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Summary of Contents for MicroAire Smart Release
- Page 1 SmartRelease Endoscopic System ® Endoscopic Carpal Tunnel Release Instructions for Use...
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Page 2: Table Of Contents
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). -
Page 3: Smartrelease Surgical Instruments And Accessories
N) Refurbished Autoclavable Endoscope REF 81023A *81023 Endoscope "for reference only." (Endoscope is no longer available for sale). SAFETY INFORMATION MARKINGS DEFINITION Attention, See Instructions For Use European Conformity Mark with MicroAire’s Notified Body Number DO NOT Lubricate DO NOT Immerse Lock Unlock... -
Page 4: Environmental Parameters
Assembly – it is designed for single use only. • WARNING: The MicroAire system uses a dry procedure. No fluid or gas should be introduced into the carpal tunnel during this procedure. Fogging may occur as a result and visualization may be compromised. -
Page 5: Instrumentation Assembly
INSTRUCTIONS FOR USE INSTRUMENTATION ASSEMBLY Screw-Lock------ The endoscope should always be protected when transported and stored. Dropping ------Scope Port Shuttle------ or bending the endoscope may damage the imaging system, which is costly to repair. The endoscope and Disposable Blade Assembly are not designed to be used as a lever or probe. - Page 6 INSTRUCTIONS FOR USE 3. ASSEMBLY - ENDOSCOPE TO CAMERA EYEPIECE ENDOSCOPE ASSEMBLY If you are using the 81025 or 81025A endoscope, reference the following: Attach the eyepiece endoscope to the camera coupler according to the recommendation of the camera manufacturer. PRECAUTIONS CAUTION: Do not use clamps or forceps when handling the Endoscope.
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Page 7: Adjusting Light And Focus
INSTRUCTIONS FOR USE 4. ASSEMBLY – ATTACHING LIGHT CABLE AND FINE-TUNING OPTICAL SYSTEM DETERMINE WHICH TYPE OF FIBER-OPTIC LIGHT CABLE A – Storz® / Olympus® fitting B – Wolf® / Dyonics® fitting C – ACMI® / Stryker® connector ATTACHING THE FIBER-OPTIC LIGHT CABLE Determine which type of endoscope fitting is installed on the fiber-optic cable, and choose one of the following options. -
Page 8: Endoscope Focus And Alignment
INSTRUCTIONS FOR USE ENDOSCOPE FOCUS AND ALIGNMENT 1. ADJUSTING THE EYEPIECE ENDOSCOPE AND CAMERA Turn the eyepiece endoscope in the coupler until the view is aligned correctly, using the alignment notch as a reference. Tighten the coupler lock screw and focus the camera coupler according to the recommendation of the camera manufacturer. Adjust the focus by using the focus ring on the coupler of the camera to focus the endoscope. -
Page 9: Cleaning Of Instrumentation
LIMITATIONS ON INSTRUMENT REUSE Many of MicroAire’s Instruments and Accessories are reusable; however, they have a limited life span. Prior to and after each use, the instruments must be inspected where applicable for sharpness, wear, damage, proper cleaning, corrosion and integrity of the connecting mechanisms. - Page 10 3. Check the action of moving parts to ensure smooth operation throughout the intended range of motion. 4. Where instruments form part of a larger assembly, check that the devices assemble with mating components. NOTE: If concerns are noted that may compromise the function of the device, please contact your MicroAire representative. PACKAGING 1.
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Page 11: Sterilization
INSTRUCTIONS FOR USE STERILIZATION Steam sterilize using one of the below cycles. The following steam parameters have been found to be successful in demonstrating a sterilization assurance level (SAL) of at least 10- GRAVITY-DISPLACEMENT STEAM Instrument / Accessory Only/In Sterilization Case Exposure Time 35 minute Full Cycle Exposure Temperature... -
Page 12: Video Endoscope Cleaning
INSTRUCTIONS FOR USE VIDEO ENDOSCOPE CLEANING INSTRUMENTS: REF: 81020 OR 81020N SOAK DISINFECT THE VIDEO ENDOSCOPE Carefully immerse the Video Endoscope, making sure that the delicate part of the Endoscope is protected during soaking. It is recommended that the endoscope and camera should be cleaned, dried and assembled before soak disinfecting together to avoid fogging of their adjacent lenses. -
Page 13: Endoscope Optical Surfaces
Rinse the optical surfaces with tap water to remove any remaining polishing paste and clean the surfaces as shown in MicroAire Instrument Cleaning Instructions. Note: Cleaning with polishing paste should not be part of your routine cleaning procedures and should only be performed when the image ‐... -
Page 14: Troubleshooting Guide
Sticky trigger Debris lodged around trigger or 1. Clean device Send handpiece back to MicroAire for maintenance and update. handpiece needing maintenance. 2. If trigger continues to stick contact MicroAire. NOTE: 1. Beware of contamination caused by disassembling the camera and the endoscope in the sterile field. -
Page 15: Warranty, Service And Repair
We may be able to help solve the problem quickly without requiring return of the item for service. DO NOT disassemble or attempt to service the equipment. It can only be serviced by MicroAire or an Authorized MicroAire Repair Facility. Unauthorized service will void the warranty. - Page 16 These companies are not affiliated with MicroAire Surgical Instruments LLC. Storz® Registered Trademark of KARL STORZ GmbH & Co. Olympus® Registered Trademark of Olympus America Inc. Wolf® Registered Trademark of Richard Wolf Medical Instruments Corporation Dyonics® Registered Trademark of Smith & Nephew ACMI®...
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