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Formlabs BioMed Flex 80A Resin - User Manual

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MANUFACTURING GUIDE
Prepared: 08/30/2023 PRNT-0111 Rev 00
BioMed Flex 80A Resin
EN Instructions for Use GA Treoracha Úsáide
DE Gebrauchsanweisung RO Instrucțiuni de utilizare
FR Mode d’emploi HR Upute za upotrebu
IT Istruzioni per l’uso MT Istruzzjonijiet għall-Użu
ES Instrucciones de uso LV Lietošanas instrukcija
PT Instruções de uso LT Naudojimo instrukcijos
NL Gebruiksaanwijzing ET Kasutamise juhised
DA Brugsanvisning SK Návod na pouitie
SV Bruksanvisning SL Navodila za uporabo
FI Käyttöohjeet PL Instrukcja użytkowania
CS Návod k použití BG Инструкции за употреба
HU Használati útmutató JP
使用説明書
GR Οδηγίες χρήσης ZH
使用说明
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Overview

The BioMed Flex 80A Resin is a USP Class VI certified, light-curable polymer-based material designed for additive manufacturing of medical-grade, biocompatible, flexible parts. It is suitable for long-term skin contact (more than 30 days) and short-term mucosal membrane contact (less than 24 hours). Users should independently verify the suitability of printed materials for their specific application and intended purpose. This Manufacturing Guide provides equipment, printing, and post-processing recommendations and requirements to ensure correct and safe usage.

Important Technical Specifications:

The BioMed Flex 80A Resin specifications have been validated using the following hardware and parameters:

  • Formlabs 3D Printers: Form 3B/3B+, Form 3BL
  • Print Accessories: Formlabs Build Platform, Formlabs Stainless Steel Build Platform, Formlabs Build Platform 2, Formlabs Build Platform 2L, Formlabs Tanks
  • Software: Formlabs PreForm
  • Layer Thickness:
    • Form 3B/3B(+): 100 µm & 50 µm
    • Form 3BL: 100 µm
  • Recommended Post-Processing Equipment:
    • Formlabs Validated Wash Unit: Form Wash, Form Wash L
    • Formlabs Validated Cure Unit: Form Cure, Form Cure L

Usage Features:

The usage of BioMed Flex 80A Resin involves several key steps:

A. Printing:

  1. Shake cartridge: Before every print job, shake the resin cartridge to prevent color deviations and print failures.
  2. Set up: Insert the resin cartridge into a compatible Formlabs 3D printer.
  3. Printing process:
    • Prepare the print job using PreForm software, importing the desired part's STL file.
    • Orient the part and generate supports as needed.
    • Send the print job to the printer.
    • Optionally, if starting with an empty resin tank, manually pre-fill the tank by pouring resin directly from the cartridge to save time.
    • Initiate the print by selecting the job from the print menu and following on-screen prompts. The printer will automatically complete the print.

B. Part Removal:

  1. Remove the build platform from the printer.
  2. To detach parts from the build platform, wedge the part removal tool under the printed part's raft and rotate the tool. Detailed techniques are available on support.formlabs.com.

C. Washing:

  1. Place the printed parts in a Formlabs-validated wash unit (Form Wash or Form Wash L) with 99% Isopropyl Alcohol (IPA).
  2. Wash for 20 minutes in the unit.
  3. After washing, either rinse parts completely with fresh IPA from a spray bottle or soak them in fresh IPA for 10 minutes.
  4. If parts do not appear clean, consider replacing the used IPA with fresh solvent.

D. Drying:

  1. Remove parts from IPA and air dry at room temperature for at least 30 minutes. An additional hour of drying may improve surface feel. Drying times can vary based on part design and ambient conditions; avoid leaving parts in IPA longer than necessary.
  2. Inspect parts to ensure they are clean and dry, free of residual solvent, excess liquid resin, or residue particles before proceeding.
  3. If residual solvent or resin is still visible, dry parts longer or rewash until clean and dry.

E. Post-Curing:

  1. Place the printed parts in a Formlabs-validated post-curing unit (Form Cure or Form Cure L).
  2. Submerge parts in a transparent, water-filled container.
  3. Place the container inside the cure unit and cure for 30 minutes at 70 °C.
  4. Allow the cure unit to cool to room temperature between cure cycles.

F. Support Removal & Polishing:

  1. Remove supports using cutting pliers or other appropriate finishing tools as needed.
  2. Inspect parts for cracks; discard if any damage or cracks are detected.

G. Cleaning & Disinfection:

  1. Parts can be cleaned, disinfected, and/or sterilized according to facility protocols. A tested disinfection method involves soaking the finished part in fresh 70% IPA for 5 minutes. The manufacturer is responsible for validating part performance post-cleaning/disinfection/sterilization. Note: If alcohol-based disinfectants are used, do not leave parts in alcohol solution for an extended time.
  2. After cleaning/disinfection/sterilization, inspect parts for damage or cracks to ensure integrity meets performance requirements. Discard if damage or cracks are detected.

H. Hazards, Storage & Disposal:

  1. Cured resin is non-hazardous and can be disposed of as regular waste.
  2. Refer to the Safety Data Sheet (SDS) on support.formlabs.com for more information.

Formlabs BioMed Flex 80A Resin Specifications

General IconGeneral
BrandFormlabs
ModelBioMed Flex 80A Resin
CategoryLaboratory Equipment
LanguageEnglish