Assessment LCF Q1 2025

• LCF Training Handbook for QC Leaders, Rev 1
• Prepared by Zalikha Syamimi
• Last updated on 18/2/2025.

Training Preparation

• Prepare necessary documents and tools for training.
• The operator should have a notebook and pen
• Pause periodically during training to ensure understanding.
• Allow time for the operator to ask questions in English.
• Ask the operator to repeat instructions to gauge understanding.
• Ensure documents and tools are stored properly after the session.

LCF Basics

• Name: EPStar Fix CS Lumen.
• LCF improves heart rhythm in patients with arrhythmias, similar to the BeeAT technique, but with a more precise and smaller tool.
• It can be used with smaller medical devices like the 2Frame and is inserted via a green lumen tube.
• LCF enables targeted treatment for heart rhythm disturbances without invasive procedures or large equipment.

LCF Part Names

• Catheter Tip.
• Ring Electrodes (10rings / 11rings).
• Braid Shaft.
• Heat Shrink tube (Sumi Tube).
• Handle.
• Single Lumen Tube.
• Connector (Red fix -10 pins / Black fix - 11pins).
• Female Luer.
• Green Lumen Tube.

LCF Models

• F11556CSL-95HT, F10556CSL-65HT, F10286CSL-65HT.
• Available as UP models
  • F11556CSL-95HT (UP)
  • F10556CSL-65HT (UP)
  • F10286CSL-65HT (UP)
• Differences between LCF models include the number of rings:
  • F11556CSL-95HT has 11 rings
  • F10556CSL-65HT has 10 rings

Quality Control

• The UP Model connector has a gap and might not be properly fixed
• JLL opens and inspects the connector shell upon arrival, an extra process not done in Malaysia.

Final Inspection Process

• The final inspection ensures the device meets safety, functionality, and effectiveness standards before patient use.
• Inspection focuses on Electrical components, Appearance, and Tip Shape.

Electrical Testing

• If readings are too high and fluctuating, it indicates the device is not stable; resistance should be ≤20 Ω ± 0.1. Flag for inspection if higher.
• Resistance Out of Spec if either lower or higher than the previous reading (< > 0.2 Ω).
• If the reading is less than 600.0ΜΩ: If found Leak Issue, Immediately pink tag the unit.
• No reading or light detected indicates Disconnection
• Inform a leader/supervisor if any of the above situations occur.

Electrical Test: Jig Usage

• The jig holds components in place during electrical tests.
• It ensures alignment and consistency during testing.
• The jig must be securely attached and used correctly.

Electrical Test: Calibration Methodology

• It is important to calibrate the test jig before the electrical test
• Check jig calibration, refer to WI-6300-COM-020 Rev1 for Electrical Test Jig Check.
• For the Calibration Steps the electrical tester connects to the jig as per the manual
• Resistance readings should be within the acceptable range.
• If readings deviate from the range, recalibrate the jig or replace parts.
• After completing the test: Recheck the Calibration to ensure results are within calibration limits.
• Perform a Final Calibration Check to ensure no shift in calibration during testing.
• Ensure the equipment is ready for the next use.

Electrical Test Procedure

• Set up equipment for the electrical test.
• Be sure to perform the the calibration before starting the electrical test
• Ensure the DMM knob is at the Ohm (Ω) symbol.
• Connect the connector until it "clicks".
• Ensure the arrow is parallel with the jig connector.
• During the sequence check test, the light should match the ring being touched.
• Make sure the entire ring is inside the test probe during the electrical test.
• Also make sure that the test probe is "locked ensure compliance.

Appearance Inspection Guidelines

• Specifications for the chosen LCF model and the quality control flow chart (QF-8260-LCF-001) should be readily available.
• Demonstrate the right method for performing visual inspection.
• Educate on how to properly use tools such as the hand scope, magnifier lens, Hirox, and size card.
• Images should be provided when available or reference the judgement list by Minakawa-san.
• Pink Tag list, Judgement File, Quality Alert and Leaders Handbook documents are all useful to ensure the test is correctly performed
• Demonstrate how to correctly complete/fill out the memo.

Appearance inspection: How to Test

• Check the shaft and handle carefully.
• Check the female luer part for defects.
• The sumi tube must have enough adhesive.
• Use a magnifying lens to inspect the female luer, handle, and shaft. Use a hand scope if needed.
• Examine the ring part and tip using a microscope.

Tip Shape Guidelines

• Use the correct template for the LCF tip.
• Tell the implications if a mistake occurs using the wrong template.
• Make sure the entire dark green area is in the template Area.