TensioMed® Arteriograph24
Contents
1. e tape measure For the 3 different size cuffs the dimensions are Bladder Sleeve Arm Dimensions Dimensions Circumference Cuff 01 34 x 8 cm 62x9cm gt 36 cm Cuff 02 26x8cm 52x9cm 27 35 cm Cuff 03 18 x 6 cm 38 x 7 cm lt 27 cm Note Correct cuff accuracy dimensions are important to achieve optimal performance and TensioMed Arteriograph24 10 TENSIONI ob oj 2 3 Installing the Device TensioMed Arteriograph24 is a battery operated device e Insert 4 durable alkaline AA batteries into the Device with taking care of the right polarity see Figure 3 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 le LR6 1 5V AA O la LR6 1 5V AA je LR6 1 5V AA O LR6 1 5V AA QI Figure 3 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 battery and it is continuously charged by the AA batteries therefore the clock time is held and resetting the time is unnecessary between battery change2. please refer to the On line Help of Windows or the Windows User Manual TensioMed Arteriograph24 is an unregistered trademark of TensioMed 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 TensioMed Arteriograph24 device Attention Before first use please read and understand this document carefully 1 2 Supplementary Information and Helpful Hints 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 Bluetooth communication The electromagnetic compatibility between the device and the PC is guaranteed EMC classification A Regular service is recommended by an approved agent at least every two years to maintain optimum performance and accuracy The cuff and the Device itself can be cleaned with a wet cloth by making sure that no liquid enter into the Device or the cuff The handling storage wrapping substance conservation and transportation of the producer s devices are defined in accordance with the general Quality Control Requirements TENSIOME TensioMed Arteriograph24 oh hp L_1 1 3 Warranty TensioMed Ltd undertakes 2 years of warranty for the device 12 months for the accessories The repairs ar
3. 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 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 Automatic motor driven pump Safety Maximum inflation 280 mmHg Deflation Automatic stepwise TensioMed Arteriograph24 TENSION 17 A EREN 3 1 Electromagnetic compatibility Electromagnetic emissions The TensioMed Arteriograph TD3 device is intended for use in the electromagnetic environment specified below The customer or the user of the TensioMed Arteriograph TD3 device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The TensioMed Arteriograph TD3 device uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The TensioMed Arteriograph TD3 device is suitable CISPR 11 for use in all establishments including domestic Harmonic emissions Not applicable establishments and those directly connected to the IEC 61000 3 2 public low voltage power supply network that supplies Voltage fluctuations
4. TensioMed Arteriograph24 TENSIONEN _____ The symbols on the bottom of the device are sown in Figure 2 O OND UI 11 12 13 14 15 16 Name of the Manufacturer The name of the device The type ID of the device The classification of the MDD requirements Il a The nominal voltage range applicable with batteries The classification of the protection against electric shock Classification patient s side CF Calling the attention to read thoroughly the present User s Manual Certification mark guaranteeing that the apparatus complies with the prescriptions and requirements of the European Union Serial number Operating ambient temperature range Year of the manufacturing Head office of the Manufacturer Level of protection against any liquid or grainy material filtering into the device IP N N N 2 Protected against solid foreign objects of 12 5mm and greater N2 2 Protection against vertically falling water drops when enclosure tilted up to 15 13 ES 17 i ated N i gt ArterioGraph24 j 40 C 055 ce A lr 1008 E K r u 2 E 12 11 16 Figure 2 i i TM TENSIONEN TensioMed Arteriograph24 E E 2 2 Accessories TensioMed Arteriograph24 device Figure 1 is supplied with the following accessories e pouch for the device with belt e four AA size batteries e 3 different cuffs e TensioMed TensioWin software on CD e User manual e Bluetooth adapter
5. on the DUttO eee k keke kk k e KAK KA KA KA eee 14 2 4 2 Data tran ST lSS O si isi si Gul nn un Ei a Ha Bed Re re 14 2 4 3 Error codes for Ve nee ae aa or at aa Ca oda al 15 24 4 SOU Ol il na na ine ts ds answer Da ci KN Sad a da a Dada 16 2 4 5 Using the device for ambulatory blood pressure monitoring keke 16 33 Specifications nein seh asien re mm mm 21 TENSI MEF TensioMed Arteriograph24 EEE A 1 Introduction Thank you for choosing TensioMed Arteriograph24 The TensioMed Arteriograph24 is a professional device for the 24 hour monitoring of arterial function stiffness and peripheral blood pressure For clinical and ambulatory requirements Arteriograph24 is 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 TensioMed Arteriograph24 device is controlled by the TensioMed TensioWin software The measurement schedule and the blood pressure readings are loaded via Bluetooth communication from and to the physician s PC respectively Automatic measurements can be set for up to 72 hours with frequencies ranging from 10 to 90 minutes Separate measurement frequencies can
6. 4 oh hp ji TensioMed Arteriograph24 22 TENSIONEN TENSIONER HEEE EEE EEE EE
7. a ij ij eee TENSIOMA N ARTERIOGraph 24 Device for the 24 hour monitoring of arterial function stiffness and peripheral blood pressure User s manual Please read the user s manual carefully before the first use With wireless communication Bluetooth TensioMed Arteriograph24 5 02 v2 00 06 Revised 21 11 2012 AA EA AAA a Table of Contents T PER OCU CEM AA A n dal Se as A 0 da tata alu sal aul seen de ne 4 1 1 contenhtsofthe maliual iia id 5 1 2 Supplementary Information and Helpful Hints eee eee eee kk kK KK KE A 5 t3 Warranty ieai A RAN 6 1 4 Ge ral Informatio asirinmi dd 6 2 The TensioMed Arteriograph24 device Eek keke keke keke ke kak ka KA KAKA A KA KAKA KAKA KA KA KA A KA 8 2 1 Explanation ES Y MOS tii A id da AAA AE deda weke HE Ev In els 8 2 2 ACCESSO ES 14s ceia A de pek k n Kan k en Ve sai 10 2 3 Installing the Device areae ea a KN a ake tan iaa data 11 2 4 Operations instructions neh kk re dena Aa rana Cca dana kabe d ke Sa lu tec 12 2 4 1 Functions of the button on the device ii eke kk keke k kake k k Kak KA KAKA A KAR KA 12 2 4 1 1 One short push of the DUttON si i ki yen eee anna rea DA ges k aaa 12 2 4 1 2 Two short pushes on the button k nene keke kk k e KAK KK KA KA KA KA A 13 2 4 1 3 Three short pushes on the DUttOn E u eee nenea k Kek ka KE KA KA eee 14 2 4 1 4 Four short pushes
8. be set for the active daytime passive night time and for a third special period 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 start 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 TensioMed Arteriograph24 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 TensioMed Arteriograph24 TENSIONEN oh Copyright 2011 TensioMed Ltd Budapest Hungary All rights reserved Under the copyright laws this manual cannot be reproduced in any form without prior written permission of TensioMed 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 TensioMed 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 XP Vista 7 operating Systems If the operator is not familiar with Windows operations
9. djacent figure The device checks the placement of the cuff during N 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 V co After this process the device shows the systolic and 130 OC diastolic BP values LO IY Then the pulse rate is shown on the display and the device stores all the measured data including the date and exact time nd ri At any time during a reading the patient can terminate the measurement 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 button 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 If the memory of the device is full this wi
10. e 2 4 1 Functions of the button on the device After switching on the device first performs the controlling measurement as follows ua IN an N jaur a au Na The voltage control of the batteries The measured value appears on the display The supply voltage is sufficient if the measured value is between 6 0 V and 5 4 V for alkaline batteries and between 5 2 V and 4 6 V for rechargeable batteries If the voltage drops below 4 4V the batteries must be replaced A warning symbol of low battery appears on the LCD If the battery voltage is adequate the device will be N ng Zaun ready for measuring and the current computer time will gt be displayed TensioMed Arteriograph24 is ready for operation 2 4 1 1 One short push of the button starts a manual measurement 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 measurement The exact time disappears from the display and then e the test figure of the display appears see WWW WLW WY adjacent figure atar atu La aa e the voltage of the batteries are checked see 5 5U adjacent figure f E TensioMed Arteriograph24 TENSIONEN o PR oj e calibration takes place setting the zero pressure N see adjacent figure After that the measurement starts by the inflation of the cuff signaled on the display see a
11. e software controlled measuring apparatus In case of any problem turn to a qualified service Only use with cuffs supplied by TensioMed Itd 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 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 AN Do not disassemble the device gt gt gt gt gt i i TM TENSIOMNEN TensioMed Arteriograph24 Ld MEE A Patient safety A 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 A Do not use the device on an arm which is being injected with intravenous injection Do not use on neonates 2 The TensioMed Arteriograph24 device 2 1 Explanation of symbols The front of the device is shown in Figure 1 Function button Offering four menu options Command symbols LCD Air connector AUNE Figure 1 a 2
12. e done by TensioMed Ltd at the place below Head office and service TensioMed Ltd 2 e K r str Budapest H 1103 Hungary Phone 36 1 433 1700 433 1701 Fax 361 433 1709 Web www tensiomed com E mail info tensiomed com 1 4 General Information 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 TensioMed Arteriograph24 can also be used with 1 5 V long life batteries size AA TensioMed Arteriograph24 TENSIONEN i Attention A 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 gt Do not remove the outer cover of the device The TensioMed Arteriograph24 device is sophisticated multipurpos
13. es are controlled The customer or the user of the TensioMed Arteriograph TD3 device can help prevent e ectromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TensioMed Arteriograph device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz W d 3 5 3 vP d 3 5 3 vP d 7 3 vP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 i i TM TENSIOMNEN i TensioMed Arteriograph24 oh hp ji TensioMed Arteriograph24 90 TENSIOME EEE AA MEA i i TM TENSIOMNEN 54 TensioMed Arteriograph2
14. flicker emissions Not applicable buildings used for domestic purposes IEC 61000 3 3 Electromagnetic immunity The TensioMed Arteriograph TD3 device is intended for use in the electromagnetic environment specified below The customer or the user of the TensioMed Arteriograph TD3 device should assure that it is used in such an environment Note Uy is the AC mains voltage prior to application of the test level Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic IEC 61000 4 2 8 kV air 8 KV air tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines Not applicable IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to line s Not applicable IEC 61000 4 5 2 kV line s to earth Voltage dips short interruptions lt 5 Ur Not applicable and voltage variations on power gt 95 dip in Uy supply input lines for 0 5 cycle IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for5s Power frequency 3 A m 3 A m If image distortion occurs it may be 50 60 Hz necessary to position the TensioMed magnetic field TensioMed Arteriograph TD3 device IEC 61000 4 8 further from
15. gn will appear on the LCD The actual data transmission does not happen yet this can be started by the TensioMed TensioWin program During the operation of the Bluetooth communication N between the device and the PC when the actual data transmission is on the following sign will appear on the LCD TensioMed Arteriograph24 14 TENSIONS T DA 2 4 3 Error codes for users The error codes which appear on the 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 TensioMed 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 1 The device could not measure the patient s blood pressure within the measuring time 3 The measurement was interrupted due to the weakness of the battery 31 The cuff is not connected to the device 32 The cuff tube is broken or something got into the tube e g water 33 The cuff or device is leaking 34 The cuff is not on the patient s arm 35 The measurement was interrupted for some reason e g because the
16. ll appear on a the display i i TM TENSIONEN a TensioMed Arteriograph24 EEE MEE A 2 4 1 3 Three short pushes on the button allows the N N W patient to indicate the time of going to bed and waking eg pa N IN r 30 up in the tabulated list of measurements The device li ELIT indicates the waking up by a D and by an N when the patient goes to bed 2 4 1 5 By four short pushes on the button the DEF device can be switched off You will see then OFF on the 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 Bluetooth communication The information loaded consists of the systolic and diastolic blood pressure values mmHg the pulse rate per minute the distinction between programmed and manual measurements the date and time of the measurement the active or passive period the diary of medication intake If a Bluetooth communication adapter is placed within ZI DUES INI the range of the device and it works as its operation is permitted the device and the PC will connect automatically This si
17. 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 101 The measuring circumstances e g the moving of the patient disturbs the measurement 102 The device cannot sense the HR 110 The measured result cannot be considered as a real BP value because of some movement or arrhythmia 111 systole gt max inflation 115 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 TENSION TensioMed Arteriograph24 15 RR N A 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 air connector of the device see figure 1 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 excessive muscle mo
18. requency range Interference may occur in the vicinity of equipment marked with the following symbol W NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines do not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 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 TensioMed Arteriograph TD3 device is used exceeds the applicable RF compliance level above the TensioMed Arteriograph TD3 device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the TensioMed Arteriograph TD3 device 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the TensioMed Arteriograph TD3 device The TensioMed Arteriograph TD3 device is intended for use in an electromagnetic environment in which radiated RF disturbanc
19. s 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 Bluetooth communication adapter or a built in Bluetooth in your PC connect the Bluetooth 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 Bluetooth communication in your PC Then if the device is within 10 m from the Bluetooth adapter the computer will get into connection with the device via the software To transmit data it is necessary to use the TensioMed TensioWin program of course i i TM TENSIONEN i TensioMed Arteriograph24 oh op ji 2 4 Operation Instructions 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 Bluetooth 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 devic
20. sources of power frequency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low TensioMed Arteriograph24 18 TENSIONS AAA AAA AE AE ee Electromagnetic immunity The TensioMed Arteriograph TD3 device is intended for use in the electromagnetic environment specified below The customer or the user of the TensioMed Arteriograph TD3 device should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the TensioMed Arteriograph TD3 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Ver 3V d 1 2vP IEC 61000 4 6 150 kHz 80 MHz Radiated RF 3 V m 3 V m d 1 2vP 80 MHz 800 MHz IEC 61000 4 3 80 MHz 2 5 GHz d 2 3VP 800 MHz 2 5 GHz where Pis 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 should be less than the compliance level in each f
21. vement 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 A z a TensioMed Arteriograph24 a TENSIONEN fd 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 Bluetooth v1 2 Class Il 115200 bps PC interface Bluetooth communication adapter Computer requirements Windows XP service pack 3 Operating environment 10 40 C Humidity 30 85 Size 116 0 x 94 0 x 47 0 mm Weight 250g 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
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