StarDental IDENTAFI Manual Del Usuario página 3

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The Identafi Examination:
Read glasses instructions before using.
Reduce ambient light to your visual requirements (dim to dark).
Clinician must wear rose colored eyewear throughout exam.
Do not use the Identafi ® without disposable mirror attached.
Disposable mirrors are for one-time use only; cleaning solvents may
distort optical clarity or cause the glass mirror to detach.
NOTE: Patient glasses are recommended.
1. Turn on the Identafi ® at the base (D) and move the selector ring (F) to turn
on the white light; additional turns of the selector ring in either direction
will change the light to violet>green-amber>white>off.
2. Establish a "normal" tissue visual context for each patient with each exam
light.
3. Conduct a thorough conventional oral exam (COE) with the Identafi
using white light as directed in your standard protocol. Record all relevant
findings.
4. Repeat the visual examination with the Identafi
a. Normal tissue will generally emit blue fluorescence and abnormal tissue
typically appears as an irregular, dark area.
b. If a suspicious area is discovered, evaluate again under white and violet
light again. Verify what has caused the region to appear abnormal.
i. Inflammation typically appears darker due to the excess blood
content. With the back side of the disposable mirror, in a sweeping
motion, apply a light amount of pressure to diffuse any blood from
the area and observe fluorescence. If the normal blue fluorescence
returns, then the lesion may have an inflammatory component.
ii. Hyperkeratosis may often appear bright because of strong keratin
fluorescence.
c. Take into consideration tissue appearance under both violet and white
light, its response to palpation, and salient patient history information.
d. Bacterial and fungi infected tissues may appear red, orange and/or
yellow.
e. Plaque fluoresces and may appear bright reddish-orange.
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5. Repeat the COE with the Identafi using green-amber light.
a. Confirm suspected tissue under violet light with green-amber light.
i. Normal tissue reflects the green-amber color and vasculature
appears more red.
ii. The contrast between the vasculature and surrounding tissue is
due to the reflectance properties of hemoglobin which gives the
doctor a second "visual context".
b. Fibroids, scars, hyperkeratosis, necrotic and/or dead tissue may appear
white.
c. Traumatized, inflamed and/or infected tissue may appear red.
6. Document all areas of concern, if you are using photography as part of your
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record keeping process, call StarDental at 866-DTE-INFO (383-4636) for
camera filter kit availability.
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The Identafi
7. Characteristics that increase suspicion of dysplasia and/or oral cancer:
a. Highly darkened appearance - strong loss of fluorescence
b. High-risk location (e.g. lateral/ventral tongue)
c. Unilateral presentation
d. Asymmetry and/or irregular shape
e. Extension over more than one kind of oral structure
8. If a suspicious area can not be ruled out as benign, a follow up examination
(typically in two to four weeks) is recommended to allow potential
confounders to heal.
a. Evaluate whether the suspicious area has changed.
b. If the suspicious area has not cleared up, use your clinical judgment
and proceed according to your standard operating procedure (e.g.
biopsy, referral to a specialist, etc.).
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c. Biopsy is the gold standard for diagnosing precancerous and cancerous
lesions.
9. Inform the patient of all relevant findings and the appropriate course of
® using Violet light.
action.
10.After the examination, turn off the device, remove and discard disposable
mirror, clean exterior metal body with approved disinfectant and place
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Identafi wand in a safe place to prevent damage.
Maintenance:
between each patient by wiping with moist towelette using an approved
disinfectant. Do not use disinfectant with alcohol content over 70%,
hyperchlorides or phenol-based disinfectants as they may degrade the finish
of the unit.
Opaciden solution
Cidex Opa Solution/Concentrate Acecide High-level Disinfectant/Sterilant
Banicide Advanced
Clean the Identafi
cloth.
The glasses should be cleaned with mild soap and water as needed - do not
use alcohol-based cleaning agents.
Do not autoclave or sterilize.
This product is not for surgical use.
Do not immerse Identafi
Disposable mirrors are for one-time use only; do not reuse
or clean using solvents, glass mirror may detach.
Do not use alcohol-based cleaning agents on glasses.
Visually inspect and test in the event the Identafi
Verify that Multi-Spectral LED lenses are intact, and the select ring moves
easily. If white light does not come on, or is pinkish, replace batteries with
new, fully charged, batteries.
Examination, continued:
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The Identafi metal body should be cleaned and disinfected
Approved Disinfectants
Cidex Activated Dialdehyde Solution
III
Aldahol High-level Disinfectant
® Multi-Spectral LED lenses with the included glasses lens
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Wand, use only approved disinfectants.
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is dropped or damaged.
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Maintenance, continued:
If white light still does not come on, call Customer Service at 866-DTE-INFO
(383-4636). 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. Remove battery cap completely and reinstall it to reset timer.
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Each Identafi is serialized for warranty and technical support.
Remove batteries if not in use for over one week.
Re-order Information
Complete Identafi® System, United States of America
Complete Identafi® System, International
Box of 100 Disposable Plastic Barriers
Box of 25 Disposable Mirrors
Patient Safety Glasses (yellow tint)
Doctor Filter Glasses (rose tint, worn over prescription glasses)
Doctor Script/Magnification Glasses
(Rose - used with magnification insert or prescription lenses)
1.0X Magnification Insert - used with Doctor Filter Glasses
1.5X Magnification Insert - used with Doctor Filter Glasses
2.0X Magnification Insert - used with Doctor Filter Glasses
2.5X Magnification Insert - used with Doctor Filter Glasses
Special 35mm Camera Screw On Lens Filter (Lens Size 52mm)
Special 35mm Camera Screw On Lens Filter (Lens Size 55mm)
Special 35mm Camera Screw On Lens Filter (Lens Size 58mm)
Special 35mm Camera Screw On Lens Filter (Lens Size 62mm)
O-Rings and Seals are specifically excluded from this warranty.
® ®
DentalEZ warrants the Identafi Oral Cancer Screening System to be free of defects in material and workmanship,
under normal usage, under the following terms:
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StarDental Products:
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Identafi Oral Cancer Screening System
Please note the following additional terms of our warranty and return policy:
• Warranties cover manufacturing defects only and do not cover defects resulting from abuse, improper
handling, cleaning, care or maintenance, normal wear and tear or non-observance of operating, maintenance or
installation instructions. Failure to use authorized parts or an authorized repair facility voids this warranty.
• Liability is limited to repair or replacement of the defective product at our sole discretion. All other
liabilities, in particular liability for damages, including, without limitation, consequential or incidental
damages are excluded.
• THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NO EMPLOYEE,
REPRESENTATIVE OR DEALER IS AUTHORIZED TO CHANGE THIS WARRANTY IN ANY WAY OR TO GRANT
ANY OTHER WARRANTY.
WARRANTY REPAIRS: Parts repaired or replaced on a product that is in warranty will be warranted for the duration
of that product's original warranty.
NON-WARRANTY REPAIRS: The warranty on parts either repaired or replaced on an out-of-warranty product will
cover the repaired part only and will be for the time frame of a new parts warranty period.
PRODUCT RETURN: Opened products or product returns more than a year old cannot be returned for credit. There
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will be a 15% ($25.00 minimum) restocking charge on all items authorized for return.
* Provided conditions in warranty are met.
EC REP
DentalEZ Dental Products (GB) Ltd.,
Cleveland Way,
Hemel Hempstead, Hertfordshire
HP2 7DY, ENGLAND
Product registration and additional clinical data and images are available
online at www.identafi.net
RT3-00108 D Date of Issue 10/30/2012
Part Number
RT3-00371
RT3-00372
RT3-00415
RT3-00105
RT3-00113
RT3-00114
RT3-22000
RT3-22010
RT3-22015
RT3-22020
RT3-22025
RT3-23052
RT3-23055
RT3-23058
RT3-23062
Limited Warranty
Warranty Period*:
1 Year from date of purchase
StarDental
1816 Colonial Village Lane
Lancaster, PA 17601
Phone: 866-DTE-INFO (383-4636)
Web: www.dentalez.com
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