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TABLE OF CONTENTS
SYSTEM DESCRIPTION AND INTENDED USE PAGE 1
SMARTRELEASE SURGICAL INSTRUMENTS AND ACCESSORIES PAGE 2
SAFETY INFORMATION PAGE 2
ENVIRONMENTAL PARAMETERS PAGE 3
DEFINITIONS PAGE 3
GENERAL WARNING AND CAUTIONS PAGE 3
PRECAUTIONS PAGE 3
INSTRUMENTATION ASSEMBLY PAGE 4
ADJUSTING LIGHT AND FOCUS PAGE 6
ENDOSCOPE FOCUS AND ALIGNMENT PAGE 7
CAMERA-TO-ENDOSCOPE SET-UP GUIDE AND SUGGESTED SURGICAL SET-UP PAGE 7
CLEANING OF INSTRUMENTATION PAGE 8
STERILIZATION PAGE 10
VIDEO ENDOSCOPE CLEANING PAGE 11
ENDOSCOPE REFERENCE CHART PAGE 11
ENDOSCOPE OPTICAL SURFACES PAGE 12
TROUBLESHOOTING GUIDE PAGE 13
WARRANTY, SERVICE AND REPAIR PAGE 14
CARPAL TUNNEL DESCRIPTION AND INTENDED USE
The MicroAire® SmartRelease® Endoscopic Carpal Tunnel Release System is comprised of an endoscope and a handpiece that holds a Disposable
Blade Assembly. The carpal tunnel device attaches to any standard video camera and light source used in endoscopic/arthroscopy procedures. The
surgeon introduces the Blade Assembly into the carpal tunnel through an incision in the wrist flexor crease.* Viewing the deep side of the
transverse carpal ligament (flexor retinaculum) through a window at the tip of the instrument, the surgeon elevates the blade to cut the ligament
as the instrument is withdrawn.
When the carpal tunnel is released endoscopically with the MicroAire Endoscopic Carpal Tunnel Release System, clinical results indicate that
postoperative morbidity is improved and time away from normal activities and full employment are reduced by as much as 46 percent.¹ The safety
of this device has also been documented in a large clinical series involving over 1,000 cases in a 63 multicenter study.² The results of this study
showed minimal complications.
For additional information, consult the MicroAire Sales Brochure, Surgical Technique and Anatomical Dissection video. Endoscopic release of the
transverse carpal ligament (flexor retinaculum) should not be attempted until the surgeon has been trained at a MicroAire-sponsored workshop or
qualified training surgeon or trained on comparable device. Operating room staff should thoroughly review the MicroAire SmartRelease
®
Instructions for Use prior to set up of this system.
Indications: The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with,
or secondary to, any other known pathology (i.e., “idiopathic” carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel
view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is
indicated for releasing the transverse carpal ligament (flexor retinaculum).
Contraindications: The MicroAire Endoscopic Carpal Tunnel Release System is not intended for use in patients with known abnormalities of their
wrist (carpal tunnel), including distal radial deformities, rheumatoid and other synovitis.
* The MicroAire SmartRelease® System uses a dry procedure. No fluid or gas should be introduced into the tunnel during this procedure.
1 Agee, JM et al. Endoscopic Release of the Carpal Tunnel: A Randomized Prospective Multicenter Study. Journal of Hand Surgery. 1992; 17(6):987-995.
2 Agee, JM et al. Endoscopic Carpal Tunnel Release: A Prospective Study of Complications and Surgical Experience. Journal of Hand Surgery. 1995; 20A (2):165-171
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