Thursday, April 5, 2012
ワンタッチ １２誘導心電図電極 グローブ
The EKG (ECG) Glove can generate and send a complete diagnostic twelve-lead electrocardiogram (“ECG”) directly to a computer or to a mobile phone on which Ineedmd’s proprietary software would be downloaded. As demonstrated in ineedmd’s clinical trials to date, the EKG (ECG) Glove produces consistent reliable EKG (ECG) waveforms and data that are equivalent by FDA standards to those produced using a conventional EKG (ECG) machine that records EKG (ECG) data on paper.
The EKG (ECG) Glove is a disposable, mitt-like device that has ten embedded EKG (ECG) sensors (electrodes) and corresponding printed circuits. Potential purchasers of the ineedmd’s complete EKG (ECG) Glove System receive from the Company the following hardware and software items:
1. EKG (ECG) Gloves – disposable mitts containing pre-positioned electrodes
2. Interface Box – industrial plastic box about the size of a pack of playing cards
3. Cable – for connection to a laptop computer (a wireless mode is being developed and is pending FDA approval)
4. Analytical Software – pre-loaded on a laptop computer, PDA, or cell phone
The EKG (ECG) Glove System is FDA cleared. The hardware and software provided as part of the complete EKG (ECG) Glove System are separately cleared by the FDA, and are commercially available as off the shelf products.
The recording of an EKG (ECG) using the EKG (ECG) Glove System requires a second person or a medical assistant to first open the sealed pouch containing one disposable EKG (ECG) Glove.
Following patient preparation (e.g., shaving the chest area on a hairy patient), the person or medical assistant places his or her right hand into the EKG (ECG) Glove and peels off a protective layer from one side of the EKG (ECG) Glove, thereby exposing the 10 electrodes embedded in the EKG (ECG) Glove.
The person or medical assistant stands on the right side of the prone patient and places his or her hand over the chest of the patient, adhesive side down, in an orientation which is depicted in a diagram on the back of the glove/mitten and is explained in the package insert.
After the glove/mitten has been applied to the chest, the person or medical assistant removes his or her hand from within the EKG (ECG) Glove, because the adhesive on the electrodes enables the EKG (ECG) Glove to remain positioned properly.
Three electrodes on the EKG (ECG) Glove are designed to be placed in specific positions on the patient’s chest, one each under the right and left collar bone and the third on the lower end of the left ribcage. These extendable electrodes can be easily picked up and put in place without effort. The right arm (RA), left arm (LA), left leg (LL) are properly marked on these extendable electrodes. Notably, no electrodes need to be applied to the patient’s arms or legs and no conductive gel needs to be applied separately by the person or medical assistant.
The EKG (ECG) Glove is designed for consistent placement of electrodes to reduce time, and thus costs, in the physician’s office and in hospital settings. As mentioned previously, the EKG (ECG) glove is disposable after one use, the algorithm box and the cable are not. Use of the EKG (ECG) Glove System completely eliminates the need for a standard, paper-based EKG (ECG) machine.
Malignant Spaghetti, A Symposium on Wireless Technologies in Hospital Health Care
November 14, 2008, Polytechnic Institute of New York University. Presentation by Dr. Govindan Gopinathan: Wireless EKG Glove: Its Applications and Commercial Potential.