AVAL ANCHE XT. the art of neuromonitoring. Thyroid surgery. Version 1.05 / Similar to illustrations! Copyright 2012 Dr. Langer Medical GmbH

Transcription

1 AVAL ANCHE XT the art of neuromonitoring Thyroid surgery Version 1.05 / Similar to illustrations! Copyright 2012 Dr. Langer Medical GmbH

2 What neuromonitoring can do for you Avoiding the risk of vocal cord paresis after thyroid surgery As a surgeon who carries out thyroid surgery, you are well aware that it is a delicate area where failure and success lie very closely together. It is your responsibility to do your utmost to benefit your patients, while at the same time keeping them safe from lasting damage. Your experience stands you in good stead, but even the most experienced surgeons may find themselves unexpectedly in a critical situation. This is where we come in. Our neuromonitoring equipment will help you avoid such situations by alerting you to potential risks in time. If we can help to keep just one of your patients safe from permanent nerve damage, we have fulfilled our mission. Thyroid surgery is a routine operation, performed not only on iodine-deficient enlarged thyroids, but also on malignant growth in the thyroid tissue, involving partial or total resection of the thyroid. 100,000 such surgeries are carried out each year in Germany alone. In spite of all the routine, some risk of damaging the vocal cord nerves remains, resulting not only in hoarseness and reduced volume of speech, but even in breathing and swal- lowing problems that seriously affect the quality of your patients lives. Method We provide the safety net you and your hospital staff can rely on for the benefit of the patient, as well as perhaps crucial forensic evidence. Our neuromonitor AVALANCHE XT has been especially developed for thyroid surgery, allowing the surgeon to trace the vocal cord nerves and test their function at every stage of the operation. Once the nerve has been identified and found intact, minute electric impulses are emitted into the tissue by a stimulation probe, activating the motor unit action potential (MUAP) in the target muscle - the vocalis muscle. Clear visual and acoustic signals alert the surgeon to the MUAP status. The MUAP is picked up by special electrodes and conducted along the endotracheal tube. Alternatively, a transligamentary needle electrode may be entered into the vocalis muscle. By stimulating the vagus nerve before and after the resection of one side of the thyroid, the entire recurrent laryngeal nerve (vocal cord nerve) can be mapped. The records may provide crucial forensic evidence for the operating surgeon. During bilateral thyroid resection, nerve function on one side can be tested before the second side is operated on. This considera- bly reduces the risk of bilateral paresis.

3 AVAL ANCHE XT Working principle System features Intuitive layout and easy-to-use touch screen Documentation of signals via drag-to-label feature Printout at the end of the op with optional individually configurable reports for an at-aglance overview of all important stimulation results Acoustic and visual indication of MUAP signals facilitates signal reading Acoustics reflecting the physiological quality of the signal Automatic measuring of amplitude and latency of motor unit action potentials Automatic recording of all stimulation responses Auto-mute function to suppress any noise in the absence of stimulation Physiological motor unit action potentials, signal changes and pitfalls can be simu- lated on the SIMULANT XS simulator. Ideal for training purposes and function con- trol of neuromonitor equipment. The unique drag-to-label documentation function allows you to assign signals to the relevant events at the swish of a finger. At the end of the operation, the documentation can be printed out at leisure. In addition, there is an optional reporting function where the colour printout can be adapted to the layout used in your institution. It will give you a one-sheet overview of events during an operation and allow you to keep track of your operations at any time.

4 New method for the continuous monitoring of the recurrent laryngeal nerve (RLN) by stimulating the vagus nerve The conventional method of intermittent neuromonitoring during thyroid surgery is flawed because it cannot alert the operating surgeon to imminent nerve damage. What is needed is an early warning system that alerts the surgeon to potential damage to a nerve by traction, pressure or heat and raises the alarm in time to prevent irreparable damage. This is precisely what we at Dr. Langer Medical GmbH have been aiming for. In 2009, we were able to introduce to the market our method of continuous monitoring of the recurrent laryngeal nerve (RLN) by stimulating the vagus nerve. A stimulation electrode remains connected to the vagus nerve throughout the operation, constantly monitoring neural transmission on the RLN. The electrode is placed at the vagus nerve in the carotid sheath, which can be done swiftly and accurately. Signal changes such as latency or amplitude fluctuations can thus be immediately picked up to warn the surgeon. Some causes of possible impairment of the nerve function, such as traction or pressure on nerve tissue by surgical instruments, can be immediately rectified. This considerably reduces the risk of permanent damage to the nerve. VA NE S S A - GUS - RVE - TIMULATION - YSTEM - DAPTER The new VANESSA Headbox with its two independent stimu- lator outputs allows you to switch easily between a handheld stimulation probe to identify the RLN in the operation area and continuous stimulation of vagus nerve at any time. Benefits of continuous monitoring Seamless monitoring of the entire RLN by continuous vagus nerve stimulation (VNS) Rapid recognition of neural function impairment by picking up signal changes, which is invaluable during complex interventions (e.g. recurrent surgery) Quick and easy positioning of the vagus electrode Electrodes designed to remain in position to ensure consistent signal quality Intermittent location of RLN by handheld stimulation probe Easy switching between stimulation modes at any time

5 AVAL ANCHE XT Working principle Thyroid VNS software with full disclosure database The Thyroid VNS (Vagus Nerve Stimulation) software was specifically developed for continuous monitoring of the RLN. Independent parameter setting for both stimulation modes Simultaneous visualisation of motor unit action potential in either stimulation mode Graphic trends making it easy to identify changes in amplitude or latency The full disclosure function gives an overview of all stimulation responses and allows the surgeon to zoom in on significant events. Thyroid VNS Software Above: Separate signal traces for the vagus electrode and the handheld stimulation probe Left: full disclosure overview with zoom by touch function

6 High quality made in Germany There is more to quality than meets the eye attention to detail is just one aspect. There may be cheaper products on the market, but we are in here for the long haul and may save you money in the future. Our neuromonitors are part of a modular range, which allows you to upgrade your system according to your needs. How is that for flexibility? High-quality components ensure that our neuromonitors deliver reliable signals any time - whether you opt for reusable parts or prefer the flexibility of disposable accessories. We have a tailor-made solution. If you are already using equipment from another manufacturer, feel free to contact us to resolve compatibility issues. There is no reason why you should not benefit from the quality of our products. Stimulation probes Our range of stimulation probes meets most needs and can be used with or without microscope, for conventional or minimally invasive surgery. We offer monopolar as well as bipolar probes. Our cable connectors are lockable, preventing stimulation probes from accidentally loosening and falling off the operating table. We can also provide customized equipment that meets your requirements. We also offer a wide range of disposable stimulation probes! Needle electrodes Alternatively, bipolar concentric needle electrodes for transliga- mentary application can be chosen to record muscle potentials. During surgery, experienced surgeons place them between thyroid and cricoid cartilage in the vocalis muscle. They can complement tube electrodes if, due to individual circumstances, tube electrodes do not record clear signals.

7 Tube electrodes Why choose Dr. Langer Medical? We offer easy-to-use disposable electrodes to record signals from the vocalis muscle, which will record reliably even with changing positions. These are adhesive tube electrodes that can be stuck on tubes of varying diameters, which simplifies logistics. The specifically developed design ensures the reliability of signals, while soft edges reduce the risk of cuts during intubation. Dr. Langer Medical GmbH was founded in 1996 at Waldkirch near Freiburg/Br., Germany. From the outset, we specialised on the development and production of systems for intraoperative monitoring (IOM) neurostimulation and relevant accessories. It is an advantage that makes us stand out, not only by the thoughtful design and functionality of our equipment we are usually just one step ahead of our competitors, thanks to our liaising with clients. We take into account every move in the operating theatre in order to simplify the handling of our neuromonitors without compromising on the features that make our equipment safe and reliable. We have a permanent workforce of highly quali- fied staff that are at the cutting edge of important research in the field and feed back their results into our production without delay. As a result, our VANESSA system was the first worldwide to introduce continuous monitoring of the recurrent laryngeal nerve early in This fills us with pride, as well as receiving first prize in the innovation competition for medical technology, awarded by the German Ministry of Education and Research in Equipment trolley Our equipment trolley offers you easy access to all system components during surgery. It features optimum surface space, a standard rail and cleverly designed cable management all in a smart mobile unit. All equipment is in place ready and connected, with no trailing cables on the floor. However, in the long run, nothing can be more important than happy clients and business partners. We are therefore extremely pleased with the continuous praise we have received for our rapid and competent service, facilitated by our friendly and obliging in-house team our hallmark. One of our main advantages is that all our services, be it research and development, production, logistics and customer services, are located on-site in Waldkirch. You as a customer will benefit from our short decision routes for your day-to-day business and long-term perspectives. You will see it is well worth talking to us! AVALANCHE XT: MDD class Applied parts Certification IIa Typ BF

8 Dr. Langer Medical GmbH Fabrik Sonntag Haus 4a Waldkirch / Germany Phone +49 (0) Fax +49 (0) info@medical-langer.de