HearTwave II Training Program

1. HearTwave II Training Program

2. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

3. Patient PreparationYou’ll Need These Materials • 7 Micro V sensors • 7 Standard Electrodes • 3M™ One Step Skin Prep • Razor • Gauze

4. Patient PreparationPrep Electrode Locations • Shave to remove all hair from the site. • Gently wipe the skin with a gauze pad if the skin is very oily or moist or has lotion. DO NOT USE ALCOHOL. • GENTLY abrade with 3M Skin Prep. Make sure to abrade an area of skin at least as big as the electrode or sensor.

5. Patient PreparationAbradeElectrode Locations • Precaution:ONLY MINIMUM ABRASION IS NEEDED.A good preparation removes only the surface layer of dead skin cells. Excessive abrasion of the skin can increase the risk of contact dermatitis.Never apply electrodes or Alternans Sensors to broken skin. • Apply the electrode or sensor immediately after prepping each site. Make sure to place the electrode or sensor exactly over the area of the skin that you just prepped. Apply the sensor with the tab pointing down. • Rub the electrode or sensor to ensure even contact. • After all electrodes and sensors are placed, connect the lead wires. Insert the tab of the sensor into the lead wire until the black line is just visible. • Make sure that the lead wires are not caught under the belt and are not pulled tight

6. Patient PreparationElectrode Placement – Flat Man • Attach Micro-V and standard leads in the positions indicated below.

7. Patient PreparationConnecting Patient Cable Leads and Patient Module • Connect all electrode leads taking care to avoid tangled leads. Use lead separators as necessary. • Attach patient leads cable to the patient module. • Attach to patient by securing the belt around the patient’s waist.

8. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

10. Performing a Test: Main Screen • Enter Physician, Technician and Protocol information using simple arrow keys and touchpad for navigation • Select a manual protocol of choice: MTWA Exer, MTWA Pace, MTWA Pharm • With the cursor in the “Patient” field, press “Enter” to open the Patient Information dialog:

12. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

15. Performing a Test: Lead Check • By pressing “Perform Test” on Heartwave II Main Screen you will enter the Lead Check Screen. • State of the art standard diagnostic 1-mm grid for onscreen interpretation of ECG waveforms. • Observe waveforms for low noise and make sure no leads are “OFF” (indicated in red below lead name) • Note the “Lead Noise” display. This provides real time baseline noise measurements which could possibly interfere with MTWA results. • The user can proactively reduce noise during testing thereby increasing likelihood of determinate results • Recommended noise thresholds for rest and exercise phases are indicated by horizontal lines on the Lead Noise display. Attempt to keep noise below these levels. • Note: It takes about 30 seconds for the lead noise bars to be calculated and displayed.

16. Performing a Test: Lead Check • If all leads are properly connected, with good electrode-to-skin contact, the screen displays “All Leads OK” with a “Start” button in the lower left corner • If skin prep was not sufficient, then leads on flat man will be color coded in yellow or red to indicate poor impedance. The screen displays “Examine Red/Yellow Leads” and you must re-perform a lead check. As with HearTwave I, overrides are discouraged • You are now ready to begin the rest phase of testing by pressing “START”

17. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

19. Performing a Test: Rest Phase(Pre-Exercise) • Use the dedicated BP/Event function key for documentation of vital patient data • Print a resting 12 lead ECG report for the patient’s record as a baseline measurement • Allow 45 minutes to conduct a complete MTWA test (ensures sufficient time for patient prep, re-prep if required, exercise testing and re-testing if required) • All MTWA protocols can be manually controlled to achieve a smooth gradual increase in heart rate profile for target ranges. As always, adjustment of grade is recommended over speed to minimize noise.

20. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

21. Performing a Test: Rest Phase(Pre-Exercise) • For MTWA exercise tests, allow the patient to get comfortable on the treadmill (without starting the belt). Check and adjust any lead cables that may be pulling • While the patient is moving, observe that the Lead Noise bars are below the EXER level. If noise levels are too high, try to identify the source (usually inadequate patient prep) • Collect at least one minute of rest data • Note dedicated custom command keys on keyboard for frequently used functions: • After informing and instructing the patient about the test, select the green “Start Treadmill” key on the keyboard • Use the red “Stop Treadmill” key to stop the treadmill • Press the “Start Exercise” key to initiate the exercise phase of the test

23. Performing a Test: Exercise Phase • Note there are two pie graphs on the HearTwave II screen: • First Pie (bottom) • 2.5 minutes between 100-110 BPM • Second Pie (top) • 1.5 minutes between 110-120 BPM • In an ideal test, the first pie is filled to 100%, and then the second pie fills to 100%, followed by recovery back to the resting heart rate. If for some reason pies cannot be filled to 100%, it is very important to fill it to at least the 60% marker. A test is likely to be indeterminate if either pie is less than 60% filled • HR Control Messages are displayed to assist with MTWA protocol • Note: As a minimum requirement, at least three minutes of data must be collected to initiate alternans processing and complete a test

24. Performing a Test: Exercise Phase New feature: Real-time 3-lead ECG monitoring • 8 seconds of diagnostic waveform display in industry standard leads (II, V2, V5) • Need to focus on only one screen for MTWA testing and patient monitoring • Simple customizable screen setup

25. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

27. Performing a Test: Recovery Phase • After satisfying HR profile requirements, proceed back to recovery allowing the patient’s heart rate to return to 90 bpm (or the resting level if higher) • Make sure at least one minute of recovery data is collected • Ability to continue monitoring patient status using on-screen 3-Lead ECG display • When ready, press the “End/Print” button and select an “End Test” Reason

29. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

31. Ending a Test: Monitoring Phase • Once an end reason is selected, data processing will begin and you will enter “Monitoring” phase • During processing, do not remove leads from patient until report results are displayed. If a result is indeterminate, repeat test after addressing reason for indeterminacy (see Indeterminacy Reference Card)

32. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

34. Printing a Test: Results Displayed • Once processing is complete, the alternans classification results will be displayed in the upper right corner of the screen • Initial interpretation is generated by the automated report classifier (“Interpreted by: Computer”) • Ability to repeat test directly from this screen without re-entering patient data

35. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

36. New Feature: Editing a Report • If desired, user can edit the classifier results by pressing “Reprint and Edit Results” button • Option of changing any of the alternans results parameters and inserting their own comments • Edited results will be saved with user name and date • Report editor is also available through review reports screen

37. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

39. Review Reports Screen and Review Mode • Ability to print alternans reports • Ability to edit alternans results • Ability to print stress reports • Ability to review entire test through review mode

42. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

44. HearTwave II MTWA Training Program • Patient Preparation • Performing a Test • Main Screen • Lead Check • Rest Phase (Pre-Exercise) • Exercise Phase • Recovery Phase • Ending a Test (Monitoring Phase) • Printing a Test (Results Displayed) • Editing a Report • Review Reports Screen and Review Mode • Data Management • System Setup

45. HearTwave II MTWA Training Program • System Setup allows the ability to fully customize common system parameters such as: Protocols Custom Text Final Reports Screen setup