English - Instruction For Use - Elos Accurate Scan Body Instrucciones De Uso

English - Instruction for use

Elos Accurate® Scan Body
1 Indications for use
The Scan Body is intended to be used together with a dental scanner to
locate the exact position of an implant/analog or abutment in relation to
prosthetic restorations. The scan body is intended to be mounted directly on
the implant/analog or abutment using the Scan Body Driver. The Scan Body
is intended to be used directly in a patient's mouth when using an Intra oral
scanner, or on a model of the patients' teeth setup when using a desktop
scanner.
2 Product Description
The Scan Body is manufactured from biocompatible titanium alloy (TiAl
ELI) and polyetheretherketone (PEEK). The corresponding Scan Body
Driver used to tighten the integrated screw is manufactured from
biocompatible stainless steel. The product is available for a variety of
implant platforms. For specific product descriptions, please refer to individual
product labels.
3 Contraindications
None known
4 Warnings and precautions

The Scan Body may only be used with the original branded
implant/analog or abutment stated on the product label.

Make sure that the seating surface, upon which the scan body is to be
placed, is clean and free of residue and liquids as well as bone or soft
tissue when mounting

Since the Scan Body is small it must be handled with caution to avoid
the patient from swallowing or inhaling it.

Tighten the integrated screw must only be done slightly by hand using
the Scan Body Driver (max. 5Ncm). To high tightening torque can
damage the device which may cause inaccurate scan results.

DO NOT use a Scan Body that has been damage or modified in any
way. Use of a damage or modified Scan Body may cause inaccurate
scan result.

Do not try to disassemble the Scan Body.

Do not try to rotate the Scan Body, when it is attached to the implant.

The Scan Body may only be used with a compatible digital library file
installed in the design software.

The Scan Body must only be used and handled by dental
professionals.

Allergies to the materials or contents of the materials may very rarely
occur.
5 Compatibility information
The Scan Body is available for a variety of implant platforms and sizes. The
individual product label refers to which implant platform and size the product
is compatible with.
Scan Body's for intra oral use are marked IO. Scan Body's marked IO can
also be used on models when using a desktop scanner.
Scan Body's marked SA are only intended for restorations seated in the
conical interface of an implant
6 Cleaning and Sterilization
The Scan Body is delivered non-sterile. Prior to attachment of the Scan
Body in the patient's mouth, it must be cleaned followed by sterilization.
Following cleaning and sterilization method is recommended:
1. Clean rinsing under flowing water while brushing with a soft brush to
remove any residue or dirt.
2. Sterilize the scan body using autoclave at a temperature of 121°C,
pressure of 2 atm. for 15 minutes or at a temperature of 134°C,
pressure of 3 atm. for 3 minutes acc. to EN ISO 17665. The products
are ready for use 20 minutes after autoclaving process.
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Document ID: DEV-00509 version 2.0
Caution: As the Scan Body is a high precision tool, it may not be used while
still warm from the autoclave, as the thermal expansion may lead to
inaccurate scanning. Before using the Scan Body it must be cooled to
temperature 18-37˚C.
7 Procedure
7.1 Scanning
1. Clean and sterilize the Scan Body according to the procedure described
in section 6. Sterilization is only required for intra oral scanning.
2. Remove cover screw, healing abutment or similar from the implant or
abutment upon which the Scan Body is intended to be placed.
Place the Scan Body onto the implant/ abutment in the patient's mouth
3.
or onto the analog when scanning a model.
4. Tighten the integrated screw slightly by hand using the Scan Body
V
Driver.
6 4
Conduct the scan according to the scanner manufacturer's instructions
5.
to obtain a digital 3D model of the patient's mouth.
6. After scanning, the Scan Body is removed using the Scan Body Driver.
7.2 Design
1. Open the obtained digital 3D model in the scanners design software
2. Select the relevant digital library which depend on the prosthetic
solution used in the specific case
3. Choose implant platform from the library corresponding to the scanned
implant/analog or abutment.
Design the prosthetic restoration according to the design software's
4.
instructions. Be aware of that each specific prosthetic solution might
have restricted design guidelines in accordance to maximum angulation
and minimum wall thickness.
8 Further information
For additional information about the use of Elos Medtech products, please
contact your local sales representative.
9 Validity
Upon publication of this instruction for use, all previous versions are
superseded.
10 Storage and Handling:
The Scan Body should be stored at room temperature (18-25°C) protected
from direct sunlight.
11 Disposal:
The Scan Body must be disposed as biological waste.
Caution: U.S. Federal Law restricts this device to sale by or on the order of
a licensed dentist or physician.
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