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Digital MacroView™
Veterinary Otoscope
Directions for use
ii
© 2014 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.
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 80019713 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
EC REP
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
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
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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.
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 general illumination of the throat and/or nasal cavities.
User Profile
The Digital MacroView is intended for licensed professionals trained in otoscopy.
1
2
Introduction Welch Allyn
Symbols
Safety symbols
WARNING Caution
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
IPXO
Not protected from the ingress of water
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.
Button symbols
Capture Image
Rotate Image
Directions for use Digital MacroView
3
Agency certifications
CERTIFIED TO:
CAN/CSA STD C22.2 NO. 601.1
CONFORMS TO:
UL STD 60601-1
IEC 60601-1
EC REP
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.
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.
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.
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.
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.
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.
7
Cutout
Lug
Caution Only accepts
Welch Allyn specula.
Attach
: Twist the specula clockwise until it clicks into the locked position.
Remove
: Turn the TipGrip or twist the specula counterclockwise.
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.
The software can also be found on the Welch Allyn Website at http://www.welchallyn.com/en/service-support/softwaredownloads.html
.
Using the Digital MacroView system
1.
Verify the power source is off and attach the Welch Allyn
Digital MacroView head to the power source
.
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.
USB Port
Directions for use Digital MacroView
9
3.
Double-click the Welch Allyn Viewer icon on your computer desktop.
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
Using the controls
Welch Allyn
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.
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
Reviewing images
Snapshot
: Click to take a snapshot from the viewer. Image displays as a thumbnail on the screen.
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.
View Full Screen
: Click to view full screen.
Press ESC to return to the normal view.
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.
Digital MacroView
11
Save All Images/Videos
: Right-click the thumbnail and select Save. Click OK.
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
: Right-click the thumbnail and select
Clear. Click OK.
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.
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.
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.
Throat
Illuminator
Throat
Illuminator
14
Operation Welch Allyn
3
Maintenance and service
Replacing the lamp
15
Caution Halogen lamps are pressurized to provide maximum efficiency and illumination. Mistreatment may cause shattering. Protect lamp surface against abrasions and scratches. Use protective eyeglasses when handling. Dispose of lamp with care.
Caution Only use Welch Allyn lamp REF 06500-U.
Caution Lamps may be hot. Allow the lamps to cool before removing.
Caution Avoid removing the lamp for reasons other than replacement.
16
Maintenance and service Welch Allyn
It is necessary to re-calibrate the white balance on the Digital
MacroView after replacing the lamp.
To recalibrate the white balance:
Use a fully-charged 3.5v power source.
1.
Connect the head to the computer and turn the power to the
full on position see “Using the Digital MacroView system” on page 8.
2.
Shine the light on a piece of white paper approximately
3.2 cm (1.25”) away.
3.
Unfold a standard paperclip and insert it into the white balance reset hole. Push slightly to activate the white balance reset button.
The image becomes blue on the computer screen. A live image returns to the computer screen when calibrated.
If the screen is red then repeat steps 1 through 3 above.
White balance reset hole
Directions for use Digital MacroView
17
Cleaning recommendation
Caution Do not apply alcohol, chemicals, or water to the lenses. Solution entering the optical assembly could damage internal components.
Use a dry cloth to clean the Digital MacroView System monthly.
18
Maintenance and service Welch Allyn
Recycling the system components
Within the EU
Do not dispose of this product as unsorted municipal waste. Prepare it for reuse or separate collection as specified by Directive 2002/96/EC of the European
Parliament and the Council of the European Union on Waste
Electronic and Electrical Equipment (WEEE).
If this product is contaminated, this directive does not apply.
For more specific disposal information, see www.welchallyn.com/weee , or contact Welch Allyn Customer
Service.
Outside the EU
When the product and its components reach end of life, recycle it locally according to national, state, and local regulations, or return it to Welch Allyn.
Directions for use
Accessories
REF
23900-10
23834
23834-S
23835-S
23835
23847
23942
23837
06500-U
23920MAN/
23960MAN
23960-QSG
Digital MacroView
19
Description
Replacement USB cable, 10 ft length
4mm Vet Reusable Specula
4.8mm Short Vet Reusable Specula
5mm Short Vet Reusable Specula
5mm Vet Reusable Specula
7mm Veterinary Instrumentation Specula
Vet Reusable Specula Set of 5
7mm Vet Reusable Specula
Lamp
Directions for Use - CD
Quick Start Guide
20
Maintenance and service Welch Allyn
Service policy
All repairs on products under warranty must be performed or approved by Welch Allyn.
Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Welch Allyn certified service personnel.
If the product fails to function properly — or if you need assistance, service, or spare parts — contact Welch Allyn.
Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to ensure that they are not causing the problem. When calling, please be prepared to provide:
• Product name and model number and complete description of the problem.
• Serial number of your product (if applicable).
• Complete name, address and phone number of your facility.
• For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number.
• For parts orders, the required spare or replacement part numbers.
If your product requires warranty, extended warranty, or non-warranty repair service, please call Welch Allyn. A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone, avoiding potential unnecessary returns.
In case a return cannot be avoided, the representative will record all necessary information and will provide a Service Notification number, as well as the appropriate return address. The Service Notification number must be obtained prior to any return.
If you have to return goods for service, follow these recommended packing instructions:
• Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate) before packing, unless you suspect they are associated with the problem.
• Wherever possible use the original shipping carton and packing materials.
• Include a packing list and the Welch Allyn Service Notification number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product must be initiated by the sender.
4
Specifications
Item
Weight
Dimensions
(approximate)
Rating
Protection against ingress of water
Operating conditions
Temperature
Relative humidity
Altitude
Shipping and storage conditions
Temperature
Relative humidity
Intermittent operation
Safety, EMC, and regulatory compliance
Patents
Classification
Specification
Approximately 95 g (0.2 lb)
Height: 7.0 cm (2.8 inches)
Length: 10.2 cm (4.0 inches)
Width: 3.7 cm (1.5 inches)
Lamp: 3.5Vdc, 810 mA
USB: 5.0Vdc, 150 mA
IPXØ
+10° C to +40° C (+50° F to +104° F)
30% to 75% noncondensing
700 to 1060 hPa
-20° C to +49° C (-4° F to +120° F)
95% noncondensing max.
< 2 minutes on, > 10 minutes off between uses
CAN/CSA C22.2 No. 601.1-M90, including amendments 1 & 2
EN/IEC 60601-1
EN/IEC 60601-1-2
UL 60601-1
Patents Pending
Class 2
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22
Specifications Welch Allyn
Limited Warranty
Welch Allyn warrants that the Digital MacroView products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within one year after the date of purchase. Neither the lamp or specula have an explicit warranty beyond out of box failures.
The date of purchase is: 1) the date specified in our records if you purchased the Product directly from us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3) the date of purchase of product from the authorized Welch Allyn distributor as documented from a receipt from said distributor.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or maintenance contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4) accidents.
If a Product or accessory covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period described above, Welch Allyn will, at its discretion, repair or replace the defective Product or accessory free of charge.
You must obtain a service notification number from Welch Allyn to return your Product before you send it to Welch Allyn’s designated service center for repair. Contact Welch
Allyn Technical Support.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN’S OBLIGATION UNDER THIS
WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A
DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL
DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.
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Limited Warranty Welch Allyn Digital MacroView
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