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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-25-02-25-793
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
HAMILTON- C2/C3
الأجهزة المتأثرة
- All HAMILTON-C2 with SW version ≤2.2.5 and neonatal option installed - All HAMILTON-C3 with SW version ≤2.0.9 and neonatal option installed
الممثل المعتمد
daleel alraeda trading est
سبب المشكلة
Affected HAMILTON-C2/C3 devices which are used for long-term ventilation in neonatal patient group will switch to the “Ambient State” if the ventilation time is exceeding 91 days.
الإجراء التصحيحي
If failure occurs, perform the following actions steps: 1. Provide alternative ventilation immediately. 2. You must switch off ventilator power to exit the “Ambient State”. 3. Once patient safety is ensured, it is required to have the ventilator serviced. (preventive maintenance. After passing the service software the device can be returned to use). For further information see chapter “Ambient State” in the respective Operator’s Manual. To avoid this malfunction, perform the following: -The device needs to be restarted regularly. Note: Switching into “standby” is not sufficient. HAMILTON recommends performing the restart of the device during the regular exchange of the breathing circuits (usually every 28 days). -For HAMILTON-C3: Please conduct the Software Update and upgrade the affected devices to SW version 2.0.11 or higher as soon as possible. Manufacturer action: Instructions and correction.
المرفقات
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