Omron Low Frequency Therapy Machine HV-F021 White
Product Description
This is a home-use low-frequency therapy device designed to relieve stiffness and pain comfortably. It is compact and easy to operate. The device is a specified controlled medical device with a medical device certification (approval) number: 225AABZX00193000. It is not recommended for use in combination with certain medical electrical equipment such as pacemakers, artificial heart lungs, and wearable medical electrical equipment like electrocardiographs as these devices may malfunction and cause serious life-threatening injuries.
Product Specification
The device measures 11.2 x 5.2 x 2.5cm and weighs 0.1kg. It is powered by DC3V (2 AAA alkaline batteries) and has a rated power consumption of 0.1W. The package includes a conductor cord B type (white), long-life pad HV-LLPAD (gray), trial batteries (2 AAA batteries), conductor storage (gray), and an instruction manual (with quality assurance certificate).
Performance and Safety Standards
The device has a maximum output current of 10mA max, a rated output voltage of 80V, and a rated treatment frequency of 1~238Hz. The pulse waveform is a short wave with a maximum output pulse width of 150μsec. The pulse energy is 2mJ or less. The output voltage accuracy, pulse width accuracy, and fundamental frequency accuracy are ±20% of the rated value.
Usage
The device should be used for 10~15 minutes per location per time, 1~2 times a day. It should not be used in humid places, while driving, or in combination with other treatment devices or application agents. Children should not be allowed to use or play with the device. If no effect is seen after using the product for a while, consult your doctor.
Precautions
Before use, ensure the device is working properly, especially if it has not been used for a long period of time. Make sure that the conductor cord, main body, and pads are properly and securely connected. During use, if any physical abnormality or skin irritation is noticed, discontinue use immediately and consult a physician. After use, disconnect the conductor cord from the main unit properly and do not leave the pad unattended or store it with soiled items.
Storage
The device should not be stored in places exposed to direct sunlight, high temperature and humidity, water, dust, near fire, subject to vibration and shock, or under a strong electromagnetic field. When not in use for a long period of time (3 months), remove the batteries.
Manufacturer and Seller
The device is manufactured and distributed by Omron Healthcare Co.
Purpose of Use or Effects/Indications
The device is intended for the relief of stiff shoulders, prevention of atrophy of paralyzed muscles, and massage effects. It is designed for general home use.
