Instruction Manual
Symbol
Meaning
Type BF applied part
Class II equipment
Waterproof level
Follow instructions for use
"WEEE (Waste Electrical and Electronic Equipment)". The waste
products should be handled legally.
2.9 EMC 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; although the product
uses RF energy only for its internal function, its RF emissions are very low and are not likely to
cause any interference nearby electronic equipment, it still needs to pay attentions to the following:
- The portable RF communications equipment including antennas can effect medical electrical
equipment, and it is used to no closer than 30cm (12 inches) to any part of the ME equipment;
- Do not use the stimulation in the present of or close to several common RF emitters (RF emitters that
are known sources of electromagnetic disturbance such as diathermy, electrocautery, and RFIDs,
walk-through metal detectors, and security systems (e.g., electromagnetic anti-theft systems, and
metal detectors), these RF emitters have not been evaluated for electromagnetic compatibility with
the subject device and it may be a source of electromagnetic disturbance and affect the safety of the
device.
- Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitor,
ECG alarms), which may not operate properly when the electrical stimulation device in use.
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.
5) The product meets the requirements of IEC60601-1-2:2014, no deviations from the collateral
standard and allowances used.
Manual and manufacturer's statement details are in the end of the article (Annex I)
3. Description of the Device
3.1 Package Content
■ Controller *1
■ Remote control *1 (Optional)
■ USB charging cable *1
■ Electrode pad *1
■ Protection board *1
■ User Manual *1
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