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The Rayocomp PS 10 med. is a Class IIa medical device approved according to the latest European directives and bears the certification number of the notified body on the rear side.
Here at a glance the classification of all the Rayocomp PS 10 devices:
Rayocomp PS 10 med.: Class IIa medical device
Rayocomp PS 10 VET: Non-medical device
Rayocomp PS 10 TCM: Non-medical device
Rayocomp PS 10 BB: Non-medical device
Rayocomp PS 10 Evolution: Non-medical device
Rayocomp PS 10 basic: Non-medical device
Rayocomp PS 10 Complete-Edition: Non-medical device
Rayocomp PS 10 Edition 35 Non-medical device
The Rayocomp PS 10 Edition 35 has been developed for medical applications in accordance with its intended use. Our quality management system in accordance with DIN EN ISO 13485 (Risk management for medical products) and the regular audits by our notified body ensure the consistently high quality of this portable medical bioresonance device according to Paul Schmidt from Rayonex Biomedical GmbH.
Highlights of the new Rayocomp PS 10 med.:
➤ Latest approval as a Class IIa medical product in accordance with DIN EN 60601-1:2013-12 and DIN EN 60601-1-2:2016-05
The device meets all the requirements of the new medical product standards that have been in force since 1 January 2019.
➤ Portable thanks to integrated rechargeable battery and low weight
Despite the integrated rechargeable battery, the Rayocomp PS 10 med. weighs only 1.7 kg. As a result, the device is ideal for use also e.g. in home care in the patient’s home. Particularly chronically ill patients then no longer have to constantly come to the practice and can treat themselves at home according to the therapist’s instructions, e.g. using an RAH “Green Card”.
The design of the Rayocomp PS 10 med. has been matched to the colours and appearance of the larger Rayocomp PS 1000 polar 4.0 med. so that the devices harmonise in design and colour.
➤ Internet update option via the Rayocomp PS 1000 polar 4.0 med.
Users of the Rayocomp PS 10 med. can now benefit from the latest developments faster than ever because the device can be automatically updated via the Internet when it is connected to a Rayocomp PS 1000 polar 4.0 med. The latest software that had previously been downloaded to the Rayocomp PS 1000 polar 4.0 med. from the Rayonex server in Lennestadt can thus be comfortably installed on the Rayocomp PS 10 med.
➤ The Rayocomp PS 10 med. – Made in Germany
The portable Rayocomp PS 10 med. is developed and manufactured in Germany, in a community called Lennestadt, in compliance with the quality management system for medical devices, the DIN EN ISO 13485. They are also audited by TÜV Nord on an annual basis.
➤ The internal components of the new device
All of the hardware components in the Rayocomp PS 10 med. comply with the industrial standard, but not the consumer standard. This means that all of the device's components are of the highest, most robust quality.
As well as the new features, the device also comes with all of the existing benefits:
➤ Large, clearly legible display
➤ Quick setting of the basic frequency values
➤ Fully integrated Bioresonance according to Paul Schmidt
➤ RAH expert system, Art. No. 2092, already integrated
➤ Modular software design (BWYN – buy what you need) for maximum
customisation and low costs
➤ Purchase and rental options
The scope of supply of the Rayocomp PS 10 med. consists of the following components:
Rayocomp PS 10 med. including mains power pack/charger, RAH module (Art. No. 2092), integrated rechargeable battery, operating manual, packaging, trolley
Of course, you as user will be comprehensively introduced to the operation and use of the device by your distributor.
We recommend the following accessories for the Rayocomp PS 10 med:
Art.-Nr. 4000: Treatment chair made from solid beech with a black eco-leather cushion, built-in detector and 5 m connection cable.
Art.-Nr. 4005: Table made from solid beech for Rayocomp with pull-out panel and detachable tray.
Art. No. 35910: RAH “Green Card”, set of 5
The set contains 5x RAH “Green Cards”. For storage of and convenient treatment with basic frequency values and RAH programs using the Rayocomp PS 10 med.
Art. No. 20125: Rayocomp PS 10 basic, basic device, case, operating manual, modules M1, M9, M11 and M12 for mobile applications in the patient's home.
The outstanding benefits of the Rayocomp PS 10 basic: The patient cannot enter his or her own therapy programmes and can only use the RAH “Green Card” created by the therapist for the therapy.
Please note that Rayonex Biomedical GmbH offers both the purchase and the rental of the devices, software modules and components.