Verathon Aperture User Manual

Surgical surveyor

Advertisement

Quick Links

Aperture™ Surgical Surveyor
User's Manual

Advertisement

Table of Contents
loading

Summary of Contents for Verathon Aperture

  • Page 1 Aperture™ Surgical Surveyor User's Manual...
  • Page 3 Aperture Surgical Surveyor User's Manual...
  • Page 4 Information in this User's Manual may change at any time without notice. For the latest version of this manual, refer to www.verathon.com. Copyright © 2008 by Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc.
  • Page 5: Table Of Contents

    Connecting to a Monitor ......41 Setting up the Strong Arm ..... . . 42 Aperture™ Surgical Surveyor User's Manual page 5...
  • Page 6 Supplying Power ....... 44 Viewing the Aperture™ Video ..... 45 ®...
  • Page 7: Symbols

    Risk of radio frequency interference to other devices in the vicinity Risk of electrical shock WARNING Low level risk which could lead to minor or moderate injury WARNING Danger of damage to equipment CAUTION Aperture™ Surgical Surveyor User's Manual page 7...
  • Page 8: Acronyms And Abbreviations

    Acronyms and Abbreviations Acronyms and Abbreviations Aperture™ Surgical Aperture Video Baton and Stat Surveyor ® ® ® GlideScope or GVL GlideScope Video Baton and ® ® (GlideScope Video GlideScope Stat Laryngoscope) Canadian Standards Association Food and Drug Administration International Electrotechnical Commission...
  • Page 9: Notice To All Operators

    Product Description and Intended Use The Aperture™ Surgical Surveyor is a device designed to be used as a retractor/dissector for surgery in addition to providing a direct view and light for open surgical work. The device was developed to assist the surgeon in minimally invasive and conventional surgery.
  • Page 10: Safety Guidelines

    Portable and mobile equipment (e.g., cellular phones) can affect electronic medical equipment. Take appropriate precautions during operation of the device. CAUTION MDD Class I Equipment Electrical Shock Hazard Refer servicing to qualifi ed personnel. WARNING page 10 Aperture™ Surgical Surveyor User's Manual...
  • Page 11 • Increase the distance between equipment. • Connect the equipment to an outlet on a circuit different from that to which the other device(s) is/are connected. • Consult your Verathon Medical representative. Aperture™ Surgical Surveyor User's Manual page 11...
  • Page 12 12 Aperture™ Surgical Surveyor User's Manual...
  • Page 13 Overview Aperture™ Surgical Surveyor User's Manual page 13...
  • Page 14 14 Aperture™ Surgical Surveyor User's Manual...
  • Page 15: Overview

    1. Overview 1. Overview The Aperture™ Surgical Surveyor includes the following main components: • Video Baton • Transfer Module • Aperture™ Stat (Stat) • Hanger • Strong Arm • Monitor and Monitor Stand This chapter describes each of these components in detail.
  • Page 16: Video Baton

    In the event the Video Baton becomes contaminated, it will not be ® damaged if immersed in water, IPA, or Steris cleaning solution. For details on cleaning, refer to Chapter 4, Cleaning and Maintenance. page 16 Aperture™ Surgical Surveyor User's Manual...
  • Page 17: Stat

    The Stat provides two ports with standard, Luer lock connectors. Surgical tubing can be connected to the fi ttings on the Stat. Gas, suction, and liquids can be delivered to the site via these two channels. Aperture™ Surgical Surveyor User's Manual page 17...
  • Page 18: Transfer Module

    There is a control pad on the front of the Transfer Module. It is used to power up the Aperture™ Surgical Surveyor, and to toggle between the ® Aperture™ Surgical Surveyor video and the GVL video.
  • Page 19 1. Overview Video Out ® ® To GlideScope To Aperture™ Video Baton Figure 3 Figure 4 Aperture™ Surgical Surveyor User's Manual page 19...
  • Page 20: Hanger

    Hanger. The Video Baton can then be stored in the Video ® ® Baton cradle; and the GlideScope can be stored in the GlideScope cradle. See Figure 5. Figure 5 page 20 Aperture™ Surgical Surveyor User's Manual...
  • Page 21: Strong Arm

    The Strong Arm is attached to an equipment rail using the Strong Arm clamp. The Stat is connected to the Strong Arm using the Device Holder. Both the Strong Arm clamp and the Device Holder are shipped with the Strong Arm. Aperture™ Surgical Surveyor User's Manual page 21...
  • Page 22: Monitor And Monitor Stand

    1. Overview Monitor and Monitor Stand The Monitor and Monitor Stand are optional products which can be ® ordered from Verathon Optionally, any ISO 60601 medical-grade monitor with composite video input can be used. page 22 Aperture™ Surgical Surveyor User's Manual...
  • Page 23 2. Setting Up...
  • Page 24 24 Aperture™ Surgical Surveyor User's Manual...
  • Page 25: Setting Up

    2 Setting Up 2 Setting Up This chapter describes how to verify the shipment and includes all procedures for setting up the Aperture™ Surgical Surveyor. This chapter covers the following: • Inspect the shipment (fi rst time only). • Assemble the Monitor Stand (optional equipment).
  • Page 26: Inspecting The Shipment

    2 Setting Up Inspecting the Shipment Upon receipt, the components of the Aperture™ Surgical Surveyor should be inspected for any obvious physical damage that may have ® occurred during shipment. Verathon recommends that a qualifi ed biomedical engineer or other professional thoroughly familiar with electronic medical devices performs this inspection.
  • Page 27: Assembling The Monitor Stand

    2 Setting Up Assembling the Monitor Stand For instructions on how to assemble and adjust the optional Monitor Stand, refer to the manufacturer's instructions. Aperture™ Surgical Surveyor User's Manual page 27...
  • Page 28: Attaching The Transfer Module

    Tilt Knob. Insert the washer between the two brackets. Figure 7 shows the top view of this step. Rotation Knob Tilt Knob Rubber Washers Parts: Transfer Module 0570-0192 Transfer Module Clamp 0130-0227 Figure 7 page 28 Aperture™ Surgical Surveyor User's Manual...
  • Page 29: Attaching To A Monitor Stand Or An Iv Pole

    fi ts around the IV pole or monitor stand, as shown in Figure 8. Rubber Knob Parts: Transfer Module 0570-0203 Transfer Module Clamp 0130-0240 Monitor Stand 0800-0299 Figure 8 Turn the rubber knob clockwise to tighten the Transfer Module in place. Aperture™ Surgical Surveyor User's Manual page 29...
  • Page 30: Attaching To An Equipment Rail

    Align the Transfer Module with the equipment rail, as shown in Figure 9. Rotation Knob Parts: Transfer Module 0570-0203 Transfer Module Clamp 0130-0240 Figure 9 Turn the rubber knob clockwise to tighten the Transfer Module in place. page 30 Aperture™ Surgical Surveyor User's Manual...
  • Page 31: Adjusting The Angle Of The Transfer Module

    Move the Transfer Module to the desired angle. Secure the Transfer Module in place by turning the tilt knob clockwise. See Figure 10. Tilt Knob Parts: Transfer Module 0570-0203 Transfer Module Clamp 0130-0240 Figure 10 Aperture™ Surgical Surveyor User's Manual page 31...
  • Page 32: Connecting The Video Baton To The Transfer Module

    To connect the Video Baton to the Transfer Module: Align the red dot on the connector at the end of the Video Baton cable with the red arrow on the Aperture™ Surgical Surveyor port on the Transfer Module. See Figure 11.
  • Page 33 Pull the connector away from the Transfer Module. ® NOTE: If the GlideScope is used in parallel with the Aperture™ it can be connected to the Transfer Module. ® When the GlideScope is connected to the Transfer Module, the Transfer ®...
  • Page 34: Attaching The Stat To The Video Baton

    Attaching the Stat to the Video Baton A new sterile disposable Stat must be attached to the Video Baton each time the Aperture™ Surgical Surveyor is used. When attaching the Stat to the Video Baton, check the integrity of the cover sleeve and the elastic window to be sure that attachment of the sleeve is effectively covering the open end of the Stat.
  • Page 35 0575-0001 Stat 0570-0199 Figure 12 NOTE: After use, pull the Video Baton away from the Stat and dispose of the Stat and cover sleeve in accordance with local regulations pertaining to biohazardous materials. Aperture™ Surgical Surveyor User's Manual page 35...
  • Page 36: Attaching The Hanger

    Slide the End Caps over the Hanger, and tighten the hex-head screws with an Allen wrench. Align the screw holes on the Hanger Clamp with the screws holes on the Hanger. See Figure 14. page 36 Aperture™ Surgical Surveyor User's Manual...
  • Page 37 Turn the rubber knob on the Hanger Clamp counterclockwise until the gap is wide enough to fi t on the rail. Turn the rubber knob clockwise to tighten the hanger in place. Aperture™ Surgical Surveyor User's Manual page 37...
  • Page 38 Line up the notch on the Hanger with the hex-head screw holes. See Figure 15. Parts: End Caps 0130-0247 Hanger 0130-0246 Figure 15 Slide the End Caps over the Hanger, and tighten the hex-head screws with an Allen wrench. page 38 Aperture™ Surgical Surveyor User's Manual...
  • Page 39 Turn the rubber knob on the Hanger Clamp counterclockwise until the gap is wide enough to fi t around the IV pole or Monitor Stand. Turn the rubber knob clockwise to tighten in place. Aperture™ Surgical Surveyor User's Manual page 39...
  • Page 40: Attaching The Video Baton Cradle To The Hanger

    3. Loosen the black knob until the clamp fi ts around the Hanger. 4. Attach the Video Baton Cradle to the Hanger, and turn the black knob clockwise to tighten in place. page 40 Aperture™ Surgical Surveyor User's Manual...
  • Page 41: Connecting To A Monitor

    2 Setting Up Connecting to a Monitor To connect to an NTSC-compatible monitor or a central system, the Aperture™ Surgical Surveyor should be connected using the supplied video output cable. To connect to a monitor: Connect one end of the Video Output Cable to the video output port on the bottom of the Transfer Module, as shown in Figure 18.
  • Page 42: Setting Up The Strong Arm

    Setting up the Strong Arm After the Strong Arm is mounted to an equipment rail, the device holder can be attached to the Strong Arm. Then the Aperture Baton can be attached to the device holder. To set up the Strong Arm: Hold the fl...
  • Page 43 To attach the device holder, slide the holding ring up, and slide the device holder into place, then slide the holding ring back down. See Figure 20. Holding Ring Device Holder Parts: Strong Arm Kit 0800-0330 Figure 20 Aperture™ Surgical Surveyor User's Manual page 43...
  • Page 44: Supplying Power

    2 Setting Up Supplying Power To supply power to the Aperture™ Surgical Surveyor: Insert the male end of the power cord into an appropriate power source. For compatibility details, see the label located on the back of the Transfer Module.
  • Page 45: Viewing The Aperture™ Video

    To turn the power off: Press the POWER button on the face of the Transfer Module. After the Aperture™ is turned off, it is ready to be cleaned. For cleaning instructions, refer to Chapter 4, Cleaning & Maintenance . Aperture™ Surgical Surveyor User's Manual...
  • Page 46: Functional Check

    2 Setting Up Functional Check A functional check should be performed prior to use. Contact your Verathon Medical representative if the Aperture™ Surgical Surveyor does not function as described below. To perform a functional check: Connect the AC power cord. See Figure 21.
  • Page 47 3. Using the Aperture ™ Surgical Surveyor...
  • Page 48 48 Aperture™ Surgical Surveyor User's Manual...
  • Page 49: Using The Surgical Surveyor

    Classically, surgical retractors have been limited to fi xation and displacing tissues to provide adequate exposure of the surgical site. The Aperture™ Surgical Surveyor's built-in video is practical for providing a simultaneous view of the operation to the surgeon and the assistant.
  • Page 50: Intended Use

    3. Using the Surgical Surveyor Intended Use The Aperture™ Surgical Surveyor is a curved rigid videoscope that has two functions: a retraction function and a dissection function. Retraction Function The Aperture™ Surgical Surveyor provides a retraction function that allows the user to lift tissues with the usual precautions related to force and tissue strength.
  • Page 51: Indications For Use

    3. Using the Surgical Surveyor Indications for Use There are two indications for use: The Aperture™ Surgical Surveyor is indicated for use when it is necessary to provide retraction in order to view and manipulate internal structures of the body during general endoscopic and laparoscopic procedures.
  • Page 52: Special Observations And Precautions

    3. Using the Surgical Surveyor Special Observations and Precautions The use of the Aperture™ Surgical Surveyor as a dissector is promoted by the blade thickness and the leading edge of the rounded lifter. The safety of this dissection is not complete: ordinary caution is required when in the vicinity of critical structures.
  • Page 53 4. Cleaning and Maintenance...
  • Page 54 54 Aperture™ Surgical Surveyor User's Manual...
  • Page 55: Cleaning And Maintenance

    To ensure patient safety, users should perform a routine inspection of the Aperture™ Surgical Surveyor before each use to ensure that all components are free of unintended rough surfaces, sharp edges, protrusions or cracks.
  • Page 56: Cleaning The Aperture™ Surgical Surveyor

    4 Cleaning & Maintenance Cleaning the Aperture™ Surgical Surveyor The following Aperture™ Surgical Surveyor components can be cleaned: • Video Baton • Transfer Module • Video Baton cradle and accessories • Strong Arm This chapter includes all cleaning instructions. page 56...
  • Page 57: Cleaning The Video Baton

    Disconnect the Video Baton from the Transfer Module. Slip the protective cleaning plug over the connector until it snaps into place. See Figure 22. Protective Cleaniing Plug Parts: Video Baton 0575-0001 Figure 22 Aperture™ Surgical Surveyor User's Manual page 57...
  • Page 58 NOTE: The Video Baton will not be damaged if it is immersed in ® water, IPA, or Steris 20 Sterilant cleaning solution. page 58 Aperture™ Surgical Surveyor User's Manual...
  • Page 59: Cleaning The Transfer Module

    Cleaning the GlideScope ® ® For directions on cleaning the GlideScope , refer to the GlideScope System User's Manual . Cleaning the Strong Arm The strong arm can be autoclaved. Follow standard autoclaving procedures. Aperture™ Surgical Surveyor User's Manual page 59...
  • Page 60: Replacing The O-Ring

    O-ring over time. Replace the O-ring immediately if there is any liquid in the connector after cleaning. To replace the O-ring: Remove the O-ring from the groove in the connector. Securely seat the new O-ring in the connector. page 60 Aperture™ Surgical Surveyor User's Manual...
  • Page 61: Transportation And Storage

    4 Cleaning & Maintenance Transportation and Storage The Aperture™ Surgical Surveyor can be safely transported and stored under the following environmental conditions: • Relative humidity range of up to 95% • Storage temperature range of -4° to 140° F (-20º to 60º C) Aperture™...
  • Page 62: Replacement Parts

    4 Cleaning & Maintenance Replacement Parts For a list of replacement parts, refer to Appendix A. Contact Information To obtain additional information regarding replacement parts for the Aperture™ Surgical Surveyor, contact Verathon Customer Care at: • 800.331.2313 (Canada and US) • +31.30.68.70.570 (Europe) •...
  • Page 63 4 Cleaning & Maintenance Verathon Medical Customer Care Contact Information Verathon Medical ® (France) Sarl Espace Europeen de l’Entreprise 2 allée d’Oslo BP 10039 Schiltigheim F-67012 Strasbourg Cedex France Tel: +33.03.88.60.14.02 Fax: +33.(0)3.88.60.46.87 ® Verathon Medical (United Kingdom) Ltd. The Granary Manor Farm Courtyard...
  • Page 64 64 Aperture™ Surgical Surveyor User's Manual...
  • Page 65 5. Specifi cations...
  • Page 66 66 Aperture™ Surgical Surveyor User's Manual...
  • Page 67: Specifi Cations

    5 Specifi cations 5 Specifi cations Verathon Medical (Canada) ULC reserves the right to change product specifi cations without notice. General Specifi cations Classifi cation: Electrical Class I, Applied Part BF Line Voltage Range: 100 - 240 VAC, 50 & 60 Hz Line Current: MAX 0.20 A...
  • Page 68 0.76 in (19.3 mm) Blade length in front of camera: 1.96 in (50.0 mm) Max blade width in front of camera: 1.15 in (29.2 mm) Maximum insertion portion width: 1.15 in (29.3 mm) page 68 Aperture™ Surgical Surveyor User's Manual...
  • Page 69: Appendix A: Parts List

    Clamp, Cradle 0130-0227 Clamp, Post Rail (Hanger Clamp & Transfer Module Clamp) 0130-0240 Strong Arm Kit 0800-0330 Aperture™ Video Baton 0575-0001 Aperture™ Video Baton and Cradle 0575-0002 Aperture™ Baton Cradle 0810-0145 Aperture™ Stat 0570-0199 Aperture™ Stat (box of ten) 0270-0436 Aperture™...
  • Page 70 70 Aperture™ Surgical Surveyor User's Manual...
  • Page 71: Appendix B: Approvals

    ANSI/IEC 60529-2004: Degree of Protection provided by Enclosure (IP Code) CAN/CSA C22.2 No. 60601-1 Series Part 1: General Requirements for Safety AU, CA, DK, IL, and US National Differences, as per CB Bulletin 107a Licenses/Listings: FDA Listed Class 1 Device E226090 Aperture™ Surgical Surveyor User's Manual...
  • Page 72 Verathon Medical (Europe) B.V. Boerhaaveweg 1 3401 MN IJsselstein The Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512 http://www.verathon.eu Manufacturer: ® Verathon Medical (Canada) ULC 4224 Manor Street Burnaby British Columbia, V5G 1B2 Canada Tel: 604.439.3009 Fax: 604.439.3039 Aperture™ Surgical Surveyor User's Manual...
  • Page 73: Appendix C: Product Symbols

    Appendix C: Product Symbols Appendix C: Product Symbols The following symbols may be found on Aperture™ Surgical Surveyor products. Symbol Meaning Power connected to mains Power disconnected from mains Type BF equipment Canadian CSA Symbol Subject to WEEE (Waste of Electronic Electrical Equipment) regulations.

Table of Contents