i-PAD

Primary DI

08809435481017

Basic UDI-DI Code

B-08809435481017

Reference

CSO-I-004-R1

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

CU Medical Systems, Inc.

The CU-SP2 is a defibrillator with semi-automated (AED) and manual modes. In AED mode, if connected to a patient, it automatically acquires and analyzes the electrocardiogram (ECG) of the patient for the presence of Ventricular Fibrillation or Ventricular Tachycardia (also known as shockable rhythms). If a shockable rhythm is detected, the CU-SP2 automatically charges itself and then prompts you to press the SHOCK button. When you press the SHOCK button after being prompted to press it, the CU-SP2 delivers a defibrillating shock. After delivering a shock, the CU-SP2 automatically goes back to ECG acquisition and analysis to determine whether another shock is necessary or not. In manual mode, the user analyzes the ECG of the patient and decides whether the patient’s ECG is shockable or not. The user may then manually charge and discharge the CU-SP2 if the patient’s ECG is shockable.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).