Intended Use - StarDental IDENTAFI Manual Del Usuario

STARDENTAL IDENTAFI
®
www.identafi.net
Do not autoclave or sterilize.
This product is not for surgical use.
Disposable mirrors are for one-time use only; do not reuse
or clean using solvents, glass mirror may detach.
Do not operate without disposable mirror attached;
verify glass mirror is attached to disposable mirror.
Do not perform oral exam without using Doctor eye
protection glasses.
Reduce ambient light to your visual requirements (best dimmer)
Description: The StarDental Identafi ® is a battery operated, hand-
held multi-spectral Oral Examination Light used in conventional
and specialized oral examinations. 1 Accessories include filtered
eyewear and single use disposable mirrors.
®
The Identafi 's white, 405 nm violet and green-amber lights each excite the
oral tissues in distinct and unique ways. Specifically, biochemical changes
can be observed with violet's fluorescence, while morphological changes can
be seen with white and green-amber's reflectance. The direct visualization of
tissue fluorescence and reflectance is using the body's natural system as an
adjunctive tool for oral mucosal examination. 2
Traditional Oral Examinations use only tactile and broadband white light. The
Identafi ® 's multi-spectral technology uses software tuned LEDs for enhanced
visualization: White (Fig 1.1) for tissue morphology, Violet (Fig 1.2) for tissues'
natural fluorescence, and Green-amber (Fig 1.3) for tissues' reflectance
properties. The rose colored glasses enable the clinician to examine tissue
under all three lights. Under white light, a lesion may appear raised or
thickened and appear either white or red. Under violet light, normal tissue
fluoresces brightly and suspicious tissue appears dark. The green-amber
light enhances optical contrast between vasculature and surrounding tissue
allowing the doctor to more easily observe the difference between normal
and abnormal vasculature. Studies indicate abnormal tissue has a diffuse
vasculature, where normal tissue's vasculature is clearly defined.
Seeing the difference between normal and abnormal vasculature improves
the doctor's ability to choose biopsy sites (Fig 2.1), and aids in determining
the appropriate margin for surgical excision as outlined with a surgical
marking pen in the violet 405 nm picture (Fig 2.2).
®
The Identafi 's violet also causes certain microorganisms, mold and fungi
to naturally fluoresce (e.g. Wood's lamp). Bacteria, mold and yeast (fungi)
infected tissues may appear red, orange and/or yellow (Fig 3.1-3.4). The
Green-amber light reflectance properties also allows the doctor to observe
inflammation which also may appear red (Fig 3.5).
®

Intended Use:

The Identafi is intended to be used by qualified health care
providers to enhance the identification and visualization of oral mucosal
abnormalities that may not be apparent or visible to the naked eye, such as
oral cancer or premalignant dysplasia.
The Identafi ® allows for conventional oral mucosal examination and excites
the tissue with Multi-Spectral lights for direct visualization of the resulting
natural tissue fluorescence, reflectance and vasculature.
1. Patent 7365844 and Patents Pending 2. Cancer Research Vol. 12, 6716-6722, Nov. 15, 2006
3. Journal of Biomedical Optics 11 (1), 014018: 1-6 (2006)
1
®
Intended Use, continued:
microorganisms, fungi and yeast infections. This may aid in the diagnosis of
disease.
®
The Identafi filtered, reuseable eyewear is worn by a health care
professional to enhance the visual effects of violet light during an oral exam.
The eyewear has been designed to block the Identafi
allow transmission of 420-700 nm fluorescence/reflectance light.
2
Contraindications No known contraindications.
Store in cool, dry place.
Precautions
Inspect each component for damage. Do not use if damaged.
Warnings DO NOT look directly at the lights, they are very bright.
Do not examine patient without doctor's glasses.
Do not reuse or reprocess disposable mirrors. Discard after
one procedure.
Exposure to high temperatures above 105°F (41°C) or cleaning
solvents may damage the Identafi
The glass mirror may come off if dropped or reprocessed.
Identafi ® Set-Up: At the start of each day, verify that the Identafi
good working order. Replace batteries with the batteries that were recharged
overnight using the instructions that came with the batteries and charger.
Only use compatible batteries with the Identafi wand. In order to ensure that
the Identafi wand performs at its optimum capability, when the batteries
need to be replaced, replace them with one of the following recommended
AA battery brands: Sanyo's 'Eneloop 1500' or Tenergy's 'Centura' . If assistance
is needed contact StarDental technical service at 1-866-DTE INFO (383-4636);
or visit the www.identafi.net web site for battery specifications.
The separation of the body (A) from the battery cap (B) is an easy two-finger
twist to unscrew. Place two fingers on taper (A), two fingers on cap (B) and
twist to open at joint (C). DO NOT unscrew the device at the select ring (E); this
will damage the device and potentially void its warranty. Open only at point
C. Put in two AA batteries, positive contact (+) facing down. Reassemble the
battery cap (DO NOT over tighten).
3
Verify that Multi-Spectral LED lenses (F) are intact. Turn the device on by
rotating the select ring (E) once and pointing the LEDs (F) toward your hand or
the counter top. White color light will appear. Turn the Select Ring (E) several
times to the right and to the left cycling through each color and off position.
The LED lights are very bright; DO NOT look directly at the LED lights. Verify
that each light provides good illumination (white, violet and green-amber).
The violet light is 7-10 times more powerful than white or green-amber,
but will appear much dimmer due to the eyes' limited ability to see 405nm
wavelength.
Verify the glass mirror (G) is attached to the disposable mirror and not
damaged. Attach the disposable mirror with the mirror facing the LEDs (Fig 4).
Inspect the doctor's glasses to ensure they are clean and in good condition.
Verify the device is in good working order by cycling through each color at
least twice. Verify violet performance by putting on the rose doctor glasses,
holding the light at a distance and looking directly at the light. The violet light
should disappear completely except for a slight violet ring around the filter.
If you see any other light, call Customer Service at 866-DTE-INFO (383-4636).
If the light flashes green, the unit has been left on for over 10 minutes. Turn
off to reset timer.
®
The Identafi aids in the identification of certain
® excitation light and
® and its disposable mirrors.
® (Fig 4) is in
2
Image Courtesy of Dr. Gillenwater
M.D. Anderson Cancer Clinic
Image Courtesy of Dr. Gillenwater
1.1
M.D. Anderson Cancer Clinic
Image Courtesy of Dr. C. Poh Image Courtesy of Dr. C. Poh
British Colombia Cancer Agency British Colombia Cancer Agency
2.1 COE white light
Confirmed SCC/CIS
3.1 Bacteria 3.2 Bacteria
Image Courtesy of Dr. M. Romer Image Courtesy of Dr. M. Romer
A.T. Still University ASDOH A.T. Still University ASDOH
3.3 Bacteria 3.4 Caries/Bacteria
Image Courtesy of Dr. M. Romer Image Courtesy of Dr. M. Nichols
A.T. Still University ASDOH Bering Omega Community Services
A-C
To insert/remove/replace batteries place fingers at points (A) and (B)
and unscrew to open at point (C).
D
Two (2) "AA" compatible rechargeable batteries.
E
Select Ring - rotates both directions to change between lights and on/off.
- DO NOT unscrew the device at the select ring (E); this will damage the
device and potentially void its warranty.
F
High output 405 nm Violet and software tuned Multi-Spectral LED
G
Disposable mirror - snaps on and off.
F
G
E
Figure 4
3
Image Courtesy of Dr. Gillenwater
M.D. Anderson Cancer Clinic
1.2 1.3
2.2 Violet 405nm light
2.2
3.5 Gingivitis
Image Courtesy of Dr. M. Nichols
Bering Omega Community Services
B
A
C
D