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Arthrex NanoScope Manual

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NanoScope™ System
The Arthrex NanoScope™ System Manual provides safety operation information for all
User's Guide
system and components of the Arthrex NanoScope™ Console, including the disposable
NanoScope™ Handpiece Kit with accessories. All operating personnel must read this
Manual thoroughly prior to using this system and follow all safety warnings, precautions,
and notes.
Console
Disposable Handpieces
0086
1370 Creekside Blvd.
Arthrex, Inc.
Naples, FL 34108-1945 USA
Toll-free 1-(800) 934-4404
www.arthrex.com
DFU-0298-1
Revision 0 07/2019
© 2019 Arthrex, Inc. All rights reserved.
Erwin-Hielscher-Straße 9
Arthrex GmbH
81249 München, Germany
Tel: +49-89-90 90 05-0
www.arthrex.de

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Summary of Contents for Arthrex NanoScope

  • Page 1 NanoScope™ System The Arthrex NanoScope™ System Manual provides safety operation information for all User’s Guide system and components of the Arthrex NanoScope™ Console, including the disposable NanoScope™ Handpiece Kit with accessories. All operating personnel must read this Manual thoroughly prior to using this system and follow all safety warnings, precautions, and notes.
  • Page 2 This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the Arthrex U.S. Product Warranty section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

  • Page 3: Table Of Contents

    NanoScope Handpiece ........................... 17 Safety, EMC, and Regulatory Requirements ................... 18 Setup & Use ......................20 Set up the NanoScope Console (Non-Sterile) ..................20 Prepare the NanoScope Handpiece Kit (Sterile) ..................22 Performing a NanoScope Procedure ...................... 23 Ending a NanoScope Procedure ......................25 Cleaning and Disinfecting ..................
  • Page 4 Table of Figures ........................... 10 IGURE COPE ANDPIECE ..........................11 IGURE COPE ANDPIECE ......................12 IGURE DDITIONAL ANDPIECE OMPONENTS ........................... 13 IGURE COPE ONSOLE ..................21 IGURE COPE ONSOLE LOGIN SCREEN AND KEYBOARD ....................22 IGURE COPE ONSOLE ON SCREEN INSTRUCTIONS .

  • Page 5: General Warnings, Training And Safety Notices - Read This First

    Prior to using the device, read and follow all warning and precautionary notices and instructions marked on the product and included in this manual. Become familiar with the operation and function of the NanoScope Console and the associated NanoScope disposable Handpiece and accessories. Failure to follow these instructions may lead to: •...
  • Page 6 NanoScope Manual procedures can be completed in the event of equipment failure. Always ensure a backup NanoScope Handpiece Kit is available in the event of damaged parts in the original package or during use. 5. Do not use in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking.
  • Page 7 Class C electrical fire suppression. 19. Surface temperatures of the Handpiece or Console may rise during use. 20. Do not re-sterilize the NanoScope Handpiece or kit components. A device labeled as a single-use device must never be reused. Reuse may pose health and/or...
  • Page 8 Console. 8. Do not expose the NanoScope Console to moisture, or operate it in a wet area, or store liquids above the Console. 9. Do not excessively bend or kink power supply cord.
  • Page 9 NanoScope Manual qualified biomedical technician or your local representative. 18. The NanoScope Console is provided with a standard VESA MIS-D, 100 mm x 100 mm (3.9 in. x 3.9 in.) threaded hole mounting pattern on the back of the unit intended for vertical mounting.

  • Page 10: Symbol Definitions

    General Warnings, Training and Safety Notices – Read This First NanoScope Manual Symbol Definitions Caution: Federal law Safety Sign restricts this device to sale Follow operating by or on the order of a instructions physician. The product meets the Authorized representative...
  • Page 11 General Warnings, Training and Safety Notices – Read This First NanoScope Manual Date of Pressure Limits for Manufacture; year Storage and Transport and month. Humidity Limits for Manufacturer storage and transport WEEE [Waste Electronics and Electrical Type BF Equipment Equipment Symbol.

  • Page 12: Shipping, Unpacking, And Warranty Information

    (7) business days of receiving the device. Refer also to our General Terms of Business. All defective products will be repaired or replaced at the discretion of Arthrex at no charge. The warranty does not cover damage caused by unlawful use or improper handling of a product.

  • Page 13: Product Description/Features/Intended Use

    NanoScope Manual 2.0 Product Description/Features/Intended Use Product Description This NanoScope System provides the user with the ability to illuminate and visualize inside a joint or cavity within the body. The AR-3200-0030 NanoScope Console provides image processing and digital documentation for endoscopic procedures. It is powered by a separate power adapter that allows for rechargeable, battery-powered, operation.

  • Page 14: Product Features

    Product Description/Features/Intended Use NanoScope Manual Product Features Figure 1 NanoScope Handpiece Kit Table 1 Handpiece Kit Components 1. Trocar 2. Obturator 3. Calibration Cap 4. Handpiece 5. Cannulas (2) 6. Stopcocks (2) 7. Handpiece Cable DFU-0298-1, Revision 0 Page 10 of 38...
  • Page 15 Product Description/Features/Intended Use NanoScope Manual Figure 2 NanoScope Handpiece 1. Rear Handpiece button Table 2 Handpiece Connection Elements 2. Front Handpiece button 3. Calibration cap 4. Handpiece cable connector DFU-0298-1, Revision 0 Page 11 of 38...
  • Page 16 Product Description/Features/Intended Use NanoScope Manual Figure 3 Additional Handpiece Kit Components 1. Cannula (quantity 2) Table 3 Kit component - Description 2. Sharp trocar 3. Conical obturator 4. Stopcock (quantity 2) Note: Irrigation fluid and luer compatible devices (e.g. saline filled 30 CC syringe) are not included in the kit.
  • Page 17 Product Description/Features/Intended Use NanoScope Manual Figure 4 NanoScope Console 1. Power button Table 4 Elements of the NanoScope Console 2. Handpiece connector 3. Microphone 4. Ethernet port 5. USB port 6. HDMI output 7. Power cable connector 8. Display & touch screen 9.

  • Page 18: Intended Use

    NanoScope Manual Intended Use The NanoScope System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

  • Page 19: Technical Specifications

    Technical Specifications NanoScope Manual 3.0 Technical Specifications NanoScope System Table 5 NanoScope Console Specifications Width 35 cm (13.5 in.) Height 6 cm (2.25 in.) Depth 30 cm (11 in.) Weight 4.5 kg (10 lbs.) Water protection IP20 Mains cable 10 A/250 V...

  • Page 20: Ambient Conditions For Operation

    Technical Specifications NanoScope Manual Ambient Conditions for Operation Table 6 NanoScope System Ambient Conditions for Operation Temperature 10° to 30° C (50° to 86° F) Relative humidity 30% to 75% Air pressure 700 hPa to 1060 hPa (21 in. Hg to 31.3 in. Hg)

  • Page 21: Nanoscope Handpiece

    Technical Specifications NanoScope Manual NanoScope Handpiece Table 8 NanoScope Handpiece Specifications Handpiece width 4.1 cm (1.6 in.) Handpiece length 25.4 cm (10 in.) Handpiece height 6.4 cm (2.5 in.) Handpiece weight 150 gr (5.3 oz.) Water protection IPX4 Functions 1 MOS sensor...

  • Page 22: Safety, Emc, And Regulatory Requirements

    According to degree of protection against Applied part is Type BF Isolated electrical shock Safety Classifications NanoScope Console is IP20 According to degree of protection against NanoScope Handpiece is IPX4 harmful ingress of water (protected against water splash) According to the degree of...
  • Page 23 European Union Compliant with (RED)(2014/53/EU) Information: For all other NanoScope Handpiece Kit and accessories refer to DFU-0266-XX for more information. Refer to Section 12.0 Electromagnetic Emissions for further details on EMC Certification. DFU-0298-1, Revision 0...

  • Page 24: Setup & Use

    The NanoScope System consists of a NanoScope Console and a NanoScope Handpiece Kit. The NanoScope Console is designed to be portable, allowing a physician to move the procedural theater to an exam room. Follow these steps each time you set up the Console in a new location.
  • Page 25 Setup & Use NanoScope Manual Figure 5 NanoScope Console login screen and keyboard 6. Follow the on-screen instructions. Note: The patient demographics can be entered before the case begins, after the case is complete, or by accessing the case history later.

  • Page 26: Prepare The Nanoscope Handpiece Kit (Sterile)

    3. Open the kit and place the contents onto a sterile field. (The Handpiece Kit tray may act as a sterile field itself, if space permits.) • Inspect each component of the NanoScope Handpiece Kit and ensure there is no damage.

  • Page 27: Performing A Nanoscope Procedure

    Setup & Use NanoScope Manual Performing a NanoScope Procedure 1. Sterilize and prepare the procedure area on and near the patient insertion site. 2. Administer local anesthetic to the site and allow the proper amount of time for the patient to be anesthetized.
  • Page 28 13. Use the NanoScope Handpiece buttons to capture images or video. 14. The NanoScope Console display can be used to capture images, videos, etc. (Note: The Console is not sterile and should only be used by someone not interacting with the sterile Handpiece.)

  • Page 29: Ending A Nanoscope Procedure

    1. Aspirate the fluid from the joint/cavity and remove the cannula(s) from patient. 2. Follow the on screen Console instructions to end the case. 3. Discard the NanoScope Handpiece Kit and accessories in appropriate biohazard containers (single use only). DFU-0298-1, Revision 0...

  • Page 30: Cleaning And Disinfecting

    NanoScope Manual 5.0 Cleaning and Disinfecting NanoScope Console The NanoScope Console is provided non-sterile and should not be sterilized. The NanoScope Console can be cleaned/disinfected using a clean cloth dampened with commercially available surfactants or surface disinfectants only. The Console must not be submersed in any liquid.

  • Page 31: Sterilization

    Sterilization NanoScope Manual 6.0 Sterilization All Arthrex NanoScope Handpiece Kit disposable devices are supplied sterile. All components except the stopcock are sterilized by ethylene oxide. The stopcock is initially gamma radiation sterilized. User sterilization is not necessary. Refer to the Directions for Use package insert for the NanoScope disposable Handpiece (DFU-0266-XX) included with each device.

  • Page 32: Maintenance

    Maintenance NanoScope Manual 7.0 Maintenance Regular and proper maintenance of your NanoScope Console is the best way to protect your investment and avoid non-warranty repairs. Recommended care and handling of the NanoScope Console includes proper day-to- day operation and cleaning, which are extremely important to ensure safe and efficient operation.

  • Page 33: Technical Support

    NanoScope Manual 8.0 Technical Support For assistance in using the products identified in this Manual, contact an Arthrex representative or call the Arthrex Technical Support Hotline at 1-(800) 391-8599, Monday through Friday from 9:00 AM to 5:00 PM EST; at +49 89 909005-8800 or techsupport@arthrex.de from 8:00 AM to 5:00 PM CET.

  • Page 34: Troubleshooting

    Table 10 Troubleshooting: Faults, Their Causes and Solutions Fault Cause Solution Unsupported Previously used device. Use a new NanoScope device Handpiece. Damaged cable. Use a new NanoScope Handpiece. Console has an internal Return to Arthrex for repair.
  • Page 35 Cause Solution 10% Battery Life Battery charge low. 1. Connect the Console to the Warning power supply. 2. Call Arthrex Technical Support. Battery fails to Battery is damaged or at the Call Arthrex Technical Support. charge. end of life. System does not Improper shut down of Power down device.

  • Page 36: Repair Policy

    NanoScope Manual 10.0 Repair Policy If after troubleshooting, the problems persist, disinfect the NanoScope Console and send it to Arthrex using the original packaging. Always send the corresponding accessory device with the Console. Please enclose a brief explanation of the malfunction.

  • Page 37: End Of Life, Environmental Directives

    Dispose of the NanoScope Handpiece in any Biohazardous sharps container and follow all local laws and regulations for proper disposal. The NanoScope Console’s expected life is two years of regular use, with up to five patient cases per day. The NanoScope Console may be repaired by Arthrex with original manufactured components beyond the warranty period, until the products end of life or due to lack of replacement component availability.

  • Page 38: Electromagnetic Emissions

    NanoScope Manual 12.0 Electromagnetic Emissions The NanoScope Console and handpiece is intended for use in the electromagnetic Table 11 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions environment specified below. The customer or the user of the NanoScope System should assure that it is used in such an environment.
  • Page 39 The NanoScope System is intended for use in the electromagnetic environment Table 13 Guidance and Manufacturer's Statement - Electromagnetic Immunity specified below. The customer or the user of the NanoScope System should ensure that it is used in such an environment. Immunity test...
  • Page 40 Electromagnetic Emissions NanoScope Manual Immunity test IEC 60601 test Compliance level Electromagnetic environment - level guidance Power 30 A/m 30 A/m @ 50 & Power frequency magnetic frequency 60 Hz fields should be at levels (50/60 Hz) characteristic of a typical magnetic field location in a doctor’s office,...
  • Page 41 Guidance and Manufacturer's Statement - Electromagnetic The NanoScope System is intended for use in the electromagnetic environment Immunity specified below. The customer or the user of the NanoScope System should ensure that it is used in such an environment. Immunity test...
  • Page 42 NanoScope Manual Recommended separation distances between portable and mobile RF Table 14 Guidance and Manufacturer's Statement – Recommended Separation communications equipment and the NanoScope System. Separation distance according to frequency of transmitter [m] Rated maximum output power of transmitter [W]...
  • Page 43 This page intentionally left blank...
  • Page 44 1370 Creekside Blvd. Arthrex, Inc. Erwin-Hielscher-Straße 9 Arthrex GmbH Naples, FL 34108-1945 USA 81249 München, Germany www.arthrex.com www.arthrex.de Customer Service 1-(800) 934-4404 Tel: +49 89 909005-0 Toll-Free Technical Support: 1-(800) 391-8599 Monday through Friday, 9:00 AM – 5:00 PM EST...

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