Table of Contents
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Table of Contents
Troubleshooting
Related Manuals for Cardioline Walk200b
Summary of Contents for Cardioline Walk200b
- Page 1 Walk200b User manual Rev. 13 – 31.03.2020 1936...
- Page 2 Walk200b 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
3.1.2. Guidance and Manufacturer's declaration - Electromagnetic immunity ......... 9 3.1.3. Guidance and Manufacturer's declaration - Electromagnetic immunity ......... 9 3.1.4. Recommended separation distances between portable and mobile RF communications equipment and the Walk200b ........................11 SYMBOLS AND LABEL ............................12 4.1. - Page 4 Walk200b 6.3. Putting on the recorder ........................23 6.4. Starting measurements ........................24 6.5. Interrupting measurements ......................... 24 6.6. Download of the recordings ........................ 24 MAINTENANCE AND TROUBLESHOOTING ....................25 7.1. Principal sources of error ........................25 7.2. Cleaning of the recorder ........................25 7.3.
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Page 5: General Information
Other important 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 correct such inconsistencies as soon as possible. The information contained in this manual is subject to change without notice. -
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 Walk200b SAFETY INFORMATION The doctor should explain to the patient that, particularly when sleeping, the equipment should be positioned in such a way that the tube cannot be compressed. If the patient is not fully competent, the equipment should be worn only under supervision.
- Page 8 The Walk200b device is designed to be connected to a PC. The system that consists of the Walk200b device and the non-medical PC equipment is defined as an electromedical system. The adoption of an electromedical system requires compliance with the requirements of the Directive.
- Page 9 Cardioline or by any authorised service centre. The device may be used with the bag or the Walk200b Waterproof case mentioned in paragraph 8.2. The bags are not meant to come into direct contact with the body; it is therefore recommended to place them over a piece of clothing (e.g.
- Page 10 (see para. 8.28.2) has IP 2x protection rating against the ingress of solid particles and water; it therefore protects the device against water drops falling at a maximum angle of 15° when used with the device. Without the Walk200b Waterproof case, the device is not protected against liquid penetration.
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Page 11: Warnings For The Patient During The Exam
If the device is used inside the bag, it may not be removed; The device is not protected against the ingress of liquids, unless it is used inside the Walk200b Waterproof case (see para. 8.2). It should therefore never get wet;... -
Page 12: Electromagnetic Compatibility (Emc)
3.1.1. Guidance and Manufacturer's declaration - Electromagnetic emissions The Walk200b is intended to operate in the electromagnetic environment specified below. The customer or the user of the Walk200b must guarantee that it is used in this environment. Emission test Compliance Electromagnetic environment –... -
Page 13: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
IEC 61000-3-3 3.1.2. Guidance and Manufacturer's declaration - Electromagnetic immunity The Walk200b is intended for use in the electromagnetic environment specified below. The customer or the user of the Walk200b should assure that it is used in such an environment. - Page 14 If the measured field strength in the location in which the Walk200b is used exceeds the applicable RF compliance level above, the Walk200b should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Walk200b.
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Page 15: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Walk200B
3.1.4. Recommended separation distances between portable and mobile RF communications equipment and the Walk200b The Walk200b is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Walk200b can help prevent electromagnetic interference by... -
Page 16: Symbols And Label
Walk200b SYMBOLS AND LABEL SYMBOLS AND LABEL 4.1. Explanation of the symbols Symbol Description Comply with the instructions in the use manual CE marking – compliance with the European Union directives 1936 Manufacturer Reference number (product code) Serial Number Lot number Year of manufacture Type BF equipment –... -
Page 17: Device Label
Walk200b SYMBOLS AND LABEL No PVC No DEHP 4.2. Device label... -
Page 18: Introduction
5.3. Intended use Walk200b is an outpatient non-invasive Ambulatory Blood Pressure (ABP) recorder for 24-hour monitoring. The device measures the systolic and diastolic blood pressure and the heart rate. The pressure is measured with the application of the oscillometric method. -
Page 19: Description Of The Device
Walk200b INTRODUCTION The device is indicated for use by a doctor or personnel acting on the order of an authorised doctor, trained in the use of devices measuring ambulatory blood pressure. The device is indicated for use by patients adequately informed by the doctor of the following warnings: ... -
Page 20: General Overview
Walk200b INTRODUCTION 5.4.1. General overview Rear view: 1. cuff tube / air connector 2. Battery compartment 3. Bluetooth interface (not visible) -
Page 21: Keys
5.4.2. Keys ON/OFF This key switches the Walk200b recorder on and off. To prevent switching it on or off by mistake, the key reacts only after 2 seconds. As with all other keys blood pressure measurement can also interrupted prematurely, causing the pressure in the cuff to be released rapidity. Warning: switch the unit on again to continue. -
Page 22: Display
Walk200b INTRODUCTION Night and day This key allows waking and sleeping phases differentiated when recording, wich is important from the point of view of statistical evaluation and graphic presentation. Briefly: the patient is instructed to operate the DAY/NIGHT Key on going to bed and again when getting up in the morning. This adjusts the monitoring interval to suit the individual patient and helps you in assessing the BP profile. -
Page 23: Execution Of An Exam
Walk200b EXECUTION OF AN EXAM EXECUTION OF AN EXAM 6.1. Initial startup Connect the cuff tube with one of the cuffs supplied (according to instructions in par. 6.3), by pushing it onto the plastic connector. Connect the cuff tube with the socket on the front of the recorder housing. -
Page 24: Clearing Memory
The following prompt 000 in the display confirms that the memory has been erased. 6.2.3. Setting the time/date The Walk200b has an internal buffer battery that allows the clock to continue running even after the batteries have been removed. You should nevertheless check the time and date before each measurement series. -
Page 25: Activation Of The Connection With The Pc
On first activation, you must carry out the pairing procedure; On the PC, click on the Bluetooth icon and select Add new Bluetooth device > Add Bluetooth or other type of device > Bluetooth > Select the walk200b serial number; if asked, use the pairing code 6624. - Page 26 Walk200b EXECUTION OF AN EXAM > > Wait until Windows has finished the installation, then click again on Other Bluetooth options and COM ports; Note down the output COM port and serial number; When asked, select the output COM port from the drop-down menu and press the key Add COM port;...
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Page 27: Putting On The Recorder
Walk200b EXECUTION OF AN EXAM 6.3. Putting on the recorder Put the equipment pouch on the patient. By varying the length of the strap you can use it either as a hip belt or a shoulder strap. Alternatively, use a normal belt that matches the patient’s clothing. -
Page 28: Starting Measurements
Download of the recordings At the end of the measurement the recordings can be downloaded from the recorder using one of the compatible Cardioline software (Cubeabpm or Webuploader). Please refer to the user manual of these software for more instructions. -
Page 29: Maintenance And Troubleshooting
Walk200b MAINTENANCE AND TROUBLESHOOTING MAINTENANCE AND TROUBLESHOOTING 7.1. Principal sources of error The following may cause faulty measurements or undesired results: Arm movement by the patient during the measurement Switching off the device (e.g. at night) Incorrect cuff size fitted ... -
Page 30: Display Maintenance
The fully charged batteries are installed in the monitor directly from the charging unit. The battery voltage is shown in the LCD display of the Walk200b monitor shortly after switching on the device, for approx. 3 sec. This voltage should be at least 2.75 V to guarantee measurement over 24 hours. -
Page 31: How To Change The Batteries
The date and time can be set after each batteries, the clock still empty. change of batteries. shows 00.00 and the The biennial calibration has not Send the device for calibration to your date 01.01.xxxx been performed. dealer or directly to Cardioline SpA... - Page 32 Walk200b to the set. program PC is faulty. 2. Walk200b is not in transfer mode 2. Switch the Walk200b off and then on (the time is shown on the display). again, without removing the connector cable. The patient ID number...
- Page 33 Possible continuous 2. Zero-point adjustment could not 2. Send the unit without delay to your alarm until a key is be performed successfully dealer or directly to Cardioline SpA for pressed checking Err 10 + continuous 1.Serious fault due to pressure...
- Page 34 Walk200b Bluetooth interface Try again. could not be configured correctly. If the error continues, send the unit to (Communication problem between your dealer or directly to Cardioline SpA Walk200b and Bluetooth module) for checking Code 3 The status of Walk200b Bluetooth Try again.
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Page 35: Technical Specifications
Walk200b TECHNICAL SPECIFICATION TECHNICAL SPECIFICATIONS Pressure measurement range .... Systolic: 60 to 290 mmHg Dyastolic: 30 to 195 mmHg Accuracy ........... ± 3 mmHg in the range indicated Static pressure range ......0 to 300 mmHg Pulse range ........30 to 240 beats per minutes Method .......... -
Page 36: Accessories
Medical devices - Application of usability engineering to medical devices 8.2. Accessories CODE DESCRIPTION 63090645 Large cuff for Walk200b 63090646 Standard cuff for Walk200b 63090647 Small cuff for Walk200b 63090648 Extralarge cuff for Walk200b 69400074 Under-cuff band 65090070 Pouch 63090733 Walk200b waterproof case (waterproof bag) -
Page 37: 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 38: Disposal
Walk200b 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 wastes. - Page 39 Walk200b...
- Page 40 Walk200b 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...