Safety test standards:
• Medical Devices Directive 93/42/EEC
• IEC60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
• 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.
• EN 980 Symbols for use in the labeling of medical devices
• EN 1041 Information supplied by the manufacturer with medical devices
• IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6: 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
●
Contraindications
Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted
metallic or electronic device, because this may cause electric shock, burns, electrical interference, or death.
Do not use this device on patients whose pain syndromes are undiagnosed.
●
Warnings
Do not apply stimulation over the patient’s side of 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.
Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the
chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
Do not apply stimulation over, or in proximity to, cancerous lesions.
Do not apply stimulation when the patient is in the bath or shower.
If you have one of the following conditions, please consult with your physician before purchasing or using this
device:
Acute disease, malignant tumor, infective disease, pregnant, heart disease, high fever, abnormal blood
pressure, lack of skin sensation or an abnormal skin condition, any condition requiring the active supervision
of a physician.
●
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 wet, high temperature and out of direct-sunlight place.
Keep this device out of reach of children.
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.
Electromagnetic Compatibility and FCC Compliance Statement
Fragile, handle with care
Keep the product in the dry
place.
Away from water and rain.
CAUTION, Avoid injury.
Read and understand owner’s
manual before operating this
product.
Type BF applied part
Symbols interpretation
Product package should be
recycled
Serial number
IP code of the device
Batch code
Unrecyclable
SN
LOT
IP22
Stop using this device at once 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.
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;
ii. disrupt the healing process after a recent surgical procedure;
(2) that the device is not effective for pain in the head area, including headache; electrodes should never be
placed anywhere on the head for use;
(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 are 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) Dispose of the battery-containing device according to the local, state, or federal laws.
The long-term effects of electrical stimulation are unknown.
12
13
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.
The safety of electrical stimulation during pregnancy has not been established.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical
conductive medium (gel). Consult your physician in this case.
Patients with suspected or diagnosed heart disease should follow precautions recommended by their
physicians.
Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians.
Use caution if stimulation is applied over the menstruating or pregnant uterus.
●
Adverse reactions
Patients may experience skin irritation and burns beneath the stimulation electrodes applied to the skin;
Patients may experience headache and other painful sensations during or following the application of
electrical stimulation near the eyes and to the head and face. Do not use device in this area.
Patients should stop using the device and should consult with their physicians if they experience any adverse
reactions from the device.
●
Environmental condition for normal working, transport and storage
- Normal working ambient temperature: 5~40°C (41°F~104°F)
- Normal working ambient humidity: 15%~90% RH
- Store and transport ambient temperature: -25 ~70°C (-13°F~158°F)
- Store and transport ambient humidity: 0%~90% RH
- Atmospheric pressure:
（
70~106
）
kPa
