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RD_K3ROS_DO_0015_User_Manual_EN_r2
User Manual
K3ROS version 1.0
November 2020
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Table of Content
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Incepto Medical
: November 2020
3760332080008 (UDI-DI)
E-mail : support@incepto-medical.com
Website : www.incepto-medical.com
This document constitutes a user manual for the product K3ROS. This manual is an integral part of the
K3ROS software application. It gives the user the necessary instructions to ensure proper usage of the
application.
Recommendations :
- K3ROS must be used exclusively by doctors who have read this manual. In the event of
uncertainty about the interpretation of present instructions, please contact Incepto Medical
using the information provided in section 1.
- The information included in this document is exclusively designed for duly authorized
personnel. Please read this manual carefully before using K3ROS.
Warnings:
- Warning 1: K3ROS must not be used in the following cases:
▪ Non validated population: patients younger than 16, OR who have a surgical
history, OR who have a metal artifact on their MRI, since K3ROS has not been
validated for these populations,
▪ Absence of T2 sequence or proton density with fat saturation, in the coronal,
sagittal and axial planes, encompassing the entirety of the volume of the knee
▪ Sequence in which the Field of View (FOV) contains both knees
▪ Patient belonging to a population group known to have knee specificities (for
example: anatomical variation)
▪ Images that come from an incompatible acquisition system
In the cases cited below, you will receive a warning explaining that the exam is not adapted to K3ROS
usage specifying the reason, and no algorithmic prediction will be provided:
RD_K3ROS_DO_0015_User_Manual_EN_r2
In the cases cited below, you will receive a warning explaining that the exam is not suitable for the
intended use of K3ROS, and algorithmic predictions will be provided:
In the cases cited below, K3ROS will not generate a report (neither warning, nor automated report):
In the cases cited below, a report will be generated, but the user must be informed that K3ROS’s
performance will potentially be degraded:
- Surgical history
- Patient belonging to a population group known to have knee specificities (for example:
anatomical variation).
- Warning 2: Users must not rely entirely on K3ROS results and must systematically
analyse the images. Users must know that K3ROS does not detect all anomalies and
presents a sensitivity and specificity inferior to 100% (risks of false positives and false
negatives). Furthermore, K3ROS does not analyse all knee structures.
- Warning 5: K3ROS only functions with knee MRIs containing T2 sequences with fat
saturation or proton density with fat saturation in three axes (axial, sagittal and frontal).
- Warning 7: Poor quality images that would not be interpretable by a radiologist must
not be analysed using K3ROS (movement, very low resolution, etc.).
Remark:
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- The figures and screens presented in this manual have been selected for illustrative
purposes only and must not be interpreted as real representations of data or results.
The users, or “authorized personnel,” must understand the K3ROS instruction manual before using the
application.
2.2. Certification
The K3ROS software application is marked CE, conforming to the Directive 93/42/CEE regulations
related to medical devices.
3. Security information
3.2. Symbols
The following symbols may be present in the documentation:
3.3. Acronyms
Acronym Definition
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4. Generalities
- ACL,
- Medial and lateral menisci,
- Medial collateral ligament,
- Cartilage of the patellofemoral, lateral femorotibial and medial femorotibial compartments.
K3ROS is capable of detecting, for each of these structures, the presence or absence of lesions, and
concerning the meniscal tears their migrated or non-migrated character. These results are automatically
generated in a unique report, in DICOM format, integrated into the radiologist’s work interface, and
appears as a supplementary “sequence” in the PACs.
K3ROS must not be used as a stand-alone diagnostic tool to determine treatment plans or recommend
further support to the patient.
● Meniscal tear and characterization of the migrated character or not of this tear
For this reason, K3ROS is designed to be used in post-traumatic or degenerative contexts; it must not
be used for tumoral or inflammatory pathologies.
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K3ROS is directly integrated into the user interface, with an automatic transfer of data and automatic
communication of results. The results can be visualized in any viewer compatible DICOM.
- ACL
o Normal
o Total or partial rupture
o Doubt on partial or total rupture.
- Cartilage
o Normal
o Chondropathy (including any loss of cartilage)
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o Bone structures.
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6. Maintenance
The software updates and periodical maintenance activities required for the product are performed
remotely with the radiologist information systems. Incepto will inform you before any periodical
maintenance activity.
7. Contact
In the event of a problem, or if you have a question related to the usage of K3ROS,
you can reach us at the following address:
support@incepto-medical.com
or:
Incepto Medical
75008 Paris
France
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