Proceduras de Controlo de Qualidade per Catéter EP
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Questions and Answers

Quale de le subsequente affirmationes es correcte pro le inspectione de le tip katheter?

  • Debet haber superficies rugose.
  • Deve esser in forma cambiate.
  • Es acceptabile con calcas visibiles.
  • Non debe haber contaminantes. (correct)

    • Qual es le requisition pro le ring elektrod in le inspectione?

  • Debet haber significationes ben definite.
  • Oportet que il non habe gaps apertos. (correct)
  • Debet esser acoperite per mais de 0.5mm de resin.
  • Non debe esser con moratos.

    • Quotidie debera se utilizar un mikroskop pro le inspectione del shaft katheter?

  • Solmente in le inspectiones periodicas.
  • Probabilmente a omne tempore. (correct)
  • Unicamente in casus de problemas.
  • Non es necessario usarlo al omne.

    • Quale conditiones es acceptabile pro le shaft katheter?

    <p>Nulle deformitates visible.</p> Signup and view all the answers

    Quale de le sequente metodos non es specificate pro le inspectione del ring elektrod?

    <p>Inspectione con una lampada de UV.</p> Signup and view all the answers

    Qual es le metodo de inspection pro le punto de control 'Catheter tip'?

    <p>Microscope</p> Signup and view all the answers

    Quo que le teste de insulazione debe registrar pro le 'Electrical test'?

    <p>≥ 30ΜΩ</p> Signup and view all the answers

    Qual es le principal criterio pro le esquema del 'Tip shape'?

    <p>Conformar al template especificate</p> Signup and view all the answers

    Quo que significa 'No gap in handle' in le inspection del 'Handle'?

    <p>Non debe haber lacunas in le connectiones</p> Signup and view all the answers

    Quo que le 'Resistance Test' requiere pro un mesura stabil?

    <p>≤ 200 (±0.10)</p> Signup and view all the answers

    Quo que constitue le criterii pro le 'Ring electrode'?

    <p>No dent, scratches, e gap aperte</p> Signup and view all the answers

    Quando debe le inspection del 'Catheter shaft' occurre?

    <p>In un base normal durante le assecuration</p> Signup and view all the answers

    Qual es le frequenza de inspection pro le 'Mid-inspection'?

    <p>Cada vice</p> Signup and view all the answers

    Quale de iste affirmativas es ver? (Select all that apply)

    <p>Le tubo debe esser apte al holder senza partes loose.</p> Signup and view all the answers

    Quante de le criteria es requirite pro un test de insulation?

    <p>≥ 30ΜΩ</p> Signup and view all the answers

    Qual methodo es recommendate pro examinar le superficie de le L Shell?

    <p>Semper examinara con le oculos simples.</p> Signup and view all the answers

    Quid debe esser verificate quando se examina le forme del tubo?

    <p>Le tubo debe conformar al template curve designato.</p> Signup and view all the answers

    Quanti criterii debent esser presentate pro un approbation de dimension?

    <p>Le forma debe esser conforme al shape template.</p> Signup and view all the answers

    Qual es un resultat acceptable pro le teste de resistentia?

    <p>≤ 200 (±0.10)</p> Signup and view all the answers

    Quo significa 'Ningun gap visible' in le inspectione?

    <p>Le gap debe esser completamente assente.</p> Signup and view all the answers

    Quid debe esser regularment verificate in relaction al holder?

    <p>Le tubi debe esser assecurate sin partes looses.</p> Signup and view all the answers

    Qual es le metodo de inspection pro verificar le forma del punta del cathetere?

    <p>Conferir con un template</p> Signup and view all the answers

    Qual es le requirimento pro le test de insulation?

    <p>Equal o plus que 30ΜΩ</p> Signup and view all the answers

    Que inspecta durante le prova de resistencia?

    <p>Quod debe exhiber un valor stabile de 200 o minus</p> Signup and view all the answers

    Qual es le frequenza de inspection pro le cathetere?

    <p>100% de le probas</p> Signup and view all the answers

    Quales defectos debe esser verificato pro le segmento del cathetere?

    <p>Null de fissuras, scratches, o contamination</p> Signup and view all the answers

    Que equipamento es usate pro examinar le anello electrode?

    <p>Microscopio</p> Signup and view all the answers

    Quales standard debe esser observate pro le cathetere shaft?

    <p>Non debe haber fissuras super 0.2mm²</p> Signup and view all the answers

    Qual es le inspection methodus utilizzate pro le controle visual del manico?

    <p>Inspection con augmentation e microscopes</p> Signup and view all the answers

    Que deve esser observate ante le esse del electrical testing?

    <p>Le flexiones previ in le punta</p> Signup and view all the answers

    Qual es le classification pro le inspection final del cathetere?

    <p>QC Final Inspection</p> Signup and view all the answers

    Study Notes

    Quality Control Procedures for EP Electrode Catheter

    • Product: EPstar Fix (Lumen)
    • Category: Intermediate/Sterilization-pre final function inspection
    • Department: Quality Control (Inspection Team)/Outsourcing/小山ファクトリー
    • Document Number: EP-QC13-006
    • Effective Date: 2021-03-22

    Inspection Procedures

    • Intermediate Inspection: Examination of various components of the catheter.
      • Appearance (Catheter Tip): Inspection for deformation, stains, and foreign matter using a microscope. 100% inspection.
      • Ring Electrode: Examination for dents, scratches, and foreign objects, open gaps, proper slant, and resin covering (under 0.3mm). All aspects should conform to specifications. 100% inspection.
      • Catheter Shaft: Assessment of surface smoothness, absence of dents, holes, cracks, and peeling. Surface characteristics are specified. The fusion area must have controlled heat application and no bubbles or constrictions. 100% inspection using magnifying lens, or microscope or hand scope as needed.
      • Handle: Assessment for scratches, bumps, stains, and foreign matter. Checks the fixations of attached tubes, gaps between surfaces, luer valve alignment, and the connector. 100% inspection.
      • Electrical Test: Includes insulation testing requiring a resistance of at least 30ΜΩ and resistance testing (stability under ≤200 with ±0.10 tolerance).
      • Tip Shape: Confirmation that the tip shape matches the specified template.
      • Shell: For specific models (F10286CSL-65HTUP, F10556CSL-65HTUP, F11556CSL-95HTUP), shell removal and evaluation needed for scratches, cracks, deformation, stains, and foreign material.

    Additional Details

    • Measurements: Different types of instruments for different stages of the inspection are mentioned (microscope, magnifying lens, Digital HITESTER etc.)
    • Frequency: Inspections are performed each time (or "repeatedly") and consistently.
    • Record Keeping: Procedures and results should be documented, though not detailed in these notes.
    • Related Documents: Reference to work instructions (WI) further detailing the procedures.

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    Related Documents

    LCF Final Inspection QC Flow Chart PDF

    Description

    Este quiz examina as proceduras de controle de qualidade para o catéter EPstar Fix. Inclui inspeções intermediárias detalhadas dos componentes do catéter, incluindo avaliação da aparência e características do material. Aprenda sobre os critérios de conformidade e inspeção completa exigida.

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