Cardioline Walk200b User Manual Download Page 14

 

Walk200b 

3. 

ELECTROMAGNETIC COMPABILITY (EMC)

 
 

 
10 

 

 

 

Radiated RF 
IEC 61000-4-3 

3 V/m 
From 80 MHz to 2.5 
GHz 

3 V/m

 

separation  distance  calculated  from  the  equation 
applicable to the frequency of the transmitter.  
Recommended separation distance: 
 

 

 

 

From 80 MHz to 800 MHz 

 

From 800 MHz to 2.5 GHz 

 
where 

P

 is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter 
manufacturer  and 

d

  is  the  recommended  separation 

distance in metres (m).  
Field  strengths  from  fixed  RF  transmitters,  as 
determined  by  an  electromagnetic  site  survey  (a), 
should  be  less  than  the  compliance  level  in  each 
frequency range (b). 
Interference  may  occur  in  the  vicinity  of  equipment 
marked with the following symbol: 

 

 

 

 

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. 
 
NOTE  2:  These  guidelines  may  not  apply  in  all  situations.  Electromagnetic  propagation  is  affected  by 
absorption and reflection from structures, objects and people. 

 
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 
land  mobile  radios,  amateur  radio,  AM  and  FM  radio  broadcast  and  TV  broadcast  cannot  be  predicted 
theoretically  with  accuracy.  To  assess  the  electromagnetic  environment  due  to  fixed  RF  transmitters,  an 
electromagnetic site survey should be considered. 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. 
 
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

Summary of Contents for Walk200b

Page 1: ...1936 Rev 13 31 03 2020 Walk200b User manual...

Page 2: ...ioline 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 by Cardioline Spa...

Page 3: ...een portable and mobile RF communications equipment and the Walk200b 11 4 SYMBOLS AND LABEL 12 4 1 Explanation of the symbols 12 4 2 Device label 13 5 INTRODUCTION 14 5 1 Purpose of the manual 14 5 2...

Page 4: ...1 Principal sources of error 25 7 2 Cleaning of the recorder 25 7 3 Cleaning of cuffs 25 7 4 Display maintenance 26 7 5 Periodic checks 26 7 5 1 Checking the battery voltage 26 7 5 2 Calibration 26 7...

Page 5: ...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 conta...

Page 6: ...y means to make an accurate diagnosis of the patient The operators for whom this device is intended must have the required competence regarding medical procedures and the treatment of patients They mu...

Page 7: ...nt such as defibrillators and ultrasound machines There is a risk of explosion Do not use the device in the presence of flammable anaesthetics There is no safety hazard if other equipment such as pace...

Page 8: ...he patient and the case of the any non medical equipment outside the patient area at the same time If the PC and any other non medical devices that are connected monitor printer etc are powered by the...

Page 9: ...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 a...

Page 10: ...cles with diameter greater than 12 mm The Walk 200b Waterproof case see para 8 28 2 has IP 2x protection rating against the ingress of solid particles and water it therefore protects the device agains...

Page 11: ...a sound to signal particular events such as an empty battery In such cases contact the doctor of reference or the outpatient clinic for instructions In case of pain during the measurement turn off the...

Page 12: ...the device is required with the surrounding devices An electronic device can generate or receive electromagnetic interference The electromagnetic compatibility test EMC has been carried out on the el...

Page 13: ...Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruption and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT...

Page 14: ...her frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field stre...

Page 15: ...of the transmitter W Separation distance according to frequency of transmitter m 150 KHz to 800 MHz 800 MHz to 2 5 GHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 6...

Page 16: ...mpliance with the European Union directives Manufacturer Reference number product code Serial Number Lot number Year of manufacture Type BF equipment defibrillation protection Device with RF communica...

Page 17: ...Walk200b 4 SYMBOLS AND LABEL 13 No PVC No DEHP 4 2 Device label...

Page 18: ...a computer via a wireless Bluetooth channel The device is indicated for use in healthcare hospitals medical clinics and offices of any size The device is designed to perform and record blood pressure...

Page 19: ...ructions The device may be damaged by impacts and falls which may impair its proper operation and interrupt the tests scheduled Inform the patient that the armband and cables must be kept away from ch...

Page 20: ...Walk200b 5 INTRODUCTION 16 5 4 1 General overview Rear view 1 cuff tube air connector 2 Battery compartment 3 Bluetooth interface not visible 1 3 2 USB...

Page 21: ...must verify the reliability of the values of the first measurement so that we can continue with successive measurements correct and the proper positioning of the cuff In the event of an error follow...

Page 22: ...t of the recorder housing It displays useful information for the doctor and patient on measurement data monitor settings and measurement errors 5 4 4 Acoustic signals The acoustic signals used consist...

Page 23: ...sometimes the rechargeable Ni Mh batteries before use with the device 6 2 Preparation for use 6 2 1 Switching on Always check the condition of your recorder first before you give it to a patient You...

Page 24: ...and date can be set with the CUBE analysis software You can also set the time and date manually by holding the START key and then pressing the EVENT key Now you are in the Set time mode Use the START...

Page 25: ...00b to be connected to the computer on which the software is installed If the device is equipped with a USB connection Open the recorder s battery door and put in the batteries then close the door Con...

Page 26: ...ws 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...

Page 27: ...nection on the cuff should therefore be directed upwards The air tube should allow free movement of the upper arm and should run over the back of the neck to the other side of the body 3 It is essenti...

Page 28: ...ressing the START key This measurement is used to determine whether the recorder is working correctly If errors occur check once more that the procedure followed in setting up and fitting the equipmen...

Page 29: ...spitals with low alcohol content The unit surface may be cleaned with a wet tissue but the liquid must never infiltrate the equipment Wash the electrodes with water and or use only cool sterilization...

Page 30: ...riodic checks Cuffs and tubes control when necessary and at least once a year General check of the functionality of the instrument and of the leakage current when necessary or at least every 2 years C...

Page 31: ...e that the same is turned off and that the patient is disconnected Open the battery compartment door Insert the batteries placing their polarities in the correct position Close the battery compartment...

Page 32: ...ay You are not in transfer mode Press and hold Event button again till to see bt on the screen No automatic measurements are performed 1 No manual measurement was performed after putting on the equipm...

Page 33: ...Send the unit without delay to your dealer or directly to Cardioline SpA for checking Err 10 continuous alarm until a key is pressed 1 Serious fault due to pressure build up outside the measurement p...

Page 34: ...not be ascertained Communication problem between Walk200b and Bluetooth module Try again If the error continues send the unit to your dealer or directly to Cardioline SpA for checking Code 4 Walk200b...

Page 35: ...Medical electrical equipment Part 1 General requirements for basic safety and essential performance Pressure measurement range Systolic 60 to 290 mmHg Dyastolic 30 to 195 mmHg Accuracy 3 mmHg in the r...

Page 36: ...30 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers EN 62304 Medical device software Software...

Page 37: ...unction of the machine other circumstances not attributable to manufacturing defects Unless otherwise specified the removable parts the accessories and the parts which are subject to normal wear are e...

Page 38: ...f its service life the user is required to contact the supplier or the manufacturer Suitable differentiated collection to allow for the subsequent recycling of the decommissioned device with environme...

Page 39: ...Walk200b 35...

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...

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