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B-2 LIFEPAK CR Plus Defibrillator Operating Instructions
Shock Advisory System
The LIFEPAK CR Plus Defibrillator was also tested using paced rhythms recorded at high-fidelity from
patients with implanted pacemakers. The high-fidelity pacemaker spikes were also added to samples of
ventricular fibrillation to test the device’s ability to reach a shock decision in the case of ventricular
fibrillation with an implanted, active pacemaker. The results are summarized in Table B-2.
Table B-2 LIFEPAK CR Plus Defibrillator SAS Performance with Active Pacemakers
The LIFEPAK CR Plus Defibrillator was also tested using ECGs acquired from hospitalized pediatric
patients ranging in age from < 1 day old to 17 years old. The results are summarized in Table B-3.
Table B-3 LIFEPAK CR Plus Defibrillator SAS Performance Table for Pediatric ECGs
Nonshockable:
asystole
43 >95% specificity 100.0% [94.8%]
Nonshockable:
all other rhythms
531 >95% specificity 95.9% [94.5%]
Intermediate:
fine VF
29 Report only 96.6% [87.2%] sensitivity
1
From Medtronic ECG database. Each sample is run 10 times asynchronously.
2
Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators
and Remote-Control Defibrillators. Arlington, VA: AAMI;1993.
3
Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting
Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. AHA Task Force on
Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997, Vol. 95, 1677-1682.
4
LCL = 90% exact one-sided lower confidence limit
VF = ventricular fibrillation
VT= ventricular tachycardia
NSR = normal sinus rhythm
Rhythm Class
ECG Test
Sample Size
Performance Goal Observed Performance
Shockable:
Coarse VF
35 >90% sensitivity 91.4% [81.9%]
Nonshockable:
Paced rhythms
35 >95% specificity 100.0% [93.6%]
Rhythm Class
ECG Test
1
Sample Size
Performance Goal
2
Observed Performance
Sensitivity or Specificity [LCL]
3
Shockable:
coarse VF
90 >90% sensitivity 100.0% [97.5%]
Shockable:
shockable VT
11 >75% sensitivity 54.5% [31.8%]
Nonshockable:
NSR
424 >99% specificity 100.0% [99.5%]
Nonshockable:
asystole
95 >95% specificity 100.0% [97.6%]
Table B-1 LIFEPAK CR Plus
Defibrillator SAS Performance Table for Adult ECGs (Continued)
Rhythm Class
ECG Test
1
Sample Size
Performance Goal
2,
3
Observed Performance
Sensitivity or Specificity [LCL]
4
- LIFEPAK CR 1
- IMPORTANT 4
- Device Tracking 4
- Revision History 4
- TABLE OF CONTENTS 1 5
- LIST OF FIGURES 7
- LIST OF TABLES 7
- INTRODUCTION 1 9
- Indications for Use 10
- Contraindications 10
- Terminology 11
- Text Conventions 12
- SAFETY INFORMATION 12
- Safety Terms 12
- General Warnings and Cautions 12
- LOT YYWW 14
- Capabilities and Features 15
- Introduction 16
- 1 Introduction 17
- GETTING STARTED 2 19
- Getting Started 20
- 2 Getting Started 21
- Inside Features 22
- Table 2-2 Inside Features 23
- WARNINGS AND CAUTIONS 26
- VOICE PROMPTS AND TONES 29
- MOTION DETECTED and 32
- STOP MOTION voice 32
- OK symbol appears on the 32
- DATA STORAGE 4 33
- Table 4-1 Patient Reports 34
- Table 4-2 LIFEPAK CR Plus 34
- Event and Test Log 35
- Defibrillator 37
- Table 5-1 Cleaning Methods 38
- ELECTRODE PACKET 39
- Replacing the CHARGE-PAK 39
- CHARGE-PAK Disposal 40
- Replacing the QUIK-PAK 41
- WARNING! 42
- Shock hazard 42
- WARRANTY INFORMATION 43
- Operating Settings 46
- Settings 47
- APPENDIX A 49
- SPECIFICATIONS A 49
- SPECIFICATIONS 51
- User Interface 52
- Environmental 53
- Physical Characteristics 53
- Accessories 53
- Specifications 54
- Prehospital Emergency 55
- APPENDIX B 57
- SHOCK ADVISORY SYSTEM B 57
- Appendixes 59
- Shock Advisory System 59
- Table B-1 LIFEPAK CR Plus 60
- Control of Shock Therapy 61
- Motion Detection 61
- APPENDIX C 63
- DECLARATION OF CONFORMITY C 63
- EC DECLARATION OF CONFORMITY 65
- APPENDIX D 67
- USER’S CHECKLIST D 67
- PLUS DEFIBRILLATOR 69
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