Biocompatibility; Essential Performance; Frequently Used Functions; User Profiles - DJO ARTROMOT-S4 Modo De Empleo

1.6 Biocompatibility

Those parts of the ARTROMOT®-S4 that
come into contact with the patient when
the device is used as intended, are designed
to fulfill the biocompatibility requirements
of the applicable standards.

1.7 Essential Performance

– The programmed angles are accurately
maintained with a tolerance of +/− 2°.
– The programmed speeds are accurately
maintained with a tolerance of +/− 5 %.
– The selected mode and mechanical set-
tings do not change during operation.
– The device can be stopped with the STOP
button and all other buttons.

1.8 Frequently used functions

a) Unpacking (device and accessories)
b) Inserting the system rack and locking it at
the chair and backrest
c) Mounting the armrest
d) Inserting the motion element and locking
it at the system rack
e) Device connections (mains power con-
nection, connecting the control unit and
the motion element)
f) Mechanical adjustments of the motion
element on the rotational axes
g) Programming the control unit
(range of motion, speed, functions)
h) Storage

1.9 User profiles

The ARTROMOT®-S4 is intended for use
by medical specialists ("professional users")
properly trained in the settings and use of
the device, such as: specialist physicians,
physiotherapists, occupational therapists
and private care nurses.
Users must be able to do the following:
– Read and understand the instructions
for use, warnings and safety notes.
This requires at least 8 years of reading
experience
– Reading and understanding the precau-
tions and contraindications of the device
– Observing and understanding the safety
labelling
– Observing the information on the display
Furthermore, the medical device is also
intended for use by patients ("lay users").
To this end, the patient must be trained in
the operation of the device, and must at
least understand how to start and stop the
device.
A patient advisor or an equivalent person
from the rental service organisation is
required for maintaining the device and
acting as a contact for the patient. This
person is in charge of assembling the device,
adjusting the mechanical settings according
to the patient's size, initial programming of
the device according to medical specifica-
tions and instruction of the patient in the
programming.
The patient caregiver must explain the
operation of the ARTROMOT®-S4 to the
patient and inform the patient about the
warnings, precautions and hazard informa-
tion contained in the instructions for use.
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