Eu Mdd Eu Md Class 2b On The Market 🇭🇺 Hungary

CA-1 AED Plus Automated External Defibrillator

Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
D-CA-1AEDPlusHV
Basic UDI-DI Code
B-CA-1AEDPlusHV
Reference
KCA1P
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

The CardioAid-1 AED Plus defibrillator is an instrument serving for stopping the ventricular fibrillation; it can change the electric operation of the heart, by applying a high energy impulse. In case of ventricular tachycardia, atrial fibrillation (cardioversion) the defibrillator can restore the normal operation, by applying synchronous defibrillation. In case of sinus tachycardia, bradycardia or strong arrhythmia, the device can normalize the heart operation, in pacing mode. The device has LOW ENERGY BIPHASIC OUTPUT WAVEFORM with patient impedance compensation up to [200-270 J] to shock all VF and VT arrhythmias. Additionally the device supports an extra high [360 J] biphasic energy selection feature for unusual, irregular circumstances in case of overweight patients without causing any additional damage to the heart muscle that is a safe additional energy option for the physician to improve the lifesaving capability of the device. In defibrillation mode the device performs Innomed Biophase® waveform, biphasic output waveform and in pacing mode it performs rectangular current impulse. The CardioAid-1 AED Plus can be used with an optional CPR module – called Innomed CPR module. The CPR module has been developed to give efficient assistance to the doctors, first-aid trainers, resuscitation instructors, untrained NHS employee and bystanders. The unit controls and gives audible voice prompts about the quality of CPR performed by the operator. So the Innomed CPR module is an extremely useful device either is used for student educational purposes (HLE). The defibrillator has the following modes of operation: SEMI-AUTOMATIC MODE, MANUAL ASYNCHRONOUS AND SYNCHRONOUS MODE (FOR SKILLED PERSON ONLY), PACER MODE (FOR SKILLED PERSON ONLY), ADVANCED LIFE SUPPORT (ALS) AND BASIC LIFE SUPPORT (BLS) WITH CPR MODULE.

CND Nomenclature Codes

Code Description
Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS

Certificates

Type Number
MDD Annex II (excluding section 4) HU19/8463

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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