Table of Contents
Advertisement
Warning and Caution Statements
A WARNING indicates a potentially hazardous situation which, if not avoided, could result in an improperly
reprocessed endoscope and/or death or serious injury to an operator.
A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury
to an operator. It may also be used to alert against unsafe practices or potential equipment damage.
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.
WARNING:
Use of HLDs other than OPA have not been validated in the System 83 Plus™ and are not
recommended for use by Custom Ultrasonics.
WARNING:
Manual Pre-Processing of endoscope(s) is important and must be completed prior to placing
endoscopes into the processing chamber of the System 83 Plus™.
pre-cleaning or failure to follow applicable endoscope manufacturers labeling requirements for
reprocessing may result in an endoscope that has not been properly reprocessed.
WARNING:
If the pressure differential of the water inlet filter system exceeds 25 psi, stop using the System 83
Plus™. Replace the filters immediately as post filter water supply quality cannot be assured if the
pressure differential is exceeded. Final rinse water quality cannot be assured if the 25 psi pressure
differentials are exceeded.
WARNING:
Rapid change over from air to water (Water Hammer Effect) can result in water filter damage.
WARNING:
Not following the filter maintenance requirements in this manual may result in inadequate reprocessing.
WARNING:
In the event that flow is restricted in a flushing adapter featuring an in-line disc filter, the operator is
instructed to replace the in-line disc filter, irrespective of its in-use time, and confirm restored flow
through the adapter. If no flow is observed through the adapter, stop using the System 83 Plus™ and
call Custom Ultrasonics for service.
WARNING:
Visually confirm flow through each of the flushing adapters of the System 83 Plus™ at the beginning
and end of a process and during an air/alcohol purge. If no flow is observed through the adapter, stop
using the System 83 Plus™ and call Custom Ultrasonics for service.
WARNING:
The System 83 Plus™ must be operated by trained personnel with the necessary understanding in the
operations of the System 83 Plus™, and the requirements for the reprocessing of endoscope(s).
WARNING:
Failure to utilize the correct endoscope flushing adapters or correct configuration may result in an
endoscope(s) that has not been properly high-level disinfected.
WARNING:
When operating automatic door (lid), do not place face or body in the way of the motion of the door,
injury may occur.
WARNING:
The System 83 Plus™ must not be located next to or near an X-Ray, CAT scan or MRI equipment.
WARNING:
The System 83 Plus™ equipment is not suitable for use in the presence of flammable mixtures with air
or with oxygen or nitrous oxide.
WARNING:
Failure to submerse the endoscope in the correct detergent solution and HLD products for the
recommended time, temperature and MEC may result in ineffective reprocessing.
WARNING:
The (F7) WASH ONLY cycle will wash and rinse 1 or 2 endoscopes per bay, but does not high-level
disinfect the endoscope(s). This wash only cycle should not be used as a terminal process prior to
patient use.
MAN–202
System 83 Plus™ Washer/Disinfector
The System 83 Plus™ is not validated for the
Revision 03082022
Service Manual
Failure to perform proper
Page 6 of 54
Advertisement
Table of Contents
Need help?
Do you have a question about the 83 Plus System 2 and is the answer not in the manual?
Questions and answers