genourob ROTAM User manual

Instruction for use of the ROTAM
DIAGNOSTIC INSTRUMENT FOR
PERIPHERALSLIGAMENTS ANDANTERIOR
LIGAMENTSINJURIES

Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
05ROTAMFT.02.008 C
SUMMARY
SUMMARY................................................................................................................................................................... 2
1. I N T R O DUC TIO N....................................................................................................................................................... 3
2. Glossary of marking symbols .................................................................................................................................. 3
3. DESCRIPTION OF THE DEVICE.................................................................................................................................. 4
4. INSTALLATION GUIDE.............................................................................................................................................. 5
4.1. Installation of the device ROTAM.................................................................................................................... 5
4.1.1 Unpacking .................................................................................................................................................. 5
4.1.2 Installation of the ROTAM......................................................................................................................... 5
4.2. Connections ..................................................................................................................................................... 6
4.3. Installation of protect connections.................................................................................................................. 6
5. ROTAM SOFTWARE .................................................................................................................................................. 7
5.1. ROTAM software installation on a PC.............................................................................................................. 7
5.2. First used of the software................................................................................................................................ 8
5.3. Tab patient record ........................................................................................................................................... 8
5.4. Tab preparation test ROTAM........................................................................................................................... 9
5.4.1 Automatic mode ...................................................................................................................................... 10
5.4.2 Information.............................................................................................................................................. 10
5.4.3 Controls.................................................................................................................................................... 11
5.4.4 Connections ............................................................................................................................................. 11
5.4.5 Results...................................................................................................................................................... 11
5.4.6 The graph ................................................................................................................................................. 12
5.5. Configuration tab........................................................................................................................................... 13
5.5.1 Configuration ........................................................................................................................................... 13
5.5.2 Information.............................................................................................................................................. 14
5.5.3 Account management.............................................................................................................................. 14
6. UTILISATION GUIDE............................................................................................................................................... 15
7. SAFETY INSTRUCTIONS AND PRECAUTIONS FOR USE........................................................................................... 21
8. TRANSPORTING THE ROTAM ................................................................................................................................ 22
9. MAINTENANCE AND RECYCLING........................................................................................................................... 23
10. C E R TIFI CA TIO N S-Manufacturing and marketing’s dates ..................................................................................... 23
11. APPENDIX I : MANUFACTURER’S DECLARATIONS............................................................................................... 24

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05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
1. I N T R O DUC TIO N
The ROTAM is a device which allows diagnosis of complete or partial failures of the anterior
crossed ligament of the knee and associated ligaments.
The principle of the device is to lead a rotation effort of the tibia relative to the femur and to
measure the resistance of knee ligaments at this opposite rotation.
We perform measurements on the 2 inferiors members and the diagnostic of failure can be done by
observing the difference between these 2 values.
2. Glossary of marking symbols
Selecting sorting components
General safety
Warning
Keep dry
Type B electromagnetic device
Mark CE of the ROTAM
Read instruction for use
Show where put hands for the
transport
Fragile –handle with care
Admissible temperature range
Admissible humidity range
Admissible air pressure range
Indicates the direction of the position
of the knee and foot cups
Direct current
Alternating current
!

Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
Force sensor
Patella attachment with
straps
A 0,30m cable of the
rotation module
A motor and rotation sensors
An USB-A/USB-B cable
(1,80m)
A 2m cable to connect the ROTAM to the electric
power supply
A 1.7m mains power cable
An emergency
stop button
Electrodes cable
Foot attachment with
straps
A protect
connections
3. DESCRIPTION OF THE DEVICE
It composed of:
-An USB key for the ROTAM® software
-This instruction manual
-An interpretation guide for results
-A quick start manual

5
05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
4. USER GUIDE
4.1. Installation of the device ROTAM
Warning, the ROTAM installation can’t be done by someone with reduced mobility
4.1.1 Unpacking
(See first instructions for use)
4.1.2 Installation of the ROTAM
The ROTAM must be on an examination table in order to place easily the legs on this device. The patient
must be lie down on the table and put his head on the headrest (optimal relaxation).
Blocking foam

6
05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
4.2. Connections
Connect the power supply cable to the ROTAM then connect the PC to the device using the USB cable.
Connect the power supply bloc to the sector (tension 100- 240 V ~ 2 A 50/60 Hz).
When thel ROTAM device is turn on, a green LED is on.
When all the connections are connect and that the ROTAM is on, start the PC.
4.3. Installation of protect connections
Install the protect connections in the next way : place the cover on the front and secure with butterflies for that.

7
05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
5. ROTAM SOFTWARE
5.1. ROTAM software installation on a PC
You have the possibility, if you wish, to install ROTAM software on a PC.
The computer and the USB cable associated to the ROTAM and on which will be installing
the ROTAM software, must be accord to the norm EN 60950-1.
This software can be installed only on a computer with the
explotation system WINDOWS.
A/ Insert the USB key in the computer drive.
B/ Click on Setup
C/ The window « Welcome to ROTAM Wizard » opens
automatically, click on Next
D/ The window « Select Installation Folder » opens,
select « Everyone » and click on Next
If you don’t wish to install the ROTAM software at
the default slot, please edit the access path
registered in the field « Folder » (You can use the
exploratory by clicking « Browse ») .
E/ The window « Confirm installation » opens, click on
Next

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05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
F/ Wait for the software installation
G/ The window « Installation complete » opens,
click on Close
5.2. First used of the software
At the launch of the software the following window shows
up :
By default, the « Name» and the « Password » are admin and admin.
It is then possible to create and delete accounts, by going into the software configuration section (cf chapter
5.5. Tab configuration).
5.3. Tab patient record
This rubric allows to enter the personnals informations of a patient and to stock them in a data base.
To create a new patient, you must click on the icon placed in the toolbar at the left.

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05ROTAM FT02.008 C EN
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
When entering a new patient, you must at least enter his « Last name », his « First name », his « Birthday »
. All the other informations are optional.
After completing at least the last name, the first name, the birthday and the sexe, to save the new folder click
on the icon representing a floppy in the toolbar:
Automatically, a unique identifier is attributed to the patient (Interest in the context of statistical studies to
achieve by example…). Show the identifier of the
patient.
Allow to delete definitively a patient of the data base (Appears only after the creation of the first
patient).
Allow to load the data of the patient stock in the data base.
To call a patient record already saved, we can use the research by date or by name:
 By date: When a date is in, with the drop-down menu (to the right of « name »), you have the list
of associated names to the date then a list of first name according to the name.
Find the researched patient and validate it by clicking on « Load ».
 By name: type the name of the patient in the correspondent case placed to the right in the toolbar
and search the first name associated with the drop-down menu.
Find the researched patient and validate it by clicking on « Load ».
If more patients are homonyms (same last name and same first name), a drop-down menu will show up
after the selction of the last name and first name and will allows you to load the right patient record with the
help of the birthday.
5.4. Tab preparation test ROTAM
This tab will allows you to set and to start a test.
Option Radio: To activate the radio mode, please check the Radio case in Options section.

05ROTAM FT02.008 C EN
EN
10
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
5.4.1 Automatic mode
Before each test, the user must select the following sets:
5.4.2 Information
This display allows you to follow in real time the saved sets by the ROTAM during the test:
- Left torque: left ligament resistance
- Right torque: right ligament resistance
- Rotation: leg rotation angle
- Tighten: tightening force of the knee
Complete the distance base-foot (data for
positioning the patient always in the same
conditions)
Choose the direction
of the leg’s rotation:
-intern
-extern
Select the rotation
force torque from the
drop-down menu or
the bar.
Complete the characteristics of the tested
knee:
-Right knee or left
-pathologic knee, healthy or operated
- The distance base-foot