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الجمعة - محرم 2, 1447
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EN
SA-22-10-24-635
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
الأجهزة المتأثرة
GIF-1TH190
الممثل المعتمد
Gulf Medical Co.
سبب المشكلة
Olympus previously issued revised cleaning instructions for the GIF-1TH190 in October 2023 to issue new updated channel drying steps. Olympus conducted user evaluation, through human factors validation, and determined further clarification is required to improve the instructions for easier understanding of each drying step. As a result, Olympus is issuing a revised IFU addendum that informs customers that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum.
الإجراء التصحيحي
Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Implement use of the enclosed Addendum stating that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new water purge requirements.
المرفقات
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