Cleveland Medical Devices Inc. 0103 Manuel D’Utilisation
ParkinSense User’s Guide v. 1.0
4
Introduction
Intended Use
ParkinSense is not FDA cleared to market. It is not intended for use in experimentation
that involves human testing without specific IRB approval.
The ParkinSense movement disorders quantification system is intended for use by
researchers analyzing quantitative features of movement disorders which require
recording motion and/or electrical activity of muscle.
THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES. OPERATION IS
SUBJECT TO THE FOLLOWING TWO CONDITIONS: (1) THIS DEVICE MAY
NOT CAUSE HARMFUL INTERFERENCE, AND (2) THIS DEVICE MUST ACCEPT
ANY INTERFERENCE RECEIVED, INCLUDING INTERFERENCE THAT MAY
CAUSE UNDESIRED OPERATION.
NOTE: THE MANUFACTURERE IS NOT RESPONSIBLE FOR ANY RADIO OR TV
INTERVERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS
EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE PATIENT’S
AUTHORITY TO OPERATE THE EQUIPMENT.
Contraindications
Interference may occur in the vicinity of equipment marked with the following symbol:
This device complies with CFR 47 – Part 15, 15.109(b) and 15.247.
Warnings
!!!! Do NOT connect the system to a computer via the mini-USB port at the same
time a subject is connected to the electromyography electrode leads.
!!!! Do NOT expose the system to water. Water exposure may permanently damage
the unit.
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