16
GC AADVA
™
IOS 1 00 P
1
Rub the surfaces thoroughly for about 30 seconds with disinfection wipes or a dry, soft, non-abrasive cloth and undiluted cleaning
solution
according to the manufacturer’s instructions. Then dispose the cloth in a rubbish container with
the classification 'Biohazard'
following local applicable regulations.
2
Dry the surfaces with a clean, non-abrasive, lint-free cloth and allow it to completely react for 5 min.
3
Examine the application device for visible contamination. If the application device is not completely clean, repeat the cleaning steps
1 to 3.
34
GC Aadva Cradle Inlays
The GC AADVA Cradle Inlay is intended for the operators of the GC AADVA IOS 100 P device.The GC Aadva Cradle Inlay must be
detached from its cradle and sterilized with each patient. Effective cleaning products are FD300 cleaning solution 2% concentrate /
FD300 top wipes undiluted. Effective disinfectants consist out of a combination of ethanol and didecyldimethyl-ammonium chloride. (FD
333 wipes from DÜRR Dental AG (Bietigheim-Bissingen, Germany). Follow the method below for disinfecting the cradle and sterilizing
the Cradle Inlay :
1.
Rub the surfaces thoroughly for about 30 seconds with an appropriate disinfectant (FD 333, Dürr Dental) following the
manufacturer’s instructions.
2.
Examine the application device for visible contamination. If the application device is not completely clean, repeat the cleaning
steps 1 to 2.
Autoclave :
1.
Wrap the inlay part in a sterilisation foil with sterilisation detector and autoclave it at 134 °C [273°F], 5 minutes, fractional
prevacuum, drying time 10 minutes.
2.
Store the sterile inlay parts in a clean, dry place.
▪
Avoid contact with the autoclave’s metal part.
▪
Wear personal protection equipment (PPE)
▪
Never use corrosive cleaning agents or solvents
▪
Do not clean using ultrasound
Replacement
After 20 cycles of sterilization it is recommended to replace the GC Aadva Cradle Inlay with a new one. The following signs are
indications of wear and degradation. Please replace the Cradle Inlay with a new one when noticing one of the following signs:
▪
Delamination and/or roughening of the surface
▪
Dimensional changes
▪
Cracks, discoloration, staining
▪
Structural damage
▪
Change in surface texture
WARNING MESSAGE
To reduce risks of cross-contamination:
•
Disinfect the application device before each use.
•
Do not clean the application device using ultrasound.
To reduce the risk of electrical and fire hazards:
•
The strain relief area (the area where the cable is connected to the application device) must not be held under water or made
moist. If this area is held under water or made moist otherwise, it must be wiped dry immediately. The strain relief must first
be completely dry before the application device is reconnected.
To reduce the risk of electrical hazards:
•
Check the application device and the system (monitor and cable) for physical damage before each use.
To reduce the risk of electrical and fire hazards:
•
Only use an earthed electrical outlet
•
Do not use extension cords or multiple-socket plugs.
CAUTION
Reducing the environmental impact:
Ensure that the disinfectants used are disposed of in accordance with the applicable guidelines.
35
Safety / Guidelines / Technology
Materials of the device which come into human contact (scanner application device) are certified in regards to the biocompatibility in
accordance with ISO 10993-1 and applicable subparts.
The definition of safety and regulatory markings are listed below:
Read the accompanying documents.
Proceed according to the Manual.
This symbol indicates "Conformité Européenne"; which
directly translates as: 'European Conformity'. This sign
is a manufacturer's declaration that the product
complies with the essential requirements of applicable
European legislation regarding health, safety and
environmental protection.
Consult instructions for use
Serial number
