Welch Allyn MacroView Directions For Use Manual

Digital MacroView™ Otoscope

Directions for Use

ii

Welch Allyn. All rights are reserved. No one is permitted to

reproduce or duplicate, in any form, this manual or any part thereof without

permission from Welch Allyn.

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.

iii

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

Reorder CD No. 23920MAN/23960MAN

DIR No. 80012182 Ver. E Printed in USA

USA + 1 315 685 4560

800 535 6663

Australia + 61 29 638 3000

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

Welch Allyn

4341 State Street Road,

PO Box 220

Skaneateles Falls, NY

13153-0220

www.welchallyn.com

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

EC REP

iv

v

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

vi

1

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 general illumination of

the throat and/or nasal cavities or assessing 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

Button Symbols

Agency Symbols

WARNING Caution

Caution: Consult

accompanying

documentation

IPXØ

Not protected from the

ingress of water

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

CONFORMS TO:

UL STD 60601-1

IEC 60601-1

US

C

166292

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.

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

EC REP

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.

Directions for use Digital MacroView 5

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.

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 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.

6 Introduction Welch Allyn

Caution To minimize external otoscope housing

temperatures, on-time should not exceed 2 minutes and

off-time a minimum of 10 minutes.

Caution Only accepts Welch Allyn specula.

Caution Use only Welch Allyn approved lamps.

Caution Do not apply alcohol, chemicals, or water to

the lenses. Solution entering the optical assembly could

damage internal components.

7

2

Operation

Using the otoscope head

Align the cutouts in the otoscope head base with power source

lugs. Push down slightly and turn 90° clockwise. To remove,

reverse this procedure. The otoscope head fits all 3.5v

Welch Allyn power sources.

Lug

Cutout

Attach: Twist the specula

clockwise until it clicks into

the locked position.

Remove: Turn the TipGrip or

twist the specula

counterclockwise.

Caution Only accepts

Welch Allyn specula.

TipGrip

8 Operation Welch Allyn

Setup

Prior to using the Digital MacroView for the first time, install the

Welch Allyn Viewer Utility following the instructions provided

with the Viewer CD.

Using the Digital MacroView System

1. Verify the power source is off and attach the Welch Allyn

Digital MacroView head to the power source

(see page 7).

2. Connect the USB cable to the port on the back of the Digital

MacroView head and to the computer USB port. The

computer gives an audible signal that the connection is

complete.

3. Double-click the Welch Allyn Viewer icon on your computer

desktop.

USB Port

Directions for use Digital MacroView 9

4. Turn the power source to FULL ON position to achieve

optimum performance. The computer displays an image.

Digital MacroView automatically optimizes the image

brightness.

If necessary, adjust the color and brightness controls on the

computer monitor for picture quality.

Using focus

Default Position: align the green line to the green dot.

Free Focus: rotate either

wheel to fine-tune the

image.

10 Operation Welch Allyn

Using the controls

Capture: Press and hold either function button for

approximately 1 second. Upon

release of the function button the

image freezes as a thumbnail on the screen. If the image is rotated

(see below) then the captured image is rotated.

Zoom: Press and hold

either function button for approximately

2 seconds. Zoom is for on-screen viewing purposes only. Capturing

an image while in zoom mode produces a standard thumbnail. Press

and hold

either function button again to zoom out.

Rotate: Press and hold

both buttons for approximately 4 seconds.

Image rotates 180° on screen. Press and hold again to return the

image to its original position.

Directions for use Digital MacroView 11

Reviewing images

Settings:

Default Directory: Click Browse and

select the file path where you want

to save your images.

Video Clip Length: Select Video

Capture Limit and select an option.

Two minutes is the maximum

allowable length of a recorded video.

Default File Format: Select an

available file type for your graphics.

View Full Screen: Click to view full

screen.

Press ESC to return to the normal

view.

Record Video Clip: Click to start

recording (green icon); click again to

stop recording (blue icon). Video clip

displays as a thumbnail on the

screen and marked as Video.

NOTE: You must have a video

recorder such as Windows Movie

Maker or Windows Media Player

installed on your computer.

Snapshot: Click to take a snapshot

from the viewer. Image displays as a

thumbnail on the screen.

View Saved Images/Videos:

Window displays default directory for

storage. Select the file or select

another diretory or folder to locate the

desired file. Double-click on the file

name to view the image.

Clear All Images/Videos: Select Yes.

To clear a single image/video:

Right-click the thumbnail and select Clear. Answer Yes.

Save All Images/Videos: Select Yes.

To save a single image/video:

Right-click the thumbnail and select

Clear. Answer Yes.

12 Operation Welch Allyn

Standby Mode

The Digital MacroView shuts down the active viewing window

after approximately 12 hours of continuous connection to the

active viewing window and computer.

To restart the Digital MacroView:

1. Press either function button and re-open Windows Explorer.

2. Open Windows Explorer and click My Computer in the left

pane. Double-click the USB Video Device.

Or double-click the My Computer icon on your computer

desktop and double-click the USB Video Device.

Directions for use Digital MacroView 13

Using the throat illuminator

The Welch Allyn Digital MacroView can transform into a throat

illuminator. While using the throat illuminator there are no images

available on screen or for capture.

1. Grasp the otoscope section with the left hand.

2. Grasp the throat illuminator’s collar at (under the silver ring).

3. Hold the throat illuminator collar stationary, twist the

otoscope section counterclockwise until the otoscope head

is removed.

To replace otoscope section, align the otoscope section with

the top of the throat illuminator and turn clockwise.

WARNING It is important to note that while the throat

illuminator section provides an excellent source of

general illumination, avoid more than momentary direct

skin contact due to possible heat build up.

Throat

Illuminator

Throat

Illuminator

14 Operation Welch Allyn

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