Norlase LION User manual

®
Laser Indirect Ophthalmoscope
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

LION User Manual
P/N: 97-4001-05, Revision 05, Release date: January 28, 2021 Page 2 of 90
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 LION™ 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 ..........................................................................................................6
INTRODUCTION ...............................................................................................................................................6
PACKAGE CONTENTS........................................................................................................................................7
LASER INDIRECT OPHTHALMOSCOPE ...........................................................................................................................7
TOUCHSCREEN TABLET CONTROL PANEL......................................................................................................................8
FOOTSWITCH WITH BATTERY......................................................................................................................................9
NORLASE LION POWER SUPPLY.................................................................................................................................9
KEYS.....................................................................................................................................................................9
TABLET CHARGER AND CABLE.....................................................................................................................................9
PAIRING CABLE .......................................................................................................................................................9
TABLET STAND........................................................................................................................................................9
USER MANUAL .......................................................................................................................................................9
DEVICE PREPARATION AND SETUP ................................................................................................................10
SETTING UP AND USING THE NORLASE LION...............................................................................................................11
ADJUSTING THE HEADBAND.....................................................................................................................................12
Comfortable Fit ............................................................................................................................................12
Ophthalmoscope Angle Alignment .............................................................................................................. 12
INTERPUPILLARY DISTANCE SETTING CONTROL ............................................................................................................13
OBTAINING A FUSED IMAGE.....................................................................................................................................13
WHITE LIGHT ILLUMINATION ...................................................................................................................................14
SETTING THE ILLUMINATION APERTURE .....................................................................................................................15
FILTER SELECTION..................................................................................................................................................15
HEADSET ILLUMINATION AND LASER ANGLE ADJUSTMENT.............................................................................................16
Illumination adjustment...............................................................................................................................16
Laser angle adjustment................................................................................................................................ 16
DEVICE FUNCTIONS ...............................................................................................................................................16
Side Panel Functions .................................................................................................................................... 16
Bottom Panel Functions ............................................................................................................................... 17
Rear Panel Functions....................................................................................................................................17
Foot Switch Panel Functions ........................................................................................................................ 18
CHARGING THE LION BATTERY ................................................................................................................................18
LASER SPOT SIZE CONSIDERATIONS...........................................................................................................................19
DEVICE START-UP AND SHUT-DOWN.............................................................................................................20
STARTING THE DEVICE............................................................................................................................................ 20
SHUTTING DOWN THE DEVICE .................................................................................................................................23
Standard Shut-down ....................................................................................................................................23
Removing Headset Cable From the Foot Switch .......................................................................................... 23
Emergency Shut-down .................................................................................................................................24
HOME SCREEN (DEFAULT DISPLAY)...........................................................................................................................25
USING THE TOUCHSCREEN INTERFACE .......................................................................................................................26
Changing Parameters on Power, Duration, and Interval ............................................................................. 26
Changing Laser Status, Laser Mode, Aiming Beam Power, and Counter Reset ...........................................27
Using Voice Control (Optional Feature) ....................................................................................................... 28
Voice Control Settings .................................................................................................................................. 28
List of Voice Commands: .............................................................................................................................. 30
Tablet Volume Control ................................................................................................................................. 31
Changing Background Color on Tablet......................................................................................................... 32
Presets Menu ............................................................................................................................................... 33
SETTINGS TAB.......................................................................................................................................................35
Pulse Count Callout ...................................................................................................................................... 35
Treatment Record Log Files.......................................................................................................................... 35

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ALIGNING THE LASER TO THE VISUAL AND ILLUMINATION AXES .......................................................................................36
INTRAOPERATIVE INSTRUCTIONS ..................................................................................................................37
LASER INDIRECT OPHTHALMOSCOPE TREATMENT PROCEDURE .......................................................................................37
BETWEEN PATIENT TREATMENTS..............................................................................................................................38
DEVICE SHUT-DOWN .............................................................................................................................................38
ANNUAL MAINTENANCE................................................................................................................................38
SYSTEM REPAIR .............................................................................................................................................38
INSPECTION AND CLEANING ..........................................................................................................................38
CLEANING THE LASER CONSOLE EXTERNAL SURFACES...................................................................................................38
CLEANING THE TABLET CONTROL PANEL SCREEN .........................................................................................................39
INSPECTING THE HEADSET CABLE..............................................................................................................................39
NORLASE LION SPECIFICATIONS.....................................................................................................................40
NORLASE LION POWER SUPPLY SPECIFICATIONS ...........................................................................................44
TROUBLESHOOTING GUIDE............................................................................................................................45
PAIRING AN UNPAIRED TABLET WITH LION LASER CONSOLE .........................................................................................48
PAIRING A PAIRED TABLET TO A DIFFERENT LION LASER CONSOLE..................................................................................48
ILLUMINATION LED REPLACEMENT................................................................................................................49
ERROR MESSAGES .........................................................................................................................................50
ERROR STATES......................................................................................................................................................50
CALIBRATION CHECK PROCEDURE .................................................................................................................57
DISCLAIMER WARNING...........................................................................................................................................57
CALIBRATION CHECK INSTRUCTIONS..........................................................................................................................57
DEVICE RELOCATION INSTRUCTIONS .............................................................................................................58
ROOM PREPARATION ....................................................................................................................................58
GENERAL SAFETY AND REGULATORY INFORMATION.....................................................................................59
SAFETY CONSIDERATIONS –ILLUMINATION.................................................................................................................59
OCULAR PROTECTION ............................................................................................................................................61
LASER SAFETY EYEWEAR .........................................................................................................................................62
ELECTRICAL HAZARDS.............................................................................................................................................63
FIRE HAZARD........................................................................................................................................................64
PROTECTING NON-TARGET TISSUES ..........................................................................................................................64
OPERATIONAL SAFETY ............................................................................................................................................65
ADDITIONAL SAFETY CONSIDERATIONS ......................................................................................................................66
REGULATORY COMPLIANCE SAFETY FEATURES ............................................................................................................67
Key Lock Switch ............................................................................................................................................67
Laser Emission Indicator .............................................................................................................................. 67
Door Interlock .............................................................................................................................................. 67
Emergency Stop ........................................................................................................................................... 67
Protective Housing ....................................................................................................................................... 68
Safety Interlocks........................................................................................................................................... 68
Safety Shutter............................................................................................................................................... 68
LOCATION OF CONTROLS ........................................................................................................................................68
MANUAL RESET ....................................................................................................................................................68
ELECTRICAL FAULT DETECTION CIRCUITRY ..................................................................................................................68
LOCATION OF REGULATORY AND OTHER SYSTEM LABELS...............................................................................................68
Norlase LION Labelling................................................................................................................................. 69
Norlase LION headset Labels ....................................................................................................................... 71

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Foot Switch Label ......................................................................................................................................... 72
Additional Labels.......................................................................................................................................... 73
ELECTROMAGNETIC COMPATIBILITY ..........................................................................................................................74
INDICATIONS FOR USE............................................................................................................................................78
USAGE PRECAUTIONS (BEFORE USE).........................................................................................................................78
USAGE PRECAUTIONS (DURING USE) ........................................................................................................................79
USAGE PRECAUTIONS (AFTER USE)...........................................................................................................................81
CONTRAINDICATIONS .............................................................................................................................................81
PRECAUTIONS IN PATIENT SELECTION........................................................................................................................82
PRECAUTIONS IN PHOTOCOAGULATION .....................................................................................................................83
ADVERSE EFFECTS AND COMPLICATIONS....................................................................................................................84
Posterior Segment Laser Procedures............................................................................................................ 84
Anterior Segment Laser Procedures.............................................................................................................85
Residual Risk ................................................................................................................................................ 85
OPHTHALMOLOGY REFERENCES ...............................................................................................................................86
CLEANING............................................................................................................................................................87
WARRANTY INFORMATION......................................................................................................................................87
WARRANTY SHIPMENTS,RETURNS,AND ADJUSTMENTS ...............................................................................................87
DECONTAMINATION OF RETURNED EQUIPMENT..........................................................................................................88
US TECHNICAL SERVICE INFORMATION......................................................................................................................88
DECONTAMINATION CERTIFICATION..........................................................................................................................89
WEEE DISPOSAL ..................................................................................................................................................90

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Indications for use / Intended use
The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures
including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Introduction
The Norlase LION is a Laser Indirect Ophthalmoscope where the laser source is built into
the headset, eliminating the need for an external laser console. LION is controlled via a
wireless tablet user interface utilizing touch screen or voice control of parameters. LION is
powered by a rechargeable battery built into the foot switch. The device may be used for all
standard single shot photocoagulation procedures listed in the indications for use section of
this manual.
The Norlase LION 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 exclusivelyby
Norlase-certified personnel.
oThe electrical installation of the treatment room complies with the applicableIEC,
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 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.
Laser Indirect Ophthalmoscope
The Norlase LION is a laser indirect ophthalmoscope with the laser console integrated into
the headset. The laser console located on the back of the headset houses the key switch,
emergency laser stop button, foot switch and power inputs, green treatment laser, red
aiming laser, and control electronics. The binocular block on the front of the headset houses
the oculars, LED, illumination apertures and illumination filters.

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Touchscreen Tablet Control Panel
Provides controls for selecting treatment parameters, voice communication and audible
feedback and displays for monitoring device 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 LION photocoagulator. The use of any unauthorized
applications may affect the performance of the device 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.
Touchscreen User Interface

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Footswitch with battery
Activates laser treatment beam when depressed while device is in READY mode.The battery
is built into the foot switch shroud and powers both the white light illumination and laser
sources.
Norlase LION Power Supply
Medical grade power supply to be connected between wall outlet and the charging
connection on the foot switch.
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 or permanent damage to the
device.

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Device Preparation and Setup
The initial installation and setup will be performed under the supervision of Norlase-certified
personnel. The instruction of User’s staff to setup the device will be part of the initial in-
service training.
Norlase LION is intended for use by trained Ophthalmologists for treatment of ocular
pathology in both the posterior and anterior segments. The device is designed for use in a
darkened office or surgery room. Optimal device performance and viewing is achieved in low
ambient light conditions.
Norlase LION power supply used for charging the battery is equipped with a 2-wire AC
power cord. Follow local electrical codes to ensure proper wiring of the AC wall power outlet.
Proper device operation requires temperatures between 15°C (59°F) and 35°C (95°F). The
relative humidity must be between 20% and 85% (non-condensing) up to 25°C (77°F) and
between 20% and 60% (non-condensing) up to 35°C (95°F). 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. Allow at least 5 cm (2 in) of clear
space around the laser to provide adequate system cooling airflow. The headband should be
worn over the users hair. Do not route the users hair through the headband. Use care when
routing device cables to prevent a tripping hazard.

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Setting up and using the Norlase LION
The Norlase LION is a fully self contained laser delivery device built into the viewing path of
the binocular block. The user can adjust the angle of projection of the laser by approximately
+/- 3 degrees. The illumination field is separately adjustable.
Oculars- Patient Side Oculars- Physician Side

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Adjusting the headband
Comfortable Fit
Adjust the size (fig.1) and the height (fig.2), so that the headset is supported comfortably
around and on top of the head.
Ophthalmoscope Angle Alignment
For vertical alignment of the eyepieces and binocular block, adjust the height of the Metal
Outer Brow Bar if necessary by using the brow band tension knobs located on the sides of
the headset.
Position the Binocular Block as close to the eyes or spectacles as possible for maximum
field of view. Slightly loosen the ophthalmoscope angle knob to allow for adjustment and
tighten when in position.
Brow Band Tension
Knob (each side)
Angle Adjust Knob

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Interpupillary Distance Setting Control
Because the eyes are dissociated, particular care must be taken to ensure the optics
(eyepieces) are set properly in front of each eye.
Always set the Aperture Selection to the large light patch for this exercise.
Place an object, perhaps the thumb, approximately 40cm from the face and centre it
horizontally in the light patch. Then, close one eye. Using the thumb and forefinger of the
opposite hand, slide the P.D. Control of the open eye (located directly under each eyepiece)
so that your object moves into the centre of the field, keeping the object in the centre of the
light patch. Repeat for the other eye.
Obtaining a fused image
Ensure that a singular, fused image is obtained as follows:

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White Light Illumination
Turn the illumination on by rotating the headband dimmer in the clockwise direction.
White Light
Illumination
Control

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Setting the Illumination Aperture
Select different apertures by rotating the lever on the left
side of the unit.
The Norlase LION has three light apertures which offer
maximum stereopsis. When you select the aperture, the
illumination and viewing mirrors automatically adjust for
maximum stereopsis.
Large
The large, round, homogeneous patch is suitable for
routine examinations through fully dilated pupils. In this
position the mirror remains in the forward position and
the optics are diverged.
Intermediate
The intermediate patch is designed to reduce reflections when entering a partially or poorly
dilated pupil (3mm). It is also ideal for closer inspection of particular fundal areas. The
mirror and optics stay in the mid position.
Small
This light patch is ideal for small, undilated pupils. The mirror moves back and the optics
automatically converge.
Filter Selection
Select different filters by rotating the lever on the right side of the unit:

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Headset Illumination and Laser Angle Adjustment
Illumination adjustment
The illumination patch can be adjusted up and
down using the illumination adjustment control.
The illumination control has a larger adjustment
range than the laser control, so it is best to
adjust the laser first then overlay the
illumination.
Laser angle adjustment
The vertical angle of projection of the laser
can be adjusted up or down the front
mounted control.
Device Functions
Refer to the following diagrams for the location of device component connections on the side
panels of the laser console.
Side Panel Functions
Laser Console Side Panel
Emergengy Off Button
Laser Key Switch

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Bottom Panel Functions
Laser Console Bottom Panel
NOTE
If using an external door interlock, a qualified electrical professional must install the external
switch. The total length of the cable should not exceed 5 m (16 ft).
Rear Panel Functions
Laser Console Rear Panel
System Status LED Meaning:
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
Door Interlock
Connection
USB Connection
Rear Headset Tension Knob
System Status LED

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Foot Switch Panel Functions
Foot Switch Panel
Charging the LION Battery
The charging port for the LION battery is located on the rear of the foot switch. Plug in the
supplied power supply to a wall outlet (100-240 VAC) and the output end into the battery
charging port. A full charge will be obtained from a depleted battery in ~3 hours.
NOTE: Use only the Norlase LION power supply to charge the battery. Using any
other power supply may cause permanent device damage and risk of fire. Using any other
power supply will immediately void the warranty. The batteries may only be replaced by
Norlase-certified personnel.
The charging status LED will display the following:
Battery Charging LED Meaning:
Flashing Green –Battery is Charging
Solid Green –Battery is fully charged
Solid Red –Error in Charging. Remove charging cable for 1 minute and retry. If solid red
LED is persistant please contact Norlase Technical Support or an authorized distributor
Connector to Headset
Battery Charging Port
Charging Status LED

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Laser Spot Size Considerations
There are many factors that can affect the spot size delivered to the target tissue. Among
these are:
•Working distance between the physician and patient.
oThe smallest spot is obtained when the laser at its focus point ~15 inches
(~381 mm) from the laser aperture.The physician should move along the
focus axis while observing the aiming beam diameter and observe the point
where the laser is at its smallest diameter. Treatment should be performed at
this optimal focus point.
•Refractive index of the eye structures.
•Refractive status of the eye. As an example using an (A) 1100 µm aerial spot and a
(B) 20D indirect lens and (C) power of the eye: A* (B/C)= spot size on the retina:
oEmmotropic Eye (~60D) = 1100* (20/60)= 366 µm on retina
oHyperopic Eye (~50D) = 1100* (20/50)= 440 µm on retina
oMyopic Eye (~70D) = 1100* (20/70)= 314 µm on retina
•Power of the indirect lens in an emmotropic eye:
o20D Lens = 366 µm on the retina
o25D Lens = 458 µm on the retina
o28D Lens = 513 µm on the retina
o30D Lens = 550 µm on the retina
The above is an example only. The refraction power will vary patient to patient.

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Device Start-up and Shut-down
Starting the Device
1. Prior to mounting the headset, connect the LION headset cable to rear of foot switch mating
cable receptacle. Please note this connector is keyed, so it must be inserted in the proper
orientation with the arrow on the connector facing UP.
2. Push connector into the foot switch receptacle until it “clicks” and locks into place
3. Insert key into key switch.