Verathon Aperture Manual de usuario

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: 425.867.1348

Fax: 425.883.2896

http://www.verathon.com

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

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.

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.

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