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Manuals and User Guides for ACIST RXI. We have
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ACIST RXI manual available for free PDF download: User Manual
ACIST RXI User Manual (124 pages)
Rapid Exchange FFR System
Brand:
ACIST
| Category:
Medical Equipment
| Size: 5.77 MB
Table of Contents
Proprietary Information Notice
2
Contact Information
2
Table of Contents
3
1 Introduction
7
Indications for Use/Intended Use
7
Intended Patient Population
7
Device Description
7
About this User's Guide
8
Manual Conventions
9
2 Warnings, Cautions, and Symbol Definitions
11
Read this First
11
Warnings
11
Cautions
13
Symbol Definitions
15
3 System Overview
17
System Hardware
17
System Console
19
System Power Supply
19
Touchscreen User Interface
20
Purpose of the Touchscreen
20
Navvus® Microcatheter
22
4 Installation
23
Unpacking
23
Preliminary Inspection
23
Package Contents
23
Installation Precautions
24
Installation Procedures
25
Mount the ACIST Rxi® System on a Bed Rail
25
System
25
Connect the ACIST Rxi® System to the Hospital's Hemodynamic System
29
Zero the Aortic Pressure on the ACIST Rxi® System
31
Enter the Facility Name and Lab ID (Optional)
32
Perform Pa Scaling
33
5 Basic Operating Procedures
35
Before Using the ACIST Rxi® System
35
Start the ACIST Rxi System
36
Power on
36
Verify that the Aortic Pressure Is Zero
37
Zero Aortic Pressure
37
Identify the Patient ID and the Vessel ID for the Case
38
Patient ID
38
Vessel ID
38
Unpack and Prepare the Navvus® Microcatheter
39
Preparation Needed
39
Deliver the Navvus® Microcatheter, Equalize Signals, and Enter Venous Pressure
43
Equalize Signals and Adjust Pv
43
Detection of Broken Navvus® Microcatheter
46
Record the FFR for the First Vessel
47
Record
47
Record the FFR for Another Vessel
50
Review the Case Summary and Export Data
50
New Vessel
50
Case Summary
50
Shutting down the ACIST Rxi® System
51
Power off
51
6 System Information and Settings
53
About the ACIST Menu
53
System Information
55
System Software Version, Date, and Time
55
System Settings
56
Change the Language Displayed in the System Software
57
Adjust the Date Setting
58
Adjust the Time Setting
59
Enter or Modify the Facility Name
60
Lab ID, Mobile or Stationary
61
Enter or Modify a Lab ID
62
Monitor Output Sensitivity Setting
63
Adjust the Audio Volume
64
Touchscreen Calibration
64
Adjust the Waveform Settings
65
Adjust the Number of Heartbeats Used for Mean Pressure Calculation
66
Adjust the Screen Sweep Speed
67
Adjust the Graph Scale Maximum
68
Pa Scaling
68
Restore the System Defaults for the Waveform Display
69
Create a Patient ID
70
Zero the Pressure Sensor
71
Summary of ACIST Menu Options
72
Additional Settings
73
Define a Vessel ID Using the New Vessel Button
73
Review the Case Summary
76
Review the FFR Recording (FFR Review)
77
Zero the Aortic Pressure
78
Adjust the Venous Pressure
79
7 Maintenance
81
Cleaning and Maintenance
81
Prevent Equipment Damage
81
Decontamination Procedure
82
Daily Cleaning
83
Optional Fiber Optic Cleaning Process
84
Monthly Inspection and Maintenance
86
8 Troubleshooting and Support
87
General Troubleshooting
87
Interpreting LED Indicator Lights
89
Navvus® Microcatheter Status Indicator LED
89
ACIST Rxi® System Status Indicator LED
89
Hemodynamic Pressure Monitoring
90
Pressure Waveform Accuracy
90
Dampened Pressure Tracing
90
Power Interruption
91
Interpreting Status Messages
92
Color-Coded Pop-Up Messages and Problem Conditions
94
9 Glossary
97
10 Technical Specifications
101
Electrical Specifications
101
Power Requirements
101
Electrical Leakage
101
UL Classification
102
Other Specifications
103
Operating Environment Requirements
103
Weight
103
Dimensions
103
Cable Lengths
104
Pressure Signal Input
104
Pressure Signal Output
104
Clinical Guidance for Use of Pd/Pa to FFR Measurements
105
EMC Tables
106
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
106
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
107
Criteria Definitions
109
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the ACIST Rxi® System
109
11 Limited Warranty
111
12 Appendix: Ao Interface Box
113
Package Contents
113
Device Description
113
Indications for Use/Intended Use
113
Option 1: Installation of Ao Box on the Rxi Console
115
Cable Connections to Ao Interface Box
115
Option 2: Ao Interface Box Installed with Remote Mounting Bracket
117
Calibration
119
Performing a Case
121
Cleaning and Maintenance
121
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