Breeze Suite ULTIMA PFX User Manual Rev C

The MedGraphics BREEZESUITE PFX Ultima User Manual is Part No. 142152001Rev C. 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.

MedGraphics is a registered trademark of Medical Graphics Corporation. Medical Graphics 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. Copyright Medical Graphics Corporation 2005. All rights reserved. Unauthorized use, copying or distribution is prohibited. Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, Minnesota 55127 (651) 484-4874 (800) 950-5597 (651) 484-8941 (Fax) www.medgraphics.com 0086

European Union (EU) Regulatory Representative Medical Product Service GmbH Borngasse 20 35619 Braunfels 49-6442-962073 49-6442-32578 (Fax) European Medical Device Directive Devices are compliant with the European Medical Directive (93/42/EEC) regarding safety and EMC.

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INDEX Start Up and Shut Down ... 6 System Start Up... 6 Shutting Down ... 7 After Gas Exchange (GX) Analyzer Calibration ... 7 At end of test ... 7 At end of day... 7 System Calibration... 8 Pneumotach Calibration ... 8 Gas Analyzer Calibration... 12 Maximal Inspiratory and Maximal Expiratory (MIP/MEP) Calibration ... 14 DLCO ... 17 DLCO Overview ... 17 DLCO Screen ... 18 DLCO Trace ... 19 DLCO Data Grid... 20 DLCO Toolbar ... 21 DLCO Test Procedure ... 22 Instructing the Patient... 22 Pre-Test Procedure ... 22 Test Procedure... 23 Automatic Gas Analysis ... 25 Repeating Test Efforts ... 25 Selecting Efforts ... 26 Using Auto Select ... 26 Manually Selecting Efforts ... 26 Selecting a Report Loop ... 26 Drawing Efforts ... 26 Printing Reports ... 26 DLCO Options... 27 Configuration... 27 Lock-out Time... 27 Anatomic Dead Space... 27 DL/VA... 27 Inspiratory Time ... 28 Keystroke to Start Test ... 28 Perform Auto-Select... 28 Evaluate Reproducibility ... 28 Display Acceptability Message... 28 Helium Shut Off Warning ... 28 Pressure Indicator On... 28 Correct TLC for FEV1/FVC ... 28 Collection Protocol ... 29 Hemoglobin Author ... 29 Start Collect Volume... 29 3

Stop Collect Volume... 29 Patient Valve Lockout ... 31 FRC TESTING... 32 FRC Overview ... 32 Using the FRC N2 Toolbar ... 33 Using the FRC N2 Data Grid ... 34 FRC Test Procedure... 35 Instructing the Patient... 35 Pre-Test Procedure ... 35 Test Procedure ... 35 Repeating FRC N2 Washout Efforts ... 36 Selecting FRC (N2) Efforts and Printing Reports... 38 Using Auto Select ... 38 Manually Selecting Efforts ... 38 Selecting a Report Loop ... 38 Selecting SVC Efforts Done in Spirometry... 38 Drawing Efforts ... 38 Printing Reports ... 38 FRC Options ... 39 Configuration... 39 Keystroke to Start Test ... 39 Perform Auto-Select... 39 Individual SVC Maneuvers ... 39 Average IC/ERV ... 39 Evaluate Reproducibility ... 41 TLC Calculation ... 41 MIP/MEP ... 42 MIP/MEP Overview ... 42 MIP/MEP Test Bar ... 42 MIP MEP Data Grid ... 43 MIP/MEP Testing Procedure... 43 Instructing the Patient... 43 Test Procedure... 45 MIP/MEP Options... 47 Keystroke to Start Test ... 47 Maximum Occlusion ... 47 Measurement Mode... 47 MIP/MEP Test Screen ... 49 VO2 Test Procedure ... 50 Preparing for a Test... 50 Test Procedure... 50 Direct Connect preVent Pneumotach for Ventilator Patients... 52 Metabolic Assessment with Ventilators Review... 52 Example of a patient on Direct Connect for Metabolic/Nutritional Assessment ... 53 Setup and Calibration of the Direct Connect preVent Pneumotach... 53 Patient Setup ... 54 Notice to PB 840 Users:... 55 4

References... 55 Replacing the Drying Line and Cartridge... 56 Replacing the Drying Sample Line ... 56 Replacing the Drying Cartridge ... 56 Sample Line Maintenance... 58 Procedure ... 58 Refreshing The O2 Cell... 60 Replacing the O2 Cell ... 61 Cleaning CO2 Analyzer... 63 Required Equipment... 63 Procedure ... 63 Gases/Regulators/Pressures ... 64

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START UP AND SHUT DOWN

System Start Up 1. Before turning the power on, plug a power conditioner into the wall outlet. Connect the power cords to the Ultima system and PF module, and plug the system and module into the power conditioner. Ensure all communication cables are securely attached between Ultima and PF module, as well as the PF arm cable and tubing connections. 2. Push the main power rocker switch on the back of both systems. The power light on the front of the Ultima system will turn from amber to green when the system is completely warmed up. 3. Flip the computer power switch to “On.” 4. Turn the monitor power to “On.” The Windows™ desktop menu displays on the screen. 5. Open Breeze. 6. Turn on the gas exchange (GX) vacuum pump in Breeze. 7. If using a drying cartridge, check to see if the blue drying crystals are still evident before calibrating or testing. 8. Wait 30 minutes for the system to warm up and stabilize. Wait 10 minutes for vacuum pump to stabilize and 12 minutes for DLCO helium (concurrent with the system warm up). Note: If the system power is turned off for a short duration (less than 15 minutes), analyzer warm-up time will be double the power-down time.

9. Turn on the printer and other external devices installed with the system. 10. Open all gas tanks by turning the gas cylinder’s top pressure valve to the left. The calibration and reference gas for the Ultima system should be set to deliver 15 psi. Ultima WD tanks are preset to 15 psi and have only one adjustment knob to open and close. Open the tanks by turning the black knob counterclockwise. 11. Set the PF module gases to 135 psi for both diffusion (DLCO), and oxygen (O2). Helium is an adjustable regulator setting between 10 – 25 psi. 12. Calibrate the pneumotach at the start of the day. 13. Automatically calibrate the gas analyzers (O2 and CO2) before each test.

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Shutting Down After Gas Exchange (GX) Analyzer Calibration Note: Gas exchange calibration (GX Autocal) calibrates the oxygen and carbon dioxide analyzer (O2 & CO2) that is used for all GX and FRC testing. The calibration and reference gases should be turned off only if there are no further GX or FRC tests performed in the next two hours.

Close the Ultima gas tanks (turn the gas cylinder pressure valve to right). For WD tanks, turn the black knob clockwise on each cylinder after completing the gas analyzer calibration process. The calibration and reference gases connected to the Ultima are used only for the calibration of the O2 and CO2 analyzers for all gas exchange and pulmonary testing.

At end of test To avoid the 30-minute gas analyzer warm-up and stabilization, allow the system to remain turned on throughout the day. Prolong the life of the vacuum pump and analyzers by turning the pump off whenever possible (the software timer will display “Ready” when the gas auto calibration can be performed). The system requires a 10-minute stabilization time when the pump is turned on.

At end of day The system’s main power switch may remain turned on overnight. To prolong the life of the oxygen analyzer, turn the vacuum pump off whenever possible. To prolong the life of the DLCO gas column, turn off the helium flow whenever possible. Close the gas cylinders by turning the valve (on top of the tank) clockwise until tight or turn the black knob clockwise on the WD tanks.

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SYSTEM CALIBRATION Allow the system to warm-up and stabilize: • •

30 minutes for the Ultima system and PF module (concurrent) 10 minutes for the vacuum pump (prior to gas calibration)

Pneumotach Calibration 1. Install the pneumotach into the clip and connect it to the rubber coupler (screen toward coupler).

Figure 1: Pneumotach clipped into the umbilical. 2. Connect the rubber coupler/pneumotach assembly to the calibration syringe. 3. Select “Calibrate” at the top of the screen to enter the calibration screen. Note: You must have the patient entry screen closed to select Calibration.

4. The software defaults to 3 liters for the calibration syringe size. If you are utilizing a different volume syringe, enter this value in place of the default value of three liters.

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5. Enter the current temperature, barometric pressure, and humidity at the bottom of the screen. Verify the units of measurement.

Flow Zero

Ambient conditions must be entered daily.

Figure 2: Ambient conditions must be entered daily 6. Click “Zero Flow” to zero the pneumotach. If the calibration is unsuccessful, a message appears stating that the flow offset is out of range. Repeat the procedure. If the zero continues to fail, try a different pneumotach and ensure the umbilical tubing is not occluded. 7. Click “Start” or press the spacebar to begin volume calibration. 8. The software will first prompt to withdraw the syringe. Withdraw the complete volume of the syringe. Use the guides/markers to assist you with the variance/speed of your calibration syringe withdraws and injections. Note: Within pneumotach calibration the flow should trace downward for all withdraws and upwards for all injections. If it does not trace downward, the pneumotach or pneumotach umbilical could be connected incorrectly or the pneumotach may have been inserted in the syringe incorrectly.

9. Push in smoothly and evenly on the plunger. Be certain to inject the complete volume of the syringe. 10. Repeat steps eight and nine until five injections and withdrawals are recorded. Withdrawals and injections should be performed at varied rates. The sequence stops automatically after five injections and withdrawals.

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Figure 3: Example of syringe calibration

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Syringe volume set-up

Flow zero

Dotted lines are for reference so different flow rates will be withdrawn and injected.

Figure 4: Different features of the calibration page

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Gas Analyzer Calibration The CPX Ultima gas calibration uses an automatic calibration (AutoCal) feature. 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 10 minutes and displays “Ready.” 1. Gas calibration begins by placing the umbilical clip into the cal/home port on the front of the Ultima.

Figure 5: Placing the umbilical clip 2. Align the bump on the umbilical so that it matches the circle located on the cal/home port of the system. 3. Select “GX AutoCal” in the software.

Figure 6: Selecting “GX AutoCal” 4. Results are displayed when the calibration is complete.

Figure 7: Calibration results

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An out-of-range result will display in RED. Click “Retry” if a measured result is displayed in red. If the gas analyzer calibration continues to fail, verify the following: • • •

• • •

The clip is properly seated in the Cal/Home port. The calibration and reference gases fully open and the tanks are full. The pink sample line is secure in the umbilical silver compression fitting. To secure the sample line, pull back the rubber strain relief by pushing inward on the side tabs and slide the tabs back from the clip. The compression fitting that secures the dry line on the front of the Ultima is not crimped. The drying sample line is securely connected to the pink sample line on the front of the system. The luer fitting is in working order. If the filter needs to be replaced, first use the purge pump to purge the sample line from the luer fitting to the clip end.

Breeze uses AutoCal to measure the gain. AutoCal sets the offset to achieve optimal min phase percentage values. Breeze may be indicating a failing O2 cell when: • •

offsets go out of range 2-90% response time goes out of range before the min phase % for O2 goes out of specification.

If the offsets continue to fail in AutoCal, the cal gas readings may be out of range and may require adjustments in the manual calibration of O2 and CO2 analyzers.

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Maximal Inspiratory and Maximal Expiratory (MIP/MEP) Calibration To calibrate for MIP/MEP testing, select “MIP/MEP” in the calibration menu. The MIP/MEP transducer requires a digital or water-type manometer to apply a pressure or signal to the transducer. 1. Select “Zero” to zero the MIP/MEP Transducer. 2. Enter the reference value of pressure that will be applied to transducer. Note: The MIP/MEP reference pressure may be set to any value less than 500 cm H2O. The default value is 20 cm H2O (see figure 8).

Figure 8: MIP/MEP calibration 3. Disconnect the luer fitting and apply the above-entered reference pressure to the transducer (see figure 9).

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Figure 9: Luer fitting 4. Apply pressure with a manometer (see figure 10) to the position of the three-way stopcock.

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Figure 10: Applying pressure with a manometer 5. Press spacebar to calibrate the MIP/MEP transducer. Note: Lung Diffusion (DLCO) does not contain an individual calibration. The calibration of DLCO testing is performed during the initial system pre-analysis.

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DLCO DLCO Overview The ability to measure lung diffusion (DLCO) is important for a number of reasons. Most importantly, diffusion capacity is the only non-invasive means of determining the functional integrity of the alveolar-capillary membrane. The diffusing capacity measurement provides a means of differentiating pathologies by the damage that they inflict on the lung parenchyma, such as the reduction in alveolar-capillary surface area in emphysema or the alveolar-capillary membrane permeability changes seen with diffuse interstitial processes. The ability to differentiate between processes greatly facilitates treatment. Note: The helium gas must be turned on at least 12 minutes before attempting a diffusion test. The helium gas flow is activated from the “Helium” button at the top of the patient test screen.

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DLCO Screen

Figure 11: DLCO screen

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DLCO Trace

Figure 12: DLCO trace

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DLCO Data Grid

Figure 13: DLCO data grid

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