DentalMonitoring Scanbox Pro Mode D'emploi page 5

III. INSTRUCTIONS FOR USE
PRESENTATION
ScanBox pro L pack (REF 1011-001) is available in a
package containing one Phone support (REF 1005-
001), one Cheek Retractor Tube Size L (REF 1008-
001) and one mesh pouch.
Optional accessory: Cheek Retractor Tube Size M
(REF 1007-001). Refer to Inserting the Cheek Retrac-
tor Tube in your mouth section.
All the following instructions can be applied to a use
of the device with a Cheek Retractor Tube Size L or
a Cheek Retractor Tube Size M.
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INTENDED PURPOSE
ScanBox retracts the cheeks to allow a full view
pro
of a patient's mouth to take pictures of the intraoral
cavity.
INDICATIONS
ScanBox is intended to be used as part of a scan-
pro
ning procedure guided by softwares, developed, and
marketed by DentalMonitoring, to monitor intraoral
health and orthodontic treatments.
TARGET GROUPS
• Target population: ScanBox is indicated for pa-
pro
tients over the age of 6.
• Intended users: ScanBox pro is intended to be used by:
- Healthcare professional in professional healthcare
facilities, such as a dental practice.
- Lay persons over the age of 6 in a non-healthcare
environment, such as the patient's own home.
• Type of use/reuse: ScanBox pro is reusable and can
be used:
- On multiple patients, when used in healthcare fa-
cility, after sterilization as descripted in the clean-
ing procedure.
- Multiple times by a single patient when used in
non-professional environment.
CLINICAL BENEFITS
There is no direct clinical benefit for the use of Scan-
Box . ScanBox
pro pro is intended to be used to ease the
taking of scans that will be processed by DentalMon-
itoring softwares.
CLINICAL PERFORMANCES
ScanBox pro has no clinical performances as it has no
direct action and effect on the patient.
8 9
TECHNICAL SPECIFICATIONS
ScanBox biocompatibility was assessed, and the
pro
product was demonstrated to be non-cytotoxic,
non-sensitizing and non-irritating.
When used by healthcare professional in profession-
al healthcare facilities, ScanBox can be sterilized.
pro
SIDE EFFECTS
No known side effects.
CONTRAINDICATIONS
ScanBox pro should not be used in the event of injured
skin or injured mucous membrane.
ScanBox pro is not intended for surgical or post-sur-
gery use, nor to take intra-oral pictures with prod-
ucts other than those marketed by DentalMonitoring.
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