DJO Global ARTROMOT-SP3 Mode D'emploi page 26

. Safety information
Definitions
It is mandatory to read the safety state-
ments before use of the CPM device. The
safety statements are classified as follows:
Danger!
This term indicates an imminent hazard.
If not avoided, this hazard will result in
death or serious injury.
Warning!
This term indicates a hazard. If not
avoided, this hazard can result in death
or serious injury.
Caution!
This term indicates a potential hazard.
If not avoided, this hazard can result in
minor personal injury and/or product/
property damage.
Safety information
Danger!
Explosion hazard –
ARTROMOT®-SP is not designed
for use in areas where an explosion
hazard may occur. An explosion hazard
may result from the use of flammable
anesthetics, skin cleansing agents and
disinfectants.
Warning!
Patient hazard –
− Only authorized individuals are al-
lowed to operate the ARTROMOT®-
SP device. Individuals are authorized
after receiving training in the opera-
tion of the device and reading this
operation manual.
– Before using the device, the operator
must ascertain that it is in correct
working order and operating condi-
tion. In particular, the cables and
connectors must be checked for signs
of damage. Damaged parts must be
replaced immediately, before use.
– Before therapy, a test run consist-
ing of several exercise cycles must
be completed, first without and then
with the patient. Check that all set-
ting screws are tightened.
– Stop therapy immediately, when you
have doubts about the device set-
tings and/or the therapy protocol
− It is important that the patient's
position is anatomically correct.
Therefore, carefully verify the follow-
ing settings/positions:
1. carriage angle
2. ankle joint axis/carriage axis
motor A
3. Footplate adjustment
4. Calf support assembly
− Movements must not cause any pain
or irritation.
− Patients must be fully conscious
while being instructed in the use of
the CPM device and during therapy.
− The choice of the therapy param-
eters to program and of the therapy
protocols to use is restricted to the
responsible physician or therapist. It
is the physician's or therapist's deci-
sion whether or not to use the CPM
device on a specific patient.
− The patient must be familiar with the
functions of the ARTROMOT®-SP
programming unit and the unit must
be within easy reach of the patient,
allowing him or her to stop therapy, if
needed. Patients unable to operate
the programming unit, e.g. paralytic
patients, must never be left unat-
tended during therapy.
− After data storage, write the patient's
name on the patient chip card¹. The
card should only be used for this pa-
tient. If the patient chip card¹ is used
for another patient, be sure to delete
the previous patient's data from
the card first (see: section 5.3, "New
patient").
¹Use original chip cards only .
− All accessories used with the
ARTROMOT®-SP device must first
be approved by DJO Global.
– Modifications to the medical device
described in this document without
the manufacturer's written consent is
prohibited.
– Stability of the physiotherapy unit
must always be ensured while it is in
use. The ARTROMOT-SP must only
be set up on surfaces that guaran-
tee its stability. Very soft or instable
surfaces (such as waterbeds) are NOT
suitable.
− Do not allow parts of the body
or any objects (such as blankets,
cushḹions or cables) to get caught in
the moving parts of the CPM device.
¹ Devices of the ARTROMOT®-SP product
family with patient chip card only.
Warning!
– Extreme caution should be taken
when in use around small children
and babies! Su cient distance to the
device is mandatory for their safety!
– Never leave the device unattended
when it is switched on! Switch the
device o and disconnect the power
line from the wall outlet!
– After use, store the device in a safe
place! Ensure device stability also
during storage!
Warning!
Shock hazard –
Strictly observe the following warnings.
Failure to do so endangers the lives of
the patient, the user and other persons
involved.
− Before use allow the ARTROMOT®-
SP to reach room temperature. If the
device has been transported at tem-
peratures below 0 °C (32°F), leave it
to dry at room temperature for about
2 hours, until any condensation has
disappeared.
– The ARTROMOT®-SP device must
only be operated in dry rooms.
– When disconnecting the device from
the power line, remove the plug from
the wall outlet first, before discon-
necting the cable from the device.
– When connecting the device to other
equipment or when creating a medi-
cal system, check that the sum of
leakage currents will not cause any
hazard. Please contact ORMED, if you
have questions in this matter.
– Do not use multiple portable socket
outlets (MPSO) to connect the device
to the power line. ARTROMOT®-SP
must be connected to a properly in-
stalled wall outlet with a non-fused
earthed wire. Before connecting the
power cord, it must be completely
unrolled and placed such that it will
not get caught in the moving parts of
the device.