Table of Contents
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Table of Contents
Related Manuals for Cardioline Walk400h
Summary of Contents for Cardioline Walk400h
- Page 1 Walk400h/Clickholter Operating manual Rev. 05 – 25/03/2020 1936...
- Page 2 Walk400h/Clickholter All rights reserved © Cardioline SpA. CARDIOLINE® is a registered trademark of Cardioline SpA. This publication may not be reproduced, in whole or in part, in any form or manner, without prior written authorisation Cardioline SpA Via Linz, 151...
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Page 3: Table Of Contents
3.3. Guidance and manufacturer's declaration – Electromagnetic immunity ........8 3.4. Recommended separation distances between portable and mobile RF communications equipment and the Walk400h/Clickholter device ..................10 SYMBOLS AND LABEL ............................11 4.1. Explanation of the symbols ........................11 4.2. - Page 4 7.4. Connecting the patient ......................... 23 7.4.1. 5-wire cable ............................24 7.4.2. 7-wire cable ............................25 7.4.3. 10-wire cable (Walk400h only) ......................26 7.5. Preparation and start of recording without PC .................. 27 7.5.1. Selection of test type ..........................28 7.5.2.
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Page 5: General Information
Important additional information This manual was written with the utmost care. Should you find any details which do not correspond to those contained in this manual, please inform Cardioline SpA, who will proceed to correct such inconsistencies as soon as possible. -
Page 6: Safety Information
SAFETY INFORMATION SAFETY INFORMATION Cardioline SpA will be held responsible for the safety, reliability and functionality of the devices only if: 1. the assembly operations, modifications or repairs are carried out by Cardioline SpA or by its Authorised Service Centre;... - Page 7 Walk400h/Clickholter SAFETY INFORMATION The device has no specific protection from defibrillation discharges. Consequently, should a defibrillator need to be used, the device must be disconnected from the patient, for instance by removing the patient cable from the electrodes before defibrillation.
- Page 8 Walk400h/Clickholter SAFETY INFORMATION The Walk400h device has been designed to be connected to a PC only if it has already been disconnected from the patient. Use of the protection bag is mandatory if the relative humidity of the environment is less than 50% (dry environment) to prevent the formation of electrostatic charges.
- Page 9 The accuracy of signals recorded with the device complies with IEC standard 60601-2-47. Walk400h is capable of recording the activity of an implanted pacemaker, but may not always detect pacemaker spike less than 1 ms. The device belongs to Class IIa in compliance with Directive 93/42/EEC.
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Page 10: Recommendations For The Patient During The Test
If the device is used inside the bag, it should never be removed; The device is not protected against the ingress of liquids, unless it’s used inside the Walk400h Waterproof case (see par. 10.2), thus it shouldn’t be wet;;... -
Page 11: Electromagnetic Compatibility (Emc)
Guidance and manufacturer's declaration – Electromagnetic emissions The Walk400h/Clickholter system is intended for use in the electromagnetic environment specified below. The customer or user of the Walk400h/Clickholter must ensure the device is used in such as environment. Emission test Conformity Electromagnetic environment –... -
Page 12: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Guidance and manufacturer's declaration – Electromagnetic immunity The Walk400h/Clickholter system is intended for use in the electromagnetic environment specified below. The customer or user of the Walk400h/Clickholter must ensure the device is used in such as environment. Compliance Immunity test... - Page 13 If the measured field strength in the location where the Walk400h/Clickholter device is used exceeds the RF compatibility level above, the device should be monitored to ensure it operates normally. If abnormal performance is observed, additional...
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Page 14: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Walk400H/Clickholter Device
Walk400h/Clickholter device The Walk400h/Clickholter device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user may help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications (transmitters) and the Walk400h/Clickholter device, as recommended below, according to the maximum output power of the communications equipment. -
Page 15: Symbols And Label
Walk400h/Clickholter SYMBOLS AND LABEL SYMBOLS AND LABEL 4.1. Explanation of the symbols Symbol Description Comply with the instructions in the operating manual – on the back of the device CE marking – compliance with the European Union directives Manufacturer Reference number (product code) -
Page 16: Device Label
Walk400h/Clickholter SYMBOLS AND LABEL Operating temperature limits Humidity fluctuation Pressure fluctuation Keep away from sunlight Do not reuse No latex No PVC 4.2. Device label Walk400h Clickholter... -
Page 17: Introduction
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). -
Page 18: Description Of The Device
5.4. Description of the device Walk400h is a Holter recorder that makes it possible to capture 3 or 12 leads for 24 or 48 hours at 250/500/1000 samples per second or up to 7 days at 250 samples per second. -
Page 19: General Overview
Walk400h/Clickholter INTRODUCTION The device includes: 1. Patient cable with 5, 7 or 10 wires (Walk400honly). 2. Bag. 3. 1 battery (AA 1.5V). 4. Disposable button electrodes (25 pcs.). 5. USB PC connection cable. 6. Operating manual. 5.4.1. General overview Front view:... -
Page 20: Navigation Button
Walk400h/Clickholter INTRODUCTION 5.4.2. Navigation button The device is fitted with a navigation button that can be pressed or moved in 4 directions (like a joystick). In this manual, the various functions of the button are referred to using the following terminology: ... -
Page 21: Audible Warning
Walk400h/Clickholter INTRODUCTION Status LED Battery LED Status SYSTEM START-UP Switching on the system and loading the system’s firmware. This operation has variable duration between 4 and 10 seconds. Do not remove the batteries during this stage. DISPLAY ON ... -
Page 22: Navigation In The Menu
Walk400h/Clickholter INTRODUCTION Event Signal RECORDING automatic shutdown Entering an “Event MARKER during 1 ACOUSTIC SIGNAL a RECORDING 5.5. Navigation in the Menu 5.5.1. Start Page After switching on, the device shows the Start Page. Start Page From these pages it is possible to access the main device functions, listed in the following table. -
Page 23: Information Page
Walk400h/Clickholter INTRODUCTION Buttons: UP, DOWN, RIGHT, LEFT: to move on the icons; ENTER: to confirm the selection. 5.5.2. Information Page The Information page shows: Firmware version Serial Number of the recorder Connected patient cable: 5 wires, 7 wires, 10 wires or no connected cable;... -
Page 24: Preparation For Use
Walk400h/Clickholter PREPARATION FOR USE PREPARATION FOR USE 6.1. Switching on the recorder To switch on the recorder insert 1 AA type, 1.5 Volt alkaline battery in the battery compartment on the back of the recorder. If you wish to perform a test lasting more than 48 hours, it is recommended to use a lithium battery. -
Page 25: Switching Off The Recorder
Walk400h/Clickholter PREPARATION FOR USE 6.3. Switching off the recorder To set the device in standby mode again, go to the Start menu, select the power off button and push it down. To completely power off the device remove the battery from its housing. -
Page 26: Execution Of The Examination
NOTE: Strictly adhere to instructions on preparing the patient, one of the most crucial stages for successful recording. 7.2. Selection of the number of channels The recorder acquires simultaneously the ECG signal from 3 to 12 channels (Walk400h only) according to configuration, installed options and patient cable used: 5-wire cable: 3-channel recording ... -
Page 27: Connecting The Patient
5. Connect the patient cable to the connector on the upper side of the device. WARNING: proper operation of the recorder is only assured if the electrodes recommended by Cardioline are used. -
Page 28: 5-Wire Cable
Walk400h/Clickholter EXECUTION OF A TEST 7.4.1. 5-wire cable The picture and table show how to use and install this cable. 5-wire cable Yellow White Green Black Electrode placement with 5-wire cable Electrode Position Yellow On the left clavicle, next to the sternum. -
Page 29: 7-Wire Cable
Walk400h/Clickholter EXECUTION OF A TEST 7.4.2. 7-wire cable The picture and table show how to use and install this cable. 7-wire cable Green White Yellow Orange Blue Black Electrode placement with 7-wire cable IEC electrode Position Ch1+ Green Second intercostal space at the left end of the sternum. -
Page 30: 10-Wire Cable (Walk400H Only)
Black On the lower rib, on the right side of the chest. 7.4.3. 10-wire cable (Walk400h only) This type of cable follows the standard convention for 12-channel electrocardiography. The only difference being that peripheral electrodes must be placed on the trunk in a position close to the respective limbs, as pictured below. -
Page 31: Preparation And Start Of Recording Without Pc
START RECORDING from the Start Page. The recorder displays the Start recording page, which shows: Duration of the recording (24 hours / 48 hours / 7 days (Walk400h only)) and sampling rate set; Information on the patient (if preloaded, see paragraph 7.6);... -
Page 32: Selection Of Test Type
Selection of test type page The device can record the following types of test, according to set-up and installed options: 1. 24hr test: 3 or 12 channels (Walk400h only) for 24 hours 2. 48hr test: 3 or 12 channels (Walk400h only) for 48 hours 3. -
Page 33: Voice Recording
Walk400h/Clickholter EXECUTION OF A TEST prolonged lack (about 7 days) of the batteries during the test as this would cause de-programming of the built-in clock. In either case, the test is automatically closed by the recorder after restart. After selecting the type of test, the device performs a memory check to ensure there is sufficient space for the selected recording. -
Page 34: Display Traces And Saturation
In real time display the number of channels per page depends on the type of patient cable: 10-wire cable (Walk400h only): 2 pages, 6 channels each o First page I, II, III, aVR, aVL, aVF o Second page: C1, C2, C3, C4, C5, C6 ... -
Page 35: End Of Preparation And Start Of Recording
This preparation method makes it possible to preload the personal information and the type of recording (cable, duration and sampling rate) before starting a recording making use of the connection with the PC via USB, using the Cardioline webuploader software. To perform recorder preparation proceed as follows: 1. -
Page 36: Placement Of The Recorder On The Patient
3. Use the webuploader software to enter the personal information and recording data (please refer to the manual of the Cardioline webuploader software for a detailed explanation). 4. Disconnect the device after ejecting the USB drive through the safe removal procedure (this operation assures the information is written correctly in the recorder’s memory). -
Page 37: Instructing The Patient
EXECUTION OF A TEST NOTE: The bag and the Walk400h Waterproof case, indicated in par. 10.2, they are not intended to come into direct contact with the body, therefore it is recommended to place them above a garment (for example a shirt). -
Page 38: Accidental Disconnection Of The Patient Cable
Walk400h/Clickholter EXECUTION OF A TEST 7.9.3. Accidental disconnection of the patient cable If the patient cable is accidentally disconnected during the recording, the device records the event as “disconnected leads” but the recording continues. Therefore, just reconnect the cable with no other operations required. -
Page 39: End Of Recording
Walk400h/Clickholter EXECUTION OF A TEST 7.10. End of recording End of recording may occur for the following reasons: 1. the programmed recording time has elapsed 2. the device is connected to the PC using the USB cable 3. the manual stop command is given by pressing and holding the DOWN button for 4 seconds, the display switches on and shows a confirmation message of interrupted recording. - Page 40 Walk400h/Clickholter EXECUTION OF A TEST USB connection page Data transfer is managed directly by the software installed in the PC. Please refer to the user manual of the analysis software for further details and instructions. Upon completion of the data transfer the recorder’s memory may be automatically cleared or not, based on...
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Page 41: Recorder Settings
Sampling rate Sampling rate used for recording 250 / 500 / 1000 Hz (1000Hz NOTE: if recording duration is set at 7 days it is only for Walk400h) possible to set frequency at 250 Hz only, other settings are not permitted. -
Page 42: Set A New Figure
Walk400h/Clickholter . RECORDER SETTINGS Field Function Possible values Date format Format for the date DMY (dd/mm/yyyy) MDY (mm/dd/yyyy) YMD (yyyy/mm/dd) Date and time Current date and time 8.1.1. Set a new figure A page is displayed that shows available figures for each setting. To make a new setting just select one of the available figures using the central button. -
Page 43: Maintenance And Troubleshooting
Walk400h/Clickholter MAINTENANCE AND TROUBLESHOOTING MAINTENANCE AND TROUBLESHOOTING 9.1. Cleaning and disinfection Clean the device after each use. Do not sterilise the device and the patient cable. To clean and disinfect the surface of the device and cables, use detergent solutions with low alcohol content, generally used in hospitals. - Page 44 Windows instructions. shown Disconnect the device form the PC and switch it on. If the problem persist contact Cardioline service. The display does not 1. The batteries were not 1. Insert both batteries again and check...
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Page 45: Technical Specifications
TECHNICAL SPECIFICATIONS ECG leads Up to 12 leads Patient Cable 5-wire cable – 3 single-pole channels 7-wire cable – 3 double-pole channels 10-wire cable (Walk400h only) – 8 channels/12 leads (standard ECG assembly) CMRR >85 dB DC input impedance > 60MOhm... - Page 46 Patient data Name Surname Date of birth Gender Dimensions 50 x 50 x 8 mm Weight 100g Protection against accidental ingress Device: IP 4x – Walk400h waterproof case : IP x2 of water or substances Packaging 15x21x5 cm, 1 Kg...
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Page 47: Harmonised Standards Applied
Medical devices - Application of usability engineering to medical devices 10.2. Accessories CODE DESCRIPTION 63050099 IEC 5-wire patient cable 63050100 IEC 7-wire patient cable 63050101 IEC 10-wire patient cable 63090306 USB connection cable 66030035C Disposable button electrode, 25 pcs 65090069 Bag for Walk400h / Clickholter... - Page 48 Walk400h/Clickholter TECHNICAL SPECIFICATIONS CODE DESCRIPTION 66030038C Disposable button electrode, 25 pcs 63090732 Walk400h waterproof case (waterproof pouch IPX2)
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Page 49: Warranty
Cardioline Spa declines all liability for any damage which may be caused, directly or indirectly, to persons or property as a consequence of non-compliance with all the prescriptions specified in the manual, especially warnings regarding installation, safety, use and maintenance of the equipment, as well as non-operation of the equipment. -
Page 50: Disposal
Walk400h/Clickholter DISPOSAL DISPOSAL Pursuant to Italian Legislative Decree no. 49 dated 14 March 2014 "Implementation of Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE)", the crossed-out "wheeled bin" symbol on the medical device indicates that, at the end of its service life, the product must be collected separately from other waste. - Page 51 Walk400h/Clickholter...
- Page 52 Sales Office: Via F.lli Bronzetti, 8 20129 Milan, Italy T. +39 02 94750470 F. +39 02 94750471 Factory: Via Linz, 151 38121 Trento Italy T. +39 0463 850125 F. +39 0463 850088...