Welch Allyn MacroView Directions For Use Manual

Digital MacroView™ Otoscope

Directions for use

EC REP

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 All yn 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.

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

For patent information, please visit www.welchallyn.com/patents.

For information about any Welch Allyn product, contact your local Welch Allyn representative: www.welchallyn.com/about/company/locations.htm.

DIR 80019712 Ver A

This manual applies to 901021 Otoscope, Wideview

Welch Allyn, Inc. 4341 State Street Road, PO Box 220 Skaneateles Falls, NY 13153 USA

www.welchallyn.com

European Regulatory Manager Welch Allyn Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland

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

iii

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

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

Cleaning recommendation . . . . . . . . . . . . . . . . . . . . . . . . . 17

Recycling the system components . . . . . . . . . . . . . . . . . . 18

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Service policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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.

Current available Digital MacroView versions:

• 23920 Digital MacroView for medical

• 23960 Digital MacroView for veterinarian

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

Consult operating instructions/directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Product identifier Reorder number

Type BF applied part Temperature limit

USB Humidity limitation

Recycle the product separate from other disposables. See “Recycling the system components” on page 18.

Capture Image

IPXO

Not protected from the ingress of water

Zoom

Directions for use Digital MacroView 3

EC REP

Agency certifications

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

CONFORMS TO: UL STD 60601-1

IEC 60601-1

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.

European Regulatory Manager Welch Allyn Ltd. Navan Business Park • Dublin Road • Navan, County Meath, Republic of Ireland

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 No modification of the equipment is allowed.

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.

Cautions

A caution statement in this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to equipment failure, equipment damage, or data loss.

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.

Directions for use Digital MacroView 5

Caution In order to obtain optimum performance and ensure patient safety, thoroughly read this booklet.

Caution The Digital MacroView System is designed expressly for use with an approved Welch Allyn 3.5v power source. Damage to the system will occur if alternate power sources are attached to the video head.

Caution Do not use the Digital MacroView if you notice any signs of damage to the components of the system. Contact Customer Service Department for immediate assistance.

Caution Before each use, the outer surface of the ear specula on the Digital MacroView which is intended to be inserted into a PATIENT should be checked to ensure there are no unintended rough surfaces, sharp edges or protrusions which may Cause a SAFETY HAZARD.

Caution Do not attempt to disinfect the Digital MacroView System using glutaraldehyde products, ethylene oxide gas, steam or any other liquid or gas disinfectant.

Caution The signal output (USB Port) connector is intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC

60950), as appropriate to the device. Connecting additional devices to the Digital MacroView System is configuring a medical system and you are responsible for verifying that the system complies with the requirements of the system standard IEC 60601-1-1

Caution This product complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment.

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