TF.16 IFU StarDevice.003.10-EN 2021-01-12
prepared by Pulavskyi A., Kolyesnik O.
12
doctor with the help of the manipulator makes a mechanical (percussive) effect on ligaments, muscles or
vertebral segments of a patient. The frequency of shocks is set in the range from 4 to 12 beats / sec., in
increments of 0.1 beats / sec. Force / intensity of shocks can be varied within the limits of 4.54 kg / cm2 -
15.87 kg / cm2 in 2.2 kg / cm2 increments, which corresponds to a scale from 10 to 35 points. There are
appropriate tips in the set of the device to influence different areas or organs of a body.
4 BEFORE USING THE DEVICE STARDEVICE
®
4.1
THE LIST OF PREPARATORY ACTIONS
Before using the device STARDEVICE
®
, you should:
• To make sure that the power supply network is used with a protective ground; that the voltage in the
network is in the range 100 - 240V, 50 - 60 Hz. The device STARDEVICE
®
is intended for connection to
type F (Schuko) sockets (European socket with CEE 7/4 grounding, DIN 49440 standard). Suitable
adapter is required to connect to other types of sockets; in any case, the presence of a protective ground
in the power socket is mandatory!
• To ensure the presence and storage of 70 - 96% hydroalcoholic solution to clean the tips;
• To ensure the presence and storage of medical alcohol wipes or cotton discs for cleaning the tips.
• To ensure the presence and storage of wet wipes for a screen that do not contain alcohol to clean the
display of the device STARDEVICE
®
!
• To organize the workplace of the operator so that the device is placed on a solid, smooth, dry and not
slippery surface, and to comply with the measures listed in the paragraph 2.3.
• Remove the device from its packaging. Check if there is no damage to the electronics housing, the
manipulator, the power cord and the manipulator cable. Switch the main switch to the "Off" position.
• Connect the manipulator cable to the corresponding connector on a back panel of the electronic unit.
• Connect the power cord to the power connector on a back panel of the electronic unit, plug the power
cord into a power socket.
4.2
THE OPERATOR’S QUALIFICATION
The device STARDEVICE
®
is intended for use by the operators having special knowledge in the field of
application of this device and the operators who has been trained how to use properly the device, as well
as the operators who has practical skills in working with similar medical procedures. The operator must
have basic physical and cognitive prerequisites, such as sight, hearing and literacy.
Besides, the operator must take into account the manufacturer's recommendations (
Chapter 1, item
1.2
"Indications for use" and item
1.3 "Contraindications"
) to be aware of the latest developments and
medical publications on shock-wave therapy for detailed information on contraindications and side effects,
not known at the time of manufacture.
It is forbidden to use the device STARDEVICE
®
for operators with disabilities (disabled people), whose
physical or mental deficiencies do not allow to actually monitor and perform a treatment procedure.
The operator must pass the appropriate training regarding the correct operation of the device before
working with the device STARDEVICE
®
:
