DataFlow Users Guide Software 1.1.

Purchase of this instrument confers no express or implied license under any Puritan Bennett patent. To obtain information about a warranty, if any, contact Puritan Bennett’s Technical Services Department (in the U.S.A. 1.800.255.6774), or your local Puritan Bennett representative, outside the U.S.A.

Contents Contents... i Safety Information... 1 Introduction ... 1 Warnings ... 1 Cautions ... 2 Notes ... 2

Introduction... 3 About DataFlow Data Management Software ... 3 Intended Use ... 3 Indications for Use ... 4 Installation Requirements ... 4 Technical Support ... 4 Overview ... 5 Getting Started ... 5 Sample Database ... 8 Using DataFlow Software with Spirometry Testing ... 9

Program Design/Interface...11 Main Interface ... 11 Resizing Columns ... 12 Resorting Columns ... 12 Views ... 12 Patients View ... 13 Sessions List ... 14 Session View ... 14 Calibrations List ... 15 Calibration View ... 16 Trends View ... 18 Spirometers View ... 19 Find Screen ... 20

Setup... 23 Application Setup Screen ... 23 Units Tab Setup ... 23 Sessions Tab Setup ... 24 Header Tab Setup ... 27 Spirometry Tab Setup ... 28 Ports Tab Setup ... 31 Compact Tab Setup ... 32 Backup Tab Setup ... 33 Print Setup ... 35

Databases... 37 Introduction ... 37

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Contents

Creating New Databases ... 37 Saving Databases ... 38 Opening Databases ... 38 Opening Databases From a Command Line ... 39 Adding Data to Databases ... 39 Database Data versus Spirometer Data ... 39

Wizards... 41 Wizards Overview ... 41 Using Wizards ... 41 Backup Wizard ... 42 Backup Wizard - File Name ... 43 Backup Wizard - Wizard Complete ... 44 Restore Wizard ... 45 Restore Wizard - File Name ... 45 Restore Wizard - Wizard Complete ... 48 Compact Wizard ... 48 Compact Wizard - Introduction ... 49 Compact Wizard - Wizard Complete ... 49 Import Wizard ... 50 Import Wizard - File Name ... 51 Import Wizard - Search ... 52 Import Wizard - Select Patients ... 54 Import Wizard - Select Sessions ... 55 Import Wizard - Import Progress ... 55 Import Wizard - Renaissance DB Data Import ... 58 Export Wizard ... 62 Export Wizard - Export Type ... 63 Export Wizard - File Name ... 64 Export Wizard - Delete Mode ... 65 Export Wizard - Export Progress ... 67 Export Wizard - Wizard Complete ... 67 Flash Upgrade Wizard ... 68 Flash Upgrade Wizard - Choose File ... 69 Flash Upgrade Wizard - Configurations List ... 70 Flash Upgrade Wizard - Validate Version ... 70 Flash Upgrade Wizard - Getting Files ... 71 Flash Upgrade Wizard - Downloading ... 71 Flash Upgrade Wizard - Wizard Complete ... 73

Patients... 75 Getting and Working with Patient Data ... 75 Editing Patient Data ... 75 Deleting Patients ... 77 Patient Demographic Reports ... 78 Creating Patient Demographics Reports ... 79 Printing Patient Demographics Reports ... 79

Session View... 81 Introduction ... 81 Session View - Fields ... 81 ii

Contents

Options ... 83 Display Options ... 83 Med Type Check Boxes ... 84 Offset Curves Check Box ... 85 Curves Display Option ... 85 Data Display Option ... 86 Both Display Option ... 87 Legend Display Option ... 88 Tabs ... 90 FVC Tab ... 90 SVC Tab ... 90 MVV Tab ... 91 FEV6 Tab ... 92 SSD Tab ... 93 Summary Tab ... 94 FVC/FVL Pre-Medication Summary Tab ... 95 FVC/FVL Post-Medication Summary Tab ... 96 FEV6 Pre-Medication Summary Tab ... 96 FEV6 Post-Medication Summary Tab ... 97 Simplicity Tab ... 97 Deleting Sessions ... 98 Comparing Sessions ... 99 Edit Session Demographics ... 99 Graphs ... 100 Understanding Session Graphs ... 100 Viewing Graphical and Tabular Formats ... 101 Viewing Offset or Overlaid Curves ... 101 Viewing Med Types ... 103 Viewing Predicted Curves ... 103 Graph Legends ... 103 Test Modes ... 104 Best and Best 3 Test Trials ... 105 Last Test Trials ... 107

Spirometers... 109 Introduction ... 109 Getting Spirometer Data ... 109 Sending Data to the Spirometer ... 110 Editing Spirometer Names ... 111 Deleting Spirometers or Calibration Dates ... 111 Clearing Spirometer Data ... 112 Upgrading the Spirometer's Firmware ... 112 Edit Spirometer Form ... 113

Calibrations...115 Getting and Working with Calibrations ... 115 Calibration Check Reports ... 115 Creating Calibration Check Reports ... 116 Printing Calibration Check Reports ... 116 Configuring Report Appearance ... 117 Calibrations List ... 117 DataFlow Software User’s Guide

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Calibrations List - Resorting Columns ... 118 Calibration View ... 118 Fields ... 119 Calibration Check Reports ... 120 Understanding Calibration Graphs ... 120

Trends... 123 Getting and Working with Trends ... 123 Trends Reports ... 123 Time Scale ... 124 Graph Points ... 125 Understanding Trends Graphs ... 125 Graph Ranges ... 128 Graph Legends ... 128 Trend View Tabs ... 129 Volume Tab ... 129 Flow Tab ... 131 Percent Tab ... 132

Graphs... 135 Changing Graph Appearances ... 135 Predicted Curves ... 136

Searches/Queries... 139 Searching and Querying ... 139 Creating a New Query ... 139 Saving Queries ... 142 Saving Queries for the First Time ... 142 Re-saving Queries ... 142 Re-saving Queries to New Names ... 143 Opening Saved Queries ... 143 Deleting Queries ... 143 Boolean Precedence ... 144 Query Parameters ... 145 Advanced Find Screen ... 146 Query Edit Screen ... 149 Query Box ... 149 Displaying the Query Edit Screen ... 150 Query Add Line Screen ... 150 Rel ... 151 Arith ... 151 Errors ... 152 Query Open Screen ... 152 Open Drop-down List ... 152 Query Menu ... 153 Query Save As Screen ... 153 Query Name ... 154 Query Menu ... 154

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Reports... 155 Creating Reports ... 155 Creating Trends Reports ... 155 Report Formats ... 156 Changing Report Appearance ... 156 Creating PDF Files ... 157 Sending Reports by Fax Machines ... 157 Trend Reports ... 157 Best Reports ... 157 Printing Best Reports ... 158 Understanding Best and Best 3 Test Trials ... 159 Configuring Report Appearance ... 159 Best 3 Reports ... 159 Creating Best 3 Reports ... 160 Printing Best 3 Reports ... 160 Last Reports ... 160 Serial Comparison Report ... 162 Printing ... 163

Printing, Faxing and E-mailing... 165 Printing ... 165 Preview Mode ... 165 Preview Toolbar ... 166 Page Numbers ... 166 Navigating ... 166 Printing Selected Sessions ... 167 Printing Trends Reports ... 167

Troubleshooting... 169 Getting Help ... 169 Error Messages and What They Mean ... 169

Glossary of Medical Terms... 173 References... 177 Index... 179

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Safety Information

Introduction

Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or caregiver.

Cautions are identified by the CAUTION symbol shown above. Cautions help you avoid damaging the equipment or losing data.

Notes are identified by the NOTE symbol shown above. Notes provide information and or additional information to the user.

Warnings Warning: Results from spirometer testing should not be the sole source for determining a patient’s diagnosis and treatment. Other clinical data, such as patient symptoms and respiratory history, should always be considered.

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Safety Information

Cautions Caution: Back up the database on a regular schedule. Backing up the database provides restoration if the database becomes inadvertently corrupted or deleted. Caution: Patient data is confidential. Be careful not to leave patient reports, faxes, fax copies, or printouts in unsecured locations. Be careful not to leave the database open on a monitor that non-medical personnel could view. Caution: Do not disconnect or switch devices while using DataFlow Software to transfer data to or from the spirometer. Caution: Clearing the spirometer will permanently delete all patient tests from the spirometer. Caution: Once installed, upgraded firmware in the spirometer is a permanent part of a device. The upgrade cannot be undone. Caution: Patient data is confidential. Securely encrypt any E-mail transmission of patient data. Caution: The database should be backed up on a regular schedule. Backing up the database allows restoring the database if it becomes inadvertently corrupt or deleted. Caution: Patient data is confidential. Install the database on a secure computer. Keep databases, database files, archives, exports, and backups in a secure location.

Notes Note: Predictive values will be extrapolated for patients with age or height outside the age and/or height limits supported by the selected normal author, but within the values supported by the DataFlow Software.

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Introduction

About DataFlow Data Management Software DataFlow™ Data Management Software is a PC-based standalone software program used in conjunction with the Puritan Bennett PB-700 Renaissance® II spirometer System and the Puritan Bennett NPB-500 Simplicity® spirometer system to transfer patient pulmonary function test data from the spirometer to a Windows based operating system. Once transferred, the DataFlow Data Management Software allows the operator to perform any or all of the following: •

edit spirometer data and DataFlow data

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add patient demographic information

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archive the test

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search for and retrieve archived test(s)

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print test reports

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compare archived tests

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export patient pulmonary function test data for use by other application software

The use of Puritan Bennett DataFlow Data Management Software does not constitute a spirometry diagnosis. DataFlow Data Management Software provides trending and graphic representations of the diagnostic data from the Renaissance II and Simplicity spirometers.

Intended Use The DataFlow Data Management Software program is intended to augment the data management capability of the Puritan Bennett PB-700 Renaissance II spirometer system and the Puritan Bennett NPB-500 Simplicity spirometer system. The DataFlow Data Management Software is for use by healthcare professionals (e.g., technicians, nurses and/or physicians) in a variety of clinical environments (i.e., hospitals, physicians offices, and occupational health departments) under the direction of a physician. The DataFlow Data Management Software is not intended for use by patients. Caution: Federal law (U.S.A.) restricts this software to sale by or on the order of a physician.

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Introduction

Indications for Use The Puritan Bennett DataFlow Data Management Software is intended to augment the Puritan Bennett PB-700 Renaissance II spirometer and the Puritan Bennett NPB-500 Simplicity spirometer system’s data management capability.

Installation Requirements To use DataFlow Software at optimum performance, the computer should have one of these operating systems: Microsoft Windows® 95

Microsoft® Windows NT® 4.0 SP6A

Microsoft Windows 98

Microsoft Windows 2000 SP2

Microsoft Windows 98 SE

Microsoft Windows XP

Microsoft Windows ME The computer minimum hardware requirements are: •

RAM - 128 MB

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CPU - Pentium 300 MHz

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Free disk space - 100 MB

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Resolution - 800 x 600

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Colors - 65535

Transfer data to or from DataFlow Software using one of these spirometers: •

PB-700 Renaissance II Spirometry System

•

NPB-500 Simplicity Spirometry System

Note: There is no need to connect the spirometer to the computer to use DataFlow Software.

Technical Support If you have any questions about DataFlow Software contact Puritan Bennett technical support at the following numbers: 4

Introduction

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Customer Services -- 1.888.744.1414

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Technical Support -- 1.800.255.6774

Overview DataFlow Software works with spirometry test trials from Renaissance II and Simplicity spirometers. DataFlow Software is a database management program designed to: •

Archive data in a database

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Easily query test results to find patients with common attributes

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Print computer reports

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Query the entire database

Additionally, DataFlow Software provides these features, among others: •

Advanced data management

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Complex database querying

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Enhanced report printing

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Graphical and tabular trending

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Both data and curve displays

Getting Started Transfer data to or from DataFlow Software using one of these spirometers: •

PB-700 Renaissance II Spirometry System

•

NPB-500 Simplicity Spirometry System

To connect the spirometer: 1. Start the DataFlow Software.

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Introduction

Initial Screen 2. Configure which port DataFlow Software monitors: •

From the toolbar, click the Setup button. The Setup screen will appear.

Setup Screen - Units Tab 6

Introduction

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Select the Ports tab.

Setup Screen - Ports Tab •

Select the port that will be connected to the spirometer.

•

Click the OK button.

3. Place the spirometer in its base (docking cradle). 4. Connect the serial cable that came with the DataFlow Software to the spirometer base and to the COM1 or COM2 port that was chosen in Step 2 above. 5. Connect the base to a power supply. 6. Power on the spirometer. Note: There is no need to connect the spirometer to the computer to use DataFlow Software. When using a Renaissance II spirometer, it is alright to power on the spirometer before placing it in the docking cradle. When using a Simplicity spirometer, do not power on the spirometer before placing it in the docking cradle. When DataFlow Software detects a spirometer, it reads its contents. DataFlow Software saves the data to the database and displays it. When opening DataFlow Software for the first time, DataFlow Software creates a default database called DefaultDB_Date_Time.dsd, where Date is the date DataFlow Software User’s Guide

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Introduction

of creation and Time is the time of creation. DataFlow Software saves this database to its installation directory on the computer. When renaming the database, a new database needs to be created. When DataFlow Software is closed, the last used database will reopen the next time DataFlow Software starts. Note: If DataFlow Software is unable to open the previous database, it will open the default database. If a default database does not exist, DataFlow Software will create one. When making changes to the database, such as changing patient data, DataFlow Software will automatically save these changes to the current database. Note: DataFlow Software creates a default database in its installation directory. When saving the database to a particular directory or with a particular file name, “create a database.” Save the database to a file name and location.

Sample Database DataFlow Software provides a sample database that can be opened. The sample database provides examples of a patient, sessions, trends, spirometer calibrations, and much more. To open the sample database: 1. From the File menu, choose Open. 2. Find the Sample.dsd file available in the DataFlow Software installation directory, and click the Open button. DataFlow Software will open the sample database.

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Introduction

Using DataFlow Software with Spirometry Testing At the start of the testing session, send patient data to the spirometer. DataFlow Software can be used during the day to change patient data in the spirometer. Connect the spirometer to the computer. Use DataFlow Software to send the changes to the spirometer. This is faster and simpler than typing the changes with the limited keyboard of the spirometer. At the end of the testing session, download all of the patient tests to the database. Connect the spirometer to the computer. DataFlow Software will recognize which data is most recent and update the database. Clear the spirometer to be ready for the next day. Note: If database data is newer than spirometer data, DataFlow Software will not delete the newer data.

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Program Design/Interface

Main Interface When first opening DataFlow Software, the main interface screen is displayed.

Main Interface Showing the Patients View The sections of the main interface screen include: Menu Bar

The menu bar lists the available menus and their commands. Click a menu to show its commands. Choose a command to perform its task.

Toolbar

The toolbar has handy buttons for some menu bar commands. Click a button to perform its related task.

Find Form

The Find screen or Advanced Find screen displays at the top of the Patients view.

Main Viewing Area

The main viewing area initially displays the Patients view. Other views may be displayed in the main viewing area. To do this, choose commands from the menu bar or toolbar, or double-click or right-click items in the main viewing area.

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Program Design/Interface

Status Bar

The status bar displays at the bottom of the DataFlow Software view and provides information about the spirometer, time, date, and status. Previous screen button. When the button is blue, it indicates that there is a previous screen to display. Clicking the button will display the previous screen.

Next screen button. When the button is blue, it indicates that there is a next screen to display. Clicking the button will display the next screen.

Resizing Columns Columns can be resized by adjusting the width of the column headers. To adjust a column header: 1. Place the mouse cursor to the right of a column header. The arrow will change to a double-arrow. 2. Use the double arrow to click and drag the column header border to the width desired.

Resorting Columns Resort columns by clicking their column headers. For more information about resorting columns, see Calibrations List - Resorting Columns on page 118.

Views DataFlow Software organizes information into views. The main views include:

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Patients view

The Patients view displays patient’s name and their details. Double-click a patient to display his/her sessions in the Sessions list. Click the Trends button to display the patient’s session trends in the Trends view.

Sessions list

The Sessions list displays a list of sessions for the selected patient. Double-click a session to display it in the Session view. Click the Trends button to display the patient’s session trends in the Trends view.