Informed Consent / Device Care, Questionnaires, Insurance forms
The Informed Consent document and the "care of your device" document has been condensed into one document. Practitioners are obligated to provide this document (linked below) to every NTI patient.
Informed Consent AND Device Care form in PDF (the old two forms have been combined into one document)
Informed Consent AND Device Care form in MS Word (that can then be customized by the provider).
MSDS: Lexan (NTI shell) (The FDA has placed no restrictions on the material used to manufacture NTI devices. Read more here). Lexan is a USP Class 1 plastic, as the NTI only contacts mucosal surfaces for a limited (less than 24 hours) time. The current provider of the type of Lexan used to manufacture NTI devices advises that this Lexan is FDA food contact compliant, but recommends that it not be used for implantable devices that require cellular compatibility, which does not apply to the NTI.
Contraindications and considerations Practitioners who provide an NTI-tss device are reminded to familiarize themselves with the contraindications and considerations of NTI-tss therapy, and to provide an Informed Consent to each patient receiving an NTI-tss device.