Does the TJF-Q180V have 510(k) clearance now? What is the 510(k) #?
The TJF-Q180V has recently received FDA marketing clearance under 510(k) #K143153.
Can I still use the same chemical in my non-Olympus AER?
For all automated endoscope reprocessors (AERs), Olympus recommends that you contact the manufacturer of your AER for further guidance and clarification on compatible chemistries.
How is the new reprocessing process different?
The new TJF-Q180V Reprocessing Manual features changes including:
- Precleaning and manual cleaning are now required even when using an Automated Endoscope Reprocessor (AER)
- The new TJF-Q180V Reprocessing Manual has updated parameters for ethylene oxide gas sterilization cycles
- Changes to the leakage test by extending the observation for bubbles through the instruction to, “Observe for approximately 30 seconds while deflecting the bending section of the endoscope by turning the endoscope's UP/DOWN and RIGHT/LEFT angulation control knobs to confirm that there is no location on the endoscope from which a continuous series of air bubbles emerges. Then observe for additional 30 seconds while raising and lowering the forceps elevator by moving the endoscope's elevator control lever to confirm that there is no location around the forceps elevator from which a continuous series of air bubbles emerges during the 30 seconds.”
This is not an exhaustive list of changes. It is important that you review the new TJF-Q180V duodenoscope Reprocessing Manual in detail. The inside cover page lists all changes in the new Reprocessing Manual.
Can I reprocess my scope in any AER?
The TJF-Q180V can be reprocessed in the Olympus OER-Pro. For all other automated endoscope reprocessors (AERs), Olympus recommends that you contact the manufacturer of your AER for further guidance and clarification on compatibility.
Can we still use our TJF-160VF & TJF-160F?
Yes. The TJF-160VF and TJF-160F duodenoscopes are unaffected by this action.