Welch Allyn Digital MacroView Otoscope User Manual

Digital MacroView™ Otoscope

Directions for Use

Caution: Federal law restricts this device to sale by or on the order of a licensed professional trained in otoscopy.

Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn, Inc. Digital Macroview is a trademark of Welch Allyn, Inc.

Software in this product is copyright Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors.

Caution: Changes or modifications not expressly approved by Welch Allyn could void the purchaser’s authority to operate the equipment.

For information about any Welch Allyn product, call Welch Allyn Technical Support:

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USA + 1 315 685 4560

Australia + 61 29 638 3000

800 535 6663

Canada 800 561 8797 China + 86 216 327 9631

European Call Center + 353 46 906 7790 France + 331 6009 3366

Germany + 49 747 792 7186 Japan + 81 33 219 0071

Latin America + 1 305 669 9003 Netherlands + 31 15 750 5000

Singapore + 65 6419 8100 South Africa + 27 11 777 7555

United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551

Reorder No. 23920MAN/23960MAN

80012182 Ver. F Printed in USA

Welch Allyn 4341 State Street Road, PO Box 220 Skaneateles Falls, NY 13153-0220

www.welchallyn.com

EC REP

European Regulatory Manager Welch Allyn Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 Fax: +353 46 90 67755

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

User Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Using the otoscope head . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Using the Digital MacroView System. . . . . . . . . . . . . . . . . . 8

Using focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Using the controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Reviewing images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Using the throat illuminator . . . . . . . . . . . . . . . . . . . . . . . . 13

3 Maintenance and service. . . . . . . . . . . . . . . . . 15

Replacing the lamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Cleaning recommendation . . . . . . . . . . . . . . . . . . . . . . . . . 16

Recycling the system components . . . . . . . . . . . . . . . . . . 17

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Service policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Introduction

The Digital MacroView System consists of a digital otoscope head and a USB Video Cable. A 3.5 volt Welch Allyn power source and a computer are necessary to use the Digital MacroView System.

The Digital MacroView System is designed for “Plug and Play” operation - all adjustments including illumination and white balance are pre-set at the factory.

System Requirements

The Digital MacroView requires a user device running Windows XP Service Pack 2 or later operating system, a viewing screen, and a USB 2.0 port.

Intended use

The otoscope is intended to allow inspection of the external ear, ear canal, and tympanic membrane under magnification. A secondary use of the otoscope may be for assessing the flexibility of the tympanic membrane (pneumatic otoscopy).

User Profile

The Digital MacroView is intended for licensed professionals trained in otoscopy.

2 Introduction Welch Allyn

Symbols

Safety Symbols

WARNING Caution

Button Symbols

Agency Symbols

Caution: Consult accompanying documentation

Type BF Temperature limits

USB Relative humidity limit

Recycle the product separate from other disposables. See “Recycling the system components” on page 17.

Capture Image

Zoom

CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1

IPXØ

Not protected from the ingress of water

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CONFORMS TO: UL STD 60601-1

IEC 60601-1

Directions for use Digital MacroView 3

The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/ EEC Medical Device Directive.

EC REP

European Regulatory Manager Welch Allyn Ltd. Navan Business Park • Dublin Road • Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 • Fax: +353 46 90 67755

4 Introduction Welch Allyn

Warnings and cautions

Familiarize all operating personnel with the general safety information in this summary. Specific warnings and cautions are also found throughout this manual. Such specific warnings and cautions may not appear here in this summary.

Warnings

A warning statement in this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to injury, illness, or death.

WARNING Do not use in the presence of flammable anesthetics.

WARNING This product has no user serviceable/ replaceable parts except for the lamp. Please refer all other service to authorized service personnel.

WARNING This instrument is not intended to be used in the eye.

WARNING This product generates and records reference images from inputs obtained from the Welch Allyn Digital Macroview. These reference images are not intended for diagnostic purposes.

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