Use Instructions

DRAFT 2/12/2019 SPW 7
 WARNING: The System should not be used while driving, operating machinery or during any activity in
which involuntary muscle contractions may put the user at risk of injury.
 Stay at least 2 feet (0.6 meter) from others when using the System. The System could be harmful to
anyone with an electronic implant such as a pacemaker. Anyone with a hearing aid or cochlear implant
may hear an audible click.
 The device could be disrupted by RF-emitting equipment including: wireless home network devices,
mobile phones, cordless telephones and their base stations and walkie-talkies. See “EMC Compliance
and Warning Statement” section for additional information on preventing unwanted interference.
 Precaution: Keep the System away from other electronic devices that depend-on (receive) or radiate
(transmit) radio frequency energy, when it is powered on.
 The operation of the System may be impaired when operated near home devices such as wireless
network routers, mobile phones, cordless telephones and their base stations and walkie-talkies. Keep
the sTMS mini device at least 2 feet (0.6 meter) from these devices when it is powered on and in use.
 Keep credit cards, audio/video tapes, computers, computer disks, flash memory sticks, cell phones,
personal digital assistants (PDAs), MP3 players, headphones, digital cameras, portable glucose meters
and other electronic devices or electronic storage media more than 2 feet (0.6 meter) away from the
System when it is in use.
 Keep any loose metal objects such as eyeglasses, keys, coins, jewelry, watches and hair clips more than
2 feet (0.6 meter) away from the System when it is in use.
 Keep wearable medical devices such as insulin pumps, medicinal pumps, monitors, bone grow
stimulators and Transcutaneous Electrical Nerve Stimulator (TENS) devices more than 2 feet (0.6 meter)
away from the System when it is in use.
 Safety and effectiveness have not been established in pregnant women, children under the age of 18
and adults over the age of 65.
 Caution should be used for patients with suspected or diagnosed heart problems.
 The System is only intended to be serviced or maintained by the manufacturer. Do not attempt to open
the device. The warranty may be invalidated. If the device is opened, contact eNeura at: +1
855.366.8355 option 1.
 Keep the System out of the reach of children.
 Side effects can include minor dizziness, nausea, vomiting, application site tenderness, muscle spasm,
headache and migraine.
 Special precautions regarding Electromagnetic Compatibility (EMC) are required when installing and
using the System. Portable and mobile communications devices can affect proper operation of the
System. See “EMC Compliance and Warning Statement” section of the Instructions for Use for more
information.