●
Precautions
- Do not use this device while driving.
- Do not use this device while sleeping.
- Do not use this device in high humidity areas, such as a bathroom.
- Keep the device away from places that are wet, hot, or receive direct sunlight.
- Keep this device out of reach of children.
- Stop using this device if you feel pain, discomfort, dizziness, or nausea and consult your physician.
- Do not attempt to move the electrode pads while the device is operating.
- Do not use the device around the heart, on the head, mouth, genitals, or blemished skin areas.
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Safety test standards:
- Medical Devices Directive 93/42/EEC
- IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
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Electromagnetic compatibility and FCC compliance statement
1) This product needs special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided, and this unit
can be affected by portable and mobile radio frequency (RF) communications equipment.
2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This
may result in incorrect operation of the unit.
3) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation!
4) Caution: This machine should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, this machine should be observed to verify normal operation
in the configuration in which it will be used.
The device is intended for use in the electromagnetic environment specified below.
The customer of the user of the device should assure that it is used in such an environment.
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
The device uses RF energy only for its internal
function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
Class B
The device is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Class A
Complies
EMISSION TEST
Guidance and manufacturer’s declaration – electromagnetic emission
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
16
17
Do not apply stimulation of this device in the following conditions:
(1) across the chest because the introduction of electrical current into the chest may cause rhythm
disturbances to the heart, which could be lethal;
(2) over painful areas. Please consult with your physician before using this device if you have painful
areas;
(3) over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean, healthy
skin;
(4) in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms). The
electronic stimulator may not operate properly when the electrical stimulation device is in use;
(5) while operating machinery, or during any activity in which electrical stimulation can put you at
risk of injury;
(6) on children.
Be aware of the following:
(1) to consult with your physician before using this device. The simulation with the device may:
i. cause lethal rhythm disturbances to the heart in susceptible individuals, and,
ii. disrupt the healing process after a recent surgical procedure;
(2) that the device is not effective for pain of central origin, including headache;
(3) that the device is not a substitute for pain medications and other pain management therapies;
(4) that the device has no curative value;
(5) that the device is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism;
(6) that the long-term effects of electrical stimulation is unknown;
(7) that the user may experience skin irritation, burns, or hypersensitivity due to the electrical
stimulation or electrical conductive medium (gel);
(8) if the user has suspected or diagnosed epilepsy, the user should follow precautions recommended
by his or her physician;
(9) to use caution if the user has a tendency to bleed internally, such as following an injury or
fracture;
(10) use caution if stimulation is applied over the menstruating uterus;
(11) use caution if stimulation is applied over areas of skin that lack normal sensation;
(12) stop using the device if the device does not provide pain relief;
(13) use this device only with the leads, electrodes, and accessories that the manufacturer
recommends;
(14) Do not share the use of the electrode pads with others;
(15) Do not use the device while it’s charging;
(16) The device contains the lithium battery. If overheating of the device occurred during the
charging, stop the charging or operation immediately and report to the distributor/seller;
(17) Dispose of the battery-containing device according to the local, state, or federal laws.
- IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part 2-10:
Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements for basic
safety and essential performance -- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
- ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
- EN 1041 Information supplied by the manufacturer with medical devices
- IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in home healthcare environment
- IEC 62304/ EN 62304 Medical device software - Software life-cycle processes
- IEC 62366/ EN 62366 Medical devices – Application of usability engineering to medical devices
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile.
If floor are covered with synthetic
material, the relative humidity
should be at least 30%.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
The device is intended for use in the electromagnetic environment specified below.
The customer of the user of the device should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic emission
