Sirius Medical Pintuition Detector, Инструкция по эксплуатации

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001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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Table of Contents
QUICK REFERENCE GUIDE
.............................................................................................................. 3
1 INTRODUCTION
........................................................................................................................ 6
1.1 Indication for Use
.................................................................................................................................... 6
1.2 Contraindications and Limitations for Use
........................................................................................... 6
1.3 Possible Complications and Adverse Events
....................................................................................... 7
1.4 Compatible components
........................................................................................................................ 7
1.5 Principle of Operation
............................................................................................................................. 7
1.6 Explanation of Symbols
.......................................................................................................................... 7
2 SAFETY
...................................................................................................................................... 8
2.1 Warnings
................................................................................................................................................... 8
2.2 Cautions
.................................................................................................................................................. 10
3 INSTALLATION AND BASIC OPERATION OF THE PINTUITION DETECTOR
...................... 12
3.1 Unpacking and Inspecting
.................................................................................................................... 12
3.2 Device Description
................................................................................................................................. 12
3.2.1 Pintuition Base Unit - Front
.............................................................................................................................. 12
3.2.2 Pintuition Base Unit – Back
............................................................................................................................. 13
3.2.3 Pintuition Base Unit – Display Interface
........................................................................................................ 13
3.2.4 Pintuition Probe (Applied Part, type BF)
........................................................................................................ 14
3.2.5 Pintuition Test Kit
............................................................................................................................................. 14
3.2.6 Audio
.................................................................................................................................................................. 14
3.3 Transport and Storage
.......................................................................................................................... 15
3.4 Installation
.............................................................................................................................................. 15
3.5 Powering the Device
.............................................................................................................................. 15
3.6 Turning the Device On
........................................................................................................................... 15
3.7 Turning the Device Off
.......................................................................................................................... 16
4 USING THE PINTUITION DETECTOR
..................................................................................... 17
4.1 Connecting the Pintuition Probe
.......................................................................................................... 17
4.2 Calibrating the Pintuition Detector
...................................................................................................... 17
4.3 System Test: Using the Test Kit
........................................................................................................... 18
4.4 Adjusting the volume
............................................................................................................................ 18
4.5 Application of sterile sheath
................................................................................................................ 18
4.6 Detection, Directionality and Accuracy
............................................................................................... 19
4.7 Surgical Procedure
................................................................................................................................ 20
4.7.1 Preparing the Procedure
.................................................................................................................................. 20
4.7.2 Preoperative – Surgical Planning (no sterile area)
....................................................................................... 20
4.7.3 Preoperative – Sterile Draping to Prepare for Use within Sterile Area
....................................................... 20
4.7.4 Perioperative – During Surgery (use within Sterile Area)
............................................................................. 21
4.7.5 Postoperative – Pathological Processing
..................................................................................................... 21
4.8 Disconnecting the Probe
...................................................................................................................... 22
5 REPROCESSING – CLEANING AND HIGH LEVEL DISINFECTION
....................................... 23
5.1 Pintuition Base Unit
............................................................................................................................... 23
5.2 Pintuition Probe
..................................................................................................................................... 23
6 MAINTENANCE AND SERVICE
............................................................................................... 26
6.1 Recommended Maintenance
............................................................................................................... 26
6.2 Replacing the Fuse
................................................................................................................................ 26
6.3 Repairs
.................................................................................................................................................... 26
6.4 Pintuition Detector – Disposal
............................................................................................................ 26
7 TECHNICAL SPECIFICATIONS
............................................................................................... 27
7.1 Compliance with Standards
................................................................................................................. 27
7.2 Electromagnetic Compatibility
............................................................................................................. 28
8 TROUBLESHOOTING
.............................................................................................................. 31
8.1 Troubleshooting Errors
......................................................................................................................... 31
8.2 Troubleshooting Tips
............................................................................................................................ 31
8.3 Obtaining Technical Assistance
.......................................................................................................... 32