Standard Operating Procedure (SOP) for IVL™ Catheter Assembly
Document ID: MIN-0434-C-SOP
Product: IVL™ Catheter
Version: 1.0
Scope: This document provides standard operating procedures for assembling the 0.018” SLT IVUS Support Crossing Catheter used in intravascular lithotripsy (IVL) procedures.
1. Safety & Precautions
- Follow Electrostatic Discharge (ESD) protocols when handling transducer components (Ref: SOP-0299).
- Ensure all adhesives and solder materials are used in a well-ventilated area.
- Use UV protective eyewear when operating the UV curing system.
- Maintain a clean and controlled environment to prevent contamination.
2. Required Materials & Tools
| Component/Tool | Description |
|---|---|
| PRT-0427-026 | Teflon-coated stainless steel mandrel (0.0195") |
| MFG-1201 | Hakko FX-971 soldering system |
| PRT-0429-007 | Platinum-cured silicone tubing (0.040” x 0.065”) |
| CON-1218 | Water-soluble flux (1 gallon) |
| Asset#0374 | Dymax 4x light guide UV curing system |
| MFG-1318 | Transducer alignment tool (0.034” OD Octagon) |
| CON-0345 | Two-part adhesive mixer nozzle |
| MFG-0351 | Phillips screwdriver No.1 (6-3/4in Length) |
For a full list of tools and materials, refer to the Materials & Equipment document.
3. Assembly Steps
0434.1 Prepare the Guidewire Lumen
- Cut the guidewire lumen (118) to the required functional length (150cm).
- Inspect the lumen outer surface (218S) for defects or irregularities.
- Position the plasma generator (133) within the guidewire lumen.
- Secure the plasma generator (133) using medical-grade adhesive.
- Allow the adhesive to cure for 30 minutes at room temperature.
0434.2 Attach the Energy Guide
- Cut the energy guide (122A) to match the catheter length.
- Align the guide distal end (122D) adjacent to the outer surface (218S) of the guidewire lumen.
- Secure the energy guide using thermal welding or micro-adhesives.
- Ensure that the energy guide (122A) can transmit laser energy efficiently.
0434.3 Assemble the Catheter Body
- Insert the guidewire lumen and energy guide subassembly into the catheter body.
- Attach strain relief components to reduce mechanical stress.
- Secure the catheter with polymer bonding at key junctions.
0434.4 Energy Source Integration
- Connect the energy guide (122A) to the energy source (124).
- Ensure proper optical alignment for efficient energy transfer.
- Perform continuity and impedance tests to verify functionality.
0434.5 Quality Assurance & Testing
- Conduct pulse echo testing to validate signal transmission.
- Perform dimensional and visual inspection for defects.
- Verify electrical impedance compliance.
0434.6 Final Packaging & Sterilization
- Seal the catheter in medical-grade pouches.
- Sterilize using ethylene oxide (EtO) or gamma radiation.
- Label with lot number, expiration date, and compliance markings.
4. Inspection & Documentation
- Record UV intensity measurements daily.
- Document adhesive curing times and test results in production logs.
- Follow internal SOP guidelines for process control.
5. Training & Certification (Extended Version Only)
Each of the 6 steps above serves as an individual training certification module. Operators must demonstrate:
Training Criteria:
-
Basic Science & Context:
- Understanding of the fundamental principles behind catheter operation and IVL technology.
- Broader medical implications and purpose of the device.
-
Procedure Rationale:
- Why each step is performed in a specific way.
- How it contributes to overall product integrity.
-
Failure Analysis & Risk Awareness:
- Potential consequences of errors in assembly.
- Safety concerns and regulatory compliance risks.
Certification Process:
- Completion of theoretical training.
- Hands-on demonstration of each step.
- Evaluation by a senior technician or quality assurance lead.
This document serves as both the Standard Operating Procedure (SOP) Inventory and the Extended Training Preparation Guide. Let me know if additional modifications are required!
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