PENTAX MEDICAL
Naso-Pharyno Laryngoscopes
Pentax Endoscopes Various Models Reprocessing Warning Addendum Sheet 1 Nov 2016
Reprocessing Warning Addendum
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![PENTAX IFU addendum No.397 R00 The addition of WARNING statements to OF-B113, OE-B5 Subject devices: Irrigation tube OF-B113 Injection tube OE-B5 WARNING Check that there is not any damage on the Luer connector prior to use OF-B113 or OE-B5. When OF-B113 or OE-B5 is connected with locking type of Luer connector, ensure that the luer connectors are properly locked. If there is damage of the Luer connector of OF-B113 or OE-B5 and/or luer connection is not properly locked, do NOT use the OF-B113 or OE-B5. The use of damaged Luer connector may result in ineffectiveness endoscope reprocessing due to water leakage from the connected part or tube disconnection, posing a risk of cross-contamination. LCPM: 01/2017/02/35201302 67-42-269 2016. 11 No. 397 R00](https://public.bioclinicalservices.com.au/library/representations/proxy/eyJfcmFpbHMiOnsiZGF0YSI6MTMwNjAyLCJwdXIiOiJibG9iX2lkIn19--0ffd132561a9f588de56e6f9e1bf54c9ab265278/eyJfcmFpbHMiOnsiZGF0YSI6eyJyZXNpemUiOiIzMjB4In0sInB1ciI6InZhcmlhdGlvbiJ9fQ==--4214356078d1f110e449cda512a9432562da3e70/Pentax%20Endoscopes%20Various%20Models%20Reprocessing%20Warning%20Addendum%20Sheet%201%20Nov%202016.pdf.png)
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PENTAX IFU addendum No.397 R00 The addition of WARNING statements to OF-B113, OE-B5 Subject devices: Irrigation tube OF-B113 Injection tube OE-B5 WARNING Check that there is not any damage on the Luer connector prior to use OF-B113 or OE-B5. When OF-B113 or OE-B5 is connected with locking type of Luer connector, ensure that the luer connectors are properly locked. If there is damage of the Luer connector of OF-B113 or OE-B5 and/or luer connection is not properly locked, do NOT use the OF-B113 or OE-B5. The use of damaged Luer connector may result in ineffectiveness endoscope reprocessing due to water leakage from the connected part or tube disconnection, posing a risk of cross-contamination.
LCPM: 01/2017/02/35201302
67-42-269
2016. 11
No. 397 R00