Pentax Endoscopes Various Models Reprocessing Warning Addendum Sheet 1 Nov 2016

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