>> SpineMED
Technological Features / Advantages
The SpineMED's engineering and design is the result of nearly a decade of hands-on clinical experience utilizing a multitude of previous decompression table technologies.
The patented technological features incorporated into the SpineMED set this device apart from previous technology, and simply cannot be duplicated. One of the many unique aspects of the SpineMED is the pelvic restraint system, which eliminates the need for traditional pelvic harnesses. This patented system provides a number of improvements to patient comfort, patient suitability, clinical efficiency, and cannot be found on any other decompression table. Traditional pelvic harnesses create a number of problems and limitations with regard to patient suitability and comfort, and in addition, limit the accuracy and efficiency of the application of force to the patient's spine.
Conventional systems, which employ the harnesses attach to a traction device through a nylon strap, which eliminate efficiency of applying the force to patients' spine and cause losses of absorption and energy. Due to the belts, gears, pulleys, drums and nylon strap inside the traction unit, there is a loss of force through the stretching and absorption of energy fo various material components. SpineMED's pelvice restraints on the other hand secure tightly at the pelvis directly and are connected to the drive mechanism, which is a high speed electrical actuator. Through our elimination of the complex "system" of belts, pulleys and gears, this efficient system has removed virtually all of the loss and absorption force found in older technology, such that the treatment tensions on the SpineMED are only a fraction of what is required on devices utilizing pelvic harnesses. The treatment protocol on the SpineMED ranges from ¼ body weight minus 10 lbs. to ¼ body weight plus 25 lbs., which is approximately 60% of the typical tensions required on the other decompression tables. These significantly lower tensions dramatically improve patient comfort and tolerance to the treatment, resulting in much wider patient suitability and conformance, where sub-acute, a geriatric patients are now more likely to tolerate the therapy.
The SpineMED system, where the patients pelvis is directly connected to the drive mechanism through the unique pelvic restraints, the electrical control system measures the instantaneous tension being applied to the patient's spine every 2.5 milliseconds. After sampling this measurement eight times, the system will make adjustments if the tension is outside the prescribed tolerances. The SpineMED therefore has the ability to adjusted applied tensions every 20 milliseconds, where the neurological response of the human body to fire the erector muscles si approximately 50 milliseconds. The SpineMED load control system has been designed to be faster that the human body. The SpineMED utilizes a state of the art high-speed electrical actuator as the force generation drive mechanism.
To accurately target specific pathology, the device has a 'tilting pelvic section' that the pelvic restraints are mounted to. Based on earlier research, the tilting section will tilt the patient's pelvis between 0-25 degrees to change the focal point of distraction to more accurately target specific pathology. The tilting mechanism is electronically controlled through the touch screen treatments menu.
To further improve patient comfort and reduce the incidence of spasm both during and after treatment, a far-infrared heat element has been incorporated into the lumbar section of the table, which heats paraspinal tissues to penetrate depth of 3 centimeters. Unlike conventional heat pads using convection, there is absolutely no risk of burning tissues with the far-infrared element.
During the treatment the patient can watch the progress though our 14" flat screen high LCD monitor. The patient may also watch regular television or use our DVD player to watch movies or listen to music through our wireless headphones.
A 15-inch monitor with touch screen technology provides the operator with a simplistic interface to the comprehensive control system, the proprietary SpineMED software system. Only secure access practitioners may use the unit with access only granted through a specific User ID and Password, which may be altered by the manager of the device. Any and all use of the device is permanently recorded in the SpineMED database for review or analysis by the device owner.
The level of computerization is extensive, as the SpineMED automatically controls most aspects of the treatment parameters, through integrated formulas and calculations based on individual patient data and a proven protocol. To reduce the incidence of human error and improve treatment repeatability, the SpineMED calculates the recommended treatment protocol and prompts the operator with default values.
Prior to any patient being treated on the SpineMED, a new, permanent file must be created in the device database for the patient. The software requires complete entry of all patient data fields, which include: extensive personal identification, known pathology related to the treatment, history of condition and previous alternate treatment undergone for this pathology. The device uses data stored in the patient's file, such as body weight, to tailor the treatment to this specific patient. With the exception of the angle of distraction, the SpineMED software calculates every parameter of the treatment. Based on a standardized 0-10 Visual-Analog scale, the patients daily pain and daily disability scores, as well as treatment comments (soap notes) are collected and permanently attached to the treatment record to track individual treatment efficacy. A digital trend-line graph of the force/time values of the treatment are displayed in real time on a system monitor, which can also be output to the printer to become permanent record in the patients chart.
Every treatment administered on the SpineMED becomes a permanent record in the device, and is stored in the patients file. This permanent record includes all the parameters of individual treatment: date, time, tensions, duration, operator ID, trend line graph, etc… These records can then be printed or sent electronically via a PDF chart.
In the event of a power failure, an integrated battery-backup system provides adequate power to operate the entire system for a full 60 minutes, and safely complete the treatment progress.
The SpineMED has been designed with separate table and control console components, which sit on casters and are interconnected via a 15-foot umbilical cord. This design provides the clinician the utmost in space variability and mobility, and fits easily into a 8' x 8' or odd-shaped space, and has a transportation weight of 550 lbs. total. The table unit has a high-low elevation function, and has the ability to support and treat larger patients; treatment outcomes are not optimal with patients larger than 400 lbs.
In every instance, the SpineMED has been engineered and built with readily available, medical-grade components to ensure simple and low cost replacement at any point throughout the devices' life cycle. Component failure with the SpineMED is unlikely, as very component hospital grade to worldwide standards. The primary "wearable" component, a high-speed actuator, has a duty cycle of 19.65 years with a clinical rate of an average 10 patients per day, 5 days per week.
The SpineMED has FDA marketing clearance, with a 510 (k) K051013. The device is UL, CSA and CE approved, which is to hospital grade standards worldwide. In addition, CERT Health Sciences is a Certified Manufacturer to ISO 13485:2003.
Although service is quite unlikely with the SpineMED, an integrated modems allows our engineer's external access to the unit via standard phone lines. Though modem access, the engineer can diagnose, troubleshoot, operate externally and also upload software upgrades to the SpineMED table through a standard phone line.
