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

LIT-219 Sunoptic Surgical®
Rev. F (English)
Page 3 of 147
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.

LIT-219 Sunoptic Surgical®
Rev. F (English)
Page 4 of 147
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

LIT-219 Sunoptic Surgical®
Rev. F (English)
Page 5 of 147
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.