Ultima Series Models CCM, CPX, CardiO2 and PFX Operator Manual Rev C

Operator Manual

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Ultima™ Series Models CCM, CPX, CardiO2 and PFX OPERATOR MANUAL

www.mgcdiagnostics.com

The MGC Diagnostics® Ultima Gas Exchange Operator Manual is Part# 142197-001 RevC. 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 Ultima™ Series 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. © 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

0086

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

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Contents CHAPTER 1: ULTIMA GX SYSTEM OVERVIEW ...6 1-1 Ultima GX System ...7 1-2 Power-up/Warm-up ...7 1-3 Gas Pressures ...8 1-4 Gas Concentrations ...8 1-5 Ultima ...9 1-6 preVent Flow Sensor ...10 1-7 Testing Components ... 11 1-8 Connecting the Patient ...11

CHAPTER II: STARTING A TEST ...13 2-1 Flow Sensor Calibration ...14 2-2 O2 & CO2 Calibration ... 15 2-3 External Device Calibration ...15 2-4 Calibration Report ...16 2-5 Patient Information ...16 2-6 Opening an Existing Patient ...17 2-7 Searching the Database ...18 2-8 Review and Test Mode ...18 2-9 Manual Data and Event Entry ...18

CHAPTER III: TESTING ...19 3-1 Slow Vital Capacity (SVC) ...20 3-2 Forced Vital Capacity (FVC) ...22 3-3 Maximal Voluntary Ventilation (MVV) ...26 3-4 Bronchial Provocation (BRP) ...29 3-5 VO2 Exercise Testing ...30 3-6 ECG/VO2 Testing with Mortara ...34 3-7 Metabolic Testing ...46 3-8 Ventilator Testing ...48 3-9 Canopy/Face Tent Testing ...52 3-10 NICO Testing ...54 Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

3-11 Exercise Flow Volume Loops ...62

CHAPTER IV: REPORTS ...64 4-1 Accessing the Switchboard ...65 4-2 Printing a Report ...65 4-3 Customizing Report Variables & Graphics ...65 4-4 Adding Graphics to a Report Header ...66 4-5 Designing a Page Header ...66 4-6 Trend Plots ...66 4-7 BRP Plot Trends ...67

CHAPTER V: SOFTWARE CONFIGURATIONS ...69 5-1 Accessing and Modifying Test Conﬁgurations ...70 5-2 Setting up the Data Grid ...70 5-3 Graph Properties ...71 5-4 GX Scripts ...71 5-5 Exercise Device Protocols ...71 5-6 Editing Patients and Staff Members ...72 5-7 Modifying Predicteds ...72

CHAPTER VI: QUALITY CONTROL ...76 6-1 Introduction ...77 6-2 Adding a Syringe QC to the Database ...77 6-3 Spirometry ...78 6-4 Gas Exchange System Validator ...78 6-5 Biologic Controls ...78

CHAPTER VII: TROUBLESHOOTING ...79 7-1 Cleaning & Maintenance ...80 7-2 General Troubleshooting ...80 7-3 O2 & CO2 Analyzer Calibration: Functional Residual Capacity (FRC) ...82 7-4 Flow Issues ...82 7-5 O2 & CO2 Calibration ...82 7-6 O2 Sensor Replacement ...83 7-7 Technical Support ...83

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

CHAPTER VIII: DB TOOLS ...84 8-1 Accessing DB Tools ...85 8-2 Loading Shape Tables ...85 8-3 Converting Old Visits ...85 8-4 Purging the Database ...85 8-5 Compact/Repair Database ...86 8-6 Backup/Restore Database ...86 8-7 Import/Export Patients, Reports & Resources ...86

CHAPTER IX: SECURITY/HIPAA ...87 9-1 Security & Compliance ...88 9-2 Create/Modify a User ...88 9-3 Deﬁning Roles ...88 9-4 Database Security ...89 9-5 Audit Trail Conﬁguration ...90

CHAPTER X: BREEZE REVIEW ...91 10-1 Selecting a Patient ...92 10-2 Interpretation/Consult ...94 10-3 Exiting ...95 10-4 Trending ...95 10-5 Graph Options ...96 10-6 Breeze Review Options ...97 10-7 Consult Options ...98 10-8 Printing Reports ...99 APPENDIX A: CHANGING OUT A GAS TANK ...100 APPENDIX B: VO2/ECG TESTING INSTRUCTIONS ...101 APPENDIX C: GAS EXCHANGE REFERENCES ...104

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

CHAPTER I ULTIMA GX SYSTEM OVERVIEW

1-1

Ultima GX System

1-2

Power-up/Warm-up

1-3

Gas Pressures

1-4

Gas Concentrations

1-5

Ultima

1-6

preVent Flow Sensor

1-7

Testing Components

1-8

Connecting the Patient

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

1-1

Ultima GX System

Computer / Monitor

Ultima Module Gas Tanks

Printer

Power Conditioner

1-2

Power-up/Warm-up

Power-up Sequence 1. Switch the power conditioner to ON. This will turn the Ultima on as well. 2. Power-up the computer. 3. Click on the BreezeSuite™ icon on the computer desktop to access the software. 4. Turn on all gas tanks.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Warm-up The following warm-up conditions must take place before the tests listed can be executed: the Ultima system for at least 30 minutes before calibration or testing. Stabilize light turns from ˚ Warm-up amber to green after 30 minutes. To avoid the 30 minute warm-up and stabilization, allow the system to

˚ ˚

remain turned on between tests throughout the day. Warm-up the vacuum pump “Vac” for 2 minutes before testing. Once 2 minutes has elapsed, the timer turns green and reads, “Ready.” Short duration off (less than 15 minutes): Analyzer warm-up time is double the power-down time

Power-Down Sequence 1. Exit the BreezeSuite software. 2. Shut down the computer. 3. Flip the switch on the power conditioner to OFF. NOTE: The system main power switch may remain turned on overnight. Ensure Vac pump is off, however before turning off computer. 4. Turn off all gas tanks.

1-3

Gas Pressures

& Reference: 6-8 psi ˚ Calibration gas tank pressure: >500 psi ˚ Adequate Calibration & Reference are used to calibrate the analyzers for GX Testing. ˚ Open tanks slowly to properly pressurize the circuit. ˚ NOTE: For instructions on how to change out a gas tank, refer to Appendix A.

1-4

Gas Concentrations

Concentration accuracy is very critical to accurate measurements. Verify from tank manufacturer if not using MGC Diagnostics gases. Calibration Gas Mixture: Oxygen and 5% CO ˚ 12% ˚ Remaining Balance N

Reference Gas Mixture: Oxygen and 0% CO ˚ 21% ˚ Remaining Balance N

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

1-5

Ultima

This is a view of the Ultima module, shown here with the front cover on.

Calibration/Home Port Plug the umbilical clip into the calibration port, indicated for gas calibration or for protection of the umbilical clip during storage. Calibration Port

O2 Sensor

Calibration Port Sample Line Connection

Umbilical Flow Connections

Ultima with cover off.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

1-6

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 ˚ The an indented notch. 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.

that the honeycomb end of the ﬂow sensor is facing the ˚ Ensure patient.

ﬂat end of the umbilical clip faces the patient and the tab side ˚ The faces away from the patient.

ﬂat end of the umbilical clip always faces the honeycomb side of ˚ The the ﬂow sensor.

connect the two units, align and insert the metal probes of the ˚ To umbilical clip into the holes at the base of the ﬂow sensor. The units should snap together and form a tight ﬁt.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

1-7

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.

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

Umbilical Cable The umbilical cable connects to the Ultima module and is the means by which the testing data is transferred to the system for processing.

DirectConnect™ Flow Sensor The use of the DirectConnect ﬂow sensor eliminates the need to use the bias ﬂow offset ﬁeld because all the measurements are made at the patient connection, (endotrachael tube) proximal to the wye of the ventilator circuit. NOTE: This is an optional hardware package for use with ventilator testing only.

1-8

Connecting the Subject

Patient Mouthpiece with Saliva Trap The patient mouthpiece is placed in the patient’s mouth while testing is being performed. noseclips ˚ Use Umbilical in 12 o’clock position ˚ Ensure plug is inserted into the saliva trap ˚

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

preVent® Masks selection and ﬁtting of the preVent mask is required to ensure ˚ Correct a leak-free ﬁt. The medium (Blue) mask will ﬁt most subjects, however,

˚ ˚

there are also extra small (Purple), small (Green) and large (Black) masks available. The photo shows a properly ﬁtted mask. When using a mask, ensure subject is breathing through their mouth and not their nose.

Proper ﬁtting of preVent Masks: 1. Install the white rubber coupler into the hole in the mask. 2. Install the ﬂow sensor. This should be ﬂush with the sensor coupler inside the mask. 3. The narrow strap (upper) should be positioned on the backside, near the “crown” of the head and the wide strap (lower) should be positioned across the back of the neck. 4. The top of the mask, with the aluminum nosepiece, should be pulled up to the top (bridge) of the nose and formed to ﬁt securely around the nose. 5. The bottom of the mask should be pulled securely under the chin so that the material between the nose and chin is slightly stretched. Typically, the mask should wrap under the chin about one inch. 6. The sensor and coupler should be located comfortably in front of the mouth. preVent Mask Troubleshooting: mask is too short on the bridge of the nose or chin, use a larger mask. ˚ IfIf the the bottom of the mask wraps more than one inch below the chin or if the coupler is positioned below the ˚ mouth, use a smaller mask. leak check the mask, place hand over the open end of the ﬂow sensor and gently have the subject blow. ˚ To There should be no air escaping from the mask.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

CHAPTER II STARTING A TEST

2-1

Flow Sensor Calibration

2-2

O2 & CO2 Calibration

2-3

External Device Calibration

2-4

Calibration Report

2-5

Patient Information

2-6

Opening an Existing Patient

2-7

Searching the Database

2-8

Review and Test Mode

2-9

Manual Data and Event Entry

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

2-1

Flow Sensor Calibration

Calibration Screen

1. To access the calibration button at the top of the Open Patient Screen, click the Done 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 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 the 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. 8. If calibration fails, do not click Reset. See Note that follows.

NOTE - If the syringe sticks during calibration, execute the following steps: STOP ˚ Click the syringe in ˚ Push Click START ˚ Fully withdraw the syringe ˚ Wait for the inject prompt to appear, then ˚ Inject the syringe ˚ Click STOP ˚ Return to step four of the ﬂow sensor calibration process above ˚

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

2-2

O2 & CO2 Calibration

The Ultima gas calibration uses an automatic calibration (AutoCal) feature. The gas AutoCal measures the signals and automatically adjusts the gain and offset values to accommodate the signal values. Ensure the vacuum pump has been on for a minimum of two minutes and displays “Ready.” Open calibration and reference tanks. 1. Gas calibration begins by placing the umbilical clip into the cal/home port on the front of the Ultima. 2. Select “GasAutoCal” from the home screen of the software.

Selecting “Gas AutoCal” 3. Results are displayed when the calibration is complete. Select OK to save calibration results. Close calibration and reference tanks. NOTE: The columns would be in red if the calibration had been unsuccessful. Click Retry if a measured result is displayed in red.

2-3

External Device Calibration

To calibrate an external device (i.e. Treadmill), select Calibration and click on the External Device tab. Follow the instructions in the message box to complete the calibration. NOTE: You must ride the bike or run on the treadmill to enable the software to read the voltage. 1. Select a device and the signal to calibrate. 2. Enter a target value for the ﬁrst point. 3. Set the device to target value. 4. Click on Collect 1st Point to begin receiving voltage values. 5. Once voltage value is stable to calculate, click Freeze 1st Point. 6. Collecting a 2nd Point is not required. When External Device Calibration is successful, the message box will turn green. 7. Repeat as necessary for all analog signals.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

2-4

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.

2-5

Patient Information

New Patient Icon

1. To create a new patient, select File > New > Patient or click the New Patient icon. 2. All information in the colored ﬁelds are required when creating a new patient. Use the Tab key or the mouse to advance to the next ﬁeld. 3. The Patient ID must be unique and the Date of Birth 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 (all 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 arrow of the drop down menu. Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

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.

2-6

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.

2-7

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. Use the necessary Display Filters by clicking on the drop down menus. 2. Click the Find button and from the Find In pull down menu, select whether to search by ID, Last Name, First Name, Middle Name, Last Visit Date, Last Review Status, or Last Vendor. 3. Fill in the search for line with enough of the name to narrow the search. 4. Click Find to run the search. The ﬁrst match will be highlighted. Click Find again to move to the next match in the list. 5. To open a patient record, either double click on the patient or select it and click Open.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

2-8

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.

Test Mode Icon in Test Mode

2-9

Large Icon Test Mode View

Small Icon Test Mode View

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.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

CHAPTER III TESTING

3-1

Slow Vital Capacity (SVC)

3-2

Forced Vital Capacity (FVC)

3-3

Maximal Voluntary Ventilation (MVV)

3-4

Bronchial Provocation (BRP)

3-5

VO2 Exercise Testing

3-6

VO2/ECG Testing with Mortara

3-7

Metabolic Testing

3-8

Ventilator Testing

3-9

Canopy/Face Tent Testing

3-10

NICO Testing

3-11

Exercise Flow Volume Loop Testing

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

3-1

Slow Vital Capacity (SVC)

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

TV resting inspiratory level

TLC ERV

maximal inspiratory level

FRC RV

Physiology A SVC test measures the vital capacity of the lungs during a slow and complete exhalation to RV. In healthy patients, there is little difference between SVC and FVC results. A 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 trapping 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).

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

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 an 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 in simple terms, demonstrating SVC breathing. Provide continuous feedback during the test, especially at maximum inspiration and expiration levels. 2. To begin a SVC test, click on the SVC Tab. The Data Collection Screen will appear, as indicated by the ﬂow sensor icon in the upper left of the graph.

Start/Stop Button

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Zero Flow Button

3. Click Zero Flow to zero the ﬂow sensor before testing. 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 and expire fully. Press the Space Bar or click Stop to complete the test. 6. When the test has been stopped, complete test results will appear in the data table. 7. The software automatically selects the largest SVC by placing a red check mark in the select column.

3-2

Forced Vital Capacity (FVC)

Key Terms & Deﬁnitions FVC: The difference between highest and lowest 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. FIFx%: The ﬂow measured at a speciﬁc percent of inhaled volume (e.g. FIF25%). FIFx-y%: The average inhaled ﬂow between two selected volume points (e.g. FIF25-75%). FEV1/FVC: The proportion of total air volume that can be expired in the ﬁrst second of expiration A 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.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Physiology A FVC 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 effort-dependent 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 acceptable FVCs must be within 150 ml. ˚ The two largest acceptable 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.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Flow Volume Loop Curves

STATIC LUNG VOLUMES

THE EFFECT OF VARIABLE

CHARACTERISTIC FLOW

DEPICTED BY FLOW

PATIENT EFFORT ON THE

VOLUME LOOPS PRODUCED

VOLUME LOOP

MAXIMAL FLOW VOLUME LOOP

BY INCREASING AIRFLOW OBSTRUCTION

RESTRICTION OF LUNG VOLUME

THE EFFECT OF VOLUME

VOLUME REDUCTION

LIMITATION OR RESTRICTION

INCREASED ELASTIC

ON THE FLOW VOLUME LOOP

RECOIL

REVERSIBLE AIRFLOW

FIXED EXTRATHORACIC

VARIABLE EXTRATHORACIC

OBSTRUCTION

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

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 in simple terms, 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 FVC test. Start/Stop Button

Zero Flow Button

2. Click Zero Flow to zero the ﬂow sensor and ensure 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. Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Patient Incentives

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

˚ ˚ ˚ ˚

3-3

Maximal Voluntary Ventilation (MVV)

Key Terms & Deﬁnitions 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

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Physiology test measures the volume of the largest breath that can be taken in and out of the lungs during a 10˚ A15MVV 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 Patients with signiﬁcant airway obstruction may derive greater beneﬁt by taking larger breaths at slower ˚ respiratory rates. Optimal MVV is achieved by matching an FEV type effort with a respiratory rate of 60 bpm. ˚ Caution: The strenuous nature of this test can cause fatigue and may be dangerous for some patients. 1

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.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Start/Stop Button Zero Flow Button

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

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

3-4

Bronchial Provocation (BRP)

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. 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, select 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 BRP execute the following steps: 1. Select the Protocol Log tab.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

2. Click on the drop down menu in the Protocol dialog box to select 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 check mark in the Select or RAW column). 7. In the Test Mode column of the FVC test, verify that a Pre/Baseline, Challenge/Max, and Post Marker have been selected. Cumulative Dose Units and PC20 are automatically calculated.

8. Click on Quick Print and go to the Report Switchboard. 9. Print the appropriate BRP Report.

3-5

VO2 Exercise Testing

Key Terms & Deﬁnitions Anaerobic Threshold (AT): The point at which oxygen can no longer be utilized efﬁciently. This is the level of exercise at which energy production from anaerobic metabolism becomes signiﬁcant, and lactic acid is produced. Gas exchange is affected by an increase in CO2 output over that produced from aerobic metabolism, resulting from the HCO2ˉ buffering of lactic acid. Also deﬁned as the highest work rate or O2 uptake that can be maintained without an increase in blood lactate. AT is used as a measure of endurance for both exercise and daily living activities. Breathing Reserve (BR): Represents the unused fraction of maximal voluntary ventilation, therefore the amount of pulmonary “reserve.” The difference between MVV and maximum exercise ventilation. Hence, this represents the body’s residual potential for further increasing ventilation at maximum exercise. (1-[Vemax/MVV]) x100. Carbon Dioxide Output (VCO2): The volume of carbon dioxide produced as a by product of the working muscles and cellular metabolism. Expressed in ml/min.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Heart Rate Reserve (HRR): The difference between the predicted highest heart rate attainable during maximal exercise and the predicted maximal heart rate. It is usually determined during exercise testing involving large muscle masses, such as during cycle or treadmill ergometry. HRR = 1- (HRmax (subject)/HR pred max) x 100. HRR represents the unused portion of the heart rate at maximal work levels. Maximal Oxygen Uptake (VO2 max): The maximum rate at which a person can consume oxygen. An indication of the oxygen transport capacity of the heart, lungs, and circulation, it is used as a measure of exercise capacity. Expressed in ml/min, L/min, or ml/kg/min (relative to body weight). METS: The metabolic cost of work or exercise. Relates work to rest. Resting level of 1 MET = 3.5 ml/kg/min VO2. Oxygen Uptake: The rate at which the body can absorb oxygen for aerobic metabolism; expressed in ml/min or ml/kg/min. V-Slope: A method of determining anaerobic threshold, VCO2 (vertical or Y-axis) is plotted breath by breath against the VO2 (x-axis) and the AT is identiﬁed as the “point at which VCO2 increases out of proportion to aerobic metabolism.” A disproportionate rise in the VCO2 relative to the VO2. The results correlate well with the AT determined from blood lactate levels. Respiratory Exchange Ratio (RER): The volume of carbon dioxide produced divided by the volume of oxygen consumed (VCO2/VO2); it is the sum of the gas exchange occurring at the muscle, the buffering of lactic acid, and the metabolic cost of work. An RER of > 1.09 indicates a maximal test. In recovery RER may rise even higher due to hyperventilation.

Testing Procedure Exercise testing requires special attention to detail and must be prepared with care. Because exercise testing includes some risk to the subject, it is essential to properly prepare both the equipment and the subject for a successful test. All personnel involved in the test must be aware of all safety considerations. To prepare for test: 1. Warm up the system. Perform the daily complete ﬂow sensor calibration and enter weather conditions. 2. Click on Vac to turn on the sample pump (only requires 2 minute warm-up). 3. Open an Existing Patient File or create a new one as required. 4. On the Patient Tab, click Add Visit to begin a new test session. 5. Fill out the Visit Demographics and Patient History tabs. 6. Instruct the subject to loosen tight clothing, describe the testing process and demonstrate proper technique prior to testing. 7. Select the GX Tab. 8. From the Settings tab, select Bike or Treadmill Script and adjust the settings if necessary. 9. Attach the umbilical clip to the cal/home port and press the GasAutoCal button. The results will be displayed on the screen. Retry the calibration if the initial calibration fails. After successful calibration, close the calibration and reference tanks. 10.Inspect the ﬂow sensor for damage. Install ﬂow sensor into the umbilical clip aligning clip tab with the ﬂow sensor notch. Position the ﬂow sensor in the saliva trap mouthpiece or preVent mask so that the umbilical clip enters from the top of the ﬂow sensor (see section 1-8 for further information). Select zero ﬂow. Place mouthpiece and noseclip or mask on patient.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Test Procedure 1. Select the Test tab. 2. Optional: Select PWave from the Tools menu to check the physiologic waveforms to verify that the equipment is set up and operating properly. Close the PWave window after verifying the waveforms. 3. Click Start on the Test Pad to begin resting data collection. 4. Click Exercise to manually activate exercise testing. Exercise testing begins when starting the protocol by clicking Exercise. While testing, use the Test Pad to: Skip to the next protocol stage by clicking Next Stage. Pause at the current stage by clicking Hold Stage. Manually control the ergometer by clicking Manual. Monitor phase and stage timers and the current device workload on the Test Pad. Click on event entry icon to add Blood Pressure and Perceived Exertion entries. 5. Click Recovery to end exercise and begin the recovery phase of testing. 6. Click Stop to end data collection. 7. Review anaerobic threshold achieved from the AT tab and adjust as necessary.

˚ ˚ ˚ ˚ ˚

8. Select and print report.

Adjusting Anaerobic Threshold Click on the AT tab to review the anaerobic threshold. MGC Diagnostics software is based on the V-Slope method for detection of AT. MGC Diagnostics anaerobic threshold detection program utilizes an iterative regression and analysis of the slope of VCO2 vs. VO2 to determine where the carbon dioxide production begins increasing disproportionately to the oxygen consumption. Although both rest and exercise data are plotted on the anaerobic threshold tab, only exercise data is evaluated in establishing the AT. After the anaerobic threshold is determined, the program computes the values at the point of occurrence of AT for selected variables. These values appear in the table to the left of the anaerobic threshold graph and are also available on the summary page. To drag the anaerobic threshold to a new position: Left click while holding the mouse button on the AT line and drag the line to a new position. To move the anaerobic threshold to the next or previous breath: Click the right and left arrow buttons to move the anaerobic threshold one breath at a time. To place a RC (Respiratory Compensation): Click on the arrow in the Adjust ﬁeld and select RC from the pull down menu. An RC line appears on the graph. Left click while holding the mouse button on the RC line and drag the line to a new position. To have the program recalculate the anaerobic threshold: Click the Find AT button. The program calculates AT and places the line accordingly.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

Using the Window Tab User Deﬁned Windows Deﬁne windows of data for use in Curve Fitting or Window Averaging. To close a user-deﬁned window, click and hold down the mouse on one end of the time period and drag it to meet the other end. This closes the window. Deﬁning the Exercise Window Only data in the exercise window is graphed and used for calculations. Use the Exercise Window function to adjust the points at which exercise begins and the recovery period starts. If the exercise window is changed, the anaerobic threshold may need to be adjusted. Be sure to select the AT tab and click Find AT to have the program recalculate the anaerobic threshold. To move a line, click and hold down the mouse on the line and drag it to the new location. Excluding Windows of Data Excluded data is still saved, but it does not appear in the graphs or reports. To exclude a time period, click and hold down the mouse at the start of the time period. Drag the cursor to the end of the period and release the mouse. To close an excluded window of data, click and hold down the mouse on one end of the time period and drag it to meet the other end. This closes the window.

Ultima™ Series Models CCM, CPX, CardiO2, and PFX Operator Manual

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