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EHY-2000 Plus

First and only Class III licensed LRHT device in Canada

(Health Canada Medical Device License No. :88986)

Loco-Regional Hyperthermia (LRHT) treatment employing the scientific principle of Modulated Electro-Hyperthermia (mEHT) administered with the Oncotherm EHY-2000 Plus.

Loco-Regional Hyperthermia (LRHT) is an integrative cancer care treatment intended as an adjunct to standard of care therapy to improve overall outcome.  The EHY-2000 Plus is the only LRHT device employing the technique of Modulated Electro-Hyperthermia (mEHT) in the integrative treatment of indicated cancer.

The EHY-2000 Plus Device consists of three (3) integrated primary components:

The EHY-2000 Plus main RF-unit (treatment tower)

The treatment tower is responsible for power generation and treatment control.  Electrical power from a standard AC 110V 60 Hz wall outlet is governed and supplied to the systems Amplifier Module.  The amplifier generates the Radio Frequency (RF) current which is fed to the RF Tuner Module for calibration and system matching.  A process Control Module provides overall system control, including extensive built in safety mechanisms as required by ISO: 13485:2003/AC:2007 Quality Management Standards and IEC 60601-1-2 Electrical Safety Standards.  The treatment tower supplies and governs power output through shielded cable to the treatment bed.

The WEY-2000 Plus waterbed (treatment bed):

The treatment bed is responsible for patient comfort, application of the mobile treatment electrode to the patient, and completion of the RF energy circuit.  The treatment bed consists of an articulated arm to which the mobile treatment electrode is attached for ease of positioning on the patient.  The treatment bed provides a platform for a water mattress on which the patient is positioned.  Also integrated into the treatment bed platform is the counter electrode that runs the length and breadth of the surface directly under the water mattress. The foot of the treatment bed houses a pumping unit that circulates cooling water to the mobile treatment electrode, as well as a heating unit that maintains the water mattress at temperatures appropriate for patient comfort and treatment efficiency.  Three (3) different diameter mobile treatment electrodes are easily interchangeable on the articulated arm to allow for coverage over varying sizes of the treatment area.  Electrode diameters: Small – 10 cm, Normal – 20 cm, Large – 30 cm.  The underside water bolus of the electrode maintains separation between the electrode transmission surface and the patient.  Cooling water circulates through transparent hoses and over the electrode as an added safety feature to ensure patient comfort.

The controlled RF energy supplied by the EHY-2000 Plus treatment tower is transmitted to the patient through the mobile treatment electrode.  The RF energy passes through the patient treatment area to the counter electrode under the water mattress, thus completing the RF energy circuit.

The Web Box (computer interface unit)

The computer interface unit is responsible for information storage and remote control of the treatment tower.  The Web Box is equipped with an electronic interface solution developed by Oncotherm that provides remote control options from a main computer workstation, located at the technicians area within the treatment room.  Control of treatment power and duration is possible through the interface software without impacting the patient safety mechanisms inherent in the EHY-2000 Plus treatment tower.  The software also incorporates a tool for creating treatment protocols, collecting/archiving patient treatment data and generating statistical information.

Intended Use

The EHY-2000 Plus device is intended for use with chemotherapy and/or radiotherapy to improve outcome, and is devoted to the non-invasive hyperthermia based treatment of indicated solid tumours.

Indication

The EHY 2000 Plus Regional Hyperthermia device is indicated for use with Chemotherapy in the treatment of localized high-risk soft-tissue sarcoma stage II, III & IV, to improve outcome.

Contra indications

Cannot be used when the patient is under deep-sedation or anesthesia. Application of analgesics in the treated area is prohibited.

Cannot be used when the patient is unconscious.

Cannot be used when patient is not able to communicate with the physician.

Do not use the electrodes in the vicinity of the patient’s metallic/prosthesis. The distance between the implanted metal and the circumflex of the upper electrode shall be more than the radius of the electrode (bone-replacement, joint support, etc.).

Before the treatment all metallic objects (necklaces, rings, jewels, watches, pipes, coins, phones, hairpins, pens, etc.) shall be removed from the patient and placed away from the treatment bed.

Do not treat patients who have earphones, hearing-aid, music devices (Walkman, walk-watch, etc.) and or/any wire-connected instruments.

Cannot be used for treating patients who have pacemaker or other types of electrical implants (e.g. deep brain stimulator (DBS), implanted hearing-aids, implanted erectile function stimulator, etc.).

Must not be used in case of tendency to hemorrhage, including menstruation or open wound (e.g. newly operated patients).

Do not apply for patients with organ-transplants or for patients who are suffering from the consequences of organ-transplant.

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Surveys using paper questionnaires have significant disadvantages:

• incompletely or ambiguously filled out forms, or even lost questionnaires.

• entering questionnaire responses into PC spread sheets is an arduous and monotonous task for staff and is therefore also prone to error.

• exhaustive analyses consume valuable staff resources, resulting in additional expenditures.

• significant post-survey delay before meaningful results can be obtained.

 

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PHONE

(+1) 778 789 4131

ADDRESS

Suite#7 - 9228 Glover Road

Langley BC V1M 2S4

Canada