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Inspect Models Before Delivery[edit | edit source]

Please pay attention to and follow all the instructions closely to ensure the bone models are printed properly and display the required visual, tactile, and acoustic fidelity for orthopedic surgical simulation training.
Use brand new white PLA filament fresh out of the sealed package to 3D print the models to optimize print quality and minimize the risk of mechanical failure during orthopedic surgical simulation training.[1]
(Optional) Please try to obtain PLA filament with a Technical Data Sheet with a Shore Hardness D value between 79D to 93D. Remember to file this Technical Data Sheet in your production and inspection records, and email this Technical Data Sheet to the consignee.
Check the 3D printer control screen to confirm the print speed is set at the manufacturer's default value of 100%.
  1. Review the quality assurance checklist to verify that each model was properly printed prior to delivery and click on the checkboxes to check the most appropriate response.
  2. Any model that does not meet the standard for all the quality assurance checklist items will be rejected and must be reprinted in accordance with the instructions below.
  3. Print the quality assurance checklist below for each shipment of 3D printed models by clicking on the "Download PDF" button in the upper righthand corner of this screen and selecting "Layout: Landscape" option for printing.
  4. Any model that does not meet the standard for all the quality assurance checklist items must be rejected and will not be delivered to the consignee.
  5. Write the model production period, total number of Adult Male Tibial Bone Models #1 and #2 accepted, date of inspection, print and sign your name, and fill in the name and address of the consignee at the bottom of the checklist.
  6. Attach the completed and signed checklist to the delivery invoice for the consignee.
  7. File and save a back-up copy of the completed and signed checklist for your production and inspection and distribution records.
Quality Assurance Checklist for Adult Male Tibial Bone Models #1 and #2
# Action Meets Standard Does Not Meet Standard Does Not Meet Standard Check most appropriate response Check most appropriate response
1 Inspect the base.
The base of each model should be smooth, clean, and display three semi-engraved model numbers, a gender symbol, and two drilling direction arrows to assist with model identification and proper orientation of the simulator.
If the semi-engraved features are not visible, the model should be reprinted with the proper settings with no raft (click here to view reference screenshot) and no support material (click here to view reference screenshot). If the base is not smooth or clean (click here to view closeup photo), clean the build plate before reprinting. For build plates that require glue for adhesion of the printed object, apply a thin, smooth, and even layer of glue to the cleaned build plate.
If the base is open, the model should be reprinted with the proper settings of Bottom Layers: set to default value and not set to "0" (click here to view reference screenshot).

Model #1 Meets Standard

Model #1 Does Not Meet Standard

Model #2 Meets Standard

Model #2 Does Not Meet Standard

2 Inspect the top.
The top of each model should display the outer cortex and inner cancellous bone porosity and microstructure because these features provide visual fidelity to the surgical simulator.
If the inner cancellous bone features are not visible, the model should be reprinted with the proper settings of Top Layers set to "0" (click here to view reference screenshot).
If there is no inner cancellous bone, the model should be reprinted with the proper Infill Density of "15%" (click here to view reference screenshott).

Model #1 Meets Standard

Model #1 Does Not Meet Standard

Model #2 Meets Standard

Model #2 Does Not Meet Standard

3 Inspect sides.
The surface of the bone model should be smooth to provide visual and tactile fidelity of the surgical simulator.
If the bone model surface is uneven or missing material, the model should be reprinted (i) using brand new white PLA filament fresh out of the sealed package, and (ii) with the proper settings including changing print speed back to default values for the Generic PLA filament profile and reducing the layer height to 0.2 mm or less.
If the bone model surface is uneven or missing material, the model should be reprinted (i) using brand new white PLA filament fresh out of the sealed package, and (ii) with the proper settings including changing print speed back to default values for the Generic PLA filament profile and reducing the layer height to 0.2 mm or less.

Model #1 Meets Standard

Model #1 Does Not Meet Standard

Model #2 Meets Standard

Model #2 Does Not Meet Standard

4 Inspect the vise attachment.
The entire surface of the vise attachment should be smooth with no missing material and the angled surface of the vise attachment should have no filament drooping.
If the angled surface of the vise attachment is uneven or has drooping filament (click here to view closeup photo), the model should be reprinted (i) using brand new white PLA filament fresh out of the sealed package, (ii) with the proper settings including changing print and fan speeds back to default values for the Generic PLA filament profile, and (iii) while reducing the layer height to 0.2 mm or less.
If any surface of the vise attachment is uneven (click here to view closeup photo) or missing material (click here to view closeup photo), the model should be reprinted (i) using brand new white PLA filament fresh out of the sealed package, and (ii) with the proper settings including changing print speed back to default values for the Generic PLA filament profile and reducing the layer height to 0.2 mm or less.

Model #1 Meets Standard

Model #1 Does Not Meet Standard

Model #2 Meets Standard

Model #2 Does Not Meet Standard

Each model must meet standards for all quality assurance checklist items in order to be used for orthopedic surgical simulation training.

Model Production Period (Day-Month-Year to Day-Month-Year):

Total Number of Models #1 Accepted:

Total Number of Models #2 Accepted:

Quality Assurance Checklist Completion Date (Day-Month-Year):

Inspected By (First Name and Last Name):

Signature:

Name of Consignee:

Address of Consignee:

Acknowledgements[edit | edit source]

This work is funded by a grant from the Intuitive Foundation. Any research, findings, conclusions, or recommendations expressed in this work are those of the author(s), and not of the Intuitive Foundation.

References[edit | edit source]

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Authors Medical Makers
License CC-BY-SA-4.0
Language English (en)
Related 0 subpages, 9 pages link here
Impact 232 page views
Created September 21, 2022 by Medical Makers
Modified June 8, 2023 by StandardWikitext bot
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