genourob ROTAM Instructions For Use Manual Download Page 4 | Manualshive

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genourob ROTAM Instructions For Use Manual Download Page 4

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

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Summary of Contents for ROTAM

Page 1: ...Instruction for use of the ROTAM DIAGNOSTIC INSTRUMENT FOR PERIPHERALS LIGAMENTS AND ANTERIOR LIGAMENTS INJURIES...

Page 2: ...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...

Page 3: ...aments 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 s...

Page 4: ...on 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 prot...

Page 5: ...ing 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 or...

Page 6: ...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...

Page 7: ...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 W...

Page 8: ...e software the following window shows up By default the Name and the Password a r e admin and admin It is then possible to create and delete accounts by going into the software configuration section c...

Page 9: ...all 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 t...

Page 10: ...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 p...

Page 11: ...This module allows you to launch the ROTAM test and doing a reset of the programme after a loss of connection software 5 4 4 Connections This module allows you to connect the software to the ROTAM Whe...

Page 12: ...ed test data The deletion is irreversible The button PDF Report allows you to generate a PDF file with the marked tests and the correspondent graph Reports can be found in My Documents PDF Genourob Ex...

Page 13: ...to the default scale 5 5 Configuration tab The configuration tab gives access to you to the account management of the printer and saves 5 5 1 Configuration Default practitioner name e n t e r here th...

Page 14: ...cument Footer information printed on top of the document 5 5 3 Account management Different fields of the account management part New user enter the name for the new user Password enter the password f...

Page 15: ...1060 HPa It removed the patient s clothes legs Explain to the patient the operation of the ROTAM to avoid the patient surprise during the test during the forced rotation of the tibia relative to the f...

Page 16: ...cup on the patella Locating the positions of the patella and the TTA and fix the patient s leg Attach the knee cup on the patella showing the trait of the patella in the center of the hole marked fro...

Page 17: ...port and take the measurement Adjust the position of the support boot until the heel fits snugly Fix the foot in position by tightening both buckles Fix the tibia by tighten with the two straps Take t...

Page 18: ...r settings rubric select the tested knee and clarify his status enter the support foot distance see 1 4 2 2 Tighten the knee cup and the thigh strap and launch the tests Secure the knee cup by tighten...

Page 19: ...both legs display the curves via the Results tab In the number table select the data you would like to see for the curve and click on the small corresponding box to the left then click on Display clic...

Page 20: ...n is situated on the front right side of the device If you need to If the patient experiences pain during the test for example press firmly on the button The test in progress will cease immediately an...

Page 21: ...do not place your fingers around the boot to avoid pinching The ROTAM has been created for a functional time of 5 minutes maximum follow by a rest time of 15 minutes minimum Do not clean with water or...

Page 22: ...CTRICAL EQUIPMENT It is strictly forbidden to delete BDDs databases from the GNRB software It is strongly recommended to save BDDs regularly to an external hard disk 8 TRANSPORTING THE ROTAM The ROTAM...

Page 23: ...lectronic equipments 10 CERTIFICATIONS Manufacturing and marketing s dates Manufacturer s address GENOUROB SAS B t 60 rue Henri G ret 53000 LAVAL France First marketing s date 29 01 2019 The manufactu...

Page 24: ...ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Electromagnetic radiation disturbance Radiated emissions CISPR 11 Group 1 ROTAM uses RF ene...

Page 25: ...Home health care environment and an environment of a professional health care facility Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 0 UT for 0 5 cy...

Page 26: ...environment of a professional health care facility Proximity fields issued by RF wireless communication devices IEC 61000 4 3 interim method 9 V m 710 MHz 745MHz 780MHz 5240MHz 5550MHz 5785 MHz 27V m...

Page 27: ...Entreprise certifi e ISO 9001 2008 ISO 13485 2003 NF EN ISO 13485 2004 par le LNE G MED 27 05ROTAM FT02 008 B...

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