Sunoptic Surgical Titan x350 User manual

LIT-218
SUNOPTIC SURGICAL
(English)
(
Xenon Illuminator
Dimming Control
Operator
EC
SUNOPTIC SURGICAL
®
Date of Revision:
Titan x350
(
Patent Pending)
Xenon Illuminator
with
Digital
Dimming Control
Operator
Manual
Sunoptic Technologies
®
6018 Bowdendale Avenue
Jacksonville, FL 32216 USA
Customer Service: 904 737 7611
Toll Free 877 677 2832
EC
|REP RMS UK, Ltd.
28 Trinity Road
Nailsea, Somerset BS48 4NU
United Kingdom
TEL: [phone]
®
Rev. A
Date of Revision:
10/04/17
Page 1 of 148
Digital

LIT-218 SUNOPTIC SURGICAL
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TABLE OF CONTENTS
1. INTRODUCTION
1.1 INDICATIONS FOR USE
2. WARNINGS / CAUTIONS
3. SPECIFICATIONS
4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS
4.1 FRONT PANEL
4.2 REAR PANEL
5. INSTALLATION
5.1 SETTING UP ILLUMINATOR
5.2 CONNECTING LIGHT CABLE
6. OPERATION
6.1 POWERING UP ILLUMINATOR
6.2 TOUCH SCREEN FUNCTIONS
6.2.1 FAULT CONDITION NOTICES
6.2.2 NORMAL OPERATING DISPLAY
6.2.2.1 LAMP HOURS DISPLAY
6.2.2.2 LIGHT BRIGHTNESS CONTROL
6.2.2.3 STANDBY
6.2.2.4 MENU
6.2.2.4.1 RESET FILTER
6.2.2.4.2 ERROR LOG
6.2.2.4.3 TOTAL UNIT HOURS
6.2.2.4.4 FIRMWARE VERSIONS
6.2.2.4.5 LANGUAGE
7. CLEANING and DISINFECTION
8. MAINTENANCE, SERVICING & REPAIR, WARRANTY
8.1 LAMP REPLACEMENT
8.2 WARRANTY
9. END OF PRODUCT LIFE
10. TROUBLESHOOTING
11. CHART OF MEDICAL AND ELECTRICAL DEVICE SYMBOLS USED
11.1 CHART OF MEDICAL DEVICE SYMBOLS USED
11.2 CHART OF ELECTRICAL SYMBOLS USED

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1. INTRODUCTION
Congratulations on the purchase of your new Titan x350 Xenon Illuminator!
This user-friendly Xenon Illuminator is a high efficiency light source utilizing state-of-the-art
illumination technology. It offers a variety of features such as:
•5600 K color temperature provides daylight brightness for perfect color definition
•Quiet operation
•Compact and light weight
•Turret accepts the four major brand styles (ACMI, Wolf, Storz, Olympus)of light
guides
•Autoshutter turret
•Air filter to mitigate dust/lint buildup inside the cabinet
•Digital dimming
•Easy lamp replacement
This operator Instructions For Use manual will help you to install the device and optimally
integrate it with other components of your system. It will instruct you on how to operate the
Xenon Illuminator and how to keep it clean. It will give you maintenance and service guidelines
as well as recommendations for best performance results.
1.1 INDICATIONS FOR USE: The intended use of this device is to provide light for fiberoptic
cables and instruments – providing light for instrumentation via fiberoptic cables for use in
surgical fields.

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2. WARNINGS/ CAUTIONS
WARNING The illuminator produces a highly concentrated (luminous energy per unit area) light
beam and this high energy density is retained through any connected lightguides and instruments. The
output of a connected instrument left in close proximity or contact with tissue or flammable materials
presents a risk of injury or fire. Qualified personnel must determine a safe working distance and intensity
setting for each application. The illuminator should never be left on unattended.
Caution Rx only. Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner.
Caution To prevent fire or electric shock, do not open or expose the illuminator unit to rain or
moisture. Refer all servicing to qualified personnel only.
Caution Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
Caution To prevent any potential electro-magnetic interference, do not use any kind of cellular
phone near the illuminator.
Caution This product should be used only with type BF endoscopic instruments which have been
certified according to IEC 60601-1 for medical equipment and IEC 60601-2-18 for endoscopic equipment.
This symbol indicates type BF equipment.
Caution User must not alter this device in any fashion. Doing so voids all warranties and
statements of suitability for any purpose.
Caution All devices connecting to the Illuminator must be classified as medical equipment.
Additional information processing equipment connected to the Illuminator, a Medical System and the
operator must determine that all equipment complies with the appropriate end-product standards (such as
IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1).
Caution Always set the intensity controlto the minimum level and insert the fiberoptic cable into the
unit before turning on the power. When light is not required at the surgical site, the intensity control
should be should be set to the fully dimmed position. If it becomes necessary to remove the fiberoptic
cable without turning the unit off, turn the intensity control to the fully dimmed position.
Caution The fiberoptic cable used with this illuminator must be electrically NON-
CONDUCTIVE. It should not have conductive shielding or any other conductive connection between the
patient and equipment. Such connection will impair safety of the equipment. It must be rinsed free of
soaking/disinfectant solution and dried before plugging into the illuminator receptacle. Ensure the optical
surface is clean before connecting the cable to the illuminator.
Caution When using high intensity illuminators at full output, the recommended distance from the
headlight module to the patient is not less than 12 inches (30.5 cm). If using less than 12 inches from the
patient, the light intensity must be reduced.
Caution User is responsible for determining if interruption of light output will create an
unacceptable risk. If this determination is made arrangements (such as a standby illuminator) should be
made to reduce the risk.

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Caution Use of this illuminator with accessories or attachments requires that the end-user follow
all accessory or attachment instructions which could affect illuminator setup, usage and/or settings.
Caution This device contains stored electrical energy, follow operating instructions when changing
lamp.
Caution Do not remove lamp immediately after operation. Allow lamp to cool 10 minutes.
Caution To prevent over heating, replace only with the same type and rating of lamp. Read
instructions before replacing lamp.
Caution Do not operate lightsource without lamp in place.
Caution For grounding reliability, use only hospital grade marked power cord and receptacle.
Caution Disconnect power supply cord before servicing to avoid electrical shock.
Caution To reduce risk of electrical shock, do not remove cover. Refer servicing to qualified
personel.
Caution Light source can cause permanent eye damage if viewed directly with unprotected eye.
Caution Do not reach hand inside unit due to risk of shock hazard.

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3. SPECIFICATIONS
Item Specification
Lamp type Ceramic type 300 watt Xenon
Power 300 Watt
Color temperature 5600 K
Lamp life 1000 hours (typical)
Lamp replacement Cartridge replacement from the side of the unit
Light guide adapter
Turret type to accommodate standard Storz, ACMI, Wolf, Olympus cable endtips
Brightness control Mechanical progressive shutter control from the front panel
Input voltage
100-120 V AC, 50/60 Hz 220-240 V AC, 50 Hz
Power consumption 750 watt max
Regulatory Approvals UL60601, EN 60601-1, EN 60601-1-2, CAN/CSA, C22.2,
No 601.1-M90
Equipment Class BF-type
Mode of Operation Continuous operation
Water Resistant Not Protected Equipment, IPX0
Operating Environment
Temperature
Relative Humidity
Air Pressure
+20° to +40° C (68° to 104° F)
30 to 85%
700 to 1060 hPa
Storage Environment
Temperature
Relative Humidity
Air Pressure
-20° to +60° C (-4° to 140° F)
0 to 95%
700 to 1060 hPa
Dimensions, mm (inch) 338 (13.3)Width x 155 (6.1)Height x 457 (18)Depth front-to-back
Weight, kg (lb) 10kg (22lb)

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4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS
4.1 FRONT PANEL
4 (TOP LINE)
1 2 3
Illuminator Front Panel
No. Name Function
1. Lamp switch Turns the illuminator on and off; illuminates blue when turned on
2. Touch screen Controls light intensity, displays notices and accesses data.
3. Turret
A
utoshutter turret a
ccepts end tip of fiber optic cable
; light is
shuttered off when no cable is inserted.
4. Lamp Hours Display Displays total hours of lamp use

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4.2 REAR PANEL
4 5
1 2 3
Illuminator Rear Panel
No. Name Function
1.
Fan Fan 12V DC, airflow for cooling of unit
2.
Circuit breaker Over current protection
3.
AC mains power switch
and input module Accepts AC Power cord and switches on AC power (Green light indicates “on”)
4.
Product label Product Label containing: Model Number, Serial Number, Electrical Ratings, Manufacturer Name, Regulatory Marks,
FDA “Rx Only” Symbol, UDI Information and Manufacture
Date.
5.
Grounding Connector For electric potential equalization

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5. INSTALLATION
5.1 SETTING UP THE ILLUMINATOR
Place the illuminator on a stable surface (cart, counter, stand, etc.).
NOTE
Avoid places where the illuminator may be splashed with liquid.
Absolutely DO NOT use in any environment with explosive or flammable gases.
This illuminator pulls cooling air into its cabinet through a filtered grille in the
bottom panel underneath the front portion and exhausts warm air from the fan in
the rear.
DO NOT block the space in front or below the front of the illuminator or impede
exhaust air flow behind or above the cabinet.
A clear space minimum of 5”/12.7cm behind and above the cabinet is required.
The illuminator should not be placed where its exhaust will influence other
devices, nor where exhaust from other devices will influence the illuminator.
Ensure the rear power switch is in OFF position.
Ensure that the lamp is properly positioned for use. Open the lamp compartment door.
Move the lamp positioning lever (found to the right of the lamp) clockwise, from
horizontal to vertical. As the positioning cones disengage the lamp should drop about
3mm. Move the lamp positioning lever counterclockwise to reengage the positioning
cones and observe that the lamp rises about 3mm as it returns to operating position.
Close the lamp compartment door.
Connect AC power cord to the power inlet located on the rear panel of the illuminator.
Ensure the power cord is completely seated into the power inlet and engage the cord
retainer if so equipped.
CAUTION
Use only power cords provided with the illuminator.
Plug the AC power cord into a wall outlet using the three (3) prong plug
supplied with theunit.
CAUTION
To prevent electric shock, connect power cords of peripheral equipment
through medical isolation transformers.
NOTE
When using medical isolation transformer, be sure to check the transformer
power ratings.Ensure that the power cord is connected to the main power with
three prong plug (USA use UL2601-1 rated isolation transformers and/or
power strips only).
CAUTION
Nearby radio or TV units may subject this equipment to radio interference.
To avoid adverse electromagnetic effects, DO NOT operate this equipment
near RF energy equipment.

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5.2 CONNECTING THE LIGHT CABLE
Connect the fiberoptic cable to endoscope or other instrument and then insert the
cable’s illuminator end tip into the appropriate port of the turret on the front panel.
You may notice a very slight normal resistance to insertion as the tip opens the auto
shutter. Push the tip all the way in.
6. OPERATION
6.1 POWERING UP THE ILLUMINATOR
To operate the illuminator: First attach the illuminator to thefiberoptic cable, instrument
or headlamp to be used.Turn on the rear power switch. Turn on the lamp switch.
The on lamp switch will light up and the fan will start. The touch screen will display
for three seconds, followed by the normal operating display:
6.2 TOUCH SCREEN FUNCTIONS
6.2.1 FAULT CONDITION NOTICES
There are twelve fault conditions detectable by sensors that will render the illuminator
inoperable until they are corrected. A fault condition notice will appear on the screen
identifying the fault and how to correct it.

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6.2.1.1 ENGAGE LAMP
(Refer to 8.1 LAMP REPLACEMENT) Disconnect power. Open the door. The lamp
positioning lever should be completely down(horizontal) to properly engage the lamp
and completely up (vertical) to release it. Raise the lever completely if not already
raised and firmly push the lamp to assure full engagement to the power connectors.
Lower the lamp engagement lever counter-clockwise, from vertical to horizontal, and
observe that the lamp rises slightly as it is engaged into proper operating position.
6.2.1.2 CLOSE DOOR
Close the door completely. (Fan will continue to run with door open.)
6.2.1.3 INCOMPATIBLE LAMP MODULE INSTALLED
Install correct SSX0350 lamp.
The Tx350D digital control system communicates with Sunoptic Surgical lamps designed
for it. Only Sunoptic Surgical lamps can be engaged by the positioning mechanism.

LIT-218
SUNOPTIC SURGICAL
(English)
6.2.1.4
INCORRECT WATTAGE
Install correct
Installed lamp does not
match
6.2.1.5
LAMP
Lamp has been used more than 1000 hours. Install new
less than 1000 hours.
The main screen always displays lamp hours, and notices are
displayed when a lamp is approaching the e
displayed when the lamp has exceed
6.2.1.6
FAN FAULT
In the event of a
fan problem the unit will turn
Turn off and restart the illuminator. If the fault pe
SUNOPTIC SURGICAL
®
Date of Revision:
INCORRECT WATTAGE
LAMP INSTALLED
Install correct
SSX0350 lamp.
match
the intended power (watts). Tx
350 units require a 3
LAMP
HAS EXCEEDED USEABLE LIFE
Lamp has been used more than 1000 hours. Install new
SSX0350
lamp or one
The main screen always displays lamp hours, and notices are
displayed when a lamp is approaching the e
nd of
its useful lamp life. This screen is
displayed when the lamp has exceed
ed its usable lifetime.
FAN FAULT
fan problem the unit will turn
off the lamp and
display this screen.
Turn off and restart the illuminator. If the fault pe
rsists the unit needs servicing
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350 units require a 3
00-watt lamp.
lamp or one
used
The main screen always displays lamp hours, and notices are
its useful lamp life. This screen is
display this screen.
rsists the unit needs servicing

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6.2.1.7 DIMMER CALIBRATION ERROR
On start up the system calibrates the dimmer plate position. If the process fails this
screen will display and the lamp will not ignite. Turn off and restart the illuminator. If the
fault persists the unit needs servicing.
6.2.1.8 LAMP FAULT
Lamp will not strike or stay lit. Replace the lamp. If the fault persists the unit needs
servicing.
6.2.1.9 LAMP COMMUNICATION FAULT
This screen is displayed when the control system does not get a response from the lamp
during startup. Turn off and restart the illuminator. If the fault persists the unit needs
servicing.

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6.2.1.10 INTERNAL FAULT
This screen is displayed whenever the control systems detect a fault between its two
processors. Turn off and restart the illuminator. If the fault persists the unit needs
servicing.
6.2.1.11 SYSTEM IS COOLING
If the lamp temperature exceeds preset limits the lamp will go off and this screen will
display. The fan will run to reduce the temperature. If acceptable reductionis achieved
within ten seconds the lamp will turn back on to resume normal operation.
6.2.1.12 COOLING SHUTDOWN
If cooling pauses are unable to acceptably restore acceptable operating temperature the
lamp will go off and this screen will display. Follow the instructions (check the air filter,
restart, check for obstructions that would impede intake air flow under the front of the
unit or exhaust air flow from the rear of the unit. If the fault persists the unit needs
servicing.

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6.2.2 NORMAL OPERATINGDISPLAY
6.2.2.1 LAMP HOURS
Shows total lamp on hours.
Lamp Hours : 950
Intensity Adjust
100
_
MENU STAND Y
+
6.2.2.2 LIGHT BRIGHTNESS CONTROL
The user may adjust the light brightness by touching the minus or plus
controls on thenormal operating displaytouch screen.
Lamp Hours : 950
Intensity Adjust
100
_
MENU STAND Y
+
NOTE
The brightness control operates a progressive electro-mechanical shutter. The
lamp is running at full power if the power switch is on no matter where the
brightness control is set.
6.2.2.3 STANDBY
Touching STANDBY dims the light by moving the shutter to fully occlude it and “softly”
(not strobe) flashes the word “STANDBY” on/off in one second Intervals. Touching
STANDBY again while in STANDBY mode will restore the light to the preset brightness
value showing on the screen.
6.2.2.4 MENU
The MENUbutton gives the operator access to five functions of information and control.
Repeatedly touching the MENU button will cycle through the five MENU functions, as follows:

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6.2.2.4.1 REPLACE LAMP NOW
Lamp Hours : 950
Replace Lamp Soon
Intensity Adjust
100
_
MENU STAND Y
+
The Replace Lamp Soon message is an information warning and does not require any
action from the user. This message displays whenever the currently installed lamp has
reached 950 hours of usage. This message begins to flash whenever the lamp reaches
975 hours of usage. This warning is shown because the lamp will no longer turn on
when the lamps usage reaches 1000 hours.
6.2.2.4.2 CHANGE FILTER AND RESET
Lamp Hours : 950
Change Filter and Reset
Intensity Adjust
100
_
MENU STAND Y
+
The Change Filter and Reset message is displayed flashing whenever the unit runtime
hours an increment of 250 hours (250, 500, 750, 1000, 1250, etc.).Every 250 hours the
unit filter is supposed to be replaced in order to keep the unit, and the lamp, cool enough
to avoid damage. After replacing the filter, the user must go into the Filter Reset menu
and press the Reset Filter button in order to clear this warning.
6.2.2.4.3 RESET FILTER
Reset Filter
MENU
RESET FILTER
Lamp Hours : 250
This screen will advise if the air filter is due for replacement. Air filter replacement every
250 hours of unit operation isadvised. When air filter replacement is due there will be a
flashing signal to the left of RESET FILTER.
After installing a new filter, touch RESET FILTER to turn off the flashing signal for the
next 250 hours of unit operation.

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6.2.2.4.4 ERROR LOG
E1
_
Error Log
MENU
+
Lamp Hours : 20
The error log functiondisplays error codes useful for repair service. The minus or
plus controls will cycle through the error codes logged.
6.2.2.4.5 TOTAL UNIT HOURS
248
Total Unit Hours
MENU
12/APR/2016 02:39:26
20Lamp Hours :
Displays total hours of unit powered up operation (rear panel mains power switch on.)
6.2.2.4.6 FIRMWARE VERSIONS
A.0 +
_
FW Date
MENU
K70
Lamp Hours : 20
Displays the firmware dates of the two processors (K70 and IC.) The minus or
plus controls will cycle between them.

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6.2.2.4.7 LANGUAGE
+
English
MENU
Language
20
_
Lamp Hours :
The minus or plus controls will cycle through the choices of variation languages.
•Press menu to enter desired language.
•To get back to default English language press menu to cycle thru functions
until back to English language button shows up; as per example below:
7. CLEANING AND DISINFECTION
NOTE
Always disconnect the power cord before cleaning the system and while
unit is drying if wet-wiped.
Disinfection agents should be commercially available cleansers commonly used for
disinfection of electronic equipment in hospitals, such as ethyl or isopropyl alcohols, or
disinfecting sprays containing quaternary ammonium compounds or hydrogen peroxide.
Do not use strongly caustic or acidic cleansers such as “Clorox” hypochlorite bleach,
ammonia, muriatic acid or similar products. Do not use acetone, methyl ethyl ketone or
halogenated / chlorinated hydrocarbon solvents or cleaners containing any of these
restricted compounds.
Apply cleaning agents by light spray or dampened towels. Do not pour liquids over the
cabinet.
Do not allow frank liquids to enter the cabinet seams or ventilation openings.

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8. MAINTENANCE, SERVICING AND REPAIR, WARRANTY
Performance of preventive maintenance is not essential. Regular maintenance can,
however, contribute to identifying potential problems before they become serious; thus,
enhancing the instrument’s reliability and extending its useful operating life. Maintenance
services can be obtained from your local representative or from the manufacturer.
Defective items or equipment are to be serviced and repaired exclusively by persons
authorized by the manufacturer. All repair work shall employ original manufacturer’s parts
only.
8.1 LAMP REPLACEMENT
WARNING!
CERAMIC lamps are at high internal pressure when cold and at operating temperature;
therefore, CERAMIC lamps may unexpectedly rupture resulting in discharge of hot
fragments of quartz and/or glass and metal.
Only handle lamps with protective covers in place. Do not handle lamps without their
protective covers unless government approved safety glasses, facemasks (with neck
protector, chest protector and gauntlets) are worn.
This illuminator is designed to use Sunoptic Surgical p/n SSX0350 lamp module ONLY.
Use of any other lamp may void the warranty.
To replace the lamp:
•Open the lamp compartment door.
•Move the lamp positioning lever (found to the right of the lamp) clockwise, from
horizontal to vertical, and pull the lamp cartridge out. (Grasp only the horizontal top
and bottom grip flanges of the plastic housing of the lamp, pull straight out to
remove the lamp.)
•Insert a new lamp, pushing firmly to assure full engagement to the power
connectors. Lower the lamp engagement lever counter-clockwise, from vertical to
CAUTION
Do not touch the lamp and patient simultaneously when changing the
lamp.
CAUTION
Always disconnect power cord and turn main switch off before lamp
replacement.
CAUTION
Take utmost care not to hit gas-seal edge of lamp; it may cause gas
lamp failure.
CAUTION
Lamp power connection pins at the back of the lamp compartment may
retain stored energy. Do not contact the lamp power connectors in the back
of the lamp compartment.

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horizontal, and observe that the lamp rises about 3mm as it moves to its proper
operating position.
•Close the lamp compartment door.
•Re-connect the power cord and turn the light source on according to 6.1. to verify
that the new lamp works and is properly installed.
NOTE
If the tamper seal on the illuminator is broken, the WARRANTY WILL BE VOIDED. There are no other user serviceable parts in the unit.
8.2 LIMITED WARRANTY
Your illumination product(s) carry(s) a 3-year warranty from the date of shipment on
workmanship and all defects of material, excluding, fiberoptic cable and lamps. Should your
product prove to have such defects within three years of the shipment, Sunoptic Surgical
®
will
repair or replace the product or component part without charge. Should your illumination
product(s) need servicing under this warranty, please contact Sunoptic Surgical
®
for return
authorization documentation . Please carefully pack the unit in a sturdy carton and ship it to the
factory. Include a note describing the defects, your name, telephone number and a return
address. Warranty does not cover equipment subject to misuse, accidental damage, normal
wear and tear or if transferred to a new owner without authorization from Sunoptic Surgical
®
.
This warranty gives you specific legal rights and you may also have other rights that vary from
state to state.
POST WARRANTY REPAIRS: You may return your product(s) for repair, shipping prepaid to
the factory. Your product will be inspected and an estimate of repair charges will be submitted
to you for approval.
In the US call: 877 677-2832 (toll free)
FAX number: 904 733-4832
9. END OF PRODUCT LIFE
In accordance with the European Waste from Electrical and Electronic Equipment (WEEE)
directive, we encourage our customers to recycle this product whenever possible. Disposal of
this unit must be performed in accordance with the applicable local environmental regulations.
In the US a list of recyclers in your area can be found at: http:/www.eiae.org/.
Please contact customer service to issue a return authorization to return product to
manufacturer at the end of product life.