MICROLAB PicoPress - Microlab Elettronica Sas
Contents
1. devices Separation distances between mobile and portable radio communication devices and surgical navigator The strength of the nominal devices maximum output of the From 150kHz to 80MHz From 80MHz to 800MHz From 800MHz to 2GHz transmitter W d 1 2 AP d 1 2 AP d 2 3 AP 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 with the maximal nominal output not reported above the separation distance recommended in meters m can be calculated using the equation applicable to the frequency of the transmitters where P is the maximal nominal output of the transmitter in Watts W according to the constructor of the transmitter Note 1 At 80 MHz and 800 MHz the highest frequency interval is applied 2 These guidelines may not be applicable to all situations Electromagnetic propagation is influenced by the absorption and by the reflection of structures objects and persons The instrument may turn itself off following an electrostatic discharge Turn it on and take the measurement again page 8 7 SYMBOLS E emerge zC m i 2011 04 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 Please note the enclosed documents must be read On and Off button Menu button USB connection to a personal computer Transducer connection tubing Battery charger connection Applied Part BF Class Il Catalogue numb2. Do not force the plunger Contact Microlab page 15 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 18 SOFTWARE INSTALLATION Caution Most problems that come up during installation are due to the fact that the operating system is not intact Microlab guarantees smooth functioning only if the operating system is intact Caution Before you connect the device to your personal computer install the software following these instructions Minimal requirements for your personal computer 1 GHz clock processor 100 MB of space available on your hard disk 256 MB of RAM memory 1024x768 points 65536 colours video resolution a free USB port Microsoft Windows XP Vista please don t use emulators on Mac or Linux Before to connect the device to the Personal Computer make sure that the software has been installed Identify the setup exe file out of those in the CD ROM and launch it installation of the instrument s software management will begin If the installation software asks for confirmation to substitute an already existing file it is best not to substitute but to maintain it When the installation has been carried out in the Set Up Programs it is possible to access the PicoPress program icon through the Start bar Connect PicoPress to one of the computers USB port using the cable furnished and turn the PicoPress on The operating system will notify that it has found a ne
3. Giorgio amp C Technical manual for users M 688 Rev 5 16 SPARE PARTS AND ACCESSORIES PicoPress con provide for the following spare parts CODE DESCRIPTION 13 00120 00 Battery charger M 668 M 669 Package containing 5 circular disposable transducers 17 TROUBLESHOOTING DISPLAY DESCRIPTION CALIBRATION NEEDED The instrument needs to be calibrated Contact Microlab ZERO ERROR Plunger pushed in before ZERO routine termination Repeat measurement ZERO ERROR The instrument is unable to carry out calibration of zero pressure It is not possible to make measurements call service Contact Microlab MEMORY FULL The limit of the number of measurements that can be memorized has been reached Erase the measurements BATTERY LOW The batteries voltage is low charge the batteries RECHARGE OVERFLOW The transducer s pressure has exceeded the limit of 189 mmHg PROBLEM POSSIBLE CAUSE SOLUTION The instrument does not turn On The batteries could be uncharged Recharge the batteries If the instrument does not turn on after the batteries have been charged contact Microlab Pressure Measurement is not stable Leak in the transducer Check the Luer connector or change the transducer The pressure stays at zero Leak in the transducer Check the Luer connector or change the transducer It is difficult to utilize the plunger of the micro pump The micro pump has been damaged
4. e lia lai aaa e T T 9 8 LABELEINGi i cc iaia 10 INR sip DEUS came uM 11 10 WARNINGS AND SIDE EFFECT S 1 ren ecrire eri hee t ede e teer e eee deese ente erre d dee te 11 11 TRANSPORTATION AND STORAGE 2 tinent terere tice t re Dd ni e a a d re a eiua d ra kde de raa n da oi cula 12 AQ INS TALCA TION Lem 12 13 DISPOSAL cide cca EE 12 14 MAINTENANCE AND CLEANING 413 15 WORKING INSTRUCTIONS 14 16 SPARE PARTS AND ACCESSORIES 15 17 TROUBLESHOOTING 15 18 SOFTWARE INSTALLATION 16 19 PRIVACY ida ca Liliaceae alii 17 20 GENERAL INSTRUGCTIONS c iii aaa iii 18 page 2 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 1 RESPONSIBILITY 1 The C mark guarantees the device s safety from the moment that it is placed on the market Microlab Elettronica is responsible for the instrument s safety and good functioning if the indications in article 2 of the instructions 93 42 CEE are respected and that is if the system is installed and utilized for the reasons and according to the methods described in this manual the operators utilizing this instrument are adequately trained and have learned how and why it is used the maintenance outlined in this manual is properly carried out by persons authorized by Microlab Elettronica the electrical network and the
5. environment where the instrument is utilized conform with norms stipulated by law Microlab Elettronica commits itself at the customer s request to providing the block schematics of the instrument This manual is to be considered an integral part of the instrument and it should thus be carefully stored in place where it will not deteriorate or be tampered with It must be available at all times to the user page 3 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 2 APPLIED NORMS C mark under 93 42 CEE d 2007 47 CEI EN60601 1 1998 and CEI EN 60601 1 1 2003 Electrical safety CEI EN 60601 1 2 2003 and CEI EN 60601 1 2 A1 2006 Electromagnetic compatibility UNI CEI EN ISO 14971 2002 1th ed Risk analysis UNI EN ISO 9001 2008 Quality system UNI EN 980 1997 and CEI EN 62 84 1997 Graphic symbols and labelling 3 PRODUCT LIFE AND GUARANTEE The lifetime of the instrument with the exception of the batteries is 5 years The battery duration depends upon their use and is quantifiable in about 300 complete charge discharge cycles This duration is valid only if the instrument has been utilized following the manufacturers instructions and if the maintenance has been carried out according to the instructions outlined in this manual The production date can be inferred by the last four digits of the series numbers indicating respectively the month and year of production for example in the seri
6. seen on the display When it has finished recharging the instrument turns itself off automatically If the batteries seem unable to guarantee a sufficient working autonomy contact Microlab s Technical Assistance to have them substituted It is advisable to wait for the instrument to indicate that the batteries are uncharged before you charge them The battery duration is about 300 complete charge discharge cycles page 13 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 15 WORKING INSTRUCTIONS Turn the instrument on by pressing down on the button b for a few seconds An acoustic signal will confirm that the instrument is on and the display will light up Placing the transducer place the transducer on the part of the limb to be examined placing it between a thin piece of gauze and the patient s skin Make sure that the transducer is stretched out completely when it is applied to the patient and while the bandage is being applied Making measurements connect the transducer to the manometer but do not force the Luer connector PULL PLUNGER OUT will appear on the display pull out the plunger of the micro pump as much as possible An acoustic signal will confirm that the plunger has been pulled out to the fullest extent possible Wait a few seconds while the instrument goes to zero indicated on the display by the words WAIT FOR ZERO PRESSURE Push in the plunger without forcing when P
7. the password is valid the program will then advise the user that the password must be changed it is the administrator s job to carry out the change With the LOG key it is possible to visualize the list of all accesses including those that were unproductive and the relative time and date It is wise to change at least the administrator s password so that only the administrator can manage the password With the Delete key it is possible to eliminate with the exception of the administrator the users In the list of the users the administrator will be identified as number ID 1 It is impossible to lay hands on the archives if you do not know the database password Contact the Microlab Elettronica if there should be problems page 17 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 20 GENERAL INSTRUCTIONS To gain access to the software introduce the user s name and password as explained above Remember to change the password after the installation Once the password has been inserted the following screen will appear The accessible keys are those that are shown in bold letters and the others are disabled in the background 1 2 4 6 Access to the archive to introduce a new patient or to review filed exams Conclusions lets you draft the final report General printing permits you to visualize the list of all the exams executed by the patient selected and to choose thos
8. MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 MICROLAB PicoPress Cod M 700 Technical manual for users WARNING Please note that the instructions listed in this technical manual are for the benefit of operators who have been appropriately trained This manual should be read in its entirety before the instrument is utilized Should there be any doubts or problems please contact Microlab s Technical service at 39 049 8968179 In order to improve the quality of this product Microlab Elettronica reserves the right to modify this manual without prior notice Rev 5 Labelling Update Date 2012 01 10 Approved Code M 688 File M 688 Manuale PicoPress rev 5 A5 inglese doc Microlab Elettronica s a s di Bergamo Giorgio amp C via G Rossa 35 35020 Ponte S Nicolo PD Italy Tel Fax 049 8968179 page 1 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 SUMMARY T RESPONSIBILITY 2 ete dt nente redet alieni ten defer cael seb ee p c tes toti teer rte ens 3 2 Musei 4 3 PRODUCT LIFE AND GUARANTEE iii 4 A CHARAGTERISTIGS edet nte ettet ct ette E ede tet td 5 Ezeue Mp Sp 6 6 ELECTROMAGNETIC COMPATIBILITY AND SAFETY li 7 Tee ON MIBOL GS
9. USH PLUNGER IN appears on the display That means that you have reached the end because there is a perceptible click You can then read the pressure measurement on the lower line of the display indicating P XXX mmHg The words M MENU 0 NEW will appear on the first line of the display By pushing b you can begin to take a new measurement the zeroing inflating and measuring phases will be repeated By pressing M you enter into the menu where the following choices are available by rotation pressing M STORE MEMORY VIEW MEMORY CLEAR MEMORY LANGUAGE EXIT By pushing b when one of these choices appears you are selecting the corresponding function STORE MEMORY the pressure value visualized during measurement will be recorded in the file A maximum of 100 measurements can be recorded VIEW MEMORY the measurements memorized in the files are shown in their chronological order By pushing M the instrument will go to the following measurement by pushing b you will exit from visualizing modality CLEAR MEMORY Erases all of the measurements memorized by the instrument Press both keys b and M at the same time LANGUAGE permits you to select one of the following languages Italian English German and French EXIT you exit from the menu options Turning the Instrument Off press the on button b at length about 2 seconds until it goes off page 14 MICROLAB ELETTRONICA S a s di Bergamo
10. d form maximum 4 exams a sheet by clicking on Alt F9 20 7 1 Printing a single examination In order to print a single examination enter into the dynamic test By clicking on F6 you can recall a examination stored visualizing it on the screen Click on F9 to print it The front page will be printed only once 20 7 2 Printing more than one examination If you click on ALT F9 the following options will appear on the screen e All Selects all the exams to be printed e Nothing Erases the selection of the examinations page 26 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 Invert Inverts all the selection Inv Select Inverts the selection of the row Print Prints all the selected examinations Print all Prints all the selected examinations Front page Lets you choose if you want to print the front page Conclusions Lets you choose if you want to print the conclusions e Colours Lets you choose if you want to print in colour 20 7 3 General Printing By clicking on 4 Print you can select and print the examinations stored as explained above 20 8 Archive Maintenance 20 8 1 Backup copy To avoid the loss of data we suggest that you periodically copy your database archive In order to make a copy find the db paz mdb and copy it on a CD You can find the path file in the Function 6 Parameters Setup of the main menu System parameters pati
11. e to print Set up the working parameters FUNCTIONS 1 Patients Archive 2 Conclusions 4 Print 6 Parameters Setup Esc Exit EXAMINATIONS A Dynamic Test B Measurements Download page 18 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 20 1 Patient Archive Click the 1 button from the function selector to gain access to the patients archives You can enter the patient s data and the last column shows the list of the exams already carried out Td Dynamic test and Lm Measurements download The box at the bottom of the right of the screen shows the reason why the patient has been sent by the physician List of the keys of the patient s archive In the upper row you can search for subject according to last and first name in order to speed up the operation New By clicking this key you can introduce a new patient The first three inputs are obligatory The birth date format is dd mm yyyy without spaces in between To go from one field to another you can push the TAB or click on the next field using the mouse In the box called Sending Notes you can add additional notes By clicking on the OK button the patient will be inserted in the archive and the corresponding row will be highlighted By clicking on S you will go back to the previous mask with the patient s name highlighted Now all functions are available To pr
12. e with Notepad program and read it e Esc Exit to the main menu By pressing the Alt key you can activate other functions e Alt F1 Reads the software version e Alt F2 Erases the selected measurements from the database visible on the left side of the screen Alt F4 The same as esc page 22 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 20 4 2 Flowchart of the Download Measurements Measurement Measurements in the PicoPress or in the database Insert the measur in the database Erase measurements and patient s data in the PicoPress Archive Patient selection GENERAL FUNCTIONS B Key Download measur Does the selected patient Are there match the measur in the patient in the PicoPress device lt lt Key Download measur Should the patient s data be updated Should the patient s data and measur be copied and erased Do not insert the measur in the database page 23 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 20 5 Conclusions This function can be used only after the patient a new one or one already in the archive has been selected By pressing the 2 key you enter into the management of the conclusions through which it is possible to describe the exams carried out Once you have inserted the concl
13. ed off and the wire of the battery charger and USB connection should be disconnected before cleaning is begun Clean and dry all of the parts that seem dirty using a slightly humid soft cloth use water with tensioactive detergent Be sure not to get the transducer wet while you are cleaning the instrument Do not use any abrasive materials We recommend having the instrument calibrated once a year at the Microlab Charging and servicing the batteries The batteries cannot be substituted by the user Do not attempt to open the module and to substitute the batteries Read the warnings in case of battery breakdown Refer to the chapter on Troubleshooting chapter 16 The PicoPress is equipped with 6 nickel metal hydride NI MH batteries without memory effect 1 2 Volt 600 mAh each which guarantees a continuous functioning autonomy of at least 5 hours Do not leave uncharged for long periods of time and recharge them only when the message on the display indicates that the charge is insufficient If the charge level is insufficient PicoPress shuts off automatically to prevent the batteries from exhausting themselves The instrument can remain indefinitely connected to the battery charger without becoming overcharged or damaged as the microprocessor will oversee the charging process interrupting it automatically Complete recharging of totally uncharged batteries takes place in approximately 6 7 hours during which time the word recharging is
14. ent database directory 20 8 2 The creation of a new empty archive If the archive should contain the data of too many patients more than a thousand the PC may slow down in visualizing data In that case we suggest that you store the current archive and then create a new empty one In this case it is no longer possible to visualize the data in the old archive even if they are safely stored But before you carry out this operation you should make a backup copy give it a new name and store it in a new directory The empty data base whose name is paz vuoto mdb must be copied in the working directory and renamed with the name of the previous database db paz mdb page 27
15. equency of the network of the network should have levels characteristic of a typical room EN 61000 4 8 in a commercial or hospital environment Immunity Aspects at radio frequency PicoPress can function in electromagnetic environments specified below The customer or user should make sure that it is being used in this kind of environment Immunity Test EN Test Level 60601 1 2 Conformity Level Electromagnetic guide RF Radiated emissions 3 Veff from 80MHz to 2 5GHz 3 Veff from 80MHz to EN 61000 4 3 2 5GHz Field strengths from fixed RF transmitters as determined in an electromagnetic investigation of the site could be less than the conformity level in each frequency interval Interference can be verified in proximity to devices pointed out by the following symbol A page 7 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 Separation distances between mobile and portable radio communication devices and surgical navigator devices PicoPress can function in an electromagnetic ambience in which RF irradiated disturbances are under control The customer or the user can contribute to preventing electromagnetic interference by making sure that there is a minimum distance between mobile and portable RF transmitters and the instrument as recommended below in relation to the strength of the maximum output of the radio communication
16. er Serial number Producer s name and address Date of manufacture yyyy mm page 9 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 8 LABELLING O R PicoPress Read carefully the manual before use ae IREF M 700 Do not use in presence of flammable gases The device can be serviced only by qualified personnel Handle with care avoid any impact Microlab Elettronica sas di Bergamo Giorgio amp C Charge the battery when requested on the display and Via Guido Rossa 35 only with original charger 35020 Ponte S Nicol PD Italy Do not force the plunger Use only with original accessories Class Il BF www microlabitalia it Do not clean with solvents Read user manual for correct disposal A Leggere attentamente il manuale prima dell uso Non usare in presenza di gas infiammabili Lo strumento pu essere riparato solo da personale qualificato Maneggiare con cura ed evitare qualsiasi urto Caricare le batterie quando richiesto sul display e solo con il caricabatterie originale Non forzare il pistone Usare solo con accessori originali Non pulire con solventi PicoPres 5 Leggere il manuale per il corretto smaltimento sl MAMMA Bey 20092002 20082012 MOES Dew page 10 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 9 INTENDED USE The PicoPress instrument is to be used exclusively t
17. es numbers PP0010907 the last four digits are 0907 indicating September 09 2007 07 General Conditions relating to the guarantee Microlab Elettronica guarantees the product for all production defects and that the instrument conforms to all of the characteristics specified here Should the product malfunction during the guarantee period the instrument will be repaired at the expense of the Microlab Elettronica Company by its laboratory in Padua Italy The instrument will travel at the buyer s expense Limits relative to the guarantee The guarantee does not cover damage caused by improper use negligence defective maintenance maintenance not carried out within the time limits indicated in the manual modifications carried out by non authorized personnel or by its use in inappropriate environmental conditions Duration of the Guarantee the duration of the guarantee is 12 twelve months from the installation date with the exclusion of the batteries whose guarantee is for 6 six months time page 4 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 4 CHARACTERISTICS The PicoPress instrument is a portable digital gauge to be utilized for medical purposes to measure the pressure exerted by a bandage PicoPress does not administer energy to the patient while it is measuring pressure The instrument utilizes a circular transducer made out of an ultra thin biocompatible material in which a kno
18. es and is not furnished by the computer To confirm that the configuration is correct and the PicoPress is connected once you have entered into the form of the dynamic test the following will appear on the display of the PicoPress CTRL Remote and V Batt x xxV where x xx is the voltage of the internal batteries If there is no communication between the device and the PC the following message will appear for a few seconds Communication Port unavailable or Device OFF It is not possible to operate the device while you are charging the batteries 20 2 2 Executing the dynamic test Patient Preparation place the sensor where the measurement must be made Make sure that the sensor is laid flat without wrinkles Connect the sensor t on the device without forcing the luer connector The plunger must be completely inserted Select the district right or left inferior limb by clicking on the F8 button If the sensor is applied to a different district select using as before F8 the district identified with a dot and insert the name of the district by clicking Alt 7 comment Push F4 a control window will open and the pressure will be zeroed Pull the plunger out completely and wait for the pressure to be zeroed When the software asks you to push in the plunger The window will close and acquisition will take place and the pressure trace will be visible on the screen The acquisition is divided into 4 phases patient ly
19. gio amp C via G Rossa 35 35020 Ponte S Nicol PD ITALY Electrical Characteristics Supply voltage 7 2 V furnished by 6 internal batteries NI MH at 1 2 V 600 mAh Maximum current consumption 50 mA 5 mA Protection fuse 500mA internal self restoring Display Negative alphanumeric 16 columns 2 lines blue illuminated background Power Absorbed at 230 V 10W while the batteries recharge Dimensions 160 mm x 90 mm x 32 mm Weight only the gauge model 320 grams Allowed Environmental conditions Use Temperature from 10 C to 30 C vedi nota Humidity maximum70 Rh at 30 C General ambulatory environment setting Storage Temperature from 5 C to 40 C Humidity maximum 70 Rh at 30 C Electromedical Characteristics Type of Instrument Risk class as 93 42 CE Applied part Type BF as IEC EN 60601 1 Insulation Class Il during recharging Internal supply during use Grade of protection from liquids IPXO Use in the presence of inflammable gases No Usage Continuous use General characteristics Measurement range from 0 to 189 mmHg Precision 3 mmHg see note Maximum allowable pressure 300 mmHg Note The instrument may be less precise if the temperature is not within the limits prescribed here If it has been kept in a room whose temperature is not within these limits it
20. ing down LAY patient standing up STAND exercise EXERCISE and recovery RECOVERY You can go from one phase to the other by pressing Enter when the square flag turns green The exam ends by pushing the Enter key during the recovery phase but the exam can be interrupted at any time by pressing the Space bar without any data loss If you would like to write a note on the diagram press Alt 7 write the text and click on OK If you would like to set the cursors click on Home two cursors will appear The first one is a short dash and the second one is a long dash The colour of the selected cursor is white otherwise it is green The selected cursor can be moved by using the left and right arrows on the keyboard or by clicking on the selected point To move the other cursor select it by clicking on home or pushing the right button on the mouse and follow the above explanation To visualize the calculation click on the asterisk To memorize the acquisition click on F5 and click on F4 to carry out a new exam To review the already stored acquisitions us the F6 key You can make changes on acquired data see post processing page 20 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 20 2 2 Meaning of the key functions F1 F4 F5 F6 F9 F10 Enter Space Checks the voltage of the device s internal batteries Starts the exa
21. is advisable to wait at least an hour before utilizing it page 6 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 6 ELECTROMAGNETIC COMPATIBILITY AND SAFETY Emission aspects Emission Test Conformity Elettromagnetico guide RF Emissions Cispr 11 Group 1 PicoPress uses RF energy only for its internal functioning Its emission is thus very low and most likely does not interfere with nearby electronic devices Class B PicoPress is adapt for use in all buildings besides domestic ones or those directly connected to a RF Emissions low tension power network which supplies buildings for domestic use It can also be utilized in all Cispr 11 buildings including domestic ones and those directly connected to a low tension public power network which supplies buildings for domestic use Immunity Aspects PicoPress can function in the electromagnetic environments specified below The customer or user should verify that it is being used in this type of environment Immunity Test EN Test level 60601 1 2 Conformity Level Electromagnetic guide Electrostatic discharges ESD 6kV at contact 6kV at contact The floor should be made in wood concrete or in EN 61000 4 2 8kV in the air 8kV in the air ceramic If the floors are covered by a synthetic material the relative humidity should be at least 30 Magnetic field at the frequency 3 A m 3 A m Magnetic fields at the fr
22. lower right hand corner on the first page of the report By clicking on the Autodetect button the device will be automatically searched and the right number of the serial port will be set Make sure that the device is switched on If the search is unproductive it is possible to manually insert the number of the COM port on which the device is connected To individuate the right number visualize the control panel peripheral management expanding the Port COM and page 24 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 LPT Port and identify the USB serial port between parentheses you can find the number of the COM port relative to the USB port This operation must be carried out with the device switched on The row Database Directory tells you the path of the file where the database is stored The Print type box will permit you to set up the printing in colour only for colour printers Press the Update button to store the modification of the parameters if you want to go back to the previous configuration press Undo 20 6 2 Front page format You can set up the front page format and text following the instructions below Type in the text you want to print in the front page Each row in the box corresponds to a printed row on the front page lt F fontname gt specifies the font character The fontname must enclosed between quote lt S NNN gt specifies
23. manual for users M 688 Rev 5 20 4 Download Measurements This function can be used only after the patient a new one or one already in the archive has been selected By pressing the B key on the main menu you can download the stored measurements Some data regarding the patient are stored in the device so you can recognize which patient and which session When you enter the Download Measurements function the software checks if the patient selected matches the patient stored in the device You will be notified by a message if there is no match The patient s data will be visualized in a box at the upper right corner of the screen The stored measurements are automatically downloaded and visualized in a box in the lower right corner of the screen By clicking the lt lt button the measurements will be transferred to the database and then stored in the hard disk You can write some notes by using the Remarks concerning measurement N for each measurement 20 4 1 Meaning of the function keys e F1 Checks the device s batteries voltage e F2 Erases all of the measurements stored in the device F3 Stores the selected patient s first and last name in the device e F4 Downloads the measurements stored in the device F7 Erases the patient s data from the device e F9 Prints on a file The path of the generated file can be read from the left bottom of the screen By double clicking on the File Name you can open the fil
24. mination Stores the examination Reviews the examinations in the order they were stored Prints the examination on the screen Changes the pressure scale Goes from one operation to the other Ends the examination By pressing the Alt key the following operations are activated Alt F1 Alt F2 Alt F4 Alt F6 Alt F7 Alt F8 Alt F9 Alt l Tells you which firmware version is being used by PicoPress Erases the exam shown on the monitor Goes back to the previous menu Reviews the exams already stored from the latest one backwards Lets you write a note Changes the name of the district Prints all of the examinations Tells you how many exams that patient has undergone 20 3 Post Processing This function can be used only after the patient a new one or one already in the archive has been selected With regards to the examinations reviewed by the archive it is possible to position or reposition the cursors to carry out new calculations store the new modifications carried out e by clicking on the F10 key you can cyclically move from the 50 100 150 and 200 scale mmHg e modify the names of the districts analysed If you want to modify the name of the district on an already stored curve recall it with F6 then ALT F8 and you can modify the name Press F5 to store the modifications add a note by pressing ALT F7 page 21 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical
25. o evaluate the pressure exerted on elastocompression bandages on the limb of a patient using a circular disposable transducer furnished by Microlab Elettronica s a s PicoPress must be used exclusively by appropriately trained medical or paramedical personnel 10 WARNINGS AND SIDE EFFECTS Read this technical manual before using the instrument Use the instrument in conformity with the instructions outlined in this manual Permit only authorized and properly trained personnel to use this instrument Use only if the environmental conditions are those delineated in this manual In particular using the instrument at a temperature higher or lower than the range described here may affect the instrument s precision Do not use high frequency instruments electrical scalpels mobile phones X rays transmitters etc in the immediate vicinity of the instrument as it might be negatively influenced The instrument may turn itself off following an electrostatic discharge Turn it on and take the measurement again Measurements cannot be made while the batteries are being recharged Utilize only the appropriate battery charger Cod 13 00120 00 to recharge the battery Operators should be careful while handling the instrument and the transducer and all types of blows are to be avoided Be sure that the transducer is stretched out completely when it is applied to the patient Do not inject liquids or other gases other than the air in the transducer or in the c
26. oceed with the exam you can choose the type of exam and follow the relative instructions e Modify Lets you modify or add data that has already been inserted Cancel Erases the patient from the archive after the program has asked you twice if it can proceed Caution Remember that you will erase all the exams that had been stored with regards to that patient and it is not possible to cancel the operation Copy If the patient should return for another examination it is not necessary to insert his data once again All you need to do is select the patient and click on the copy button The software will automatically update the file with the patient s repeated name and the date that the new exam is being carried out Select Lets you select a patient to review the examinations stored or to execute new exams Sending Notes The box at the bottom of the right of the screen shows the reason why the patient has been sent by the physician 20 2 1 Dynamic Test This function can be used only after the patient a new one or one already in the archive has been selected Clicking on the A button from the main menu you can gain access to the dynamic test PicoPress must be switched on and connected to the computer through the USB cable page 19 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 When the device is connected to the computer the power supply in any case comes from the internal batteri
27. onnector of the manometer There are no parts that can be repaired by the user on the inside of the instrument Do not attempt to gain access to the internal parts Do not apply the transducer if the patient s skin is injured We advise that gauze be placed between the patient s skin and the transducer The transducers are disposable Do not utilize the same transducer on more than one patient Do not use solvents to clean the instrument Do not force the plunger of the micro pump Use only original Microlab transducers and accessories The instrument must be used exclusively for the purpose expressed here It should not used in the operating room Do not apply it to injured skin The instrument cannot be used as a sphygmomanometer page 11 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 e The liquid contained in the batteries is highly corrosive and can cause burns or skin injuries In case of contact wash the part abundantly with water and contact a physician Do not for any reason whatsoever touch your eyes with your hands or the part of the body that had contact with the battery liquid 11 TRANSPORTATION AND STORAGE The instrument should be stored in a dry clean ventilated place at a temperature between 5 and 40 C Exposition to direct sunlight to temperature extremes and excessive humidity should be avoided Storing the instrument at a temperature above or below the temperature range li
28. re N is the height in cm of the logo The width is set up automatically in a proportional manner with the established height e X N where N is the horizontal position in the page in cm with reference to the logo in the top left corner e Y N where N is the vertical position in the page in cm with reference to the logo in the top left corner It is possible to call a guide of the present description by clicking Guide 20 6 3 Firmware Upgrade By clicking the Upgrade button you can upgrade the firmware of the device This operation should be carried out only when the batteries are fully charged and if the new firmware is a more recent version than the installed one You can visualize the release of the firmware in the device on the first row and the release of the new available firmware on the second row By clicking the Upgrade button PicoPress will switch off automatically it should then be switched on again by the operator and the OK button should be pressed This operation does not erase the measurements or the patient s data stored in the device just as it does not erase the calibrations It is in any case an extremely delicate operation and must be carried out only if absolutely necessary Microlab declines any responsibility if the device does not function correctly after the firmware has been uploaded erroneously 20 7 Printing From the dynamic test it is possible to print all the examinations in a compresse
29. sted here may cause damage to the instrument Do not bend tighten or excessively rotate the wires and or tubing of the measuring transducer Use the bag that is furnished whenever the instrument is being transported or stored making sure to remove the transducer connected to the manometer from the connector The instrument and its accessories must be stored in a dry place protected from dust in the environmental conditions described in chapter 5 of this manual 12 INSTALLATION The instrument is normally tested and the batteries are charged before shipment We recommend in any case recharging the instrument before putting it into use To guarantee the system s safety utilize only the furnished battery charger Cod 13 00120 00 13 DISPOSAL When the product can no longer be utilized it must be appropriately disposed of Non toxic materials for human beings and for the environment have been used and most of the instrument has been made of recyclable substances such as plastic copper etc Operators should be careful to dispose of the batteries which though they do not contain lead should be treated as special refuse In those areas where there are no specific disposal norms the instrument and its accessories can be returned to Microlab which will see to its disposal page 12 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 14 MAINTENANCE AND CLEANING Attention the system should be turn
30. the font dimension NNN must be an integer number lt A L gt specifies the row justification L Left alignment to the left lt A C gt specifies the row justification C Center central alignment lt A R gt specifies the row justification R Left alignment to the right e B lt U gt lt I gt indicate respectively Bold face Underline Italics The order of the commands can be in any order and you can join all the commands as long as you do it at the beginning of the row and close them between triangular parentheses Example lt F Times New Roman S 12 A C B From this point on the text will be printed with the Times New Roman font font size 12 pt centered on the page in bold letters If you want to eliminate the bold letters you must insert the following instructions at the beginning of the line lt F Times New Roman 8 12 A C gt and the rest of the text will be printed in normal letters It is also possible to insert a logo in the title page but remember that the file of the logo must be a bmp type bitmap it must be called logo bmp and it must be memorized in the C directory program files picopress sysfiles The printing position and the logo s dimensions on the page are defined in the logo pos file in the same C directory program files picopress sysfiles with the following instructions page 25 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 DY N whe
31. usions press F5 to store them If you want to utilize the stored conclusions some other time press F7 Memo STD A window will appear in which it is possible to type a name in order to identify the conclusion Press OK to store it To utilize the already stored conclusions press F8 Load STD to have the list of the stored standard conclusions Select a conclusion and then press OK to automatically copy it in the conclusions box To erase a standard conclusion select it and click on Erase Report Cancel the same as ESC By clicking F9 from the screen of the standard conclusions you can print the report complete with the patient s data typed on the screen We advise you to draft the conclusion before printing the examinations because the latter will be printed automatically when you print at least one examination The front page and conclusions will be printed only once for each patient 20 6 Parameters From main menu by clicking the 6 button Parameters Setup it is possible to gain access to the following options e System parameters Front page e Firmware upgrade 20 6 1 System parameters In the three rows called Generality it is possible to type the name of the ward or of the physician This information will be printed as a single row at the top of each page of the patient s report In the City row you can type the clinic s address which will be printed in the
32. w hardware component and will automatically detect the installation procedure of the new hardware Wait for the end of procedure and then the system will notify that usually in a box at the bottom of the screen the new hardware has been installed and ready for use To access the software s functions insert the user name and password at the first execution it is possible to gain access calling oneself admin user and utilizing 12345 as the password Enter the configuration of the parameters by clicking on the 6 key make sure that you have access and the device is connected and click the autodetect key Once the software has realized that the communication port through which the device is connected click on Update and then on Exit The hardware is now ready to use page 16 MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 19 PRIVACY To assure respect for the privacy law access to the system that contains data concerning vital statistics is controlled by the password Protection of data in the archives takes place by identifying users with passwords The functions that only the administrator can carry out are by pressing the Alt P keys from the principle menu it is possible to access management of the password Using the Add New key the administrator can add a user and the computer s relative password It is possible to set up the length of time that
33. wn quantity of air is inserted The transducer is placed between the limb and the bandage The pressure detected by the transducer is measured by a microprocessor digital gauge and visualized by means of an alphanumeric display which also provides the essential operative instructions The instrument incorporates a micro pump which is manually activated by introducing a known volume of air The micro pump is furnished with a detection sensor The instrument is furnished with firmware software resident in the microprocessor which memorizes a maximum of 100 readings and which can be connected by a USB to a personal computer The transducers are not sterile as they are made out of disposable biocompatible material The instrument is furnished with rechargeable batteries permitting at least 5 hours of use and including a battery charger The firmware checks the charging process with opportune algorithms and messages to optimise battery use The batteries are completely charged in about 6 hours time The instrument consists in the following modules M 700 compact digital gauge complete with a manual micro pump Cod 13 00120 00 battery charger Cod M 668 carrying case Cod M 669 package of 5 disposable circular transducers Cod M 688 User manual English Version page 5 5 TECHNICAL DATA MICROLAB ELETTRONICA S a s di Bergamo Giorgio amp C Technical manual for users M 688 Rev 5 Producer Microlab Elettronica s a s di Bergamo Gior
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