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QUANTIEN
St. Jude Medical QUANTIEN User Manual
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QU
AN
TIEN™ Mea
surem
ent
System
Di
agnost
ic Com
puter
C12787
Instructions
for Use
State:
Released
Date:
2019.03.06 22:30 GMT
2
Table of Contents
Default Chapter
3
Table of Contents
3
QUANTIEN™ Measurement System
5
Introduction to the Instructions for Use (IFU)
5
Highlights Used
5
Product Description
6
Introduction
6
Intended Use
7
Indications for Use
7
Contraindications
7
Users
7
Product Interface and Symbols
7
Symbols Used on Product, Packaging, and IFU
9
Remote Control Symbols and Functions
11
Additional Devices and Accessories
11
General Warnings, Precautions, and Safety Information
12
Graphical User Interface
14
Indicator Lights and Sounds
16
Basic Setup Using Wi-Box™ AO Transmitter (Wireless AO Source)
16
Install Wi-Box™ AO Transmitter
17
Unpack QUANTIEN™ Measurement System
17
Mount QUANTIEN™ Main Unit in the Cath Lab
18
Room Configuration
20
Measure FFR or RFR
21
Warnings and Precautions
21
Live Window
22
FFR/RFR Measurement Procedure
23
Review Recordings
29
Review Window
29
Study Summary
30
Review Recording
30
Export Data
32
Review Archived Studies
34
Archive Window
34
Export and Delete Files in Archive
35
Settings
36
System Settings Overview
36
Room Setup
36
Regional Settings
39
User Settings
39
Security Settings
40
Connections
41
Network Configuration
45
Display Settings
48
Service
50
Demo Mode
50
Troubleshooting
51
On Screen Messages
51
Tracing EM Interference
57
Troubleshooting Tables
59
Maintenance
71
Remote Control Battery
71
System Backup Battery
72
Disposal
72
Cleaning
72
Preventative Maintenance Schedule
72
Leakage Current Measurement
73
Testing PW in
74
Testing PW out and Associated Monitor Channel
75
Testing AUX in 1 and Associated Monitor Channel
76
Testing AUX in 2 and Associated Monitor Channel
77
Testing AUX out 1 & 2 and Associated Monitor Channel
77
Test Probes
78
Leakage Adapters
79
Service or Repair
79
Technical Specifications
79
Pressure Measurement
79
Electrical Specifications
79
Specifications Interfaces
79
Dimensions
81
Environmental Conditions
81
Isolation Diagram
82
File Formats
83
Compliance with Regulatory Requirements
83
Compliance with Standards and Directives
83
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
84
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
85
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and QUANTIEN™ System
87
Warranty Disclaimer
88
Australian Warranty
88
4
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St. Jude Medical QUANTIEN Specifications
General
Brand
St. Jude Medical
Model
QUANTIEN
Category
Diagnostic Equipment
Language
English
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