LCF Final Inspection Assessment

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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 (A)

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?

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

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

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

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

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

Which statement is false for Appearance Inspection - Handle?

<p>The connector and tube are fixed properly with a gap (C)</p> Signup and view all the answers

What is the frequency to check LCF units at QC Final Inspection?

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

Flashcards

EP Electrode Catheter

A type of medical device used to conduct electrical signals within the heart for diagnosis and treatment.

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

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

A measurement used to assess the resistance of a material to the flow of electricity. It is an important parameter for electronic devices as it determines the amount of current that can flow through the device.

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Resistance

A measure of the opposition to the flow of electric current through a conductor. It determines how much current will flow for a given voltage.

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Load Test

A test conducted to evaluate the ability of a product to withstand mechanical stress such as bending, flexing, or twisting. It is important for products that need to be durable and withstand potential damage.

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Resistance Test

A test used to measure the electrical resistance of a device or material, typically using a device called a Digital Hitester or a Digital Multimeter.

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Circuit Conduction Test

A test to ensure that the electrical circuit of a device is complete and functioning correctly. It typically involves applying a signal to the circuit and measuring the response.

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Inspection Record

A document that details the procedures and criteria used to carry out an inspection of a product.

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Curve Template

A visual guide used to ensure the accurate shape of a product.

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Visual Inspection

A method used to visually examine a product to identify any defects or inconsistencies. It is often conducted using a magnifying glass or microscope to enhance visibility.

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Appearance Inspection

A type of inspection that focuses on assessing the physical appearance and characteristics of a product, such as the presence of scratches, dirt, or other defects.

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Dimension Inspection

A type of inspection that involves examining the dimensions of a product to ensure they meet the specified requirements.

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Electrical Test

A type of inspection that focuses on evaluating the performance of a product's electrical components and systems to ensure they meet safety and functional specifications.

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Standard Operating Procedure (SOP)

A document that outlines the steps and procedures involved in performing a specific task.

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Revision History

A record of the changes made to a document, including the date of the change, the description of the change, and the person responsible for making the change.

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Process Inspection

An inspection conducted on a specific part or assembly of a product during the manufacturing process.

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Final Inspection

An inspection that verifies the product meets specified quality standards at the end of the manufacturing process.

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Catheter Tip

The small, pointed end of a catheter used for delivering medication, conducting electrical signals, or other medical procedures.

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Ring Electrode

A conductive ring located on the catheter shaft that contacts the heart tissue to facilitate the conduction of electrical signals.

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Catheter Shaft

The main body of the catheter that connects the tip and handle. It ensures a smooth passage of electrical signals and provides flexibility to navigate the heart.

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Handle

The part of the catheter that the user holds, containing the connectors for various electrical and bio-fluid inputs/outputs. This handles are designed for easy grip and safe usage.

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Female Luer

A specialized connection point resembling a syringe needle, allowing for the attachment of syringes or other medical devices.

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Connector Arrow

A feature found on the handle of the catheter indicating the direction of the electrical signal flow. This helps in correctly positioning the catheter in the heart.

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UV Adhesive Application Area

The area on a catheter where UV-cured adhesive is used to seal and secure critical components, preventing potential leaks or misalignment.

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Air Leak Test

A test conducted to assess the ability of a product to withstand air leaks. This is crucial for medical devices that require airtight sealing to maintain sterility.

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Curve Template

A visual guide used to confirm the proper shape and curvature of the catheter, especially for devices used in complex anatomical procedures.

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Circuit Conduction Test

An examination conducted to ensure the proper positioning and function of the electrical components and conductors within the catheter. It verifies no interruptions or defects in electrical signal transmission.

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Appearance Inspection

An evaluation of the overall physical integrity of the catheter, including the catheter shaft, handle, connectors, and tip. It checks for visible defects, damage, contamination, and other abnormalities.

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Resistance Test

A test performed to measure the resistance of the catheter's electrical components to the flow of electricity. This ensures proper electrical conductivity and minimizes any potential hazards.

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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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