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50 Chapter 3
Table 3.3: Material composition of FlexDiamond.
Parts Name VeroClear (%) TangoBlackPlus (%)
(a) ST top cover 100 0
(b) ST body 95 5
(c) Camera bottom cover 100 0
(d) ST bottom cover (connector) 100 0
(e) BT top cover (connector) 100 0
(f) BT body 95 5
(g) BT bottom cover 100 0
BT, Bending tube; ST, shooting tube.
3.3.4 Key performance targets
We were able to achieve a bending angle of above 90 degrees during our experiments.
However, continuous flexing of the manipulator at above 90 degrees will cause the prototype
to tear, as the prototype is made of softer and less durable material (95% VeroClear-RGD810
and 5% TangoBlack FLX973). Hence we limit the bending angle to 90 degrees to minimize the
wear and tear of the prototype. Additionally, we were able to translate in the z-axis by
extension and contraction of 5 mm. The prototype can be used for nasopharynx detection and
surveillance purposes. The prototype should be cleaned and sterilized before and after use.
3.3.5 Future prototype classification and comparisons
Due to the intended use of FlexDiamond in the nasal region, the first search technique of
searching by medical specialty was employed, followed by the second search method to
cross-check. It belonged to the medical specialty, numbered 77 (ear, nose, throat), in part
874 of the 21CFR. The classification regulation of FlexDiamond was further found to be
under the subpart E (surgical prototypes) classified as nasopharyngoscope. FlexDiamond is
a tubular endoscopic prototype made of medical-grade polyurethane (soft plastic) intended