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.
Table of Contents
- 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
- 3.1 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
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
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
- 10.1 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
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
Section 1: Introduction >>