DJO 80.00.040, Operating Instructions Manual

Page: 37 / 160

33
English
m Warning!
Patient hazard –
− It is important that the patient's
position is anatomically correct .
Therefore, carefully verify the following
settings/positions:
1. femur length
2. knee joint axis
3. tibia length and leg rotation
4. leg support assemblies
− Movements must not cause any pain
or irritation .
− The patient must be fully conscious
while being instructed in the use of
the CPM device and when using the
device.
− The choice of the therapy param-
eters to program is restricted to the
responsible physician or therapist.
The
physician or therapist
must de-
cide on a case-by-case basis whether
the device can be used with a particu-
lar patient.
− The patient must be familiar with the
functions of the ARTROMOT®-K1
classic control pendant and the
control pendant must be within
easy reach of the patient, allowing
him or her to stop therapy if needed.
Patients unable to operate the con-
trol pendant , e.g. paralytic patients,
must never be left unattended during
therapy.
The ARTROMOT®-K1 classic must
only be used with accessories ap-
proved by DJO.
− Do not allow parts of the body or
any objects (such as blankets, cush-
ions, or cables) to get caught in the
moving parts of the CPM device .
− Modifications to the medical device
described in this document without
the manufacturer's written consent
are prohibited.
− The simultaneous treatment of both
legs by simultaneous use of two CPM
devices is not permitted because the
motion elements might interfere with
each other.
− Stability of the CPM device must al-
ways be ensured while it is in use. The
ARTROMOT-K1 classic must only be
set up on surfaces that guarantee its
stability. Very soft or instable surfaces
(such as waterbeds) are NOT suitable.
m Warning!
− Special care must be taken when
small children and babies are present
while the device is in use! Sufficient
distance to the device is mandatory
for their safety!
− Never leave the device unattended
when it is switched on! Switch the
device off and disconnect the power
line from the wall outlet!
− After use, store the device in a safe
place! Ensure device stability also dur-
ing storage!
m Warning!
Shock hazard –
Strictly observe the following warnings.
Failure to do so endangers the lives of
the patient, the user, and other persons
involved.
− Allow the
ARTROMOT®-K1 classic
to reach room temperature
before
use. If the device was transported
at
temperatures below 0°C (32°F)
,
allow it to stand at room temperature
for about 2 hours, until all condensa-
tion has disappeared.
− The ARTROMOT®-K1 classic 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 DJO, if you
have questions in this matter.