Non-transcranial Electroanesthesia Device
Vanderbilt University
Dr. James Berry, Supporting Faculty Member
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Problem to be solved
Present anesthesiology techniques primarily utilize gas and liquid anesthetics. Gas
anesthesia is complicated to administer and the equipment is expensive, while
intravenous anesthetics are expensive to purchase (Clarke 155-160). In many cases,
intravenous anesthesia is between three and nine times more expensive than gas
anesthesia per volume (Kurpiers et. al., 69-75). However more gas is required per
treatment raising the cost to around twenty to forty dollars a patient (Kurpiers et. al., 6975). Anesthesia and analgesia may be produced through the application of
electromagnetic fields to the brain. Electroanesthesia will reduce the high cost of
anesthesia for surgery and other procedures by reducing the need to keep large quantities
of liquid and gas anesthesia on hand. In addition, because electroanesthesia may be
delivered non-invasively through the skin, a highly trained anesthesiologist will not be
required. By combining the premedication and paramedication capacity of liquid,
electroanesthesia as a method for administering general anesthesia is a more cost
effective design. Electroanesthesia is thought to affect the same areas of the brain as
chemical anesthesia and therefore provide the same effects. Due to apprehension about
the long term effects of passing electrical current across the brain voiced by the Food and
Drug Administration, an alternative method for administering electroanesthesia must be
developed to bring electroanesthesia to market in the United States (Fries 2005).
Problem objective statement
By utilizing the vagal nerves’ direct connections to the brain, a theoretical
alternative method for the application of electroanesthesia is proposed. Vagal nerve
stimulation (VNS) currently offers the “analgesia” aspects of anesthesia (Kirchner et al.,
Ness et al.). There are fewer side-effects with transcranial electroanesthesia than
conventional anesthesia techniques due to its biological benefits (Sances and Larson and
Larson 1975), and non-transcranial electroanesthesia may also boast these benefits.
Through the development of and further research into VNS, full anesthesia (hypnosis and
analgesia) may be achieved. The goal of this design project is to develop a device to
control and administer non-transcranial electroanesthesia using the vagal approach. The
device will be portable, self sustaining, and rechargeable. Further research into VNS and
other methods for administering electroanesthesia will be addressed in a later project. The
exact parameters for stimulation will be variable allowing the device to be adaptable to
altered stimulation parameters determined with any future research. The electrical pulses
required for the electroanesthesia will be generated by the computer’s soundcard and then
output from the sound jack to an external amplification circuit. This circuit will amplify
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
the signal to the desired voltage and a set of electrodes will deliver the signal to the
surface of the skin.
Documentation of the final design, including applicable standards and risk analysis
The device is classified as a Class III medical device because insufficient
information exists to ensure safety and effectiveness solely through general or special
controls. Because the FDA relies upon only valid scientific evidence to determine
whether there is reasonable assurance that the device is safe and effective1, further
extensive investigation of the device will be necessary upon completion and production
of the final design before use.
Using the Design Safe 3 program, some possible risks of our device and their
solutions were investigated (See Report in Appendix G). One of the conceivable risks of
this device or any device creating electrical pulses is the possibility of shocking the
physician or patient during use or the maintenance technician during normal upkeep or
repair of the device. In our device, this risk is small due to the low currents (sub mA) and
voltages used. To further mitigate this risk, the amplification circuit will be enclosed
within the device housing and all wires properly insulated. The laptop, circuit, and
internal fans will also be grounded to prevent static charges from building up creating the
possibility of shocking the user. The most serious risks associated with this device
involve the cessation of function of the device. If it stops working for any reason, the
anesthetic effects will almost immediately cease creating a serious problem if it occurs
during a procedure. This failure could result if there is an error in the LabVIEW code, an
error in the computer function, the battery dies, or the applicator becomes dislodged from
the patient. Thorough testing of the code will be conducted under all possible parameters
until all bugs have been removed. Although it is impossible to completely eliminate the
risk of computer failure, by having a computer with a fast processor and an excess of
memory that only runs our desired program this risk will be minimized. While not in our
prototype, the laptop used for the device should have two battery ports allowing for
extended battery life and the ability to recharge one battery while the other is powering
the device. The electrodes themselves are highly adhesive to the skin and have a low
probability of accidentally falling off the patient (Appendix D(a).iv). To further reduce
this risk, a self-adhesive medical tape will be wrapped around the head or neck across
both electrodes, securing them to the patient.
Prototype of the final design
The operation of our device will be controlled by a laptop running a LabVIEW
virtual instrument (vi) (See Appendix E(d)). The program will accept the input of patient
1
Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies,
studies and objective trials without matched controls, well-documented case histories conducted by
qualified experts, and reports of significant human experience with a marketed device, from which it can
fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use. (FDA title 21.860.7)
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
information either manually or from a patient database. Based on the patient information
such as age, sex, or any special conditions, the pulse duration, amplitude, and frequency
of the waveform will be set. When our unit is first turned on, the computer will boot up
and automatically open the LabVIEW vi. The ON/OFF button turns the signal generation
on or off but does not close the program. There are dials to control pulse duration,
amplitude, and frequency of the output signal. The STOP button exits the program
completely. There is also a SAVE command which saves the data from all of the plots.
During waveform generation, a plot showing the current waveform generation and a plot
showing a ten second window of all of the pulses during the session are displayed. The
user can access a complete log of the signal by using the scroll bar at the bottom of the
graph. The program also has a third plot space which will be utilized to display patient
vital signs when the device is attached to appropriate vital signs equipment (See
Appendix D(a).iii).
The LabVIEW vi consists of one general loop that runs the entire vi. Outside of
the general loop there are sound property operators that condition the program for the
creation of sound. In the general loop there are 3 conditional loops, conditional operators,
string matrix constructors, and a light boolean. The string matrix constructor creates
strings for saving data for each plot. The light boolean is used to indicated that the
stimulus is active. The conditional operators allow for the selection of which type of
patient information is being used for display and saving. These operators also control
which type of patient information should be activated for input. In addition, they control
whether the device is on or off and whether the stimulus is active or inactive.
Two conditional loops allow for access to patient information entry protocol and
one for signal generation. The patient information protocol is contained in two separate
conditional loops that are controlled by a conditional operator. The first conditional loop
allows for manual input, while the second allows for the use of a local or network drive to
access patient information from a database or file. The signal generation conditional loop
controls the audible signal generation. This loop contains an audible signal player
correlated to the square wave generated. The loop is activated when the stimulus is turned
on. This loop contains the controls for the properties of the stimulus. There is a divider
operator associated with the voltage control to ensure a mono-polar signal and a
multiplier to amplify the signal going out. The design links pulse length to duty cycle to
achieve the desired audible output, thus the duty cycle dial is inactive at all times.
The computer output uses a gain stage of 23 (See Appendix E(c)) to amplify the
signal for patient delivery to any desired voltage between 13.8 and 59.8V. The circuit
consists of a precision instrumentation amplifier, resistors, fans, and a battery power
supply contained under the laptop (See Appendix D(a).ii). The instrumentation
amplifier used is a Burr-Brown INA114AP-ND amplifier. This amplifier is used because
of the wide power range of +/-2.25V to +/-18V. Other advantages of the amplifier are a
high CMRR of 115dB and a gain range of 1 to 1000. The gain of the amplifier is
determined by one resister. When testing the device, the gain may be changed by
replacing the resistor. The power supply to the amplifier is a 9V rechargeable Nickel
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Metal Hydride battery with a voltage divider to reduce the voltage of the circuit to 4.5V.
Using a lower voltage prevents the amplifier from generating unnecessary heat without
compromising function. The battery is also connected to a RadioShack 9V charger. A
rechargeable battery maintains the portability of the device while also offering an easy
way to recharge the system. A 5V Orion fan is used to cool the amplifier from the heat of
the computer and insulation surrounding the circuit. The life expectancy of the fan is
over 50,000 hours. Using a separate 9V Ni-MH battery and 9V RadioShack charger, the
fans are powered. There is a power strip fed through the back of the box connecting all
components in the housing. This allows for one cord to be plugged in while the device is
charging. The circuit output is then connected to electrodes attached to patient.
Shielded wires run out of the housing for connection to either clips, for a generic
2.75 in. diameter pad electrode, or needle electrode for application purposes. The white
foam backing of the pad electrode allows for stretch-ability and memory over repeated
use. The carbon/silver film gives uniform current distribution and lower impedance levels
for more comfort for up to 6 hours. A monopolar 1 in., 28 gauge conical tip needle
electrode will be used to delivery the desired signal for any length of time. The conical
tip of the needle electrode will provide for low penetration resistance. At a price of
roughly $2 to $3 per electrode, the pad and needle electrode will offer the proper
functions with a minimal cost. The placement of the electrodes (See Appendix D(a).iv)
will be behind the ear on the vagal nerve..
The laptop and amplification circuit are be housed within an 18" x 18" x 10"
compartment constructed from rigid high-density polyethylene from Tap plastics (See
Appendix D(a).i). The top of the box is hinged allowing for access to the laptop which
sits on a shelf near the top of the casing. The right side of the box has a fan to remove
heat produced by the laptop and circuit. Underneath the laptop is space for the circuit, a
battery and charger to run the circuit and fans, a power strip to connect all of the devices,
and extra space for the storage of the recommended vital signs equipment (See Appendix
E(b)).
Proof that the design is functional and will solve the problem
The use of the vagal nerve to administer “complete” electroanesthesia is
theoretical. It has been shown that pain can be controlled by electrical stimulation of the
vagal nerve (Kirchner et al., Ness et al.) or the transcutaneous nerve (Strassburg). These
nerves lead into the brain and allow for the control of pain without using a transcranial
method. Cork et al (2004) showed that pain control was possible via clips on the earlobes
(possibly stimulating the brain via the facial nerve). Ammons et al. (1983) proposed that
there are sites on the brainstem that can activate descending inhibitory pathways via the
stimulation of the vagal and surrounding nerves. Noxious and non-noxious stimuli were
inhibited in spinothalamic cells by stimulation of the left vagal nerve. Complete
inhibition was observed in cells with low background activity while cells with high
background activity showed partial inhibition (See Appendix E(a).iii). George et al.
(2002) showed that motor cortex excitability was reduced while the vagal nerve was
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
being stimulated. A descending mechanism of inhibition was confirmed by Garcia-Larrea
et al. (1999) when a reduction in spinal reflexes resulted from motor cortex stimulation.
Hammond et al. (1992) showed that the action potential of a stimulus travels via afferent
fibers to the nucleus of the solitary tract and the area postrema. Hammond also reported
that “synchronous bursts of potentials could be dispersed to widespread areas of the
brain.” When inhibitory neurons are tonically excited, other inhibitory neurons are
excited through mutual inhibitory connections (Jefferys et al. 202-208). Kirchner et al.
(2000) confirm the use of vagal nerve stimulation to suppress pain in an experimentally
induced pain study. Postulating that the mechanism of VNS involves central inhibition
and not peripheral nociceptive mechanisms, Kirchner and his colleagues showed that
there was widespread distribution of inhibition in the central nervous system, confirming
the findings of Jefferys et al. The finding that VNS has widespread effects is significant
because pain perception and response results from sensory inputs that are modulated by
feedback mechanisms and the influence of the central nervous system (Melzack et al.
971-979). The release of GABA and glycerin by stimulated C-fibers (Woodbury and
Woodbury 94-107) mediates inhibition (See Appendix E(a).ii). Our stimulation
parameters were estimated from the findings of George et al. (2002) who discovered that
5 Hz signals resulted in less of an effect in the brain than did VNS at 20 Hz. Additionally,
a pulse length of 250 µs (Liporace et al. 885-886) at 50 µA (Kirchner et al. 1167-1171)
and 25 V produced the best results. The exact stimulation parameters will be varied based
on the age, sex, and other parameters of the patient.
The device output has been verified using an oscilloscope. The oscilloscope
confirmed that the device produces a square pulse with the parameters that are set in the
vi (See Appendix D(b)). This confirms that the output of the device is being produced
and administered properly. The device was able to run while unplugged for three hours
without any changes in performance and should run indefinitely when plugged in. The
output signal could be cleaned up by the use of a better sound card. By changing the
BIOS shell of the computer, any lag in the signal can be eliminated.
Results of a patent search and/or search for prior art, assessment of patentability
A patent search revealed no patents involving non-transcranial electroanesthesia. A
patent was found (4383522, 1983) that describes a transcranial method of delivering
electroanesthesia using electrodes placed on the neck and the forehead. This method uses
two power supplies to pass up to 2.5 mA at 100-200 Hz through the brain. In this patent,
electric pulses are used in conjunction with muscle relaxants, nitrous oxide and oxygen to
produce anesthesia. Considering another potentially patentable part of our design, our
device will use the output of a computer’s soundcard to produce the pulses used to
produce the electroanesthesia. A patent search revealed a conceptually similar although
different use for the output of a soundcard. The paragraph below describes patent number
6,393,319 received on May 21, 2002.
“Data defining electrical waveforms for physical therapy is created on a computer and
stored in a removable machine-readable medium such as a CD-ROM or
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
semiconductor memory module. The data is played back, for example on a portable
CD-ROM player, to produce the physical therapy waveforms at any time and location
convenient or desired by the patient. An interface circuit amplifies and conditions the
resulting waveforms for applying them to the skin of the patient via leads and
electrodes. Since most therapies use waveforms within the audio frequency range,
ubiquitous low-cost audio playback equipment can be used. Advantages of the
invention are providing physical therapy at any location and at low cost, without
requiring presence of a clinician or other health care professional on location.” (US
Patent Office online)
Instead of prerecorded data, our device will use a continuously tunable LabVIEW
interface to produce the data stream output by the soundcard. This dynamic
electroanesthesia signal will be administered to the patient without any chemical
anesthesia during the procedure. The electrical stimuli will be delivered to the vagal
nerve either behind the earlobe or at the side of the neck.
Anticipated regulatory pathway
To date, the FDA has not approved any electroanesthesia devices and considers
them to be Class III medical devices under 21CFR868.5400. Approval for such a device
needs to go through a Premarket Approval (PMA) or Product Development Protocol
(PDP). Extensive clinical testing, the disclosure of specifications, intended use,
manufacturing methods, and proposed labeling would be required for the PMA process.
In order to collect preliminary data and show proof of concept, animal testing would have
to be conducted first. Before proceeding with animal testing, Institutional Review Board
(IRB) approval would need to be obtained. After these studies, an investigational device
exemption (IDE) would need to be cleared for human trials to begin. Specific success
criteria for each end-point would be determined in advance. If the protocol is approved
and the clinical trial yields data that meet or exceed these criteria, the process would be
completed and the device should be approved.
Although no electroanesthesia devices have been approved in the US as stated
previously, a cranial electrotherapy stimulator (CES) has been cleared as substantially
equivalent for insomnia. Under 21CFR882.5800, this device is considered Class III and
requires a 510(k) approval. These devices typically deliver about 4mA of high frequency
current via applicators at each temple. Manufactures of these devices claim that they are
useful for a variety of applications from reducing pain, to improving sleep, to increasing
brain power (Red Circuits). There are also several transcranial electroanesthesia devices
approved in Europe. These devices can produce general anesthesia either alone or in
conjunction with conventional drugs or muscle relaxants. These devices are different
from our proposed device because they deliver the electroanesthesia across the whole
head instead of across the vagal nerve as in our device. This difference could make our
device much safer with a reduced chance of side-effects.
Estimated manufacturing costs
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
The cost to produce this device would be somewhere around $1000. This
manufacturing cost includes $600 for the computer to run the stimulation program, $20
for the electrical components and connections, $150 for housing and constructive
material, $2-3 for electrode applicator, $30 for manufacturing, and $200 for research and
development and quality assurance of the device. Vital signs monitoring and interface
equipment would be added to the device for $2,000. The initial production number is
estimated to be 1,000 units.
The computer being used would not be an after market unit like that of the one in
the prototype, thus it may cost less than the $600 estimate. The estimate is high to
provide for the use of a high quality sound card and microprocessor, as these components
are integral to the device and its operation. The final device housing would be injection
molded instead of our current prototype design. By eliminating the need for many
expensive brackets and fastenings, the housing costs will be reduced by $50. The
electrical components will be less expensive when bought in bulk. Manufacturing costs
will also decline with bulk production. The estimated cost for research and development
and quality assurance includes provisions for defective units. Those units that are not
shipped would be either fixed and sold at a discounted price or disassembled and parts
salvaged. Research and development costs will be ongoing to continue to improve the
device as technology improves. The initial production of 1,000 units is a conservative
estimate considering the potential market size. This is an estimate of the number of units
to beta test the device efficiently.
Market analysis
A non-transcranial electroanesthesia device could be used as a substitute for
intravenous and gas anesthesia in any medical procedure requiring general anesthesia
below the neck. According to Aspect Medical Systems over an estimated 20 million
people undergo surgery using general anesthesia each year in the United States. Our
device would be applicable for most of these making its market potential substantial. In
less developed countries, the high cost of anesthesia and lack of medical expertise make
anesthesia hard to administer. An electroanesthesia device would reduce the cost of
anesthesia and the need for a highly trained anesthesiologist. In developed countries
where advanced anesthesia devices are used, an electroanesthesia device would reduce
the dependence of gas and liquid anesthesia. There is nothing on the market in the US
similar to the proposed device; there are electroanesthesia devices in Europe that utilize
transcranial methods, but these are not approved by the FDA (Takakura).
The device can be produced relatively inexpensively and the sale price can be set
at a fraction of the cost of present anesthesia devices while still providing a profit for
reimbursement. The long term effects of non-transcranial electroanesthesia can be
approximated by the long term effects of vagal nerve stimulation. Considering the market
size, the long term return on the production of a device of this type is considerable. If the
device were sold for $3,500 including vital signs equipment, the profit would be $500.
The cost of current anesthesia equipment is more than $20,000. So the sale of an
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
electroanesthesia device at $3,500 would be easily achieved. The price to include
Vanderbilt royalties and company profit margins would be $4,500. This would provide a
$1,500 profit, $900 of which would go to Vanderbilt in royalties and $600 for company
profits. If the technology were bought outright from Vanderbilt, then the price could be
adjusted to ensure company profit and amortization of the cost of the purchase of the IP.
Distribution of the device will be done through medical device companies on both
a large scale and to private small medical equipment businesses. The sale price to these
companies will be different as the volume of purchases will be different. Sales
agreements will govern the price for these companies. This will assure the purchase of a
set number of units per year. Sales for non-contracted purchases will be based upon the
price for production of a set number of units a year for this purpose.
Executive Summary
Administering gas or intravenous anesthesia requires highly trained physicians
using expensive equipment and expensive gas or liquid anesthetics (Clarke 155-160).
Electroanesthesia will reduce the high cost of anesthesia for surgery and other procedures
by reducing the need to keep large quantities of liquid and gas anesthesia on hand. In
addition, because electroanesthesia will be delivered non-invasively through the skin, a
highly trained anesthesiologist will not be required. These advantages provide a market
for replacement of or the addition of another anesthesia device in all physicians' offices
and hospitals when presented with findings from research and development.
Transcranial electroanesthesia boasts many advantages over gas and intravenous
anesthesia such as a quicker recovery time and fewer biological effects during and after
surgery (Photiades, 218-225) and non-transcranial electroanesthesia may also exhibit
these benefits. Patients heal better when anesthetized with electroanesthesia and are less
affected by the process (Sances and Larson, 21-27). With electroanesthesia there is less
of a build up of naturally produced gases in the body compared to chemical anesthesia
techniques because normal body functions are less impaired (Sances and Larson, 218219). According to research done in Europe there is no harmful effect on
electrocardiograms (ECG) or electroencephalograms (EEG). In mammalian testing, there
was a change in the EEG (Sances and Larson, 55-58) but little on ECG and little neural
tissue change. Hammond et al. (1992) states that in human testing there is obvious change
in scalp recording of EEG with VNS. Furthermore the extracellular and intracellular
fluid of the brain showed little change in potassium and sodium concentration levels with
electroanesthesia (Sances and Larson, 148-175). These electrolytes are important to the
function of many systems, homeostasis, and iron regulation in the body and play a role in
nerve stimulation. This electrolyte concentration stabilization differs from research data
for liquid anesthesia where electrolyte levels are decreased due to changes by the
chemical agents (Sances and Larson, 148-175). Electroanesthesia also yields decreased
gastric acid secretion (Sances and Larson, 33-46), leading to less of a chance for stomach
ulcers seen with other anesthesia.
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
The use of the vagal nerve to administer electroanesthesia is theoretical. Through
the development and further research into VNS, full anesthesia may be achieved. It has
been shown that pain can be controlled by electrical stimulation of the vagal nerve
(Kirchner et al., Ness et al.) or the transcutaneous nerve (Strassburg). These nerves lead
into the brain and allow for the control of pain without passing current through the brain.
Cork et al (2004) showed that pain control was possible via clips on the earlobes.
Ammons et al. (1983) proposed that there are sites on the brain stem that can activate
descending inhibitory pathways via the stimulation of the vagal nerves and the
surrounding nerves. Noxious and non-noxious stimuli were inhibited in spinothalamic
cells by stimulation of the left vagal nerve. A descending mechanism of inhibition was
confirmed by Garcia-Larrea et al. (1999) when a reduction in spinal reflexes resulted
from motor cortex stimulation. Hammond et al. (1992) showed that the action potential of
a stimulus travels via afferent fibers to the nucleus of the solitary tract and the area
postrema. Hammond also reported that “synchronous bursts of potentials could be
dispersed to widespread areas of the brain.” When inhibitory neurons are tonically
excited, other inhibitory neurons are excited through mutual inhibitory connections
(Jefferys et al. 202-208). Kirchner et al. (2000) confirm the use of vagal nerve stimulation
to suppress pain in an experimentally induced pain study. Kirchner and his colleagues
showed that there was widespread distribution of inhibition in the central nervous system,
confirming the findings of Jefferys et al.
To date, the FDA has not approved any electroanesthesia devices and considers
them to be Class III medical devices under 21CFR868.5400. Approval for such a device
needs to go through a Premarket Approval (PMA) or Product Development Protocol
(PDP). Extensive clinical testing, the disclosure of specifications, intended use,
manufacturing methods, and proposed labeling would be required for the PMA process.
In order to collect preliminary data and show proof of concept, animal testing would have
to be conducted first. Before proceeding with animal testing, Institutional Review Board
(IRB) approval would need to be obtained. After these studies, an investigational device
exemption (IDE) would need to be cleared for human trials to begin.
At the present time there is nothing on the market in the US similar to the
proposed device; there are electroanesthesia devices in Europe that utilize transcranial
methods, but these are not approved by the FDA (Takakura). One such device is the
TRANSAIR system. When using this system, the patient is fitted with a headset of
electrodes that are connected to one of 3 different signal generators. The first and most
simple generator can be used by the patient or other non-professional operators. It
generates a monopolar impulse and can run off rechargeable batteries. The second
generator is for use by practitioners and is set to deliver either mono or bipolar impulses.
This generator also comes with an LCD, timer, frequency control, alarm and other
protection systems. The last generator is for use by hospitals and outpatient clinics only.
Additional features for this device include automatic control and verbal dialogue with
user (See Appendix E(e)). In the future, any competitive design would have to utilize
non-transcranial methods to be approved for use in the United States. Alternative
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
methods are not known at this time and therefore speculation of possible other methods is
difficult.
A non-transcranial electroanesthesia device could be used as a substitute for
intravenous and gas anesthesia in any medical procedure requiring anesthesia below the
neck. According to Aspect Medical Systems over an estimated 20 million people undergo
surgery using general anesthesia each year in the United States. Our device would be
applicable for most of these making its market potential substantial. In less developed
countries, the high cost of anesthesia and lack of medical expertise make anesthesia hard
to administer. An electroanesthesia device would reduce the cost of anesthesia and the
need for a highly trained anesthesiologist. In developed countries were advanced
anesthesia devices are used, an electroanesthesia device would reduce the dependence on
gas and liquid anesthesia. The device can be produced very inexpensively and the sale
price can be set at a fraction of the cost of present anesthesia devices. The cost of current
anesthesia devices is more than $10,000. The price including Vanderbilt royalties and
company profit margins would be $4,500. This would provide a $1,500 profit. If the
technology were bought outright from Vanderbilt, then the price could be adjusted to
assure company profit and amortization of the cost of the purchase of the IP.
Distribution of the device will be done through medical device companies to both
large corporations and small, private medical equipment businesses via sales agreements.
Sales for non-contracted purchases will be based upon the price for production. In this
situation the buyer could be either a company or a hospital/physician's office. The end
user in all cases would be the hospital staff/physician in non-hospital situations. These
users would provide anesthesia to their patients at a reduced cost from that of present
techniques and in non-hospital situations unlike present use of anesthesia.
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix
A. Student Résumés
a. Matthew Wesley Jackson (Team Leader)
Phone: 239 - 340 - 8064
email: matthew.w.jackson@vanderbilt.edu
b. Ryan Thomas Demeter
Phone: 314 - 580 - 0151
email: ryan.t.demeter@vanderbilt.edu
c. Caroline Schulman
Phone: 917 - 226 - 6079
email: caroline.schulman@vanderbilt.edu
d. Matthew James Whitfield
Phone: 865 - 548 -4239
email: matthew.j.whitfield@vanderbilt.edu
B. Letter of Support
James Berry
Phone: 615-936-1206
Email: james.berry@Vanderbilt.Edu
C. IP policies
D. Photographs
a. Prototype
i. Overall
ii. Circuit
iii. Interface
iv. Applicator
b. Oscilloscope display of stimulus from device
E. Schematics
a. Nerve Information
i. Vagal Nerve Information
ii. Nerve Fiber Information
iii. Nerve/Stimulation Interaction
b. Final design
c. Circuit
d. LabVIEW
e. European Devices
F. Business Plan
a. Budget
G. References
H. Design Safe Report
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix A
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Current Address:
Vanderbilt University
VU Station B #353886
Nashville, TN 37235-3886
239-340-8064
EDUCATION
Matthew W. Jackson
matthew.w.jackson@Vanderbilt.edu
Permanent Address:
15821 Shamrock Dr.
Fort Myers, Fl 33912
239-481-5083
Vanderbilt University
Bishop Verot Catholic High School
May 2002 Top 10% of class
Nashville, TN
Fort Myer, FL
HONORS
Dean’s List-Fall 2002/2005
ACTIVITIES
Vanderbilt Student Volunteers for Science
Participant
Spring/Fall 2003, Spring/Fall 2004. Spring/Fall 2005.
Teacher Coordinator
Fall 05/Spring 06.
Communicated between the program advisor and the coordinator teachers in the classrooms of the schools visited.
Weekly e-mails were sent to the teachers each week informing them of the visitation of VSVS groups to the
classroom. Feedback was collected and expressed to the executive board of the group, which I sat on at the end of
the semester.
Admissions Office Greeting
Fall 2003, Spring 2004.
Freshman Residential Advisor
Fall 2004, Spring 2005.
Head Resident
Upper-classman
Summer 2005
Freshman
Fall 2005/Spring 2006
The Head Resident (HR) is a part-time paraprofessional staff member for the Office of Housing & Residential
Education. The Head Resident works closely with the Assistant Directors and supervision of the Resident Adviser
staff in his building. The Head Resident provides staff leadership by demonstrating and encouraging responsible
behavior for both his staff and students within their residential community. , .
Lambda Chi Alpha international Fraternity (Greek social fraternity ΛΧΑ) –
Steward
April 2004 to March 2006
Meals were arranged with local restaurants to feed the brothers of the fraternity after the weekly meetings. A 7 meal
dinning plan was developed with the two dinners and 5 lunches a week for the Spring and Fall 2005 semesters. The
Spring 2006 semester was reduced to one dinner and three lunches, with the same level of planning. .
Member
2003 to present.
Children’s Emergency Department
Volunteer
June 2004-present.
EXPERIENCE
Project Design
Team member
Fall 2002 (ES 130), Spring 2004 (BME 102) Fall 2004 (BME 210) Spring 2005 (BME 271).
Worked to design various devises to satisfy design specification. Research in how our product would play a role in
the market and in what market to enter into was necessary. Possible side-effect or after effect were researched.
Photography and Resource Management
Summer 2003
Photographer for a picture book for a pool contracting company. Once pools were photographed, the photographs
were organized by type of construction and then placed in binders for use in sales and on a data base for use in
internet contact and the company web site. I was liaison to the web-site hosting company to help update and
redesign the web site. Additionally I collected the input of the company’s customers about after construction
comments. I also was a resource management consultant to a business student undergrad working at the company.
Together the student and I were able to map out the location of customers and re-organize the pool service routes for
the company. With the knowledge and comments fielded by the customers, pool service for the company was
increased 5 fold within 3 months. .
SKILLS &
Certified SCUBA Diver. First Mate and cook on an Open Water Sports
INTERESTS
Fishing Boat. Proficient with Matlab, Microsoft WORD, Excel and
Power Point.
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Ryan T. Demeter
14066 Boxford Court
Chesterfield, Mo 63017
Cell -(314) 580-0151
Home -(314) 576-4293
ryan.t.demeter@vanderbilt.edu
EDUCATION
VANDERBILT UNIVERSITY
Biomedical Engineering – December 2006
BE
GPA – 2.8
Nashville, TN
CHAMINADE COLLEGE PREP
May 2002. Top 10 % of class.
St. Louis, Mo
HONORS
National Honor Society (2001 & 2002)
Nation Merit Semi-Finalist (2002)
EXPERIENCE
'00-'02
St. Louis, Mo
THE INFIELD
Attendant
Attendant for go-carts, batting cages, miniature golf. Assisted customers who
experienced problems or that broke the ground rules.
Summer '03
Chili's Resteraunt
Server. Gained experience in customer relations as a server at a bustling resteraunt
near
downtown Nashille.
Summer '04
Pacific, Mo
AMI
Automated Drill Operator
Operated a drill designed to fabricate custom made plastics, synthetics, metals. Gained
insight on the design process and large factory environments.
ACTIVITIES
BMES (Biomedical Engineering Society) (2003-2005)
Kappa Sigma MDA lock-up philanthropy event volunteer ( 2004 & 2005)
Assisted in organizing the physical set-up of the event and coordinated the arrival of
and
placement of donors.
Kappa Sigma assistant rush chair (2003)
One of five people living in the fraternity house. Coordinated rush activities and other
events for incoming freshman
National Honor Society (2001 & 2002)
Nation Merit Semi-Finalist (2002)
COMPUTER
SKILLS
Major Packages: Microsoft Office (including Work, Excel, PowerPoint, Access, and
Project), Matlab, LabView, AutoCAD LT
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Caroline Schulman
322 Central Park West
New York, NY 10025
Phone (917) 226 - 6079
Home Phone (212) 678 - 2096
Email caroline.schulman@vanderbilt.edu
P E R S O N A L
Biomedical and Electrical Engineering Undergraduate Student
E D U C A T I O N
School of Engineering, Vanderbilt University, Nashville, TN
Class of 2006. Majoring in Biomedical and Electrical Engineering,
Concentrating in Mathematics and Sociology
Dean’s List, Freshman and Junior Year
Canterbury School, New Milford, CT
Graduating Class of 2002
High Honor Role
Honor Society
E X P R I E N C E
Research Assistant, St. Luke’s Hospital
2004
Robotic cardiac surgery unit, summer position, research involving robotic
cardiac machine, virtual reality programs, aneurysm study. Published study
below.
Studies in Health Technology and Informatics, Vol. 111/2005, pp. 414-417
Server, Brinker International, Chili’s
2003- 2004
Required interpersonal skills, organizational skills, punctuality, reliability,
friendliness
Volunteer, Engineering World Health
2003- 2004
Repair broken medical equipment, electrical experience with circuit design
Teacher, Vanderbilt Student Volunteers for Science
2003- 2004
Present scientific lessons and experiments to middle school students
including basic chemical reactions
Member, Biomedical Engineering Society
2003- 2004
Local school chapter; attend lectures, special events, trips
Lab Assistant, Science Department of Canterbury
2001- 2002
I N T E R E S T S & A C T I V I T I E S
 National Biomedical Engineering Society Member (2003 - Present)
 Biomedical Engineering Society Conference Volunteer (2003)
 Heifer Project Participant (1995 - 2004)
 March of Dimes Participant (2001 - 2002)
 Visit and tour of Vanderbilt Clinical Research Center (2003)
S K I L L S
 Recent laboratory experience in Biology, Chemistry, Physics
 Highly organized, responsible; Strong problem-solver
 Basic computer programming in Matlab
 Familiarity and experience with Microsoft Excel, including statistical
experience
 English and intermediate Spanish
 Web page design in Notepad, use of JavaScript
 Driver’s license
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Matthew J. Whitfield
matthew.j.whitfield@vanderbilt.edu
Vanderbilt University
VU Station B #354177
Nashville, TN 37931
865-548-4239
Education
Permanent Address:
6641 Cate Rd
Knoxville, TN 37931
856-945-3243
Vanderbilt University, Nashville, TN
Bachelor of Engineering, Biomedical Engineering major, Neuroscience minor
GPA: 3.76/4.00. May 2006
Karns High School, Knoxville, TN
May 2002, Valedictorian
Honors Dean’s List – every semester
Paul Harrawood Honors Undergraduate Scholarship – full tuition
Tau Beta Pi – engineering honor society
National Merit Scholar
Eagle Scout
Experience
Vanderbilt University Medical Center – Department of Ophthalmology
Student Worker, September 2004 – present
Utilizing microscopic imaging and advanced computer analysis of rat optic nerves to
observe the progression of macular degeneration. Created and modified programs and
macros in Matlab, Visual Basic, and Image Pro to collect and interpret data.
Vanderbilt University – Department of Civil and Environmental Engineering
Intern, Summer 2004
Conducted extensive field work collecting samples from streams in Davidson County.
Performed bacterial, pH, temperature, and chlorine level tests, mapped locations with
GPS system, and cataloged all data in Access.
Oak Ridge National Lab – Chemical Sciences Division
Intern, Summer 2003
Constructed and used an apparatus to test electrode arrays for byproduct formation in
eye-like environments as part of an overall project to create an artificial retina.
University of Tennessee – Plant Molecular Genetics
Lab Technician, Summer 2002
Learned many basic laboratory techniques, assisted in experiments, managed MSDS
inventories, conducted field work, assisted in setup of new laboratory.
Activities
V^2 Mentor – Upperclassmen get paired with a group of freshmen and help them find
classes, get settled into the university, and answer any questions.
Vanderbilt Students Volunteering for Science – Went to local middle schools and
taught students simple science lessons for four semesters.
Meals on Wheels – Delivered meals to shut-ins in the mornings for a couple of summers
Skills and
Interests
Microsoft Office Suite (Word, Excel, PowerPoint, and Access), Matlab, Visual Basic
Ultimate Frisbee – traveling club team
Backpacking
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix B
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
April 3, 2005
National Collegiate Inventors and Innovators Alliance
100 Venture Way
Hadley MA 01035
Re: “Non-Transcranial Electroanesthesia Device” proposal
Dear Sirs:
I am writing to offer my support to the applicants: Matthew Jackson, Ryan Demeter,
Caroline Schulman, and Matthew Whitfield in their proposal entitled “Non-Transcranial
Electroanesthesia Device.”
Besides having a novel and potentially marketable device, these inventors have
potentially opened a new line of investigation into electromagnetic influences on the
central nervous system. This device represents a new approach to anesthesia and
analgesia not previously explored, and it is clearly patentable as a novel application of
portable computer soundcard-generated medical energy.
They have my full support and the support of the University and the Medical Center.
Please let me know if I may be of any further service to you.
Sincerely,
James Berry MD
Professor and Division Chief
Division of Multispecialty Anesthesiology
Medical Director, Main Operating Rooms
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Department of Anesthesiology
Appendix C
INTELLECTUAL PROPERTY RIGHTS FOR VANDERBILT
SPONSORED SENIOR PROJECTS
If you use Vanderbilt resources (including funds, facilities, laboratories, or personnel)
while conducting a senior project, any intellectual property generated as a result of the
project work will be governed by the University’s “Policy on Technology and Literary
and Artistic Works”. This Policy may be found in the Vanderbilt Faculty Manual, Pages
103 - 109, or it may be accessed on-line at: http://www.vanderbilt.edu/facman/. Click on
"Part III. University Principles and Policies," and proceed to Page 103.
The Policy on Technology and Literary and Artistic Works states, in brief, that
intellectual property, such as an invention or process improvement, generated as a result
of work performed in this course shall be assigned to, and owned by, Vanderbilt
University if it is created “with the use of University facilities or funds administered by
the University.” In return, students are entitled to a portion of the royalties generated by
the invention as provided in the Policy.
Students must inform their faculty sponsor and the Vanderbilt Office of Technology
Transfer and Enterprise Development (OTTED) if there are any other agreements that
involve the intellectual property to be created. OTTED will, in turn, determine whether
to pursue patent or intellectual property rights protection, and, if so determined, will
obtain that protection. Income received as a result of exploiting this intellectual property
will be shared with the inventor(s)/creator(s) in accordance with the Policy. If the
University waives, or elects not to pursue its intellectual property rights, and assuming
that there are no other contractual rights with respect to the intellectual property, the
inventors/creators will be offered the rights to the intellectual property.
By my signature below, I acknowledge that I am aware of Vanderbilt’s Policy on
Technology and Literary and Artistic Works.
_____________________
Signature
_____________________
Name (printed)
_________
Date
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix D
Section a
Part i
Overall
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix D
Section a
Part ii
Circuit
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix D
Section a
Part iii
User Interface
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix D
Section a
Part iv
Applicator
Needle Electrode
Pad Electrode
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix D
Section b
Oscilloscope display of stimulus from device
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section a
Part i
Vagal Nerve Information
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section a
Part ii
Nerve Fiber Information
Compound
nerve
action potentials
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section a
Part iii
Nerve/Stimulus Interaction
Normal Nerve reaction to a stimulus
“Relative refractory zone” Inhibition of function
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section b
Final Design
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section c
Circuit
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section d
LabVIEW
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix E
Section e
European Devices
A. Shape of impulses and limits of frequency modulation.
B. 1 – Headset of electrodes 2 – Monopolar output impulse, rechargeable
3 – For practictioners, mono- and bipolar output impulses, LCD, timer, frequency control,
alarm
4 – For hospitals and outpatient clinics, mono- and bipolar output impulses with or without
frequency modulation, LD indicators, timer, automatic control, alarm and protection systems,
verbal dialogue with user in process of adjustment of parameters, plug in
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix F
Business Plan
Section a
Budget
Box and mountings ($214.15)




Case (Dimensions: 18" x 18" x 10") ($124.12)
Foam Padding (VU BME Donated)
Keyboard Hand Rest ($8.75)
Hardware Mounting ($81.37)
Applicator ($0)


Pad Electrode (VU BME Donated)
Needle Electrode (VUMC borrowed)
Circuit and Supplies ($155.78)



2 Fans ($18.00)
3 Amplifiers ($45)
Supplies from Radio Shack ($92.78)
Computer ($0, VUMC Loaned)


1.6 GHz
1 GB Hard drive
Miscellaneous ($130)
Total Budget =$500
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix G
References
Ammons, W. Steve, Robert W. Blair, and Robert D. Foreman. "Vagal Afferent Inhibition
of Primate Thoracic Spinothalamic Neurons." Journal if Neurophysiology 50.4
(October 1983): 926-940.
"Anethesia PAteint Information". Aspect Medical Systems. Accessed 11/14/05.
<http://www.aspectmedical.com/patients/information/default.mspx>
Clarke, H.L. "Anaesthesia for Out-Patient Procedures." The West African
Medical Journal 11 (1962): 155-160.
Cork, Randall C., Patrick Wood, Norbert Ming, and Clifton Shepherd et al. "The Effect
of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia."
The Internet Journal of Anesthesiology (2004): 1-7.
“Cranial Electrotherapy Stimulator” Red Circuits. 27 March 2006.
<http://www.redcircuits.com/Page19.htm>
Fries, Richard. E-mail interview. 5 2005.
“FDA: Significant Risk and Nonsignificant Risk Devices”. Mount Sinai School of
Medicine. 1 September 2005.
<http://www.mssm.edu/irb/pdfs/appendix/13.pdf>
Garcia-Larrea, L., R. Peyron, P. Mertens, M.C. Gregoire, F. Lavenne, D. Le Bars, P.
Convers, F. Mauguiere, M. Sidou, and B. Laurent. “Electrical stimulation of motor
cortex for pain control: a combined PETscan and electrophysiological study.” Pain
83(1999): 259-273
George, M.S. MD, Z. Nahas, MD D.E. Bohning, PhD F.A. Kozel, MD B. Anderson, RN
J.-H. Chae, MD M. Lomarev, MD PhD S. Denslow, PhD X. Li, MD C. Mu, MD PhD.
“Vagus Nerve Stimulation Therapy.” Neurology 59 (2002):s56-s61
Hammond , EJ, BM Uthman, SA Reid, and BJ Wilder. "Electrophysiological studies of
cervical vagus nerve stimulation in humans: I. EEG effects.." Epilepsia. 33 (1992):
1013-1020.
Jefferys, John GR, Roger D. Traub, and Miles A. Whittington. "Neuronal networks for
induced '40 Hz' rhythms." Trends in Neuroscience 19 (1996): 202-208.
Kano, T, GS Cowan, and RH Smith. "Electroanesthesia (EA) studies: EA
produced by stimulation of sensory nerves of the scalp in Rhesus
monkeys." Anesthesia and Analgesia (1976): 536-541.
Kirchner MD, A., F. Birklein MD, H Stefan PhD, and H.O. Handwerker PhD.
"Left vagus nerve stimulation suppresses experimentally induced
pain." Neurology 55.8 (2000): 1167-1171.
Kurpiers EM, Scharine J, Lovell SL. “Cost-effective anesthesia: desflurane versus
propofol in outpatient surgery.” American Association of Nurse Anesthetists Journal.
1996 Feb;64(1):69-75.
Liporace MD, J., D. Hucko RN, BSN, R. Morrow MD, G. Barolat MD, M. Nei MD, J.
Schnur BA, and M. Sperling MD. "Vagal nerve stimulation: Adjustments to reduce
painful side effects." Neurology 57.5 (2001): 885-886.
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Melzack, Ronald, and Patrick D. Wall. "Pain Mechanisms: A New Theory." Science
150.3699 (1965): 971-979.
Ness, T.J., R.B. Fillingim, A. Randich, and E.M. Backensto. "Low intensity vagal nerve
stimulation lowers human thermal." Pain 86 (2000): 81-85.
Photiades, Dimitri P., Janus Garwacki, K.C. Whittaker, and Andeas S.
Lambis. "Electroaneasthesia in Major Surgery ." The West African
Medical Journal (October 1963): 218-225.
Sances Jr., Anthony, and Sanford J. Larson. Electroanesthesia
Biomedical and Biophysical Studies. New York: Academic Press,
Inc., 1975.
Strassburg, H.M. "Influence of Transcutaneous Nerve Stimulations (TNS)
on Acute Pain." Journal if Neurology 217.1 (1977): 1-10.
Takakura, Kintomo. “Transcutaneous Electrical Nerve Stimulation for Relieving Pain:
Physiological significance of the 1/f frequency fluctuation.” Accessed 11/4/05
<http://www.everbest.com.au/TENSforRelievingPain1ffrequencyfluctuation.html.>
Woodbury, JW and DM woodbury. “Vagal Stimulation Reduces the Severity of Maximal
Electroshock Siezures in Intact Rats: Use of a Cuff electrode for Stimulating and
recording.” Pacing and clinical electrophysiology 14 (1991):94-107
VUMC. E-mail interview. 10 2005.
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Appendix H
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
maintenance
technician
periodic
maintenance
electrical /
electronic
shorts / arcing / sparking
bad circuit design,
equipment damage
Slight
Remote
Negligible
Low
other design change, fixed
enclosures / barriers
maintenance
technician
periodic
maintenance
electrical /
electronic
unexpected start up /
motion
Improper shut down and
powering down of device.
Slight
Remote
Negligible
Low
instruction manuals, on-the-job
training (OJT)
maintenance
technician
maintenance
technician
set-up or
changeover
set-up or
changeover
material
handling
material
handling
storing
movement to / from
storage
precarious positioning
Minimal
Remote
Negligible
Low
other design change, safety
mats / contact strip
heavy
Minimal
Remote
Negligible
Low
maintenance
technician
clean up
electrical /
electronic
energized equipment / live
parts
improper handling of tools
Serious
Remote
Negligible
Low
maintenance
technician
clean up
electrical /
electronic
lack of grounding (earthing
or neutral)
could cause problems seen
in 1-1-4
Slight
Occasional
Possible
Moderate
maintenance
technician
clean up
electrical /
electronic
insulation failure
improper handling of tools
Serious
Remote
Negligible
Low
maintenance
technician
clean up
electrical /
electronic
shorts / arcing / sparking
Slight
Remote
Negligible
Low
electrical /
electronic
electrical /
electronic
energized equipment / live
parts
lack of grounding (earthing
or neutral)
Slight
Remote
Negligible
Low
All Users
normal
operation
normal
operation
improper handling of tools
electrodes carry current
which could be dangerous
at high voltages. computer
is actively using elctricity
could cause problems seen
in 1-1-4
other design change
special procedures, on-the-job
training (OJT), instruction
manuals
special procedures, on-the-job
training (OJT), instruction
manuals
special procedures, on-the-job
training (OJT), instruction
manuals
special procedures, on-the-job
training (OJT), instruction
manuals
fixed enclosures / barriers,
audible alarm or sounds,
visible alarm or signal,
instruction manuals
Slight
Occasional
Possible
Moderate
prevent energy buildup
All Users
normal
operation
electrical /
electronic
insulation failure
exposed wires or circuits
Serious
Remote
Negligible
Low
prevent energy release, fixed
enclosures / barriers
normal
operation
normal
operation
electrical /
electronic
electrical /
electronic
shorts / arcing / sparking
bad circuit design,
equipment damage
Slight
Remote
Negligible
Low
Serious
Remote
Unlikely
Moderate
normal
operation
electrical /
electronic
energized equipment / live
parts
charge buildup and storage
electrodes carry current
which could be dangerous
at high voltages. computer
is actively using elctricity
Slight
Remote
Negligible
Low
other design change, fixed
enclosures / barriers
prevent energy buildup,
grounding
fixed enclosures / barriers,
audible alarm or sounds,
visible alarm or signal,
instruction manuals
normal
operation
electrical /
electronic
insulation failure
exposed wires or circuits
Serious
Remote
Negligible
Low
other design change, fixed
enclosures / barriers
normal
operation
electrical /
electronic
shorts / arcing / sparking
bad circuit design,
equipment damage
Slight
Remote
Negligible
Low
prevent energy buildup, fixed
enclosures / barriers
All Users
All Users
All Users
Physician
and/or
Nurse
Physician
and/or
Nurse
Physician
and/or
Nurse
electrostatic discharge
Non-transcranial Electroanesthesia Device
Ryan Demnter, Matthew Jackson, Caroline Schulman, Matthew Whitfield
Physician
and/or
Nurse
Physician
and/or
Nurse
Physician
and/or
Nurse
Physician
and/or
Nurse
software errors
computer virus, bad
programming
Catastrophic
Occasional
Possible
High
electrical /
electronic
power supply interruption
electrical outage, EMP,
battery discharge, short
circuit
Catastrophic
Remote
Possible
High
thoroughly test prototype and
incorporate backup
mechanisms
other design change (backup
measures), other devices,
audible alarm or sounds,
visible alarm or signal,
standard procedures
normal
operation
material
handling
movement to / from
storage
improper handling
Minimal
None
Negligible
Low
on-the-job training (OJT),
instruction manuals
shut down
electrical /
electronic
electrostatic discharge
improper grounding
Serious
Remote
Unlikely
Moderate
other design change, fixed
enclosures / barriers
normal
operation
electrical /
electronic
normal
operation