17
06
10) Discontinue and do not increase the intensity level if you feel discomfort during use.
11) Stimulation should not be applied transcerebrally.
12) Stimulation should be stopped if discomfort is felt or reported.
13) The safety of electrical stimulation during pregnancy has not been established.
14) Patients with suspected or diagnosed heart disease should follow precautions
recommended by their physicians.
15) Patients with suspected or diagnosed epilepsy should follow precautions re-
commended by their physicians.
Adverse Reactions
* Skin irritation and burns beneath the stimulation electrodes have been reported
with the use of powered muscle stimulators.
Skin Care
* Skin should be clean and free of any perfumes, alcohol, lotion or debris.
* Skin prep pads may be used during NMES mode but may interfere with the
sEMG signal for EMG testing or ETS mode.
* Presence of facial hair may interfere with electrode function however skin may
be very sensitive after shaving so it is recommended to wait several hours
after shaving before applying electrodes to avoid irritation.
* Gently remove electrodes from the skin.
Chapter 6 Specifications and Parameters
Power: rechargeable lithium battery 7.4V
Safety class: internal power BF type
Protection type: Class II device
Shutdown current: < 0.1mA
Operating current: 0 ~60mA
Measuring range: 10uV ~999uV
Highest resolution: < 2uV
Input noise: <10uV
Transmission bands: 120Hz ~ 1000Hz (-3dB)
Differential mode input impedance: >5M
Ω
Common mode rejection ratio: >100dB
NMES
Frequency, 5-100Hz, biphasic balanced wave ±10%
Pulse width: 50 ~ 450uS (±10%
）
Output intensity: load 1000
Ω
, min 1mA, max 60mA
ETS
Frequency: 18 Hz, biphasic balanced wave ±10%
Pulse width : 150 uS (±10%)
Output intensity: load 1000
Ω
, min 1mA, max 60mA
Working Environment
Temperature: 5
℃
~ 40
℃
Relative humidity :
≤
80%HR
Atmos.: 86Kpa ~ 106Kpa
Storage Environment
Temperature : -20
℃
~ 55
℃
Relative humidity :
≤
93%HR
Atmos.: 70Kpa ~ 106Kpa
Device size: 112mm*56mm*18mm
Device weight: 93g
6) Electrode placement and stimulation settings should be based on the guid-
ance of a physician, speech therapist, speech-language pathologist, occu-
pational therapist or physical therapist.
5) Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium. The irritation can
usually be reduced by use of an alternate conductive medium, or alternate
electrode placement.
7) Powered muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
8) Since the effects of stimulation of the brain are unknown, stimulation should
not be applied across the head, and electrodes should not be placed on
opposite sides of the head.
9) Use caution applying stimulation over the patient's neck because this could
cause severe muscle spasms resulting in closure of the airway, difficulty in
breathing, or adverse effects on heart rhythm or blood pressure.
* Patients should stop using the device and consult their physicians if they
experience adverse reactions with the device.
* Patients may experience headache and other painful sensations during or
following the application of electrical stimulation near the eyes and to the face.