Manuel D'utilisation CONSTELLATION® Vision System-238-306
Manuel D'utilisation CONSTELLATION® Vision System-238-306
INTRODUCTION
This section of the manual is designed to inform the operator of basic care and
maintenance of the instrument. If a problem occurs on the instrument, call the Alcon
Technical Services Department and give details of the breakdown circumstances and
effects. From these elements, a specialized technician will evaluate the problem and
determine the maintenance requirements.
CAUTION
There are no operator replaceable parts, including the illuminator lamps. Contact Alcon
Technical Services for all servicing issues.
WARNING!
The Constellation™ Vision System battery can only be serviced by a factory-trained
Alcon service personnel. Access by untrained personnel can lead to injury.
• Follow cleaning and maintenance schedules outlined in this section of the manual.
• Periodically check chassis appearance.
• Pay attention to correct operation of controls, connectors, and indicators.
• Damaged hardware must be replaced to ensure safe operation. Call Alcon
Technical Services for assistance.
WARNING!
A qualified technician must perform a visual inspection of the following components
every twelve months:
• Warning Labels (see section one of this manual)
• Power Cord
In case of a deficiency, do not use the system; call Alcon Technical Services.
A qualified technician must check ground continuity for leakage current every
twelve months to ensure they are within the applicable standards (for example:
EN60601-1/IEC601-1). Values must be recorded, and if they are above the applicable
standards, do not use the system; call Alcon Technical Services.
CAUTION
Do not remove tubing from cassette or fluid in cassette reservoirs will leak down front
of machine.
1 Select End Case - Press End Case tab at top right corner of screen. The system
will confirm that you want to end the case. Select Yes or No.
2 Ensure infusion clamp is closed and turn Infusion off - Press “Infusion” icon
at top left corner of screen to turn infusion off. The system will confirm that
you want to turn off infusion. Select “Continue” and the cassette will start the
cleaning process.
3 Once cleaning is complete, remove irrigation bottle from hanger and set aside.
Remove spike from irrigation bottle.
4 Push ejection button above cassette to remove. Discard cassette with tubing per
facility guidlines.
5 Move the irrigation bottle holder to its storage position.
6 Press Standby switch located at top of rear panel (or Shutdown in Options
menu) to remove operating power from the system.
7 Turn the Main power switch OFF. It is located in the middle of the rear panel
above the power cord.
8 Remove air hose. Turn off C3F8 and SF6 valves.
9 Disconnect the power cable from the wall receptacle and wind the cable around
the cord wrap.
10 Place the footswitch and cable in storage compartment in front of base.
11 If required, the front panel, the console, the footswitch, and the remote control
may be wiped with non-corrosive germicidal solution, alcohol, or mild soap and
water.
CAUTIONS
• Do not clean console or accessories using solvents or abrasives.
• Avoid spilling BSS™ solution, or moisture of any kind, around the electrical
handpiece connectors.
12 Clean handpieces, probes, cables, forceps, etc., as instructed in DFU's supplied
with each accessory.
STERILIZATION INSTRUCTIONS
Please consult the accompanying Directions For Use (DFU) for cleaning and
sterilization instructions for Alcon approved reusable accessories. The DFU will
provide the recommended time and temperature guidelines for steam autoclave
cycles performed by Alcon, Inc. The sterility assurance level achieved with these
parameters must be validated by each surgical facility. Please refer to Association
for the Advancement of Medical Instrumentation (AAMI) Standards or your facility’s
standard procedures for the most current specifications.
NOTE: The reusable items will withstand steam autoclave cycles at 134° C
(273°F). Due to the variations found in steam autoclaves and the variable
bioburden on devices in clinical use, it is not possible for Alcon to provide
specific parameters to ensure an adequate sterility assurance level. Validation of
the individual autoclave, and verification of the sterility assurance level achieved
with a given steam sterilization cycle, must be performed by each surgical
facility. Please refer to current AAMI Standards or your facility’s standard
procedures for the most current specifications.
WARNING!
The bulb of the xenon lamp is under constant high pressure. There is a risk it may
burst with explosive force if knocked or damaged. Protective measures:
- Keep the lamp in its protective sleeve at all times during installation
- If you are handling the lamp without its protective sleeve, always wear safety
goggles, a face mask, gauntlets with wrist protectors and a breast protector.
In the USA contact the Alcon Technical Services Department for lamp disposal at
800/832-7827. Outside the USA contact your local Alcon affiliate.
WARNING!
Changing batteries will cause the remote to default to channel A; therefore the
remote may need to be reset to the instrument's unique channel after installing
new batteries.
1 Loosen two captive screws on the rear cover with a standard slotted screwdriver
and remove cover.
2 Replace old batteries and replace cover (correct battery positions are identified
inside each battery slot). When closing the cover it is important that the rubber
buttons slide into the slots in other half of the remote without binding (see
Figure 4-1).
3 To check correct installation of batteries, press a backlight button on the side of
the remote and verify that the remote control buttons illuminate, then turn off
after a few seconds. If illuminated buttons don't turn off, rubber buttons are not
properly inserted into slots, so you must repeat the procedure.
4 Dispose of batteries following local governing ordinances and recycling plans.
Rubber Buttons(2)
must enter slots
without binding
LASER MAINTENANCE
Calibration verification must be performed at least every twelve months to verify that
the laser output is within tolerance and calibration is not required. It is recommended
to call Alcon Technical Services before conducting the calibration verification
procedure.
CAUTION
Serious damage to the instrument may occur if these procedures are not performed by
qualified personnel.
Special Tools
• Computer with browser software (MicroSoft** Internet Explorer or equivalent);
TFTP file transfer program, or equivalent.
• Custom service ethernet cable (Alcon p/n 023-100)
• Power Meter, Thermopile type (Coherent FieldMaster w/ LM-10 head or
equivalent)
• Energy Meter (optional) for direct energy measurements (Ophir Nova meter, with
3A-P or PE25-BB head, or equivalent)
• Oscilloscope / Voltmeter (Fluke Scopemeter, or equivalent)
• Laser Safety Goggles (OD4 or above, at 532 nm wavelength)
• Optics cleaning kit, including spectroscopic grade methanol, lens paper, and air
blower
• LIO Voltage Load Box (Alcon dwg 995-5620-069)
• Timing Photocell (Alcon dwg 995-5320-038)
The ethernet cable used for service computer connection is a custom cable. Contact
Alcon Technical Services for more information.
WARNING!
Laser light emitted from the fiber and laser head is powerful enough to cause
serious eye or skin damage. Maintenance should be performed only by
properly trained personnel, following established guidelines for laser safety.
The use of protective eye wear is mandatory.
NOTE: Calibrated Power / Exposure Time may be verified by two different test
methods:
1) Watts X Time method: Use an oscilloscope to measure exposure
time, and power meter to measure output power, and perform the
multiplication to enter value in the energy matrix on the data sheet.
2) Energy method: If an appropriate energy-meter is available, enter
“N/A” for the exposure time and power fields on the data sheet, and use
the energy-meter to measure and record values directly into the energy
matrix.
3.3 Set the treatment power to 0.10 W then press the Standby/Ready key.
3.4 Fire the laser and record the power reading as determined from the Wattmeter.
3.5 Repeat steps 3.3 and 3.4 for each value listed in the LIO section of Table 4-1.
Product of
0.50 W 0.51 0.00561 power x time entered
here and compared to
(0.00425 - 0.00575) tolerance in brackets.
4.2 Ensure that all calculated results are within the values listed in each matrix cell.
The listed values are ±15% of the set energy.
• If all calculated energy values are within the specified limits, the system
calibration is OK.
• If any of the calculated energy results are not within the specified limits,
the terminal efficiencies will need to be adjusted. Perform the "Setting the
Calibration Factor (Terminal Efficiencies)" procedure following Table 4-1,
or call Alcon Technical Services.
5 Aiming Beam Calibration
5.1 With the unit off, connect the service ethernet cable between the Constellation™
console “Tethered Laser” connector on the rear panel, and service computer
then turn the system ON. Allow two minutes for the Laser Module to initialize.
5.2 Type the IP address into the address box, and hit return. When the page loads,
enter the password. Click the Output Calibration tab at the top of the screen.
5.3 Adjust aiming beam power output for Port 1 as high as possible but less than
950 μW.
5.4 Click “Set Max Value” for Aiming Beam on the computer.
5.5 Repeat for Port 2.
>
0.10 W
ENDOPROBE
(0.0085 - 0.0115)
0.30 W
(0.0255 - 0.0345)
0.70 W
(0.0595 - 0.0805)
0.10 W
(0.0085 - 0.0115)
LIO
0.30 W
(0.0255 - 0.0345)
0.70 W
(0.0595 - 0.0805)
LASER CALIBRATION
WARNING!
Laser light emitted from the fiber and laser head is powerful enough to cause
serious eye or skin damage. Maintenance should be performed only by properly
trained personnel, following established guidelines for laser safety. The use of
protective eye wear is mandatory.
1 With the unit off, connect the service ethernet cable between the Constellation™
console “Tethered Laser” connector on the rear panel and service computer, then
turn system ON. Allow two minutes for the laser module to initialize.
3.17 Input the power, as previously measured, into the Actual High Power Field, and
press Save.
3.18 Repeat the Pmon 1 High-Power Calibration as needed (two or three times) to
bring Displayed/Actual tracking as close as possible.
3.19 Repeat steps 3.1 through 3.20 for Low/High Power Calibration for Pmon 2.
3.20 Repeat Laser Power Verification and Setting the Calibration Factor as required
to successfully complete the Energy Matrix for each delivery device, then
continue to step 4.
SYSTEM MESSAGES
The system communicates information to the user through the display of System
Messages which are displayed and described to the user as Faults, Errors, Advisories
or System Information. These terms are used to classify the level of response required
to ensure fail-safe operation of the system. The presentation of a System Message
alone does not indicate that a malfunction has occurred. System Messages typically
occur when the system detects a condition that is not met but is required for the
system to continue. System Messages and associated actions are intended functions
presented as a precursor to mitigate an unanticipated condition.
System Messages are priority based, with Fault Messages being the highest priority,
followed by Error Messages, Advisory Messages, and Information Messages. Each
type of message is color coded as follows:
• Fault:
- Recoverable Fault - Red stop sign with blue background
- Unrecoverable Fault - Red stop sign with black background
• Error - Yellow
• Advisory - Green
• Information - Blue
Each message also has a number associated with it that indicates the submodule
that prompted the message. The number range for each submodule in the system is
assigned as follows:
• Host Submodule - 1000 to 1999
• Supervisor Submodule - 2000 to 2999
• Fluidics Submodule - 3000 to 3999
• US/Diathermy Submodule - 4000 to 4999
• Table Top Illuminator Submodule - 5000 to 5999
• Pneumatics Submodule - 6000 to 6999
• Auxillary Illuminator Submodule - 7000 to 7999
• Laser Submodule - 8000 to 8999
The Event Log (shown in Figure 5-10) displays a list of the system messages that
have occurred on the system. It is recommended to view the Event Log for details of
a system message prior to calling your local Alcon representative for assistance.
For additional assistance in determining what action to take in the event a system
message is displayed, refer to the Troubleshooting Guide in Figure 5-11.
The system performs the following actions when a fault condition is detected:
• The applicable System Fault screen is shown with appropriate Fault Number and
one or more acknowledgment buttons.
• A fault tone is generated.
• All surgical functions are placed in a safe state.
• All operator input from the touch screen and footswitch is ignored (with the
exception of the [Start Recovery], [Quick Start], and [Shutdown] buttons).
The majority of all generated system faults are recoverable and the displayed Fault
message includes the following recovery instructions:
Recovery Instructions:
1) Stabilize eye. Leave infusion cannula in, remove other
instruments (i.e. vit probe/illuminator) and plug trocar
cannulas/sclerotomies.
2) Press the "Start Recovery" button.
After the system recovers from a fault, the system state is restored to the state when
the fault occurred.
Power Lost/Recovery
If the system experiences a loss of power, all surgical functions are stopped and the
"Power Lost" message shown in Figure 5-5 is displayed. If system power is not
restored within 1 minute, the system automatically powers down.
If power is restored within 1 minute, the system displays the "Power Recovered"
message and the system will be restored to the doctor and settings in use at the time
of power loss. Accumulated metrics and calibration state are not restored. In order to
resume a procedure after a loss of power, the handpieces/probes must be recalibrated/
reprimed.
Standby
Switch
Figure 5-6 Standby Switch Location and Quick Start Button on Fault Screen
2 Immediately clamp smaller infusion cannula tubing with hemostats. (See Figure
5-7). Infusion pressure will be off when Setup Screen is displayed.
NOTE: The yellow stopcock is optional and may not be part of setup.
Green Luer Fitting Yellow Stopcock
Infusion tubing
with Snap Clamp
Infusion Cannula
Infusion ON Button
7 Select “Start Prime”. NOTE: Priming will take about 1 minute to complete.
8 Press Infusion ON button and clear any bubbles.
9 Close the snap clamp.
10 Reconnect the green luer fitting.
11 Open snap clamp and remove hemostats from the smaller infusion tubing.
12 Select Doctor and Procedure, then continue the case.
Event Log
Figure 5-10 shows the Event Log where system messages are displayed that have
occurred during the previous seven days. The list can be filtered to display a specific
type of message by pressing the associated button on the right side of the screen.
NOTE: Refer to the Directions For Use (DFU) included with each accessory kit/consumable
pack for detailed instructions on how to setup that accessory.
1 Part contacts the patient or fluid path during surgery (an applied part).
2 Part contacts the patient or fluid path during surgery (an applied part).
The procedure packs are an assemblage of accessories (listed in the previous tables)
specifically for use with the Constellation™ Vision System. Contact your local Alcon
Representative for available Constellation™ Procedure Packs.
The PurePoint™ LIO is connected to the laser via a fiber optic cable for the treatment
and aiming beams, and by electrical cable for illumination. The illumination light is
adjustable from approximately 0 to 1000 lux using the illumination control knob on
the power supply.
A permanent Doctor Protection Filter protects the surgeon against incidental laser
beam reflections. The operator will have a colored† view through the Doctor
Protection Filter due to blocking of the 532 nm wavelength (green).
† Newer Doctor Protection Filters will have less tint than older ones.
WARNINGS!
The head-worn Laser Indirect Ophthalmoscope (LIO) is designed solely for examination
and treatment of the eye, particularly the retina.
Use only the illumination power supply provided on the Constellation™ Vision System
or the PurePoint™ Laser System (in tethered mode). It is specially designed for the
PurePoint™ LIO.
Insure that the selection on the Constellation™ Vision System display is LIO. It is the
responsibility of the operator to verify that the selection is correctly confirmed.
The operator will have a colored** (pink) view through the Doctor Protection Filter due to
blocking of the 532 nm wavelength (green).
The operator must be careful to avoid potential secondary reflections; therefore the room
used to treat the patient should be approved by a qualified laser safety officer.
All personnel in the treatment room must wear protective eyewear (OD 4 or above at 532
nm) when the system is in Standby, Ready, or Firing modes.
The laser delivery system is an integral part of the LIO and is not designed to be used
with an observer. Never use a teaching or observation system in conjunction with the LIO.
There is no eye protection provided for the observer.
Before each use of the headset, the operator must check the permanent Doctor Protection
Filter for scratches, breaks, or alterations. If there is any doubt, please call Alcon Technical
Services, and discontinue use of device.
There are potential hazards when inserting, steeply bending, or improperly handling of
the fiber optic cable. Not following the recommendations of the manufacturer may lead to
damage to the fiber or delivery system and/or harm to the patient or user.
Since the aiming beam passes down the same delivery system as the treatment beam,
it provides a good method of checking the integrity of the delivery system. If the aiming
beam spot is not present at the distal end of the delivery system, or its intensity is reduced
or it looks diffused, this is a possible indication of a damaged or not properly working
delivery system. If there is any doubt, contact Alcon Technical Services.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen should be avoided. Some materials - for example cotton wool when saturated with
oxygen - may be ignited by the high temperatures produced in normal use of the laser
equipment. The solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser equipment is used. There is
also danger of ignition of endogenous gases.
A qualified technician must perform a visual inspection of the following components every
twelve months: warning labels, power cords, and fuses. In case of a deficiency, do not use
the system; call Alcon Technical Services.
A qualified technician must verify the LIO performance by performing an LIO calibration,
power output, and energy matrix test every twelve months to ensure the LIO is operating
within specifications. See Section Four of this operator's manual for instructions. If the
LIO is not operating within specifications, do not use the system; call Alcon Technical
Services.
A qualified technician must check and record ground continuity and both polarities for
leakage current every twelve months to ensure they are within the applicable standards
(for example: EN60601-1/lEC601-1). If they are above the applicable standards, or 50%
above initial measurement, do not use the system; call Alcon Technical Services.
Manufacture Date
Laser Aperture
NOTE: The LIO may use either of the label examples shown above depending upon the date of manufacture.
To pivot the overband, press the Overband Adjustment Knob with the right hand
and pivot the overband into the desired position (up for the “rest” position and down
for the “working” position). When the unit is properly adjusted, the overband can
be lowered into the same pre-selected working position. Once set, changing the
adjustments is required only if another examiner uses the instrument.
2. Place the LIO on your head and adjust the circumference and height using the
Circumference and Height Adjustment Knobs so that the headband is firmly
positioned but comfortable.
3. For convenience, use clothing clip to attach the fiber/cable assembly to clothing.
4. Move the eyepieces as close as possible to your eyes and look at the light spot
at a distance of 30 cm. A small object (such as a pencil) held in front of the
eyepieces at 30 cm must be clearly focused.
5. Using the Delivery Mirror Control Knob, adjust the optics so that the light spot
is centered vertically in your field of view, then tighten the Observation Optics
Adjustment Knob.
6. If the light spot is not centered horizontally, adjust the headband left or right
accordingly.
7. Adjust the pupil distance setting by viewing the light spot alternately with the
left eye then the right eye, and sliding the eyepieces so that the spot is centered
within your field of view.
8. Remove the LIO and look at the scale on the eyepieces to insure that the pupil
distance is symmetrical. If not, center the headset and readjust the eyepieces.
Correct adjustment of the optics is particularly important when examining small
pupils.
Once set, changing the adjustments is required only if another examiner uses the
instrument.
The Delivery Mirror Control Knob can be rotated to move both the illumination beam
and the laser beam in the vertical plane.
CAUTION
Do not use the LIO with the illumination power supply set at maximum intensity for
more than 10 continuous minutes. The LIO must be allowed to cool down at least
20 minutes between uses. Use as little observation/illumination light as possible and
always switch power supply OFF using the illuminator power knob.
Circumference
Adjustment Knob
(on backside of band)
Observation Optics
Adjustment Knob
Aperture Lever
Delivery Mirror
Control Knob
WARNING!
All the personnel in the room during the operation must wear protective safety
eyewear with a minimum optical density OD 4 to filter 532nm radiation.
Before each use of the headset, the operator must examine the permanent
Doctor Protection Filter for scratches, breaks, or alterations by looking through
the ocular lens. If there is any doubt, discontinue use of device and please call
Alcon Technical Service.
NOTE: The PurePoint™ LIO is shipped with +2 diopter ocular lenses installed.
These may be changed with 0 (zero) diopter lenses.
1. If desired, change the ocular lenses by unscrewing the eyecup retainer in the
counterclockwise direction, change each lens, and replace the eyecup retainers.
Ensure that the new lenses are clean; i.e. no fingerprints or debris. Refer to the
PurePoint™ LIO maintenance section for cleaning instructions.
Figure 6-5 Eyecup Retainers and Ocular Lens on the PurePoint™ LIO
2. Turn the Constellation™ Vision System console power ON and make the
appropriate selections.
3. Select the appropriate illumination field size by toggling the illumination
aperture lever to the desired setting.
4. Adjust the illumination intensity using the LIO Intensity up/down buttons.
5. On the touchscreen, set the power below the nominal titration level. If the power
parameter is not set below the nominal titration level, the message “Set Power <
xxxx mW” will appear on the display.
6. If necessary press the Reset button to reset the shot counter to 0.
You can now adjust exposure time, aiming beam power, and treatment beam
power.
7. Select exposure time by pressing the Exposure Time Adjustment arrow buttons.
WARNING!
Verify that all personnel are wearing protective eyewear (OD 4 or above at 532 nm)
as soon as the system is in Standby/Ready mode, as well as during treatment.
NOTE: It is not recommended to use exposure times longer than two seconds
in CW (Continuous Wave) mode. Depending on the thermal load,
the system may shut down prior to the footswitch being released. A
message will appear on the display indicating this condition.
8. Select the aiming beam intensity by pressing the Aiming Beam up/down
buttons.
WARNING!
Do not attempt treatment if aiming beam is not present. Patient injury may occur.
9. Set the desired treatment power by pressing the Power up/down buttons.
10. Select the laser spot size using the Laser Spot Size lever (see Figure 6-4). The
positions of the Laser Spot Size lever for large (approximately 1 mm) and small
(approximately 0.5 mm) laser spot sizes are marked with large and small black
dots on the right side of the box, respectively. The change of laser spot size from
large to small results in approximately four times increase in irradiance within
the treatment area, provided that laser power was not adjusted.
It is recommended to adjust laser power each time the Laser Spot Size Control
setting is changed. Start with low power and a short duration pulse, then
increase until the desired coagulation result is achieved.
WARNING!
If unsure which settings are required, select a low power, short duration, and large
laser spot size. Failure to properly adjust delivered energy may lead to patient injury.
11. Press the Ready selection under Laser Mode on the touchscreen. The system
will emit a voice confirmation that it has entered Ready mode.
NOTE: The aiming beam is off during treatment beam exposure, except in
repeat mode.
14. Repeat the firing procedure as often as necessary, making adjustments to power
output and duration as appropriate to complete the treatment session.
15. When the treatment is completed, release the footswitch and press the Standby
button on the touchscreen.
NOTE: The Emergency switch on the front panel must only be used in case of
emergency. After using the Emergency switch, return it to its initial
position to restore power and start the instrument.
Any damaged hardware must be replaced. Contact your Alcon Technical Service
representative.
CAUTION
Care and cleaning operations must be performed with the instrument turned off and
power disconnected.
Storage
The PurePoint™ LIO should be stored either on the headset stand or in its storage
case when not in use to prevent inadvertent damage to the headset or cables.
WARNING!
The bulb and bulb connector may be hot, and can burn your fingers.
CAUTION
Do not touch the glass part of the new bulb directly with your fingers. Oil from fingers
can dramatically reduce bulb life.
4. Clean the new bulb with a soft, clean cloth.
5. Insert the new bulb so its locating pin engages in the housing slit.
6. Rest the bulb connector on the base of the bulb and firmly screw it in.
7. Re-connect the cord socket.
Intended Use(s)
The PurePoint™ LIO is intended to be used to facilitate coagulating or cutting tissue
of the eye, orbit, or surrounding skin by a laser beam.
The PurePoint™ LIO is intended to be used by licensed ophthalmic surgeons
Indication(s) for Use
The PurePoint™ LIO is an accessory to be used with the PurePoint™ Laser System
or the Constellation™ Vision System for delivery of laser treatment beam to patients.
The LIO is indicated for use in treatments of the following disease states:
• Proliferative diabetic retinopathy
• Macular degeneration
• Retinal detachment
Contraindications
There are no specific contraindications for the PurePoint™ LIO.
Clinical Benefits
The intended clinical benefit of the PurePoint™ laser system, when used as indicated,
in conjunction with a compatible Alcon surgical system and/or with compatible
accessories, is to contribute to ophthalmic surgical interventions that improve or
preserve vision.
The PurePoint™ LIO must be installed by an Alcon trained representative for power
output verification prior to the initial use. To schedule installation, contact the Alcon
Technical Services Department at 800-832-7827. Outside the USA, contact your local
Alcon Affiliate.
Insure that the selection on the Constellation™ Vision System display is LIO. It is the
responsibility of the operator to verify that the selection is correctly confirmed.
The operator must be careful to avoid potential secondary reflections; therefore, the
room used to treat the patient should be approved by a qualified laser safety officer.
All personnel in the treatment room must wear protective eye wear (OD 4 or above at 532
nm) when the system is in Standby, Ready, or Firing modes.
The laser delivery system is an integral part of the LIO and is not designed to be used
with an observer. Never use a teaching or observation system in conjunction with the
LIO. There is no eye protection provided for the observer.
Never treat a patient when the PurePoint™ Laser is connected to a service computer.
Before each use of the headset, the operator must check the permanent Doctor
Protection Filter for scratches, breaks, or alterations. If there is any doubt, please call
Alcon Technical Services, and discontinue use of device.
There are potential hazards when inserting, steeply bending, or improperly handling the
fiber optic cable. Not following the recommendations of the manufacturer may lead to
damage to the fiber or delivery system and/or harm to the patient or user.
Since the aiming beam passes down the same delivery system as the treatment beam,
it provides a good method of checking the integrity of the delivery system. If the aiming
beam spot is not present at the distal end of the delivery system, or its intensity is
reduced or it looks diffused, this a possible indication of a damaged or not properly
working delivery system. If there is any doubt, contact Alcon Technical Services.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen should be avoided. Some materials - for example cotton wool when saturated
with oxygen - may be ignited by the high temperatures produced in normal use of the
laser equipment. The solvents of adhesives and flammable solutions used for cleaning
and disinfecting should be allowed to evaporate before the laser equipment is used.
There is also danger of ignition of endogenous gases.
A qualified technician must verify LIO performance every twelve months to ensure the
LIO is operating within specifications. See Section Four of this operator’s manual for
instructions on verifying and calibrating the system. If the LIO is not operating within
specifications, do not use the system; call Alcon Technical Services.
This device must only be used by clinicians trained in the use of ophthalmic laser
devices.
This device is designed for safe use with a laser of 532 nm wavelength. Check the
markings on the top of the LIO (near the optical fiber connection) and ensure they match
those on the connected Laser.
Always look through the ophthalmoscope when the treatment beam is activated. Do not
look over the ophthalmoscope when the treatment beam is activated.
Do not disassemble or modify the battery. There are no serviceable parts inside.
Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle
a damaged or leaking battery with care. If you come into contact with electrolyte,
wash exposed area with soap and water. If it contacts the eye, seek medical attention
immediately.
Use only Alcon supplied batteries, chargers and power supplies as per the accessories
listed.
When replacing lithium battery pack, turn illumination power off and attach new pack.
Remove batteries when device may not be used for prolonged periods.
Do not charge battery in any environment where the temperature may exceed 40˚C or fall
below 0˚C.
Ensure device is securely held in docking station to minimize risk of injury or damage to
equipment.
The LIO is intended to be used with the LIO LED only. Any other light source used with
the LIO will not function.
The LIO is intended to be used with the LIO docking station only.
No other equipment apart from the LIO and spare battery should be mounted onto the
charging dock when fixed to the wall to prevent the likelihood of the charging dock from
falling.
Switch off the electrical supply and disconnect from the mains electrical supply before
cleaning and inspection.
Do not fit mains power adapter into a damaged mains outlet socket.
Route charger power cords and fiber optic cable safely to eliminate risk of tripping or
damage to equipment.
LED’s can reach high temperatures in use – allow to cool before handling.
Maintenance, care, and cleaning must be performed with the instrument turned off and
power disconnected.
To minimize hazardous light exposure, operate light source at lowest intensity setting
consistent with adequate visibility of the surgical area.
The light emitted from this instrument is potentially hazardous. The longer the duration
of exposure, the greater the risk of ocular damage. Exposure to light from this instrument
when operated at maximum intensity will exceed the safety guideline after 60 minutes
using a ancillary 20D lens.
Do not use the PurePoint™ LIO if it is received in a defective condition. In this case,
contact:
By phone:
USA - (800) 757-9780
EU/International: Contact your local Alcon Representative.
By website: https://www.alcon.com/contact-us/
CAUTION
The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure, the greater the risk of ocular damage. Exposure to light from this
instrument when operated at maximum intensity will exceed the safety guideline after
60 minutes using a ancillary 20D lens.
Manufacturer CE Mark
Headband Circumference
Adjustment Knob
Brow Band
Tension Knob (2)
Observation Optics
Adjustment Knob Aperture
Lever
Filter
Selection
Lever
Illumination LED
Under some single fault conditions the
temperature of the surface shown below
could get hot and there is a possible risk of
a burn if touched.
Aperture Lever
The Aperture Lever shown in Figure 6-11 allows you to choose between three
different-sized illumination fields. The choice of illumination field size depends
mainly on the size of the patient’s pupil. When an aperture is selected, the
illumination and viewing mirrors automatically adjust for maximum stereopsis.
Aperture Lever
• Large - This large, round, uniform 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 (3 mm). It is also ideal for
close 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.
White Circle - Clear light; select the clear with no filter when inspecting a
specific pathology and a brighter, whiter light is desired.
Green Circle - Red free filter; this filter reduces the red light so blood will appear
black, silhouetted against a dark background.
Diffuser - This unique extra wide beam of diffused light permits a more relaxed
technique during more challenging fundus examinations. When using this filter,
the alignment between the headset, the condensing lens, and the pupil, in order to
achieve a full lens image, is not as critical as with the conventional beam.
Charging Spare
Battery LED
Charging Battery
on LIO Headband
LIO Headband
Charging Dock
Figure 6-15 Reference Diagram for Mounting the Battery Charging Station
3. Replace the power supply blanking plate with the appropriate mains plug
adaptor (if required). Plug the power supply into an appropriate mains plug and
connect it to the charging station.
The battery attached to the LIO headset will take approximately 2 hours to fully
charge and will last approximately 2 hours on the full power setting. The spare
battery will take approximately 4 hours to charge.
Power
Supply
Connector
Release Button
Figure 6-17 Removing and Replacing the Battery on the LIO Headset
2. Place the LIO on your head and adjust the circumference and height using the
Circumference and Height Adjustment Knobs so that the headband is firmly
positioned but fits comfortably on the head (see Figure 6-18).
3. For convenience, use clothing clip to attach the fiber/cable assembly to clothing.
4. Ophthalmoscope Angle Alignment
4.1 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 each side of the headset.
4.2 Position the Binocular Block as close to the eyes or spectacles as possible
for maximum field of view and tighten the Observation Optics Adjustment
Knob.
WARNING!
To minimize hazardous light exposure, operate light source at lowest intensity
setting consistent with adequate visibility of the surgical area.
WARNING!
All the personnel in the room during the operation must wear protective safety
eye wear with a minimum optical density OD 4 to filter 532 nm radiation.
Before each use of the headset, the operator must examine the permanent Doctor
Protection Filter for scratches, breaks, or alterations by looking through the
ocular lens. If there is any doubt, discontinue use of device and please call Alcon
Technical Service.
NOTE: The PurePoint™ LIO is shipped with +2 diopter ocular lenses installed. These
may be changed with 0 (zero) diopter lenses.
12. If desired, change the ocular lenses by unscrewing the eyecup retainers in the
counterclockwise direction, change each lens, and replace the eyecup retainers.
Ensure that the new lenses are clean; i.e., no fingerprints or debris. Refer to the
PurePoint™ LIO maintenance section for cleaning instructions.
13. Turn the Constellation™ Vision System console power ON and make the
appropriate selections as specified in this manual.
14. Turn LIO Illumination ON.
15. Select the appropriate illumination field size using the Aperture lever.
16. Adjust the illumination intensity using the Illumination Intensity Adjustment
knob.
17. On the touchscreen, set the power below the nominal titration level.
18. If necessary, press the Reset button to reset the shot counter to 0.
19. Select exposure time by pressing the Exposure Time Adjustment arrow buttons.
WARNING!
Verify that all personnel are wearing protective eye wear (OD 4 or above at
532 nm) as soon as the system is in Standby/Ready mode, as well as during
treatment.
NOTE: It is not recommended to use exposure times longer than two seconds in
CW (Continuous Wave) mode. Depending on the thermal load, the system may
shut down prior to the footswitch being released. A message will appear on the
display indicating this condition.
20. Select the aiming beam intensity by pressing the Aiming Beam up/down
buttons.
WARNING!
Do not attempt treatment if aiming beam is not present. Patient injury may occur.
21. Set the desired treatment power by pressing the Power up/down buttons.
22. Press the Ready selection under Laser Mode on the touchscreen. The system
will emit a voice confirmation that it has entered Ready mode.
NOTE: The aiming beam is off during treatment beam exposure, except in
repeat mode.
25. Repeat the firing procedure as often as necessary, making adjustments to power
output and duration as appropriate to complete the treatment session.
26. When the treatment is complete, release the footswitch and press the Standby
button on the touchscreen.
Turn Off Sequence
27. Turn the key to the OFF (O) position and, for safety reasons, remove the key.
NOTE: The Emergency switch on the front panel must only be used in case
of emergency. After using the Emergency switch, pull it back to its initial
position to restore power and start the instrument.
28. Place the Illumination On/Off switch to the OFF (O) position.
Storage
The PurePoint™ LIO should be stored either on the Charging Station or in a storage
case when not in use to prevent inadvertent damage to the headset or fiber optic cable.
WARNING!
The LED may get hot during prolonged use.
Illumination LED
Red switch in
forward position
POWER VERIFICATION
Alcon recommends that a power verification be performed on an annual basis as an integral
part of the laser system with which it is used. Refer to Section Four of this manual for system
calibration information.
Symbols D
3D SUBMODE........................................................................ 2.90 Detailed Setup........................................................................ 2.74
(Hold) Duration....................................................................... 2.36 DFU.......................................................................................... 4.3
% Time On............................................................................ 2.119 diagnostics............................................................................... 3.1
Diathermy/Coagulation Handpieces..................................... 2.166
A
Diathermy Global Control....................................................... 2.64
Diathermy Power.................................................................... 1.27
Directions For Use (DFU)......................................................... 4.3
About Constellation™............................................................. 2.50 display panel................................................................... 2.1, 2.14
ABS™................................................................................... 2.162 display screens....................................................................... 2.14
Accessories Setup Panel....................................................... 2.71 DISPOSAL OF XENON LAMPS............................................... 4.4
Accessory Equipment............................................................. 1.12 Doctor Protection Filter........................................................... 1.37
Accurus™ Classic.................................................................. 2.85 DOCTOR SETTINGS............................................................. 2.22
AcrySof™ intraocular lenses................................................ 2.166 drainage bag........................................................................ 2.168
Add Favorite........................................................................... 2.19 DVD/CD.................................................................................. 2.46
Add to Procedure................................................................... 2.19 DVD/RW................................................................................... 2.7
Advisory Messages........................................................... 5.3, 5.4 Dynamic Rise....................................................................... 2.103
Aiming Beam On During Standby Mode................................ 2.36
Air Pressure Requirements.................................................... 1.12
Aspiration Bypass System.................................................... 2.162
Audio Input........................................................................ 2.7, 2.8
E
AUTO GAS FILL............................................................ 2.44, 2.80 eConnectivity.......................................................................... 2.39
Auto Gas Filling...................................................................... 2.71 Electrical Connectors............................................................... 2.1
Auto Gas Fill Purge Cycles.................................................... 2.38 electrical interconnections........................................................ 2.7
AutoSert™ IOL Injector........................................................ 2.166 Electromagnetic Emissions.................................................... 1.14
Auxiliary Illuminator Module Eject Button................................. 2.9 Electromagnetic Immunity...................................................... 1.15
EMC Statement...................................................................... 1.14
B
End Case................................................................................ 2.57
END CASE........................................................................... 2.150
Endoprobe Power Verification.................................................. 4.6
Barcode Reader....................................................................... 2.7 Energy Matrix........................................................................... 4.8
Barcode scanner connection............................................. 2.7, 2.8 Environmental Limitations........................................................ 1.6
Basic Setup............................................................................ 2.66 Equipotential Ground Connector.............................................. 2.9
batteries are installed............................................................. 2.13 error message........................................................................ 1.19
Bimanual mode...................................................................... 2.88 Event Log............................................................................... 2.49
biohazards................................................................... 1.25, 2.169 Exposure Time Verification....................................................... 4.6
Bottle Hanger........................................................................... 2.2 EXTRACT SUBMODE.......................................................... 2.147
Bubble Suppression Insert................................................... 2.163 EXTRAS................................................................................. 2.43
BURST SUBMODE................................................... 2.110, 2.112 EXTRUSION MODE............................................................. 2.133
buttons.................................................................................... 2.14
C F
Facility Pressure Source Connectors....................................... 2.8
CALIBRATION VERIFICATION................................................ 4.4 Fault Messages........................................................................ 5.2
CARE AND CLEANING............................................................ 4.1 FCC Compliance Statement................................................... 1.16
care and maintenance.............................................................. 4.1 Field Service........................................................................... 2.43
CASSETTE.......................................................................... 2.168 Fill Progress........................................................................... 2.44
caster wheels........................................................................... 2.4 FIXED SUBMODE................................................................ 2.125
Cautions.................................................................................... viii Fluid/Air Exchange (F/AX) Global Control............................. 2.62
CD/DVD.................................................................................. 2.46 Fluidic Management System.................................................... 2.1
Circulating Nurse...................................................................... 3.1 fluidics module.......................................................................... 2.1
Clean Cassette....................................................................... 2.43 Fluidics Module........................................................................ 2.1
cleaning.................................................................................... 4.1 Fluidics Setup Panel............................................................... 2.67
cleaning and sterilization instructions....................................... 4.3 footswitch........................................................................ 2.2, 2.10
Coagulation Handpieces...................................................... 2.166 Footswitch....................................................................... 2.4, 2.30
Composite Video In/Out.................................................... 2.7, 2.8 Footswitch Button Actions...................................................... 2.31
Configure Printer.................................................................... 2.38 footswitch cable connector....................................................... 3.2
CONNECTING A PUREPOINT LASER.................................. 3.11 Footswitch Configuration........................................................ 2.35
Connectors............................................................................... 2.1 Footswitch Storage Hook......................................................... 2.2
connectors and outlets............................................................. 2.7 Force English......................................................................... 2.41
Consumables................................................................ 2.45, 2.79 Forceps.................................................................................. 2.71
Continuous........................................................................... 2.122 FORCEPS MODE................................................................ 2.142
CONTINUOUS SUBMODE...... 2.107, 2.109, 2.120, 2.122, 2.123 Fragmatome™* handpiece.................................................. 2.160
Contra Indications.................................................................. 1.38 Fragmentation Handpiece.................................................... 2.160
Copying data.......................................................................... 2.48 FRAGMENTATION MODE................................................... 2.123
Creating New Tables............................................................ 2.153 front display panel.................................................................. 2.14
Customer Service................................................................... 1.26 Front Display Panel.................................................................. 2.1
Custom Procedure................................................................. 2.86 FRONT PANEL......................................................................... 2.1
CUSTOM SUBMODE................................................ 2.113, 2.115
H
LIO Maintenance........................................................... 6.19, 6.39
LIO Power Verification.............................................................. 4.6
LIO Safety Features...................................................... 6.14, 6.28
handpieces and probes........................................................ 2.159 LIO Technical Specifications................................................... 6.13
Handpiece Setup Panel.......................................................... 2.69 Load Plunger button.................................................. 2.135, 2.136
Help........................................................................................ 2.53 logo screen............................................................................... 3.1
Hi-Def Margin......................................................................... 2.41 Longitudinal Pulse Duration................................................. 2.106
High Definition Video Overlay................................................. 2.41 Longitudinal / Torsional Ratio............................................... 2.106
HIGH DEFINITION VIDEO OVERLAY................................... 2.41
horizontal/vertical switches..................................................... 2.10
M
I Mackool** U/S Tips............................................................... 2.162
Main Power Switch................................................................... 2.9
I/A handpiece........................................................................ 2.164 Main Screen........................................................................... 2.15
IEC Standard.......................................................................... 1.13 Manual Revision Record............................................................. ii
Illumination............................................................................... 2.4 Menu Bar................................................................................ 2.16
ILLUMINATOR........................................................................ 1.31 Metrics.................................................................................. 2.151
Illuminator Global Control....................................................... 2.65 MicroSmooth™* Infusion Sleeves........................................ 2.163
Illuminator Module Eject Button................................................ 2.9 Modify Procedure................................................................... 2.19
Indications for Use.................................................................... 1.3 MOMENTARY SUBMODE.......................................... 2.93, 2.129
Industry of Canada (IC).......................................................... 1.17 Monitor Type........................................................................... 2.40
Infiniti™ Ultrasonic (U/S) Handpiece.................................... 2.161 moving the instrument.............................................................. 2.4
Information Messages.............................................................. 5.5 MP3................................................................................... 2.7, 2.8
Infusion sleeves.................................................................... 2.163 MULTICUT SUBMODE........................................................ 2.143
Infusion Sleeves................................................................... 2.163 multi media card (MMC)........................................................... 2.1
Initial Rate............................................................................ 2.135 Multiple Cut or MPC submode............................................. 2.143
INITIAL SYSTEM SETUP......................................................... 3.2
Inject..................................................................................... 2.148
Injector.................................................................................. 2.166
INJECT SUBMODE.............................................................. 2.148
N
installation.............................................................................. 1.12 N2........................................................................................... 1.12
Installation.............................................................................. 1.12 Navigation.............................................................................. 2.57
instrument tray.......................................................................... 2.2 Network Connection............................................................... 2.38
Instrument Tray........................................................................ 2.2 NGENUITY*.......... 1.3, 2.7, 2.8, 2.30, 2.41, 2.53, 2.53–2.56, 3.16
intraocular lenses................................................................. 2.166 NGENUITY* 3D Visualization................................................. 2.38
INTREPID™ AutoSert™ IOL Injector................................... 2.166 NGENUITY * Auxiliary............................................................ 2.30
IOL Injector.................................................................. 1.22, 2.166 NGENUITY* Image Orientation.............................................. 2.30
IP Settings dialog.................................................................. 2.105 NGENUITY* Margin............................................................... 2.41
IRRIGATION/ASPIRATION (I/A) MODE............................... 2.131 NGENUITY* Menu................................................................. 2.30
Irrigation Global Control......................................................... 2.63 NGENUITY* Setup Screen..................................................... 2.54
IV Pole...................................................................................... 2.2 Nurse........................................................................................ 3.1
IV pole extender....................................................................... 2.2
O
J Operator Profile......................................................................... viii
No entries O-ring tool............................................................................. 2.165
Ozil™.................................................................................... 2.104
OZIL™ BURST..................................................................... 2.112
K OZIL™ CUSTOM PULSE..................................................... 2.115
OZil™/Phaco Sequence......................................................... 2.28
key tone.................................................................................. 2.14 OZIL™ PULSE..................................................................... 2.119
OZil™ Torsional Handpiece.................................................. 2.161
L
LABELING....................................................................... 1.9, 1.10
P
Label Opacity......................................................................... 2.40 Paks....................................................................................... 1.26
Language............................................................................... 2.37 Patient Eye Level Offset......................................................... 2.23
Languages.............................................................................. 2.50 phaco handpieces................................................................ 2.160
Laser........................................................................................ 2.4 PHACO MODE..................................................................... 2.103
Laser Calibration Verification.................................................... 4.4 Phaco Ultrasound Handpieces............................................. 2.160
Laser Indirect Ophthalmoscope (LIO)........................... 6.11, 6.21 PIN......................................................................................... 2.22
LASER MODE...................................................................... 2.138 Pneumatic Scissors.............................................................. 2.159
Lasers..................................................................................... 1.39 pole extender............................................................................ 2.2
T
PUREPOINT™ LASER SAFETY FEATURES....................... 1.35
Push Prime............................................................................. 2.78
W
Warnings................................................................................... viii
WARRANTY........................................................................... 1.30
WETANT SUBMODE.................................................. 2.99, 2.101
Wireless LAN device.............................................................. 1.16
X
No entries
Y
No entries
Z
No entries