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

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.

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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

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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

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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

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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

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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.

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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

2

2

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

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2

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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.

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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.

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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 ˚

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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.

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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

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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 ˚

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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.

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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

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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.

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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.

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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

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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

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).

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