ENVITEC - Alcotec Company Limited
Contents
1. The PhysioQuant Recorder requires either two nickel metal hydride rechargeable batteries or two alkaline batteries When starting the recorder via the PhysioQuantWin software please ensure that the relevant power source has been selected see 6 6 Programming the recorder page 30 In addition the device also has a built in lithium cell to indicate the time The capacity of two fully charged rechargeable batteries or two new batteries ensures at least 30 hours of operation or 200 measurements 23 48 Battery capacity reduces in line with increased use If the capacity of the two fully charged rechargeable batteries clearly falls below 24 operating hours then you need to replace them Always insert two fully charged rechargeable batteries or two new batteries before taking a new measurement 4 5 Inserting batteries The battery compartment is located on the underside of the recorder In order to open this compartment use your thumb to move the battery compartment lid approx 6 mm backwards and then remove the lid in an upward direction Please ensure that the batteries are inserted correctly 24 48 4 6 Function control The PhysioQuant recorder will automatically carry out a self test when it is switched on which will activate all symbols and segments of the LCD display The device will then check the inserted rechargeable batteries and will display the available capacity In this context e g C100 refers to2. ANALYSIS OF MEASUREMENT RESULTS 8 1 Starting the programme 8 2 Find delete measurement results 8 3 Representation 8 4 Overview 8 5 Single value graph 8 6 Single value table 8 7 Hourly mean values graph and table 8 8 Findings report 8 9 Printing 8 10 GDT export to general practice IT systems 9 ERROR CODES 10 SCOPE OF DELIVERY 11 ACCESSORIES AND SPARE PARTS 12 CLEANING AND MAINTENANCE 12 1 Cleaning and disinfection of device surface 12 2 Cleaning and disinfection of cuffs 12 3 Cleaning of tubes 12 4 Maintenance and validity check prior to any use 12 5 Calibration mode 12 6 Disposing of the device 13 TECHNICAL INFORMATION 6 48 37 37 37 38 38 38 39 40 40 40 40 40 41 41 42 43 43 44 44 44 45 45 46 46 47 1 General Remarks Symbols This symbol means please consult the manual It refers to things to which you should pay careful attention when using the device The safety instructions in this manual are indicated in the following way This refers to a potentially dangerous CAUTION situation Failure to observe this warning may result in injuries and or damage to the product 7 48 2 Safety Instructions and Use e The product PhysioQuant carries the CE mark CE 0123 in accordance with European Council Directive 93 42 EEC in relation to medical devices and complies with the fundamental requirements stated in Appendix of this Directive The device has
3. a 100 rechargeable battery capacity fully charged and C50 refers to a 50 rechargeable battery capacity half empty In order to carry out a 24 hour measurement the capacity needs to be at least 90 If the capacity is below 90 then you will need to insert new batteries or fully charged rechargeable batteries When the self test has been completed successfully the following information will appear on the display after the power supply test e The actual time e The measurement phase day night e Whether any measurement data has been stored 25 48 4 7 Connecting the cuff to the recorder To connect the blood pressure cuff to the recorder plug the metal connection of the cuff as far as possible into the connection point at the recorder until it clearly clicks into place The cuff can be removed again from the recorder by pulling back the external metal plug cover 5 PhysioQuant Cuffs Various cuff sizes are available for the PhysioQuant standard large and children size Please select the correct cuff size see printed text on the cuff Cuffs that are too small will result in measurements that are too high Cuffs that are too large will result in measurements that are too low Replace the cuffs at regular intervals Damaged Velcro fasteners may lead to incorrect measurements 26 48 6 6 1 6 2 Commencing Long Term Blood Pressure Measurement Connecting the recorder Connect the Physi
4. an internal power source and comes within Class lla MDD e The device has an application part of the type BF e Standard EN 60601 1 Medical electrical equipment Part 1 General Requirements for Safety is complied with as well as the immunity requirements of standard EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Equipment e The device is interference free in accordance with EN 55011 Class B e The CE mark only includes those components described in the delivery overview e This manual forms part of the device It should always be kept near to the device Correctly observing the manual ensures that the device will be used in an appropriate manner and for the purpose it is intended It will also ensure the health and safety of users and patients dependent on it e Please read through the whole manual carefully since information that is relevant to several sections is only provided once e The printed text of this manual is in accordance with the version of the device as well as the relevant safety instructions standards at the time that this manual was printed All industrial property rights are reserved in relation to any devices circuits processes software programs and names described in this manual e The quality assurance system used by EnviteC Wismar GmbH in all the company facilities complies with standards EN ISO 9001 and EN ISO 13485 e In order to ensure the highest level of safety for pati
5. disinfect the device isopropyl alcohol 70 ethanol 70 Microzid Burazon liquid Sporicidin or Cidex After you have disinfected the cuff rinse it thoroughly with water and leave it to dry at room temperature 12 3 Cleaning of tubes Remove the tube from the device Rub the tubes with a moist cloth soapsuds NEVER dip the tube into any fluid 12 4 Maintenance and validity check prior to any use o Prior to using the device manually check the device for any mechanical damage e If you notice any damage or functional errors which may endanger the safety of the patient and user of the device then you should only use the device again after it has been repaired Measurement technical check The PhysioQuant is a measuring device in accordance with the German Medical Device Code Operation V MP Betrieb V 11 Appendix 2 As a result the device must undergo a measurement technical check every 2 years The first of these checks should take place on the date indicated on the calibration mark 45 48 12 5 12 6 46 48 Calibration mode To check for example for any leakages in the pneumatic cycle the PhysioQuant Recorder can be switched into a calibration mode e Connect the pump ball over the T piece between the supplying tube and cuff e Roll up the cuff tightly o Switch the device off and on quickly e Wait until the display shows the time e Press the INFO button 3 times the displ
6. graph page 40 37148 8 Analysis of Measurement Results 8 1 Starting the programme After the PhysioQuant software has started the main screen appears To request saved measurement results click on the Analysis tab to open the relevant menu alDl EB Analse ENVITEC PhysioQuant 8 2 Find delete measurement results The selection window of the patient database is displayed Select the required patient see 6 3 Selecting a patient page 28 The measurement result selection window appears for those patients whose data have been stored in the database 38 48 8 3 Patient data Analyses 15 11 2004 10 48 Name Public 29 10 2004 09 02 29 10 2004 07 48 First name John Q 19 10 2004 15 55 Patient ID 5362 Date of birth fo 01 1960 Gender male female Height 190 cm Weight 90 kg wo Select x Abort it Delete You can request the relevant saved measurement results by double clicking on the relevant data in the selection window di Deleting measurement results In order to delete a specific measurement result from the database you need to click on the relevant date line in the selection window the line will appear in blue Then click on Delete After a confirmation message appears the result will be deleted Representation The saved measurement values can be represented in various ways by clicking on the relevant tabs Read Publ
7. Next To install to a different directory click Browse and select another directory You can choose not to install PhysioQuantwin by clicking Cancel to exit Setup Destination Directory C Programme PhysioQ uant Win Browse lt Back Next gt Cancel The programme will normally be installed under your standard program directory You can change this location via Browse 12 48 Start Copying Files x Setup has enough information to start copying the program files If you want to review or change any settings click Back If you are satisfied with the settings click Next to begin copying files Current Settings Setup Type Vollstandig Target Folder C ProgrammePhysioQuantWin User Information Name Dr John Q Public Company Dr John O Public A lt Back Cancel InstallShield All settings are summarised before installation commences After confirming with Next the copy and installation process begins Setup Complete 4 Setup has finished copying files to your computer Setup will now launch the program Select your option below IV Yes Launch the program file Click Finish to complete Setup InstallShield lt Back Finish Once the installation has been completed the PhysioQuant programme starts automatically and the required settings can be selected 13 48 3 2 Settings After the programme has started the main screen will be displayed To configure t
8. PhysioQuant Ambulatory Blood Pressure System User Manual ENVITEC 2 48 User Manual PhysioQuant Ambulatory Blood Pressure System The greatest care has been taken in preparing this manual However if you still come across any incorrect details in this manual when using the system then please contact us This will allow us to correct any errors as soon as possible The information and images contained in this manual are subject to any changes that may result from optical or technological developments All trademarks stated and used in the text are the property of the present owner and are protected by law All reproduction translation and duplication in any shape or form including extracts require the written approval of the manufacturer This manual is subject to updates by EnviteC Wismar GmbH Doc No 45 07 0500002 a 2004 Envitec Wismar GmbH Printed in Germany Envitec Wismar GmbH Tel 49 0 3841 360 1 Alter Holzhafen 18 Fax 49 0 3841 360 222 23966 Wismar Email info envitec com Germany Website www envitec com 3 48 ENVITEC Wo ahead in Tezkari EU Conformity Statement We declare with sole responsibility that the product System for long term Blood Pressure Reading PhysioQuant 45 00 0500 complies with the basic requirements according to appendix of the Regulations of the Council on Medical Products of 14 June 1993 93 42 EWG The pro
9. T data is available and processes it If no data is found then a normal programme start will take place Note During GDT operation the option for manually adding new patients should not be active so as to avoid any incorrect input or non corresponding patient master data general practice IT system and PhysioQuant database Identification The ID is a unique identifier that consists of a minimum of 1 and a maximum of 8 characters which uniquely identifies the PhysioQuant system during GDT data transfer 19 48 20 48 File names The file names that are used for the communication between general practice IT systems and PhysioQuant software should be entered in the File names field File names consists of a device identification code 1 4 characters e g PHYQ and a EDP identification code 1 4 characters for the general practice IT systems e g EDP Both these identification codes are then used to create file names which will always have the extension GDT Directory for communication data files The data transfer folder can be created where you want In order to avoid any networks errors a separate folder should be created for each individual work station e g on a local PC NB GDT data files will need to be read and then deleted by the general practice IT system before any further GDT data files can be generated Data transfer Prior selection will determine which data is transferred to general pr
10. actice IT system Example Short summary one line LZBDM Day 108 67 78 Night O O 78 100 100 100 Example Table 24 h BPM Day phase Night phase Difference 06 00 21 59 22 00 05 59 Day Night phase Mean values Ps mmHg 108 0 100 Pd mmHg 67 0 100 HR P min 78 O 100 4 PhysioQuant Recorder 4 1 Operation controls 1 2 3 aj s Cuff connection Start Stop button to delete additional measurements and to interrupt a measurement in process Info button to display the most recently measured values The following values will be displayed respectively Systolic value S mmHg Diastolic value D mmHg Pulse frequency HR min 1 Day Night button to change the measurement interval between day and night interval LCD display to display all information 21 48 6 On Off switch Battery compartment lid Connecting port for PC connecting cable 4 2 Symbols on the device AY Warning please observe the manual 5 Data export data import Application part type BF defibrillation proof 22 48 4 3 LCD display with all symbols and display options M e Flashes for every detected oscillation e Displayed constantly when measurement data has been stored a e Flashes when batteries are running out e Continuous display when batteries are empty and no measurements can be made 3 e Day phase has been selected e Night phase has been selected 4 4 Power supply
11. ard adult blood pressure cuff carrier bag belt and manual 11 Accessories and Spare Parts Standard cuff Adult 45 00 0509 Large cuff Adult 45 00 0510 Cuff Child 45 00 0511 Interface cable 45 00 0515 Bag 45 00 0513 Belt 45 00 0512 43 48 12 Cleaning and Maintenance 12 1 Cleaning and disinfection of device surface Danger of electric shock CAUTION Always disconnect the device from your PC before cleaning it Switch off the PhysioQuant Recorder Use only a moist cloth and ensure that no fluid enters the device The most commonly used cleaning and disinfection agents in practices and clinics can be used Damage to the device CAUTION Do NOT use any disinfection agents that contain phenol and peroxide for disinfecting the surface of the device If any fluid has entered the device then it should only be used again after having been checked and approved by the Service Department 12 2 Cleaning and disinfection of cuffs 44 48 Light stains can be removed by using a moist cloth For heavier stains rinse the cuff with soapsuds or disinfected cleaning agent not in the washing machine No fluid should enter the cuff inflation section or the connecting tube therefore please remove the inflation section when cleaning the cuff After you have cleaned the cuff you need to rinse it thoroughly with water and let it dry at room temperature for approx 15 hours You can also use any of the following to
12. ay shows an internal value which should be between 25 and 100 If the displayed value is outside this range then the PhysioQuant Recorder must be sent away for maintenance Press the Start Stop button The display shows 0 current pressure in mmHg Create a test pressure of 200 mmHg and measure the decrease in pressure after waiting a minimum of 30 seconds Decreases in pressure of 3 5 mmHg are normal Decreases in pressure gt 6 mmHg indicate the presence of an unacceptable leakage In such an event the PhysioQuant Recorder will need to be sent away for repair You can exit the calibration mode by pressing the Start Stop button Disposing of the device At the end of its useful life you need to dispose of the device described in this manual including all its accessories in accordance with the disposal regulations for devices of this type If you have any questions in relation to disposal then please contact EnviteC Wismar GmbH or one of its representatives 13 Technical Information Measurement Measurement method Measurement duration Data preservation Measurement intervals Capacity Measurement range Systole Diastole Heart rate Cuff Connection Size Cuff pressure Display operation controls Patient display Operation controls Interfaces PC connection Other Dimensions L x W x H Weight Operating temperature Rel humidity Air pressure Power supply oscillometric 30 45 sec de
13. ble inflation pressure of 280 mmHg e the device is not inflating beyond the set maximum pressure and is waiting for the next measurement time The maximum inflation time of 60 seconds has elapsed Error refers to a loose cuff or tube or another faultysealing Insufficient oscillations have been detected At least 8 oscillations need to be detected for a correct measurement The cuff should be attached sufficiently tightly you should be able to put one finger beneath the cuff but not two PhysioQuant will regulate the deflation rate for follow up measurements accordingly Memory full 200 blood pressure measurements have been carried out and the memory of the device is full Movement during diastole recognition Diastole is outside of the measurement range Systole is outside of the measurement range E12 and E20 are displayed when the calculated systole or diastole values are outside the range in which the oscillations are recorded Systole is below the measurement range Systole is above the measurement range Difference between systole and diastole is too small 10 mmHg or less Movement during systole recognition Air deflation speed is too high e g as a result of leakage 10 Scope of Delivery PhysioQuant System 45 00 0501 Includes PhysioQuant standard adult blood pressure cuff PhysioQuantWin software interface cable carrier bag belt and manual PhysioQuant Recorder 45 00 0502 Includes PhysioQuant stand
14. bsequent measurements can be programmed to range between 2 and 90 minutes Max pump pressure Limits the max cuff pressure to the value set between 200 mmHg and 280 mmHg The number of all programmed measurements will be displayed for each measurement interval and a summary is provided for each 24 hours The Standard button will reset the parameters to the following values 2 measurement intervals Interval 1 day phase 06 00 21 59 Exact every 15 min 250 mmHg Interval 2 night phase 22 00 05 59 Exact every 30 min 250 mmHg After saving the selected configuration the starting sequence of the recorder will commence by clicking on the Start button The recorder will first check whether there are any previous measurements that have not yet been read If this is the case then a warning will be displayed If this is not the case then the recorder will be switched off and the new patient data and measurement intervals are stored in the recorder NB Only when a new long term measurement is started will the recorder delete all old patient data and measurement values 31 48 6 7 32 48 Attaching the cuff and the recorder The PhysioQuant Recorder must not CAUTION be connected to a PC while it is being attached to the patient Please remove the connecting cable to the PC Attach the cuff to the arm that is less used by the patients For adults approx 2 finger widths above the elbow For children sli
15. d oscillation the letter M will be displayed Once the measurement has been taken the following information is displayed sequentially Systolic value S mmHg e Diastolic value D mmHg Pulse rate HR min 1 lf an error message is displayed instead of the measurement value e g E 08 insufficient recognition of oscillation then attach the cuff more firmly and press the Start Stop button again lf the test measurement has been successful then the device is ready for automatic measurement 33 48 6 9 Instructing the patient Explain to the patient how the device works automatic blood pressure measurement at regular intervals and make the following points Stay calm during the measurement so that there will be no incorrect readings as a result of any movement by the patient During the night it is best to place the PhysioQuant Recorder in its carrier bag on the bedside table It is possible to manually switch between the day phase and the night phase Record any unusual events in the patient diary master copy on CD and also carry out an additional measurement with the Start Stop button if this happens At any time measurement can be interrupted via the Start Stop button Cuff pressure will then decrease Do not open the battery compartment Important guidelines for patients CAUTION 34 48 Cancel the measurement with the Start Stop button if the cuff remains inflated for more than approx 2 m
16. duct was classified according to appendix IX of the Regulation S3 42 EWG as Class Ia CE mark awarded Issued by ENVITEC WISMAR GMBH Alter Holzhafen amp D 23966 Wismar Germany Place Date Wismar 0 06 2004 Authorised signature eccy pne A PROOUET O45 PEALE G Kononmibeseklirmg Pms biun 2s pel 4 48 Contents 1 2 3 3 1 3 2 3 3 3 4 3 5 4 4 1 4 2 4 3 4 4 4 5 4 6 4 7 5 6 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 6 9 GENERAL REMARKS SYMBOLS SAFETY INSTRUCTIONS AND USE INSTALLATION Software Settings Attaching the connecting cable to the recorder Network installation GDT interface PHYSIOQUANT RECORDER Operation controls Symbols on the device LCD display with all symbols and display options Power supply Inserting batteries Function control Connecting the cuff to the recorder PHYSIOQUANT CUFFS COMMENCING LONG TERM BLOOD PRESSURE MEASUREMENT Connecting the recorder Starting the programme Selecting a patient Adding a new patient Editing patient data Programming the recorder Attaching the cuff and the recorder Test measurement Instructing the patient 6 10 Important measurement information 6 11 Button functions 11 11 14 17 18 18 21 21 22 23 23 24 25 26 26 27 27 27 28 29 29 30 32 33 34 35 36 5 48 7 IMPORTING RECORDER DATA AFTER MEASUREMENTS 7 1 Connecting the recorder 7 2 Starting the programme 8
17. ents and a minimum of interference as well as keeping in line with the relevant testing precision level the device should only be used in combination with original accessories provided by EnviteC Wismar GmbH e No warranty claims can be made in the event of any damage as a result of using other inappropriate accessories and consumable materials 8 48 EnviteC will only assume responsibility for devices in relation to their safety reliability and functioning in the following cases Assembly enhancements resettings alterations and repairs carried out by EnviteC or at locations that have been expressly authorised by EnviteC to carry out such repairs Devices that have been used in accordance with their manuals Intended use PhysioQuant is a manually operated blood pressure measuring device carried by the patient for long term measurement of non invasive blood pressure It can be used for adults children and infants by applying the corresponding cuffs PhysioQuant must not be used for newborn babies and is not suitable for use in Intensive Care Units PhysioQuant can be used to take blood pressure measurements at various intervals for up to 30 hours and is able to store measurement results Biocompatibility The product components described in this manual including accessories which when used for their intended purpose come into contact with patients have been explained in such a way that they conform to the bioco
18. ghtly closer to the elbow Ensure that the cuff does not rise up when the arm is being bent Please ensure that e the connecting tube points upwards to the shoulder the side of the cuff with Patient written on it makes contact with the skin e the arrow lies over both the arteria brachialis and arteria femoralis the cuff is attached tightly and closely surrounds the tissue but exerts no pressure on the veins 6 8 Switch on the PhysioQuant Recorder and place it in the carrier bag Use the belt to attach the bag to the body of the patient For hygienic reasons the bag should not come into direct contact with the skin Place the cuff tube around the patient s neck in order to release any strain and connect it to the PhysioQuant see 4 7 Connecting the cuff to the recorder page 26 Ensure that the tube cannot become disconnected while the measurement is being taken Test measurement A test measurement must always be carried out after the cuff has been attached and the recorder connected In order to avoid any incorrect measurements please ensure that the patient remains calm while the measurement is being taken The patient may stand up or sit down START Begin the measurement by pressing STOP After a brief moment the device will inflate the cuff Once the required inflation pressure has been reached the device will gradually decrease the pressure Cuff pressures are displayed and for every detecte
19. he software click on the Settings icon to open the Settings menu Settings menu com xl C APROGRA 1 PHYSIO 1 DATEN Engish X pomm zl hrm z F manual patient new admission TIK P with erroneous meast m m Facharzt f r Allgemeinmedizin 12345 Musterstadt Tel 040 777 777 0 Fax 040 888 888 8 C PROGRA 1SPHYSIO 14GDT 14 48 SYSTEM Setting the serial PC interface to which the PhysioQuant Recorder will be connected System Recorder connection This displays all serial interfaces of the system Setting changing the folder for the database also see 3 4 Network installation page 18 Table ot the databank Selecting another folder for the database CAPROGRATTI PHYSIOMT DATEN E Setting language date and time format Language English hi Date format DOMM YYY Time format hhmm CRITICAL VALUES Setting the critical values for day phase and night phase Critical value Diastole Shstole Day phase 30 To 7140 Might phases Ta EE These critical values will be displayed as lines in the graphic representation of the analysis and will be part of the statistical calculations 15 48 Activate print J with preview preview lv Summary Single values graphical view Single values table with erroneous meas Selecting standard print pages Hourly averages graphical vi Ho
20. ic John Q Overview Single values Hourly averages Findings Graphical view Table 39 48 8 4 8 5 8 6 8 7 8 8 40 48 Overview The overview displays a numerical summary of the long term blood pressure measurements as well as the statistical measurement results for the whole monitoring period according to day and night phase Single value graph This graph displays the results of all individual measurements The set critical values for the day and the night phase see 3 2 Settings page 14 are displayed as red lines Single value table All measurement results are listed by date time systole diastole heart rate and mean pressure Additional measurements that have been carried out manually by using the Start Stop button are displayed behind the time indication and marked with the symbol Deleting individual measurements In order to delete individual measurements you need to click on the relevant line the line will appear in blue Then click on Delete After a confirmation message appears the measurement will be deleted Hourly mean values graph and table In order to ensure a clear representation the calculated hourly mean values are only displayed as a graph and a table Findings report You can create a small report in relation to the findings of the long term blood pressure measurements This text will be summarised and can when activated also be forwarded to the ge
21. inutes Take off the cuff if it remains inflated after pressing the Start Stop button It may be that the tube has been disconnected Further measurements should only be carried out after the cuff has been correctly attached again 6 10 Important measurement information For the first measurement the device will inflate the cuff to approx 160 mmHg starting pressure For subsequent measurements the inflation pressure will be 25 mmHg above the last measured systolic value minimum 120mmHg If the measurement value is in excess of the inflation pressure then additional inflation of 50 mmHg will take place A manual measurement can be taken at any time between automatic measurements This will be indicated by in the measurement value table After an incorrect measurement the measurement will be repeated after 2 minutes An error message is only displayed in the error table with its corresponding error code after 3 incorrect measurements After the error messages E04 Empty battery rechargeable battery E07 Inflation time finished and E10 200 measurements carried out the measurement will not be repeated After error message E07 the subsequent measurement will again take place according to the selected measurement cycle After error messages E04 and E10 have been displayed the device will switch to a power saving mode in order to avoid complete discharge of the rechargeable batteries This mode can only be ca
22. mpatibility requirements of the relevant standard when used for their intended purpose If you have any questions in this regard then please contact EnviteC Wismar GmbH or one of its representatives Cleaning No fluid should enter the device If any fluid has entered the device then it should only be used again after having been checked and approved by the Service Department Only clean the PhysioQuant Recorder when it is not connected to another device 9 48 CAUTION The device is not suitable for use in areas where explosions may occur Such areas may appear as a result of using inflammable anaesthetics skin cleaning and skin disinfection products The device should only be used together or in combination with components of other equipment when you have ensured that this connection does not adversely affect the health and safety of patients and users or the environment If the information provided with the device is not clear on how to make a safe connection that will ensure the health and safety of patients users as well as the environment then please contact the manufacturer or consult a technical expert At all times observe standard IEC 60601 1 1 The PhysioQuant Recorder can be connected to and operated from a PC on which PhysioQuantWin software has been installed Please note that no patient should be connected to the PhysioQuant Recorder as long as it is connected to the PC Before using the device on a patien
23. name J ohn Q 19 10 2004 15 55 Patient ID 5362 Date of birth fo 01 1960 Gender male female Height 190 cm Weight 30 kg f Select X Abort if Delete 6 5 Editing patient data Patient data that has been entered can be edited and updated at any time Edit button in the Patient selection window EXCEPTION Patient ID cannot be changed once it has been entered and saved 29 48 6 6 30 48 Programming the recorder After you have selected the patient a window will appear for configuring and programming the PhysioQuant Recorder Number of measuremed intervals fe 2 a Cd Batten From To Measured rate Minutes Max Number Pump pressure accurately fis 250 Bad 05 59 a Jaccurately 30 250 Em 16 Ue UU E During 24 hours 680 measurements are taken Standard nf Start x Abort Number of measurement intervals Up to 4 different measurement intervals can be selected The standard setting is at 2 intervals day and night phase Power supply The type normal battery or rechargeable battery that is used for long term measurements is set From To The beginning and end of selected intervals can be set in minutes Measurement interval Exact measurements are taken at the exact intervals in minutes that have been set Approx measurements randomly vary at approx 2 minutes around the times set Minutes The interval between su
24. ncelled by switching the device on and off 35 48 6 11 Button functions Recorder buttons have the following functions during long term blood pressure measurements START i l STOP is used too begin and end a measurement INFO is used to display the most recent measured values or o d the most recent error message G is used to manually switch the measurement intervals from the day to night phase and vice versa Note You can only manually switch between day and night phase when 2 measurement intervals only have been programmed via the PhysioQuantWin software when the starting sequence of the recorder was commenced If more or less measurement intervals have been programmed then the Day Night button has no effect on the measurement intervals 36 48 7 7 1 7 2 Importing Recorder Data after Measurements Connecting the recorder Connect the PhysioQuant Recorder to the PC see 3 3 Attaching the connecting cable to the recorder 17 and switch on the recorder gt The recorder display will show PC gt Starting the programme After the PhysioQuant software has started the main screen appears To import data from the recorder click on the Import tab to open the relevant menu alt ENVITEC PhysioQuant The measurement values are imported from the recorder and assigned to the relevant patient The graphical representation of the measurement results is also displayed see 8 5 Single value
25. neral practice IT system 8 9 8 10 Printing You can print every page displaying measurement results by using the Printing button The size of the printout can be determined on an individual basis You can define a standard format under Settings See 3 2 Settings page 14 Printer selection og x Printer S470 CL 412 Paper format A 210 297 mm Paper supply Auto Print ou fw with preview W Summan Single values graphical view Single values table To with erroneous meast Hourly averages table The integrated printing preview allows you to view the selected pages prior to printing GDT export to general practice IT systems If the PhysioQuant software of the general practice IT system interface has been activated you can then create a GDT file in accordance with the selected settings by using the GDT export tab which will be saved in the configured directory 41 48 9 Error codes E 03 E 04 E 05 E 06 E 07 E 08 E 10 E 11 E 12 E 20 E 21 E 22 E 24 E 23 42 48 Internal hardware error contact the Service Department Batteries are empty This is displayed as soon as the batteries have insufficient capacity to carry out measurements Measurement time has elapsed This is displayed when measurement time without inflation time exceeds 60 seconds This error code will be displayed when e the actual cuff pressure exceeds the maximum allowa
26. oQuant Recorder to the PC see 3 3 Attaching the connecting cable to the recorder 17 and switch on the recorder The on off switch is located beneath the lid of the battery compartment see 4 PhysioQuant Recorder No 6 page 21 The recorder display will show PC Starting the programme After the PhysioQuant software has started the main screen appears To programme the recorder click on the Start tab to open the relevant menu alo ENVITEC PhysioQuant 27 48 6 3 Selecting a patient The selection window of the patient database appears in search Name I Patient ID late of birth Patient ID Name eo Abort In the NAME field enter the first letter of the patient s surname All patients whose names start with this letter will then be displayed e g those beginning with P Patient search Name P Patient ID Name First name 01 01 1960 5362 Public John Q D v tt x New Edit Select Delete Abort Select the required patient by double clicking on the relevant line 28 48 6 4 Adding a new patient If the required patient is not in the database then you can directly enter new patient data To do so open the entry screen with the NEW button Enter all the required data and save it to the database with Save Patient data Analyses 15 11 2004 10 48 Name Public 29 10 2004 08 02 29 10 2004 07 48 First
27. pends on patient unlimited 2 90 min programmable 200 measurements or 30 hours 60 260 mmHg 40 220 mmHg 35 240 beats min Metal locking device available in various sizes 300 mmHg maximum adjustable LCD measurement values error codes Keypad Start Stop Day Night Info digital interface RS 232 USB via adapter 10 5 cm x 8 0 cm x 2 7 cm 190 g incl batteries 10 to 40 30 75 non condensing 700 1060 hPa 2 batteries type Mignon AA alkaline 2 NiMH rechargeable batteries type Mignon AA 1500 mAh 47 48 ENVITEC Envitec Wismar GmbH Alter Holzhafen 18 23966 Wismar Germany Tel 49 0 3841 360 1 Fax 49 0 3841 360 222 Email info envitec com Website www envitec com 48 48
28. t the user should check that the device functions safely and as intended Users must be familiar with how to operate the device Medico technical devices should only be used by suitably qualified or experienced persons who can ensure that the device is used correctly The device does not contain any components that need to be replaced by users Never open the casing of the device please contact the Service Department 10 48 3 Installation 3 1 Software e Put the PhysioQuant CD in your CD ROM drive e If the Auto start Function of your CD ROM drive is activated then installation will begin automatically If not Open Windows Explorer select your CD ROM drive and double click on setup exe e The installation wizard appears PhystaQuantW tn 5 01 Eo amp amp 8 8 6 amp Poo hoy ocr Bat po ond al einer belo ramets Sap open milaner e r aa sar vein pper epena gall talein a e Confirm that you are to start the installation by clicking on Next and follow the on screen instructions 11 48 User Information InstallShield Type your name below You must also type the name of the company you work for Name Dr John Q Public Company Dr John Q Public lt Back Cancel Enter your name and that of your practice and confirm with Next Choose Destination Location InstallShield Setup will install PhysioQuantWin in the following directory To install to this directory click
29. t software as described in Section 3 Installation page 11 The folder for the shared database is then created under Settings whereby selection is facilitated by the integrated Explorer functionality Table of the databank CAPROGRA TSPHYSIO 1 DATEN f GDT interface The GDT interface is a standard produced by the German Quality Assurance Medical Software QMS Qualitatsring Medizinische Software for system independent data transfer between medical devices and general practice IT systems The PhysioQuantWin software has an integrated GDT interface Device Data Carrier interface Gerate Daten Trager and therefore allows for easy data transfer with a general practice IT system Please contact your general practice IT dealer to find out what the correct settings of the GDT interface are in relation to the relevant IT system All standard settings in the GDT standard Version 2 0 can be adjusted on an individual basis Active i nactive manual patient new admission Frogram name PhysioQuant ID 12345 Version 2 00 File name Equipment td code PHYG ED td code Env File name receive EDYIPHYO GDT File name send PHYQEDY1T GDT Table of communication dat W Summan Table Findings Operation This setting activates and deactivates the GDT interface When the GDT interface is activated the software will check during the start of the programme whether the defined GD
30. urly averages table Headers Headings that should be included with every print out GDT The description of the GDT interface and the required settings can be found in Section 3 5 GDT interface 18 16 48 3 3 Attaching the connecting cable to the recorder In order to start the recorder and read information from it the recorder must be connected to the PC via a special connecting cable This special connecting cable is connected to a free serial interface of the PC COM x via the 9 pin DSB port If the recorder only has a USB connection then the connection can also be made by using one of the commercially available USB to serial converters Please contact your specialist dealer for more information The cable also needs to be plugged into the 6 pin black port which is located at the back of the casing of the device Please ensure that the plug is in the right position when connecting it nose up 17 48 3 4 3 5 18 48 Network installation The PhysioQuantWin software can be used in networks This allows for central storage of patient information and measurements i e on the server This information can then be accessed from all workstations To this end a corresponding directory is first created on the central server This folder must be connected as a drive on all workstations A local programme installation is then carried out on all workstations that will use the PhysioQuan
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