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Advantages of the NESS L300™ over traditional FES systems

In order to enable proper daily application by hemiparetic users and to provide effective and safe gait, FES systems for the correction of drop foot should comply with variety of ergonomical, technical and other design requirements.

For many years, non invasive FES foot drop devices suffer technical and ergonomical problems which make its problematic for independent use at home and technically unreliable. In a survey* performed in 2002 among 98 users of non-invasive, drop foot stimulators, the following was found:

· 13% - Reported that they have no problems

· 72% - Problem with finding the correct electrode positions

· 58% - Difficulties with wires and foot-switches

· 25–30% of the users ultimately reject the device.

* (Gerard M. Lyons, Thomas Sinkjær, Jane H. Burridge, and David J. Wilcox, IEEE, Vol.10, no.4, December 2002)

The NESS L300 system addresses these and other existing traditional barriers, ensuring precise electrode location, wireless communication, comfortable and safe stimulation and dynamic agait synchronization. The system’s innovative design and features ensure effective and safe use at the patient’s home while providing simple, user friendly configuration and application at the clinic environment.

More specifically, the NESS L300™ system offers the following advantages:

§ All system components communicate wirelessly by RF, thus avoiding the need for cumbersome wires and connectors, making the system simple and comfortable to use. The wireless communication also increases the reliability of the system by avoiding the possible malfunction of wires and connectors.

§ The unique ergonomic design of the hybrid orthosis and its ability to be precisely located over the lower leg provides accuracy and repeatability of electrode placement, thus ensuring constant and balanced foot movement. Receiving the exact same movement set by the clinician while using the system daily at home is an essential requirement which has functional and safety aspects.

§ The “Automatic” location feature of the orthosis allows even severely injured hemiplegic patients to put on and remove the device using one hand only.

§ Level of tightening of the hybrid orthosis (and thereof the attachment of the electrodes) to the limb is initially set by the clinician and precisely repeated by the user each time the orthosis handle is closed on the cradle.

§ An advanced design of the orthosis ensures comfort for use all day long while providing optimal electrode contact with the limb at all time.

§ The perfectly balanced, rectangular pulse shape and the relatively large and qualitative electrodes optimize the comfort of stimulation and reduce the risk of skin irritation.

§ A miniature remote control unit enables friendly operation and provides indications of the system status. It eliminates the need to bend toward the lower leg in order to modify the intensity or turn ON/OFF the system, and allows operation while standing or walking. Providing on-line audio and visual indications and allowing system operation while standing or walking has both functional and safety implications.

§ The system includes a proprietary gait sensor with dedicated gait software. The software automatically adapts to different weights pressures and therefore the system can be reliably used by very light weighed persons as well as by heavy and even obese users. The dynamic gait recognition algorithms adapt in real time to various gait velocities, rhythms and styles. Reliability is established even while walking on various terrains such as carpets, grass, stairs, slopes, obstacles etc. The gait sensor’s structure, capsulation and algorithms also compensate for possible changes in its mechanical and electronic profile caused by the harsh in shoe environment, thus ensuring long lasting function and safety.

§ The system allows users to walk with a wide range of shoes. The NESS L300 system supports multiple gait sensors enabling the user to exchange shoes without the need to transfer the gait sensor from shoe to shoe. The small transmitter comfortably attaches to the shoe rim.

§ The Gait sensor includes a sophisticated power management system which allows it to be operated by a small coin battery for prolonged duration.

§ The hybrid orthosis is cosmetically acceptable due to its attractive and low profile design. This is especially important when wearing shorts or a skirt.

§ Replacement of system modules at the patient’s home can be easily performed independently by the “RF registration” automatic procedure. The patient simply press two buttons of the replaced component to initiate the procedure, in which the new component is registered to the rest of the system and the configuration parameters are automatically transmitted wirelessly to it.

§ The orthosis “electrode bases” allows simple process of electrodes emplacement by the paralyzed person.

§ The orthosis RF stimulation unit and the control unit are rechargeable.

In addition to its advantages in the home setting, the NESS L300 system optimally adjusted to be used at the clinic environment:

§ A PDA (Portable Digital Assistant) with proprietary software (the Intelli-Gait™ software) is used for system configuration. The software and its unique interface enables user friendly configuration process of stimulation and gait parameters and tracking of patient’s history and gait log up to two years back. It also includes data base of the system users with its configuration parameters and history.

§ When connected to the control unit, the PDA transmits the configuration commands wirelessly to the rest of the system. A special housing (configuration cradle) is provided to allow wireless and completely mobile configuration process. The configuration is therefore enabled while the clinician is either distant or in close proximity to the patient and while the patient is walking inside or outside the clinic.

§ The system support use by multiple patients in the clinic. For fast re-configuration the clinician simply select the relevant patient in the PDA database for immediate downloading of his configuration parameters to the system.

§ In order to preserve the precise electrode location of each patient and to allow fast restoration of this specific location, the clinician kit of the system includes disposable “Personal panels” that are designed for fast connection and detachment from the orthosis. Upon connection to the orthosis, the panel accurately locates the electrodes on the orthosis in the specific arrangement of the patient while establishing the required mechanical and electrical connection. The Personal panels also ensure that hygiene is maintained when transferring the system from one patient to the other.

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