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Stimpod NMS460 by Xavant Receives FDA Approval

PRETORIA, South Africa, Aug. 1, 2017 /PRNewswire/ — Xavant Technology (Pty) Ltd today announced that the U.S. Food and Drug Administration (FDA) cleared their Stimpod NMS460. With the U.S. patent awarded on proprietary hybrid pulsed radio frequency (PRF) waveform, this non-invasive neuromodulation device is focused on the symptomatic relief and management of chronic intractable pain, as well as an adjunctive treatment in the management of post-surgical pain, post-traumatic acute pain problems, and an adjunct for pain control due to rehabilitation.

The need for this device is profound. More than 100 million Americans report that they have a problem with pain.[1] Chronic pain is characterized by neuroplastic changes that cause sensitization of the nervous system. These changes result in anatomical and physiological changes that affect neurological function, which causes long-term potentiation and gene expression changes that then allow the pain to continue with or without further peripheral input, and a lower pain threshold; this dysfunction then also accounts for the epiphenomena associated with the disease, including emotional, memory, and motor changes, which then becomes the illness of chronic pain.[2]

Treatment of chronic pain in the United States is estimated to cost $600 billion annually.[3] The current standard of care for chronic pain includes drug cocktails such as Corticosteroids, Opiate pain relievers, injections, and beyond combined with treatments like physical therapy and counseling. Treatments can come with various short-term and long-term side effects.

The Stimpod NMS460, however, will greatly impact the industry as a non-invasive, non-drug solution with zero side effects and a fast onset of effect at a fraction of the cost of comparable treatments. The device applies its patented PRF waveform to the affected area transcutaneously. This waveform creates electromagnetic effects similar to invasive pulsed radio frequency treatments, and several case studies have shown instant and dramatic relief of chronic intractable pain. The Stimpod NMS460 also incorporates the nerve-locating technology which features a nerve mapping probe that enables practitioners to locate nerves and evaluate the treatment progress of damaged nerves. Bell Medical has been selected as the master distributor for both the U.S. and Canada.

“We are thrilled at the news that our revolutionary device can now be used in the U.S.,” said Corlius Birkill, CEO of Xavant Technology (Pty) Ltd. “This groundbreaking technology has the ability to help tens if not hundreds of millions of people just in the U.S. as a valuable treatment asset for neurologists, chiropractors, acupuncturists, physical therapists, physiatrists, and medical pain practitioners.”

About Xavant Technology (Pty) Ltd
Xavant Technology (Pty) Ltd is a leading supplier of nerve stimulators for regional and general anesthesia applications. The current Stimpod range has three models – the NMS410, NMS450 and NMS460. The Stimpod NMS460 is a neuromodulation device used for symptomatic relief of chronic intractable pain, implementing a unique patented Pulsed Radio Frequency waveform for the treatment of neuropathies. The Stimpod NMS410 model is a specialized nerve locating device, with its unique nerve mapping and locating cable, used primarily during Regional Anesthesia procedures. The Stimpod NMS450 adds the option to monitor neuromuscular blocking agents with its advanced three-dimensional accelerometer. Learn More About STIMPODNMS460 at http://www.stimpodnms460.com.

Media Contact:
Lourie Höll
Phone: +27 12 743 5959
Email: [email protected]

[1] Gaskin, Darrell J., and Patrick Richard. “The Economic Costs of Pain in the United States.” The Journal of Pain: Official Journal of the American Pain Society (2012): 715-24. Web. 21 June 2017.

[2] American Academy Of Pain Medicine. Neuropathic Pain Recognized as a Disease. N.p.: American Medical Association, 27 Sept. 2016. PDF. https://assets.ama-assn.org/sub/meeting/documents/i16-resolution-912.pdf

[3] Gaskin, Darrell J., and Patrick Richard. “The Economic Costs of Pain in the United States.” The Journal of Pain: Official Journal of the American Pain Society (2012): 715-24. Web. 21 June 2017.

Source: PR Newswire

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Amsorb Plus Review

When choosing a type of CO2 absorbent, it is important to understand the absorbents environmental impact, effect on patient safety, ease of use and the effect on the consumption of volatile anesthetics. Today we are going to review Amsorb vs. soda limes that contain traces of Sodium Hydroxide, NaOH, such as Medisorb, Sodasorb, Dragersorb and others.

Environmental Impact

Soda limes can have a pH of up to 14 and may require disposal as a hazardous waste according to U.S. Federal Code of Regulations. Soda limes contain sodium hydroxide and are considered corrosive.

Amsorb Plus has a pH of less than 12.5 and is safe for our water table and landfills where it will break down into harmless organic compounds. Amsorb Plus comes with certification of such (see Amsorb Plus disposal document). Kaiser Permanente independently tested all the types of CO2 absorbents readily available on the market and determined Amsorb Plus to be the only one that was safe for disposal in regular landfills. Other types of CO2 absorbents had higher pH and needed to be red bagged and incinerated at greater expense. Amsorb Plus is not harmful in disposal to the environment which translates into a cost savings for hospitals and surgery centers since red bagging is expensive and time consuming.

Patient Safety

Soda limes are known to degrade volatile anesthetics to Carbon Monoxide, Compounds A – F, and Formaldehyde.

Amsorb Plus has no strong alkali and is incapable of producing any of these toxins. Clinical Anesthesia by Barash, 2012, recommends using Amsorb Plus by name and states doing so: (Amsorb Plus)

eliminates all of the potential complications related to anesthetic breakdown and therefore minimizes the possibility of additional costs from those complications, including additional laboratory tests, hospital days, and medical/legal expenses. Adoption of [Amsorb Plus] into routine clinical practice is consistent with the patient safety goals of our anesthesia society.

Ease of Use & Consumption of Volatile Anesthetic

Soda Lime users generally change absorbent based on color change and never know for sure when to change product. Users usually error on the side of caution and change soda lime more often (a wasteful and confusing practice) because if they don’t change soda lime it is possible to endanger the patient by producing toxins such as Compound A, Formaldehyde and Carbon Monoxide. Soda Lime includes a dye that changes color to indicate exhaustion. However, it does not retain color change for long before reverting back to looking fresh. The user can never be sure when product should be changed. Ask any clinician that has used a soda lime and they will verify it is not uncommon to begin a case with what they think is fresh absorbent only to immediately find out they have high levels of FiCO2 and rapid color change of their absorbent.

Soda Limes “adsorbs” (significant amounts of volatile anesthetic which means clinicians wait longer periods of time for their machines and vaporizers to equilibriate. They are less able to reach desired drug percentages without increasing vaporizer settings.

Amsorb Plus has permanent, consistent, and reliable color change. Thus allowing the user to easily tell the state of the absorbent at a glance. Amsorb Plus also adsorbs far less anesthetic vapor than soda limes so machines and vaporizers reach equilibriation faster and accurately reach desired drug percentages without needing to increase vaporizer settings above what is desired for patient inspiration. This saves time and money (utilizing less anesthetic vapor).

Amsorb vs. Soda Lime Review Summary

Soda Lime Amsorb Plus
Environmental Impact
Patient Safety
Ease of Use & Consumption of Volatile Anesthetic

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Neuromuscular Blocking Agent Monitoring with Stimpod NMS 450 Quantitative TOF Monitor

A presentation to the ASATT or American Society of Anesthesia Technicians and Technologists at the 2016 ASATT meeting in Chicago, IL was delivered by Kevin Lueders of Bell Medical and Corlius Birkill of Xavant Technologies of South Africa. This power point presentation discusses neuromuscular blocking agents history and usage. It also presented the various methods of monitoring NMBAs with traditional peripheral nerve stimulators and with the new quantitative or objective Train of Four, TOF monitor such as the Stimpod NMS 450 using accelerometry.

[slideshare id=68006063&doc=asatt2016bellnmbapresentation2-161101185645]

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Alar Nasal Pulse Oximetry Sensor: Anesthesia Application

Ventilator Circuit, Disposable, Latex-Free

Alar Nasal Pulse Oximetry Sensor works on the most challenging patients!

Anesthesia Advantages

“It works when other sensors fail.” The monitoring site is unaffected by non-invasive blood pressure measurements thus reducing false alarms and giving the anesthesia provider uninterrupted oximeter measurements. The Alar Nasal Pulse Oximetry Sensor can be left on for PACU and SICU providing oximeter measurements for the entire length of stay of the post-surgical patient saving the hospital thousands and enhancing patient comfort.

Reliable accuracy – unaffected by poor peripheral perfusion or low saturations

The Alar Nasal Pulse Oximetry Sensor fits comfortably on the fleshy part of the side of the nose. The site is fed by both the external and internal carotid arteries; the latter also provides blood to the brain. The rich vascular supply to this region provides a strong, reliable signal, even when it is difficult or impossible to get a signal at the fingertips.

Monitoring Site results in faster detection of oxygen saturation changes

Because the Alar Nasal Pulse Oximetry Sensor measures the oxygen saturation from a vessel also supplying blood to the brain, changes have been proven to be detected up to 30 seconds faster than with a finger sensor.

Improved patient comfort

The hands-free Alar Sensor does not impede normal patient functions such as eating, drinking or talking. It is less bothersome and is not likely to become disconnected.

Cost effective and convenient

The single-patient-use Alar Sensor does not use adhesives at the sensor site. The sensor can be removed and reapplied for up to 7 days saving hospitals up to $232 for the SICU patient. Proven accuracy reduces false alarms improving patient safety, patient satisfaction and nurse productivity.

Call 800-875-BELL(2355) for More Information.

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TOF Watch Discontinued! Stimpod NMS 450 available NOW!

The German manufacturer, MIPM – Mammendorfer Institut für Physik und Medizin GmbH has announced that effective June 30, 2016 the TOF Watch, TOF Watch S and TOF Watch SX neuromuscular monitors will no longer be manufactured.  The official announcement of the discontinuance of the TOF Watch is below:

TOF-Watch – objective neuromuscular monitoring
Product cancelation Note
We wish to inform you that the TOF Watch monitors are not produced and sold any more effective July 1st 2016.

Their USA distributor Blue Star Enterprises will continue selling the TOF Watch while supplies last. They will also offer the replacement alternative from Bell Medical and Xavant called the Stimpod NMS 450. The only accelerometer based neuromuscular monitor now available is the Stimpod NMS 450 from Xavant distributed in the USA and Canada by Bell Medical Inc. The Stimpod NMS 450 is a neuromuscular monitor that offers Quantitative TOF Monitoring as endorsed by the Anesthesia Patient Safety Foundation or APSF.

Stimpod NMS 450 Nerve Stimulator and TOF Monitor

Stimpod NMS 450The Stimpod NMS 450 Nerve Stimulator and TOF Monitor includes a Tri-axial accelerometer which provides real time feedback of the strength of contraction of the affected limb (Train Of Four, Double Burst and Post Tetanic Count modes). The strength of each measured contraction is displayed graphically and the relevant ratios are calculated and also displayed.

The fine movement differences that can be detected by utilizing accelerometry offer major advantages over gauging contraction strength visually or tactilely.

Tri-axial accelerometry calculates the movement vector of the contraction in three dimensions. This negates the need for calibration as is the case with one-dimensional accelerometers, and reduces the setup time of the procedure.

Combined Nerve Mapping and Nerve Location

Auto sensing technology provides a solution for simultaneous nerve mapping and nerve location. The Stimpod monitors whether the mapping probe or needle touches the patient and adjusts the current range accordingly, ensuring quick and precise nerve location.

The Stimpod Nerve Mapping Probe was designed to enable transcutaneous nerve mapping at higher currents (to a maximum of 20mA), whilst the tip offers a contact surface small enough to ensure effective discrimination.

Current Range Load Impedance Stimulating Modes
Nerve Locating: 0.0 – 5.0mA
Nerve Mapping: 0 – 20mA
NMBA Monitoring: 0 – 80mA
Nerve Locating: 0 – 20kΩ (100V)
Nerve Mapping: 0 – 20kΩ (400V)
NMBA Monitoring: 0 -5kΩ (400V)
Train-of-Four (TOF)
Double Burst (DB)
Post-Tetanic-Count (PTC)
Tetanus (TET)
Twitch (1Hz, 2Hz, 5Hz)

Kit includes:

  • STIMPOD NMS450
  • NMBA Monitoring Cable
  • Nerve Locating Cable
  • Nerve Mapping/Locating Cable
  • Carrying Case

Stimpod NMS 450 Comparison Study

TOF Watch (discontinued) STIMPOD NMS450
NMBA Monitoring (Objective) Yes – 1 Dimensional Accelerometer Yes – 3 Dimensional Accelerometer, enhanced accuracy
Calibration Before TOF Monitoring Yes No, easier setup and operation
Nerve Mapping No Yes – Integrated StimPen results in superior nerve blocks
Nerve Block Application Yes Yes
Pulse Width Selections 0.04ms, 0.2ms 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms
Current Range Nerve Locating 0.0 – 6.0 mA
Nerve Mapping None
NMBA Monitoring 0 – 60 mA
Nerve Locating 0.0 – 5.0 mA
Nerve Mapping 0 – 20 mA
NMBA Monitoring 0 – 80 mA
Adjustable Timers Yes Yes
Auto Sensing Technology Yes Yes – Combination Cable Auto Sensing
Warranty Limited One Year Warranty Two Year Warranty
TOF Bar Graph Display No Yes
Lead Wire Construction 18 Gauge OD, thin and fragile 12 Gauge OD, thick and heavy duty, easy thumb application, 6 month cable warranty
Lead Wire & Accelerometer Cable Replacement Cost $296 $260, 12% savings
Device Attachment IV Pole Attachment Drape clip or IV pole option

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CO2 Absorbent Study Shows CO w Fresh Medisorb!

Pediatric Circuit with Gas Sampling Elbow, Fixed Wye, 1 Liter Bag, Filter

Key findings from 2010 study on CO2 absorbent surprisingly ignored!

Detection of Carbon Monoxide During Routine in Infants and Children

Richard J. Levy, MD,* Viviane G. Nasr, MD,* Ozzie Rivera, BS,† Renee Roberts, MD,* Michael Slack, MD,‡ Joshua P. Kanter, MD,‡ Kanishka Ratnayaka, MD,‡ Richard F. Kaplan, MD,*and Francis X. McGowan, Jr., MD§ (Anesth Analg 2010;110:747–53)

Excerpts and quotes from the study:

Carbon Monoxide was detected routinely during general anesthesia in infants and children when using fresh GE Medisorb, a soda lime. (It has long been known that CO is produced in desiccated soda lime yet surprising to be found when using fresh soda lime.)

Carbon Monoxide is a known neurotoxin. Exposure to low concentrations of CO (12.5ppm) can cause neurotoxicity in the developing brain and may lead to neuro developmental impairment. Peak CO levels measured in the anesthesia breathing circuit were in the range thought to impair the developing brain.

The study suggests that use of carbon dioxide adsorbents that lack strong metal hydroxide (ie. the Amsorb Plus CO2 absorbent) could limit inspired CO if detection was attributed to degradation of volatile anesthetic. …findings suggest the use of carbon dioxide absorbents that lack strong metal hydroxide (the Amsorb Plus CO2 absorbent does not use strong metal hydroxides).
Young children exposed to inhaled anesthetics were twice as likely to develop behavioral or developmental disorders after exposure.

The study measured CO levels in the circuit and in the blood stream via COHb.

CO binds 240 times more avidly to hemoglobin than oxygen.

The APSF recommends using adsorbents that do not use strong metal hydroxides(sodium hydroxide), (the Amsorb Plus CO2 absorbent does not use strong metal hydroxides or sodium hydroxide).

The APSF recommended not using absorbents based on strong alkali or metal hydroxides. The Amsorb Plus CO2 absorbent does not contain strong alkali or metal hydroxides and is thus recommended by the APSF.

For more information on Amsorb Plus CO2 absorbent contact Bell Medical at 314-772-5600.

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Nasal Alar Pulse Oximetry Sensor

Like other anesthesia pulse sensors, the Nasal Alar Pulse Oximetry Sensor from Bell Medical is designed for low profusion patients and multi-day stay ICU patients. The Nasal Alar Pulse Oximeter Probe is FDA approved for up to 28 days on a patient.

The Nasal Alar Pulse Oximeter Probe is lightweight and comfortable to wear. Patients LOVE IT!

Nasal Alar Pulse Oximetry Sensor works on the most challenging patients!

Reliable accuracy – unaffected by poor peripheral perfusion or low saturations with Nasal Alar Pulse Oximetry Sensor

This oxygen and pulse sensor fits comfortably on the fleshy part of the side of the nose. The site is fed by both the external and internal carotid arteries; the latter also provides blood to the brain. The rich vascular supply to this region provides a strong, reliable signal, even when it is difficult or impossible to get a signal at the fingertips.

Monitoring Site results in faster detection of oxygen saturation changes with Nasal Alar Pulse Oximetry Sensor

Because the Nasal Alar Pulse Oximeter Probe measures the oxygen saturation from a vessel also supplying blood to the brain, changes have been proven to be detected up to 30 seconds faster than with a finger sensor.

Improved patient comfort with Nasal Alar Pulse Oximetry Sensor

The hands-free Alar oxygen and pulse sensor does not impede normal patient functions such as eating, drinking, or talking. It is less bothersome to the patient and is not likely to become disconnected.

Cost effective and convenient with Nasal Alar Pulse Oximetry Sensor

The single-patient-use Alar Sensor does not use adhesives at the sensor site. The sensor can be removed and reapplied for up to 7 days saving hospitals up to $232 for the ICU patient. Proven accuracy reduces false alarms improving patient safety, patient satisfaction and nurse productivity.

https://youtu.be/EiNXL7lTFv8

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Amsorb Plus CO2 Absorbent

Amsorb Plus CO2 Absorbent improves patient safety by eliminating potential toxins plus it provides permanent color change so you always know the status of your absorbent. Your health organization is currently using GE Medisorb which is a traditional sodalime that can produce toxins when desiccated or fully spent. Since your facility does not change your absorbent until you have a reading of over 5 mmHg inspired CO2 the risk of exposure to toxins such as Compound A, Carbon Monoxide and Formaldehyde is increased. With Amsorb Plus you can continue to push your absorbent to complete exhaustion with no worry of toxins. Because Amsorb Plus CO2 Absorbent produces no toxins ever, your clinicians may also deliver lower flows while administering Sevoflurane and thus save the hospital system thousands. Amsorb Plus CO2 Absorbent is part of many health systems “green initiative” because Amsorb Plus has a lower pH than sodalimes such as GE Medisorb when spent. Amsorb Plus is NOT a sodalime. Amsorb Plus CO2 Absorbent is safe for the environment and safe for landfills. GE Medisorb and sodalime are often required to be “red bagged” for incineration at great expense due to spent sodalime’s high pH (see attached Kaiser Permanente disposal document).

Amsorb Plus CO2 Absorbent

Amsorb Plus offers numerous benefits at no additional cost for the actual absorbent. We offer Amsorb Plus CO2 Absorbent under our price matching program that guarantees savings since you save on anesthetic agent and on product disposal.

Bell Medical would be happy to provide you with product to conduct your own evaluation and trial with the hopes that your positive experience would allow Amsorb Plus to be considered as a product of choice. Please review the attachments and let us know how best to proceed with a local or corporate evaluation. Thank you for your interest and support.