Sunoptic Surgical Titan X400 Operator'S Manual Download Page 1 | Manualshive

Page: 1 / 12

Sunoptic Surgical Titan X400 Operator'S Manual Download Page 1

LIT-259 Sunoptic Surgical

®

Rev. B English)

Page 1 of 100

Titan X400

(US Patent 9,772,094 and 7,510,313)

Xenon Illuminator with Manual 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: +49 211 54059 6030

1
2
3
...
»

Summary of Contents for Titan X400

Page 1: ...510 313 Xenon Illuminator with Manual 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 49 211 54059 6030 ...

Page 2: ...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 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 ...

Page 3: ...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...

Page 4: ...njury 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 ...

Page 5: ...t 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 v...

Page 6: ...ETER 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 freque...

Page 7: ...W FRONT PANEL No Name Function 1 Lamp Switch Turns illuminator ON and OFF Illuminates blue when ON 2 Intensity Control Mechanically adjusts light intensity 3 Turret Auto Shutter turret accepts end tip of fiber optic cable Light is shuttered when no cable is present ...

Page 8: ...abel Device and Manufacturer information 3 Hour Meter Allows tracking of total running time on unit and provides tracking of individual lamp running hours 4 Ground Stud For potential equalization 5 AC Mains Inlet and Switch Accepts AC Power cord and switches on AC power 6 Circuit Breaker Over current protection ...

Page 9: ...c 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 mat...

Page 10: ...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...

Page 11: ...the factory Your product will be inspected and an estimate of repair charges will be submitted to you for approval PHONE 1 877 677 2832 INTERNATIONAL 1 904 737 7611 FAX 1 904 733 4832 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 the circuit breakers If necessary reset Power input switch is in the of...

Page 12: ... Use CE mark Do not use if package is damaged Not for disposal in general waste Medical device Caution Hot Surface 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 ...

Reviews:

No comments