustable mounting plate shown in Fig. 3. The array module must be
positioned, aligned, and focused by the technician to match the Slit Lamp’s
focal point/plane.
Fig. 3 Array Head Mounting Plate
The array module, touch screen, and touch pad\3D mouse are connected to
the console by a service technician. The console is mounted to a laser
system or at a location chosen by the user. The console is connected to a

Operation ●11
laser system by the service technician. An aiming beam control port is
installed in the laser system.
Fig. 4 Console Ports
Fig. 5 Cables
Footswitch Port Laser Control Port

12 ●Operation
Fig. 6 Laser System Ports
After the Array LaserLink has been set up by a technician, it can be
detached and reattached to the laser system by the user. The console
cables will only attach one way preventing improper connection.
To detach the Laser System:
Detach the laser control cables from the laser system. The cables
include the aiming beam control cable, remote cable, and foot
switch cable.
Detach the foot switch from the console port and attach it to the
laser system.

Operation ●13
To attach the laser system:
Remove the foot switch from the laser system and connect it to the
console.
Attach the laser control cables (foot switch, remote, and aiming
beam control) to the laser system.
If the Array Module is removed from the compatible Slit Lamp for any
reason, it must be reinstalled by a Lumenis-certified technician.
The Array LaserLink must be installed so that the wall plug is accessible for
ease of disconnecting.
CAUTION - Grounding reliability can only be achieved when the
equipment is connected to an equivalent receptacle marked
“Hospital Grade” or “Hospital Only”.
Connecting an Eye Safety Filter
The Eye Safety Filter blocks the transmission of laser light, thereby
protecting the physician’s eyes from laser exposure while looking through
the Slit Lamp.
The Eye Safety Filter is a component that is not connected to the Array
LaserLink, but is part of the Lumenis Photocoagulator Laser System that is
being used in conjunction with the Array LaserLink. Operating and
installation instructions for the Eye Safety Filter are located in the Operator’s
Manual of the Lumenis Photocoagulator Laser System which is being used.
CAUTION - During treatment, the Eye Safety Filter must be attached
to the Slit Lamp. Failure to do so could result in serious ocular
injury.
CAUTION - Eye safety filters are labeled for laser model or
wavelength compatibility. Use only Eye Safety Filters that are labeled
for your laser model or wavelength. Use of an incorrect Eye Safety
Filter could result in serious ocular injury.
Installing Observation Equipment
Install observation equipment according to the instructions that accompany
those accessories.

14 ●Operation
Array LaserLink Operation
CAUTION - Before each use, inspect the system for dirt, debris, or
damage. Check the Eye Safety Filter cable and the Eye Safety Filter
extension cable, if applicable, to ensure that they are not frayed or
split. Check the optical fiber to ensure that it is not punctured,
fractured, or sharply bent.
CAUTION - Check to ensure there is no debris or object in the beam
path. If any problems are noticed, do not use the device until unit is
in appropriate working condition.
CAUTION - To prevent accidental laser exposure, always turn off the
laser, as instructed in your laser operator manual, before connecting
the delivery device.
NOTE - Refer to the Connection Instructions section of your laser
operator manual, and perform the laser operating instructions in
sequence with the instructions outlined in this manual.
1. Turn the laser system on, as instructed in your laser system operator
manual.
2. Turn the Array LaserLink delivery device on by pressing the |(on) switch
on the Array LaserLink Console rear side and press the On/Off button on
the front side.
Fig. 7 Power Switch Location
Power Switch

Operation ●15
The Treatment Screen
The Array LaserLink provides a touch sensitive graphical user interface for
controlling the Array LaserLink delivery device. Most laser treatment
parameters are directly adjustable from the treatment screen, as shown in
Fig. 8, making it unnecessary to interact with the laser system directly. In
fact, it is recommended that you perform all treatment adjustments using the
Array LaserLink treatment screen. Some treatment parameters that are
adjustable on the treatment screen are also adjustable on the touchpad\3D
mouse.
The treatment screen is composed of panels in the upper left corner. One
panel is visible at a time and is selected using the tabs at the bottom of the
panel.
Shape: The Shape Panel is where you will work during
treatment. This panel is used for selecting the shape and
setting the number of spots in the selected shape.
Options: The Options Panel is used for setting up your preferred
system settings.
Presets: The Presets Panel allows up to 5 doctors to customize
their personal treatment settings.
Report: The Report Panel generates treatment reports.
Fig. 8 The Array LaserLink Touchscreen

16 ●Operation
Touchpad
Fig. 9 shows the Array LaserLink touchpad. This touchpad facilitates making
adjustments without having to remove your eyes from the binoculars. It also
allows you to rotate the shape and perform fine positional adjustments
(micromanipulation). In addition to the touch sensitive surface, the touchpad
has two buttons for controlling the power settings and a pair of “middle”
buttons which control titrate mode. The setup of the touchpad is covered
later in this manual in the Setting System Options section.
Fig. 9 The Array LaserLink Touchpad
Titrate
Titrate

Operation ●17
3D mouse
Figure 10 shows the Array LaserLink 3D mouse. This device allows you to
perform the following operations:
- Micromanipulation - fine positional adjustments.
- Change laser power settings - The 3D mouse has two buttons for
controlling the power settings.
- Control Titrate mode - Pushing the main controller down toggles titrate
mode on/off.
- Change number-of-spots - Rotating the main controller clockwise will
increase the number of spots. Rotating the main controller counter-
clockwise will decrease the number of spots.
Figure 10 –The Array LaserLink 3D Mouse controls
Power-Down
Power-Up
Increase number of spots
Decrease number of spots
Micromanipulation
Push-down to
control titration

18 ●Operation
Setting Treatment Parameters
CAUTION - Always verify that the desired treatment parameters are
displayed on the touchscreen before initiating treatment.
CAUTION - If there is no change in display when you interact with the
touchscreen or touchpad\3D mouse, or if the touchscreen appears
otherwise erratic, do not use the laser. Contact your local Lumenis
Representative.
Selecting the Shape
Seven shapes are available: single spot, square, line, triangle, circle,
quarter circle and half circle. Select the desired shape by pressing the
corresponding shape selector; the shape appears in the Shape Panel as
seen in Fig. 11 and is traced by the aiming beam on the retina.
Press the and buttons on each side of the Spot Size display to
increase or decrease the range of spots; the total number of spots is shown
in the Total Spots display.
You may also use the Touchpad to select the shape by sliding your finger
along the left edge as shown in Fig. 9 on the previous page.
Fig. 11 The Shape Panel

Operation ●19
Titrating
The Array LaserLink provides a shortcut to simplify titrating. After you
have selected a shape, you can instantly switch to a single spot for
making adjustments to power level and spot size, etc. Press the
Titrate button to activate the single spot. In titrate mode, the
treatment screen shows the dimmed pattern with a single spot in the
center as shown in Fig. 12. On the retina, only the single spot will be
visible. To return back to the orginal shape, press the Titrate button
again.
Fig. 12 Titrate Preview
Frame Mode
Press the Frame button to display only an outline of the shape for a
less obstructed visualization of the target. When frame mode is
selected, the treatment screen displays the selected shape in a
bounding frame as seen in Fig. 13.
Fig. 13 Frame Mode Preview
The screen shows the spots that will be delivered during treatment.
On the retina, only the outline will be visible.
NOTE –Treatment cannot be delivered in Frame Mode. User must go
back to normal aim beam mode to treat.