Medexpert CBPM24 IrDA User Manual
Contents
1. LR6 1 5V AA GI Figure 4 The Ni MH NiCd batteries are rechargeable approximately one thousand times If the capacity of the rechargeable batteries is low it is shown on the LCD automatically In this case please change all the four batteries not only the ones you think are weak The clock circuits of the device are powered by a type Ni Cd HA 35 storage battery and it is continuously charged by the AA batteries therefore the clock time is held and resetting the time is unnecessary between battery changes If you do not intend to use the device for a long period of time remove the batteries and store them in a cool and dry place Do not apply heat to the batteries or an internal short circuit may occur Dispose of spent batteries immediately in an environmentally safe way The batteries and charging appliances have their own Instructions for use we suggest you study them and follow manufacturers guidelines In case you do not have a infrared communication adapter or a built in infrared in your PC connect the infrared communication adapter to your PC and do the setting If you find it necessary ask for the help of your system supervisor who is responsible for your computer Allow the infrared communication in your PC Then if the device is within 1m from the infrared adapter the computer will get into connection with the device via the software To transmit data it is necessary to use the Medexpert TensioWin program of course2. the date and time of the measurement the active or passive period the diary of medication intake If a infrared communication adapter is placed within the range of the device and it works as its operation is Ir lio permitted the device and the PC will connect automatically This sign will appear on the LCD display The actual data transmission does not happen yet this can be started by the Medexpert CBPM24 program During the operation of the infrared communication between the device and the PC when the actual data COPC transmission is on the following sign will appear on the LCD display 14 lil med 2 4 3 Error codes for users The error codes which appear on the LCD display and their meanings are described below Please note that you should not make any conclusions if an error appears once because the movements of the patient can imitate several types of errors If the device cannot measure the blood pressure e g because of movement the measurement will be interrupted With the Medexpert TensioWin program in case of a faulty measurement it is possible to set the device to repeat it according to the measuring plan after 1 minute The meanings of the error codes shown by the device are as follows 3 ire measurement was merupiea aue tote weainess orite wanen 32 Thecuube traten or somete poro tre wate erwan e e 34 The cuff is not on the The cuffisnotonthepatient sarm 24 sarm a
3. 2 4 Operation Instructions ll med To set up the 24 hour automatic BPM in operating mode first check power supply The frequency of measurements will be downloaded from the physicians PC via infrared communication To operate the device there is one single button The measured data and information about the status of the device appear on the LC Display The patient by the one single button can give four different commands to the device 2 4 1 Functions of the button on the device After switching on the device first performs the controlling measurement as follows The voltage control of the batteries The measured value appears on the display If the batteries are well charged the measured potential will be between 5 4V 4 4V The nominal potential is 4 8V If the voltage is under 4 4 V the batteries need replacing The replace battery message will be displayed If long life batteries are used to power the device the measured nominal voltage will be 6V The battery change symbol will be the same as above If the battery voltage is adequate the device will be ready for measuring and the current computer time will be displayed Medexpert CBPM24 is ready for operation 2 4 1 1 One short push of the button starts a manual measurement 5 0V During the ambulatory measuring mode there might be a need for manual measurements for example when the patient feels unwell One short push of the button sets up the
4. EN medexpert putting precision first CBPM 24 Ambulatory blood pressure monitor with central blood pressure measurement User Manual CBPM Ma ir Ambulatory A Lt Jl Central Blood Pressure Monitor WIM medexpert VO putting precision XP a z pa D N 3x ON OFF 4x With wireless IrDA communication 9 8 medexpert ll med Table of Contents LATO ON ee ee o Po O ee ee eoseeeenees 4 LL Contents ofthe Mande once 5 1 2 Supplementary Information and Helpful Hints cccoocccncnocnnonncononnncnnonaconnonarononanonnonacononaronenanonnnnos 5 REEE tic E E A E E E AE ea 6 LAAN O ee en Te 6 2 The Medexpert CBPIM 24 aevice euere 8 2 1 EX DI anal l0N 0 MO Saa 8 An a ee ee O io An 10 2 Installine the DeVICO sucinta dai dldaos 11 2 A OPENS INS CHO AS ctra 12 2 4 1 Functions of the button ON the device ccccceesecccssecccesceeceesececeececaeececeeseceseecessuecesseneeeseaness 12 24 dl One short USOT tie UCU OU ee een 12 2 4 1 2 Two short PUSHES on the button cccconccnccnccnncnonononacononanononononononarononarononnnnononaronennaronenanons 13 2 2 1 3 Three short pushes on the DUON en een ee 14 24 14 Four short pushes on the DU ON sir sr anna 14 2 4 2 Data transmission ae a ee an ee een 14 2 4 3 AM PPP 15 ZA SOUNO SONS 16 2 4 5 Using the device for ambulatory blood pressure monitoring ccccocccncnnccnncnoonnnonaconenaronenanonos 16 e nce e o IA 17
5. attention to read thoroughly the present User s Manual 13 Certification mark guaranteeing that the apparatus complies with the prescriptions and requirements of the European Union 14 Serial number 15 Operating ambient temperature range 16 Year of manufacturing 11 16 H 1103 Budapest K er u 2 d 10 13 14 12 15 Figure 2 17 Infrared communication window i med 17 Figure 3 2 2 Accessories Medexpert CBPM24 ambulatory blood pressure monitoring device Figure 1 is supplied with the following accessories pouch for the device with belt four AA size batteries 3 different cuffs Medexpert TensioWin software on CD User manual IrDA adapter For the 3 different size cuffs the dimensions are Bladder Sleeve Arm Dimensions Dimensions Circumference cutf 0 sBx7em 18 22em Note Correct cuff dimensions are important to achieve optimal performance and accuracy 10 Y med 2 3 Installing the Device Medexpert CBPM24 is a battery operated device e Insert 4 durable alkaline AA batteries into the Device with taking care of the right polarity see Figure 4 e Or insert 4 AA sized rechargeable Ni MH or NiCd batteries as per the above instruction Please note that new batteries must be pre charged o For problem free operation minimum 1 500 mAh chargeable Ni MH or NiCd batteries are recommended LR61 5V AA LR6 1 5V AA AA gt T O a lt O
6. f the measurements out of 3 were within 5 mmHg Average difference from the auscultatic Korotkov measurements systolic diastolic 0 5 0 4 mmHg The range of the difference systolic diastolic 2 8 2 8 mmHg Pressure sensor Piezo resistive Inflation Automatically controlled pump Safety Maximum inflation 280 mmHg Deflation Automatic Working mode of the device Continuous 17 med 9 8 medexpert 18 9 8 medexpert 19 e CBPM4 putting precision first Medexpert CBPM24 IrDA User Manual 2011 Medexpert Ltd All rights reserved
7. irst use please read and understand this document carefully 1 2 Supplementary Information and Helpful Hints e This device does not produce electromagnetic disturbances during its operation and its immunity to the environmental disturbances is also good The download of the measured data to the physician s PC is done by infrared communication The electromagnetic compatibility between the device and the PC is guaranteed EMC classification A e Regular service is recommended by an approved agent at least every two years to maintain optimum performance and accuracy e The cleaning of the cuff is by wiping over with a damp cloth only e The handling storage wrapping substance conservation and transportation of the producer s devices are defined in accordance with the general Quality Control Requirements e The device meets the following requirements i med EN 60601 1 1995 A1 1993 A2 1995 A13 1996 EN 60601 1 2 2001 EN 1060 1 1995 A1 2002 EN 1060 3 1997 MSZ EN 1060 4 2005 EN ISO 14971 2000 93 42 EEC 1993 ESH International Protocol 2002 1 3 Warranty Medexpert Ltd undertakes 2 years of warranty for the device 12 months for the accessories The repairs are done by Medexpert Ltd at the place below Head office and service Medexpert Ltd T r kk u 5 7 Budapest H 1037 Hungary Phone 36 1 250 4490 Fax 36 1 433 3795 Web www medexpert hu E mail arterialcare medexpert hu 1 4 General Informa
8. lil med 1 Introduction Thank you for choosing Medexpert CBPM24 The Medexpert CBPM24 ambulatory blood pressure monitor is a professional device for clinical and ambulatory requirements validated according to the British Hypertension Society and the Association for the Advancement of Medical Instrumentation standards The device uses oscillometric method for blood pressure determination It can also be used for conventional home measurements executed by the patients offering a high level measuring quality and additional features Medexpert CBPM24 device is controlled by the Medexpert TensioWin software The measurement schedule and the blood pressure readings are loaded via infrared communication from and to the physician s PC respectively Automatic measurements can be set for up to 48 hours with frequencies ranging from 10 to 90 minutes Separate measurement frequencies can be set for the active daytime passive night time and for a third special period Four different types of blood pressure measuring plans with different measuring frequencies can be programmed even by pressing the button of the device without using a computer This measuring plan covers a 24 hour period from the time of programming The measured data namely the systolic and diastolic BP value the pulse rate the date and time of the measurement will be stored in the EEPROM of the device Apart from the programmed measurements the patient may sta
9. measurement The exact time disappears on the display and then e the test figure of the display appears see adjacent figure e the voltage of the batteries are checked see adjacent figure 12 e calibration takes place setting the zero pressure see adjacent figure After that the measurement starts by the inflation of the cuff signaled on the display see adjacent figure The device checks the placement of the cuff during inflating If the cuff on the arm is too loose or not the proper size of cuff has been chosen e g it is bigger the following sign will be on the display accompanied by a beeping signal Check the cuff and its tightness and repeat the blood pressure measurement The deflation of the cuff is shown by the adjacent figure After this process the device shows the systolic and diastolic BP values Then the pulse rate is shown on the display and the device stores all the measured data including the date and exact time At any time during a reading the patient can terminate a reading by pressing once the single button A termination symbol will appear on the display for 10 sec see adjacent figure Then the time will appear and the units ready for measurement for manual and programmed mode 2 4 1 2 Two short pushes on the button Pill allows the patient to keep his electronic diary concerning taking his antihypertensive medication After taking his medicine two short pushes on the butto
10. mobile phone near the unit during measurement Do not use the device when it is exposed to mechanical vibration e g in vehicles Prevent the device to be exposed to direct sunlight to get in contact with liquid or from excessive mechanical impact P gt P P P bb AN Do not disassemble the device Patient safety The device has an integrated safety mechanism which prevents the cuff pressure to exceed 300 mmHg If however the inflation continues above this value or the pressurization lasts too long unplug the pneumatic connector of the cuff from the device and remove the cuff from the subject Do not use the device on an arm which is being injected with intravenous injection LAK medexpert ee A Do not use on neonates 2 The Medexpert CBPM24 device 2 1 Explanation of symbols 1 Name of the device 2 Function button Offering five menu options see section 2 4 1 3 Command symbols see section 2 4 1 4 LCD display 5 Air connector f CB BPM Ambulatory Central Blood Pressure Monitor Em xper 5 Figure 1 The symbols on the bottom of the device are sown in Figure 2 6 The manufacturer s label 7 The name of the apparatus 8 The type number of the apparatus 9 MDD certification of device Il a 10 The nominal voltage range applicable with batteries 11 The classification of the protection against electric shock Classification patient s side CF 12 Calling the
11. n stores the date and time in the memory During a day it is possible to store additional pill consumptions By downloading all the data from the device to the physician s PC he will be able to monitor the medication intake and therefore the compliance of the patient lf the memory of the device is full this will appear on the display 13 i med CAL CO 8 Al FULL lil med 2 4 1 3 Three short pushes on the button allows the patient to indicate the time of going to bed and waking up in the tabulated list of measurements The device indicates the waking up by a triangle showing upwards and by a triangle showing downwards when the patient goes to bed 2 4 1 4 By four short pushes on the button the device can be switched off You will see then OFF on the FF display In this state the series written above cannot be applied and the measuring plan you set in the device will be interrupted If you intend to use the device again press the button again five times Then OFF will disappear from the display all functions of the device can be used again and the set measuring plan will be continued 2 4 2 Data transmission The device downloads all the stored data to the physician s PC via infrared communication The information loaded consists of the systolic and diastolic blood pressure values in mmHg the pulse rate per minute the distinction between programmed and manual measurements
12. rt a manual measurement e g he shows symptoms or feels sick This can be done by a simple push button operation All manually initiated measurements are stored and displayed on the software report The Medexpert CBPM24 can be used without the software program for conventional manually started BP home monitoring The high accuracy of the measurements and the storage of the measured data offer greater flexibility The storage Capacity of the device is 1000 measurements med Copyright 2011 Medexpert Ltd Budapest Hungary All rights reserved Under the copyright laws this manual cannot be reproduced in any form without prior written permission of Medexpert Ltd Every effort has been made to ensure that the information in this manual is accurate Succeeding models and manuals are subject to change without notice Medexpert is not responsible for printing or clerical errors This Manual is produced on the assumption that the operator is an experienced user of the Windows 2000 XP Vista operating Systems If the operator is not familiar with Windows operations please refer to the On line Help of Windows or the Windows User Manual Medexpert CBPM24 is an unregistered trademark of Medexpert Ltd Other company and product names mentioned herein may be trademarks of their respective companies 1 1 Contents of the manual This manual helps you in setting up and starting to use the Medexpert CBPM24 device Attention Before f
13. s The measurement was interrupted for some reason e g because the patient pressed the button 91 97 The BP measurement was not successful due to the failure of the device or the batteries are weak 100 The measured result cannot be considered as a real BP value or the patient has arrhythmia m The measuring circumstances e g the moving of the patient disturbs the measurement The device cannot sense the HR 110 The measured result cannot be considered as a real BP value because of some movement or arrhythmia systole gt max inflation The HR cannot be calculated or cannot be considered as a real HR value 116 Not enough evaluable results either from sys or from dia 15 lil med 2 4 4 Sound signals Ifthe device is working beeping signals can be heard when pressing its button 2 4 5 Using the device for ambulatory blood pressure monitoring place the cuff on the non dominant arm place the cuff with the tube exiting the cuff upward in the region of the brachial artery Make sure that the hosing allows for free ambulation to avoid skin irritation a thin shirt might be used below the cuff the tube of the cuff should be inserted into the black opening on the left side of the device Attention Please take care of the connection of the cuff because it should not be too loose it should not leak You can connect it properly if you insert the plug with a twisting motion until it stops during measurements avoid e
14. tion warnings and precautions We strongly suggest that you carefully study the Operating Instructions of this multipurpose blood pressure monitoring device and that you note the listed precautions For optimum performance it is recommended to use Nickel Metal Hybrid Ni MH rechargeable batteries or Nickel Cadmium NiCd rechargeable batteries with1500 mAh Capacity size AA The Medexpert CBPM24 can also be used with 1 5 V long life batteries size AA med Attention If the device is not used for a longer period remove the batteries from the battery compartment Furthermore please keep the device out of reach of children if it is out of use Pay special attention when applying the ambulatory BPM device to patients with serious mobility or other impairments also unconscious or otherwise incapable patients and patients with coagulation disturbances For children it is also recommended to apply the unit with special care Children should not use the device on their own Do not remove the outer cover of the device The Medexpert CBPM24 24 hour BPM device is sophisticated multipurpose software controlled measuring apparatus In case of any problem turn to a qualified service Only use with cuffs supplied by Medexpert Ltd Use of cuffs supplied by a third party can lead to erroneous measurement results Confirm blood pressure measurement with auscultation when erroneous results are suspected Do not use a microwave device e g
15. xcessive muscle movement particularly in the arm as this may lead to longer measurement or measurement error and it may decrease the accuracy of the measurement Ask the patient to keep a diary on his her daily activities symptoms and the time of going to bed and waking up in the morning 16 3 Specifications Power Source 4 long life batteries size AA The mode to prevent electric shock The device is powered by inside low voltage source The category to prevent electric shock CF type patient part Display Liquid Crystal Display Data Storage EEPROM Flash memory Data Transmission Infrared PC interface IrDA communication adapter Computer requirements Windows XP service pack 3 Operating environment 10 40 C Humidity 30 85 Size 128x77 5x45 5 mm Weight 310g including batteries Blood Pressure measurement method Oscillometric Data Storage Max 1000 measurements Blood Pressure measurements range 30 280 mmHg Static accuracy 3 mmHg or 2 of the measured value Measuring accuracy Systolic 94 out of 99 comparisons were within 5 mmHg 95 in case of 33 out of 33 patients 2 comparisons out of 3 were within 5 mmHg O out of 33 patients where none of the measurements out of 3 were within 5 mmHg Diastolic 93 out of 99 comparisons were within 5 mmHg 94 in case of 32 out of 33 patients 2 comparisons out of 3 were within 5 mmHg O out of 33 patients where none o
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