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1-1. General
This Instructions for Use (IFU) has been written in accordance with 21CFR
Part801, ISO 17664, and national guidelines on reprocessing of medical
products.
1-1-1. Application
WARNING
Reprocessing may affect device functionality. Prior to use, always inspect the
endoscope, components, and accessories for proper function to determine
that they are appropriate for patient use.
Components and Accessories for Video Bronchoscopes
TYPE
MODEL Video Bronchoscopes
Name Number
EB-1570K
EB-1970K
EB-1970TK
EB-1575K
EB-1975K
EB-1170K
EB-1990i
Endoscope
Component
Suction Control Valve OF-B179 Y Y
Inlet Seal OF-B190 Y Y
Accessory Bite Block - Adult Size OF-Z5 Y Y
Reprocessing
Accessory
PVE Soaking Cap OE-C9 Y Y
Ventilation Cap OF-C5 Y Y
Cleaning Adapter OF-B155 Y Y
Cleaning Brush CS6002SN Y Y
Cleaning Brush CS6015ST Y N
Cleaning Brush CS3010S N Y
Cleaning Brush CS-C3S Y Y
Y : YES
N : NO
1
1 CARE AFTER USE
General