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MC10
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BioStamp nPoint
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34
BioStamp nP
oint User Manual
Unassign and P
ower O Sensors
7
Once data has been synced
, you
may unassign and po
wer o Sensors
(for batt
er
y life pr
eser
vation) in the
Sensors tab on the Investigator A
pp
.
33
35
Table of Contents
Main Page
Default Chapter
4
Table of Contents
4
Introduction, Safety, and Component Overview
6
System Description
7
Important Safety Information
8
Indications for Use
8
Contraindications
8
Warnings
8
Precautions
9
Storage and Handling
9
Device and Packaging Symbols and Markings
10
Regulatory Information
13
Applicable Standards
13
FCC Compliance Notification
13
Biostamp Npoint Platform Components
14
Biostamp Npoint Component Assembly and Function Overview
15
Link Hub
15
Tablet
16
Sync Phone
16
Link Phone
17
Biostamp Sensors
18
Adhesives
20
Maintenance
24
Upgrading System Components
24
Cleaning and Disinfection
24
Executing a Study
26
Investigator Portal Study Design
27
Run a Supervised Study
30
Run a Remote Study
35
Subject Assessment and Data Analysis
38
Troubleshooting and Manufacturer
42
Troubleshooting
43
Manufacturer
43
Appendix A
45
Appendix A Biostamp Npoint Platform Components
45
Biostamp Npoint Component Service Life
45
Technical Specifications
46
Biostamp Technical Specifications
46
Biostamp Recording Modes
47
Adhesive Technical Specifications
47
Link Hub and Biostamp Sensor Frequency and Transmission Specifications
48
Hardware LED Status Indicator Table
48
EMC Declaration and Guidance
49
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
49
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
50
Appendix B
54
Appendix B
54
Implemented Protocols
54
Information Flow
54
IT-Network
54
Hazardous Situations
55