Chapter 1
Health and Safety Compliance ......................................................................... 1
Important Information ................................................................................................................................................. 1
Intended Use ............................................................................................................................................................. 2
Overview of the PINPOINT System ........................................................................................................................... 2
Components .......................................................................................................................................................... 2
User Qualifications ..................................................................................................................................................... 4
General System Safety .............................................................................................................................................. 4
Electrical Safety – General .................................................................................................................................... 4
Electrical Safety – Power....................................................................................................................................... 5
Light Safety- Illumination ....................................................................................................................................... 5
Warning Labels on the PINPOINT System ............................................................................................................ 7
Electromagnetic Compatibility (EMC) and Environmental Safety .......................................................................... 7
Advice When Used with High Frequency Surgical Equipment .............................................................................. 8
Damaged or Malfunctioning Equipment ................................................................................................................ 8
Cleaning and Sterilizing ......................................................................................................................................... 9
Repair and Modification ....................................................................................................................................... 10
Disposal of PINPOINT System Components ........................................................................................................... 10
Symbols Used on the PINPOINT System ................................................................................................................ 11
Chapter 2
Unpacking and Setting Up the PINPOINT System ..........................................17
System Parts ........................................................................................................................................................... 17
Setting Up the PINPOINT Imaging System ............................................................................................................. 19
Selecting an Appropriate System Installation Location ........................................................................................ 19
Connecting the Video Processor / Illuminator (VPI) ............................................................................................ 20
Connecting to a Medical-grade Video Monitor..................................................................................................... 21
Connecting to a Medical Recorder ...................................................................................................................... 22
Connecting to Ancillary Video Devices (Optional) ............................................................................................... 22
Selecting the Appropriate Video Output Format .................................................................................................. 22
Connecting the PINPOINT Camera to the VPI .................................................................................................... 24
Connecting the Light Guide Cable to the Laparoscope ....................................................................................... 25
Connecting and Disconnecting the Laparoscope to the PINPOINT Camera ....................................................... 27
Storing and Transporting Laparoscopes.............................................................................................................. 28
Chapter 3
Handling, Preparation, and Administration of ICG .........................................29
About Indocyanine Green (ICG) Imaging Agent ...................................................................................................... 29
ICG Safety ............................................................................................................................................................... 29
Clinical Pharmacology ......................................................................................................................................... 29
ICG Contraindications ......................................................................................................................................... 29
ICG Warnings ...................................................................................................................................................... 30
ICG Adverse Reactions ....................................................................................................................................... 31
General ICG Preparation Instructions ...................................................................................................................... 31
ICG Administration via Central or Peripheral Venous Line ...................................................................................... 32
Supplies Required for each Imaging Sequence .................................................................................................. 32
PINPOINT Endoscopic Fluorescence Imaging System Operator's Manual
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