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Manual
This document is subject to change without notice.
® ®
Ellex , Super Q , Total Solution™ and the Ellex logo are trademarks or registered trademarks of Ellex
Medical Pty Ltd.
Kowa® is a registered trademark of Kowa Company Ltd (Japan) and Kowa Opitmed Inc. (US).
All other trademarks and copyrights are the property of their respective owners.
This manual describes how to operate and maintain the third generation Super Q LQP3106 laser model,
which started production from serial number 11000 in June 2012. This model has the control panel located
on the delivery head.
US federal law restricts this device to sale by, or on the order of, a physician.
These instructions comprise part of the product and must be kept for the life of the product. If the product
is sold, these instructions must be provided to the new owner. Ensure that any amendment is incorporated
into the instructions.
This document contains confidential and proprietary information, and may only be reproduced in whole or
in part for use with the devices described herein.
Contents
Warnings .................................................................................................................... 5
Overview .................................................................................................................... 9
About this manual ............................................................................................................... 9
Device description............................................................................................................. 10
Assembly ................................................................................................................... 17
Assembling the device....................................................................................................... 17
Checking optical alignment ................................................................................................ 20
Verifying calibration ........................................................................................................... 20
Disassembling the device .................................................................................................. 20
Safety interlock ................................................................................................................. 21
Clinical Use ................................................................................................................ 23
General purpose ............................................................................................................... 24
Indications ........................................................................................................................ 24
Contraindications .............................................................................................................. 24
Operational indications and contraindications ...................................................................... 24
Further reading ................................................................................................................. 24
Safety........................................................................................................................ 25
Before first use.................................................................................................................. 25
Precautions during use ...................................................................................................... 26
Warnings .......................................................................................................................... 26
Safety interlock ................................................................................................................. 28
Laser safety monitoring ..................................................................................................... 28
Operation .................................................................................................................. 29
Warnings
All warnings used in this manual are listed below. You must read and understand all warnings
before using this device.
Do not use the device if segments of the display are absent or unclear. Contact your Authorised Ellex Distributor.
When removing the slit lamp/delivery head place it upright and support it from underneath to avoid crushing the
electrical cable.
Avoid trapping your fingers when placing the console on the top plate.
To ensure adequate electrical safety, you must connect this device to a mains power outlet that has a reliable
protective earth conductor.
To protectively earth the device, the power lead from the mains power outlet to this device must incorporate an
earth terminal and earth conductor.
The safety interlock socket is a switched input type circuit. Do not connect external electrical connections to this
socket.
This information is a guide only and is not intended to present complete or thorough instructions. It does not
replace the judgement of a trained ophthalmic physician.
Do not aim, focus or fire this device in or on or near the fovea; in or on the macular or any part of the retina; in or
on corneal structures; in or on the patient’s lens (natural or artificial); or on any other structure of the human body
that is not related to the treatment of an eye disorder or disease.
Use of controls or adjustments, or performance of procedures other than those specified in this manual may result
in hazardous radiation exposure.
This device is designed for use with a range of Ellex approved attachments. The use of unapproved attachments
may result in serious injury to the patient and/or physician and voids the warranty. In no event shall Ellex, its
employees, officers, directors, representatives or affiliates, be held liable for any injury occurring through such use.
Do not operate the device until you are familiar with all the precautions.
Do not use the device if you experience an abnormal operating condition. Contact your Authorised Ellex Distributor.
Do not modify this device. Unauthorised modifications may create a safety hazard.
Do not fire the laser if you cannot see the aiming beam or beams.
Do not look into the aiming beam or beams unless under the control of a qualified physician.
Do not look into the treatment beam unless under the control of a qualified physician.
Safety glasses, or safety filters providing protection from other wavelengths, may not offer any protection from the
treatment wavelength and should not be used. Ordinary spectacles offer no protection.
Objects that reflect visible light will reflect treatment laser light. Avoid placing reflective materials such as glass,
metal and polished plastic in the path of the laser beam.
Some materials (for example, cotton wool saturated with oxygen) may be ignited by the high temperatures
produced by the treatment laser. Before using the device, allow the solutions of adhesives and flammable solutions
(used for cleaning and disinfecting) to evaporate.
Do not use the device unless you understand the potential hazards inherent in laser technology.
Do not place your hands, arms, or any other body parts or tissue in the path of the treatment laser.
To protect the patient from possible retinal damage, use the lowest practical aiming beam intensity during
treatment.
Dangerous laser radiation is emitted from the laser aperture when the treatment laser is fired.
Wait at least 10 seconds after turning off before turning the device on again, to allow the device to restart properly.
Do not use the device if the external optics are scratched. Contact your Authorised Ellex Distributor.
Use one tissue or swab per wipe and then discard it. Do not use dry tissues or swabs as they may damage the
surface of the optic.
Do not use the device if the eye safety filter is damaged or discoloured. Contact your Authorised Ellex Distributor.
Do not use the device if you cannot make the aiming spots converge (twin aiming beam devices), or if you can
move the aiming beam out of the field of view. Contact your Authorised Ellex Distributor.
Do not use the device if the aiming beam is not centred in the burn mark. Contact your Authorised Ellex Distributor.
The globe may be hot. Wait until the globe cools before replacing it.
Do not use the device if the measured values are not within ±15% of the power setting that appears on the device.
In such cases, investigation by your Authorised Ellex Distributor is necessary to determine if the device requires
recalibration or if the delivery device has poor transmission.
Only use Ellex approved consumables and accessories. Using unauthorised parts may result in injury, increased
electromagnetic emissions, or decreased immunity of the device. Use of unapproved parts will void the warranty.
Overview
Device description
User accessible controls, connectors and labels are described below. Some controls are located
on both sides of the delivery head.
10
11
3 12
4 13
6 14
7 15
16 18 19 20
17
om_sq_0006
1 Binocular thumbscrew
2 Magnification changer thumbscrew
3 10× 16× 28× Magnification changer
4 Binocular
Adjustable to suit the operator’s interpupillary distance.
The focus of each eyepiece may be individually adjusted.
5 Control panel (refer to Control panel on page 11 for more information).
6 Posterior Offset
Adjusts the focus of the treatment laser in relation to the aiming lasers. Continuously
variable, with detents at MIN, +150 µm and +250 µm.
7 Energy
Adjusts the treatment laser beam energy. Continuously variable from 0.3 mJ to at least
10 mJ (typical). An automatic test fire occurs whenever the energy is changed.
8 Joystick with fire button
Moves the delivery head backwards, forwards, left and right. Rotating the joystick adjusts
the height. The fire button only operates when key is turned to On, the laser button is
depressed (On) and the device is READY.
9 Fixation lamp
10 Headrest
19 Cross slide locking screw (one on either side of the delivery head)
Prevents the delivery head from moving on the tabletop.
20 Chinrest mount. Electrical connector for fixation lamp is incorporated on the right side.
Control panel
Controls
The control panel has two small lights to indicate if the device is in STANDBY or READY. The
device beeps when you press a button on the control panel.
3 5
4 6
om_sq_0005
1 Contrast
Controls the contrast of the LCD.
2 State
Select between STANDBY and READY. Only available if the laser button is depressed (On).
A light next to the icon indicates the status of the device.
STANDBY
READY
3 Energy Test
Manually fires a treatment laser test shot (in STANDBY or READY) with the safety shutter
closed to prevent emission. The resulting energy appears on the display.
4 Energy Reset
Resets the cumulative delivered energy total to zero. Press this before each procedure to
track the energy delivered to the patient.
5 Pulse Set
Select between single (default), double or triple pulse. Press the switch once to select
double pulse mode, press it again to select triple pulse mode. Pressing it once more
selects single pulse mode again. A test fires occurs every time the pulse is changed.
6 Pulse Reset
Resets the total delivered pulses to zero. Press this before each procedure to track the
number of pulses delivered to the patient.
Display
Extreme cases of electrostatic discharge may cause segments of the display to go blank. If this
occurs turn the device off and then restart it.
WARNING! Do not use the device if segments of the display are absent or unclear. Contact your Authorised Ellex
Distributor.
1 2
ENERGY 12 mJ total
999
3 999
3 4
om_sq_0008
1 Energy
The energy of the last test fire, which will be delivered during a treatment laser fire. Move the thumbwheel to
display the predicted energy, which is then replaced by a new energy value from the subsequent test fire.
2 Total energy
Cumulative total delivered energy used during a procedure (provided it was reset at the start). Only increments
when a treatment shot is fired, not when a test shot is fired, so at the end of the procedure the energy delivered to
the patient is displayed.
3 Pulses
Indicates the selection of single, double or triple pulses per shot.
4 Total pulses
Cumulative total of delivered pulses. Increments in single, double, or triple units, depending on the pulse mode
selected. Only increments when a treatment shot is fired.
In single pulse mode the values increment by one pulse and one unit of energy per fire. In double
pulse mode the registers increment by two units, and in triple pulse mode the registers increment
by three units.
Slit lamp
3
6
4
7
5
om_sl-cso_0001
1 Slit Rotation
Adjusts slit rotation through 90º either side of vertical.
90 60 30 0 30 60 90
2 Slit Width
Continuously variable between closed to 12 mm.
3 Aperture
Adjusts the illumination aperture between 0.5 mm, 5.0 mm, 8.0 mm, 12.0 mm and tear
drop (variable between 1.0 mm and 11.0 mm).
4 Product logo (located on the side of the slit lamp).
5 Filters
Blue-green, violet-blue, heat absorbing (28% attenuation), none.
6 Type of globe fitted to the slit lamp (halogen)
Console1
1 2
3 4
5 6 7 8 9 10
11 12 13 14 om_sq_0004
2 Mains power indicator. Illuminated (green) when the key is turned to On.
6 Keyswitch
The main power switch for the device. Key cannot be removed unless it is in the Off
position. Device cannot be turned on if the Emergency Stop switch is activated.
| On
0 Off
7 Safety interlock
1
Table top and drawer not shown. Patient handles (not shown) are screwed vertically to the table top on either side of the
chinrest.
8 Mains power inlet (with mains supply voltage, fuse type and rating label).
1 2 3
om_sq_0003
2 Electrical connector
3 High voltage connector
Laser aperture
The location of the laser aperture is shown below. The laser aperture label is located immediately
below the aperture.
om_sq_0001
Compliance label
om_common_0007
Manufacturer
SN Serial number
Date of manufacture
Recycling symbol
Symbol in compliance with EU Directive 2002/96/EC on waste electrical and electronic
equipment (WEEE) indicating the use of separate collection and recycling methods when
disposing of this product.
Type B equipment symbol
The equipment provides protection against electric shock through the limiting of leakage
current and the provision of a protective earth connection.
Pollution control label in compliance with People’s Republic of China (PRC) standards.
European Conformity (CE) mark in compliance with the EU Medical Device Directive (MDD).
0805
The user must read and comprehend the operator manual before use.
om_sq_0012
Assembly
Your Authorised Ellex Distributor should assemble and check the device. The Distributor will
complete a Product Acceptance and Fault (PAF) report which formally documents this process.
Packing cartons opened by unauthorised personnel may void the warranty.
Retain all packing cartons in case you need to transport the device.
Check the packing list and contact Ellex immediately if any item is missing or damaged.
Short and long power cables are included with the device.
WARNING! When removing the slit lamp/delivery head place it upright and support it from underneath to avoid
crushing the electrical cable.
A A
A
B B
B
+ + +
The standing figure indicates the physician and the seated figure represents the patient.
Console
WARNING! Avoid trapping your fingers when placing the console on the top plate.
1 Ensure that the Total Solution table is on a level surface and lock the castors (if present).
The front of the assembly must be on the same side as the column switch. Ensure that the
rubber feet of the console fit into the recesses on the top plate.
4 Screw the four top plate captive screws into the console.
2 Insert the shaft into the slit lamp/delivery head and reattach the gearwheel.
3 Ensure that the delivery head and slit lamp are locked in place.
4 Lift the delivery head and slit lamp onto the console. Ensure that the electrical cables exit
from the rear of the slit lamp and are placed in the access hole in the middle of the
tabletop.
5 Position the gearwheels on the tracks. Ensure that the gearwheel shaft is parallel to the
console.
6 Unlock the cross slide shaft and move the slit lamp to the front of the console.
7 Lay the cables in the groove on the left hand side of the cable tray.
8 Remove the two rear panel screws (one located on either side of the console) and lower
the rear console flap.
9 Fit the electrical connector to the electrical socket and tighten the two connector
thumbscrews.
10 Insert the high voltage connector into the high voltage socket and rotate it clockwise until
it clicks into position.
12 Move the slit lamp over the full extent of its travel: from left to right, and forward and
back. Ensure that the cables are not strained or tightly bent, and that the slit lamp moves
freely over the full extent of travel.
Reposition the cable if necessary so that it is not strained and there is no rubbing on the outer
sleeve.
13 Close the rear console flap and secure it in place with the two screws.
14 Verify that the safety filter is not damaged and then fit the binocular to the delivery head.
Chinrest
1 Ensure that the electrical connector protruding from one chinrest support is clean.
2 Stand in the patient’s position and, with the chinrest electrical connector on your left,
lower the chinrest all the way into the chinrest mounts.
3 Screw the chinrest to the mounts using the supplied Allen key and screws.
4 Fit the chinrest paper and optionally attach the head strap.
Final assembly
1 Remove all remaining protective plastic from the device.
4 Connect the console to the power socket at the top of the column.
5 Connect the power cable from the table column base to the mains power and turn
mains power on. The power indicator on the column will illuminate.
The power cable has an EU style plug; replace with a locally approved type if necessary.
Power cables may be held in place with a metal strain relief to ensure the cable is not
accidentally dislodged from the connector. To remove the power cable, lift the strain relief.
WARNING! To ensure adequate electrical safety, you must connect this device to a mains power outlet that has a
reliable protective earth conductor.
WARNING! To protectively earth the device, the power lead from the mains power outlet to this device must
incorporate an earth terminal and earth conductor.
8 Insert the key and turn it to On. Verify that the device starts up.
Verifying calibration
Your Authorised Ellex Distributor will verify calibration during installation. Refer to the Maintenance
chapter for more information.
3 om_sq_0016
Safety interlock
A safety interlock connection is provided for connection to the theatre or clinic door. If the door is
opened, the treatment laser turns off immediately and the device enters STANDBY. The interlock
wiring is rated at 3.3 V DC.
A suggested circuit diagram is shown below (pins 1 and 3 of the DIN plug are wired). All cables
and switches are user supplied. Ellex recommends that the cable is wired to the connector and
switch by an electrician. Microswitch Omron VX56-1A3 or similar should be used, with 2-core
shielded 18-22 AWG cable.
WARNING! The safety interlock socket is a switched input type circuit. Do not connect external electrical
connections to this socket.
NC NC
S1 S2
NO NO
S1 S2
NO NO P
NO NC O
NC NO O
NC NC O
om_common_0005
Clinical Use
WARNING! This information is a guide only and is not intended to present complete or thorough instructions. It
does not replace the judgement of a trained ophthalmic physician.
Ellex accepts no responsibility for negligent medical practices, or for any event that results from the
improper use of this equipment.
Only use this device in accordance with the purpose, indications and contraindications described
below.
WARNING! Do not aim, focus or fire this device in or on or near the fovea; in or on the macular or any part of the
retina; in or on corneal structures; in or on the patient’s lens (natural or artificial); or on any other structure of the
human body that is not related to the treatment of an eye disorder or disease.
Always use the appropriate handheld contact laser lens recommended in peer reviewed literature
for the appropriate treatment of an eye disorder or disease.
Treatment should be performed prudently following the principle of ALARA (As Low as Reasonably
Achievable).
The information provided under the General purpose, Indications and Contraindications headings
(see below) has been cleared by the US Food and Drug Administration (FDA). This information is
generally valid for other countries.
General purpose
The Super Q is intended to be used to perform procedures that rupture eye tissue.
Indications
This device is indicated for use in:
• posterior capsulotomy
• posterior membranectomy
• iridotomy and iridectomy.
Contraindications
These pre-existing ocular pathologies may represent contraindications of Nd:YAG laser surgery:
• corneal edema that interferes with visualization of the capsule
• diffuse haze of the aqueous humour
• extensive corneal dystrophy
• chronically elevated intraocular pressure, especially when uncontrollable under medication
• eyes with no potential visual function
• subjects with glass posterior chamber IOLs, except in those subjects whose medical condition
precludes invasive surgery.
Like all Nd:YAG ophthalmic laser surgery, there are risks involved and the use of the laser may be
contraindicated for patients with certain pre-existing pathologies. Objective assessment of
candidate patients for this procedure must be done in light of the risks.
Further reading
Visit the Ellex website for whitepapers and other educational material. A small selection of relevant
publications is listed below.
Boyd S. Laser surgery of the eye. Highlights of Ophthalmology; 2005.
Fankhauser F, Kwasniewska, S, editors. Lasers in ophthalmology: basic, diagnostic and surgical
aspects: a review. The Netherlands: Kugler Publications; 2003.
Hora HJ, Schwarz H. Laser interaction and related plasma phenomena: volume 3a.
Massachusetts: Kluwer Academic Publishers; 1974.
Hora H, Schwarz H. Laser interaction and related plasma phenomena: volume 3b. New York:
Plenum Press; 1974.
Joffe SN, Goldman L, Muckerheide MC, editors. Neodymium: YAG laser in medicine and surgery.
Elsevier Science; 1983.
Lim ASM. A colour atlas of posterior chamber implants. Philadelphia: W.B. Saunders; 1985.
Niemz, MH. Laser-tissue interactions: fundamentals and applications. Berlin: Springer-Verlag;
2007.
Pattnaik NK. Laser in ophthalmology: principles and techniques. Jaypee Brothers; 1995.
Sliney DH, Wolbarsht ML. Safety with lasers and other optical sources. New York: Springer-Verlag;
1980.
Safety
The content of this chapter is common to the service and operator manuals for all major Ellex laser
devices. Be aware that some information may not apply to the Ellex device that you have
purchased.
Only fully trained and qualified physicians may operate this device.
WARNING! Use of controls or adjustments, or performance of procedures other than those specified in this manual
may result in hazardous radiation exposure.
WARNING! This device is designed for use with a range of Ellex approved attachments. The use of unapproved
attachments may result in serious injury to the patient and/or physician and voids the warranty. In no event shall
Ellex, its employees, officers, directors, representatives or affiliates, be held liable for any injury occurring through
such use.
This device is a safe instrument when used correctly. However, like all laser surgical equipment, it
can cause injury if not used in accordance with the correct safety procedures and operating
instructions.
Warnings
WARNING! Do not operate the device until you are familiar with all the precautions.
WARNING! Do not use the device if you experience an abnormal operating condition. Contact your Authorised Ellex
Distributor.
WARNING! Do not modify this device. Unauthorised modifications may create a safety hazard.
Electrical safety
WARNING! To ensure adequate electrical safety, you must connect this device to a mains power outlet that has a
reliable protective earth conductor.
WARNING! To protectively earth the device, the power lead from the mains power outlet to this device must
incorporate an earth terminal and earth conductor.
To isolate the equipment from the mains supply turn the device off at the mains supply (wall) outlet
or similar.
Aiming laser
WARNING! Do not fire the laser if you cannot see the aiming beam or beams.
WARNING! Do not look into the aiming beam or beams unless under the control of a qualified physician.
Treatment laser
WARNING! Do not look into the treatment beam unless under the control of a qualified physician.
Eye safety
Everyone attending the procedure (except the physician and patient) must wear safety glasses,
goggles or masks designed to prevent transmission of the treatment beam. Safety glasses, with a
minimum optical density (OD) value as listed below, are required for the treatment wavelengths.
Ellex product Minimum optical density (OD)
YAG/SLT/2RT 5
Photocoagulators 3.5
Appropriate safety glasses should be made available close to the door outside the treatment room.
WARNING! Safety glasses, or safety filters providing protection from other wavelengths, may not offer any
protection from the treatment wavelength and should not be used. Ordinary spectacles offer no protection.
(European customers) Safety eyewear must have a protection class of L5 to meet the EN 207
specification.
Cover windows and viewing ports in the room while the device is in use.
Reflection
WARNING! Objects that reflect visible light will reflect treatment laser light. Avoid placing reflective materials such
as glass, metal and polished plastic in the path of the laser beam.
All surfaces in the room should be matt finished to prevent possible reflection of the treatment
laser. Avoid using reflective instruments.
Fire hazard
WARNING! Some materials (for example, cotton wool saturated with oxygen) may be ignited by the high
temperatures produced by the treatment laser. Before using the device, allow the solutions of adhesives and
flammable solutions (used for cleaning and disinfecting) to evaporate.
Electromagnetic compatibility
Radio frequency sources (for example, mobile phones) may affect the device. Make sure that all
mobile phones in the treatment room are turned off while the device is in use.
The device has been certified to be compliant to the emission limits of EMI (electromagnetic
interference) for medical devices, and must be connected to an earthed power outlet to ensure
compliance and reduce the risk of interference to other devices.
Physical safety
WARNING! Do not use the device unless you understand the potential hazards inherent in laser technology.
WARNING! Do not place your hands, arms, or any other body parts or tissue in the path of the treatment laser.
Warning signs
You should display safety signs outside the treatment room warning of the type of laser being
used. Consider installing warning lamps outside the treatment room to indicate that a laser is in
operation.
Safety interlock
A safety interlock connection is provided for connection to a theatre or clinic door. When
connected, if the door is opened:
• the treatment laser is immediately disabled and the device is placed in STANDBY
• a warning sounds
• an interlock warning icon is displayed on the device.
A separate fibre interlock detects the presence of an optical fibre connection. The treatment laser
is disabled if an optical fibre is not connected.
Operation
Slit Lamp
Only the slit lamp and fixation lamp operate when the key is turned to On (with the Laser button
released (Off)).
Laser On
With the key turned to On, push in the Laser button to turn the laser on. In Laser On mode, the
device has two states: STANDBY and READY.
STANDBY
The device automatically enters STANDBY when the key is turned to On and the Laser button is
depressed (On). In STANDBY you can select treatment settings, target and focus the aiming beam
knowing that the treatment laser cannot be accidentally fired. The device automatically returns to
STANDBY if an interlock or other error occurs.
READY
Press the State button to place the device in READY.
Treatment workflow
Before starting the device
1 Ensure that the safety interlock (or emulation plug) is connected.
2 Ensure that all observers are wearing appropriate eye safety glasses and are aware of
the device’s safety requirements
4 Adjust the height of the chinrest until the patient’s chin sits comfortably in the chinrest,
and their forehead rests firmly against the headrest.
5 Lock the castors (or wheels) if the device is mounted on a mobile table.
6 (Optional) Fit the head strap to ensure that the patient’s head cannot move.
7 Position the fixation lamp and ask the patient to focus on it.
2 If the Emergency Stop switch was activated, turn it clockwise to release it.
The device can now be used as a slit lamp. Note that the Laser button is illuminated.
WARNING! To protect the patient from possible retinal damage, use the lowest practical aiming beam intensity
during treatment.
1 Adjust the binocular for a clear view of the focal plane. To do this:
4 Select a filter.
2 Set aiming beam intensity to the minimum setting that provides good spot contrast on
the target background.
You can place the illumination tower on axis in the centre of the slit lamp, or move it off axis if
necessary. You will have better depth perception if you position the slit lamp slightly off axis to
the aiming beam.
The device test fires every time you change the number of pulses, and the energy value is
updated. The safety shutter remains closed during this process.
4 Set the energy. This is the predicted energy at the selected position.
The device performs a test fire every time you change the energy, and updates the energy
display to the actual energy of the test shot. The new energy value may vary slightly from the
predicted value: this is not a fault. The safety shutter remains closed during this process.
6 Use the joystick to move the slit lamp forward/backward until the two aiming beams are
coincident on the target.
Multiple reflections of light from the aiming beams and slit lamp can make accurate focusing
difficult. Use a contact lens, vertically orient the aiming beams, slight off-axial positioning of the
slit lamp, and selective positioning of the patient may solve this problem.
9 If you are using a contact laser lens, place it in position on the patient’s eye.
10 Position the aiming laser beam accurately to where the laser is to be delivered.
WARNING! Dangerous laser radiation is emitted from the laser aperture when the treatment laser is fired.
If you press the fire button longer than two seconds, the device will automatically return to
STANDBY and emit a warning sound.
14 (Optional) Record the total energy and total pulses for this patient.
WARNING! Wait at least 10 seconds after turning off before turning the device on again, to allow the device to
restart properly.
3 Remove the key and store it in a safe place to prevent unauthorised use.
Test firing
You may perform a test fire at any time in STANDBY or READY to check the energy level. This is a
safe process: the safety shutter remains closed during the test.
F
MIN +150 +250
Status flags
A status flag appears on the display if one or more operating characteristics of the device have
changed. Status flags do not prevent you from using the device, and are described in the table
below. Contact your Authorised Ellex Distributor if a status flag appears.
P01 Single pulse operating voltage has changed by 30-55V Turn the device off and on again to clear the flag.
and energy has degraded by more than 20%
P02 Single pulse operating voltage has changed by 30 to 55
volts from the last calibration
P03 10,000 or more shots have been fired An indication only. You may continue using the device
normally. To clear this flag, perform the Operator Test
(see below).
Operator test
An operator test can be performed at any time and confirms that the device is operating correctly.
It also clears the P03 status flag. The test checks the laser operating voltages and energies, and
stores new average energies.
4 The text ‘Diagnostic (User)’ and ‘350’ will appear on the display. The number will change
om_sq_0002 over the course of the test.
2 If the test is successful, the text ‘PASS’ will appear on the display.
3 If the test is unsuccessful an error will flash on the display. Turn the device off and
contact your Authorised Ellex Distributor.
Troubleshooting
This content of this chapter is common to all major Ellex laser devices. Be aware that some
information may not apply to the Ellex device that you have purchased.
Contact your Authorised Ellex Distributor if you cannot resolve a problem. Always quote the entire
error code or message.
Problem Probable cause Resolution
Device does not start Power cable is not connected Check that the power cable is
connected to the local supply and to the
stand, and from the stand to the device
No mains power Check that the local supply is
functioning and switched on. Check with
another appliance to be certain.
Emergency Stop switch activated Release the switch
Blown fuse Replace the fuse
No slit lamp illumination Slit closed Open slit
Slit lamp globe incorrectly seated Reseat globe
Slit lamp illumination control in off Turn control on
position
Slit lamp globe blown Replace globe
Blurred illumination Slit lamp globe incorrectly seated or Reseat globe. If illumination is still
faulty blurred, replace the globe.
Aiming beam not visible or intensity too Incorrect illumination setting Increase the aiming beam intensity
low
Internal laser failure Contact your Authorised Ellex Distributor
(Solitaire) Dirty optics in delivery device Refer to cleaning instructions supplied
with the delivery device
(Solitaire) Internal misalignment Contact your Authorised Ellex Distributor
Low aiming beam when set to Dirty optics Clean external optics
maximum intensity
Optical fibre is damaged, misaligned or Contact your Authorised Ellex Distributor
dirty
Remote control display not working Remote cable not connected Connect remote control cable to the
console. Check the cable connection at
the remote.
Laser button set to Off Press laser button to turn it on
No treatment beam and no aiming beam Internal laser failure Contact your Authorised Ellex Distributor
(Ultra Q) The RCI is jammed or the return Contact your Authorised Ellex
spring is broken. Device indicates a Distributor.
shutter error.
No treatment beam, aiming beam is READY not selected Select READY
present
Footswitch not pressed or not connected Press or connect footswitch
Defective footswitch Contact your Authorised Ellex Distributor
Internal laser alignment error or failure Contact your Authorised Ellex Distributor
No controls operate, no aiming beam, Safety interlock has been activated Correct safety interlock condition (close
remote control is illuminated, a door or fit emulation plug)
continuous audible tone may be heard
(Integre range, Integre Pro range) Fibre Fit optical fibre to console fibre port
interlock activated
Treatment and aiming beams not Internal misalignment Contact your Authorised Ellex Distributor
aligned
Treatment beam ineffective Dirty objective lens Clean objective lens
(SLT) Low pigmentation of treated tissue Refer to the Clinical use chapter
(YAG) Posterior offset incorrectly set Adjust offset
(Solitaire) Delivery device not properly Check the fibre and electrical
connected connections (should be indicated on the
control panel display)
(Solitaire) Optical fibre or delivery device Refer to cleaning instructions supplied
optics dirty with the delivery device
(Solitaire) Optical fibre damaged Contact your Authorised Ellex Distributor
(Super Q) Slit lamp illumination tower is Swing the tower another 10°.
occluding the treatment beam
Flashing up or down arrows in mJ field Energy has deviated from the set value Reset energy but observe the delivered
on the remote, a beep is heard every by more than 20% energy. If beeping continues, contact
time a shot is fired your Authorised Ellex Distributor.
Only one treatment pulse is delivered (Integre range, Integre Pro range, Release footswitch
Solitaire) Footswitch held down when
device in single pulse mode
(Integre range, Integre Pro range, Select an interval greater than 0
Solitaire) Device not in repeat mode
Aiming beam movement is restricted (Integre range, Integre Pro range) Contact your Authorised Ellex Distributor
Damaged or sticky movement
Zoom warning appears on the remote (Integre range, Integre Pro range) Spot Do not touch or adjust any control while
control size control was moved while the laser the device is firing
was firing
Flashing thermal warning indicator (Integre range, Integre Pro range) Laser Put the device in STANDBY and allow it
appears on remote control, device will cavity temperature too high to cool for a few minutes before
automatically revert to STANDBY if continuing.
indicator appears but is not flashing If device automatically switched to
STANDBY, READY cannot be selected
until the temperature has returned to a
safe level.
Change in laser emission audible tone (Integre range, Integre Pro range) Power The device can be used normally
delivered is 20% less than or more than however if this occurs frequently,
set value contact your Authorised Ellex Distributor
as the device may need to be
recalibrated
No treatment beam, no aiming beam, (Super Q) Safety interlock has been Correct safety interlock condition (close
STANDBY light is on and the control activated door or fit emulation plug)
panel is illuminated
Device switches from READY to (Super Q) Fire button held down for Press the fire button for less than half a
STANDBY more than two seconds second
Display is frozen and the control panel Device turned on too quickly after being Turn the device off. Wait 10 seconds
buttons do not work turned off and turn it on.
Check calibration (press any key (Super Q) Laser degraded or device The device can be used normally but
message) malfunction observe the delivered energy. Contact
your Authorised Ellex Distributor.
Two beeps when firing the laser (Super Q) Delivered energy has deviated The device can be used normally but
by more than ±20% observe the delivered energy. Contact
your Authorised Ellex Distributor if this
occurs frequently.
Error messages
If a fault is detected the device disables the firing mechanism, reverts to STANDBY, and an error
code is displayed. The device cannot be used until the fault is rectified.
If the error code clears, you may use the device normally.
If the error code remains, follow the next step.
If the error code no longer appears and the device functions normally you may continue to use
device. If the error code appears again contact your Authorised Ellex Distributor.
Maintenance
This content of this chapter is common to all major Ellex laser devices. Be aware that some
information may not apply to the Ellex device that you have purchased.
Also refer to the documentation supplied with the delivery device or adapter for specific
maintenance instructions.
Your responsibilities
As the operator of the device, you must:
• Determine the level of cleaning and disinfection of patient contact surfaces.
• Train staff how to clean and disinfect the device.
• Ensure that cleaning and disinfection methods do not damage the instrument.
• Ensure that the device is routinely cleaned and disinfected.
Contact areas
You must:
• Clean all patient contact surfaces at the start of each clinical procedure using mild detergent,
isopropyl alcohol or hospital grade disinfectant.
• Use disposable chinrest papers and change them between patients.
Routine maintenance
This device is designed to provide trouble free operation and requires very little user maintenance.
There are four routine maintenance tasks:
• cleaning the device
• cleaning the external optics
• checking the safety filters
• checking optical alignment (only for devices that include a slit lamp).
2 Wipe external surfaces (except the optics) using a damp (not wet) cloth and either mild
detergent, isopropyl alcohol or hospital grade disinfectant.
WARNING! Do not use the device if the external optics are scratched. Contact your Authorised Ellex Distributor.
3 Gently wipe the tissue or swab across the optical surface in a linear stroke.
WARNING! Use one tissue or swab per wipe and then discard it. Do not use dry tissues or swabs as they may
damage the surface of the optic.
4 After cleaning, check that the coating is not scratched, chipped, or has lifted from the
optic surface.
4 Carefully check the safety filters (the two glass windows in the mounting plate) for
imperfections, cracks or discolouration.
WARNING! Do not use the device if the eye safety filter is damaged or discoloured. Contact your Authorised Ellex
Distributor.
Solitaire
Check the optical alignment by examining the appearance of the aiming beam. The aiming beam
spot should be bright enough to be easily observed, and should appear round and symmetrical.
If the aiming beam is not round or symmetrical, check the laser and delivery device for obvious
damage such as a broken, missing, or dirty delivery device mirror. If no obvious damage is present,
contact your Authorised Ellex Distributor.
If you are using an adapter or laser indirect ophthalmoscope (LIO), the aiming beam should appear
centred in the delivery device field of view, unless purposely moved by delivery device alignment
adjustments.
2 Attach the supplied target plate to the chinrest and affix fundus to the side facing the
laser aperture.
om_sl_0005
3 Select the largest spot size (where possible) and low aiming beam intensity.
WARNING! Ensure that there are no reflective surfaces behind the target.
5 Compare what you see through the binocular to the illustrations below. Illustration A is
optimal. Consider contacting your Authorised Ellex Distributor if you observe B. Contact
your Authorised Ellex Distributor immediately if you observe C or D.
A B
C D
YAG
om_common_0001
WARNING! Do not use the device if you cannot make the aiming spots converge (twin aiming beam devices), or if
you can move the aiming beam out of the field of view. Contact your Authorised Ellex Distributor.
WARNING! Do not use the device if the aiming beam is not centred in the burn mark. Contact your Authorised Ellex
Distributor.
Additional maintenance
Replacing fuses
The mains power socket includes a fuse holder. Always keep a spare fuse on hand. Fuses rarely
need replacing and a blown fuse may indicate an internal fault. Contact your Authorised Ellex
Distributor if you need to replace a fuse. Fuses are also located in the mains power socket on Total
Solution tables.
om_common_0003
Replacing a fuse
1 Turn the device off.
A B
om_sl_0002
WARNING! The globe may be hot. Wait until the globe cools before replacing it.
3 Pull the restraining clip to one side and pull out the globe holder.
4 Replace the globe. Ensure that the globe notch is on the left.
5 Ensure that the globe is correctly seated and push the holder back.
3 Pull off the lower front of the slit lamp illumination box.
4 Open the restraining clip and pull the globe holder out.
WARNING! The globe may be hot. Wait until the globe cools before replacing it.
6 Insert the globe holder with the notch facing right, and lower the restraining clip.
7 Tighten all locking screws on the slit lamp and delivery head.
8 (Total Solution Mobile and Wheelchair Accessible, Mobile tables) Unlock the castors.
9 (Total Solution Wheelchair Accessible table) Stand in the patient’s position and raise the
table so the base pads are only just clear of the floor. The device can then be moved
using the wheel in the base.
If a Total Solution table is not in use, remove the table extensions (where fitted) and have two
people lift the device from the left and right sides.
11 (Total Solution Mobile and Wheelchair Accessible, Mobile tables) Lock the castors.
12 Reconnect the safety interlock (where used), footswitch (where used), table extensions (if
removed) and mains power cable.
Service visits
Contact your Authorised Ellex Distributor at least every 12 months to arrange a preventive
maintenance visit. At each visit the Distributor will (as applicable for the device):
• clean the external optics
• check the eye safety filters
• optically align the device
• verify calibration
• check the performance of the device
• check ground resistance and earth leakage.
Service work must only be performed by fully trained and qualified Ellex Service Technicians.
When used in relation to servicing an Ellex device the term Ellex Authorised Distributor refers to
suitably qualified Ellex Service Technicians who are fully trained by Ellex, and who have access to
the appropriate Ellex Service Toolkits and service information.
Service information is only available to Ellex Service Technicians. Service information includes:
• circuit diagrams
• list of components
• descriptions
• alignment instructions
• calibration instructions.
Verifying calibration
WARNING! Only Authorised Ellex Distributors should perform this procedure.
The accuracy of the externally delivered laser emission from this device must be verified at least
annually. This is a routine part of the service visit performed by your Authorised Ellex Distributor.
The calibrated laser power/energy meter used to verify calibration accuracy must be traceable to
the US National Institute of Standards and Technology (NIST) or other international standard.
The power/energy meter must be able to measure the full laser power/energy range at the
treatment wavelength or wavelengths that this device emits. Refer to the Specifications for
treatment laser specifications.
2 Follow the laser energy meter instructions to measure the output from this device at all
power settings.
WARNING! Do not use the device if the measured values are not within ±15% of the power setting that appears on
the device. In such cases, investigation by your Authorised Ellex Distributor is necessary to determine if the device
requires recalibration or if the delivery device has poor transmission.
Product lifetime
This device has a normal use lifetime of at least seven years from the date of manufacture
(recorded on the compliance label).
Product disposal
This device contains natural resources and may contain hazardous substances that could have a
harmful effect on the environment and human health if disposed of improperly. Do not dispose of
this device as unsorted municipal waste: use appropriate recycling systems to reuse or recycle its
component materials. Contact local or regional waste administration for more information about
the collection, reuse or recycle systems available in your area.
China RoHS
Solitaire
部件名称 有害物质或元素
控制台箱和机械固定支架 X 0 0 X X X
控制台布线和电器元件 X 0 0 X X X
光学模块 X 0 0 X 0 0
电线 X 0 0 0 X X
注解:迄今为止,未能发现标有"X"的有害物质或元素的替代品,但是本仪器可以有效安全使用.
仪器支柱与底座 X 0 0 X X X
桌面,侧翼和固定支架 0 0 0 X X X
变压器模块 X 0 0 X X X
控制台箱和机械固定支架 X 0 0 X X X
控制台布线和电器元件 X 0 0 X X X
照明灯和下巴托架 0 0 0 X X X
激光箱及布线 X 0 0 X X X
激光光学模块 X 0 0 X 0 0
遥控模块 X 0 0 X X X
电线 X 0 0 0 X X
注解:迄今为止,未能发现标有"X"的有害物质或元素的替代品,但是本仪器可以有效安全使用.
Specifications
General
2
Weight (kg) 26
Dimensions (mm)
Width 755
Depth 435
Height 575
Operating conditions +10 °C to +40 °C
10% to 85% relative humidity non-condensing
Storage and transport −10 °C to +40 °C
conditions 10% to 85% relative humidity non-condensing
Power supply
Voltage (VAC) 100–240
Frequency (Hz) 50/60
Power consumption (VA) 400
Fuses (A) 6.3 anti-surge
2
Includes all accessories, manual and table mounting plate.
Aiming laser
Type Visible laser diode
Wavelength (nm) 670 (red)
IEC Class 2
Operation Continuous wave
Power Continuously variable intensity up to 200 µW maximum total of two beams.
Treatment laser
Type Q-switched Nd:YAG
Wavelength (nm) 1064 (near infra-red)
IEC Class 3B
Operation Pulsed
Air breakdown (mJ) ≤4
Spot size (µm) 11 (calculated 84% of energy contained in this diameter)
8 FWHM (Full Width Half Maximum calculated)
Energy range (mJ) 0.3 to ≥ 10.0, single pulse, continuously variable.
Pulse duration (ns) 4 (typical)
Maximum repetition rate (for 2.0 Hz in single pulse mode
20 consecutive shots) 1.8 Hz in double pulse mode
1.6 Hz in triple pulse mode
Focusing system Continuously variable posteriorly
Setting Offset (µm)
Min 100
−150 250
−250 350
Safety filters OD ≥ 3 @ 1064 nm
Nominal ocular hazard 5.5
distance (NOHD) (m)
Beam divergence 16° +0/−1.6° cone angle
Slit lamp
Type Galilean stereoscopic microscope with converging optics.
Objective lens 1.25×
Eyepiece lens 12.5× dioptre adjustable in range of ±5D. One lens includes Kowa style cross hair reticle.
Magnification changer Three position (10×, 16×, 28×) removable.
Interpupillary distance 55–88
adjustment (mm)
Working distance (mm) 55
Focal length (mm) 92
Slit width (mm) 0–12
Illumination view field (mm) 0.5, 5.0, 8.0 and 12.0 + Teardrop 1–11.
Slit rotation ±90°
Illuminating angle 180° at horizontal plane (90° for right/left)
Contact your Authorised Ellex Distributor for details of the consumables and accessories available
for this device.