Semi-automatic external defibrillator
Basic Information
- Primary DI
- 06970658140646
- Basic UDI-DI Code
- B-06970658140646
- Reference
- 204
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Ambulanc(Shenzhen)Tech.Co., Ltd.
Additional Description
AED is a kind of medical electronic equipment that uses electric shock to treat arrhythmia patients. It has the advantages of high curative effect, quick action, simple operation and non-invasive.The widely accepted view of electric shock defibrillation is that, under the action of electric field formed by discharge, a sufficient number of cardiomyocytes are forced to depolarize and enter the refractory period at the same time, so that the wave front of ventricular fibrillation cannot continue to propagate and the original chaotic electrical activity is suppressed.The heart muscle then returns to normal rhythm, driven by spontaneous excitation of the sinoatrial node.The mode of action can be simply described as: "A treatment in which a strong pulse of controlled energy is administered to the human heart to eliminate arrhythmias and restore sinus rhythm." The electrophysiological basis of defibrillation technique is that the phase of activity of each part of the myocardium is not synchronized, and the arrhythmia is sustained due to the back and forth transmission of excitement. The ultimate purpose of electric shock is to force the whole heart to enter the depolarizing state immediately, to realize instant cardiac arrest, and to restore synchronization of the activity phase of each part of the myocardium. After electric shock, the sinus node with the highest automaticity may be awakened to repace the heart, control the heart beat, and restore it to normal sinus rhythm.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030503 | AUTOMATIC DEFIBRILLATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 705577 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).