HeartStart Home OTC DefibrillatorFDA Panel Presentation

Introduction

Carl MorganCompany Co-Founder and Scientist

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We propose to remove the prescription requirement for the Philips HeartStart Home Defibrillator.

Introduction to todays discussion

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Rx requirement:

CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

HeartStart Home Rx cleared in 2002

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Improving access to help save lives

Mission Prevent unnecessary deaths due to sudden cardiac arrest.

FocusImproving access by developing and deploying automated external defibrillators (AEDs) that can be used by virtually anyone to help save a life.

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Timeline

Heartstream founded1992ForeRunner launched1996First save on American Airlines1998Initial discussions with the FDA re: OTC 1999FR2 launched2000Filed pre-IDE2001HeartStart Home Defibrillator launched2002Filed 510(k) for OTC clearance2004

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Medical device labeling

The Food, Drug and Cosmetic Act requires that medical device labeling must bear adequate directions for use (502 (f)(1))

directions under which the layman can use a device safely and for the purposes for which it is intended. (21CFR801.5)

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The prescription caution

A prescription caution must be included in labeling if a device:

is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which adequate directions for use cannot be prepared.

(21CFR801.109)

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Basis for removing the Rx requirement for the HeartStart Home Defibrillator

Demonstrate established history of safe use.

Demonstrate that the HeartStart Home Defibrillator can be used safely and for its intended purpose based upon its labeling alone.

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Presenters

David SnyderDirector of Research, Philips

Dr. Lance BeckerProfessor of MedicineDirector, Emergency Resuscitation Center, University of Chicago

Dr. Jeremy RuskinFounder and Director, Cardiac Arrhythmia Service and Clinical Electrophysiology Laboratory, Massachusetts General HospitalArrhythmia research

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Product overview

David SnyderDirector of Research, Philips

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Philips HeartStart Home Defibrillator

Received FDA clearance in November 2002.

Indications for use:Unresponsive or not breathing normally.If in doubt, apply pads.

Safety and effectiveness already established.

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Demonstration

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Designed as safety equipment

If you have concerns about your health or an existing medical condition, talk to your doctor. A defibrillator is not a replacement for seeking medical care.

Cannot predict who might need it, or when.

Equipment may be used once in a lifetime.

Key characteristics:Safe for allReady when neededEasy in the moment

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History of Philips AED technology

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Sophisticated arrhythmia detection

No single parameter can lead to shock advised. Multiple parameters required.

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Field-demonstrated sensitivity/specificity

Biphasic waveform study 1st generation AED--ForeRunner286 out-of-hospital patients (1st 100 VF)100% sensitivity, 100% specificity

American Airlines study 1st generation AED--ForeRunner200 consecutive uses; 15 VF patients100% sensitivity, 100% specificityIncludes use as a rhythm monitor Tens of thousands of analyses

One known inappropriate shock.Successful defibrillation, followed by AF with no ventricular activity; indistinguishable from fine VF. Patient survived with normal neurological function.

Gliner et al., Biomed Instrum Technol. 1998;32(6):631-643.

Page et al., N Eng J Med. 2000;343:1210-1216.

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Volunatry post-market study shows commitment.

Philips AED use estimates Through 12/31/2003

Over 150,000 AEDs deployed since 1996.

> 1,000,000 total patient applications.~ 200,000 patients required shocks.~ 800,000 patients did not require shocks.Non-random sampling based on ForeRunner AEDs.

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Based on 738 ForeRunner AEDs in sample.

We did not attempt to apply the estimates to HS1, since ForeRunner includes a large proportion sold to higher-use rate customers.

Most ForeRunner AEDs were returned for self-test failures which are customer-type and use-independent.

Field performance

Six confirmed AED emergency use failures across Philips installed base (> 1,000,000 patient applications).4 no patient impact1 patient impact indeterminate1 possible patient impact

No complaints about shock effectiveness.

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MDR summaryForeRunner and FR2 Top 3 issues and predominant causes, confirmed & unconfirmed

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IssuenPatient ImpactPredominantCauseNo voice prompts35No patient involvementOpen speaker circuitPoor patient-pads connection11IndeterminateSuspected pads damageAlgorithm sensitivity6IndeterminateECG did not meet rate criteria (too low)

HeartStart Home DefibrillatorDesign features relevant to top 3 ForeRunner and FR2 MDR issues

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ForeRunner/ FR2 issueHeartStart Home Defibrillator design featureNo voice promptsWeekly speaker self-test.Poor patient-pads connectionPads enclosed in rigid cartridge. Pads self-test every 24 hours.Algorithm sensitivityNo change to (cautious) design.

First-year annualized failure rate for Philips defibrillators (all causes)

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Very first year for each product

Order of magnitude since FDA Working Group in the 80s/90s (see Field Summary Report)

Defibrillator safety has improved significantly over the past two decades, and reliability improved by an order of magnitude with introduction of first Philips AED in 1996

Heartstart Home product family failure rate 0.04%

3 failures were caught during defibrillator self-tests

no failures during emergency use

Automated self-test

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Iterative design process

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ProblemSolutionDelayed device activationAdded fire alarm-style handle with the word PULL.Put pads on top of clothesAdded emergency scissors. Voice instruction: Begin by removing all clothing from the patients chest. Cut clothing if needed.Failed to remove liner from padsContrasting liner color. Voice instruction: Peel one pad from the yellow plastic liner.Poor pad positionExplicit graphics on each pad. Voice instructions: Look carefully at the picture on the white adhesive pad Place pad exactly as shown in the picture.Accidental device turn-offMust hold power button down for 2 seconds.

HeartStart Home life-cycle support

Philips Customer Service

Product Information, Training Resources, Consumables, Data Retrieval, Grief Counseling, Physician Access

Set-Up

Training

Storage & Maintenance

Use

Post-Use

Purchase

HeartStart Home Defibrillator

Primary labelingVoice Prompts, Device Icons, Self-Test

Product Packaging

Sales Materials

Product Website

ResourcesFAQs

HeartStart Home Defibrillator

Secondary labelingQuick Reference, Owners Manual, Training Video, Quick Start, Training Coupons, Product Registration Card

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Philips HeartStart Home Defibrillator

Designed as safety equipment.

History of safety and readiness.

Designed for ease of use.

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Clinical overview Safety and usability study

Dr. Lance BeckerProfessor of Medicine, University of Chicago

Disclosures

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Sudden Cardiac Arrest: A leading killer in the United States

American Heart Association. Heart Disease and Stroke Statistics 2004 Update. Dallas, Tex.: American Heart Association; 2003.

Litwin et al., Ann Emerg Med. 1987;16:787-791.

Majority have no prior symptoms.

Nearly 80% happen in the home.

More than 50% of home arrests witnessed.

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American Heart Association. Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Dallas, Texas: American Heart Association, 2000.

Cummins et al., Circulation. 1991;83:1832-1847.

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Time is key to survival

Response curve (exponential decay rate) is after: De Maio et al., Ann Emerg Med. 2003;42:242-250.

Time intervals after Herlitz et al., Eur Heart J 2003;24:1750-5. Blackwell et al., Academic Emerg Med. 2002;9:288-295., Braun et al., Ann Emerg Med. 1990;19:1058-64., White et al., Resuscitation. 2002Oct;55(1):17-23., Myerburg et al., Circulation. 2002;106:1058-1064.

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Early access can help save more lives

Response curve (exponential decay rate) after: De Maio, et al. Ann Emerg Med. 2003;42:242-250.

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Early defibrillation programs

Page et al., N Eng J Med. 2000;343:1210-1216.

Caffrey et al., N Eng J Med. 2002;347:1242-1247.

Valenzuela et al., N Eng J Med. 2000;343:1206-1209.

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American Airlines program(Philips AEDs)191 uses in aircraft, 9 in terminal15 VF patients; 40% (6/15) survived to dischargeNo adverse eventsChicago OHare & Midway Airport programs(Philips AEDs)21 cardiac patients in 2 years18 VF patients; 61% (11/18) survived to dischargeNo adverse eventsCasino security officers program(Various manufacturers AEDs)148 cases in 32 months90 VF patients; 59% (53/90) survived to discharge, 74% for those shocked

NHLBI-sponsored Public Access Defibrillation (PAD) trial: Will AEDs improve survival?

Study objective Will AEDs improve cardiac arrest survival compared with CPR alone?20,000 lay responders in facilities with a pre-defined risk of an event.

ResultsSurvival in CPR+AED group doubled (n=29) compared with CPR alone (n=15).No serious adverse events associated with AED use.89.3% of evaluated responders (n = 3,671) demonstrated adequate AED skills 3 months after training.*

ConclusionLaypersons can use AEDs safely to provide early defibrillation.

Ornato J. AHA Scientific Sessions 2003.

*Sehra et al., (Abstract 2002);Suppl to Circulation, Vol 106, No 19, pg II-403.

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Rapid response saves lives

Time is critical Early defibrillation is highly effective.

Primary question Can the HeartStart Home Defibrillator be used safely by lay people?

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The question is, will a defibrillator arrive in time when a person suffers cardiac arrest? We all know that identifying and managing CAD and other at-risk patients is a challenge. It is documented that the majority of victims have no previously reported symptoms of heart disease. As physicians, we are all too familiar with the unpredictability of sudden cardiac arrest. Just like its name saysit strikes suddenly and without warning. It is impossible to predict when and where a sudden cardiac arrest will occur to ensure that a defibrillator will reach the victim in time.

The bottom line is that defibrillators save lives when they do reach SCA victims quickly. For those Americans who choose to be prepared for a sudden cardiac arrest emergency and who are willing to pay for it themselves we need to make this technology more broadly accessible.

Remember, it is all about time. Early defibrillation saves lives.

Safety and usability study

Hypothesis #1 The Philips HeartStart Home Defibrillator and FR2 are safe even in the absence of training.

Hypothesis #2 The HeartStart Home and FR2 have high usability when used with primary labeling components (voice prompts, product graphics) plus training video.

Study methodMock cardiac arrest scenario with a fully dressed manikin and AED.

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Enrollment and randomization

FR2

HeartStart Home

Simulated Use Test

Simulated Use Test

Powered to detect a 20% difference between nave and video trained for

each device with power = 0.80 and alpha = 0.05 (approx. 62 per group).

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HeartStart Nave

n = 62

FR2 Naven = 69

Simulated Use Test

FR2 Videon = 63

8 minute training video

Simulated Use Test

HeartStart Naven = 61

HeartStart Videon = 63

3 minute training video

Simulated Use Test

Simulated Use Test

Primary and secondary endpoints

Primary endpointsSafe: no touching of patient in a manner that could result in a shock across the rescuers chest.Successful: shock delivered with pads positioned in a manner likely to defibrillate (includes power on, attach pads with appropriate pad placement, analyze, and defibrillate within 5 min).

Secondary endpoints (based on starting time from when participant entered the room).Time-to-pads on Time-to-shock

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Safeemphasize that the therapy and the device itself are already considered safe. The point of this study was to determine whether users could use it safely.

FR2 results: Simulated-use test

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FR2 results: Time-to-shock

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HeartStart Home results: Simulated-use test

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HeartStart Home results: Time-to-shock

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Study limitations

Simulated use vs. reality

Demographics

Human anatomy more varied

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Conclusions

The HeartStart Home Defibrillator and the FR2 were used safely in all cases (n = 132, 124 respectively).

FR2 success rate significantly improved by video training from 48% to 86% (p < 0.001).

HeartStart Home Defibrillator successfully used by both nave and video trained volunteers at 87% (79% LCL, n = 61) and 89% (81% LCL, n = 63) with no difference detected between nave and video trained.

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Labeling evaluation and simulated use Lay user surveyPost-market study

David SnyderDirector of Research, Philips

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Labeling evaluation and simulated usePurpose

Labeling evaluation: Test comprehension of secondary labeling materials for the Philips HeartStart Home OTC Defibrillator.Owners ManualQuick ReferenceTraining VideoQuick Start Poster

Simulated use: Demonstrate safe and successful use after review of only one component of labeling. Owners Manual Quick Reference

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Secondary labeling materials

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Methods

Recruitment in 3 geographically diverse shopping malls.

No medical or defibrillator training, no CPR training within 2 years.

Age range 21-74.

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Methods

Hypothesis for comprehension test:The written labeling materials are well understood.Approximately 90% passing grade (LCL > 80%).

Hypotheses for simulated use:The HeartStart Home Defibrillator is safe.The HeartStart Home Defibrillator can be successfully used by laypersons to deliver a defibrillation shock.Non-inferiority vs. 90% (10% margin).

Study methodMock cardiac arrest scenario with a fully dressed manikin and AED

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Enrollment and randomization

30 min

15 min

Simulated Use Test

Comprehension sample size determined to establish 95% LCL of 80% for presumed success rate (C grade or better) of 90%.

Simulated use powered for a non-inferiority delta of 10% versus presumed success rate of 90% with power = 0.80 and alpha = 0.05.

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Owners Manualn = 89

Written comprehension Test

Simulated Use Test

Quick Referencen = 89

Written comprehension Test

Simulated Use Test

Training Videon = 79

Written comprehension Test

Quick Startn = 73

Written comprehension Test

Primary and secondary endpoints

Primary endpointsSafe: no touching of patient in a manner that could result in a shock across the rescuers chest.Successful: shock delivered with pads positioned in a manner likely to defibrillate (includes power on, attach pads with appropriate pad placement, analyze, and defibrillate within 5 min).

Secondary endpoints (based on starting time from when participant entered the room).Time-to-pads on Time-to-shock

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Safeemphasize that the therapy and the device itself are already considered safe. The point of this study was to determine whether users could use it safely.

Comprehension test

Written labeling materials at a 6th grade reading level or lower (Flesch-Kincaid).Test topics included:Definition of SCA (vs. MI, stroke, etc.)Set-upTrainingStorageMaintenanceWhen to use defibrillatorRescue stepsPost-shock careInfant/child use

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Results: Median comprehension scores

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Results: Simulated-use test

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Results: Median time-to-shock

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Limitations and conclusions

Study limitations same as safety and usability study.

All labeling well understood with at least 90% receiving a passing grade. Passing grade LCL 88% for all tests.

Defibrillator used safely in all cases (n = 178).

Successful use 97% (92% LCL, n = 89) with Quick Reference.Recommended labeling for emergency response.

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Follow-up

Added information to training video and Quick Start poster regarding intended use of various labeling materials.

Cover of Owners Manual modified to clarify its purpose as a guide to set up, maintenance, and accessories.

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Lay user surveyPurpose

Determine if lay use of Philips AEDs results in any previously unreported problems.

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Jorgenson et al., Resuscitation. 2003;59:225-233.

Lay user surveyMethods

Owned AED at least 1 year

Medical professionals excluded

Lay users identified

145 homes 2,683 businesses and public facilities

Initial contact by phone center (at least 7 contact attempts)

YesUse by a layperson

Detailed interview with medical professional

Brief interview Use by layperson?

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Lay user surveyResults

Surveyed 78 homes and 1,645 businesses.No problems reported.209 businesses (13%) had used an AED at least once.9 uses in homes/home offices.

Conducted 11 detailed interviews regarding pads applied to unresponsive patients.EMS called in all cases.3 patients appropriately received no shocks.8 patients received shocks.6 survived to hospital admission.4 received shocks solely from lay responders, and all survived to hospital admission.

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Lay user surveyLimitations and conclusions

LimitationsSurvey and interview participation was voluntary.

ConclusionsNo harm or injury to users, bystanders or patients.No malfunctions or problems.All users willing to use defibrillator again.No safety or effectiveness issues reported.

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Ongoing HeartStart Home post-market studyPurpose

Evaluate lay uses of HeartStart Home Defibrillator for safe and appropriate application.

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Methods

Contact lists generated:

HeartStart Home owned > 1 year

or 1 year since last surveyed

Detailed interviewwith medical professional

Pads re-ordered or use

reported to Philips

AEDused?

Contact owner

Yes

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Proposed extension to HeartStart Home post-market study

Extend ongoing post-market study to 200 home uses total or 4 years from HeartStart Home OTC Defibrillator clearance.Results to be reviewed by DSMB and reported annually to FDA.

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Clinical perspective

Dr. Jeremy RuskinDirector, Cardiac Arrhythmia Service, Massachusetts General Hospital

Disclosures

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Sudden death - Risk stratification

"High-Risk" Pts

VT-VF

Survivors

Prior MI

LV Dysfxn

CHF

VEA

+EPS

50%

65%

50%

50%

65%

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Ruskin et al., NEJM. 1980;303:607-613.

Wilber et al., NEJM. 1988;318:19-24.

Sudden deathRisk stratification

"High Risk" Pts

VT-VF

Survivors

Prior MI

LV Dysfxn

CHF

VEA

+EPS

50%

65%

50%

50%

65%

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Ruskin et al., NEJM. 1980;303:607-613.

Wilber et al., NEJM. 1988;318:19-24.

Evolving role of defibrillation

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Safety equipment

Fire extinguisher

Smoke alarm

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Benefits and limitations

Ahrens, M. U.S. experience with smoke alarms and other alarm devices, Nov 2003, National Fire Protection Association, Fire Analysis and Research Division, 1 Batterymarch Park, Quincy, MA 02169-7471

National Highway Safety Administration, Air Bag Facts, Safety Fact Sheet, 11/02/1999 http://www.nhtsa.dot.gov/airbags/factsheets/numbers.html

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Smoke AlarmsSeat BeltsAirbagsBenefitsReduces chance of dying in a fire by 40%. 11,000 lives saved each year. Reduces risk of death in car crashes by 45%. Reduces risk of death in frontal car crashes by 31%. 4,758 total lives saved through 1999.

LimitationsNuisance alarms result in alarm deactivation. Not used 30% of the time.May cause injury or death for children and small adultsapprox. 140 deaths through 1999.

SCA and motor vehicle injury deaths in US (1999)

State-Specific Mortality from Sudden Cardiac Death--- United States, 1999. CDC, MMWR, February 15, 2002/ 51(06); 123-6

10 Leading Causes of Unintentional Injury Deaths, United States, 1999, All Races, Both Sexes. CDC Website

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10-year expectations for emergency events

U.S. Experience with Smoke Alarms and other Fire Alarms, Ahrens, Fire Analysis and Research Division, National Fire Protection Association, Nov 2003. Projections of the Number of Households and Families in the United States: 1995 to 2010, P25-1129, US Dept of Commerce, Bureau of the Census, April 1996. How Many Homes Are There? US Census Bureau, American Housing Survey, http://www.census.gov/hhes/www/housing/ahs/01dtchrt/tab2-1.html. Safety Fact Sheet, National Highway Traffic Safety Administration, 11/2/99, http://www.nhtsa.dot.gov/airbags/factsheets/numbers.html. ZJ Zheng, et al, State-Specific Mortality from Sudden Cardiac Death-- United States, 1999. MMWR Weekly, CDC, Feb 15, 2002/ 51(06); 123-6.

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CDC data Incidence climbs markedly as the age of the household increases. Fires and MVAs are unlikely to kill you.

These young pts have no incentive to call their MDs; they feel well. In our practice, we do not get these calls ever from people we do not know. The general public does not freely call their MDs in this type of situation it is not encouraged and there is a practical barrier.

Benefits of removing the Rx requirement

Broader access to a safe and effective technology that is the only definitive treatment for SCA.

Provide an opportunity to save some of the lives that would otherwise be lost to SCA.

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By removing the prescription requirement and making the HeartStart Home OTC more widely available, the benefit is that lives will be saved that would have otherwise been lost to sudden cardiac arrest.

Clearly, this benefit must be balanced against the potential harm that could be caused.

RisksCan the AED cause harm?

HeartStart Home OTC is the same intended user and patient population as Rx.

Robust safety features.ECG analysis systemArtifact detection No manual override

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Philips AED field performance

> 1,000,000 total patient applications.~ 200,000 patients required shocks.~ 800,000 patients did not require shocks.One known inappropriate shock.No complaints about shock effectiveness.

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Summary

Safe design and established history of safe use.

The HeartStart Home Defibrillator can be used safely and for its intended purpose based upon its labeling alone.

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Theoretical risks

Will OTC AEDs interfere with medical care?Not a substitute for medical care. Risk factors still need to be addressed.Care and prescribed therapies for pre-existing conditions need to continue.Physicians retain option to prescribe AEDs in cases of medical necessity.Target populations are different.Will OTC defibrillators interfere with EMS response?SCA survival rate is

HeartStart Home Defibrillator: Realistic expectations

SCA is an epidemic and a major public health problem; the most common cause of death in adults.

Survival rates are abysmally low (

HeartStart Home Defibrillator: Realistic expectations

OTC defibrillators represent a paradigm shift and a step toward wider access.

Potential to save some lives that would otherwise be lost.

Long term: even a small impact could double current survival rates.

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Strategies for addressing SCA

Prevention of coronary artery disease.

Revascularization and ICDs in high-risk patients.

Availability of on-site rapid defibrillation.

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Successful defibrillation depends on immediate recognition of the emergency and prompt application of the external defibrillator.

Paul M. Zoll, M.D. 1956

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Volunatry post-market study shows commitment.

Based on 738 ForeRunner AEDs in sample.

We did not attempt to apply the estimates to HS1, since ForeRunner includes a large proportion sold to higher-use rate customers.

Most ForeRunner AEDs were returned for self-test failures which are customer-type and use-independent.

Very first year for each product

Order of magnitude since FDA Working Group in the 80s/90s (see Field Summary Report)

Defibrillator safety has improved significantly over the past two decades, and reliability improved by an order of magnitude with introduction of first Philips AED in 1996

Heartstart Home product family failure rate 0.04%

3 failures were caught during defibrillator self-tests

no failures during emergency use

The question is, will a defibrillator arrive in time when a person suffers cardiac arrest? We all know that identifying and managing CAD and other at-risk patients is a challenge. It is documented that the majority of victims have no previously reported symptoms of heart disease. As physicians, we are all too familiar with the unpredictability of sudden cardiac arrest. Just like its name saysit strikes suddenly and without warning. It is impossible to predict when and where a sudden cardiac arrest will occur to ensure that a defibrillator will reach the victim in time.

The bottom line is that defibrillators save lives when they do reach SCA victims quickly. For those Americans who choose to be prepared for a sudden cardiac arrest emergency and who are willing to pay for it themselves we need to make this technology more broadly accessible.

Remember, it is all about time. Early defibrillation saves lives.

Safeemphasize that the therapy and the device itself are already considered safe. The point of this study was to determine whether users could use it safely.

Safeemphasize that the therapy and the device itself are already considered safe. The point of this study was to determine whether users could use it safely.

CDC data Incidence climbs markedly as the age of the household increases. Fires and MVAs are unlikely to kill you.

These young pts have no incentive to call their MDs; they feel well. In our practice, we do not get these calls ever from people we do not know. The general public does not freely call their MDs in this type of situation it is not encouraged and there is a practical barrier.

By removing the prescription requirement and making the HeartStart Home OTC more widely available, the benefit is that lives will be saved that would have otherwise been lost to sudden cardiac arrest.

Clearly, this benefit must be balanced against the potential harm that could be caused.

Having a HeartStart Home Defibrillator is not a replacement for medical care or the doctor/patient relationship. People need to talk with their doctors if they have concerns about their health or an existing health condition. They need to make the difficult lifestyle changes to manage risk factors.

The recent Medicare coverage decision to reimburse for AEDs for patients meeting specific criteria, including being contraindicated for an ICD, should not be impacted by the decision to make the HeartStart Home Defibrillator available over-the-counter. Patients on a course to receive an ICD, should receive one. In cases, such as those outlined by the Medicare criteria, physicians will still need to prescribe the AED. This is no different than aspirin for example. We all buy aspirin over the counter. But for post-MI patients, or those who are post stent placement, have high blood pressure, are post TIA, or post stroke, it is the standard of care for physicians to prescribe aspirin.

FR2 Nave

n = 69

Simulated Use

Test

FR2 Video

n = 63

8 minute training

video

Simulated Use

Test

HeartStart Nave

n = 61

HeartStart Video

n = 63

3 minute training

video

Simulated Use

Test

Simulated Use

Test

Owners Manual

n = 89

Written

comprehension

Test

Simulated Use

Test

Quick Reference

n = 89

Written

comprehension

Test

Simulated Use

Test

Training Video

n = 79

Written

comprehension

Test

Quick Start

n = 73

Written

comprehension

Test