PRODUCT SHEET: Clickholter Description of product: Clickholter is a new generation holter ECG recorder that allows you to record 3 ECG channels with a 5 or 7 wires patient cable and up to 7 days, with a sampling rate of up to 500 samples per second, for both adult and pediatric patients. Clickholter is available in two configurations: BASE and PLUS. BASE configuration provides up to 48 hours at 250 samples per second recording. PLUS configuration adds the capability to extend the recording duration to 7 days and the sampling rate to 500 samples/second (up to 48hrs). 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. Clickholter 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 3 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 Device Web Manager or Webuploader software. Data are transferred via a USB cable. With Device Web Manager or 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. GENERAL INFORMATION Product name Generic name Product code Cardioline S.p.A. Headquarters Via Linz, 151 38121 Trento Italia

Walk400h/Clickholter is an ECG Holter recorder intended for continuous ECG signal recording. The signal recorded in the devices’ internal storage is intended to be transferred to a PC for analysis via a designated ECG Holter analysis software. The ECG signal is recorded with a patient cable that may have 5, 7 or 10 wires (Walk400h only), according to the number of ECG channels to be recorded: 3 channels with 5 or 7-wire cables and 12 leads with 10-wire cable (Walk400h only). The recorded data are transferred to the PC through a USB connection. A colour graphic display shows up to 6 channels during...

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 250 samples/second/channel: up to 48 hours (PLUS and BASE) 500 samples/second/channel: up to 48 hours (PLUS) 250 samples/second/channel: 7 days (PLUS) Internal memory 16 GB SD card Capacity above 100 3-channel recordings,...

Specifications Dimensions 100g with battery (80g without battery) 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 60601-1 – Electrical...

Classification according to IEC 60601-1-2 – Electromagnetic compatibility Group Performance Standard Other classifications GMDN 12388 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 electrical equipment - Part 1: General requirements...

Clickholter USB connection cable Disposable snap electrodes, 25 pcs Disposable snap electrodes, 50 pcs Disposable snap electrodes, 100 pcs (only for Telemedicine) Fixing system for patient cable Walk400h waterproof case (waterproof pouch IPX2)