Intended Patient Population; Intended Contact Points Of The Device With The Patient's Tissue; Intended Application Setting; Expected Service Life - DJO ARTROMOT-S4 Modo De Empleo

1.10 Intended patient
population
The ARTROMOT®-S4 is intended for passive
mobilisation of the shoulder joint. To this
end, the device settings should be optimally
adapted to the patient. The following re-
quirements apply to the patient:
– At least 8 years of reading experience
is required to read and understand the
operating instructions.
– The patient weight should not exceed
175 kg
– To enable an anatomically correct adjust-
ment, the patient should not be taller
than 210 cm
– To enable safe operation, the patient
must be awake, alert and mentally
competent
1.11 Intended contact points of
the device with the pa-
tient's tissue
The patient sits on the device seat, touching
the surface of the seat (31), the backrest (30)
and the headrest (28). The to be treated arm
of the patient rests on the arm support as-
semblies (19, 20, 25) of the motion element
(32). The healthy arm of the patient rests on
the armrest (4).
The device may only come into contact with
healthy skin. A closed wound treatment for
the affected arm or shoulder must therefore
be ensured.
1.12 Intended application
setting
Professional setting:
The ARTROMOT®-S4 is intended for use in a
clinical setting (hospital/rehabilitation facil-
ity) or medical practice and can be moved
from room to room.
Home environment:
On the basis of a doctor's prescription, the
ARTROMOT®-S4 can also be used in the
patient's home environment (e.g. as part of
a rental service model).

1.13 Expected service life

The "expected service life" of the medical
device, including all parts and accessories
supplied, is 10 years under normal use and
correct maintenance. Any use beyond this
period is the responsibility of the operator.
1.14 Ambient conditions during
operation
See Chapter 8. "Technical data" – "Ambient
conditions (operation)"
61