JEWEL P-WCD Manuals

Manuals and User Guides for JEWEL P-WCD. We have 2 JEWEL P-WCD manuals available for free PDF download: Patient Manual, Instructions For Use Manual

JEWEL P-WCD Patient Manual

JEWEL P-WCD Patient Manual (164 pages)

PATCH WEARABLE CARDIOVERTER DEFIBRILLATOR

Brand: JEWEL | Category: Medical Equipment | Size: 11 MB

Table of Contents

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JEWEL P-WCD Instructions For Use Manual

JEWEL P-WCD Instructions For Use Manual (119 pages)

Patch Wearable Cardioverter Defibrillator

Brand: JEWEL | Category: Medical Equipment | Size: 9 MB

Table of Contents

Table of Contents
3
Introduction
4
Indications for Use
4
Contraindications
4
Intended Operator, Use, and Location
5
Safety Information
5
Safety and Efficacy Data
8
Clinical Studies
8
The Jewel IDE Study
8
Jewel EP Lab Study
11
Device Description
12
Defibrillator Unit
14
Patch Unit
14
Placement Accessory
15
Application and Removal Accessories
16
Mobile App (Optional)
16
Therapy Report Generator (Optional)
16
Detection and Therapy
16
Sensing Configuration
16
Arrhythmia Detection
17
Cardioversion / Therapy Delivery
17
Post Shock
17
Report Generator
18
Patient Training
19
Patient Support and Reference Material
19
Alerts and Notifications
20
Heart Rhythm Alarms
20
Device Status Notifications
21
Technical Information
23
Specifications
23
Device Specifications
23
Operating Environment
26
Storage Environment
26
Transportation Environment
27
Product Lifetime
27
Conformance to Standards
27
Electromagnetic Compatibility (EMC) Testing
29
IEC 60601-1-2:2020 EMC Manufacturer's Declaration
30
RFID Immunity Standard AIM 7351731 Manufacturer's Declaration
31
Defibrillating Pulse Waveforms
31
Symbols Glossary
33
Skin Preparation
42
Replace Device
53
Status Check
85
Supplies Needed
106

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