As previously announced in our December 20, 2024, notice titled “Temporary Suspension of Orders for MSD reltec, etc.,” we would like to provide an update regarding warranty and repair services for MSD reltec and HsD in light of subsequent reports of malfunctions.
For more details, please see “Warranty Period for Main Power Switch Malfunctions” below.
An accessory designed to supply electrons to the human body and apply a negative voltage. The MSD and HsD models use the Output Plate ACs, a compact version of the Output Plate AC.
The Output Plate AC has a basic structure consisting of a metal plate covered with an insulating coating and is connected to the main unit via a plate cable. The function of the Output Plate AC is to restrict the flow of electrons (current) and allow only a portion of it to pass through.
There are two types of output plate ACs: “S” and “H.” Since the microcurrent flowing through the human body is “H > S,” the theoretical number of electrons that can be supplied is also “H > S.” The type of output plate AC that can be selected varies depending on the model of the electron reduction therapy device.
Since output plate ACs degrade over time with cumulative use, Reltech recommends replacing them every year.
The MSD reltec unit has a built-in current monitoring function, and the HsD power supply unit has a built-in output monitoring function.
The current monitoring function alerts the user when the current value exceeds the upper or lower limit of a preset acceptable range. Currently, MSD is the only manufacturer of reduced-electron therapy devices that offers this feature.
The output monitoring function alerts the user when the current level falls below a preset lower limit. The HsD is the only reduction electron therapy device that features this function.
As described above, the current monitoring function monitors both the upper and lower limits of the current during use of the electron reduction therapy device, while the output monitoring function monitors only the lower limit.
Thanks to these features, MSD reltec and MsD have eliminated the need for “Energy Check,” the testing device previously included with reduction electron therapy devices to verify the presence or absence of output.
A medical concept conceived and advocated by Dr. Yutaka Horiguchi, Director of Horiguchi Clinic, part of the Medical Corporation Kenshokai. It refers to “a treatment that safely supplies large amounts of electrons to the human body transdermally (via transdermal electron supply) for the purpose of antioxidant therapy.”
Reduced Electron Therapy® is a registered trademark held by the Medical Corporation Kenshokai under Class 44, “Medical Practice; Provision of Medical Information.”
All Reduced Electron Therapy devices manufactured by Reltech are equipped with a transdermal electron supply function.
The internal designation for Reltech products equipped with a function that safely supplies large amounts of electrons to the human body through the skin for antioxidant purposes (transdermal electron supply function).
There are two types of reducing electron therapy devices: (1) medical devices and (2) electron supply devices; (2) electron supply devices are not classified as medical devices under the Pharmaceutical and Medical Devices Act.
The reduced-electron therapy device is a unique product developed in-house by Reltech, and has been continuously developed, improved, and manufactured for over 20 years.
A treatment in which the human body is insulated from the ground and a negative high voltage is applied to it. Direct current is typically used.
There are two types of medical devices for potential therapy (potential therapy devices): (1) direct current (DC) potential therapy devices and (2) alternating current (AC) potential therapy devices. Reltech’s potential therapy devices are of type (1), while most potential therapy devices from other manufacturers are of type (2 ).
The goal of antioxidant therapy is to safely supply large amounts of electrons to the human body through the skin.
Note that oxidation refers to the loss of electrons, while reduction (antioxidation) refers to the gain of electrons.
QMS (Quality Management System) is the common name for the “Ministerial Ordinance on Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Medical Devices” (Ministry of Health, Labor and Welfare Ordinance No. 169 of Heisei 16), which establishes standards for manufacturing control and quality control of medical devices and in vitro diagnostic medical devices
It is one of the requirements for obtaining manufacturing and marketing approval or certification for medical devices and in vitro diagnostic medical products (Article 23-2-5, Paragraph 2, Item 4 of the Act on Pharmaceuticals and Medical Devices, etc. (including cases where it is applied mutatis mutandis under Article 23-2-17, Paragraph 5), and Article 80, Paragraph 2).
Medical device manufacturers and distributors are required to implement manufacturing and quality control for their products in accordance with the QMS Ministerial Ordinance. As a condition for obtaining a manufacturing and distribution license, they must comply with the “Ministerial Ordinance Concerning Standards for Systems Performing Manufacturing or Quality Control Operations for Medical Devices or In Vitro Diagnostic Medical Devices” (Heisei 26 Ministry of Health, Labor and Welfare Ordinance No. 94; commonly known as the QMS System Ordinance), which establishes the standards necessary for compliance with the QMS Ministerial Ordinance(Article 23-2-2, Item 1).
Manufacturers and distributors must undergo a compliance audit (QMS audit) against the QMS Ordinance when seeking approval or certification for medical devices, etc., as well as at regular intervals after receiving such approval or certification.
An internal term used by Reltech to collectively refer to its proprietary technologies designed to safely deliver large amounts of electrons to the human body through the skin for antioxidant purposes (transdermal electron delivery function); this technology is applied to Reltech’s reducing electron therapy devices.
An electric current that flows in a fixed direction and whose magnitude changes periodically. A rectified current exhibits a periodic waveform on either the positive or negative side, and this waveform is called a pulsating current.
The output current of Reltech products is a direct current (negative) current obtained by rectifying and smoothing the alternating current from an AC power source using an AC/DC adapter or a switching power supply; therefore, it has an extremely smooth waveform with minimal ripple. Note that in this context, “ripple” refers to the AC component (waveform fluctuations) that cannot be eliminated even through rectification and smoothing.
In the case of Lertech medical devices, a tingling sensation may be caused by a very weak current in the µA range, or by a sharp jolt resulting from the discharge of a charged weak current (static electricity).
CAM (Complementary and Alternative Medicine)
A general term for medical practices that complement standard treatments based on Western medicine or serve as alternatives to such treatments. In Japan, treatments provided on a self-pay basis (those not covered by medical insurance) are effectively considered complementary and alternative medicine.
Even if a treatment is highly advanced, if the scientific evidence supporting it is insufficient, it is classified as complementary and alternative medicine rather than standard treatment, and is therefore not covered by medical insurance.
Standard of Care
A treatment recommended for patients with a given disease based on scientific evidence that it is the “best available treatment” at present, or a treatment that is widely practiced in general
In Japan, this is essentially synonymous with treatments covered by health insurance
Medical devices that may be used only under a physician’s supervision
A physician may use such a medical device on a patient only after diagnosing the patient and determining that treatment with that medical device is necessary.
Microcurrent refers to the extremely weak currents (measured in µA) that constantly flow through the human body as part of its natural bioelectric activity.
Since microcurrent is generally considered effective for treating injuries and pain, medical devices and beauty devices that utilize microcurrent are now on the market and widely available.
An international standard for quality management systems aimed at maintaining the safety and quality of medical devices (Medical devices – Quality management systems – Requirements for regulatory purposes). It is used as the basis for quality management practices in medical device regulations around the world.
This standard is intended for organizations in the medical device industry engaged in the design, manufacture, installation, and ancillary services of medical devices, as well as the design, development, and provision of related services. The standard is structured as an extension of ISO 9001, with additional requirements necessary to ensure the safety, effectiveness, and quality of medical devices.
