While not medical devices and not approved as such, there is sufficient evidence to consider off-label usage for humanitarian purposes in the effort to ease the suffering and possibly reduce the mortality rates associated with Ebola virus.
Pinson, AL, December 01, 2014 - Urgent Request for evaluation of the Humanitarian Potential of ParaZapper MY with Ebola Viral Disease.
Without making specific, treatment of disease, claims, the ParaZapper technology may offer potential benefit regarding suffering and the mortality rate in the current Ebola outbreak in Western Africa.
ParaZapper MY is a precision controlled electronic device that uses safe, low voltage pulsed electric fields, LVPEF, to kill or inhibita broad spectrum of microbes in water based environments. The basis of this is established in the food and drink processing industry where PEMF (1,2) is used to destroy all microbes in food or drink such as milk, juices, etc. Due to the high volume of material being produced at any time, the application of pulsed electric fields to these foods and drinks requires a very fast and powerful pulse as the material is flowing at a very high rate. These particular pulse generators are not suitable for use on humans whereas ParaZapper uses a safer technology.
When electric fields are applied to smaller volumes or volumes that are in minimal motion, then the strength of the fields can be reduced to a lower strength and applied more frequently over a longer duration to achieve reasonable results.
This has been demonstrated under microscopic observation with bacteria, protozoa, and yeast, as wells as with some fungi (3,4,5). These types of studies are not practical on virus due to the inability to observe functioning virus under the microscope.
While these devices are not medical devices and have not received any approval as such, there is sufficient evidence to have them considered to be used off-label for humanitarian purposes in the effort to ease the suffering and possibly reduce the mortality rates associated with Ebola virus. The effects of such usage in this application are unknown, however, the devices should be considered to be inherently safe for the following reasons.
The output voltage is 10.0 volts or less and it operates on a 9 volt battery.
The output signal is current limited to a safe level so as not to risk any personal
injury.
The company has sold many thousands of these units to customers worldwide for the purpose of investigating electric water purification. We note the off label use on humans may be relatively common with no complaints of personal injury and no significant side effects other than what would be found with the destructive inhibition of any large volume of microbial inhabitants in the human body.
While FDA approval has not been applied for, the FDA has investigated these products
and this company. In the case of this company, based on the information obtained by the FDA, in a letter to the CEO of the company, the FDA found that these products should be considered to be Class 3 devices, capable of preserving human life, if and when used for the prevention or cure of disease or illness. FDA approval has not been applied for because these devices are sold as experimental water treatment devices, "for water not intended for human consumption
The unit would need to be applied to a patient for several hours a day, if not continuously, for the duration of the illness.
The unit will generally run for 24 hours on a single 9 volt alkaline battery.
Para Systems, Inc., in private transaction, will provide 5 research units at cost plus shipping and handling in consideration of the humanitarian nature of this issue.
Certain substantiating information is listed below. Kindly contact the writer for further private discussion of the potential therapeutic benefits of this technology.
The most important point of this communication is that the off-label use of this water treatment device has the potential of saving human lives as well as reducing the level of suffering associated with Ebola and potentially other illnesses and this potential needs to be thoroughly tested.
The World Health Organization (WHO) stated, on August 12, 2014, that “… the panel reached consensus that it is ethical to offer unproven interventions There was unanimous agreement that there is a moral duty to also evaluate these interventions…
http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en
Contact:
David Etheredge, President
Para Systems, Inc.
1)Kinetics of Microbial Inactivation for Alternative Food Processing Technologies --
Pulsed Electric Fields http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm101662.htm
2)Food Processing by Pulsed Electric Fields: Treatment Delivery, Inactivation Level,
and Regulatory Aspects
M.M.
G¢ngora-Nietoa, D.R. Sep£lvedaa, P. Pedrowb, G.V. Barbosa-C novasa,
B.G. Swansonc http://www.sciencedirect.com/science/article/pii/S0023643801908801
3)ParaZapper
Parasite Zapper Works Video demonstrating destruction of protozoa using ParaZapper. Produced by David L. Etheredge - http://paradevices.com/zapper_works.html
4)Photo of water, almost completely cleared of microbes in two one-hour zappings
demonstrating broad spectrum effect of ParaZapper MY - Photo image by David L.
Etheredge http://paradevices.com/Water_zapping_jars_070813_reg.jpg
5)Evaluation Study on the Effect of Three Electric Currents on The Candida Albicans Fungus Cells - ElbietaPuacz, Ph.D., LiliannKristinnElmborg, M.A. http://www.medi-flowery.com/upload/file/ScientificStudy1_09_3.pdf
6) Studies on the Effect of Medikzap and NE 555 Devices used in Natural Medicine
on The Candida Albicans Fungus Cells - ElbietaPuacz, Ph.D.,
LiliannKristinnElmborg, M.A. http://www.medi-flowery.com/upload/file/ScientificStudy1_09_2.pdf
Contact:
David Etheredge
President
Para Systems, Inc,
5537 Balboa Ct.
Pinson, AL 35126
866-765-5116
http://huldaclarkparazapper.com
Pinson, AL, December 01, 2014 - Urgent Request for evaluation of the Humanitarian Potential of ParaZapper MY with Ebola Viral Disease.
Without making specific, treatment of disease, claims, the ParaZapper technology may offer potential benefit regarding suffering and the mortality rate in the current Ebola outbreak in Western Africa.
ParaZapper MY is a precision controlled electronic device that uses safe, low voltage pulsed electric fields, LVPEF, to kill or inhibita broad spectrum of microbes in water based environments. The basis of this is established in the food and drink processing industry where PEMF (1,2) is used to destroy all microbes in food or drink such as milk, juices, etc. Due to the high volume of material being produced at any time, the application of pulsed electric fields to these foods and drinks requires a very fast and powerful pulse as the material is flowing at a very high rate. These particular pulse generators are not suitable for use on humans whereas ParaZapper uses a safer technology.
When electric fields are applied to smaller volumes or volumes that are in minimal motion, then the strength of the fields can be reduced to a lower strength and applied more frequently over a longer duration to achieve reasonable results.
This has been demonstrated under microscopic observation with bacteria, protozoa, and yeast, as wells as with some fungi (3,4,5). These types of studies are not practical on virus due to the inability to observe functioning virus under the microscope.
While these devices are not medical devices and have not received any approval as such, there is sufficient evidence to have them considered to be used off-label for humanitarian purposes in the effort to ease the suffering and possibly reduce the mortality rates associated with Ebola virus. The effects of such usage in this application are unknown, however, the devices should be considered to be inherently safe for the following reasons.
The output voltage is 10.0 volts or less and it operates on a 9 volt battery.
The output signal is current limited to a safe level so as not to risk any personal
injury.
The company has sold many thousands of these units to customers worldwide for the purpose of investigating electric water purification. We note the off label use on humans may be relatively common with no complaints of personal injury and no significant side effects other than what would be found with the destructive inhibition of any large volume of microbial inhabitants in the human body.
While FDA approval has not been applied for, the FDA has investigated these products
and this company. In the case of this company, based on the information obtained by the FDA, in a letter to the CEO of the company, the FDA found that these products should be considered to be Class 3 devices, capable of preserving human life, if and when used for the prevention or cure of disease or illness. FDA approval has not been applied for because these devices are sold as experimental water treatment devices, "for water not intended for human consumption
The unit would need to be applied to a patient for several hours a day, if not continuously, for the duration of the illness.
The unit will generally run for 24 hours on a single 9 volt alkaline battery.
Para Systems, Inc., in private transaction, will provide 5 research units at cost plus shipping and handling in consideration of the humanitarian nature of this issue.
Certain substantiating information is listed below. Kindly contact the writer for further private discussion of the potential therapeutic benefits of this technology.
The most important point of this communication is that the off-label use of this water treatment device has the potential of saving human lives as well as reducing the level of suffering associated with Ebola and potentially other illnesses and this potential needs to be thoroughly tested.
The World Health Organization (WHO) stated, on August 12, 2014, that “… the panel reached consensus that it is ethical to offer unproven interventions There was unanimous agreement that there is a moral duty to also evaluate these interventions…
http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en
Contact:
David Etheredge, President
Para Systems, Inc.
1)Kinetics of Microbial Inactivation for Alternative Food Processing Technologies --
Pulsed Electric Fields http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm101662.htm
2)Food Processing by Pulsed Electric Fields: Treatment Delivery, Inactivation Level,
and Regulatory Aspects
M.M.
G¢ngora-Nietoa, D.R. Sep£lvedaa, P. Pedrowb, G.V. Barbosa-C novasa,
B.G. Swansonc http://www.sciencedirect.com/science/article/pii/S0023643801908801
3)ParaZapper
Parasite Zapper Works Video demonstrating destruction of protozoa using ParaZapper. Produced by David L. Etheredge - http://paradevices.com/zapper_works.html
4)Photo of water, almost completely cleared of microbes in two one-hour zappings
demonstrating broad spectrum effect of ParaZapper MY - Photo image by David L.
Etheredge http://paradevices.com/Water_zapping_jars_070813_reg.jpg
5)Evaluation Study on the Effect of Three Electric Currents on The Candida Albicans Fungus Cells - ElbietaPuacz, Ph.D., LiliannKristinnElmborg, M.A. http://www.medi-flowery.com/upload/file/ScientificStudy1_09_3.pdf
6) Studies on the Effect of Medikzap and NE 555 Devices used in Natural Medicine
on The Candida Albicans Fungus Cells - ElbietaPuacz, Ph.D.,
LiliannKristinnElmborg, M.A. http://www.medi-flowery.com/upload/file/ScientificStudy1_09_2.pdf
Contact:
David Etheredge
President
Para Systems, Inc,
5537 Balboa Ct.
Pinson, AL 35126
866-765-5116
http://huldaclarkparazapper.com
