HD+
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HD+ General Information Product name Generic name Product code Cardioline Spa Head Office and Production: Via Linz, 151 38121 Trento Italy Sales Office: Via F.lli Bronzetti, 8 20129 Milan Italy HD+ is a digital portable acquisition device which can acquire the physiological electrocardiographic signal of 12 standard leads. The HD+ transmits acquired data wirelessly and in real-time to a computer/device (i.e. PC or Tablet) on which compatible CARDIOLINE software is installed. HD+ uses standard Bluetooth data transmission technology to transmit 12-lead ECG data over a proximity range of approximately 3 meters, providing electrical insulation and freedom of movement for the patient. HD+ guarantees the acquisition of an ECG signal, meeting the most stringent standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). HD+ is light and compact, comfortable to wear, minimizing motion artifact caused by traditional electrodes and patient cables. An LED indicator allows for easy monitoring of the device link status (off when unit is powered down, blinking when unit is attempting to connect with the receiver, steady when unit is connected with the receiver) and a key press sends macro commands to the receiving system (i.e. acquires an ECG). Low-power technology allows for continuous usage of the device for more than 10 hours from full battery charge. Device function consists of acquiring and wirelessly transmitting ECG signal for displaying, processing and presenting ECG signal for the purpose of supporting the diagnosis of patient conditions. HD+ is a wireless acquisition device, used as a common ECG front-end for PC/tablet (Windows, Android) platforms, both for Resting ECG and Stress ECG applications. The device implements communication via Bluetooth wireless technology. Connected with a receiver via Bluetooth, HD+ sends data to the host, without analysis or filtering. HD+ is not intended to control or analyse heart function and/or diagnose the patient's health status. The analysis program on the host is a separate product. Results of the analysis must always be validated by qualified, trained medical personnel.   HD+ allows the patient to be ambulatory. HD+ is intended to be used on adult and all paediatric patients. HD+ uses a standard 12 lead ECG cable to acquire the physiological signal from the patient. HD+ is intended for use in a medical environment (hospitals, clinics and medical practices), in homecare or in an emergency environment (ambulances).

HD+ is intended for use by qualified, trained nurses and physicians. Technical specifications ECG acquisition ECG leads Patient cable 10 wire, non-replaceable lead wires Sampling rate of the input stage Sampling rate for signal analysis 1,000 samples/second/channel 500 samples/second/channel Selectable via software Dynamic range Pacemaker detection Hardware detection coupled with digital convolution filter AAMI/IEC standard Front-end performance Data transfer Bluetooth 2.0+ EDR with “secure pairing” Lead-fail detection Compatible devices Cardioline touchecg, Cardioline cubestress....

Storage Environmental Specifications Temperature Regulations and Safety Classification according to MDD 93/42/EEC Class Rule 10 annex IX Directive 93/42/EEC and its amendments Notified Body Classification according to FDA 510K number Product Code Review Panel Regulation Number Classification according to IEC 60601-1 - Electrical Safety Protection against electric shock Applied parts Protection against harmful ingress of water or particular matter IP40 / IP42 (with protective shell) Suitability for use in an oxygen rich environment Continuous operation Classification according to IEC...

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