Quality Control Procedures for EPstar Fix Catheter
13 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What are the two main types of electrical tests conducted on the EPstar Fix (Lumen) catheter?

  • Continuity Test and Impedance Test
  • Insulation Test and Resistance Test (correct)
  • Voltage Test and Current Test
  • Signal Strength Test and Noise Level Test

    • The catheter tip should have no burrs at the tip or in the lumen, according to the QC checklist.

    True

    What is the maximum acceptable size of a dent on the catheter shaft?

  • 0.2mm² (correct)
  • 0.5mm²
  • 1.5mm²
  • 1.0mm²

    • What is the minimum acceptable insulation resistance for the EPstar Fix (Lumen) catheter?

    <p>≥30MΩ</p> Signup and view all the answers

    What is the maximum acceptable resistance for the EPstar Fix (Lumen) catheter?

    <p>≤200</p> Signup and view all the answers

    The catheter tip should have no burrs exceeding 0.5 mm at the backend of the tip induction heating part?

    <p>True</p> Signup and view all the answers

    During the final inspection of the EPstar Fix (Lumen) catheter, the winged part of the female luer must be within ±45° of the horizontal plane.

    <p>True</p> Signup and view all the answers

    What procedure should be conducted before each insulation test conducted on the EPstar Fix (Lumen) catheter?

    <p>The catheter should be bent 180° and then flexed 90° each side 3 times.</p> Signup and view all the answers

    The tip of the EPstar Fix (Lumen) catheter must conform to a given curvature template.

    <p>True</p> Signup and view all the answers

    The connector length of the EPstar Fix (Lumen) catheter must be 110±11mm.

    <p>True</p> Signup and view all the answers

    The EPstar Fix (Lumen) catheter is sterilized with ethylene oxide gas.

    <p>False</p> Signup and view all the answers

    The EPstar Fix (Lumen) catheter is also used for intracardiac ablation.

    <p>True</p> Signup and view all the answers

    All EPstar Fix products undergo final inspection in QC (Quality Control) and approved by the team.

    <p>True</p> Signup and view all the answers

    Study Notes

    Quality Control Procedures for EPstar Fix (Lumen) Catheter

    • Product Name: EPstar Fix (Lumen)
    • Product Category: Intermediate/Sterilization-Prior-Final-Function-Test
    • Department: Quality Control (Inspection Team)/Outsourcing/Koyama Factory
    • Document Number: EP-QC13-006
    • Revision Date: March 22, 2021

    Intermediate Inspection Procedures

    • Inspection Area: Catheter Tip, Catheter Shaft, Handle, Electrical, Tip Shape
    • Catheter Tip: Inspect for deformation, dirt, or foreign material. Microscope. 100% inspection. Check for dents, scratches, foreign objects, open gaps, slanted attachments, and resin buildup (0.3mm or less).
    • Catheter Shaft: Examine for smoothness, dents (0.2mm² max), cracks, and peeling. Magnifier lamp/microscope, up to 100% inspection. Check for surface smoothness, cracks, foreign substances, and flaws at the fusing area.
    • Handle Inspection: Assess for damage, imperfections, dirt and foreign material. Visual check (aided with magnifier/microscope if needed). Check for correct tube/mesruler alignment, correct gap measurement (within ±15° of downward arrow from female luer), and the absence of gaps in the handle.100% inspection.

    Electrical Test

    • Insulation Test: Minimum 30MΩ. Use a DIGITAL HITESTER or equivalent multimeter.
    • Resistance Test: Stable at ≤200 (±0.10). Use a DIGITAL HITESTER or equivalent multimeter.

    Tip Shape Inspection

    • Shape Conformity: Must conform to specified templates. Determine conformity visually to the template. 100% inspection.

    Additional Considerations for Specific Products

    • Shell inspection (Models F10286CSL-65HTUP, F10556CSL-65HTUP, F11556CSL-95HTUP): Remove shells and check for damage, cracks, deformation, debris and dirt.
    • Curve Pattern: Follow the specified curve templates for quality assurance. 100% inspection.

    LM BeeAT Final Inspection QC Flow Chart

    • Product Name: BeeAT with inner lumen
    • Department: Quality Control (Inspection Team)
    • Control Points: Catheter Tip, Lumen, Catheter Shaft, Handle, Connectors, Electrical, Tip Shape, Curves.
    • Testing Procedures: Detailed visual inspections and measurements are required for each component.
    • Measurements/Inspection Methods: Visual examination, magnifiers, pocket microscopes, digital multimeters and template comparisons. 100% inspection rate expected for every category.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    LM BeeAT Final Inspection QC Flow Chart QF-8260-LMB-001 Rev3

    Description

    This quiz focuses on the quality control procedures specific to the EPstar Fix (Lumen) catheter. It covers the intermediate inspection procedures, including detailed checks for the catheter tip, shaft, and handle. Understanding these protocols is essential for maintaining product standards and ensuring patient safety in medical devices.

    More Like This

    Use Quizgecko on...
    Browser
    Open
    Browser
    Browser