genourob GNRB User manual

DIAGNOSIS I N ST RUM E N T
FOR ANTERIOR LIGAMENT KNEE I NJUR IES
INSTRUCTIONS FOR USE OF THE GNRB®

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
GNRB FT.02.008 O EN
ACKNOWLEDGEMENT
Thank you for having purchased this
G NR B
®
.
The GNRB® is a revolution in instrumental methods for measuring laxity of the knee. It is more
precise, reliable and consistent than other measuring instruments.
The device was designed in 2005, the result of an initiative by Dr Henri Robert and Stéphane
Nouveau. They noted that ACL injury screening was neither consistent, nor quantifiable, using
physical examinations and existing instrumental methods. Partial injuries were hard to detect.
With the support of the ESIEA (French Institute of Applied Electronics and Computing), they
designed and developed the GNRB®, which provides solutions to each of the drawbacks of other
existing measuring appliances. This device provides more precision and good measurement
repeatability. See Publication « Orthopaedics & Traumatology : Surgery & Research (2009) 95,
171-176 ».
In the light of current repair innovations in ACL reconstruction, this device has the advantage of
detecting partial injuries, enabling a single bundle to be repaired.
The device can be used in pediatrics for diagnosing knee sprains.
There have been several French (SOFCOT, SFA and SOO) and international publications (ESSKA
Porto 2008, ISAKOS OSAKA 2009) on this subject.
Again, thank you for purchasing this device, we welcome the opportunity of working with you.
Please feel free to send us the results of your tests, along with any comments and suggestion you
may have concerning the use of the GNRB®. This is all part of an ongoing progression to ensure
that our device meets as closely as possible the requirements of those who use it.
Stéphane NOUVEAU Henri ROBERT
Director Orthopaedic Surgeon

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
GNRB FT.02.008 O EN
S UMMAR Y
1. I N T R O DUC TIO N ___________________________________________________________________ 5
2. LIST OF MARKING SYMBOLS _________________________________________________________ 6
3. D ES CR IPTIO N _____________________________________________________________________ 7
4. GENERAL SAFETY INSTRUCTIONS _____________________________________________________ 8
5. INSTALLATION G U I D E _______________________________________________________________ 9
5.1.Installation of the GNRB® device__________________________________________________________ 9
5.1.1. Unpacking ________________________________________________________________________________ 9
5.1.2. Installation of the GNRB®__________________________________________________________________ 9
5.2.Connections _________________________________________________________________________ 10
6. USING THE GNRB® FOR THE FIRST TI M E ______________________________________________ 11
6.1.Login/Password ______________________________________________________________________ 11
6.2. First time use________________________________________________________________________ 12
7. DESCRIPTION OF THE GNRB® SOFTW AR E ______________________________________________ 13
7.1.Toolbar _____________________________________________________________________________ 13
7.2.Patient file tab _______________________________________________________________________ 13
7.2.1. Identity f orm _____________________________________________________________________________ 13
7.2.2. Medical in f o rmat ion ______________________________________________________________________ 14
7.2.3. Additional examinations __________________________________________________________________ 15
7.3. GNRB test preparation tab _____________________________________________________________ 16
7.3.1. S ett ing s_________________________________________________________________________________ 16
7.3.2. Co n tr ols _________________________________________________________________________________ 16
7.3.3. GNRB status_____________________________________________________________________________ 17
7.3.4. Push force _______________________________________________________________________________ 17
7.3.5. Number of test measurements ____________________________________________________________ 18
7.3.6 Radiology Option ____________________________________________________________________________ 18
7.3.7. Contraction Option __________________________________________________________________________ 18
7.3.8. Data table _________________________________________________________________________________ 18
7.4.The results tab _______________________________________________________________________ 19
7.4.1. Selecting results_____________________________________________________________________________ 19
7.4.2. Graphs ____________________________________________________________________________________ 20
7.4.3. Differential Results __________________________________________________________________________ 21
7.5.Configuration tab _____________________________________________________________________ 22
7.5.1. Configuration_______________________________________________________________________________ 22
7.5.2 Print document in the PDF format_______________________________________________________________ 22
7.5.3. Information ________________________________________________________________________________ 24

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
GNRB FT.02.008 O EN
8. INSTALLATION OF THE GNRB® SOFTWARE ONTO A PC____________________________________ 26
9. INSTRUCTIONS FOR U SE ___________________________________________________________ 28
10. Calibration of the device __________________________________________________________ 33
11. S afety in str u ct ion s a nd p reca u t ion s f o r u se ___________________________________________ 35
12. TRANSPORTING THE G NRB
®
_______________________________________________________ 37
13. MAINTENANCE AND R E C Y C LI N G ____________________________________________________ 38
14. C E R TIFI CA TIO N S- Manufacturing and marketing dates __________________________________ 39
15. APPENDIX I : MANUFACTURER'S DECLARATIONS_______________________________________ 40

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
5
GNRB FT.02.008 O EN
1.
I N T R O DUC TIO N
The GNRB® is a device that diagnoses total or partial ruptures of the anterior cruciate ligament of
the knee.
For years, we believed that the analysis of laxity at 134 N or at 250 N was enough to explain the
lesions or not, of the LCA. It seems very clear now that a dynamic analysis of the elasticity of the
capsulo-ligamentary complex is more relevant and it is that which the GNRB® allows by the
analysis of the slopes of resulting curves.
Some arthrometers had begun the analysis of the displacement curves but these devices had
the problem of a very bad consistency (manual traction, no parameter setting of the tightening…).
The GNRB® is a device which allows the diagnosis of total or partial ruptures of the anterior
cruciate ligament of the knee.
It has a number of advantages:
the device is non-invasive
it does not use X-rays or other dangerous techniques
it adapts to the morphology of each patient
it is easy to install and use
it produces reliable and repeatable results
its results are operator free
it is easy to transport and clean
the software is easy to use for beginners
The principle of the device is to apply pressure to the calf using an articulated mechanical system
and to record the displacement of the tibia for each force (from 0 to 300 N) via a sensor placed on
the ATT (Anterior Tibial Tuberosity).
A microprocessor controls the device and transfers the recorded data to a computer (the data is
recorded and analyzed using specially-designed software).
Measurements are performed on both legs and the diagnosis is obtained from comparing the two
sets of values and, above all, from the gradients of the curves obtained.
The installation tutorial provided on the following pages will help you set up your device quickly
and easily.
Detailed descriptions are included in the various chapters of the instruction manual.
Please read this instruction manual carefully. Follow safety instructions to ensure that your
G NR B
®
operates correctly. GENOUROB® cannot in any way be held responsible in the event of your failure
to comply with these instructions.