ZOLL Medical Corporation Sales Training

1. ZOLL Medical CorporationSales Training

2. 12-lead ECG

3. Agenda Introduction What is a 12-lead? Features and Benefits Demonstration In-Service Hands-on The key reasons for in-hospital 12-lead are the bottom 3 : A means of reducing the time to treatment being the key driver here. Thrombolytic therapy needs to be given quickly and the time to treatment after arrival in the hospital averages anything for an hour to hour and a half which is 2 to 3 times longer than necessary to initiate therapy. Patients treated within the first 75 minutes of chest pain can show a 50% reduction in the size of MI.Improved patient care is self explanatory.The MUSE system allows you to compare the current ECG with the patients previous ECG history and look at changes in the morphology and interpretive statements.The key reasons for in-hospital 12-lead are the bottom 3 : A means of reducing the time to treatment being the key driver here. Thrombolytic therapy needs to be given quickly and the time to treatment after arrival in the hospital averages anything for an hour to hour and a half which is 2 to 3 times longer than necessary to initiate therapy. Patients treated within the first 75 minutes of chest pain can show a 50% reduction in the size of MI.Improved patient care is self explanatory.The MUSE system allows you to compare the current ECG with the patients previous ECG history and look at changes in the morphology and interpretive statements.

4. FACTS AMI ( Acute Myocardial Infarction ) is THE leading cause of death in the US 1.1 MILLION people have an MI annually 439,000 women 668,000 Men Approx 500,000 will die Costs for CAD ( Coronary Artery Disease ) in the US in 2001 were $298 billion NRMI ( National Registry Myocardial Infarction) Database

5. Indications for the 12-lead ECG Chest Pain Stroke Dysrhythmias Post-Resuscitation Following Emergency Cardioversion Suspected Electrolyte Disturbances For Asystole confirmation PEA ( Pulseless Electrical Activity) to identify cause

6. Ischemia Lack of oxygenation ST depression or T inversion Injury Prolonged ischemia ST elevation Infarct Death of tissue May or may show in Q wave This information will aid in understanding the ECG subsets in the next section. Define ischemia, injury and infarct. Note that the definitions are correlated with specific ECG criteria. Note that �injury� is also ischemia and does not imply any permanent damage or death to tissue. The term injury simply means ischemia identified by ST segment elevation. This information will aid in understanding the ECG subsets in the next section. Define ischemia, injury and infarct. Note that the definitions are correlated with specific ECG criteria. Note that �injury� is also ischemia and does not imply any permanent damage or death to tissue. The term injury simply means ischemia identified by ST segment elevation.

7. ST Segments

8. 12-lead ECG

9. 12-lead Electrode Placement

10. Inferior Wall Leads II, III, aVF Left Leg 12-Lead ECG KNOWLEDGE

11. Lateral Wall Leads I and aVL Left Arm 12-Lead ECG KNOWLEDGE

12. Septal Wall Leads V1, V2 Along sternal borders 12-Lead ECG KNOWLEDGE

13. Septal Wall V3, V4 Left anterior chest 12-Lead ECG KNOWLEDGE

14. Lateral Wall Leads V5 and V6 Left lateral chest 12-Lead ECG KNOWLEDGE

15. The three ECG subsets Non diagnostic: no ST or T wave abnormalities Suspicious for ischemia: ST depression or T wave inversion Suspicious for injury: ST elevation The 12-lead ECG can be categorized into one of three groups. These three groupings will be the basis for treatment decision-making. It is critical to commit these three groups to memory. Each category is now discussed in more detail.The 12-lead ECG can be categorized into one of three groups. These three groupings will be the basis for treatment decision-making. It is critical to commit these three groups to memory. Each category is now discussed in more detail.

16. 12-Lead ECG KNOWLEDGE What�s the Value of a12-Lead? Provides baseline ECG before treatment Early and rapid identification of AMI Triage to correct facility Cath Lab or Thrombolytics Quicker diagnosis Reduced time to triage / treatment in hospital Improved patient care

17. M Series with 12-lead ECG option Features and Benefits

18. 12-Lead ECG KNOWLEDGE Description: Simultaneous 12-lead ECG acquisition, storage, display, transmission and analysis Uses GE Medical Systems 12SL� analysis program Interface with MUSE� for direct transmission of 12-lead ECG records from defibrillator to hospital MUSE system.

19. 12-Lead ECG UNDERSTANDING Key Differentiators AHA Class I recommendation GE 12SL = Gold Standard for analysis Direct transmission to MUSE Bluetooth Wireless Options Module to Interlink to RescueNet Code Review Fax and email Bluetooth Activation Pod Kit Fax or MUSE

20. The GE 12SL PROGRAM Background Validated on clinically correlated �Gold Standard� databases Annually evaluated by a group of over 50 top consulting Cardiologists and physicians from around the world ( ECG Analysis seminar) Detailed Physician�s Guide explains the ECG Analysis morphology ( obtained from GE) The GE 12SL was developed in 1980 and has been constantly evaluated and enhanced over the past 21 years.The 12SL Statement of Validation and Accuracy is the summary of all the testing done to date and can be shared with customers.The � Gold Standard� Databases are a list of 14 different databases used to test the problems being investigated ie MI,LBB etc.For something like MI GE will use a database in conjunction with other evidence ie cath, echo,autopsy etc and for something like measurements or arrhythmia statements they will use the ECG together with expert opinion.The GE 12SL was developed in 1980 and has been constantly evaluated and enhanced over the past 21 years.The 12SL Statement of Validation and Accuracy is the summary of all the testing done to date and can be shared with customers.The � Gold Standard� Databases are a list of 14 different databases used to test the problems being investigated ie MI,LBB etc.For something like MI GE will use a database in conjunction with other evidence ie cath, echo,autopsy etc and for something like measurements or arrhythmia statements they will use the ECG together with expert opinion.

21. 12SL PROGRAM KEY Points : Worldwide name recognition (Analysis by 12SL) Introduced in 1980 and consistently enhanced Most independently validated algorithm in the scientific literature Adult & Pediatric programs available Published statement of �Validation & Accuracy� Established value and is now the Standard of Care GE also tests the 12SL on a wider range of data,They do this by measuring the 12SL performance against a database of >150,000 ECGs which have been acquired from MUSE systems.This can be done in a day and the 12SL is tested with multiple diseases and differing degrees of normality.When this testing is done,changes or enhancements are made to the program if needed, GE also tests the 12SL on a wider range of data,They do this by measuring the 12SL performance against a database of >150,000 ECGs which have been acquired from MUSE systems.This can be done in a day and the 12SL is tested with multiple diseases and differing degrees of normality.When this testing is done,changes or enhancements are made to the program if needed,

22. Sensitivity Refers to recognition If the test always recognizes the disorder, sensitivity would be 100% False negatives are failures of sensitivity A false negative occurs when the condition exists but the test fails to find it

23. Specificity Refers to the number of diagnoses confirmed If the diagnosis were corroborated every time the test identifies it, it would be 100% specific False positives are failures in specificity A false positive occurs when the test indicates the disease is present, when in fact it is not Sensitivity refers to recognition. If the test always recognizes the disorder, sensitivity would be 100%. False negatives are failures of sensitivity. A false negative occurs when the condition exists but the test fails to find it. Specificity refers to the number of diagnoses confirmed. If the diagnosis were corroborated every time the test identifies it, it would be 100% specific. False positives are failures in specificity. A false positive occurs when the test indicates the disease is present, when in fact it is not. Sensitivity refers to recognition. If the test always recognizes the disorder, sensitivity would be 100%. False negatives are failures of sensitivity. A false negative occurs when the condition exists but the test fails to find it. Specificity refers to the number of diagnoses confirmed. If the diagnosis were corroborated every time the test identifies it, it would be 100% specific. False positives are failures in specificity. A false positive occurs when the test indicates the disease is present, when in fact it is not.

24. GE 12SL PROGRAM Infarction Sensitivity 65% ( refers to recognition) Specificity 98% ( refers to diagnostic accuracy) Overall 74% sensitivity for Chest Pain Patients �� clearly adequate for first line screening of patients with chest pain by paramedics or in the ER�. � � specificity is superior to that of the trained electrocardiographer� Sensitivity refers to recognition : if the test always recognizes the disorder,the sensitivity would be 100%.Specificity refers to the number of diagnoses confirmed.If the diagnosis were verified every time the test identifies it that would be 100% Computer analysis is NOT a substitute for human interpretation : computer ECG Analysis is statistically very accurate BUT is not able to look at the entire clinical picture of the patient.The 12-Lead ECG must always be viewed with all clinical data and circumstances. The UNCONFIRMED statement is a standard : an ECG must always be over read and confirmed by the cardiologist. Sensitivity refers to recognition : if the test always recognizes the disorder,the sensitivity would be 100%.Specificity refers to the number of diagnoses confirmed.If the diagnosis were verified every time the test identifies it that would be 100% Computer analysis is NOT a substitute for human interpretation : computer ECG Analysis is statistically very accurate BUT is not able to look at the entire clinical picture of the patient.The 12-Lead ECG must always be viewed with all clinical data and circumstances. The UNCONFIRMED statement is a standard : an ECG must always be over read and confirmed by the cardiologist.

25. 12-Lead ECG KNOWLEDGE 12-lead Summary Reports 4x3: Prints 10 seconds of 12-lead ECG in four staggered 2.5 second segments (default) 4x3 Median: Prints single median beat for each of the 12 leads as computed by 12SL algorithm 2x6: Prints all 12-lead ECG data recorded during first 5 second interval. Inhibits printing of the 12SL analysis and lead II rhythm strip Measurement Matrix: Prints measurements for each segment of each lead. This option must be changed in the configuration menu.

26. M-Series ECG Filters ECGs are acquired from a predetermined frequency range.MONITORS use a narrower bandwidth to eliminate as much artifact as possible.MONITORS do not accurately reflect ST Segments for diagnostic purposes.12-lead ECG picks up a wider window of frequencies to provide an accurate picture of diagnostic changes in the ST Segments.This Wider window allows more artifact to come in,which is why skin prep and quality electrodes are vital.ECGs are acquired from a predetermined frequency range.MONITORS use a narrower bandwidth to eliminate as much artifact as possible.MONITORS do not accurately reflect ST Segments for diagnostic purposes.12-lead ECG picks up a wider window of frequencies to provide an accurate picture of diagnostic changes in the ST Segments.This Wider window allows more artifact to come in,which is why skin prep and quality electrodes are vital.

27. Features and Benefits Integrated in the M Series Easy to Use Recorder Button automatically provides 4x3 printout 12-lead Acquisition Button Provides 4x3, Interpretation and Measurements Faster 12-lead print-out v LP12 Prints the first 3 lead groups after 2.5 seconds LP12 waits 10 seconds and then prints 12-lead report

28. Features and Benefits One-Step Patient Cable Ease of Configuration 12SL Analysis Implementation Fast Acquisition Compressed ECG pre transmission

29. Features and Benefits Fax/Modem Card 12-lead Transfer today Wireless coming in Oct 2003 12-lead ECG compression LP12 Physio sends raw ECG data M Series compresses before we send MAY help transmission speeds!! Preconfigured telephone numbers Saves time / easy /Auto redial Manual dial option ( Buried in LP12 configuration)

30. Why ZOLL�s 12-lead? Key Points GE Medical Systems 12SL Analysis Program Rapid 12-lead Acquisition ECG compression for transmission Transmission capabilities of M Series 12SL Best in Class v other ECG Programs Cost-effective pricing Connectivity options ie MUSE The above features are key to positioning and selling the 12-lead option to any prospective customer.The GE 12SL is the most recognized and tested algorithm in the field. You want to make sure that the customer understands why we can transmit ECG data quicker than Physio : we compress the ECG before sending which results in quicker times to transmit versus Physio who are sending raw ECG data. The 12SL program accuracy is superior to other ECG programs out there ie HP ECL09 and Burdick.More to follow. Talk about the price of 12-lead in a fully integrated defib/monitor especially when looking at the ECG carts in the hospital. Stress the direct connectivity option we have to MUSE and that no other vendor is able to provide this.The above features are key to positioning and selling the 12-lead option to any prospective customer.The GE 12SL is the most recognized and tested algorithm in the field. You want to make sure that the customer understands why we can transmit ECG data quicker than Physio : we compress the ECG before sending which results in quicker times to transmit versus Physio who are sending raw ECG data. The 12SL program accuracy is superior to other ECG programs out there ie HP ECL09 and Burdick.More to follow. Talk about the price of 12-lead in a fully integrated defib/monitor especially when looking at the ECG carts in the hospital. Stress the direct connectivity option we have to MUSE and that no other vendor is able to provide this.

31. 12-lead ECG APPLICATION 12-lead Demo

32. M Series 12-lead Being prepared Review Operators Guide Review 12-lead Monitoring Insert Understand electrode placement V1: 4th intercostal space at right sternal margin V2: 4th intercostal space at left sternal margin V4: 5th intercostal space on left midclavicular line V3: Between V2 and V4 V5: Left anterior axillary line at horizontal level of V4 V6: Left midaxillary line at horizontal level of V4

33. Demo Tips Configure the device to automatically transmit after a 12-lead Have a 12-lead simulator Pre-connect all leads to the simulator Have the M Series already in 12-lead monitor mode Configure to come up in Lead II Do not enter in the age, gender or ID# Explain how M Series 12-lead begin to print out after the first 2.5 seconds on the Leads I , II , III LP12 waits 10 seconds before print out Explain how ZOLL compresses the data V-Pak electrode samples

34. M Series 12-lead Have the proper equipment! 12-lead cables!!!!!!!!!!!!!!! 12-lead simulator Fresh batteries Pre-attached leads Configure M Series for desired operation Carry a spare modem card and cables TEST THE TRANSMISSION IN ADVANCE

35. 12-Lead ECG KNOWLEDGE Basic Operation - 12-Lead Acquisition Attach electrodes Turn selector switch to MONITOR Press 12 LEAD soft key to enter 12-lead menu Acquire, Settings, PT Info, Alarms is displayed Press ACQUIRE to begin 12-lead acquisition (takes 10 seconds) Wait for ACQUISITION COMPLETE message before patient movement allowed Transmission screen will automatically be displayed after acquisition if configured To print only: Press and hold PRINT for 3 seconds

36.  12 Lead � Miscellaneous

37. 12-lead Accessories Modem Extension Cable Revision B (Dec 02) Connects to Ositech King of Hearts or Viking Cellular Ready modems only Does not fit the older Viking Modem cards Part # 8000-0086 Xtreme Pak Comes with modem cable built in to plate See Bulletin 52802 for all Part # Sales Bulletin # 55302 /52602 for details

38. M Series 12 Lead Opportunities Adding 12 lead increases ASP and gets you to quota faster $7,395.00 is like selling two defibrillators instead of one

39. Qualifying Questions Is 12-lead currently in your scope of practice? What is your current protocol for AMI assessment in your department? What 12-lead devices do you currently use? Are you transmitting 12-leads? If so, where to? Once in the ER, how long does it take before a 12- lead ECG is taken? What�s your average on scene time? Do you have a 24 / 7 Cath lab in your area?

40. Troubleshooting 12-lead Do they prep the skin before applying the ECG electrodes to the patient? Were the electrodes pre-attached potentially drying out the electrodes? Is there proper lead placement? Check for placement on boney prominences or for correct lead placement. Do they place the limb leads on the chest or limbs? Check to make sure the ER does the same placement. If they transmit, do they have drop out areas? If they get a fax busy signal, does the ER have a dedicated fax machine? Have they programmed their M Series with the appropriate fax numbers and cell phone?

41. 12-lead ECG UNDERSTANDING 12-lead In-Service