My Question:
Does anyone know of a cranial helmet fabrication facility that will accept
Structure Scan 3D image files ? Those who use Structure Scanner, do you get
an accurate enough image to produce a good helmet with?
Sincerely,
Jeff A. Zeller, CP, BOCPO
Spectrum Prosthetics & Orthotics Inc.
1844 South Street
Redding, CA
96001
My Conclusion:
Cranial Remolding helmets are regulated by the FDA. The FDA has only
granted certain scanners and facilities the permission to use their
scanners and facilities to produce these helmets. I need to investigate the
the cost vs. ROI on the purchase of the necessary equipment vs. California
reimbursement on this product line before making the investment.
Thank you all for your prompt responses!
Jeff
Responses:
We have done testing in our facility. Structure sensor scans are NOT
accurate. It is a cheap scan for things that don’t need the accuracy like a
tlso which you can get away with being close. We would never use structure
sensor for plagio.
I would not trust a structure scanner for a helmet scan. Reach out to
BioSculptor they have some used units of a great scanner available I
believe.
Please provide a follow up to this question. I am curious myself. Thanks!
I would appreciate reviewing the comments you receive. I’ve used the scanner
for a protective helmet and a variety of other devices but not for cranial
remolding. I don’t know of any company that is accepting
scans for cranial remolding. As of last year, Cascade DAFO did not accepts
scans with structure scanner for any devices.
My experience with this scanner is that it takes extremely accurate scans,
but only if the object can remain completely still. Difficult to do with
this population. I have used the scanner for custom shoes and athletic face
mask, with great results. I don’t believe there are any current helmet
manufactures that have added this scanner to their FDA approvals.
The only source for my CRO is Orthomerica. You can check with them about
the particulars of your scanner’s technology.
Try Boston Brace they where the first ones to take digital files and they
may not be able to tell the difference in where the file comes from! Let me
know if anyone does. The scanner is great and accurate but with helmets
being class 1 devices the regulatory documentation is likely prohibitive.
For example I believe every new iPad or iPhone would have to be re
validated! app and updates ugh! I recommend digiscan as the scanning app.
So when I was experiencing this issue in ancient history before any helmet
manufacturer would accept any digital file (except their own scanners) I
would scan (polemus scanner) carve the head and sent them the carving! I
know it is ridiculous but that let them work within their FDA guidelines.
If you are using iPad structure scanner , I don’t think any fabrication
facility will accept scans for Custom Cranial Helmet . Because for cranial
helmet one has to use FDA approved scanner Like Creaform scanner ( also
sold by Tecmed, Vorum and Willowwood).
As far as accuracy of iPad structure scanner is concerned , lot depends on
what software / app you use with the scanner. So far I have seen Standard
Cyborge app gives you fairly good accuracy with the scanner.
can you forward replies please. Just looking at structure today.
