Instruction Manual

- Do not leave the Electrode Pad attached to the skin after treatment. Prolonged attachment may cause

skin irritation or infection.

- Be careful not to allow any metal object, such as a belt buckle or necklace to come into contact with

the Electrode Pad during treatment.

- Do not use cellular phones or other electronic devices near this device.

- Do not use this device to treat one region for a long time (more than 30 minutes).

2.4 Special Population

The Electronic Pulse Stimulator is suitable for use only in adults.

2.5 Adverse Reactions

Some users may experience skin irritation or burns beneath the electrode pads. Please stop using the

device and consult a doctor.

2.6 Environmental Condition for Normal Operation, Transportation and Storage

Operating: Temperature Range: 5~40℃

Humidity: 15%~90%RH

Storage: Temperature Range: -25~70℃

Humidity: 0~90%RH

Atmospheric Pressure: 700~1060hPa

2.7 Conformity Standards

● IEC 60601-1-2 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and

Essential Performance

● IEC 60601-1 Medical Electrical Equipment –Part 1-2: General Requirements for Basic Safety and

Essential Performance –Collateral Standard: Electromagnetic Disturbances –Requirements And

Tests

● IEC 60601-1-11 Medical Electrical Equipment –Part 1: 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

● IEC 60601-2-10 Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic

Safety And Essential Performance Of Nerve And Muscle Stimulators

● ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Test for In Vitro Cytotoxicity

● ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Test for Irritation and Skin Sensitization

2.8 Symbol Interpretation

Information essential for proper use shall be indicated by using the corresponding symbols. The

following symbols may be seen on the device and its labellings.

Symbol

Meaning

Lot number, composed of manufacturing date and batch

Batch (start from 001)

Month (double-digit, for example 08, it mean August)

Year (four-digit, for example 2018, it mean 2018 year)

Manufacturer

Date of manufacture

Caution