05ROTAM FT02.008 C EN
EN
21
Entreprise certifiée ISO 13485 : 2016, NF EN ISO 13485 : 2016
par le LNE G'MED
7. SAFETY INSTRUCTIONS AND PRECAUTIONS FOR USE
- This device is only for use by medical staff.
- The data is only to be interpreted by medical staff trained by an instructor from GENOUROB®.
- For patients who underwent intervention of the anterior crossed ligament, it is strictly forbidden to make a
ROTAM test on a plasty less than three months.
- Do not use this device with patients who are unable to understand or follow the instructions given by the
medical staff at the controls.
- Do not use this device with patients affected by contagious skin infections (follow good medical practice):
the device may be covered with a disposable sheet without affecting its performance.
- We recommend disinfecting the device with an alcohol-based product (see description below) or wipe
before using for the first time and between patients.
- The customary precautions regarding hygiene for equipment in contact with patient
s’ skin must be followed:
the device must be disinfected using bactericidal products (EN 1040, EN 1276, NF T72-
190, active against Mycobacterium tuberculosis) and fungicidal products (EN1275, EN1650, active against
HIV-1, active against BVDV, rotavirus and herpesvirus).
- It is forbidden to use this device in an operating theatre in order to avoid any bodily or medical fluid
.
- In case of power supply interruption, the device can function again only after a launch of ROTAM software. At
this moment, the boot takes again his neutral position, BE CAREFUL, 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 other liquids.
- If a power failure should occur during the test, unstrap the knee cup as quickly as possible.
-
You are working with an electrical device. Misuse results in risk of electric shock. Only food, ASTEC reference
DPS55-M (Certified Medical: maximum temperature 43 ° C), provided by the company GENOUROB® should be
used to electrically power the ROTAM.
-
The parties applied to the patient (shell boot straps) can reach 45 ° C when using the ROTAB within the
maximum permitted environmental conditions (ambient temperature 40 ° C).
-
To avoid electrical shock, this appliance may only be connected to a power supply network with a protective
ground
.
-
An additional base multiple sockets or extension cord shall not be connected to electro-medical ROT
AM
-
Power must be connected to the 230 Volt-50 Hz (100-240 V 50/60 Hz 2
).
-
It is prohibited to use the device with a damaged power strip or connecting cables exposed.
-
Leave the plug accessible area in order to proceed safely stop
ROTAM
-
Do not disassemble the machine: the maintenance and calibration are carried out by personnel trained for
this purpose within the GENOUROB® society
.
-
Prohibition to change the GNRB ROTAB undocumented GENOUROB: spare parts can only be replaced by
personnel trained for this purpose within the GENOUROB® society
.
-
The use of sensors and cables other than those specified, with the exception of the sensors and cables
sold by the company GENOUROB® equipment as replacement of internal components can result in
increased levels of emissions or decrease in the equipment immunity levels
.