JLL BeeAT Final Inspection QC Flow Chart PDF

# BeeAT Final Inspection QC Flow Chart ## Brand Name: JLL ## Product: Internal atrial cardioversion catheter ## BeeAT | No | Process | Control Points | Location | Specification | Measuring tools etc | Inspection method | Test frequency | Time | Control | | |---|---|---|---|---|---|---|---|---|---...

# BeeAT Final Inspection QC Flow Chart ## Brand Name: JLL ## Product: Internal atrial cardioversion catheter ## BeeAT | No | Process | Control Points | Location | Specification | Measuring tools etc | Inspection method | Test frequency | Time | Control | | |---|---|---|---|---|---|---|---|---|---|---| | 1 | Final Inspection | Appearance | Tip electrode | - No burr, dent, scratch, stain / foreign material<br>- Catheter tube covering less than 0.3mm of tip electrode<br>- Gap between catheter shaft is less than 0.25mm | - Magnifying lamp<br>- Microscope | For normal work, use magnifying lamp. When required use microscope | Every unit | 100% | 100% | | | | | | Ring electrode | - No burr, dent, scratch, stain / foreign material<br>- No open gap (gap between shaft & ring electrode) | - Magnifying lamp<br>- Microscope | Use stand scope when required for 23 - For normal work, use magnifying lamp. When required use microscope | Every unit | 100% | 100% | | | | | | Catheter shaft Until 250mm from tip | - Surface must be smooth<br>- No dent, hole, crack which opens up when bent, peeling exceeding 0.2mm²<br>- No foreign material | - Magnifying lamp<br>- Microscope | For normal work, use magnifying lamp. When required use microscope | Every unit | 100% | 100% | | | | | | Catheter shaft After 250mm from tip | - No blade protruding from shaft<br>- No abnormality on the boundary with ring electrode<br>- Surface must be smooth<br>- No dent, hole, crack which opens up when bent, peeling exceeding 0.3mm²<br>- No foreign material<br>- No blade protruding from shaft | - Magnifying lamp<br>- Microscope<br>- Impurity reference chart | For normal work, use magnifying lamp. When required use microscope and impurity reference chart | Every unit | 100% | 100% | | | | | | Handle | - No scratch, crack, deformation, stain and foreign material<br>- Handle not wobbly/rattling<br>- Arrow on collet nut is within ±30°of inspection surface<br>- Red collet nut is on the right while the black collet nut is on the left<br>- Each collet nut is fixed properly and not loose | - Visual<br>- Handle jig<br>- Protractor | Place handle with tapping screw on the bottom | Every unit | 100% | 100% | | | | | Dimension | Effective length | Refer to Ap-QF-8260-001.04 | - Scale | Type A: Decide based on measurement using scale | Every unit | 100% | 100% | | | | | | Ring electrode gap length | Refer to Ap-QF-8260-001.04 | - Scale | Type A: Decide based on measurement using scale | Every unit | 100% | 100% | | | | | | Electrode group gap length | Refer to Ap-QF-8260-001.04 | - Scale | Decide based on measurement using scale - Refer WI for checking location - Refer Ap-QF-8260-BAT-001.02 for electrode location | Every unit | 100% | 100% | | | | | | Outer diameter | Able to pass through ring gauge (until tip of electrode #1 only) - Conducted by MFG. QC to review Manufacturing Records to confirm results only | Ring gauge (used by MFG) / Manufacturing Records | Check OK quantity as shown in Manufacturing Records | Every unit | 100% | 100% | | | | | | PVC tube length | 35±5mm | - Scale | Decide based on measurement using scale - Refer WI for measuring location | Every unit | 100% | 100% | | | 1 | Final Inspection | Bending test | Curve pattern | Must conform to designated curve template | - Curve template<br>- Sheath<br>- Handle jig (*For S20884-100M & S20848-100AOC, use knob jig for bending*) | Must conform to designated curve template when operated | Every unit | 100% | 100% | | | | | | Maximum curve length | Must conform to designated curve template<br>- Knob must have effect within 3 gradations (excluding ST model) | - Curve template<br>- Sheath<br>- Handle jig (*For S20884-100M & S20848-100AOC, use knob jig for bending*) | Type A: Check distance between tip electrode and shaft by using template | Every unit | 100% | 100% | | | | | | Curve flatness | Within 8mm | - Curve template<br>- Sheath<br>- Handle jig (*For S20884-100M & S20848-100AOC, use knob jig for bending*) | Type E: Decide based on measurement using scale - Check when shaft between ring 8-9 (inner side) is aligned with ring 6 or 7 (inner side) from top view | Every unit | 100% | 100% | | | | | | Axis shifted | Within 8mm<br>- Within 10mm (Tapping screw on handle facing upwards) | - Curve template<br>- Sheath<br>- Handle jig (*For S20884-100M & S20848-100AOC, use knob jig for bending*) | Type A: Decide based on measurement using scale - Measure vertically the highest point of the curve and the tip | Every unit | 100% | 100% | | | | | | Knob operability | Smooth movement, no stuck etc | - Touch<br>- Sheath | Type A: Operate knob | Every unit | 100% | 100% | | | | | | Appearance | No broken part at shaft, crumples, fold and peeling. Surface must be smooth | - Visual<br>- Sheath | Check shaft appearance | Every unit | 100% | 100% | | | | | | Knob return | Turn knob to maximum then release hand. Ensure tip does not move. | - Visual | Check if knob returns when hand is released at maximum knob turn | Every unit | 100% | 100% | | | | | Electrical Test | Insulation test | O.L. is displayed | - Digital Multimeter<br>- Electrical test jig for EP (26electrode)<br>- Flat probe (big) | Decide based on measurement using Digital Multimeter - Measurement is done during normal condition and at maximum curve | | | | | Resistance test | CCSS-use: stable at ≤170 (±0.10)<br>- AGCU-use: stable at <7Ω (±0.10) | - Digital Multimeter | Decide based on measurement using Digital Multimeter - Measurement is done during normal condition and at maximum curve | Every unit | 100% | 100% | | | | | | Circuit conduction test | No disconnection (<1ΜΩ) - for model with circuit | | Decide based on result done using push-button jig and measurement using Digital Multimeter | Every unit | 100% | 10% | | | | | | Appearance | No curve abnormality after electrical test (at maximum curve) | - Visual | | Every unit | 100% | 100% | | # Revision History | Rev | Effective Date | Description of change | Revised By | Approved By | |---|---|---|---|---| | 0 | 05.12.2019 | Newly Establish | Ayuni | Masujima | | 1 | 12.06.2020 | Typing error on specifications for collet nut position | Ayuni | Masujima | | 2 | 04.08.2020 | - Location Quality Characteristics: Outer diameter<br>- Specification: Change from (until electrode #20) to (until tip of electrode #1 only)<br>- Inspection method: "sheath gauge" to "ring gauge" | Ayuni | Masujima | | 3 | 02.09.2020 | Due to risk of peeling &increased rework activity, outer diameter will be checked by Manufacturing. In Final Inspection, QC will review Manufacturing Records to confirm results only. | Ayuni | Masujima | | 4 | 15.03.2022 | 1) Changed the Doc ID to F-8260-BAT-01<br>2) Changed appearance WI to WI-8260-COM-001<br>3) Changed electrical test WI to WI-8260-COM-002<br>4) Added exclusion of ST model in maximum curve<br>5) Added remark, "*For S20884-100M & S20848-100AOC, use knob jig for bending" in tools<br>6) Added specification "<1ΜΩ"<br>7) Added "Measurement is done during normal condition and at maximum curve"<br>8) Described judgment method based on measurement of Digital Multimeter | Ayuni | NA | | 5 | 02.01.2024 | Resistance Test: Add specification for AGCU model.<br>- Add "BeeAT" on the header title | Syamimi | Kashiwakura | | 6 | 25.04.2024 | i) Add Malay Translation<br>ii) Add word BeeAT infront of title | Syamimi | Wataru Niiya |