Johnson & Johnson Medical

Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems Instructions for Use

260 Pages

0902-90-111 Rev. F 2797  en  Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems Caution: USA law restricts this device to sale by or on the order of a physician.  DESCRIPTION The navigation instruments for the EXPEDIUM® and VIPER® MIS Spine Systems are reusable spine surgical instruments designed to be tracked using Brainlab and/or Medtronic StealthStation Navigation Systems. The navigated handles, Jamshidi, and trocar are to be navigated with only the Brainlab navigation system. The taps, awls, awl tip taps, probes, and drivers for the Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems may be navigated using Brainlab or Medtronic StealthStation Navigation Systems. The navigation instruments for EXPEDIUM and VIPER MIS Spine Systems are reusable spine surgical instruments designed to be tracked using Brainlab and/or Medtronic StealthStation Navigation Systems. In the case of the interface with the Brainlab system, some of the instruments will be pre-calibrated within the Brainlab software. For Medtronic StealthStation, the instruments will need to be manually calibrated. All of the Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are intended to be used as part of the surgical technique for implantation of already-cleared EXPEDIUM 5.5 Spine System (including EXPEDIUM VERSE™ Spine System), VIPER System (including VIPER®2 and VIPER SAI Systems). The Universal Navigation Instruments have an adaptor and clamp attachment to interface with navigation systems’ arrays. Each of the tracking arrays contains pins for the rigid attachment of reflective marker spheres. The tracking arrays, with reflective marker spheres attached, reflect infrared light generated by the navigation system camera which the camera then receives for detection of the position and orientation of the spheres. In order for an instrument to be tracked the dimensions of the instrument relative to the locatable reflective marker spheres on the tracking array must be either acquired through calibration (manualcalibrated) or loaded and integrated into the Brainlab Navigation  2019-10-28 01:37:12  Software (pre-calibrated). The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems can only be pre-calibrated into the Brainlab Navigation System. All other navigation systems require manual calibration. The VIPER and EXPEDIUM navigation handles are manufactured from stainless steel, silicone, and Radel®. The navigation handle containing the pre-calibrated Brainlab tracking array has a titanium nitride coating on the post that supports the array. The navigated instrument shafts are manufactured from stainless steel and aluminum.  INDICATIONS FOR USE Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems The Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using tracking arrays provided by the navigation manufacturer. These procedures include but are not limited to spinal fusion. These devices can be pre-calibrated and/or manually calibrated with Brainlab Navigation system, where other navigation systems require manual calibration.  VIPER and EXPEDIUM Navigated Instruments The VIPER and EXPEDIUM navigated instruments are image guided surgical instruments for use in the implantation of VIPER and EXPEDIUM pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition  This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.  1 of 9
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