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The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories. The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use. The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.

The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks: - 1. EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end - 2. Impedance meter function - 3. peripheral channels for additional sensors, ERP synchronization and biofeedback Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting. The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.

The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).

The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG. It transmits the ECG data in a specified format by Bluetooth transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.

The HBldb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

The Human Brain Index Software (HBldb) product is a software program for the post-hoc statistical analysis and comparison with a reference data (the Human Brain Index Reference Database (HBIRD)) of the human electroencephalogram (EEG) including spontaneous oscillations of the human brain potentials and event-related potentials (ERPs). The EEG is recorded on a separate device under the standardized HBIdb conditions and is transferred to the HBIdb in EDF+ format for - display . - . spectral analysis and - analysis of event-related potentials . - comparison of the gathered parameters against the Human Brain Index Reference Database . (HBIRD), and - compilation of a report. . Results of comparison of individual EEG/ERP parameters with the database are intended for use as an aid to diagnosis. No medication or treatment is applied based on this comparison alone. The results have to be considered only in conjunction with other clinical findings.

The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is processed by the B1 device and then transmitted via a standard wireless link to a monitoring device, such as a P or hand-held device for display, review, printing, saving and post event processing by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.). Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.

BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed. The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation. BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram. BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells. Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.

The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software. For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices. The EEG NeuroAmp is not intended for diagnostic purposes.

The purpose of the EEG NeuroAmp is to act as user-friendly high-performance interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy. The EEG NeuroAmp contains four function blocks: - 1. EEG amplifier, two channels, aligned and high-resolution - 2. Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out - 3. Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer). - 4. An output for audio/visual/tactile feedback