Introduction; Indication For Use - CUSTOM ULTRASONICS 83 Plus System 2 Service Manual

This manual is to be used with the System 83 Plus™ 2 and System 83 Plus™ 9 Washer/Disinfectors that are labeled
and distributed exclusively by Custom Ultrasonics, Inc.

Introduction

The System 83 Plus™ Washer/Disinfector is intended for the cleaning and high-level disinfection of one or two
submersible flexible endoscopes (per bay) that feature several internal channels that do not contact normally sterile
areas of the body i.e., semi-critical devices. The types of flexible endoscopes for which this System 83 Plus™
Washer/Disinfector is labeled to reprocess include those that are used to examine, diagnose and treat diseases of
the upper and lower gastrointestinal tract and pulmonary tracts.
gastroscopes, bronchoscopes and specific duodenoscopes.
WARNING: The duodenoscopes that are validated for reprocessing in the System 83 Plus™ are the Olympus
TJF-Q180V and the Pentax ED-3490TK using ortho‐Phthalaldehyde Solution high‐level disinfectant
(OPA) for a minimum of 12 minutes at 20°C.
reprocessing of the FUJIFILM duodenoscopes and of duodenoscopes with open elevator wire
channels.

Indication for use

System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible
submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are
pre-cleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plus™,
may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact
conditions of the high level disinfectant.
Note: The System 83 Plus™ device includes two models.
• The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time.
The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time
•
in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.
MAN–202
System 83 Plus™ Washer/Disinfector
Service Manual for Models:
System 83 Plus™ 2
System 83 Plus™ 9
Revision 03082022
System 83 Plus™ Washer/Disinfector
Service Manual
Examples include flexible colonoscopes,
The System 83 Plus™ is not validated for the
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