Cardiac insight, Inc. Cardea SOLO™ ADX S400 Operator’s Manual

Model S400: Includes instructions for Cardea SOLO™ ADX: Software, D400   Smart Cable, C400  Sensor, M400, and APP RhythmView, A400    Website: www.cardiacinsightinc.com

Information contained in this document is proprietary to Cardiac Insight, Inc.

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Table of Contents

1 Introduction 3

• 1.1 Indications for Use 3
• 1.2 Intended Use 3
• 1.3 Contraindications 3
• 1.4 Clinician’s Responsibility 3
• 1.5 Definitions of Symbols Used 4

2 Getting Started – Cardea SOLO™ ADX S400 System Components 6

• 2.1 Cardea SOLO™ ADX S400 Software Blister Pack 6
• 2.2 Cardea SOLO™ ADX S400 Smart Cable Shipping Carton 6
• 2.3 Cardea SOLO™ ADX S400 Sensor Shipping Carton 6
• 2.4 User-Supplied Personal Computer (PC) Requirements 6
• 2.4.1 PC Supported Operating Systems and Associated Components 7
• 2.4.2 PC Hardware Requirements 7
• 2.5 Hardware Setup 9
• 2.6 Cardea SOLO™ ADX S400 Software Installation 10

3 Sensor Operation 13

• 3.1 Precautions 13
• 3.2 Pouch Contents 15
• 3.3 Sensor – Getting Started 16
• 3.4 Sensor Placement 18
• 3.5 SOLO CRV 21
• 3.5.1 Application Installation 21
• 3.5.2 Adding Demographic Information 21
• 3.5.3 Rhythm Review 21
• 3.6 Wearing Instruction 23
• 3.7 Recommendations for Patient Use 23
• 3.8 Completion of Monitoring and Removal 24
• 3.9 ECG Retrieval 24
• 3.10 Troubleshooting 25

4 Cardea SOLO™ ADX S400 Software – Administrative Setup 27

• 4.1 Initial Start-up 27
• 4.2 User Setup (Manage Users) 30
• 4.3 Manage Physicians 33
• 4.4 Import / Export 33
• 4.5 Manage Updates 34
• 4.6 Archive / Delete 35

5 Patient Registration (Optional) 36

• 5.1 Registration 36
• 5.2 Registration Report 37

6 Cardea SOLO™ ADX S400 Software – Creating the Report 38

• 6.1 User Login 38
• 6.2 Data Transfer, Demographics and the Draft Report 39
• 6.2.1 Connecting the Electronics Module 39
• 6.2.2 Starting Data Transfer 40
• 6.2.3 Demographic and Diary Data Entry 41
• 6.2.4 Draft PDF Report 45

7 Cardea SOLO™ ADX S400 Software – Clinical Review 48

• 7.1 ECG Trace Review 49
• 7.2 Edit Demographics 71
• 7.3 Edit Dx 71
• 7.3.1 Delete AFib and VT Findings 72
• 7.3.2 Record Status and Confirmation 73
• 7.4 ST Analysis 74
• 7.5 Heart Rate Variability (HRV) 75
• 7.6 Activity Summary 77
• 7.7 Open Report (.pdf) 78
• 7.8 Report Completion 78

8 QT Analysis 79

• 8.1 Measuring QT 79
• 8.2 QT Versus RR 81
• 8.3 QT Versus Time 84

9 Review and Editing of Previous Reports, Cohort Reporting, Help and Operator’s Manual 86

• 9.1 Previous Reports – PDFs 86
• 9.2 Quick Patient Status Summary 87
• 9.3 Previous Reports – Full Disclosure ECG 87
• 9.4 Edit Demographics 87
• 9.5 Over-Reading and Confirming Diagnosis 87
• 9.6 Operator’s Manual 88
• 9.7 Help About 88
• 9.8 Cohort Reporting 89

10 System Characteristics 96

• 10.1 System Bandwidth and Baseline Wander Filtering 96
• 10.2 AC Line Filtering 96
• 10.3 Beat and Rhythm Sensitivity and Positive Predictive Value 97
• 10.4 Slowest Heart Rate 98

11 Maintenance 99

• 11.1 Cleaning the Smart Cable 99

12 EMC Declaration Tables – Smart Cable, Sensor 100

• 12.1 Electromagnetic Emissions 100
• 12.2 Electromagnetic Immunity for Sensor 100
• 12.3 Electromagnetic Immunity for Smart Cable 101
• 12.4 Recommended Separation Distances 103
• 12.5 FCC Notice 104

13 Environmental Specifications 105

• 13.1 Transport Environment – Sensor 105
• 13.2 Storage Environment (Recommended) – Sensor 105
• 13.3 Operating Environment – Sensor 105
• 13.4 Transport Environment – Smart Cable 105
• 13.5 Storage Environment (Recommended) – Smart Cable 105
• 13.6 Operating Environment – Smart Cable 105