Podcast
Questions and Answers
What are the two main types of electrical tests conducted on the EPstar Fix (Lumen) catheter?
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.
The catheter tip should have no burrs at the tip or in the lumen, according to the QC checklist.
True (A)
What is the maximum acceptable size of a dent on the catheter shaft?
What is the maximum acceptable size of a dent on the catheter shaft?
- 0.2mm² (correct)
- 0.5mm²
- 1.5mm²
- 1.0mm²
The catheter tip should have no burrs exceeding 0.5 mm at the backend of the tip induction heating part?
The catheter tip should have no burrs exceeding 0.5 mm at the backend of the tip induction heating part?
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.
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.
The tip of the EPstar Fix (Lumen) catheter must conform to a given curvature template.
The tip of the EPstar Fix (Lumen) catheter must conform to a given curvature template.
The EPstar Fix (Lumen) catheter is also used for intracardiac ablation.
The EPstar Fix (Lumen) catheter is also used for intracardiac ablation.
All EPstar Fix products undergo final inspection in QC (Quality Control) and approved by the team.
All EPstar Fix products undergo final inspection in QC (Quality Control) and approved by the team.
Which statement is false for Appearance Inspection - Handle?
Which statement is false for Appearance Inspection - Handle?
What is the frequency to check LCF units at QC Final Inspection?
What is the frequency to check LCF units at QC Final Inspection?
Flashcards
EP Electrode Catheter
EP Electrode Catheter
A type of medical device used to conduct electrical signals within the heart for diagnosis and treatment.
Intermediate Inspection
Intermediate Inspection
The initial inspection of a product during manufacturing to identify any defects or inconsistencies. This is a critical step to ensure product quality.
Final Inspection
Final Inspection
The final inspection of a product before it is released for sale or use. This involves a thorough examination of all aspects of the product to confirm it meets all quality requirements.
Insulation Resistance
Insulation Resistance
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Resistance
Resistance
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Load Test
Load Test
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Resistance Test
Resistance Test
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Circuit Conduction Test
Circuit Conduction Test
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Inspection Record
Inspection Record
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Curve Template
Curve Template
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Visual Inspection
Visual Inspection
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Appearance Inspection
Appearance Inspection
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Dimension Inspection
Dimension Inspection
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Electrical Test
Electrical Test
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Standard Operating Procedure (SOP)
Standard Operating Procedure (SOP)
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Revision History
Revision History
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Process Inspection
Process Inspection
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Final Inspection
Final Inspection
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Catheter Tip
Catheter Tip
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Ring Electrode
Ring Electrode
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Catheter Shaft
Catheter Shaft
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Handle
Handle
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Female Luer
Female Luer
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Connector Arrow
Connector Arrow
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UV Adhesive Application Area
UV Adhesive Application Area
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Air Leak Test
Air Leak Test
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Curve Template
Curve Template
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Circuit Conduction Test
Circuit Conduction Test
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Appearance Inspection
Appearance Inspection
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Resistance Test
Resistance Test
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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.
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