Welch Allyn MacroView - User Manual

Digital MacroView™ Otoscope
Directions for use

Summary

Introduction

System Requirements

Details hardware and software necessary for Digital MacroView operation, including OS and USB port.

Intended Use

Defines the medical applications for the otoscope: external ear, ear canal, and tympanic membrane inspection.

User Profile

Identifies the target users as licensed professionals trained in otoscopy for the Digital MacroView.

Symbols Explained

Clarifies safety and button symbols used in the manual for proper understanding and operation of the device.

Agency Certifications

Lists product compliance with safety and medical device standards, ensuring regulatory adherence.

Warnings and Cautions

Highlights critical safety warnings and cautions to prevent injury, damage, or incorrect use of the device.

Operation

Otoscope Head Attachment

Instructions for attaching the otoscope head to the power source and securing specula correctly.

System Setup

Guide to installing Viewer Utility software and connecting the Digital MacroView system components.

Using the Digital MacroView System

Steps for connecting the device, launching software, and powering on the Digital MacroView for use.

Achieving Focus

Explains methods for obtaining optimal image focus, including default and fine-tune adjustments.

Device Controls

Details the functions of capture, zoom, and rotate buttons for managing images and views.

Image Review and Management

Guides on taking snapshots, recording video clips, viewing full screen, and saving images.

Standby Mode Operation

Information on how the Digital MacroView enters standby and the procedure to restart the active viewing window.

Throat Illuminator Use

Instructions for converting the otoscope to a throat illuminator and associated safety precautions.

Maintenance and Service

Lamp Replacement

Provides essential instructions and safety cautions for the proper replacement of the otoscope lamp.

White Balance Recalibration

Procedure to reset white balance after lamp replacement for accurate color reproduction in images.

Cleaning Recommendations

Guidance on cleaning the Digital MacroView system, with specific cautions regarding lens care.

Component Recycling

Explains proper disposal and recycling procedures for the product and its components, including WEEE directives.

Available Accessories

Lists compatible accessories for the Digital MacroView, such as specula, cables, and replacement lamps.

Service Policy and Warranty

Details warranty terms, repair procedures, and contact information for technical support and service.

Specifications

Limited Warranty

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features
5. Accessories

The Welch Allyn Digital MacroView Otoscope is a medical device designed for the inspection of the external ear, ear canal, and tympanic membrane under magnification. It can also be used for assessing the flexibility of the tympanic membrane (pneumatic otoscopy). This system is intended for use by licensed professionals trained in otoscopy.

Function Description:

The Digital MacroView System consists of a digital otoscope head and a USB Video Cable. To operate, it requires a 3.5-volt Welch Allyn power source and a computer running Windows XP Service Pack 2 or later operating system, a viewing screen, and a USB 2.0 port. The system is designed for "Plug and Play" operation, with illumination and white balance pre-set at the factory.

The otoscope head attaches to a power source by aligning cutouts in the head base with power source lugs, pushing down slightly, and turning 90° clockwise. Removal is achieved by reversing this procedure. The otoscope head is compatible with all 3.5V Welch Allyn power sources. Ear specula are attached by twisting clockwise until they click into the locked position and removed by turning the TipGrip or specula counterclockwise. Only Welch Allyn specula are accepted.

To set up the system, the Welch Allyn Viewer Utility software must be installed on the computer. This software can be found on the provided Viewer CD or the Welch Allyn website. After installation, the USB cable connects the Digital MacroView head to the computer's USB port. The power source should be turned to the FULL ON position for optimum performance, and the Welch Allyn Viewer icon on the desktop should be double-clicked to display the image. The system automatically optimizes image brightness, but color and brightness can be adjusted on the computer monitor if needed.

The otoscope features a focus mechanism with a default position where a green line aligns with a green dot. Fine-tuning the image is done by rotating either of the focus wheels.

The device includes function buttons for various operations:

• Capture: Press and hold either function button for approximately 1 second to freeze the image as a thumbnail on the screen. If the image is rotated, the captured image will also be rotated.
• Zoom: Press and hold either function button for approximately 2 seconds to zoom in for on-screen viewing. Capturing an image in zoom mode produces a standard thumbnail. Pressing either function button again zooms out.
• Rotate: Press and hold both buttons for approximately 4 seconds to rotate the image 180° on screen. Pressing and holding both buttons again returns the image to its original position.

The Welch Allyn Viewer Utility allows for image and video management:

• Snapshot: Click to take a snapshot from the viewer, which displays as a thumbnail.
• Record Video Clip: Click the green icon to start recording and the blue icon to stop. Video clips display as thumbnails marked "Video." A video recorder (e.g., Windows Movie Maker, Windows Media Player) must be installed on the computer.
• View Full Screen: Click to view the image in full screen. Press ESC to return to normal view.
• Settings: Allows users to set the default directory for saving images, specify video capture limit (maximum two minutes), and select the default file format for graphics.
• Save All Images/Videos: Right-click a thumbnail and select "Save."
• View Saved Images/Videos: The window displays the default directory. Users can navigate to files or folders to locate and double-click files to view images.
• Clear All Images/Videos: Right-click a thumbnail and select "Clear."

The Digital MacroView can also transform into a throat illuminator. This is achieved by grasping the otoscope section with one hand and the throat illuminator's collar (under the silver ring) with the other. Twist the otoscope section counterclockwise while holding the collar stationary to remove the otoscope head. To replace, align the otoscope section with the top of the throat illuminator and turn clockwise. When used as a throat illuminator, no images are available on screen or for capture.

Important Technical Specifications:

• Weight: Approximately 95 g (0.2 lb)
• Dimensions (approximate): Height: 7.0 cm (2.8 inches), Length: 10.2 cm (4.0 inches), Width: 3.7 cm (1.5 inches)
• Rating: Lamp: 3.5Vdc, 810 mA; USB: 5.0Vdc, 150 mA
• Protection against ingress of water: IPX0 (Not protected from the ingress of water)
• Operating conditions:
  • Temperature: +10°C to +40°C (+50°F to +104°F)
  • Relative humidity: 30% to 75% noncondensing
  • Altitude: 700 to 1060 hPa
• Shipping and storage conditions:
  • Temperature: -20°C to +49°C (-4°F to +120°F)
  • Relative humidity: 95% noncondensing max.
• Intermittent operation: ≤ 2 minutes on, ≥ 10 minutes off between uses (To minimize external otoscope housing temperatures)
• Safety, EMC, and regulatory compliance: CAN/CSA C22.2 No. 601.1-M90, including amendments 1 & 2; EN/IEC 60601-1; EN/IEC 60601-1-2; UL 60601-1
• Classification: Class 2

Usage Features:

• Digital Imaging: Provides magnified digital images of the ear canal and tympanic membrane.
• "Plug and Play" Operation: Pre-set illumination and white balance for ease of use.
• Software Integration: Utilizes Welch Allyn Viewer Utility for image and video capture, storage, and review.
• Adjustable Focus: Allows for fine-tuning of the image for optimal clarity.
• Image Manipulation: On-screen zoom and 180° rotation capabilities.
• Throat Illuminator Functionality: The otoscope head can be detached to use the base as a throat illuminator.
• Standby Mode: The active viewing window shuts down after approximately 12 hours of continuous connection to the computer. It can be restarted by pressing either function button and re-opening Windows Explorer or by double-clicking "My Computer" and then "USB Video Device."

Maintenance Features:

• Lamp Replacement: The only user-serviceable/replaceable part is the lamp (Welch Allyn lamp REF 06500-U). Halogen lamps are pressurized and require careful handling with protective eyeglasses. Lamps may be hot, so allow them to cool before removal.
• White Balance Recalibration: After replacing the lamp, the white balance must be recalibrated. This involves connecting the head to the computer, turning the power source to FULL ON, shining the light on a piece of white paper (approx. 3.2 cm away), and inserting an unfolded paperclip into the white balance reset hole to activate the reset button. The image will turn blue, then return to a live image when calibrated. If the screen turns red, the process should be repeated.
• Cleaning: Use a dry cloth to clean the Digital MacroView System monthly. Do not apply alcohol, chemicals, or water to the lenses, as solution entering the optical assembly could damage internal components.
• Recycling: Within the EU, dispose of the product for reuse or separate collection as specified by Directive 2002/96/EC (WEEE). If contaminated, this directive does not apply. Outside the EU, recycle locally or return to Welch Allyn.
• Service Policy: All repairs under warranty must be performed or approved by Welch Allyn. Unauthorized repairs void the warranty. For assistance, service, or spare parts, contact Welch Allyn Customer Service. When returning goods for service, obtain a Service Notification number, remove ancillary products, use original shipping carton and packing materials, and include a packing list and Service Notification number. Insure returned goods.

Accessories:

• Replacement USB cable, 10 ft length (23900-10)
• Insufflator bulb for MacroView (23804)
• 3.5v Throat Illuminator section only (23857)
• Universal Poly Reusable Speculum (2.5mm, 3mm, 4mm, 5mm) (24302-U, 24303-U, 24304-U, 24305-U)
• Set of 4 Universal Reusable Speculum (24400-U)
• Disposable Ear Specula (2.75mm, 4.25mm) (52432-U, 52434-U)
• SofSeal Small, Disposable Sealing Tip (24320)
• SofSeal Medium, Disposable Sealing Tip (24330)
• Lamp (06500-U)
• Directions for Use - CD (23920MAN/23960MAN)
• Quick Start Guide (23920-QSG)

Welch Allyn MacroView Specifications