Verathon Aperture User manual

Aperture™ Surgical Surveyor
User's Manual

ApertureTM Surgical Surveyor
User's Manual

Corporate Headquarters
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011
USA
800.331.2313 (Canada and US only)
Tel: [phone]
Fax: [phone]
http://www.verathon.com
Verathon Medical (Europe) B.V.
Boerhaaveweg 1
3401 MN IJsselstein
The Netherlands
Tel: [phone]
Fax: [phone]
http://www.verathon.eu
Manufacturer
Verathon Medical (Canada) ULC
4224 Manor Street, Burnaby
British Columbia, V5G 1B2
Canada
Tel: [phone]
Fax: [phone]
For additional contact information visit our corporate web site:
http://www.verathon.com.
Verathon®, Verathon Medical, Aperture™, GlideScope®, and GVL®, are either
registered trademarks or trademarks of Verathon Inc. in the US and/or other
countries.
GCX®is a registered trademark of GCX Corporation.
Sony®is a registered trademark of Sony Corporation.
The Aperture™ and GlideScope®technologies are covered under US Patents
(6,655,377) (6,543,447) (6,142,144) as well as European Patent 1307131.
Additional patents pending.
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.
PN: 0900-1585-00-60

Aperture™ Surgical Surveyor User's Manual
Contents
page 5
Contents
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . 8
Notice to all Operators. . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Product Description and Intended Use . . . . . . . . . . . . . . 9
Sale of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Video Baton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Stat. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Transfer Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Hanger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Strong Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Monitor and Monitor Stand. . . . . . . . . . . . . . . . . . . . . . . 22
2Setting Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Inspecting the Shipment . . . . . . . . . . . . . . . . . . . . . . . . 26
Assembling the Monitor Stand. . . . . . . . . . . . . . . . . . . . 27
Attaching the Transfer Module. . . . . . . . . . . . . . . . . . . . 28
Attaching the Clamp to the Transfer Module . . . . . 28
Attaching to a Monitor Stand or an IV Pole . . . . . . 29
Attaching to an Equipment Rail . . . . . . . . . . . . . . . 30
Adjusting the Angle of the Transfer Module. . . . . . 31
Connecting the Video Baton to the Transfer Module. . . 32
Attaching the Stat to the Video Baton . . . . . . . . . . . . . . 34
Attaching the Hanger . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Attaching the Video Baton Cradle to the Hanger. . . . . . 40
Connecting to a Monitor. . . . . . . . . . . . . . . . . . . . . . . . . 41
Setting up the Strong Arm . . . . . . . . . . . . . . . . . . . . . . . 42

Aperture™ Surgical Surveyor User's Manual
Contents
page 6
Supplying Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Viewing theAperture™ Video. . . . . . . . . . . . . . . . . . . . . 45
Viewing the Cobalt GVL®Video . . . . . . . . . . . . . . . . . . . 45
Turning the Power Off. . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Functional Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
3Using the Surgical Surveyor . . . . . . . . . . . . . . . .49
Clinical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Retraction Function . . . . . . . . . . . . . . . . . . . . . . . . 50
Dissection Function . . . . . . . . . . . . . . . . . . . . . . . . 50
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Special Observations and Precautions. . . . . . . . . . . . . . 52
4Cleaning and Maintenance. . . . . . . . . . . . . . . . . .55
General Maintenance Information. . . . . . . . . . . . . . . . . . 55
Cleaning the Aperture™ Surgical Surveyor . . . . . . . . . . 56
Cleaning the Video Baton . . . . . . . . . . . . . . . . . . . . . 57
Cleaning the Transfer Module . . . . . . . . . . . . . . . . . . 59
Cleaning the Video Baton Cradle andAccessories . . 59
Cleaning the Cobalt GVL®. . . . . . . . . . . . . . . . . . . . . 59
Cleaning the Strong Arm . . . . . . . . . . . . . . . . . . . . . . 59
Replacing the O-ring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . 61
Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Contact Information . . . . . . . . . . . . . . . . . . . . . . . . 62
5Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Appendix A: Parts List. . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Appendix B: Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Appendix C: Product Symbols . . . . . . . . . . . . . . . . . . . . 73

Aperture™ Surgical Surveyor User's Manual
Symbols
page 7
Symbols
The following table lists the symbols used in this guide.
Symbol Meaning
Risk of radio frequency interference to
other devices in the vicinity
WARNING
Risk of electrical shock
WARNING
Low level risk which could lead to minor
or moderate injury
CAUTION
Danger of damage to equipment

Aperture™ Surgical Surveyor User's Manual
Acronyms andAbbreviations
page 8
Acronyms and Abbreviations
Aperture™ Surgical
Surveyor Aperture Video Baton and Stat
GlideScope®or GVL®
(GlideScope®Video
Laryngoscope)
GlideScope®Video Baton and
GlideScope®Stat
CSA Canadian Standards Association
FDA Food and Drug Administration
IEC International Electrotechnical Commission
IPA Isopropyl Alcohol
ISO International Standards Organization
LED Light Emitting Diode
MDD Medical Device Directive
NTSC National Television Standards Committee

Aperture™ Surgical Surveyor User's Manual
Important Information
page 9
Important Information
Notice to all Operators
All operators should read this manual prior to using the Aperture™
Surgical Surveyor. Failure to follow these instructions may compromise
the system performance and may void the system warranty.
To avoid personal injury or damage to the equipment, all operators
should review the safety guidelines in this document before assembling
or using the Aperture™ Surgical Surveyor.
All operators should practice using the Aperture™ Surgical Surveyor on a
mannequin before clinical use.
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. It offers
a retraction function that allows the user to lift tissue with the usual
precautions related to force and tissue strength. The blunt tip is designed
to open tissue planes loosely approximated by connective tissue (thereby
acting as a dissector).
Sale of the Device
Federal (USA) law restricts the sale of this device to sale by, or on the
order of, a physician.

Aperture™ Surgical Surveyor User's Manualpage 10
Important Information
Safety Guidelines
The symbols are used in this guide.
Symbol Warning
CAUTION
Do not expose the Video Baton to temperatures
above 140° F (60° C). Do not disinfect or sterilize
the Video Baton using devices such as autoclaves
or pasteurizers. Do not use ultrasonic cleaners.
Using these methods to disinfect or sterilize the
Video Baton will cause permanent damage to
the device and will void the warranty. Refer to
Chapter 4,
Cleaning & Maintenance , for a list of
approved cleaning products and procedures.
CAUTION
Portable and mobile equipment (e.g., cellular
phones) can affect electronic medical equipment.
Take appropriate precautions during operation of
the device.
WARNING
MDD Class I Equipment
Electrical Shock Hazard
Refer servicing to qualified personnel.

Aperture™ Surgical Surveyor User's Manual
Important Information
page 11
Symbol Warning
This equipment has been tested and found to
comply with the standards listed in Appendix B,
Approvals . These limits are designed to provide
reasonable protection against harmful interference
in typical medical installations.
The equipment generates, uses, and can radiate
radio frequency energy. If used properly it is very
unlikely to cause harmful interference to any other
devices in the vicinity.
However, there is no guarantee that interference
will not occur in a particular installation;
interference can be determined by turning the
equipment on and off. If this equipment does cause
harmful interference with other devices, try to
correct the interference by taking one or more of
the following measures:
Relocate the device that is having• interference problems.
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 Manualpage 12

Aperture™ Surgical Surveyor User's Manual page 13
1. Overview

Aperture™ Surgical Surveyor User's Manualpage 14

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 15
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.

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 16
Video Baton
The Video Baton contains the video camera, six high-output white LEDs
for the video camera and a bank of six high-output general illumination
LEDs. (Figure 1.)
The general illumination LEDs can be directed downwards over the site
to improve lighting during open procedures.
Figure 1
Before use, the Video Baton is inserted into the Stat and locked together
to ensure proper alignment. For assembly details refer to Chapter 2,
Setting Up. During use, the re-usable Video Baton is encased in the
disposable Stat and has no direct contact with the patient.
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.

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 17
Stat
The Stat is a single-use, disposable device that attaches to and covers
the Video Baton. It provides a sterile barrier between the Video Baton
and the patient. The Stat can function as either a retractor or dissector.
See Figure 2.
Figure 2
The Stat has an integrated handle that enables the operator to manually
position the Video Baton.Alternatively, the Stat can be connected to
a Strong Arm which provides a clamping system for holding the Video
Baton in place, thereby freeing the hands of the operator. The Stat
should not be used to lift loads heavier than 10 lb (4.5 kg).
The Stat provides two ports with standard, Luer lock connectors. Surgical
tubing can be connected to the fittings on the Stat. Gas, suction, and
liquids can be delivered to the site via these two channels.

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 18
Transfer Module
The Transfer Module has four main functions:
Contains the electronics to power the Video Baton.•
Displays the video image.•
Allows toggling between video images.•
Provides a video output to transfer video to an external monitor.•
The Video Baton is powered through the Transfer Module. The Transfer
Module is powered via an AC power cord.
The Transfer Module provides an integrated display for both the
Aperture™ Surgical Surveyor and the GlideScope®Video Laryngoscope
(GVL®). To allow for improved viewing, the Transfer Module also includes
a port and a video output cable for connecting to a large-scale video
monitor.
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. See Figure 3.
The Transfer Module can be mounted on an IV pole, a rail, or a roll
(monitor) stand. Figure 4 shows the Transfer Module mounted on an IV
pole.

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 19
Figure 3
Figure 4
To GlideScope®GVL®To Aperture™
Video Baton
Video Out

Aperture™ Surgical Surveyor User's Manual
1. Overview
page 20
Hanger
The Hanger provides a place to store both the Video Baton and the
GlideScope®GVL®when they are set up but not in use.
The Hanger can be attached to a rail or an IV pole. Once the Hanger
is attached, the Video Baton cradle and the GlideScope®cradle can be
attached to the 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