Sunoptic Surgical Titan x450 User manual

LIT-219 Sunoptic Surgical®
Rev. F (English)
Page 1 of 147
Titan X450
(US Patent 7,510,313 & 9,772,094)
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
AJW Technology Consulting GmbH
Breite Straße 3
40213 Düsseldorf, Germany
Telephone: [phone]

LIT-219 Sunoptic Surgical®
Rev. F (English)
Page 2 of 147
TABLE OF CONTENTS
1. INTRODUCTION
1.1 Indications for Use
1.2 Functions of Design
2. WARNINGS AND CAUTIONS
2.1 Warnings
2.2 Cautions
3. SPECIFICATIONS
4. CLASSIFICATION
5. OVERVIEW
6. SETUP AND OPERATION
6.1 Device Setup
6.2 Operation
6.2.1 Fault Condition Notices
6.2.2 Normal Operating Display
6.2.2.1 Lamp Hours
6.2.2.2 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 Limited Warranty
8.3 Repair
8.4 Troubleshooting
9. END OF PRODUCT LIFE
10. SYMBOLOGY

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Rev. F (English)
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1. INTRODUCTION
Congratulations on the purchase of your new Titan x450 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 which adapts to various types of light guides
•Mechanical Iris
•Easy lamp replacement
•Touchscreen Interface
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.
The xenon illuminator is intended to be used in a controlled operating room environment by
qualified medical personnel. The illuminator is provided non-sterile and is not intended to be
sterilized. The system has an expected, but not limited, three-year service life.
The illuminator is not intended to be used for monitoring, diagnostic, or other life support functions.
This device does not sustain nor support life. The device is not intended to compensate for injury,
handicap, replacement or modification of anatomy, or control of conception. No special intervention
is necessary in the event of device failure. As such, this device has no essential performance as
defined by IEC 60601-1, and should this device fail to operate, a suitable backup should be
available for any procedure where it may be used.
There are no contraindications.
1.2 Functions of Design
The xenon illuminator comprises a standalone, mains-powered illuminator that produces 390klux
(minimum) with a standard headlight at 16-inch (40cm) distance in the visible spectrum range. The
illuminator is typically used with a fiberoptic light guide that connects to a light port located on the
front panel. Light intensity is controlled via touchscreen interface located on the front panel of the
console.

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2. WARNINGS AND CAUTIONS
Use of this equipment may present hazards to the user and/or patient. Before operating this device,
please read this operating manual thoroughly and follow all warnings, cautions, and instructions for
use. The words warning, caution, and note carry special meaning and should be carefully reviewed:
WARNING: Indicates risks to the safety of the patient or user. Failure to follow warnings may result in
injury to the patient or user.
CAUTION: Indicates risks of improper use and/or damage to the equipment. Failure to follow cautions
may result in loss of function or product damage.
NOTE: Indicates special information to clarify instructions or present additional useful information.
The appropriate “WARNING”, “CAUTION” or “NOTE” symbol in this manual is intended to alert the user
to the presence of important operating and maintenance instructions in the manual.
2.1 Warnings
•Federal law restricts this device to sale by or on the on the order of a licensed practitioner.
•The illuminator produces highly concentrated light. Avoid shining light beam into eyes or
looking directly into the light beams at the ends of connected instruments and/or light
guides. When not using the device, it is advised to fully dim the illuminator.
•Qualified personnel must determine a safe working distance between the ends of
connected instruments and/or light guides and the patient for each application. There is a
risk of patient injury if a light guide or instrument connected to the light source comes to
close to the patient.
•User is responsible for determining if interruption of light output will create an unacceptable
risk. Having a backup illuminator is advised.
•Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen
or nitrous oxide.
•For endoscopic procedures: the illuminator should only be used with type BF endoscopic
instruments which have been certified to IEC 60601-1 and IEC 60101-2-18.
This symbol indicates type BF equipment.
•All devices and/or instruments connecting to the illuminator must be classified as medical
equipment. It is the user’s responsibility to ensure that all equipment used with this device
meets all applicable standards such as IEC 60601-1.
•To prevent fire and/or electric shock, do not open or expose the illuminator to liquids.
•The illuminator-side light guide connection may become hot during use. Allow adequate
time to for end tip to cool before removal from illuminator.
•Instruments and/or light guides connected to the illuminator must be NON-CONDUCTIVE.
There should be no conductive shielding or any conductive connection between the
illuminator and the patient. Such connections present a risk to patient safety.
•Instruments and/or light guides should be clean and dry before being connected to the
illuminator.
•DO NOT modify the equipment without authorization from the manufacturer.
•The illuminator is provided non-sterile and is not intended to be sterilized.
•Use only the power cord supplied with illuminator or medically approved power cords with
less than 200mΩof ground impedance and less than 16ft (<5m) of length. If unauthorized

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Rev. F (English)
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cables are used, the device may have increased electromagnetic emissions and/or
decreased electromagnetic immunity which may result in improper operation.
•This device meets CISPR 11 Class A limits and is suitable for use in a hospital and
industrial environments. If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
•Performance of this device may be affected in proximity of another device and/or
equipment capable of producing high levels of RF emissions. The device should be used
no closer than 12 inches (30 cm) to any part of RF equipment including cables. In the
event performance of this device is affected due to high levels of RF emissions, relocation
of the suspected device and/or equipment producing high levels of RF emissions, or the
headlight system may reduce or eliminate the problem.
2.2 Cautions
•Before each procedure, carefully check the illuminator for damage. DO NOT use a
damaged illuminator.
•The user should verify the light guide end tip and the active illumination port are of the
same type before insertion. DO NOT attempt to force an end tip into an incorrect port.
•All servicing and repair must be performed by the manufacturer or qualified service
technicians.
•Ensure that the air vents located on the illuminator are not obstructed to allow the device
to receive the necessary cooling to prevent an overheating.
•Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established.

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3. SPECIFICATIONS
PARAMETER
VALUE
Light Source Type
Ceramic 400W Xenon
Color Temperature
5600 K (typ.)
Lamp Life
1000 hours (typ.)
Lamp Replacement
Cartridge replacement
Brightness Control
Mechanical progressive shutter control via touchscreen interface
Light guide adaptor
Rotating turret with STORZ, ACMI, WOLF, and OLYMPUS
Input Power
100-240 VAC, 50/60 Hz
750W (max.)
Circuit Protection
Resettable
Operating Conditions
68 to 104⁰F (20 to 40⁰C), 30 to 85% RH non-condensing, 700 to
1060 hPa
Storage Conditions
-4 to 140⁰F (-20 to 60⁰C), 0 to 95% RH non-condensing, 700 to
1060 hPa
Dimensions
13.3” x 6.1” x 18” (W x H x D)
33.8 x 15.5 x 45.7 cm (W x H x D)
Weight
22 lbs / 10.0 kg
4. CLASSIFICATION
PARAMETER
VALUE
System Classification
FDA Class I, 510(k) exempt
EU Class I, Active device per Annex IX, rule 1
Isolation
Type BF
EMC Certifications
CISPR 11 Class A, IEC 60601-1-2 4th Edition
Electrostatic discharge: ±8 kV contact, ±15 kV air
Radiated RF EM Fields: 3 V/m, 80 –2700 MHz
EFT / Burst: ±2 kV, ±1 kV signal lines, 100 kHz
SURGE: ±0.5, ±1 kV
Conducted disturbance: 3 V 150 kHz –80 MHz and 6 V in ISM
bands
Power frequency magnetic fields: 30 A/m
Voltage dips: 0% Un / 0.5 cycles at 0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°, 40 % Un / 5 cycles, 70 % Un / 25 cycles
Voltage interruptions: 0% for 5000 ms
Proximity fields: in accordance with EN 60601-1-2: 2015 table 9
CE Marking
Regulation (EU) 2017/745
Degree of protection against
harmful ingress of water
IPX-0; no protection.
Degree of safety in the
presence of Flammable
Anesthetics
Equipment is NOT suitable for use in the presence of
flammable anesthetics.
Mode of operation
Continuous

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5. OVERVIEW
FRONT PANEL
No.
Name
Function
1
Lamp Hours Display
Top line of touchscreen displays total running hours of lamp
2
Turret
Auto Shutter turret accepts end tip of fiber optic cable. Light is
shuttered when no cable is present
3
Filter Tray
Contains replaceable filter media which blocks dirt and dust from
accumulating in the console
4
Touchscreen
Controls light intensity, displays notices, and system information.
5
Lamp Switch
Turns the illuminator on and off; illuminates blue when turned on

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REAR PANEL
No.
Name
Function
1
Fan
Accpets AC Cord Mains Power
2
Product Label
Device and Manufacturer information
3
Ground Stud
For potential equalization
4
AC Mains Inlet and
Switch
Accepts AC Power cord and switches on AC power
5
Circuit Breaker
Over current protection

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6. SETUP AND OPERATION
6.1 Device Setup
Place the Illuminator on a stable surface such as a cart, counter, stand, etc.
WARNING: DO NOT use the device in any environment with explosive or flammable gases.
WARNING: Avoid placing the device in an area where the illuminator may be splashed with liquids. A
clear space minimum of 5 inches (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.
WARNING: DO NOT obstruct the exhaust or cooling vents of the illuminator. User must ensure that
environment air temperatures surrounding the unit are within the allowable limits.
Make sure the power switch is in the 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 unit or cables approved for medical use.
WARNING: To prevent electric shock, connect power cords of peripheral equipment through medical
isolation transformers.
NOTE: When using a medical isolation transformer, ensure that the transformer has sufficient power
ratings. Ensure that the power cord is connected to mains power with a three-prong plug.
Connect a fiberoptic light guide to the topmost position of the rotating turret, ensuring that the
fiberoptic end tip type matches the accepting port. There may be slight resistance upon insertion
from the autoshutter mechanism. This is normal.

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6.1 Operation
After the power cable and light guide are properly connected, turn on the illuminator by pressing
the lamp power switch located on the front panel. The power indicator light within the switch should
illuminate, the fan will start, and the touchscreen will display a boot screen for three seconds. After
boot, the main operating screen will display.
Boot Screen Home Screen
6.2.1 Fault Condition Notices
6.2.1.1 Engage Lamp
Refer to Section 8.1 –Lamp Replacement.
Disconnect power. Open the lamp door. The lamp module
positioning lever should be pressed fully down (horizontal) to
properly engage the lamp and fully raised (vertical) to
release it. Raise the lever and firmly push the lamp along the
black module shroud to ensure the lamp module is fully
seated on the power connectors. Lower the lamp
engagement lever, from vertical to horizontal to re-engage
the lamp module, ensuring that the lamp module rises
slightly.
6.2.1.2 Close Door
ACTION: Close the lamp door completely.
NOTE: Fan will run with lamp door open.

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6.2.1.3 Incompatible Lamp Module Installed
ACTION: Install correct SSX0450 lamp module.
The illuminator digital control system communicates with
specific Sunoptic Surgical lamp modules. Only Sunoptic
Surgical lamp modules can be installed in the system.
6.2.1.4 Incorrect Wattage Lamp Installed
ACTION: Install correct SSX0450 lamp module.
The currently installed lamp module does not match the
intended power of the device. The illuminator requires
400W lamp.
6.2.1.5 Lamp has Exceeded Usable Life
Occurs when lamp module has been used more than 1000
hours.
ACTION: Install a new SSX0450 lamp module or one with
less than 1000 hours of runtime.
NOTE: The main screen always displays the lamp
module runtime hours at the top of the screen.
A notice is displayed in the topleft corner of the home screen when a lamp module has reached 950
hours of use. This notice will begin to flash when the lamp module exceeds 975 hours of use.

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6.2.1.6 Fan Fault
In the event of a fan fault, the device will turn off the lamp
and display this screen.
ACTION: Restart the illuminator.
If fan fault persists, the unit will need servicing.
6.2.1.7 Dimmer Calibration Error
On startup, the system calibrates the dimmer plate position.
If this process fails, this screen will display, and the lamp
will not ignite.
ACTION: Restart the illuminator.
If the fault persists, the unit needs servicing.
6.2.1.8 Lamp Fault
Signifies that the lamp will not ignite or stay lit.
ACTION: Replace lamp module.
If the fault persists, the unit needs servicing.
6.2.1.9 Lamp Communication Fault
This screen is displayed when the control system cannot
communicate with the lamp module.
ACTION: Restart the illuminator.
If the fault persists, the unit needs servicing

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6.2.1.10 Internal Fault
A fault is detected in the internal control system.
ACTION: Restart the illuminator.
If the fault persists, the unit needs servicing.
6.2.1.11 System is Cooling
Displays when the lamp module becomes overheated.
The lamp will turn OFF. If acceptable cooling is achieved
within ten seconds, the lamp will reignite and resume
normal operation.
6.2.1.12 Cooling Shutdown
If lamp module is unable to achieve adequate cooling, the
lamp will turn OFF.
ACTION: Disconnect unit from AC power. Check air filter
for clogging. Replace if necessary. Check vents for
obstruction.
If fault persists, the unit needs servicing.
A notice to change the illuminator dust and particulate filter is displayed every 250 hours. It is advised to
change the filter every 250 hours to maintain thermal efficiency. To remove the message, enter the menu
and press the reset filter icon. See section 6.2.2.4.1.

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6.2.2 Normal Operating Screens
6.2.2.1 Lamp Hours
Depicted on the top line of the main display.
6.2.2.2 Brightness Control
Brightness may be adjusted by touching the or icons on the main
display.
NOTE: The brightness controls operate a progressive mechanical shutter. The lamp is running at full
power regardless of the brightness leve.
6.2.2.3 Standby
Touching the icon fully dims the output of the illuminator. The word
STANDBY will flash on the screen in one second intervals. Touching the
icon again, will restore the illuminator to the previous brightness setting.
6.2.2.4 Menu
Touching the icon will cycle the touchscreen through five additional
MENU functions. Keep pressing the icon to return to the home screen.
6.2.2.4.1 Reset Filter
It is advised to replace the dust and particulate filter every 250 hours. After the filter
is changed, press the to remove the Change Filter and Reset
message from the home screen.

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6.2.2.4.2 Error Log
The error log displays error codes used for certified repair technicians. The
and icons are used to cycle through the various error codes.
6.2.2.4.3 Total Unit Hours
Displays the total hours of illuminator runtime (rear panel mains switch ON).
6.2.2.4.4 Firmware Versions
Displays the firmware versions for the two main processors. Use the or
icons to cycle.

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6.2.2.4.5 Language
The language sub menu allows users to change the display language. Use the
and icons to cycle through the options and press the icon
to confirm the selection.
NOTE: To reset language back to English, press the icon to cycle through the menu.
When the icon appears, press it.
7. CLEANING AND DISINFECTION
WARNING: Ensure that the illuminator is de-energized and disconnected from mains power before
attempting to clean and disinfect.
The illuminator can be wiped down with commercially available cleansers commonly used for
disinfection of electronic equipment in hospitals such as ethyl or isopropyl alcohols, disinfecting sprays
containing quaternary ammonium compounds, or hydrogen peroxide.
WARNING: 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 cleansers containing any of these restricted compounds.
Apply cleaning agents by light spray or dampened towels. Do not pour liquids onto the device. Do not
allow liquids to enter the device seams or ventilation openings.
Follow all applicable bloodborne pathogen procedures as required by OSHA and/or your hospital
when cleaning and disinfecting the product.
WARNING: The illuminator is not sterilizable. DO NOT attempt to autoclave the devic

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8. MAINTENANCE, SERVICING, REPAIR & WARRANTY
Performance of preventative maintenance is not essential. 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: Ensure that the illuminator is unplugged from mains power and de-energized before
attempting to replace the lamp.
WARNING: Ceramic Xenon lamps are at high internal pressure when cold and at operating
temperature. Ceramic Xenon 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.
WARNING: Do not change lamp while touching patient.
NOTE: This illuminator is designed for exclusive use with the Sunoptic Surgical P/N: SSX0450 lamp
module. Failure to use this lamp could void warranty.
Turn unit off and unplug from mains power. Open lamp door located on side of illuminator.
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 one (lamp pointed to the left), pushing firmly to assure full
engagement to the power connectors. Lower the lamp engagement lever counterclockwise, from
vertical to 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.
8.2 Warranty
The illuminator carries a 3-year warranty from the date of shipment on workmanship and all defects of
material.
Should your product prove to have such defects within three years of shipment, Sunoptic Technologies®
will repair or replace the product or component part without charge. Should your product(s) need servicing
under this warranty, please contact Sunoptic Technologies®or a local distributor for return authorization
documentation.
Please carefully pack the unit in a sturdy carton and ship it to the factory. Please 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 Technologies®. This warranty gives you specific legal rights and you may
also have other rights that vary from state to state.
8.3 Repair
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.
PHONE: [phone] INTERNATIONAL: [phone]
FAX: [phone]

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8.4 Troubleshooting
Problem
Solutions
The power indicator (refer to
section 5) is not lit.
Check that the AC power cord is properly connected
Check power input switch position
Check the circuit breakers. If necessary, reset.
The power indicator is lit but the
lamp will not ignite.
If any inoperable fault condition is displayed on the screen,
correct the condition shown per section 6.2.1.
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.
10. SYMBOLOGY
Manufacturer
Date of manufacture
(YYYY-MM-DD)
Symbol for Authorized Representative in the European
Community
Caution, consult accompanying documents
Consult Instructions for Use
CE mark
Do not use if package is damaged.
Not for disposal in general waste
Medical device
Caution: Hot Surface

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Caution: Dangerous Voltage
Storage / Shipping Humidity
Barometric Pressure
Unique Device Identifier
Keep Dry
AC Current
Product Safety Mark
Equipotentiality
Power on
Power off
Type BF
Protective Earth (Ground)

LIT-219 Sunoptic Surgical®
Rev. F (Deutsch)
Seite 20 von 147
Titan X450
(Zum Patent angemeldet 7,510,313 und 9,772,094)
Xenon-Lichtquelle mit digitaler
Dimmfunktion Gebrauchsanleitung
Sunoptic Technologies®
6018 Bowdendale Avenue
Jacksonville, FL 32216 USA
Kundendienst: 904 737 7611
Gebührenfrei 877 677 2832
AJW Technology Consulting GmbH
Breite Straße 3
40213 Düsseldorf, Germany
Telephone: [phone]