OMNIHI5
USER MANUAL
52
MNL-0022
12. Use Specification
Item
Description
Product Name
Nerve and Muscle Stimulator
Product model
XFT-2003E
Intended use/indications for use
Functional Electrical Stimulation (FES).
Improvement of hand function and active range of motion
in patients with hemiplegia due to stroke or upper limb
paralysis due to C5 spinal cord injury.
Neuromuscular Electrical Stimulation (NMES);
Increase or maintain hand range of motion;
Reduce muscle spasms;
Retard muscle atrophy;
Reeducate muscles;
Increase local blood circulation.
Intended patient population
Patients with limited hand function.
Intended part of the body or type
of tissue applied to or interacted
with
The intact skin on the area of the upper limb to be
stimulated.
Intended user profile
Intended user includes patient, medical persons and/or
other operators, they are required to meet below
requirement at least:
•
Ability to read and understand user manual, and
follow the instruction to operate device;
•
Are healthy or use the device under doctor
’s direction;
•
No nationality or race limitation;
•
Can identify parts of body.
Use environment
•
Reusable
•
Hospital use or home use
•
Use the EMC environment for group 1 class B
•
Work conditions:
Temperature 5~40°C,
Humidity ≤80%(Non-condensing)
Atmospheric pressure 86~106kPa
Operation principle
Place the Stimulator to correct position:
Extensor Digitorum Muscle. To optimize individual
function the stimulator position might be adjusted slightly.
Contraindications
•
Do not use with electronic monitoring equipment,
NMR-imaging pace-maker, defibrillator and high-
frequency medical device.
•
Powered muscle stimulators should not be used on
patients with cardiac demand pacemakers
•
Do not use if you have a history of autonomic
dysreflexia
•
Do not use FES following recent surgery where
muscle contraction may disrupt the healing process.
Install type
Wearable
