1.2 Indications for use
ViMove2 is a wireless medical device system that measures,
records and analyses movement parameters of the lumbar
spine and other body regions. The system provides real-
time biofeedback in the form of visual signals encouraging
appropriate postures and movements, assisting in rehabilitation
and decreasing the recurrence of pain and dysfunction.
1.3 Warnings
None noted.
1.4 Contraindications
• Subjects with an implanted electronic device (for example a
cardiac pacemaker) should not be subjected to use unless
specialist medical opinion has first been obtained.
• Subjects with undiagnosed pain conditions.
• Subjects with diminished mental capacity or physical
competence limiting the use of the device.
• Pregnant Subjects, unless specialist medical opinion has
first been obtained.
• Subjects with a known skin condition or allergy, unless
specialist medical opinion has first been obtained.
1.5 Precautions
The following precautions should be observed when using the
ViMove2 device:
• When using any dorsaVi system, please plug the power
plug directly into a wall socket. Do not plug via a power
board / power strip unless the power board has been tested
and certified to all relevant electrical safety standards and
regulations.
• Please handle the power plug and charging cable with care.
Do not twist the charging cable. If twisting of the cable or
other deformities are observed, please contact dorsaVi
support.
• To preserve battery life, please ensure that the system is
fully charged at least once every 3 months. Failure to do
so may result in reduced battery performance (less than
12 hours).
• All skin mounted devices used to measure lumbopelvic
movement are subject to errors due to soft tissue artifact.
Determination of the pelvic orientation using ViMove2 has
not been validated for use on subjects with high Body Mass
Index (BMI) or adiposity.
• Only use the unit for purposes for which it is intended.
• Always ask the subject about skin allergies they may have
prior to ViMove2 use. Gauge the severity of the allergy
and assess whether a reduced session on ViMove2 and /
or using a protective film on the skin prior to application,
would be safer for the subject, or whether they should not
use ViMove2 at all if the allergy is of a serious nature.
• In order to reduce the risk of skin irritation, it is advised not
to wear the sensors for any more than 24 hours in any 72
hour period.
• There is the potential for patient injury or re-injury if there
is a function failure and the device fails to alert the patient
of risk related movements. To prevent this, the device has
been programmed to alert the patient / user if a signal loss
or other malfunction occurs. Ensure the patient is informed
of these features and is aware they may not receive reliable
movement data if one of these warnings is shown.
• Use only with the supplied power supply.
• As with all batteries there is a risk of battery leakage or
explosion. The manufacturer recommends operating
conditions between 0-45°C and storage 21-25°C.
• Do not clean the equipment with Acetone. Use alcohol
wipes for cleaning.
• Do not immerse any components of the device in water or
any other liquid substance.
• Use of any equipment should be immediately terminated
upon any sign of treatment-related distress or discomfort.
• Not to be connected to a subject undergoing MRI (Magnetic
Resonance Imaging), Electro surgery or defibrillation.
• Operations in close proximity to shortwave or microwave
therapy equipment may produce instability in the ViMove2
output.
• Do not operate the device within 10 feet (3 meters) of
powerful radio interference producing sources such as
arc welders, radio thermal treatment equipment, x-ray
machines, or any other equipment that produces electrical
sparks. Portable and mobile RF communication equipment
may also affect this equipment.
• Radiated radio frequency electromagnetic fields can cause
performance degradation in ViMove2.
• After use, the Sensor Adhesives may be a biohazard.
Following use, dispose of these materials in accordance
with accepted medical practice and any applicable local,
state and federal laws and regulations.
• The operator is responsible for ensuring the safety of any
devices controlled or triggered by ViMove2 equipment or
software, or by any software or hardware receiving data
from equipment. dorsaVi Ltd equipment must not be
configured or connected in such a way that failure in its
data acquisition, processing or control functions can trigger
subject feedback stimulus that poses an unacceptable
level of risk.
• Between uses of the device, wipe down components with
alcohol wipes or swabs.
• Ensure the subject does not perform any movement that
could cause an injury or that is beyond their capacity. The
clinician should use ViMove2 at their discretion and use
knowledge about the subject’s condition to inform their
decision making when conducting each assessment to
ensure safety.
1.6 Adverse reactions
The potential adverse reactions that may be experienced with
the use of the device include:
• Skin irritation beneath the Sensor Adhesives.
