BeeAT Final Inspection Assessment
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Questions and Answers

What is the maximum allowable peeling area for the catheter shaft up to 250mm from the tip?

  • 0.5 mm²
  • 0.2 mm² (correct)
  • 1.0 mm²
  • 0.3 mm²

What is the inspection method used for the tip electrode during the final inspection?

  • Only visual inspection
  • Ultrasonic testing
  • Use of a magnifying lamp or microscope (correct)
  • Microfluidic assessment

How frequently is the final inspection conducted on each unit?

  • Daily
  • Hourly
  • Once per batch
  • Every unit (correct)

What is the maximum allowable resistance for the AGCU-use test?

<p>&lt;7Ω (±0.10) (C)</p> Signup and view all the answers

Which test ensures that there is no disconnection in the circuit?

<p>Circuit conduction test (C)</p> Signup and view all the answers

During the knob return test, what is checked specifically after turning the knob to its maximum?

<p>The tip's movement (D)</p> Signup and view all the answers

Which tool is necessary for the insulation test?

<p>Digital Multimeter (D)</p> Signup and view all the answers

Which of the following conditions must be checked in the handle inspection?

<p>Presence of deformations (D)</p> Signup and view all the answers

What is the requirement for the operability of the knob in the final inspection?

<p>Smooth movement, no stuck issues (A)</p> Signup and view all the answers

For the PVC tube length, what is the specified standard range?

<p>35±5mm (D)</p> Signup and view all the answers

What is indicated if the collet nuts are not fixed properly?

<p>It has dysfunctionality issues. (C)</p> Signup and view all the answers

Which method is used to check curve flatness during the final inspection?

<p>Measurement with a scale (A)</p> Signup and view all the answers

What is the allowance for axis shifted top?

<p>8mm (A)</p> Signup and view all the answers

What is the allowance for axis shifted bottom?

<p>10mm (B)</p> Signup and view all the answers

What item use to check dimension?

<p>ruler (A)</p> Signup and view all the answers

Flashcards

Tip Electrode Appearance

The tip electrode should be free of any burrs, dents, scratches, stains, or foreign material. The catheter tube covering should be less than 0.3mm, and the gap between the catheter shaft should be less than 0.25mm

Ring Electrode Inspection

The ring electrode should be free of any burrs, dents, scratches, stains, or foreign material. The electrode should not have any open gaps.

Catheter Shaft Inspection (Up to 250mm)

Up to 250mm from the tip, the catheter shaft surface must be smooth. There should be no dents, holes, cracks that open when bent, peeling greater than 0.2mm², or foreign material

Catheter Shaft Inspection (After 250mm)

After 250mm from the tip, the catheter shaft should not have any blades protruding. There should be no abnormalities at the boundary with the ring electrode. The surface should be smooth and free of dents, holes, cracks, peeling greater than 0.3mm², foreign material, and protruding blades.

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Final Inspection Process

This visual inspection uses magnifying lamps and microscopes to ensure the catheter meets all requirements. The inspection frequency is 100%.

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Catheter Shaft Surface

The catheter shaft should be smooth and free of any defects, such as dents, holes, cracks, peeling, or foreign material. This ensures proper functionality and prevents complications during use.

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Catheter Electrical Testing

The electrical properties of the catheter are assessed through various tests including insulation resistance, circuit conduction, and resistance. These tests ensure that the circuitry is properly functioning and that the catheter will perform as designed.

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Knob Return Test

The catheter knob is turned to its maximum setting and then released. The tip of the catheter should not move, indicating a secure connection and proper operation of the knob mechanism.

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Handle Inspection

A visual inspection of the handle to ensure there are no scratches, cracks, deformations, stains, foreign material, or wobbling.

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Effective Length

The distance measured from the tip of electrode #1 to the end of the shaft.

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Ring Electrode Gap Length

The distance between the ring electrode and the shaft, measured using a scale, according to the specifications in Ap-QF-8260-001.04.

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Electrode Group Gap Length

The distance between the electrode group and the shaft, measured using a scale. The location of the electrode group is provided in the WI (Work Instruction) and the electrode location is defined in Ap-QF-8260-BAT-001.02.

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Bending Test

The ability of the sheath to bend according to the designated curve template without any issues.

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Maximum Curve Length

The distance between the tip electrode and the shaft, measured using the curve template.

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Curve Flatness

A visual check to ensure the sheath is flat within an 8mm tolerance while the shaft is aligned with specific rings.

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Axis Shifted

A measurement to ensure that the shaft's axis shifts within a specified tolerance during the bending process. For tapping screw facing upwards, the tolerance is 10mm.

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Knob Operability

The ability to rotate the knob smoothly without any sticking or resistance.

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Appearance Inspection

A visual inspection for any defects such as broken parts, crumples, folds, and peeling on the shaft.

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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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Related Documents

JLL BeeAT Final Inspection QC Flow Chart PDF

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.

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