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.

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
6
GNRB FT.02.008 O EN
2. LIST OF MARKING SYMBOLS
Selective sorting components
G eneral safety
Warning
Keep dry
Type B electromagnetic device
Read instructions for use
Show where put
hands for the
transport
Fragile - handle with care
A dmissible temperature range
Admissible humidity range
A dmissible air pressure range
Indicates the direction of the position
of the knee and foot cups
Direct current
Alternating current
!

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
3. D
ES CR IPTIO N
It is also composed by :
-An USB key for the GNRB software
-This instruction manual
-A PC together with its power supply cables and user manual
-A results interpretation guide
Pushed dish
Emergency stop
button
An electric jack
USB interface cable
(1.80m)
A displacement sensor
placed on the ATT
Adjustable straps for fixing
the patient’s patella
Displacement sensor
cable (0.3m)
Cable to connect the GNRB to the electric
power supply (2m) + mains power (1.70m)
Adjustable straps for fixing
the patient’s foot
Force sensors

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
8
GNRB FT.02.008 O EN
4. GENERAL SAFETY INSTRUCTIONS
You are working with a device that applies radio frequency energy and which is se n s i t i ve to
devices that transmit radio frequency energy. Please refer to the declaration ta bl es regarding
electromagnetic emissions and electromagnetic immunity in Appendix 1 of t hi s instruction
ma nu a l.
You are working with an electrical d ev i ce . Incorrect use may cause electric s ho cks . Only the
Mascot power supply, Ref. ASTEC DPS55-M, supplied by GENOUROB® s hould be used for
supplying electric power to the G NRB
®
The level of protection against electric shocks of the parts applied to the p at i e n t (displacement
sensor, the curved support under the calf, the leg support and stops) classifies the GNRB® as a
type B d ev i ce .
Use of accessories, sensors and cables other than those specified, with the exception of
sensors and cables sold by GENOUROB for the equipment or as spare parts for internal
components, can cause equipment emission levels to rise or fall.
The power cable must be connected to a 230 Volt-50 Hz mains supply.
To prevent risk of electric shock, this device must be connected to a supply network with fitted
earthing plug
It is forbidden to use the device with a damaged power supply unit or with bare connection
cables.
Do not dismantle the device: maintenance and calibration is to be performed by trained
GENOUROB® staff.
The GNRB® should not be used adjacent to or stacked with other equipment. If this is
unavoidable, you should first check that the GNRB® functions correctly like this.
The instructions in the installation guid eand instruction manual must be f ollow e d exactly.

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
9
GNRB FT.02.008 O EN
5. INSTALLATION
G U I D E
5.1.Installation of the GNRB® device
5.1.1. Unpacking
(See first instructions for use)
5.1.2. Installation of the GNRB®
The GNRB® should be placed on an examination table so that the patient’s legs can be positioned
comfortably on the device. The patient must be able to lie down on the table and rest their head on
the support (optimal relaxation).
The GNRB® can also be placed on a floor mat as an alternative to a table.
Using the cross block screws, raise the displacement sensor to the highest point of the rod (up to
the cap) and pivot it vertically.
Do not knock or pivot the block located at the end of the sensor.
Cross block
Blocking foam

Certified Company ISO 13485 : 2016, NF EN ISO 13485 : 2016 by
LNE GMED
10
GNRB FT.02.008 O EN
5.2.Connections
Connect the power supply cable to the GNRB®, and then connect the PC to the device using the
USB cable.
Connect the power supply unit to the mains (230 V –50 Hz).
When t he GNRB® is powered a green ligh t shows.
When the connections are all made and the GNRB® is switched on, switch on the PC.
The front