The user manual is issued by Roche Diabetes Care as a vital notice for users of the Accu-Chek Insight insulin pump system. Roche is dedicated to maintaining high quality standards and advancing their products to ensure they meet the therapeutic needs of people with diabetes. The focus of this notice is on a new safety feature for the Accu-Chek Insight insulin pump system with serial numbers below 32100000.
Roche has developed new key frames designed to prevent unintended activation of the pump keys and quick bolus buttons. These enhancements are prompted by the necessity to reduce the risk of accidental operation of the device, addressing issues reported by users and enhancing overall patient safety. The notice specifies that pumps with serial numbers above the mentioned threshold are not subject to this concern.
Contents of the Safety Frame Kit
The safety frame kit provided includes the new key frames along with a cleaning tissue, and instructions detailing the application process of the key frames to the pump.
Application Instructions
Key precautions for the users when preparing the pump for the frame’s application are highlighted:
- Ensure the frames are at room temperature for at least one hour prior to application.
- Remove the protective foil from the pump display to allow frames to adhere properly.
- Use the provided cleaning tissue following the given advice, and let the surfaces dry for approximately one minute before affixing the frames.
After the application of the safety frames, users are requested to send back an acknowledgment form to Roche via email, fax, or mail as a confirmation of compliance.
Additional Support
Users are directed for general information about the pump keys and quick bolus buttons to the Accu-Chek Insight pump manual. Roche expresses appreciation for the users’ time and cooperation. Users requiring additional assistance or having further questions are encouraged to contact Roche’s Accu-Chek Customer Care line.
The manual also mentions that Roche has informed the national competent authority about this field action, signifying regulatory compliance and transparency in their operations. This notice reiterates Roche’s commitment to ensure safety and functionality for its users by closely monitoring customer reports and feedback.
The manual serves to instruct and inform users on the use of the new safety frame feature, reflecting Roche’s responsiveness to customer needs and ongoing product optimization.
Manual:
Download: Accu-Chek Insight Insulin Pump System Safety Frame Kit User Manual
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