Clarity® MIS Port System
The Clarity® MIS Port System provides minimally invasive access to the spine for PLIF/TLIF, microdecompression and microdiscectomy procedures. This system comes complete with radiolucent ports, easy-to-use table attachments, light cable and light source for simple yet effective MIS access.
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Aluminum Ports
- Radiolucent to enhance visualization during fluoroscopy
- Integrated light passages allow for easy attachment of the light cable
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Instruments are supplied nonsterile. For sterilization instructions, please reference the package insert.
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Port* Warning/Precaution
- CAUTION: US Federal law restricts this device to sale by or on the order of a physician.
- Product is intended to be used by trained surgeons.
- TSI products are to be used only with the TSI retractor systems and may not be used with other manufacturer’s products.
- Normal repeated use has minimal effect on these instruments. End of life is normally determined by wear and damage due to use.
- Use of this instrument for any purpose, or in any manner other than those described here may cause instrument damage or failure which could result in serious patient injury or death. If needed, all TSI metal products or fragments thereof may be located by means of an X-Ray.
- To prevent corrosion, instruments made of different alloys should be physically separated during cleaning and sterilization.
- To maintain intended clamping capacity of the table clamp, do not tighten the rail clamping knob when the articulating arm column is not fully installed.
- TSI light cables should only be used with the TSI light source.
- The light source must remain off until the reusable light cable is inserted into the retractor blade(s).
- Place the light source away from items that are flammable.
- Once the reusable light cable is connected to the light source, do not place the reusable light cable on drapes, sponges, or any flammable object.
- Once the reusable light cable is connected to the light source, do not allow the reusable light cable to hang over the side of the sterile field.
- To verify that the proper amount of light output is achieved, hold single fiber optic end up to room light and look in bifurcated end or single end to check for the percentage black dots seen (the black dots represent broken fibers in the bundle). If greater than fifty percent (50%) of the fibers are broken, the light cable may need to be replaced.
Guidewire* Warning/Precaution
- CAUTION: US Federal law restricts this device to sale by or on the order of a physician.
- Do not reuse. Reuse may compromise the structural integrity of the device and/or lead to device failure. Reuse also presents biological hazards associated with disease transmission and immune/allergy issues, some of which could cause severe illness or be fatal.
- TSI products are for use only with the TeDan Retractor system and may not be used with other manufacturer’s products.
- The decision to use Phantom K-Wire is based upon suitability of patient bone condition.
- Use of this instrument for any purpose, or in any manner other than those described here may cause instrument damage or failure which could result in serious patient injury or death. If needed, all TSI metal products or fragments thereof can be located by means of an X-Ray.
Light Source† Indications
The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery) The light is transmitted from the light source through a fiber optic cable.
NOTE: Light source is designed to work with TeDan Surgical Innovations light cable (TSI) only and is used during spine, hip, neuro, cardiac, vascular and thoracic surgeries.
The LED Light Source is used with the proprietary TSI lights cables. The ferrule (end of the cable) is specifically designed to work with this TSI Light Source. The light port is also proprietary and designed to only accept TSI light cables.
Contact TeDan Surgical Innovations for additional information or needs.
Light Source Warnings/Cautions
Caution Federal law restricts this device to sale by or on the order of a licensed practitioner.
Caution To prevent fire or electric shock, do not open or expose the LED light source 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 light source.
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 LED Light Source must be classified as medical equipment. Additional information processing equipment connected to the LED Light Source, 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 control to 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 fiber optic cable without turning the unit off, turn the intensity control to the fully dimmed position.
Caution EQUIPMENT CONNECTION – The fiber optic cable must be a NON-CONDUCTIVE CABLE. 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 LED light source receptacle. Ensure the optical surface is clean before engaging into the light source.
Caution User is responsible for determining if interruption of light output will create an unacceptable risk. If this determination is made arrangements should be taken to reduce the risk.
*Phantom Retractor Tube and Phantom K-Wire. Manufactured by TeDan Surgical Innovations (TSI), LLC. 12615 W. Airport Blvd., Suite #200, Sugarland, TX 77478 USA. t: 713.726.0886. www.tedansurgical.com.
†Phantom Light Source. Manufactured by Sunoptic Technologies, 6018 Bowdendale Ave., Jacksonville, FL 32216 USA. t: 877.677.2832. www.sunoptictech.com.
See product specific package insert for complete instructions and labeling limitations.