Welch Allyn OAE Data Manager User Manual

®
Welch Allyn
Directions for use
OAE Data Manager
© 2014 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, 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 statement of intended use published in this manual.
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company/locations.htm.
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39411-1 (CD)
Material Number 105889 DIR 80019029 Ver. B
Manufactured for Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA
Grason-Stadler 7625 Golden Triangle Drive Eden Prairie, Minnesota 55344USA
www.welchallyn.com
39411-2 (printed copy)
Material Number 105890, DIR 80019029 Ver. B
GSI 8104595 Rev. B

Contents

Introduction ............................................................................................. 1
Symbols ................................................................................................... 3
Setup ........................................................................................................ 5
iii
Indications for use ................................................................................................ 1
About warnings and cautions ............................................................................... 3
Precautions for patient confidentiality .................................................................. 5
Warnings and cautions ......................................................................................... 5
System requirements .......................................................................................... 6
Install the data manager ....................................................................................... 6
Connect the screener .......................................................................................... 7
Understand the data manager interface ............................................... 9
Ribbon elements .................................................................................................. 9
Home tab ........................................................................................................... 10
Settings and Audit tab ........................................................................................ 20
View patient results ............................................................................... 23
Patients and Recent Results tabs ...................................................................... 23
Customize the display ........................................................................... 29
Sort the patients list ........................................................................................... 29
Move columns ................................................................................................... 30
Add columns ...................................................................................................... 30
Remove columns ............................................................................................... 30
Change the size of a window ............................................................................. 30
Remove sections ............................................................................................... 30
Typical use case: Transfer patient names to screener and data to the
data manager .........................................................................................
Typical use case ................................................................................................. 31
Transfer patient names to the screener and test ............................................... 31
Test patients ...................................................................................................... 31
Transfer results from the screener to the data manager ................................... 31
Print results ........................................................................................................ 32
Transfer results from the screener to the data manager ................................... 32
31
Typical use case: Collect, transfer, and assign results to a patient
record ..................................................................................................... 33
Use case: Collect, transfer, and assign results to a patient record .................... 33
iv
Contents Welch Allyn® OAE Data Manager

Introduction

This directions for use describes the capabilities and operation of the Welch Allyn OAE Data Manager (data manager).
The data manager is data management software that compliments the Welch AllynOAE Screener (screener). It provides the ability to transfer patient otoacoustic emissions (OAE) test data from the data manager to a computer to view, archive, manage, or print OAE reports; and transferring patient names to the screener. For Newborn Hearing Screening Programs, the data manager integrates with third party database tools, such as HiTrack and OZ eSP.
1
Reports can be saved in different electronic formats or image formats and attached to electronic medical records (EMRs):
Format Options
Electronic .pdf, .rtf
Image .jpg, .tif, .gif, .png, .bmp, .emf, and .wmf

Indications for use

The data manager is used to view, archive, and report OAE data acquired from test results saved in the screener. The screener is connected to a computer and the OAE data is transferred to the computer, where it is accessed by the data manager. The data manager also can generate patient names and transfer the names to the screener. The OAE data is incorporated into hearing screening programs for patients of all ages and used by pediatricians, internists, family practitioners, nursing staff, or nurse managers. The screener and data manager have to be connected to a computer in order for test results to be transferred, viewed, and saved. Data previously transferred to the data manager may be viewed for evaluation without connecting to the screener. Data transferred from the screener includes Distortion Product Otoacoustic Emissions (DPOAEs) from each ear; they are displayed in graphic and tabular formats. The data includes screening data from one or both ears. Screening data result options are PASS, REFER, NOISE, and NO SEAL. The patient demographic and test result data are saved to a directory for future retrieval or convertion to an electronic format for transfer to an EMR program.
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Introduction Welch Allyn® OAE Data Manager

Symbols

Documentation symbols

WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.
3
CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols.

Regulatory symbols

Symbol
Description Symbol Description
Serial number EU Authorized
Manufacturer Reorder number
Consult Operating Instructions

About warnings and cautions

Representative
Warning and caution statements appear on the Welch Allyn OAE screener (screener), on the packaging, and on the shipping container.
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Symbols Welch Allyn® OAE Data Manager

Setup

Precautions for patient confidentiality

Protecting patient information is essential to the relationship between provider and patient. It is critical to develop policies and procedures that safeguard electronic patient information stored by your organization. The following processes help ensure the security of your patient data.
Create regular backups the data.
Store a backup of the data in a safe manner.
Encrypt data to avoid misuse if stolen.
Create unique computer logins for all users.
Encrypt all communication to the data manager when using a third party networked software in case information is captured during network transmission. See your third party user manual for details.
Create unique software logins for everyone using a third party networked software. This enables you to trace and identify anyone who updates or deletes data from the data manager. See your third party user manual for details.
5

Warnings and cautions

WARNING Use only the provided power supply to charge the screener. Injury to personnel or damage to the screener can result when a three­prong to two-prong adaptor is connected between the screener power supply and a mains outlet.
WARNING No modifications to the screener are allowed by anyone other than a qualified Welch Allyn service representative. Modification of the screener could be hazardous to patients and personnel.
WARNING The screener has been verified by an independent laboratory to conform to international standards for electromagnetic emissions and immunity (EMC). The user is advised to avoid installation and use of this screener in proximity to other products or equipment that may emit or be susceptible to electromagnetic interference, including cellular phones. If the screener is used adjacent to other products or equipment, you are instructed to verify that no disturbance is found in the operation of this or other equipment in proximity.
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Setup Welch Allyn® OAE Data Manager
WARNING Any program aimed at obtaining reliable measurements of otoacoustic emissions should be staffed and supervised by appropriately trained individuals.

System requirements

Systems requirements are listed for:
Computer (minimum)
Operating systems
Software

Computer requirements

Following are the minimum computer requirements needed for the data manager.
CPU: 1 GHz
RAM: 512 MB
Hard Disk: 2 GB
USB Port: 1 each for the screener, data manager and, if used, a printer
Display Resolution: 1024 x 768
CD-ROM: Required if installing from a CD
Network connections: 1 each if installing from a network location or printing to a network printer
Internet browser: Internet Explorer 6.0 or later and current service pack are recommended

Supported operating systems

Microsoft Windows® 7, 8, Vista, XP Professional or Home (Service Pack 3)
Microsoft Windows® Server (2003 or newer); Windows Imaging Component (WIC) also must be installed

Software requirements

Microsoft .NET Framework version 4.0 (bundled with installer if not already installed)
Adobe®Reader
FTDI USB Driver for instrument connection

Install the data manager

Always make a copy of the database file and store the file in a safe location before a new installation or upgrade.
Each screener comes with a data manager. The data manager can be installed from the supplied flash drive or from the CD.
Directions for use Setup 7

Install from the CD

1. Insert the CD into the computer’s CD drive.
2. Go to Windows Explorer > Computer: > CD Drive (X:) > setup.exe.
3. Double-click setup.exe, and then follow the directions.

Connect the screener

There are two options for connecting the screener to a computer:
From the screener to a computer using a USB connection.
From the screener cradle to a computer using a USB connection.
From the screener to a computer using a Bluetooth WiFI connection
The instructions in this Directions for use assume connections are made directly to the screener using a USB connection. However, all functions also can be performed with the screener in the cradle using a USB connection or a WiFi Bluetooth connection.

Connect the screener to a computer

Use a standard USB to micro-USB cable to connect the screener to a computer:
1. Power on the screener and ensure that the screener is charged.
2. Plug the micro-USB connector into the port on the bottom of the screener.
3. Plug the USB connector into a USB port on the computer.
4. Power on the computer, and then launch the data manager.
The message, “Waiting on computer” appears on the screener.
5. Begin data or name transfers.

Connect the screener cradle to a computer

Use a standard USB to micro-USB cable to connect the screener cradle to a computer:
1. Power on the screener and ensure that the screener is charged.
2. Plug the micro-USB connector into the port on the bottom of the screener cradle. The cradle does not need to be connected to a mains outlet for data transfer.
3. Plug the USB connector into a USB port on the computer.
4. Place the screener in the cradle.
5. Power on the computer, and then launch the data manager.
The message, “Waiting on computer” appears on the screener.
6. Begin data or name transfers.
Connect the screener to a computer using Bluetooth
You can only pair one device with the screener at any given time.
1. Power on the screener and ensure that the screener is charged.
2. Power on the computer, and then launch the data manager.
®
Setup Welch Allyn® OAE Data Manager
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The message, “Waiting on computer” appears on the screener.
3. If this is the first time the screener is being connected using Bluetooth, then on the Transfer section of the Home tab, click Detect Com Port.
4. Ensure that the screener is paired to your computer.
Pairing is only required upon initial data transfer.
5. On the Main menu of the screener, press the UP control panel button.
The BT menu appears.
6. Press the LEFT or RIGHT control panel button to begin data or name transfers.
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