SHOULDER PACEMAKER
TM
- User Manual 04-06EN
16
ALARMS
Alarm activation is signaled by the lighting of the red led placed as described in (e).
For a low charge level, this red led lights up in permanent flashing mode to indicate to the user the battery status and therefore the need to
stop stimulation. This led lights up when the battery charge level falls below a specific critical threshold value (20%) for the battery. The
automatic shutdown of the device will take place for a threshold value (1%) of battery charge.
In Wireless mode, the software/application interface allows you to receive error messages through a log message window.
For example, if a parameter’s value entered is out of the permitted range, an error message will appear with an explanation of the error type
on the software application interface and no out-of-range parameter is accepted by the application and by the device.
For each stimulation session, any error messages will be automatically saved and inserted into a file saved locally on the user's computer or
mobile phone. In the first case, make sure you have enough storage space for that archive, by checking file size and free space left on your disk
(refer to you operative system manual for these standard computer maintenance procedures). Error and log messages contain important data,
hence the Shoulder Pacemaker Control software does not provide any archive deletion feature. Do not manually delete error and log archive.
External storage permission is required to use the MySPM and MySPM @ Home applications. The application reports if the battery level of the
stimulation device and the tablet is below 20%. The application generates an alarm if the stimulation device disconnects and if the Internet
connection is lost.
PROGRAMS
MANUAL MODE
The
Manual
Operating
program
(M)
is performed at the beginning of the training program to get the patient’s confidence with the
stimulated muscle sensation. In this program the stimulation voltage intensity is increased/decreased manually by the operator by turning
the wheel and it remains constant in the absence of wheel's movement. When the button is pressed, the program will set the recovery
phase reaching one third of the selected threshold. Press the button again to exit the program and return to the selection menu.
AUTOMATIC MODE
The
Automatic Operating
program
(A)
implements an algorithm for activating/deactivating stimulation according to the arm angle. The
subject's movement is detected by the MIMU (Magneto-Inertial Measurement Unit) technology which electrostimulation is equipped
with. These sensors record the acceleration and angular velocity data of the device and allow to estimate the movement of the subject's
arm. In this way you can choose to inhibit the stimulation in specific movement conditions/static phases, and then activate it again when
these conditions are no longer verified.
To establish the level of stimulation, initially, the subject manually chooses the maximum tolerated stimulation value. Manual selection
implies that the subject, by rotating the wheel, progressively increases the intensity of the stimulation. Once the maximum tolerated
intensity level has been reached, the subject presses the button, the value of that intensity is recorded and the session begins.
In the range of elevation from 0° to 180°, stimulation occurs at different levels:
•
from 0° to 20° at the recovery value (one third of the selected maximum value)
•
from 20° to 70° linearly increasing as a function of the elevation angle up to reaching the selected maximum value
•
from 70° to 180° at the selected maximum value.
TRAINING
The
Training
program is the heart of the stimulation session. During the tetanic muscle contraction, the patient can perform rehabilitative
exercises, established and described by the reference medical staff.
Each training mode consists, primarily, of choosing the maximum contraction value and, then, repeating load cycles and unloading cycles.
The manual selection of the threshold, must be performed on each use. Manual selection implies that the subject, by rotating the wheel,
progressively increases the intensity of the stimulation. Once the maximum tolerated intensity level has been reached, the subject
presses the button, the value of that intensity is recorded and the training session begins.
The four training methods differ for the duration of each phase:
Training 5 seconds= loading phase 5 seconds, recovery phase 4 seconds
(P1)
Training 7 seconds= loading phase 7 seconds, recovery phase 4 seconds
(P2)
Training 9 seconds= loading phase 9 seconds, recovery phase 5 seconds
(P3)
Training 11 seconds= loading phase 11 seconds, recovery phase 6 seconds
(P4)
The voltage value reached during the load phase is equal to the initially defined threshold value. The voltage value reached during the
recovery phase is equal to one third of the stored threshold value.
The exercise session and the type of training must be agreed with the medical staff.
WIRELESS MODE
The SPM01K2/SPM01K3/SPM01K4 product configurations includes a stimulator with an operation program that can be set via wireless or
Bluetooth® Low Energy (BLE), in addition to the previous stimulation programs that can be set manually as described above.
To use wireless controlled feature, you must use:
a laptop running the Shoulder Pacemaker Control 1.1.2.0 software supplied by the manufacturer (SPM01K2 product configuration).
Radio transmission with a laptop complies with the IEEE 802.15.4 PHY standard.
or a mobile phone/tablet compatible with BLE communication running the MySPM or MySPM@Home application supplied by the
manufacturer (SPM01K3/SPM01K4) product configuration) and available from Android 6.0 onwards.
In
Wireless mode
(W)
, the user has a graphical interface that allows to set the stimulation training settings.
Summary of Contents for SHOULDER PACEMAKER SPM Series
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