Quality Control Procedure for EPstar Fix Catheter

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Questions and Answers

What is the main method of inspection for the appearance of the electrode ring?

Visual inspection under natural light

Magnifying glass inspection

Thermal imaging inspection

Microscope inspection (correct)

Which of the following specifications is NOT listed for the shaft of the catheter?

No peeling less than 0.2mm²

No cracks that are open

Presence of holes (correct)

Smooth surface

How frequently is the inspection for the appearance of the catheter tip performed?

Once per batch

Every time (correct)

Once a day

Every 10 minutes

What is the maximum allowed gap for the electrode ring to not be considered defective?

0.3mm Signup and view all the answers

Which tool is suggested as the primary choice for inspecting the surface of the catheter shaft?

Magnifying glass Signup and view all the answers

What is the maximum acceptable deduction for the appearance of the catheter tip during mid-inspection?

100% Signup and view all the answers

Which tool is NOT used for inspecting the catheter shaft?

Digital caliper Signup and view all the answers

What is the minimum acceptable insulation resistance for the electrical test?

≥ 30ΜΩ Signup and view all the answers

How often should the inspections for the described processes be conducted?

Each time Signup and view all the answers

What is one of the criteria for the ring electrode during inspection?

No open gap Signup and view all the answers

Which inspection method is used for ensuring proper connection of the handle?

Visual assessment Signup and view all the answers

What adjustment is permissible for the alignment of the luer valve when turned 90°?

±15° Signup and view all the answers

What tool is used to verify the shape of the catheter tip during inspection?

Curve template Signup and view all the answers

What is the required insulation resistance in the electrical testing?

≥ 30ΜΩ Signup and view all the answers

What method should be primarily used for inspections?

Naked eye Signup and view all the answers

Which of the following is NOT a requirement for tube connections?

Tube must be loosely attached Signup and view all the answers

What should be checked for the L Shell surface inspection?

Both A and C Signup and view all the answers

What is the maximum allowable resistance during the stability test?

≤ 200 (±0.10) Signup and view all the answers

What shape does the tip need to comply with?

Designated template shape Signup and view all the answers

Which equipment is appropriate for performing the insulation resistance test?

DIGITAL HITESTER or DMM Signup and view all the answers

What must be confirmed regarding the connector arrow when turned down to 0°?

Alignment must be within ±15° Signup and view all the answers

What is the correct method used for inspecting the appearance of the catheter tip?

Microscope inspection is required Signup and view all the answers

Which of the following is NOT a quality characteristic for the catheter shaft?

Thickness of insulation Signup and view all the answers

What is the required shape for the catheter's tip as per inspection processes?

Should match the specified curve template Signup and view all the answers

During the electrical testing, what is the minimum insulation resistance that must be achieved?

30 ΜΩ Signup and view all the answers

Which of the following features must NOT be present on the handle of the catheter?

Visible gaps or spaces Signup and view all the answers

What should be confirmed about the ring electrode during inspection?

It should have no dings or scratches Signup and view all the answers

What type of tools are primarily used for the inspection of cracks and surface on the catheter shaft?

Magnifying glass and microscope as needed Signup and view all the answers

During final inspection, how should the appearance of the shell be checked?

Visually, with close examination Signup and view all the answers

How frequently should the testing of insulation resistance be conducted during inspection?

Every time inspections are performed Signup and view all the answers

What quality criteria must be checked for the handle part of the catheter?

All tubes must be securely fixed to the handle Signup and view all the answers

Study Notes

Quality Control Procedure for EP Electrode Catheter (EPstar Fix)

Product: EPstar Fix (Lumen) electrode catheter
Category: Intermediate/Sterilization Pre-Final Functionality Inspection
Department: Quality Control (Inspection Team)/ Outsourcing/小山 Factory
Document Number: EP-QC13-006
Revision Date: 2021-03-22

Inspection Steps

Mid-inspection: Involves checking the catheter tip for deformation, dirt, and foreign material.
Ring Electrode: 100% inspection; checks for dents, scratches, foreign objects, open gaps, slanting, and resin covering (≤0.3mm)
Catheter Shaft: 100% inspection including smoothness, dents, holes, cracks, and peeling (≤0.2mm²) for scratches and foreign objects. Also examines fusion (welding) areas for heat irregularities, bubbles, or constrictions.
Handle: 100% inspection for scratches, bumps, dirt, foreign objects, tube tightness, lumen tube and luer fitting gaps, connector and tube tightness, luer connector 90° turn and single lumen integrity, connector arrow angle (±15°), and handle gaps.
Electrical Test:
- Includes insulation testing (≥30ΜΩ)
- Resistance testing (≤200 with ±0.10 tolerance)
Tip Shape: Ensuring the tip conforms to the specified template.
Shell Inspection (Specific Models): Removing the shell to check for scratches, cracks, deformations, and foreign particles.

Measuring Tools & Methods

Visual Inspection: Used for many steps, sometimes with magnification (microscope or magnifying lens).
Microscope: Used to inspect the catheters for minute details.
Magnifying lens/Hand scope: Used in conjunction with naked eyes or microscopes where necessary.
DIGITAL HITESTER (Digital multimeter): Used for electrical tests.
EP Electrical Test Jig: Used for specific electrical testing procedures.

Additional Notes

Specific model names (F10286CSL-65HTUP, F10556CSL-65HTUP, F11556CSL-95HTUP) are addressed only in the shell inspection.
Examination and bending tests are performed on the electrode prior to testing.
A curve template is used to verify tip shape.

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Description

This quiz covers the quality control procedures for the EPstar Fix electrode catheter, focusing on mid-inspection and various inspection steps for the catheter tip, ring electrode, catheter shaft, and handle. Participants will learn about the critical points of inspection necessary to ensure product integrity and functionality.