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Questions and Answers
What is the maximum allowable peeling area for the catheter shaft up to 250mm from the tip?
What is the maximum allowable peeling area for the catheter shaft up to 250mm from the tip?
What is the inspection method used for the tip electrode during the final inspection?
What is the inspection method used for the tip electrode during the final inspection?
How frequently is the final inspection conducted on each unit?
How frequently is the final inspection conducted on each unit?
What is the maximum allowable resistance for the AGCU-use test?
What is the maximum allowable resistance for the AGCU-use test?
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Which test ensures that there is no disconnection in the circuit?
Which test ensures that there is no disconnection in the circuit?
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During the knob return test, what is checked specifically after turning the knob to its maximum?
During the knob return test, what is checked specifically after turning the knob to its maximum?
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Which tool is necessary for the insulation test?
Which tool is necessary for the insulation test?
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Which of the following conditions must be checked in the handle inspection?
Which of the following conditions must be checked in the handle inspection?
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What is the requirement for the operability of the knob in the final inspection?
What is the requirement for the operability of the knob in the final inspection?
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For the PVC tube length, what is the specified standard range?
For the PVC tube length, what is the specified standard range?
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What is indicated if the collet nuts are not fixed properly?
What is indicated if the collet nuts are not fixed properly?
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Which method is used to check curve flatness during the final inspection?
Which method is used to check curve flatness during the final inspection?
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What is the allowance for axis shifted top?
What is the allowance for axis shifted top?
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What is the allowance for axis shifted bottom?
What is the allowance for axis shifted bottom?
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What item use to check dimension?
What item use to check dimension?
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Study Notes
BeeAT Final Inspection QC Flow Chart
- Product: Internal atrial cardioversion catheter (BeeAT)
- Inspection Points: Includes tip electrode, catheter tube covering, ring electrode, catheter shaft, handle, sheath, and bending tests.
- Control Items: Appearance, quality characteristics, specifications (e.g., dimensions, tolerances), and electrical tests are crucial checkpoints.
- Specifications: Precise measurements and tolerances are listed for various components, such as tip electrode size, gap between catheter parts, shaft smoothness, and handle integrity.
- Quality Characteristics: Visual inspection for defects (burrs, dents, scratches, stains, foreign materials, etc.) and physical attributes like smoothness and absence of cracks are important.
- Testing Methods: Various tools like magnifying lamps, microscopes, stand scopes, scales, protractors, and Digital Multimeters are used.
Flow Chart details
- Measurements: Specific measurements are taken at different locations along the catheter shaft.
- Bending Test: The catheter's ability to bend to specified shapes, without structural damage, is tested.
- Electrical Test: Insulation, resistance, and circuit conduction tests are conducted to ensure proper electrical function.
- Electrical Parameters: Results (e.g., stable resistance values) for different electrode types must adhere to specifications to ensure safety.
- Appearance Checks: A visual inspection is performed to verify conformance to specified standards.
Terminology
- Tip electrode: The electrode at the tip of the catheter.
- Catheter tube covering: The layer covering the tip electrode.
- Ring electrode: An electrode on the body of the catheter.
- Shaft: The main cylindrical part of the catheter.
- Handle: The part of the catheter used for operation.
- Sheath: The protective layer around the catheter shaft and components.
- Curve pattern: The shape the catheter takes when bent
- Curve template: A guide used to evaluate shape during bending.
- Manufacturing Records: Documents maintained by the manufacturer.
- QC: Quality control team's involvement in the overall process.
Additional Information
- Document References: Additional documents (SOPs, Work Instructions, etc.) are cited for further details on inspection procedures and specific measurement techniques.
- Revision History: A log of changes made to the QC Flow Chart over time.
- Malaysian Translation: A section of the document exists containing the same information in Malay.
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Description
This quiz explores the quality control flow chart for the internal atrial cardioversion catheter (BeeAT). It covers inspection points, control items, specifications, quality characteristics, and testing methods used in the inspection process. Test your knowledge on the essential checkpoints and quality standards for medical devices.
