Setup Guide

11
ENGLISH
Dry theTRIOS scanner tipcarefully withanon-
woven swab.
Step 3: Sterilize TRIOS scanner tip
Put theTRIOS scanner tip ina sterilizationpouch.
Thepouch should be sealed. Use either aself-
adhesive orheat-sealed pouch.
Sterilize thepouched TRIOS scanner tip
inaDynamic-Air-Removal Steam Sterilizer
(Class B autoclave) withone ofthetwoprograms
depending on your region:
In the US: Autoclave the TRIOS scanner tip at 132 °C
(269.6 °F) with acycle of 4 minutes exposure time
and 30 minutes dry time.
In the EU: Autoclave the TRIOS scanner tip at 134 °C
(273.2 °F) with acycle of 3 minutes exposure time
and 30 minutes dry time.
CAUTION
Thewindow intheTRIOS scanner tip isadelicate optical component.
Itscleanandundamaged surface iscritical forthescanquality.
Thewindowshould be handled withcare. Donot scratch it.
Becareful not tosmudge it before scanning apatient.
CAUTION
Always cleantheTRIOS scanner tip immediately after use.
Ifbiological materials (bioburden) are allowed todry onequipment,
disinfectionandsterilizationprocesses may not beeffective.
CAUTION
Never autoclave aTRIOS scanner tip that isnot wrapped, since thiswill
leave unremovable stains onthemirror. Seetheautoclave manual
formore information.
CAUTION
New TRIOS scanner tips must be cleaned andsterilized before using
them forthefirst time.
CAUTION
A class B Vacuum autoclave according to EN 13060 is required
for sterilization of the TRIOS scanner tip.
CAUTION
The TRIOS scanner tip can be re-sterilized up to 60 times and must
be disposed afterwards as described in section 9 Disposal.
7.4 Cleaning of Batteries, Battery Charger and Other
Parts of the System
For cleaning of batteries, battery charger, and other parts of the system, please follow
the instructions below:
Cleaning of battery:
Apply a mild detergent to a soft, damp cloth
and wipe the surface of the battery.
Cleaning of battery charger:
Apply a mild detergent to a soft, damp cloth
and wipe the surface of the battery charger.
For general cleaning, apply a mild detergent to a soft, damp cloth.
CAUTION
Do not spray directly onto any parts of the system, as the liquid solution
can accumulate at the seals and leak into the TRIOS scanner, cords or pod.
8. Optical Maintenance
In case of smudges or stains on the TRIOS scanner tip window or the TRIOS scanner window,
follow these steps for optimal scan quality:
Step 1: Take a damp non-woven swab and gently rub it on the inside and outside
of the TRIOS scanner tip window as well as on the window on the mirror housing.
Step 2: Use a dry non-woven swab to dry the windows.
CAUTION
Do not use acetone, IPA, alcohol, or any oxidizing solutions to clean
the TRIOS scanner tip window or the TRIOS scanner window.
If the problem persists, please contact support ([e-mail]).
9. Disposal
Electronic waste must not be treated as unsorted municipal waste, but
must be collected separately! Please contact support ([e-mail])
who can inform you about the local requirements for disposal of electronical,
clinical waste. By disposing of the device in the proper manner, you help to avoid
possible hazards for the environment and public health that could otherwise be
caused by improper treatment of waste equipment.
Disposal of the TRIOS scanner tip and TRIOS Sleeve
Please dispose according to standard operating procedures or local regulations for disposal
of contaminated medical waste.
CAUTION
Dispose the TRIOS scanner tip and TRIOS Sleeve as clinical waste.
Disposal of the TRIOS System and packaging
Please dispose according to standard operating procedure or local regulations for disposal
of general waste and electronic waste.
CAUTION
Batteries need to be removed and recycled or disposed of properly.
TRIOS scanner batteries need to be disposed of as lithium-ion batteries.
Lithium-ion batteries are recyclable and must not be treated as unsorted
municipal waste, but must be collected separately.
If in doubt, please contact support ([e-mail]).
10. Technical Maintenance
CAUTION
All technical service and repair of the TRIOS system must be performed
by 3Shape or 3Shape-authorized personnel only.
No regular maintenance is needed other other than cleaning, disinfection and sterilization,
as described here. Preventive and scheduled maintenance are not required.
11. Consumable Accessories
The consumable accessories to the TRIOS system are the scanner tips, batteries and
TRIOS sleeves. New consumable accessories can be re-ordered by contacting 3Shape.
Replacements
TRIOS Tip Tips 3-pack TST-11-3
TRIOS Sleeve TRIOS Sleeve TSL-01
TRIOS Battery Battery 3-pack TB-04-3
12. Vigilance
In case of any serious incident that has occurred in relation to the use of the device, please
report the incident to 3Shape at email: [e-mail] and you can also report it
to the competent authority of the state in which the user and/or patient is established.