CPFS-D USB Spirometer Operator Manual Rev F

Operator Manual

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CPFS/D™ USB Spirometer OPERATOR MANUAL

www.mgcdiagnostics.com

MGC Diagnostics® CPFS/D™ USB Operator Manual is Part# 142155-001 RevF. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician if it is to be used for diagnosis and/or prescribing of therapy. MGC Diagnostics® and preVent® are registered trademarks of MGC Diagnostics Corporation, BreezeSuite™, and CPFS/D™ are trademarks of MGC Diagnostics Corporation. MGC Diagnostics Corporation makes no claim for use of the product other than for those uses speciﬁed herein and disclaims any liability resulting from other uses. Observe all warnings and cautions. Windows is a registered trademark of Microsoft Corporation. © 2012 MGC Diagnostics Corporation. Unauthorized use, copying, or distribution is prohibited.

MGC Diagnostics Corporation through its subsidiary Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, Minnesota USA 55127-8599 T +1 651.484.4874 800.950.5597 F +1 651.484.8941 www.mgcdiagnostics.com

European Union (EU) Regulatory Representative Medical Product Service GmbH Borngasse 20 35619 Braunfels T 49-6442-962073 F 49-6442-32578

European Medical Device Directive 0086

Devices are compliant with the European Medical Directive (93/42/EEC) regarding safety and EMC.

CPFS/D USB Spirometer Operator Manual

Contents CHAPTER I: SYSTEM OVERVIEW ...5 1-1 Installation ...6 1-2 Power-up/Warm-up ...6 1-3 preVent Flow Sensor ...7 1-4 Testing Components ...7 1-5 Flow Sensor Testing Circuit Assembly with Barrier Filter ...8 CHAPTER II: STARTING A TEST ...9 2-1 Flow Sensor Calibration ...10 2-2 Patient Information ...11 2-3 Opening an Existing Patient ...13 2-4 Searching the Database ...13 2-5 Review and Test Mode ...14 2-6 Manual Data and Event Entry ...14 CHAPTER III: TESTING ...15 3-1 Slow Vital Capacity (SVC) Testing ...16 3-2 Forced Vital Capacity (FVC) Testing ...18 3-3 Maximal Voluntary Ventilation (MVV) Testing ...23 3-4 Bronchial Provocation (BRP) Testing ...24 CHAPTER IV: REPORTS ...26 4-1 Accessing the Report Switchboard ...27 4-2 Printing a Report ...27 4-3 Customizing Report Variables & Graphics ...27 4-4 Adding Graphics to a Report Header ...28 4-5 Designing a Page Header ...28 4-6 Trend Plots ...29 4-7 BRP Trend Plots ...30 CHAPTER V: SOFTWARE CONFIGURATIONS ...31 5-1 Accessing and Modifying Test Conﬁgurations ...32 5-2 Setting up the Data Grid ...32 5-3 Graph Properties ...33 CPFS/D USB Spirometer Operator Manual

5-4 Editing Patients and Staff Members ...33 5-5 Modifying PF Predicteds ...33 CHAPTER VI: QUALITY CONTROL ...36 6-1 Introduction ...37 6-2 Adding a Syringe QC to the Database ...37 6-3 Spirometry ...37 CHAPTER VII: TROUBLESHOOTING ...38 7-1 Cleaning & Maintenance ...39 7-2 Flow Drift and Zero Flow Errors ...40 7-3 Technical Support ...40 CHAPTER VIII: DB TOOLS ...41 8-1 Accessing DB Tools ...42 8-2 Converting Old Visits ...42 8-3 Purging the Database ...42 8-4 Compact/Repair Database ...42 8-5 Backup/Restore Database ...43 8-6 Import/Export Patients, REports & Resources ...43 CHAPTER IX: SECURITY/HIPAA ...44 9-1 Security & Compliance ...45 9-2 Create or Modify a User ...45 9-3 Deﬁning Roles ...45 9-4 Database Security ...46 9-5 Audit Trail Conﬁguration ...47 CHAPTER X: BREEZE REVIEW ...49 10-1 Selecting a Patient ...50 10-2 Interpretation/Consult ...51 10-3 Exiting ...52 10-4 Trending ...52 10-5 Graph Properties ...53 10-6 Breeze Review Options ...54 10-7 Consult Options ...55 10-8 Printing Reports ...56 APPENDIX A: PULMONARY REFERENCES ...49 CPFS/D USB Spirometer Operator Manual

CHAPTER I SYSTEM OVERVIEW 1-1

Installation

1-2

Power-up/Warm-up

1-3

preVent Flow Sensor

1-4

Testing Components

1-5

Flow Sensor Testing Circuit Assembly with Barrier Filter

CPFS/D USB Spirometer Operator Manual

1-1

Installation

1. Install BreezeSuite™ software and any accompanying update CDs before proceeding. BreezeSuite should be at Version 6.4.1 Service Pack 4 (SP4) or higher. 2. With the system unplugged from the computer USB port click on Start, All Programs (Windows XP), MGC Diagnostics, WFA USB Driver v2.0. 3. Select Install at the “Install Driver” dialog box. At the “Installation Successful” dialog box select OK. 4. Connect the CPFS/D USB to the computer. Windows® will automatically detect the system and install the necessary drivers. At the end of the Windows driver installation you may need to click on Finish to complete the process. 5. Once the driver has been installed, open BreezeSuite and go to FILE>OPEN>SITE. Open the “Current Site”, then click on the Workstation Tab at the bottom of the screen. In the Hardware drop-down menu select “CPFS USB”, click on the ﬂoppy disk icon on the Icon Bar to save the conﬁguration and exit BreezeSuite.

1-2

Power-up/Warm-up

Power-up Sequence 1. Verify the connection from the CPFS/D USB to the computer’s USB port. 2. Power on the computer. 3. Launch the BreezeSuite software. NOTE: The system should be powered on for at least five (5) minutes before testing.

Power-down Sequence 1. Exit the BreezeSuite software. 2. Shut down the computer.

CPFS/D USB Spirometer Operator Manual

1-3

preVent® Flow Sensor

The preVent ﬂow sensor is a respiratory device used to measure inspiratory and expiratory airﬂow. The ﬂow sensor requires calibration on a daily basis; recalibration between patients is not required.

preVent Flow Sensor/Umbilical Assembly The following instructions demonstrate the proper method for connecting the preVent ﬂow sensor to the umbilical clip: base of the ﬂow sensor has a tab protruding outward and an indented notch. ˚ The The base of the umbilical clip also has a tab protruding outward. When the two pieces are connected, the umbilical tab snaps into the notch of the ﬂow sensor.

˚ Ensure that the honeycomb end of the ﬂow sensor is facing the patient. ﬂat end of the umbilical clip faces the patient and the tab side faces away from ˚ The the patient. ﬂat end of the umbilical clip always faces the honeycomb side of the ﬂow ˚ The sensor. connect the two units, align and insert the metal probes of the umbilical clip ˚ To into the holes at the base of the ﬂow sensor. The units should snap together and form a tight ﬁt.

1-4

Testing Components

preVent Flow Sensor The ﬂow sensor is the clear component of the ﬂow sensor testing assembly that a patient forces air through during testing to measure inspiratory and expiratory airﬂow.

Barrier Filter If a Barrier Filter is used, dead space must be entered into the software as follows: File>Open>Site (current)>Workstation Tab (Do Not click Add Workstation). Enter external dead space. (Be sure to check with your ﬁlter manufacturer for this information.) The preVent™ Filter (shown) provides a minimal resistance of 0.23 cmH20/L/ sec and minimal dead space of 35 ml. CPFS/D USB Spirometer Operator Manual

Patient Mouthpiece The patient mouthpiece is placed in the patient’s mouth while testing is being performed.

Noseclips Noseclips are placed over the patient’s nose during testing to prevent leaks.

Umbilical Cable The umbilical cable connects to the CPFS/D USB and is the means by which the testing data is transfered to the system for processing.

1-5

Flow Sensor Testing Circuit Assembly with Barrier Filter

preVent Flow Sensor Testing Circuit Refer to the photo above, and follow the steps below for assembling the Flow Sensor Testing Circuit (only when using a preVent ﬁlter): 1. Gather the following parts:(preVent Flow Sensor, preVent Filter, Patient Mouthpiece.) These parts comprise the Flow Sensor Testing Circuit. 2. Firmly push the patient mouthpiece onto the white end of the preVent ﬁlter. 3. Firmly push the preVent ﬁlter onto the honeycomb side of the preVent ﬂow sensor. 4. Attach the umbilical clip to the preVent ﬂow sensor.

CPFS/D USB Spirometer Operator Manual

CHAPTER II STARTING A TEST 2-1

Flow Sensor Calibration

2-2

Patient Information

2-3

Opening an Existing Patient

2-4

Searching the Database

2-5

Review and Test Mode

2-6

Manual Data and Event Entry

CPFS/D USB Spirometer Operator Manual

2-1

Flow Sensor Calibration

1. To access the calibration button at the top of the Open Patient Screen, click the Cancel button. 2. Click the Calibrate button, on the BreezeSuite computer screen, to calibrate the ﬂow sensor, then enter the appropriate values for temperature, barometric pressure and humidity (circled at the bottom of the calibration screen). 3. Attach a syringe to the patient end of the preVent ﬂow sensor. 4. Click the Zero Flow button (circled at the top of the screen). 5. Click Start, then withdraw and inject the syringe according to varied rates. Follow the computer prompts to know when to withdraw and inject. 6. Vary the speed of subsequent strokes to test the linearity of the ﬂow system. Always provide smooth, consistent strokes. 7. BreezeSuite conﬁrms when the calibration is successful. Click OK to save the calibration. 8. Do not click Reset. If calibration fails, see Note that follows.

NOTE: If the syringe sticks during calibration, do the following: 1. Click Stop 2. Push the syringe in 3. Click Start 4. Fully withdraw the syringe 5. Wait for the inject prompt to appear 6. Inject the syringe 7. Click Stop 8. Return to step four of the ﬂow sensor calibration process above

CPFS/D USB Spirometer Operator Manual

Calibration Report

To print a Calibration Report, click the Print button on the bottom of the calibration screen. To save an electronic copy only, click OK. All calibrations are stored electronically and can be pulled up at a later date by clicking on the Cal Log button at the bottom of the calibration screen.

2-2

Patient Information

1. To create a new patient, choose File > New > Patient or click the New Patient icon. 2. All information in the colored ﬁelds are required to create a new patient. Use the Tab key or mouse to advance to the next ﬁeld. New Patient Icon

CPFS/D USB Spirometer Operator Manual

3. The Patient ID must be unique and the Date of Birth ﬁeld must contain a four-digit year. Click the black arrows of the appropriate drop down menu to enter Race and Sex, or type the ﬁrst letter of your selection. 4. Select the Add Visit button. 5. Enter the patient’s height and weight (colored ﬁelds are required). 6. Click the black arrows of the appropriate drop-down menu to enter an existing physician or technician. (NOTE: A new physician or technician can be added by selecting New.) Click on the appropriate PF and/or GX Predicted Set Selection by clicking on the black arrows of the drop down menu.

7. Optional: Select the Patient History tab, at the bottom of the screen to enter the patient’s medical and smoking history.

8. Click the desired test tab. BreezeSuite will calculate predicted values. CPFS/D USB Spirometer Operator Manual

2-3

Opening an Existing Patient

If a patient has previously been seen, highlight the patient’s name in the Open Patient screen and click Open. Previous information and visit dates will be displayed. If the Open Patient Screen is not displayed, click the Open Patient icon to display the patient list.

2-4

Searching the Database

If the list of patients is long, it may be difﬁcult to ﬁnd a patient. Rather than scrolling through a long list, use the search tool to ﬁnd a patient. 1. From the Search Column pull down menu, select whether to search by Last Name, First Name, Middle Name, or Last Visit Date. 2. Fill in the search for line with enough of the name to narrow the search. 3. Click Find to run the search. The ﬁrst match will be highlighted. Click Find again to move to the next match in the list. 4. To open a patient record, either double click on the patient or select it and click Open.

CPFS/D USB Spirometer Operator Manual

2-5

Review and Test Mode

Test Mode To perform a test, BreezeSuite must be in Test Mode. When creating a new visit and starting the test, the system is automatically in test mode; BreezeSuite displays the Test Mode icon in the corner of the test graphs and the test pad. Click the Test Mode icon at the top of the screen to switch from Review Mode to Test Mode.

Review Mode Review Mode offers additional analysis options. In review mode, the user can draw graphs of multiple efforts, zoom graphs, show graph labels, etc. After opening an existing visit, BreezeSuite automatically operates in Review Mode. To switch from Test Mode to Review Mode, click the Review Mode icon. TIP: When clicking a time stamp of an effort to draw it, BreezeSuite switches to Review Mode. Click the Test Mode icon to re-enter Test Mode.

2-6

Manual Data and Event Entry

1. Click the Event Entry icon to open the Event Entry dialog. 2. Enter event text or click the arrow to select predeﬁned event text. Tip: Click the + icon to add a text entry to a predefined text list. 3. When entering data, select a data type tab and click the arrow in a variable ﬁeld to select from a menu of all available variables for that data type. Enter the data in the value ﬁeld. 4. If events or data are entered during a test, BreezeSuite automatically records a timestamp. For information entered after a test, enter the associated time in the Time Field. 5. Click OK when the event and data entries are complete. 6. BreezeSuite incorporates manually entered data into test screens. To view events, as well as associated manually entered data, select the Protocol/Log tab. Click the event text to view data.

CPFS/D USB Spirometer Operator Manual

CHAPTER III TESTING

3-1

Slow Vital Capacity (SVC) Testing

3-2

Forced Vital Capacity (FVC) Testing

3-3

Maximal Voluntary Ventilation (MVV) Testing

3-4

Bronchial Provocation (BRP) Testing

CPFS/D USB Spirometer Operator Manual

3-1

Slow Vital Capacity (SVC) Testing

A Slow Vital Capacity (SVC) test displays the volume of gas measured on a slow complete expiration after a maximal inspiration without forced or rapid effort.

Key Terms & Deﬁnitions Inspiratory Reserve Volume (IRV): The maximum amount of air that can be inhaled beyond the tidal volume end-inspiratory level. Inspiratory Capacity (IC): The maximum amount of air that can be inhaled from the tidal volume endexpiratory level. Tidal Volume (TV): The volume of air that is inspired and expired with each breath during normal breathing. Functional Residual Capacity (FRC): The volume of air remaining in the lungs at the tidal volume end/ resting-expiratory level. Expiratory Reserve Volume (ERV): The maximum amount of air that can be exhaled below the tidal volume end-expiratory level. Vital Capacity (VC): The volume of air that can be exhaled from the lungs after a maximum inspiration. Residual Volume (RV): The volume of air remaining in the lungs at the end of a maximum expiration (measured indirectly). Total Lung Capacity (TLC): The volume of air in the lungs after a maximum inspiration.

CPFS/D USB Spirometer Operator Manual

Physiology A Slow Vital Capacity test measures the vital capacity of the lungs during a slow and complete exhalation to residual volume (RV). In healthy patients, there is little difference between SVC and FVC results. An SVC test provides speciﬁc data on lung volume compartments (IC, ERV) which helps in detecting and evaluating disease states. A SVC test should include no fewer than four preliminary tidal breaths, followed by a maximum inspiration, then a slow and complete expiration. By exhaling slowly, the patient reduces the possibility of trapped gas, which may affect the results of a SVC test. As the patient exhales, BreezeSuite measures and plots a graph of volume (in liters) vs. time (in seconds).

SVC Requirements tests can be performed as inspiratory, expiratory, or mixed IC/ERV efforts. ˚ SVC The patient must perform at least four consecutive stable tidal breaths before beginning a SVC. ˚

Performing a SVC Test 1. Before beginning a test, make sure the patient is comfortable and fully understands the purpose and maneuvers necessary to complete the test. Explain each test maneuver, demonstrating SVC breathing. Provide continuous feedback during the test, especially at maximum inspiration and expiration levels.

2. To begin a Slow Vital Capacity Test, click the SVC Tab. The Data Collection Screen will appear, as indicated by the ﬂow sensor icon in the upper left corner of the graph. 3. Click Zero Flow to zero the ﬂow sensor.

CPFS/D USB Spirometer Operator Manual

Start/Stop Button Zero Flow Button

4. Click Start or press the space bar to begin the test. Instruct the patient to take four relaxed, even tidal breaths. 5. Instruct the patient to inspire then expire fully. Press the space bar or click Stop to complete the test. 6. When the test has been stopped, complete test results appear in the data table. 7. The software automatically selects the largest SVC by placing a red checkmark in the select column.

3-2

Forced Vital Capacity (FVC) Testing

A Forced Vital Capacity (FVC) test measures the maximal volume of gas that can be expired as forcefully and rapidly as possible after a maximal inspiration to total lung capacity. Caution: FVC testing can cause fatigue and may be dangerous for some patients. Some patients may be at risk for vertigo, arrhythmia or fainting. A maximum of eight (8) tests is recommended.

Key Terms & Deﬁnitions FVC: The difference between the lowest and highest volumes obtained during a forced maneuver. FEFmax: The highest ﬂow value measured during forced expiration. FEFx%: The ﬂow measured at a speciﬁc percent of exhaled volume (e.g. FEF25%). FEFx-y: The average exhaled ﬂow between two selected volume points (e.g. FEF25-75%). FEV1: The volume exhaled during the ﬁrst second of a forced expiratory maneuver started from the level of total lung capacity. FIFmax: The highest ﬂow value measured during forced inhalation.

CPFS/D USB Spirometer Operator Manual

FIFx%: The ﬂow measured at a speciﬁc percent of inhaled volume (e.g. FEF25%). FIFx-y%: The average inhaled ﬂow between two selected volume points (e.g. FEF25-75%). FEV1/FVC: The proportion of total air volume that can be expired in the ﬁrst second of an expiration

Physiology A Forced Vital Capacity Test begins with even tidal breaths. After tidal breathing, the patient inhales maximally then exhales as rapidly, forcefully, and completely as possible (a minimum of six seconds of exhalation is recommended). The ﬂow volume loop, as a picture, can be very informative. The trained eye can easily identify different pulmonary function patterns without using numbers or predicted values. FEFmax is the highest ﬂow achieved during the FVC maneuver. A very effortdependent value, a poorly reproduced FEFmax will indicate inconsistent patient efforts. A good effort shows a sharp point, or peak, versus the rounded pattern of a poor effort.

FVC Test Requirements

The following are requirements for the FVC test procedure: inspiration, smooth and continuous exhalation until complete. ˚ Full An abrupt and unhesitating start (the patient cannot cough during the ﬁrst second of the test). ˚ Six second expiratory time or ﬂow plateau. ˚ A minimum of three/repeatable acceptable efforts: ˚ The two largest FVCs must be within 150 ml ˚ The two largest FEV s must be within 150 ml ˚ 1

Caution: The opening at the end of the ﬂow sensor must not be obstructed. Make sure that the patient does not block it with their ﬁngers. This will result in volume and ﬂow that are erroneously high.

CPFS/D USB Spirometer Operator Manual

Flow Volume Loop Curves

STATIC LUNG VOLUMES DEPICTED BY FLOW VOLUME LOOP

RESTRICTION OF LUNG VOLUME

REVERSIBLE AIRFLOW OBSTRUCTION

THE EFFECT OF VARIABLE PATIENT EFFORT ON THE MAXIMAL FLOW VOLUME LOOP

CHARACTERISTIC FLOW VOLUME LOOPS PRODUCED BY INCREASING AIRFLOW OBSTRUCTION

THE EFFECT OF VOLUME LIMITATION OR RESTRICTION ON THE FLOW VOLUME LOOP

VOLUME REDUCTION INCREASED ELASTIC RECOIL

FIXED EXTRATHORACIC OBSTRUCTION

CPFS/D USB Spirometer Operator Manual

VARIABLE EXTRATHORACIC OBSTRUCTION

Performing a FVC Test Before starting a FVC test, make sure that the patient is comfortable and fully understands the maneuvers necessary to complete the test. Explain the test maneuvers, demonstrating FVC breathing and providing continuous feedback during the test, especially near maximum inspiration and expiration levels. 1. Click the FVC tab to initiate a Forced Vital Capacity (FVC) Test.

2. Click Zero Flow to zero the ﬂow sensor and ensure that there is no airﬂow through the ﬂow sensor. 3. Click Start or press the space bar to begin the test. Instruct the patient to take normal, relaxed breaths. 4. Instruct the patient to inhale fully, then exhale as rapidly, forcefully, and completely as possible (try to have the patient exhale until the yellow indicator box turns green, indicating end of test criteria), then inhale fully. 5. Click Stop or press the space bar to stop the test. After stopping the test, the completed test results appear in the data table. The BreezeSuite software automatically selects all efforts that meet American Thoracic Society (ATS) criteria. 6. To manually select or deselect efforts, click in the Select column to add or remove the red check mark. Data in the gray row displays the values used in the ﬁnal report.

Start/Stop Button Zero Flow Button

CPFS/D USB Spirometer Operator Manual

Patient Incentives

1. To display patient incentive animations, right-click the FVC graph and select Properties. 2. Under Graph Type, choose from four incentive types: Clown Rooster Balloon Birthday Cake 3. In this example, as the patient exhales, the rooster runs toward the ﬂag until the patient reaches Vital Capacity (VC).

˚ ˚ ˚ ˚

CPFS/D USB Spirometer Operator Manual

3-3

Maximal Voluntary Ventilation (MVV) Testing

Key Terms MVV: The maximal ventilation that can be achieved within 10 - 15 seconds. RR: Average respiratory rate observed during the MVV maneuver. TV: Average tidal volume achieved during a MVV maneuver.

Physiology test measures the volume of the largest breath that can be taken in and out of the lungs during a 10 ˚ A- 15MVV second interval with voluntary effort. the patient is clearly unable to complete the 12 seconds, pressing the space bar will end the test and ˚ Ifextrapolate the results. who ﬁnd it difﬁcult to take deep breaths may beneﬁt more fully from higher respiratory rates. ˚ Patients with signiﬁcant airway obstruction may derive greater beneﬁt by taking larger breaths at slower ˚ Patients respiratory rates.

˚ Optimal MVV is achieved by matching an FEV type effort with a respiratory rate of 60 bpm. 1

Caution: The strenuous nature of this test can cause fatigue and may be dangerous for some patients.

Performing a MVV Test 1. To begin a MVV test, click the MVV Tab. 2. Click Zero Flow to zero the ﬂow sensor and ensure that there is no airﬂow through the ﬂow sensor.

CPFS/D USB Spirometer Operator Manual

3. Click Start, or press the space bar to begin the test. Immediately have the patient breathe deep and fast. To give the patient time to achieve maximal ventilation “count-down” breaths appear next to the start button. BreezeSuite will ignore the ﬁrst few breaths before collecting data. 4. After 12 seconds the test will stop automatically. To manually end the test, click Stop, or press the space bar after 6 seconds have elapsed but before 12 seconds.

Start/Stop Button Zero Flow Button

5. A red check mark in the Select column indicates which effort will be saved for the ﬁnal report.

3-4

Bronchial Provocation (BRP) Testing

BRP challenge tests are typically performed to determine the extent of airway hyper reactivity in patients with symptoms of bronchospasm. Spirometry measurements are taken after the patient inhales a dosage of the drug. The dosage increases throughout the protocol. When there is a 20% change from baseline FEV1, the test is positive. A bronchodilator is administered to return the patient to baseline. Requirements for BRP Testing include the following: must be asymptomatic, with no coughing or wheezing, with a FEV baseline greater than 80% of ˚ Patients the predicted value. 1

physician, familiar with Methacholine challenge testing, must be available during testing, since the ˚ Aprocedure can present health risks to the patient.

˚ Observe the patient after each concentration, for symptoms such as chest tightness or wheezing.

CPFS/D USB Spirometer Operator Manual

Protocol Selection

Select the Protocol/Log tab. Select the appropriate protocol from the Protocol drop down menu. If the speciﬁc protocol needed is not listed, a custom protocol can be created. 1. To enter a customized protocol, choose File > New > PF Protocol. 2. Enter a Protocol Name and Challenge Agent for the custom protocol. 3. Add stages to the protocol by selecting the Insert Stage button. 4. After the stages are added, populate the Stage Label, Dosage and Breaths ﬁelds. 5. To Save the custom protocol, the Protocol Name must be unique. Always save the protocol before closing. NOTE: Once a protocol is used, it cannot be edited

Performing Bronchial Provocation (BRP) Testing To conduct a Bronchial Provocation (BRP) test, execute the following steps: 1. Select the Protocol Log tab. 2. Use the drop-down menu in the Protocol dialog box to choose the desired protocol. 3. Click on the tab of the ﬁrst test to be executed. 4. Complete all testing for each stage before proceeding to the next stage. Upon completion of a stage, click on the Protocol Stage drop down menu to select the next stage. 5. Skipping stages is allowed, if not needed for a particular patient. 6. When all testing is complete, verify that each stage has at least one effort selected (red checkmark in the Select or RAW column). 7. Verify, by looking at the Test Mode columns of the FVC test, that a pre/Baseline, Challenge/Max and Post Marker have been selected. Cumulative Dose Units and PC20 are automatically calculated. (This is only done for Pleth tests.) 8. Click on Quick Print and go to the Report Switchboard. 9. Print the appropriate BRP Report.

CPFS/D USB Spirometer Operator Manual

CHAPTER IV REPORTS

4-1

Accessing the Report Switchboard

4-2

Printing a Report

4-3

Customizing Report Variables & Graphics

4-4

Adding Graphics to a Report Header

4-5

Designing a Page Header

4-6

Trend Plots

4-7

BRP Trend Plots

CPFS/D USB Spirometer Operator Manual

4-1

Accessing the Report Switchboard

Quick Print brings together the features of a default report switchboard and a report design function into a single application. To access the Report Switchboard from the toolbar:

˚ Select Quick Print > Report Switchboard; the Report Switchboard contains a selection of ﬁnal reports. 4-2

Printing a Report

To print a report: 1. Select Quick Print > Report Switchboard. 2. Choose the report to be printed and select Print. 3. Post-test comments may be added to a printed report by typing the comments into the Post Test Comments dialog box.

4-3

Customizing Report Variables & Graphics

Follow the instructions below for customizing report variables and graphics. To Modify Page Settings: 1. Select Quick Print > Reports. Choose the report to be customized and click Open. 2. The report pages list the pages that are selected for the report. The ﬁrst part of the page name gives the location of the report page (e.g., PF Pages – Complete w/Interp). The second portion provides the Conﬁguration Name. Click tools > options. 3. Go to the tab of the report page you want to modify (e.g., PF Pages, FVC, etc.), Press F5, and select the report page from the Conﬁguration drop down menu. 4. Unlock the page by clicking on the drop down menu arrow to the right, and selecting Unlock. 5. Click OK to close the options window.

CPFS/D USB Spirometer Operator Manual

To Modify Test Variables Highlight a row or variable, then right-click to insert or remove rows. Once a row has been inserted, use ˚ the drop-down menu arrow to select a variable from the list. To Modify Graphics: on the graph to access properties or to change a graph type. ˚ Right-click Modiﬁcations include graph type, axis variables, color, and effort selection. ˚

4-4

Adding Graphics to a Report Header

To add graphics to a Report Header: 1. Select Quick Print > Headers > Open > Default Header. 2. Adjust the Header ﬁelds to create space for a graphic image. 3. Select a ﬁeld, or create a new ﬁeld, where the image can be inserted. In the Field Properties dialog, select Type, and scroll up to Bitmap. 4. Select File and choose the appropriate bitmap stored on the system. The graphic will appear in the Header ﬁeld. 5. Drag the graphic to the desired location and size it appropriately.

4-5

Designing a Page Header

To design a Page Header: 1. Select Quick Print > Headers > Open. 2. Design ﬁeld properties for the header, according to Type, Text, Font Size, Font Style, Alignment and Color. 3. To modify a ﬁeld, click on the box surrounding the variable; it will turn red. 4. Use the mouse to change the width, length, and height of the variable. 5. To move a variable, click on the ﬁeld and drag it to a different location. 6. Click the Save icon or go to File > Save to store the new header and ﬁeld properties.

CPFS/D USB Spirometer Operator Manual

4-6

Trend Plots

Select F5 or Tools > Options. Click on the Trend tab and select show tab. Within a patient ﬁle, select the Trend tab and press F5 or Tools > Options. Select the Report page from the conﬁguration drop down menu. Unlock the page by clicking on the drop down menu arrow to the right and selecting Unlock. The Trend graph plots all of a patient’s visits. Select variables for view on the Trend graph.

1. Right click on the graph and select Properties. 2. Select the Variables tab. 3. In the Variables window, click a variable that you would like to plot. 4. Click the right arrow to move the variable to the Variables to Plot window. A maximum of four variables can be plotted.

Remove variables from the trend graph.

1. Right click on the graph and select Properties. 2. Select the Variables tab. 3. In the Variables to Plot window, click the variable that you would like to remove. 4. Click the left arrow to remove the variable from the Variables to Plot window.

Selecting variables to report on trend grid.

1. Select the variable by clicking on the top row of the grid. 2. For each variable the “absolute”, “percent predicted” (at date of visit), or “percent change” can be reported.

Choose to plot pre, post or challenge efforts.

1. Right click on the graph and select Properties. 2. Select the Efforts tab. 3. In the Efforts to Plot frame, choose Pre, Post, or Chlg.

Modify the graph.

1. Right click on the graph. 2. Left click on Properties to view the graph property page. 3. In the Axis tab, modify the graph properties as necessary. Click Help for information on the graph property options.

CPFS/D USB Spirometer Operator Manual

4-7

BRP Trend Plots

Select the BRP Trend tab. Press F5 or Tools > Options and select the Report page from the conﬁguration drop down menu. Unlock the page by clicking on the drop down menu arrow to the right and selecting Unlock. The BRP Trend graph plots all efforts within a single patient visit. Select variables for view on the Trend graph.

Remove variables from the trend graph.

Choose to plot pre, post or challenge efforts.

1. Right click on the graph and select Properties. 2. Select the Efforts tab. 3. In the Efforts to Plot frame, choose Pre, Post, or Chlg.

Modify the graph.

1. Right click on the graph. 2. Left click on Properties to view the graph property page. 3. In the General and Axis tabs, modify the graph properties as necessary. Click Help for information on the graph property options.

Selecting variables to report on BRP trend grid.

1. Select the variable by selecting each box in the left most column and using the drop down. 2. Labels (i.e. spriometry) are at the bottom of the list. 3. % change and % predicted are also at the bottom of the list.

Press F5 or Tools > Options. Lock the page by clicking on the drop down menu arrow to the right and selecting lock.

CPFS/D USB Spirometer Operator Manual

CHAPTER V SOFTWARE CONFIGURATIONS

5-1

Accessing and Modifying Test Conﬁgurations

5-2

Setting up the Data Grid

5-3

Graph Properties

5-4

Editing Patients and Staff Members

5-5

Modifying PF Predicteds

CPFS/D USB Spirometer Operator Manual

5-1

Accessing and Modifying Test Conﬁgurations

Follow the instructions below for accessing and/or modifying a conﬁguration: 1. Open a Patient Visit and click the appropriate test tab, then select Tools > Options (F5) to edit the Test Conﬁgurations. 2. Most testing conﬁgurations are locked, indicated by a padlock icon. To unlock the conﬁguration, use the side arrow and select unlock. Changes made to an unlocked conﬁguration will be the default for any subsequent patients. Changes made to a locked conﬁguration are only for the current patient visit.

5-2

Setting up the Data Grid

1. To adjust column width, click and drag the splitter bar to the desired width. 2. Click on a column header, then click the drop down menu button and select the desired parameter. 3. Click on the second row in a column, and then click on the drop down menu button to select the data format. Selections are as follows: - Absolute value. ˚ Absolute % Predicted - Percent of predicted value. ˚ % Change - Percent change from previous value. ˚ % P/C - Percent predicted for Pre test stage, and percent change for subsequent ˚ stages. 4. Repeat the process until all parameters are formatted.

CPFS/D USB Spirometer Operator Manual

5-3

Graph Properties

To Modify Graphics: 1. Right-click on the graph to modify and select Properties. 2. Modiﬁcations include: Graph Type, Axis Variables, Graph Color, and Effort Selection.

5-4

Editing Patients and Staff Members

Edit a Staff Member, select File > Open > Staff. Choose the Staff Member to be edited. After making ˚ To edits to the Staff Member, click the Save and Close icons. Edit Patient demographics, select the patient from the Open Patient list and choose Edit. After ˚ To making edits to the patient, click the Save and Close icons. BreezeSuite will automatically recalculate

˚ ˚ ˚

the “PF Predicteds” for the patient. To edit a Patient Visit, select the patient from the open patient list and open. Click on the desired visits date/time. After making the edits, click the save and close icons. BreezeSuite will automatically recalculate the “PF Predicteds” for the patient. To Delete a Staff Member, select File > Delete > Staff. Select the Staff and click Delete. BreezeSuite will prompt for conﬁrmation of staff member to be deleted. To exit this screen, click Cancel. To Delete a Patient, select File > Delete > Patient. Select the Patient and click Delete. BreezeSuite will prompt for conﬁrmation of patient to be deleted. To exit the Delete Patient Screen, click Cancel.

NOTE: Once a patient has been deleted, it cannot be recovered. Combine staff members, select File > Combine > Staff. Click Select to choose the staff members ˚ To from both the “From” and “To” lists, then click Combine. Combine Patients, select File > Combine > Patient. Click Select to choose the patients from both the ˚ To “From” and “To” lists, then click Combine.

5-5

Modifying PF Predicteds

Selected Author Sets BreezeSuite software allows customization of a particular author set based on the needs of certain physician recommendations or other requirements. Simply modify the Default set, create a new set, or make a copy of set and modify as needed.

Applying Predicted PF Sets to a Patient File From the Visit Demographics tab, select which set of PF predicteds to use for the selected patient by clicking the drop-down arrow next to the PF Predicted Set Selection. To create or edit a PF Predicted Set: From the Tools menu, choose PF Predicteds > Sets > Open to edit an existing set, choose New to create a new predicted set or choose Copy to copy an existing set but maintain the original.

CPFS/D USB Spirometer Operator Manual

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MGC Diagnostics

Spirometers

CPFS-D USB Spirometer Operator Manual Rev F