LiFEGAIN

Primary DI

08809435483011

Basic UDI-DI Code

B-08809435483011

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.

Manufuacturer : CU Medical Systems, Inc (website : www.cu911.com/en ) The CU-HD1 is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation. The CU-HD1 is available in load ambulance, not in air ambulance. The CU-HD1 is a portable and lightweight monitor/defibrillator with the following modes of operation: - Automated External Defibrillation (AED) Mode - Manual External Defibrillation Mode - Monitoring Mode - Pacing Mode In AED Mode, the CU-HD1 analyzes the ECG of the patient to determine whether the patient has a shockable or nonshockable ECG rhythm. In this mode, the CU-HD1 provides you with voice and text prompts throughout its operation. In Manual External Defibrillation Mode, the CU-HD1 lets you control the defibrillation process. You assess the ECG of the patient and set the energy of the shock to be delivered. You may also perform synchronous cardioversion for the treatment of atrial fibrillation in this mode. In synchronous cardioversion, the defibrillating shock is delivered within 60 milliseconds of the occurrence of a QRS peak in the patient’s ECG. In Monitoring Mode, the CU-HD1 acquires ECG, SpO2, NIBP, and EtCO2(with CU-CM1) signals from the patient for defibrillation. Various alarms may be activated in this mode. This mode is also used in tandem with the manual modes in order to get a display of the patient’s ECG rhythm. In Pacing Mode, the CU-HD1 delivers noninvasive pacing therapy in demand a

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