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AngioDynamics NanoKnife System - User Manual
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AngioDynamics, Master Manual T
emplate 8.5 in 1
1in, 156T851
1 Rev/V
er.
A, Manual, Nanoknife System User Manual Ver 3.0, 16795933-21C_English
16795933-21 REVC - English
2024-03
NanoKnife System
User Manual
V
ersion 3.0
2
Table of Contents
Main Page
Table of Contents
3
Section 1: Introduction
8
Overview
8
Intended Purpose / Indication for Use
8
Intended Purpose
8
Indication for Use
8
Intended User Profile
8
Components
8
Sections
8
Symbols
9
Specific Part Symbols
11
Section 2: Safety Instructions
12
Overview
12
Safety Features of the Generator
12
Contraindications
13
Warnings
13
Clinical Issues (Including Arrhythmia, Hypertension, and Thrombus Risks)
13
Use of Electrodes
13
Use of Generator (Including Electrocution Hazard)
14
Precautions
14
Potential Adverse Effects
16
Section 3: Generator Components
17
Overview
17
Nanoknife Generator Description
18
Nanoknife Generator - Lower Front Components
19
Nanoknife Generator Power Unit - Lower Back Components
20
Nanoknife Generator Back Handle
21
Equipment and Supplied Components
21
Touchscreen LCD Display
21
Console Components
22
Electrode Probe Components
22
Section 4: Installation and Start-Up
23
Location and Installation
23
Installation Instructions
23
Nanoknife Generator Start-Up Self Test
23
Section 5: System Operation
25
Procedure Overview
25
Procedure Setup (before Patient Enters Procedure Room)
25
Patient Preparation
25
Procedure Planning
26
Procedure Setup
26
Probe Placement
27
Pulse Generation
28
Probe Removal and Disposal
28
Equipment Shut-Down, Cleaning, and Storage
29
Procedural Guidelines and Recommendations
29
Procedure Parameter Settings
30
Table of Buttons
31
Table of Status Symbols
35
Section 6: Procedure Setup
37
Procedure Setup Screen Overview
37
Patient Information
38
Case Information
40
Probe Selection
40
Probe Connection Status
42
Pulse Delivery Mode Setting
46
How to Change Pulse Delivery Mode to 90 PPM
46
How to Change Pulse Delivery Mode to ECG Synchronized
47
Case Notes
47
How to Enter Case Notes
48
Proceed to Next Screen
49
Section 7: Procedure Planning
50
Procedure Planning Screen
50
Probe Placement Grid
51
Targeted Ablation Area Settings
53
Target Zone Rotation Handle
55
Pulse Parameters Table
56
Pulse Parameter Constraints
58
How to Modify Pulse Parameters
59
How to Modify Pulse Parameters for All Active Probe Pairs
60
How to Re-Assign P+ and P- Parameters
60
How to Reverse Polarity of Active Probe Pairs
62
How to Enter Probe Pair Distances Manually
62
How to Re-Enable the Probe Placement Grid
64
Add and Delete Row Buttons
64
How to Delete Probe Pairs from Pulse Parameters Table
64
How to Add Probe Pairs to the Pulse Parameters Table
65
Distance Solver
66
How to Use the Distance Solver
66
Quick Adjust Tab
68
How to Quickly Add or Remove Probe Pairs
69
How to Quickly Modify Pulse Length for All Probe Pairs
69
How to Quickly Modify Number of Pulses for All Probe Pairs
69
How to Quickly Modify Voltage Setting for All Probe Pairs
70
How to Enter Probe Exposure for All Probe Pairs
70
Polarity Tab
71
How to Re-Assign Polarity of a Probe Pair
71
How to Re-Assign Polarity of All Probe Pairs
71
Options Tab
72
Probe Placement Grid Options
72
How to Modify Probe Placement Grid Options
73
Restore Default Settings
73
Proceed to Next Screen
74
Section 8: Pulse Generation
75
Pulse Generation Screen
75
Pulse Generation Table
76
How to Modify Pulse Parameters
77
How to Modify Pulse Parameters for All Probe Pairs
78
How to Reverse Polarity of Active Probe Pairs
78
How to Deactivate Probe Pairs
79
How to Activate Probe Pairs
80
How Current Measurements Are Calculated
80
How to Evaluate Pulses Delivered and Status
81
Probe Pair Status Grid
82
Electrical Results Chart
82
How to Toggle between Electrical Results Charts
83
Electrical Results Chart During Pulse Delivery
83
Electrical Results Chart after Pulse Delivery
84
Voltage Gauge and Charge Options
85
How to Discharge Capacitors
85
How to Charge Capacitors
85
Audible Indications During Pulse Delivery
86
Pulse Delivery Control Panel
86
How to Start the Conductivity Test
88
High Current Detected During the Conductivity Test
90
Low Current Detected During the Conductivity Test
91
How to Modify Pulse Parameters after the Conductivity Test
92
How to Start Pulse Delivery
92
How to Stop Pulse Delivery
95
How to Resume Pulse Delivery
95
How to Reset Pulse Delivery MID Pulse Delivery
96
How to Skip Probe Pairs During Pulse Delivery
96
Low Current Conditions During Pulse Delivery
97
High Current Conditions During Pulse Delivery
98
How to Deliver Additional Pulses
100
How to Reset Pulse Delivery for a Pullback Ablation
100
How to Reset Pulse Delivery for an Overlapping Ablation
101
How to Use the Red STOP Button
101
Storage of Pulse Parameters and Electrical Results Charts
102
Section 9: End of Procedure
104
Export Procedure Files
104
How to Export Procedure Files
104
Disconnect Electrode Probes
106
Reset the Nanoknife Software for a New Patient
106
Shut down the Nanoknife Generator
106
Section 10: Ecg Synchronization
108
Overview
108
External R-Wave Detector / Cardiac Gating Device
108
ECG Synchronization
108
Before the Conductivity Test
108
ECG Synchronized
108
ECG Lost
109
ECG Noisy
109
During the Conductivity Test
109
ECG Synchronized
109
ECG Lost
110
ECG Noisy
110
During Pulse Delivery
111
ECG Synchronized
111
ECG Lost
111
ECG Noisy
112
Section 11: Electrode Probes
114
Nanoknife Single Electrode Probes
114
Section 12: Troubleshooting
116
Overview
116
Documented Problems and Solutions
116
Error Messages
119
Section 13: Maintenance & Service
125
Overview
125
Preventative Maintenance and Periodical Verifications
125
Cleaning
125
Replacing Main Fuses
126
Section 14: Technical Data
127
General Information
127
Power Supply Specifications
127
Fuse Type Specifications
127
Environmental Conditions
127
Operating Conditions
127
Transport and Storing Conditions
127
Classifications
127
60601-1 Classification
127
Protection against Electric Shock
128
Ingress of Liquids
128
Safety Level
128
Council Directive 93/42/EEC Concerning Medical Devices
128
FDA Classification
128
Applied Parts
128
Use Conditions
128
Physical Specifications (Without Packaging)
128
Technical Specifications
128
Essential Performance
128
Radio Frequency Identification
129
Summary of Application Specification
129
Intended Medical Conditions
129
Intended Patient Population
129
Intended Part of the Body
129
Intended User Profile
130
Intended Conditions of Use
130
Operating Principle
130
Section 15: Warranty and Electromagnetic Compatibility
131
Warranty
131
Section 16: Symbols Glossary
137
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AngioDynamics NanoKnife System Specifications
General
Brand
AngioDynamics
Model
NanoKnife System
Category
Medical Equipment
Language
English
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