Resources

Sunoptic Surgical brochures and equipment instruction manuals with worldwide support are great benefits to our physicians, dentists and other customer communities

Brochures

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Sunoptic Surgical Product Brochure
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Sunoptic Surgical Lamp Brochure
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Instructions for Use (IFU)

Light Sources

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TITAN X450 Xenon Illuminator - All Translations
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TITAN X350 Xenon Illuminator with Digital Dimming Control - All Translations
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TITAN X300 Xenon Illuminator
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SSL-4000 - All Translations
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SSL-3000 - All Translations
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SSL-2000 LED Lightsource - All Translations
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LED ROVER IV - All Translations
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Headlights

SSL-LX2
SSL-LX2 LED Headlight System - English and All Translations
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Headlamp System Operator Manual - All Translations
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SSL-5500 LED Headlight System - All Translations
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SSL-9500 LED Headlight System - English and All Translations
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Camera System

LIT-239 Rev. B SUNOPTIC SURGICAL HDC-300C TITAN HD CAMERA INSTRUCTIONS FOR USE (ENGLISH AND ALL TRANSLATIONS)
HDC-300
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Cables

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Sunoptic Surgical Fiberoptic Cables
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Replacement Parts & Accessories

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2 Bay Charger - All Translations
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Single Bay Battery Charger - All Translations
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Smart Battery Pack - All Translations
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Certifications

Sunoptic Technologies® manufactures Medical Devices in compliance with the current Good Manufacturing Practice (CGMP) requirements set forth in the FDA Quality System Regulation (QSR), Title 21 Part 820 of the Code of Federal Regulations. This QSR helps assure that medical devices are safe and effective for their intended use.

The QSR requires that specifications and controls be established for devices; that devices be designed and manufactured under a quality system to meet these specifications; that finished devices meet these specifications; be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Basically, a quality management system must be established to cover design through servicing of a finished device and Sunoptic Technologies® has an effective system in place.

Sunoptic Technologies® is certified to ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes” and ISO 9001:2015 “Quality management systems – Requirements.” Our focus is on the customer and our continual improvement of the quality management system will enhance customer satisfaction.

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ISO 9001-2015
Certification

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ISO 13485-2016
Certification

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MDSAP
Certification

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