IceCure ProSense FAS3100000-2 System Manuals

Manuals and User Guides for IceCure ProSense FAS3100000-2 System. We have 1 IceCure ProSense FAS3100000-2 System manual available for free PDF download: User Manual

IceCure ProSense FAS3100000-2 User Manual

IceCure ProSense FAS3100000-2 User Manual (133 pages)

Cryoablation System

Brand: IceCure | Category: Medical Equipment | Size: 5.97 MB

Table of Contents

Table of Contents
2
Overview

8
- Introduction
  8
- Intended Use
  8
- Indications for Use
  8
- Prosense™ Qualified Users
  10
- Clinical Decisions
  10
- Contraindications
  10
- Qualified Technician
  10
- Advanced Operator
  11
Safety Notes

12
- Warnings and Cautions
  12
- Basic Safety Principles
  12
- Ownership
  12
- Qualification
  12
- Training
  13
- Clarity
  13
- Clinical Assessment
  13
- Voltage and Power Ratings
  15
- Installation and Setup
  15
- Proper Use
  15
- Cyber Security
  18
- Operating Warnings
  19
- Liquid Nitrogen
  20
- Danger - Explosion and Fire Hazard
  21
- Opening the Dewar Compartment
  21
- Liquid Nitrogen Safety
  21
- Burn Hazards
  24
- Grounding
  24
- Sterility
  24
- Mechanical Handling of Hose and Cryohandle
  25
- Emergencies and Errors
  25
- Emergency Stop Button
  25
- Emergencies Causing Procedure Halt
  25
- Predictable Adverse Events
  26
- General Surgery/ Minimal Invasive Procedures
  26
- Anesthesia
  27
- Cryoablation Procedure in General
  27
- Percutaneous Ablation Procedure
  27
- Laparoscopic Procedure
  28
- Breast - Fibroadenoma and Breast Cancer
  28
- Urology - Renal and Prostate
  28
- Thoracic Surgery - Lung and Cardiac Arrhythmia
  28
- Liver
  29
- Musculoskeletal
  29
- Gynecology
  29
- Confidential User Manual
  29
- Dermatology
  29
- General Predictable Adverse Events When Using the Introducers
  30
- Disposal
  30
- Compliance
  30
- Compliance with International Safety Standards
  30
- Equipment Classification
  30
- Accompanying Labels
  30
- Figure 1: ON/OFF Switch Label
  32
- Figure 2: Emergency Stop Button Label
  32
- Figure 3: System Identification Labels
  32
- Figure 4: Prosense™ Straight Handle Identification Labels
  33
- Figure 5: Follow Instructions for Use
  33
- Figure 6: High Voltage Caution
  33
- Figure 7: Label 6 - Line Voltage Danger
  33
- Figure 8: Foot Pedal
  33
- Figure 9: Risk of Explosion Label
  34
- Figure 10: Single Use Cryoprobe Label
  34
- Figure 11: Color Tag Labels for Cryoprobes (A) and Introducers (B), and Their Location on the External Box
  34
- Figure 12: Single Use Temperature Sensor Label
  35
- Figure 13: Liquid Nitrogen Dewar Label
  35
- Figure 14: Black Dewar Label
  35
- Figure 15: Cold Area Sticker
  35
- Figure 16: Empty LN2 Dewars Sticker
  35
- Figure 17: BF Applied Parts Symbol
  36
- Figure 18: Holder Label
  36
- Figure 19: Shipping and Storage Conditions Sticker
  36
- Important Symbols and Labels
  37
- Figure 20: Shipping Label
  37
- Figure 21: Crate Opening Restriction Sticker
  37
- Figure 22: Single Use Introducer Labels
  37
System Description

42
Installation and Setup

53
Operating the System

56
Computer Interface

110
- The Technician Menu
  110
- Reading the Screen
  110
- System Messages
  110
- Status Messages
  110
- Figure 115: a Sample Touch Screen
  110
- Figure 116: Status Message Example
  110
- Warning Messages
  111
- Error Messages
  111
- Figure 117: Warning Message Format Example
  111
- Figure 118: Error Message Format Example
  111
Accessories

113
System Maintenance

116
Troubleshooting

118
- General
  118
- Troubleshooting Guide
  118
Prosense™ Cryoablation System - Step-By-Step Procedure

123
System Specifications

124
Limited Warranty Certificate

125
Customer Complaint Form

126
Report Customer Complaint

127
Cryoablation Clinical References

128
Manufacturer's Declaration of the EUT

131

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