Norlase Leaf User manual

®
Green Laser Photocoagulator
Operator Manual
Norlase ApS Norlase Inc. USA
Brydehusvej 13 895 Hurlingame Ave
Ballerup 2750 DENMARK Redwood City, CA 94063 USA
Phone: [phone] Phone: [phone]
Toll Free 833.667.5273 USA Only
™

Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 2of 85
This manual is copyrighted with all rights reserved. Under the 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 Norlase. 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 data given in
this document is accurate, the information, figures, illustrations, tables,
specifications and schematics contained herein are subject to change without
notice.
Norlase™, Norlase Leaf™ are trademarks or registered trademarks of Norlase.
BEFORE USE, PLEASE READ THIS MANUAL
Be sure to read this operator’s manual in its entirety prior to using the device to
understand the safety precautions and operating procedures.
United States federal law restricts this device to sale by or on the order of a
licensed physician.
Safety precautions must be strictly followed at all times. Please see the
appropriate sections of this manual for detail pertaining to Warnings, Cautions and
Precautions.
Keep this manual handy for reference.
In the contents of this manual are signal words attached to the symbol
to designate the degree or level of safety alerting.
The definitions are as follows:
Indicates a potentially hazardous situation which, if not avoided, may result in
death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in
minor, moderate or severe injury or property damage.
Indicates potentially hazardous situations which should be completely understood
before attempting any use of the system on a patient.

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Table of Contents
INDICATIONS FOR USE / INTENDED USE ......................................................................................................................................5
INTRODUCTION ...........................................................................................................................................................................5
PACKAGE CONTENTS ...................................................................................................................................................................6
SLIT LAMP LASER ADAPTER.....................................................................................................................................................................6
TOUCHSCREEN TABLET CONTROL PANEL ...................................................................................................................................................7
FOOTSWITCH.......................................................................................................................................................................................8
LASER POWER SUPPLY...........................................................................................................................................................................8
KEYS ..................................................................................................................................................................................................8
TABLET CHARGER AND CABLE ..................................................................................................................................................................8
PAIRING CABLE.....................................................................................................................................................................................8
TABLET STAND.....................................................................................................................................................................................8
USER MANUAL ....................................................................................................................................................................................8
SYSTEM PREPARATION AND SETUP.............................................................................................................................................9
CONNECTING THE SYSTEM COMPONENTS................................................................................................................................................10
ATTACHING THE NORLASE LASER TO A SLIT LAMP .....................................................................................................................................12
SYSTEM START-UP AND SHUT-DOWN .......................................................................................................................................14
STARTING THE SYSTEM ........................................................................................................................................................................14
SHUTTING DOWN THE SYSTEM..............................................................................................................................................................16
Standard Shut-down..................................................................................................................................................................16
Emergency Shut-down...............................................................................................................................................................16
HOME SCREEN...................................................................................................................................................................................17
USING THE TOUCHSCREEN INTERFACE.....................................................................................................................................................18
Changing Parameters on Power, Duration and Interval ...........................................................................................................18
Changing Laser Status, Laser Mode, Aiming Beam Power and Counter Reset .........................................................................19
Changing the Spot Size Diameter ..............................................................................................................................................20
Using Voice Control (Optional Feature).....................................................................................................................................22
List of Voice Commands: ...........................................................................................................................................................23
Voice Control Settings ...............................................................................................................................................................24
Tablet Volume Control...............................................................................................................................................................25
Changing Background Color on Tablet......................................................................................................................................26
Using µSec Mode.......................................................................................................................................................................27
Setting a Custom µSec Duty Cycle .............................................................................................................................................29
Presets Menu.............................................................................................................................................................................30
SETTINGS TAB....................................................................................................................................................................................32
Pulse Count Callout ...................................................................................................................................................................32
Treatment Record Log Files.......................................................................................................................................................32
ALIGNING THE LASER TO THE SLIT LAMP VISUAL AND ILLUMINATION AXIS .......................................................................................................33
INTRAOPERATIVE INSTRUCTIONS..............................................................................................................................................34
SLIT LAMP TREATMENT PROCEDURE.......................................................................................................................................................34
BETWEEN PATIENT TREATMENTS...........................................................................................................................................................35
SYSTEM SHUT-DOWN..........................................................................................................................................................................35
ANNUAL MAINTENANCE ...........................................................................................................................................................35
SYSTEM REPAIR .........................................................................................................................................................................35
INSPECTION AND CLEANING......................................................................................................................................................35
CLEANING THE CONSOLE EXTERNAL SURFACES .........................................................................................................................................35
CLEANING THE CONTROL PANEL SCREEN.................................................................................................................................................36
INSPECTING THE POWER SUPPLY............................................................................................................................................................36
NORLASE LEAF SPECIFICATIONS.................................................................................................................................................37

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TROUBLESHOOTING GUIDE .......................................................................................................................................................41
PAIRING AN UNPAIRED TABLET WITH LASER CONSOLE ...............................................................................................................................45
PAIRING A PAIRED TABLET TO A DIFFERENT LASER CONSOLE........................................................................................................................45
ERROR MESSAGES .....................................................................................................................................................................46
ERROR STATES ...................................................................................................................................................................................46
CALIBRATION CHECK PROCEDURE .............................................................................................................................................53
DISCLAIMER WARNING........................................................................................................................................................................53
CALIBRATION CHECK INSTRUCTIONS .......................................................................................................................................................53
SYSTEM RELOCATION INSTRUCTIONS........................................................................................................................................54
ROOM PREPARATION................................................................................................................................................................54
GENERAL SAFETY AND REGULATORY INFORMATION ................................................................................................................55
OCULAR PROTECTION..........................................................................................................................................................................55
LASER SAFETY EYEWEAR ......................................................................................................................................................................56
ELECTRICAL HAZARDS..........................................................................................................................................................................58
FIRE HAZARD.....................................................................................................................................................................................59
PROTECTING NON-TARGET TISSUES........................................................................................................................................................59
OPERATIONAL SAFETY .........................................................................................................................................................................60
ADDITIONAL SAFETY CONSIDERATIONS ...................................................................................................................................................62
REGULATORY COMPLIANCE SAFETY FEATURES..........................................................................................................................................63
Key Lock Switch .........................................................................................................................................................................63
Laser Emission Indicator............................................................................................................................................................63
Door Interlock / External Emission Indicator.............................................................................................................................63
Emergency Stop.........................................................................................................................................................................64
Protective Housing ....................................................................................................................................................................64
Safety Interlocks ........................................................................................................................................................................64
Safety Shutter............................................................................................................................................................................64
LOCATION OF CONTROLS......................................................................................................................................................................64
MANUAL RESET .................................................................................................................................................................................64
ELECTRICAL FAULT DETECTION CIRCUITRY ...............................................................................................................................................64
LOCATION OF REGULATORY AND OTHER SYSTEM LABELS............................................................................................................................64
Console Labels ...........................................................................................................................................................................65
Slit Lamp Adapter (SLA) Labels..................................................................................................................................................68
Additional Labels.......................................................................................................................................................................69
ELECTROMAGNETIC COMPATIBILITY........................................................................................................................................................70
INDICATIONS FOR USE .........................................................................................................................................................................74
USAGE PRECAUTIONS (BEFORE USE)......................................................................................................................................................74
USAGE PRECAUTIONS (DURING USE) .....................................................................................................................................................75
USAGE PRECAUTIONS (AFTER USE)........................................................................................................................................................76
CONTRAINDICATIONS ..........................................................................................................................................................................76
PRECAUTIONS IN PATIENT SELECTION .....................................................................................................................................................77
PRECAUTIONS IN PHOTOCOAGULATION...................................................................................................................................................77
ADVERSE EFFECTS AND COMPLICATIONS .................................................................................................................................................79
Posterior Segment Laser Procedures.........................................................................................................................................79
Anterior Segment Laser Procedures ..........................................................................................................................................79
Rarely, severe iritis may occur, related to either an unusual patient response or improper spot location. ..............................80
Residual Risk..............................................................................................................................................................................80
OPHTHALMOLOGY REFERENCES.............................................................................................................................................................81
WARRANTY INFORMATION...................................................................................................................................................................82
WARRANTY SHIPMENTS,RETURNS,AND ADJUSTMENTS.............................................................................................................................82
DECONTAMINATION OF RETURNED EQUIPMENT .......................................................................................................................................83
US TECHNICAL SERVICE INFORMATION ...................................................................................................................................................83
DECONTAMINATION CERTIFICATION.......................................................................................................................................................84
WEEE DISPOSAL................................................................................................................................................................................85

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Indications for use / Intended use
The Norlase Leaf Photocoagulator is intended to be used in ophthalmic laser
procedures including retinal and macular photocoagulation, iridotomy, and
trabeculoplasty.
Introduction
The Norlase Leaf is a monolithic green laser system/delivery device designed to be
user-detachable from the Slit Lamp. Leaf is controlled via a wireless tablet user
interface utilizing touch screen or voice control of parameters. The system may be
used for all standard single shot photocoagulation procedures listed in the
indications for use section of this manual.
The Norlase Leaf enables the physician to deliver laser energy via footswitch
depression emitting a single spot or series of laser pulses by utilizing auto repeat
mode of operation. The red aiming beam displays the target location for the green
laser emission
Norlase accepts full responsibility for safety, reliability and performance of the
device only if:
oService, readjustments, modifications and/or repairs are performed exclusively
by Norlase-certified personnel.
oThe electrical installation of the treatment room complies with the applicable
IEC, CEC and NEC requirements.
The warranty is void if any of these warnings are disregarded.
Norlase reserves the right to make changes to the device(s) herein. Device(s),
therefore, may not agree in detail with the published design or specifications. All
specifications are subject to change without notice. Please contact Norlase or
your local Norlase representative for information on changes and new products.

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Package Contents
The Contents of the package will contain the following major components. Other accessories may
be included depending on the configuration. Please consult the packing list in the shipping box for
the complete component and accessory list.
Slit Lamp Laser Adapter
Houses the key switch, emergency laser stop button, foot switch and power inputs, green
treatment laser, red aiming laser, Spot size adjusting optics and control electronics.
Recommended connectivity to Haag-Streit style slit lamps. Check with Norlase or your
authorized distributor for complete list of compatible slit lamps.

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Touchscreen Tablet Control Panel
Provides controls for selecting treatment parameters, voice communication and
audible feedback and displays for monitoring system information.
The tablet Operating System (OS) and other control functions are locked (kiosk
mode) to prohibit the installation and use of any consumer grade applications. The
tablets sole use is intended for the operation of Norlase Leaf photocoagulator. The
use of any unauthorized applications may affect the performance of the system and
is prohibited.
The tablet Wi-Fi is locked to prevent connection to any network and cannot access
the internet. Power charging cable and power supply are included.

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Footswitch
Activates laser treatment beam when depressed while system is in READY mode.
Laser Power Supply
Medical grade power supply to be connected between wall outlet and connection on Laser
system.
Keys
User removable keys (2) to turn on laser system.
Tablet charger and cable
Wall-plug charger and power charging USB cable.
Pairing cable
USB pairing cable.
Tablet Stand
A sturdy stand to allow easy access to the touch screen interface of the tablet.
User Manual
Provides User instruction for operating laser system. It also provides important safety and
specification information.
WARNING: The USB connectors in the tablet and in the laser console are dedicated to the 2
USB cables provided in the package. No other items, devices or cables must be inserted into the
USB connectors. Doing so risks unauthorised access to the system.

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System Preparation and Setup
Norlase certified personnel will perform the initial installation and setup. The
instruction of User’s staff to setup the device will be part of the initial in-service
training.
Norlase Leaf is intended for use by trained Ophthalmologists for diagnosis and
treatment of ocular pathology in both the posterior and anterior segments. The
system is designed for installation on a compatible slit lamp and use in a darkened
office or surgery room. Optimal system performance and viewing is achieved in low
ambient light conditions.
Norlase Leaf power supply is equipped with a 3-wire AC power cord. When selecting
the location for system installation, ensure that the AC wall power outlet is correctly
grounded. Follow local electrical codes to ensure proper grounding of the AC wall
power outlet. A correctly grounded power connection is required for safe system
operation.
Select an appropriate location that can accommodate the system size and allow for
easy access by both the patient and the physician. Ensure proper ventilation,
temperature and relative humidity. Select a well-ventilated space in an office or
surgery room. Proper system operation requires temperatures between 15°C (59°F)
and 35°C (95°F), with relative humidity between 20% and 85% non-condensing.
Position the system to aim the treatment beam away from windows and doors. Post a
laser safety sign at the entrance to the treatment room.
Do not block cooling airflow or cooling vents on the laser system. Allow at least 5 cm
(2 in) of clear space around the laser system to provide adequate system cooling
airflow. Use care when routing system cables to prevent a tripping hazard and to
protect the optical fiber from damage by being crushed under foot or being rolled over
by a chair. If the cord must cross a floor where there is traffic, use of a floor cord/cable
cover is recommended.
Example of Norlase Leaf attached to a slit lamp

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Connecting the System Components
Refer to the following diagrams for the location of system component connections on
the side panels of the console.
Side Panel Functions
A
DC Power Supply Connection
B
Foot Switch Connection
C
Key Switch
D
System Status LED
Flashing Blue - Searching for Tablet
Solid Green - Tablet Connected and in STANDBY
Solid Yellow - Tablet Connected and in TREAT
Flashing Yellow - Tablet Connected, in TREAT and footswitch is pressed
Solid Red –System Error, Turn Key OFF then ON
Flashing Red –System Error with No Tablet Connected, Turn Key OFF then
ON and connect tablet
A
B
D
C

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A
Emergency Off Switch
B
Micro USB Connection
C
Door Interlock / Warning Light Connection
NOTE
If using an external door interlock, a qualified electrical professional must install the
external switch, and the total length of the cable should not exceed 5 m (16 ft).
Bottom Panel Functions
A
B
C

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Attaching the Norlase Laser to a Slit Lamp
The Norlase Leaf Laser System is designed to attach to the tonometer mount of Haag Streit (top
illumination) style slit lamps. Consult Norlase technical support or your local Norlase distributor
for compatibility information.
Attempting to attach the laser system to a non-compatible slit-lamp may result in compromised
system and slit lamp performance and possible mechanical damage.
Laser mounted on Haag-Streit style slit lamp
Tonometer Mount

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1. Swing the slit lamp illumination tower to the left side ~45 degrees from the center.
2. Carefully place the Laser on the tonometer mount post using the mounting hole in the
adapter plate. If the illumination tower does not clear the laser unit, loosen the adjustment
screw and reposition the laser unit. Then tighten the adjustment screw.
3. Make sure the plate is completely seated onto the tonometer mount and tighten locking screw.
4. Swing the illumination tower back in behind the laser.
Tonometer mount
locking screw

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System Start-up and Shut-down
Starting the System
1. Connect system power supply to a wall power outlet.
2. Connect power cable to laser. Please note this connector is keyed so it must be inserted in
the proper orientation.
3. Connect footswitch cable to laser. Please note this connector is keyed so it must be inserted
in the proper orientation.
4. Insert key into key switch.
5. Turn key to the ON position.
6. Press and hold the “ON” button of the display tablet until the tablet powers up.
Cable Connections & Key Switch
Key Switch OFF
Key Switch ON
Foot Switch Connection
Power Input Connection

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7. The laser status LED will illuminate green when the tablet and laser have established a
connection.
Status LED
Power Button

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Shutting Down the System
Standard Shut-down
From the Treatment screen:
1. Place system in STANDBY mode.
2. Turn key switch on Laser to OFF position.
3. Remove key to prevent unauthorized use of system.
4. Press and hold tablet power button until “Power Off” is displayed. Select “Power Off” until
tablet screen shuts off.
NOTE
If the power cable is still connected to the electrical source, some internal circuits
remain energized (current comsumption is less than 0.1 Watts). To de-energize all
internal circuits, unplug the power cable from the wall.
Emergency Shut-down
If the system becomes unresponsive during laser emission, press the emergency
laser stop button on the front of the console. Turn the key switch to the OFF position.

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Home Screen

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Using the Touchscreen Interface
Changing Parameters on Power, Duration and Interval
To change any parameter, lightly press your finger along the active area of the arc and slide until
the desired setting is reached. The parameter selected will change colors to indicate the region
is being adjusted.
Alternate methods of adjustment include touching and holding a region along the arc for 2
seconds and the value will immediately jump to the touchpoint setting on the scale.
A setting may also be incremented to the next higher or lower value by touching the “+” or “-“
next to each parameter.

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Changing Laser Status, Laser Mode, Aiming Beam Power and Counter Reset
Laser status may be selected between Standby and Ready by pressing in the active region. The
selected setting will be displayed. In the Ready mode, the laser starburst symbol will be
highlighted in yellow.
To toggle between Continuous Wave (CW) and µSec (Optional) modes, touch within the active
region. The active setting will be displayed
Aiming Beam intensity can be adjusted by using the slider to select the desired intensity and can
be adjusted from 10-100%. At 100% setting, the power delivered to tissue is <1 mw.
The Pulse Count can be reset to zero by touching the “Reset” icon within the Count region.
Please Note: The Pulse Count can only be reset by pressing the reset button. Power cycling the
system will still display the previous pulse count number.

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Changing the Spot Size Diameter
The Norlase Leaf is equipped with an electronic spot size adjustment selected from the User
Interface. To change the delivered spot size:
1. Select the User Interface toggle to enable the Spot Size popup
2. To change spot size, lightly press your finger along the active area of the arc and slide
until the desired setting is reached. The parameter selected will change colors to indicate
the region is being adjusted. Alternate methods of adjustment include touching and
holding a region along the arc for 2 seconds and the value will immediately jump to the
touch point setting on the scale. A setting may also be incremented to the next higher or
lower value by touching the “+” or “-“ next to each parameter.
3. Select “Apply” to change the Spot Size to the new value.
If the spot diameter is reduced after a power level has been selected, the following warning will
be displayed: