Walk400h
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Walk400h General Information Product name Generic name Product code Cardioline Spa Head Office and Production facility: Via Linz, 151 38121 Trento Italy Sales Office: Via F.lli Bronzetti, 8 20129 Milan Italy Walk400h is a new generation holter ECG recorder that allows you to record, with any patient cable configuration, up to 48 hours, with a sampling rate of up to 1000 samples/second and up to 7 days, with a sampling rate of 250 samples per second, for both adult and pediatric patients. It is possible to choose the number of channels to be recorded using a 5, 7 or 10-wire cable. The device automatically recognises the inserted cable and consequently selects the type of recording. Through the software it is also possible to select the sampling rate to be used by the device while recording. Walk400h offers the operator the option to record a 20s voice message during the preparation of the exam. The user interface is simple and intuitive. A TFT 2.2” colour display shows up to 6 traces simultaneously, allowing the physician to check good signal quality before starting recording. A 4-way joystick plus pressure allows you to easily navigate the menu and configure the device. Two LEDs, a green one and a blue one, provide indications on battery and device status, while a buzzer signals any errors. The recorder comes with a compact design in terms of weight and dimensions to ensure that the appliance is comfortable to wear. The recorded data may be downloaded and analysed via the Cardioline Cubeholter software or downloaded and sent to a remote computer via the Cardioline Webuploader software. Data are transferred via a USB cable. With Webuploader it is also possible to prepare the recorder, by transferring patient data onto it and the type of recording to be performed. The power supply with standard AA battery ensures that the recorder is easy to prepare. Technical specifications ECG recording ECG leads Patient Cable 5-wire cable – 3 single-pole channels 7-wire cable – 3 double-pole channels 10-wire cable – 8 channels/12 leads (standard ECG assembly)

Sampling rate for signal analysis and storage User selected: 250 – 500 – 1000 samples/second/channel Signal resolution for analysis and storage Dynamic range Linear phase digital diagnostic high-pass filter (compliant with IEC 60601-2-25 2nd ed.) Front-end performance Pacemaker detection Hardware detection coupled with digital convolution filter Compliant with 60601-2-47 201.12.4.4.109 Defibrillation protection Patient cable recognition Automatic identification of patient cable used Lead-fail detection Maximum recording duration 500/1000 samples/second/channel: 48 hours 250...

Patient data ID Name Surname Date of birth Gender Specifications Dimensions Protection against accidental entry of water or substances IP 4X IP 42 with Walk400h waterproof case Environmental operating specifications Temperature 50% ÷ 95% - without the pouch 15% ÷ 95% - with the pouch Environmental storage 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 Number 510K Product Code: Review Panel: Regulation Number: Classification according to IEC...

Operation mode Continuous operation Classification according to IEC 60601-1-2 – Electromagnetic compatibility Group Performance Standard Other classifications GMDN Recorders, Long-Term, ECG, Portable RDM (Medical Device Catalogue) Medical devices - Symbols to be used with labels, labels and information on medical devices to be supplied - Part 1: General requirements Information supplied by the manufacturer of medical devices Medical devices - Quality management systems - Requirements for regulatory purposes Medical devices - Application of risk management to medical devices Medical...