Safety Information - DJO Global ARTROMOT-E2 Manual De Instrucciones

3. Safety information

Deinitions
Read the safety statements before use of
the CPM device. The safety statements are
classiied as follows:
m Danger!
indicates an imminent hazard. if not
avoided, this hazard will result in death
or serious injury.
m Warning!
indicates a hazard. if not avoided, the
hazard can result in death or serious
injury.
Caution!
m
indicates a potential hazard. if not
avoided, the hazard may result in minor
injury and/or product/property damage.
58
Safety information
Danger!
m
Explosion hazard—
The ARTROMOT®-E2/-E2 compact
is not designed for use in areas of
medical locations where an explosion
hazard may occur. An explosion hazard
may result from the use of lammable
anesthetics, skin cleansing agents and
disinfectants.
Warning!
m
Patient hazard —
− Only authorized individu-
als are allowed to operate the
ARTROMOT®-E2/E2 compact. indi-
viduals are authorized after receiving
training in the operation 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, irst 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.
Warning!
m
Patient hazard —
− Ensure an anatomically correct
setup of the CPM device suitable for
the patient to be treated. Therefore,
carefully verify the following settings/
positions:
(also refer to the numbers on the
device):
1. horizontal adduction/abduction
(horizontal extension/lexion)
2. height adjustment
3. Adjustment of the positioning
angle
4. Adjustment of the forearm length
5. Axis adjustment motor A and mo-
tor b
6. backrest adjustment
7. ROM adjustment
− it is not permitted to change the
adjustment of 1 through 6 while the
CPM device is applied on a patient.
– 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 parame-
ters 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 speciic patient.
− The patient must be familiar with the
functions of the ARTROMOT®-E2/-E2
compact 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 unattended during
therapy.
59
– write the patient's name on the
patient chip card. The card should
only be used for this patient.
if the patient chip card is used for
another patient, be sure to delete
the previous patient's data from
the card irst (see sections 4.1 and 5.3,
paragraph „new Patient").
use original chip cards only.
− All accessories used with the
ARTROMOT®-E2/-E2 compact must
be approved by djO Global.
– Modiications to the medical device
described in this document without
the manufacturer's written consent
is prohibited.
– Ensure that the medical device is
securely set up on solid ground dur-
ing use.
– 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.
− Always seat the patient on a chair
with four legs and without armrests
when using the ARTROMOT®-E2
compact.
Warning!
m
– Extreme caution should be taken
when in use around small children
and babies! suicient distance to the
device is mandatory for their safety!
– never leave the device unattended
when it is switched on! switch the
device of and disconnect the power
line from the wall outlet!
– After use, store the device in a safe
place! Ensure device stability also
during storage! do not rest or lean on
or push the assembled device because
it might tip over.