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 lumbar spine.

Traditional harnesses are cumbersome, and most often have to be secured so tight to prevent slippage, that they are uncomfortable to the patient. The Pelvic restraint system captures any patient physique comfortably and accurately, with a very light application against the pelvis and are completely unnoticeable to most patients. Those familiar with conventional systems, which employ pelvic harnesses to capture the patient’s pelvis will agree that it is difficult to comfortably capture the wide spectrum of patient sizes, and regardless of how secure the harnesses are applied, they will often slip over the hips, causing an interruption in treatment. The pelvic restraints cannot slip over the patient’s pelvis, so that treatment interruption is eliminated with the SpineMED.

Conventional systems, which employ pelvic harnesses attached to a traction device through a nylon strap, are limited in their efficiency of applying the force to the patient’s spine, as there is significant loss and absorption of energy through this ‘system’. The ‘system’ described consists of all components between the force generation device (electric motor), and the patient’s spine. Within these belts, gears, pulleys, drum and nylon strap inside the traction unit, along with the straps and pelvic harness external to this unit, there is a loss of force through the stretching and absorption of energy of the various material components. (nylon has a 12-14% stretch factor) In addition, the traditional pelvic harness has to deliver the distraction force (energy) through the patient’s fat, muscle and tissue surrounding their lower torso to be delivered to the skeletal structure. The Pelvic Restraints, on the other hand, capture the patient’s pelvis directly, and are directly connected to the drive mechanism, which is a high-speed electrical actuator. Through the elimination of a complex “system” of belts, pulleys and gears, this efficient system has removed virtually all of the loss and absorption of 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 typically tensions required on other decompression tables. The significantly lower tensions dramatically improve patient comfort and tolerance to the treatment, resulting in much wider patient suitability and conformance, where sub-acute, frail, and geriatric patients are now more likely to tolerate the therapy.

The Pelvic Restraint System also facilitates a rate of adjustment within the load control system that simply cannot be duplicated by conventional systems. In all of the sophisticated decompression tables, an electronic system is utilized to monitor and adjust the tensions that are applied to the patient during treatment (load control system). In older technology, where straps, pulleys and pelvic harnesses are utilized, the ability of this system to quickly respond and adjust the prescribed tensions is limited, and in most cases requires up to two seconds to make these adjustments (load control) to where the actual tension being applied to the spine is changed. Ie. The load control system would have to signal the circuit to turn the electric motor either clockwise, or counter-clockwise to either bring in, or let out the nylon strapping on the drum assembly in the traction box to modify the tension on the belt assembly. With the SpineMED system, where the patient’s pelvis is directly connected to the drive mechanism through the unique pelvic restraints, the electronic 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 adjust applied tensions every 20 milliseconds, where the neurological response of the human body to fire the erector muscles is approximately 50 milliseconds. The SpineMED load control system has been designed to be faster than 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 and 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 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 soft tissues to a penetration depth of 3 centimeters. Unlike conventional heat pads using convection, there is absolutely no risk of burning tissues with the far-infrared element.

A 14” adjustable LCD monitor allows the patient to view the treatment progress through the display of the operator screen from the control console. This monitor can also be used to display cable TV or DVD programming through the incorporated DVD system. Wireless headphones allow efficient audio transmission of the DVD programming, or relaxation music to the patient via music CD.

A 15-inch colour monitor with touch screen technology provide the operator with a simplistic interface to the comprehensive control system, the proprietary SpineMED software system. Secure access provides the practitioner or clinic management with ultimate control over the use of the SpineMED unit, eliminating any unauthorized or unskilled use of the device. Access to the device is limited to operators with a valid User ID and Password, which can only be added or modified 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.

Every aspect of the SpineMED’s use will not only be controlled, but will be known by the manager of the device through the integrated database. 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. An individual patient must be selected in the database to initiate a treatment session. 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, every parameter of the treatment is calculated by the SpineMED software. The operator of the device has the ability to override the Maximum Tension prompted by the System, to ensure patient specific tailoring of the treatment according to the SpineMED protocol. Based on a standardized 0-10 Visual-Analog scale, the patient’s 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 the system monitor, which can also be output to the printer to become a permanent record in the patient’s chart.

Every treatment administered on the SpineMED becomes a permanent record in the device, and is stored in the patient’s file. This permanent record includes all of the parameters of the individual treatment; date, time, tensions, duration, operator ID, trend line graph, etc.

The incorporated database allows for ‘digital charting’ of patient treatment with the device. At the touch of a digital “button”, the SpineMED prints comprehensive patient reports to the incorporated laser printer or output as an electronic PDF file; 1) A Daily Treatment Report which includes all of the specific parameters of the treatment, including all patient information, pathology, date, time, force parameters, pain and disability scores, and a digital graph of the treatment. 2) A Daily Progress Report, which is a compiled report of EVERY treatment administered to the patient, including all patient information, pathology, date, time, force parameters, pain and disability scores, and daily comments. 3) A Procedure Report, which is customizable to suit different insurers needs with ten customizable fields. These reports are customized to the SpineMED practitioner, as a “Letterhead” with the clinic or practitioner’s name and address.

The combination of the unique patient capturing system and the SpineMED control software allow for a clinical efficiency that is far superior to any other decompression table. The patient setup time is less than two minutes, which can save the clinician between 4 and 7 minutes PER PATIENT in setup time. More importantly, with the SpineMED, it is unnecessary for the clinician to wait for approximately 4 minutes, to allow the device to run through 3 cycles, and subsequently “open the lower table section”, to allow free movement of the lower pallet. In addition, the need, to halt the treatment and re-position the lower harness on the patient as a result of the harness slipping over the pelvis during treatment is eliminated. The SpineMED is the most operator time-efficient decompression table available. This superior clinical efficiency allows the SpineMED to be integrated into an existing facility without any additional staff requirements or impact on existing patient schedules.

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 in progress.

The simple two-component design of the SpineMED is also a result of significant clinical experience with older technology. Rather than engineer a large, static, and immobile unit, 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 versatility and mobility, and eliminates the need to hire a factory technician to disassemble the unit in the event that it must be moved 10 feet or 10 miles. The SpineMED easily fits into an 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 a patient weight suitability rating of 400 lbs. Although the device has the ability to support and treat larger patients, treatment outcomes are not optimal with patients larger than 400 lbs.

In every possible 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 device’s life cycle. Rather than incorporate proprietary components, which are only available from the table manufacturer, the SpineMED utilizes many off-the-shelf components, which can be easily purchased and replaced by the clinician if necessary. The ability to obtain OEM replacement parts for the SpineMED through innumerable electronic suppliers rather than proprietary components only available from the table manufacturer ensures fast and fair priced replacement of any failed components, regardless of warranty situation. The heart of the system, the computer, is a rack-mounted design, which simply slides out of the control console on slides to allow simple, end-user replacement. However, component failure with the SpineMED is unlikely, as every component is hospital grade to worldwide standards. The primary “wearable” component, the high-speed actuator, has a duty cycle of 19.65 years with a clinical rate of use of an average of 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.