User Manual - IBP Medical
Contents
1. Calibration period When delivered new from the factory each device is adjusted and calibrated before shipment To ensure reliability we recommend the following intervals for verifying calibration Parameter Calibration period Temperature Once per year Pressure Once per year Daily before each use A complete function test and calibration of the device should be done once a year According to ISO 10012 1 General Quality Assurance Requirements for Measuring Equipment the error attributable to calibration should be as small as possible In most areas of measurement 1t should be not more than one third and preferably one tenth of the permissible error of the confirmed equipment when in use In other words the accuracy of the references to adjust or calibrate the HDM must have at least a tree times higher accuracy For liability reasons you should not carry out these tests and calibration and verification yourself If IBP performs the calibration you will receive a calibration certificate in accordance to ISO9001 which documents the calibration verification results 93 Maintenance Tolerances For calibration the instrument must met the deviations listed below 25 00 C 0 05 C Temperature 74 00 uS cm 0 60 uS cm 720 Siem 600nSlem Conductivity 2 77 mS cm 0 03 mS cm cc O 6 70 mS cm 0 03 mS cm tis ras msn o stan roo mstan rooson OCC AMET oww AMET IEEE CTI AMET angosta ooe AMET TU2. On the CD HDM97 Pocket you will find templates for all versions of the HDM97 Pocket These templates are prepared fort wo three and four measuring channels Do not use a template which is prepared for more measuring channels than measuring channels meter has Disconnect USB Before terminating the USB connection please terminate the IBP View software Disconnecting with running data acquisition may end in a system freeze Main Window Fa IBP iew 2 0 joj xj File Options Page Hardware P li Start Stop Pause Setup CETHIL 11 06 00 11 08 00 11 10 00 t a ma Curve 1 T9 T Rie ol o 2 m W y Zoom interp Follow Marker Special Previous W Print Export Copy General This manual describes only the basic functions which are necessary to get familiar with IBPView Further information can be obtained using the Software s help function IBPView is intentionally not limited to HDM instruments It can be configured independently and therefore achieves its maximum flexibility to be ready for future IBP products Hardware Interface IBPView uses serial COM ports for communication This can be common RS232 serial interfaces like many multimeters on the market use or like the HDM97 Pocket virtual serial ports based on USB Using virtual COM ports it is necessary to define the number of the port once COM1 COM2 COM3 etc The COM port number of the hardware is defined automatically during the dr
3. redes If the wrong number of channels is selected the data transmission will not work correctly In case the pH channel is disabled in the base settings of the HDM97BP the meter has only three measuring channels
4. tooo AMET IET AMET Fe oe OOOO 355 2 mV pH 1 AE 59 2mV ApH 177 6 mV pH 4 AE 59 2mV ApH 118 4mV pH 5 AE 59 2mV ApH I I I I 4 I Troubleshooting 24 Troubleshooting Problem USB cable connected but the battery is not being charged Reason USB port of laptop does not provide enough power Solution Connect the meter to the battery charger or a USB port which 1s able to supply at least 500 mA Reason USB cable broken Solution Replace cable Problem The meter can not be switched on Reason Battery is empty Solution Connect the meter to a battery charger or an USB port Reason Other problems Solution Press and hold the on off key for at least 5 seconds The meter will perform a Low Level Reset and should start afterwards Problem The meter powers off itself after a couple of seconds Reason Battery empty Solution Connect the meter to a battery charger or an USB port Problem pH channel can not be selected only Version BP Reason pH channel is disabled in basic settings menu Solution enable pH channel in basic settings menu Problem Pressure value does not tare zero balancing does not work only versions BO and BP Reason There is still pressure applied to the pressure transducer Solution Disconnect pressure hose directly at meter 25 Interface Technical data Conductivity 0 to 30 0 mS cm 4 Pole probe Resolution and accuracy Resoluti
5. it also switches off after a specified time if one of the conditions listed below becomes true for the specified time period e In pressure mode The value remains 0 for the specified time period e In conductivity mode The conductivity is 0 us cm for the specified time period e In pH mode The pH probe is not connected for the specified time period Displaying battery charge progress and finish If the battery is being charged the symbol at the left top corner in the display is animated in 4 steps There is a delay of one second displaying each step After the last step has been displayed the animation starts from again like illustrated in the picture below ACIS O gt D gt my A y E e e After the battery has been charged up to its maximum capacity the inner 3 columns of the battery symbol start to blink in a one second period as shown is the illustration below AC gt NY A y E e e General 10 Battery gauge display during operation If nothing is connected to the USB port during operation the internal battery is used to supply power to the instrument The battery symbol in the left top corner of the display shows the remaining capacity of the internal battery The combinations have the meanings listed below The battery is 100 full The battery has approx 2 3 of its capacity left The battery has approx 1 3 of its capacity left The battery is empty approx 10 is left If this symbol start
6. this function there must not be any pressure on the pressure transducers inlet This is assured when the pressure tube is not connected Then the environmental pressure represents zero Procedure 1 Make sure there is no pressure applied to the pressure transducer 2 Press and hold down the key until the upper display line shows ZERO this will take three seconds 3 The measuring value is not set to zero Pressure drop measurement In pressure measuring mode the drop measurement function can be invoked by pressing the key Display PRES 60 60 means 60 seconds countdown 406 2 start value example Keys gt Stores the current value internally and starts a 60 second countdown The bottom line displays the difference between the current value and the stored start value gt Cancels the function and return to normal pressure measurement After the countdown has finished the instrument beeps 5 time and displays the following values Display PRES 00 400 0 example value after 60 second countdown 6 2 example internally stored start value end value after 60 seconds Key gt Returns back to normal pressure measurement pH measurement The HDM97 Pocket can perform pH measurement in four different ways of temperature compensation By pressing the key you can choose between these four compensation modes e pHat 20 C Display PH 20 0 C e pHat 25 C Display PH 25 0 C e pH at37 C Display PH 37 0 C e pH comp
7. to hardware channels bee IBP iew 2 0 BI x File Options Page Hardware 7 a 5 e 2 Le ff 2 920 0 Qjeazxrx Setup Start Stop Fause Zoom interp Follows Marker Special Previous W ee Y MES Print Export Plotter 1500 ms E 100ms mS cm 10 02 00 10 04 00 1 0 06 00 mt i M Conductivity il 4 Temperature ar Pressure iv pH In the main window the list of channels is located left The assignment of a particular graph to a specific hardware channel is done by performing a double click on the channel s name in the list This double click leads to a dialog xi x Cannel configuration picture in the ame en properties Select hardware channel middle You can change Name Basic Conductivity units Decades Ranges and much more Color Channel 1 nit i By clicking on the button Assign you Basicunit cae can assign each graph a hardware channel sl Channel 4 like shown in the picture right Decade m Milli Automatic For conductivity please use the base unit S cm and select for example m milli as iscellaneous Decade to show the values in mS cm Differential values Offset o El Inertia Factor fi OUrCe f Hardware Calculation Cancel 35 IBPView List of channels Depending on the version the HDM97 Pocket is equipped with up to 4 channels Channel Description i HDM97BN HDM97BO HDM97BP Temperature 0 00 100 00 Y
8. to the HDM using the navigation keys dh and HF It is mandatory to wait until the measuring value becomes stable After the measuring value finally becomes stable the adjustment point can be applied using the navigation key LOK The instrument jumps immediately to the next adjustment point so the procedure can be repeated After the last adjustment point has been applied the instrument displays CAL OK in the upper line of its display If the adjustment is not correct the instrument displays CAL ERR in the display along with a long warning beep In this case the adjustment values will be discarded and the procedure has to be started from the beginning A failed adjustment can also be an outcome of a defective instrument o mo oomme 10 mig Conductivity The adjustment of the conductivity channel is done by adjusting the cell parameter To achieve this only one adjustment point is necessary Display Cell parameter Initial Conductivity First of all set the displayed adjustment value to the value of your reference solution Then make sure that the solution has a stable temperature of exactly 25 00 C Wait until both the temperature and the conductivity values in the display become stable before pressing the navigation key LOK _ After that the cell parameter is being calculated and will be stored in the instrument pH It is necessary to adjust th pH channel before each usage It is achieved using two adjustment points Dis
9. 00 1 V 1 00 1 V 2 00 CE ox SAFETY INSTRUCTIONS For your and your patients safety read and consider the safety instructions below carefully Read the entire manual carefully before using the HDM97 Pocket Keep the instrument away from unauthorised persons Only use the HDM97 Pocket as reference instrument to measure Conductivity Temperature Pressure and pH depending to it s equipped features Never use the HDM97 Pocket as a replacement of sensors of a medical device Do not use the HDM97 Pocket in conjunction with a medical device during a treatment Only use the instrument in a dry environment and do not touch it with wet hands Make sure that no liquids intrude inside the instrument or it s inlets outlets Always use a clean protection filter for the pressure transducer inlet Prevent every mechanical overstraining of electrical wires Never buckle or pull the cable of the conductivity probe If the acquired values seem to be not believable make sure that the HDM97Pocket is not defective Prevent electrostatic discharge on the connectors This can lead to substantial damage of the instrument Make sure to be completely discharged before touching the connectors or cables connected to the instrument Adjust the meter only if you are familiar with the consequences of the adjustment Consider the hints for reference solutions in the user manual Potentials above 42V against earth ground are dangerous This poten
10. 14 00 7 0 1 9 14 17 1 2 Which temperature coefficient you should use First of all please double check the Temperature coefficient with the machine manual If you have machines from one manufacturer only in your use the temperature coefficient that the dialysis machine uses for compensation If you have different types of dialysis machines in your unit the best solution is to use a temperature coefficient of 2 07 C for all machines This avoids confusion with different readings of the conductivity on different machines Selecting the temperature coefficient Be aware that changing the temperature coefficient will lead to changes in values displayed by the meter Therefore only change the temperature coefficient if you are fully aware of its consequences If the temperature coefficient setting is wrong it will lead to false display values and at the end to hazards for the patient The HDM97 Pocket enables the user easy to choose between vendor specific temperature coefficients as well as a free adjustable value called USER TC To achieve this press the L key while in Conductivity Temperature measuring mode Use the mM and WWY navigation key to select between the machine manufacturers By pressing the navigation key LOK_ the setting will be applied Pressing the navigation key discards the setting and the meter returns back to measuring mode Adjustment of customer specific temperature coefficient USER TC Pressing the navigat
11. 9 POWER SAVING TUNC OMen ais 9 Displaying battery charge progress and finish ccccconncncoconconcconnnnonanonnnnonennonnncnnconannnnnnnnrnnonaroncnnannrnnonanens 9 Battery gauge display during OPeratiON oocccccccconncnncccnonnconononnnonnnonnnncnnnonnnnncnnnnonnnnnnnnnnnnrnnnnnnnnnrnnnnennnnnnos 10 Battery AGUNG rsrrcaa iio dato laico 10 Battery replacement ONLY BY MANUFACTURER ooccooocccnncncnncccnncnncnccnccononcconnnonnnncnnnnonnnnennnonannnnncnnnnncons 10 Me nn Pr E Eaa n e nena aise 12 Measures 13 Conductivity and temperature measurement ccseeeccceceeeeeeeeeceeeeeeeeeseeseceeeeeeaeeeeeeeseaeeeesssageeeessaeeeeeeeeaas 13 Temperature GOCHICI SIS ses sa2 o cc ssa casscanactdesosncteeconssueexoaenecenewatadecmans ES 13 Temperature measure me orssrastanciar iio 15 Presse Measurement asas a 15 Pressure drop measurement aaa 16 A O aS 16 Fundamental information about pH MeasureMent ooccnncccccnccnnccccnncnncnnnonennncnnnncnnnnnnnnnrnnnonnnnrnnnnnnnnrnnnnnnnancnss 16 Adjustment and Calibration iii idad 17 A a nS ee ene ee ee eee 17 o A saceed Gane toate aa ahd weno a chao 17 entraran tandas 17 Handling of Reference SolutiONS oooccccccocnconccononcnononononcnnnononnnonnnnnnnnnnnnnnnnnncnnnnnnnnnrnnnnnnnrnnnnnnorannnnnnnnnanenns 18 Adjusting the ADMSTPOCke asi cid 18 Maintenance of HDMITPOCKe diana 21 IFOUDIESNOO IM tit A A iaa 24 Technical data cidos 25 PO INC iia ean 27 USB IMENICE i a eee sar A 27 Interfa
12. MBP HDM97 Pocket Reference Meter Series User Manual HDM97 BN HDM97BO HDM97BP Preface The information contained in this is subject to change without notice IBP Medical GmbH its distributors and subsidiaries take no responsibility for any errors or omissions in this document The contained software is being delivered on the basis of a general licence contract or in single license Use or reproduction of the software is allowed only in agreement with the contractual arrangements Whoever transfers this software and or this manual on magnetic tape diskette or any other media except for the purpose of own use without written authorization of the IBP Medical GmbH is liable to prosecution Copyright C 2008 IBP Medical GmbH All rights reserved All brand names mentioned in this document are property of their respective owners Publishers Phone Fax Internet E Mail Manual authors Document Number Revision history IBP Medical GmbH IBP Medical Inc Ikarusallee 15 4113 W St Charles Ave D 30179 Hannover Phoenix AZ 85041 Germany USA 49 511 651647 1 866 214 5579 49 511 652284 1 866 243 0187 http www ibpmedical com http www ibpmedical com support ibpmedical com america ibpmedical com Dipl Ing Werner Pfingstmann Holger Kleinert DHDM97 0220 00 Rev 0 29 05 2008 HKL This manual is only valid for the software revisions listed below HDM97BP HDM97BO HDM97BN IBPView V 1 00 1 V 1
13. Materials and are sealed with tamper evident packaging To ensure standard solution and calibration verification accuracy e Keep solutions tightly capped to avoid evaporation e Do not return used solutions to the storage bottle e Do not remove solutions from their original bottle e Keep the solutions in a cool place e Use only fresh reference solutions for calibration and verification e Use the solution immediately after pouring evaporation will cause errors e Discard solution the appropriate number of days after opening the bottle e Discard solution after the expiration date Adjusting the HDM97 Pocket Use these functions only if you are fully aware of their consequences Wrong adjustment values will lead to false measurement values and in consequence these false values may lead to hazards for patients The entire procedure is guided by using software it 1s not necessary to open the instrument To invoke the adjustment menu first select the channel you want to adjust Then press and hold down the keys E und ES at the same time for at least 5 seconds If you want to cancel the operation press navigation key ESC Temperature Temperature adjustment is done using 2 sampling points The order of the adjustment points 1s preassigned and the value range of each point 1s restricted by boundaries Normally an adjustment is not necessary because the sensor has no drift The temperature sensor must be dipped into a liquid with known t
14. anty gives you specific legal rights and you may also have other rights that vary from state to state For further warranty information contact IBP Medical GmbH Overview 6 Product Overview pH Pressure Conductivity and Temperature cable is attached Measuring Channels Only use accessories provided with the HDM97Pocket Use of other devices may damage the instrument and will void the warranty Conductivity Temperature Probe The Conductivity Temperature Transducer is a quadropole design for greater accuracy and longevity than other designs Pressure transducer To avoid damage or inaccurate measurement ensure that no fluids enter the instrument We recommend the use of a Transducer Protector for this purpose pH The input connector is designed exclusively for pH electrodes It is optimized for glass electrode single rod measuring cells with a slope of AE of 59mV at 20 C Its absolute maximum allowable input voltage span extends from 3 Volts to 3 Volts with respect to BNC Shield Applying any voltage beyond these boundaries will possibly destroy the instrument Precautions using the pH Probe input Due to the high sensitivity of the pH input it can not be fully protected against electrostatic discharge It can only be protected by plugging the protective cap to its BNC receptacle Always attach the protective cap if the pH input is not used Do not leave the input open otherwise the circuit inside may be damaged The
15. cal Devices and then drag and drop it to the right box Existing hardware devices Drag Drop existing devices to use to the list on the right 2 After the drag and drop procedure a window opens which can be used to set the number of the serial COM port and the number of channels for the instrument For a HDM97BP four channels are possible In case the pH channel is disabled in the base settings of the HDM97BP the meter has only three measuring channels Selecting of a wrong channel number than the meter really provides will result in a not working data transmission E E System a ad Anschl sse COM und LPT To find out which COM Port the USB E Ereignisanzeige ioo obe m Y ECP Druckeranschluss LPT1 Driver has selected please select the Freigegebene Ordner beeen on UY Kommunikationsanschluss COMI l a Lokale Benutzer und Gruppe i beeen m Y AO Ia RESTE OLE CC Windows System Manager and than the ed Leistungsprotokolle und War BESES lt gt HOM Interface COM Device Manager Under group Conncetions fe a Ger te Manager H Audio a und Gamecontroller COM and LPT you should find the port 3 After this the device is displayed in the x right box Other hardware devices can be a E added if needed Click on OK to close the IBP medical GmbH window ES TEN i E Data Translation E Miscellaneous DragDrop existing devices to use to 2 the list on the right Setup Delete IBPView 34 Assigning graphs
16. ce parameters for serial COM port emulatiON oooccccnnccccccooonncnnnnccnnononnnnnnnnnnnnnnnncnnnnnonononaanncnnns 27 Driver installation example for Microsoft Windows XP Service Pack 2 cccccccscssecscsesersesesesseseresstseseseeres 28 BAO rt a Dados 30 IBP Wanna 31 Whatis IBP MIS West locas 31 EA e O E e A R 32 CNS ES assert O E E TA 32 Disconnect USB tao ist adri polonia 32 o 2 asta ieits E nar tes ae seheean ah otete gal EE E Sree aati ae 32 Selecting Na dWare sad oro dt dardo 33 Assigning graphs to hardware camelias nen yswcesan sububaranottds see ssuiadiootudanntanate ans cetaetyanaans 34 PIS One Ma NCIS eesssts noche hoc ssads ane uae ecodues ater tees ace ace ae ace danies a aoecmmsenee te eee sean ne neae nace bien ate E A 35 Introduction 2 Introduction The HDM97 Pocket meter series are reference instrument designed for the calibration of medical devices such as hemodialysis machines Please read this entire manual carefully before the first use of the instrument Application Depending on the version the HDM97 Pocket may be equipped with up to 4 acquisition channels pwm A EC Temperature pe pS The instrument was designed to be used as a dialysis machine maintenance instrument but can also be used as laboratory measuring instrument as well as instrument for environmental purposes This instrument displays measuring values numeric Graphical displays are available through a PC or Notebook using the op
17. come of a defective instrument Cancelling the adjustment procedure If you are uncertain to have entered the correct values at any step in the adjustment procedure you can cancel the process at any time Cancelling the operation will discard the adjustment values Restoring adjustment values with factory adjustment values If you have failed to adjust the instrument properly you can overwrite the user adjustments with a factory adjustment value set which has been stored into the instrument during production process Please refer to chapter Basic settings 97 Maintenance Maintenance of HDMO 7 Pocket Generally the HDM97 Pocket can be considered as an easy care instrument Like all measuring instruments there is a minimum of maintenance and care necessary to ensure that all functions work flawlessly Operate the instrument only in a dry environment and do not touch it with damp hands Ensure that no fluids intrude into the interior of the device or into the sockets at the front There are no parts in the HDM97Pocket which you can repair yourself Contact our technical support team in the event of any malfunction If the device should become damaged or malfunction send it to IBP or your distributor for repair Storage Keep the device in a dry place Suitable is for example the original packaging in which you have received the HDM97Pocket or the carrying case offered by IBP as accessory If you do not use the device over a longer p
18. e probe These technical data may be changed without notice 26 27 Interface PC Interface USB Interface The USB interface of the HDM97 Pocket 1s electrically isolated from the appliance part Two drivers are needed for installation One driver is made for invoking the interface like any other USB device and the other driver is used to emulate a serial COM port device Interface parameters for serial COM port emulation The HDM97 Pocket uses the preset values below for serial COM port emulation Property Baud rate Data bits Parity Stop Bit Handshake Interface 28 Driver installation example for Microsoft Windows XP Service Pack 2 l Insert the Installation CD in the CD or DVD drive of your computer Ze Connect the HDM97Pocket via the USB cable with a free USB port of the running computer It does not matter whether the instrument is switched on or off 3 A Found New Hardware Wizard Window will appear on the screen like that right here from the text 4 Choose No not this time and afterward click on the button Next 5 Driver source selection dialog Choose Install from a list or specific location Advanced and click on the Next button afterwards 6 Choose Search fort he best driver in these locations and check Include this location in the search Then use the Browse button and choose your CD DVD drive s letter and add the folder drivers to it In the g
19. emperature This known temperature must be adjusted using the navigation keys a and WH It is mandatory to wait until the measuring value becomes stable After the measuring value finally becomes stable the adjustment point can be applied using the navigation key LOK_ The instrument jumps immediately to the next adjustment point so the procedure can be repeated After the last adjustment point has been applied the instrument displays CAL OK in the upper line of its display If the adjustment is not correct the instrument displays CAL ERR in the display along with a long warning beep In this case the adjustment values will be discarded and the procedure has to be started from the beginning A failed adjustment can also be an outcome of a defective instrument 19 Adjustment and Calibration Pressure The pressure transducer has no nonlinear drift so an adjustment is normally not necessary Use the tare function to balance the pressure transducers environmental pressure change drift The pressure channel is adjusted using 7 sampling points This improves the accuracy of the pressure measurement because it recalculates slightly nonlinearities of the pressure transducer The order of the adjustment points starts with point 1 and is preassigned The value range of each point is restricted by boundaries Apply the pressure values to the instruments pressure transducer inlet as shown in the table below Adjust the value of your reference or standard
20. ensated by simultaneous measured temperature Display PH Fundamental information about pH measurement For measuring pH a combined electrode is used Combination pH electrodes are combinations of one reference electrode and one measuring electrode in a glass tube The pH value in the dialysate is measured by an unbreakable pH electrode The glass body is protected with a plastic coat and due to the jelly electrolyte filling it is maintenance free This electrode s diaphragm must be stored in 3 mol l KCI solution The protective cap must be refilled every three to four weeks to prevent the electrode from drying out Before use the electrode must be checked for exterior damage and crushed glass Crusts caused by leaking electrolyte can be removed easily by rinsing with reverse osmosis treated water The sample volume should be 100 ml of dialysate or 1 liter of untreated water The sample should be poured into a clean glass container with a tube or hose coming into as little contact with air as possible The pH value must be measured immediately in the same container Make sure that the display stabilizes before the value is read In stirred solutions the response rate is faster the value however must be measured at resting fluid The pH electrode must be dabbed only with a lint free cloth and never rubbed dry Rubbing destroys the jelly layer on the glass surface which results in a longer response time for the electrode Pressure and fluid cur
21. eriod of time you should connect it to the included charging device about every month for one hour to avoid exhausting the batteries Cleaning Never clean the device with any fluids In case of pollution you can wipe the surface of the HDM97 Pocket with a dry and clean cloth For measurements in the lower conductivity range the cleaning of the conductivity temperature measuring cell is recommended Remove water soluble substances by rinsing with deionized water fats and oils with warm water and household dish washing detergent Lime and hydroxid crusts can be dissolved by a 10 citric acid solution In each case the measuring cell needs to be washed with deionized water after the cleaning Basically the conductivity measuring cell does not decay over time Particular measuring media for example strong acids and caustic solutions organic solvents or too high temperatures shorten the service life considerably and or lead to damage Caring for the conductivity temperature electrode Thorough cleaning of the electrode is particularly important for measuring low conductivities Water soluble substances must be removed by rinsing with deionized water Remove lime deposits with a 10 citric acid solution To do this immerse the electrode in the solution for 2 hours at room temperature then rinse it thoroughly with deionized water Do not touch the electrode surface with your fingers If necessary clean the surface with acetone Maintenance 22
22. from a HDM97Pocket device It works with a USB connection of the HDM97Pocket The software can also be used with several hardware devices such multimeters from Voltcraft or Metex IBPView is compatible with Microsoft Windows 2000 Microsoft Windows XP and Microsoft Windows Vista Several curves can be plotted into a single diagram Several diagrams can be arranged on one or more pages if necessary Plot options like pen width or pen color can be used to create perfectly styled diagrams You can even create your own plotter designs Comfortable zoom functions are available on a single click to analyse plot details or to return to the plots overview Setting markers makes it easy to read differential values of a plot or to determine the amplitude or period of a sampled signal A comfortable preview allows you to add comments or project data when printing diagrams Export functions can be used to use measured data with other applications like MS Excel etc The help function of IBPView includes instructions for basic operations using a small project as an example If you follow these instructions it will be a good start for you in understanding the basics IBPView 32 Installation Insert the CD IBPView into the CD Drive The installatio will start automatically In case open the directory SETUP and start setup exe On then first menu select the language the installation process is self explaining Quickstart
23. her mmedistely or im the hubure Microsoft rronqlp mremmenda Hal yoo slap ha nak Whalen cov rl contac the hardware vendos for rofberare that has passed windows Lopa testing STOP instalar 29 Interface 8 The driver installation is in progress This can BIAS EAM EES a IL take a couple of minutes Please wait while the wizard installs the soltera E USB HOH Inparac 9 The driver installation was successful click on HA Ad m the button Finish to complete the Completing the Found Naw procedure a Hardware Wizard The wizsd has fnihed indiai thee sofa Lor USA lt gt ADM irte sa Le raih ba ds le eel After you have finished this procedure another similar Wizard will popup Do exactly the same you did in the first procedure as described earlier One installation 1s for the COM port emulation the other installation 1s for the USB interface itself Checking the driver installation optional The USB interface of the HDM97 Pocket emulates a serial COM port and offers a proprietary interface to communicate directly with the USB interface Ports COM amp LPT F Communications Port COMI y Communications Port OMe 4 ECP Printer Port LPT1 Use the My Computer Manage function to open the 8 48 Performance Logs and Alerts Device Manager and search for a Group called Ports g Device Manager COM and LPT You should find an entry called S N sees USB lt gt HDM Interface At the end of
24. his feature LANGUAGE Selects the display language w AUTO OFF gt Hi OFF gt disables function Hi 30 MIN gt 30 minutes delay gt A 60 MIN gt 60 minutes delay gt i 90 MIN gt 90 minutes delay Then to apply this setting or to discard this setting w gt LANGUAGE gt i DEUTSCH gt German language gt Hi ENGLISH English language Then LOK to apply this setting or to discard this setting w gt CAL RES gt Press 5 seconds until the counter in the display reaches zero Then a calibration dataset reset will be performed This takes a couple of seconds The instrument performs a restart afterwards w gt PH or TEMP gt A ON gt pH channel or temp channel enabled gt i OFF gt pH channel or temp channel disabled Then to apply this setting or ESC to discard this setting wy gt gt BEEP gt Ht ON gt keypad beep enabled gt Mi OFF gt keypad beep disabled Then LOK to apply this setting or gt C to discard this setting Value adjustment The adjustment of values is done via the navigation keys dh and WY By pressing and holding down one of these keys the last right digit of the value will be incremented or decremented depending on the key If this digit reaches the boundary it remains 0 and the next digit will begin to change If the key is being released and pressed again the procedure will start again beginning with the last digit Example sh
25. ion key LOK while adjusting the temperature coefficient to USER TC the HDM97 Pocket enters a second dialog to adjust the value itself instead of directly going back to measuring mode wy gt USER TC enters the dialog to adjust the user temperature coefficient ESC cancel and discard setting Display USER TC 2 070 Example old value 2 071 Example new value navigation key uh has been pressed once Keys gt gt increments current value Y gt decrements current value 15 Adjustment and Calibration gt Applies the value to USER TC and chooses USER TC as new temperature coefficient ES Discard adjustment and goes on using the last active temperature coefficient setting Temperature measurement This mode is only available 1f enabled in the basic settings menu This mode exists to save power in case conductivity measurement is not needed By pressing the key you can switch between unit C and F Pressure measurement In this mode the instrument displays the pressure in the middle line Unit By pressing the key you can choose between units mmHg mbar and kPa The values will be recalculated automatically It is not necessary to tare or adjust the meter if the unit is changed Offset balancing tare Caused by drift of the pressure probe the pressure display may sway slightly around zero The HDM97 Pocket is equipped with a tare function which sets the value to zero if drift occurs While performing
26. iven example on the right side the CD DVD driver has drive letter D assigned Click on the Next button afterwards i Windows Logo Test Choose Continue Anyway Foucd Hyw Had dere Ward Welcome to the Found Hew Hardens Wizard Wire ral e hor rendida gether bp hal on our pompa ont de adas mai LD ar or tando pde eet le aah us pee ccd Ae uf e oe S y C ndida corral a rd pdas lo bd fei o Cira Em bores ob TEL ee ad ery Ge l corri A AA re Fas rad Gham Gare Dick Hoz le torre heund Her Hiddins Wizard Tin srl eps poe rl ofre lor Lee lt gt POU rra Bi pra der caer mh an mala CU 2 e Ropey dih inver dl miw Wohl do pu mami e Pad ba doy brala a pears rro Perera ay ratal bom et or pci loco dra Lick Has So contri bound How Hardwaro Wirard Race chocar pra teach ad rita Arona Gi Gesarch kr de beet deem n bere locators ne des chak beas Peete do lint o topar es cel aul e abarh reducer Local A eval bow miisi l bemc met peda Poppe COA E include fu pcaton in Be arch De haere i L SS CA Dor asas ll ll choque Chop dera la rail Die e caper ll pol Be dede rra hon ll Are does ral Gunman hat Cs Hardware Installation The pofhusre ns are rita for thet hardware USA ia HOH Inirilant has nol parand mes Logo testo ho veiy its compaihiy A MPP Laia ef thas A A Continuing pour installation of this vofbrare moy impar a declatekre lhe condi operation ol pow role em
27. iver installation The application must know this number in order to communicate with the device For obtaining the number for the HDM97Pocket please refer to chapter Checking the driver installation In this example COM3 is used Be aware that connecting the HDM97Pocket to different physical USB receptacles will result in different COM port numbers one for each receptacle This is done to make multiple HDM meters work with one computer concurrently 33 IBPView Template projects Project files are named in the way Name ibp To get an easy start with IBPView there are preconfigured version specific templates for each type of instrument These templates include all common setting for start working with the application Only the number of the COM port must be adjusted to the number the driver installation has chosen if it is not coincidentally the same number is used For help to select the right COM port read also chapter Checking the driver installation Templates are available on the CD HDM97Pocket Selecting hardware xi Supported hardware devices Existing hardware devices Er 1ER medical GmbH 1 Click on Hardware in the main window E Multimeter and choose menu entry Define Then a d3 Data Translation window named Hardware configuration E Miscellaneous like that right from this text will open Open in the left box Supported hardware devices the group IBP Medical GmbH click on the entry IBP Medi
28. lysis A solution s conductivity will change according to temperature With increasing temperatures the measured solution s conductivity will increase too To achieve meaningful measurement results the conductivity value displayed is compensated to 25 C In other words the display is always converted to a solution temperature of 25 C The temperature coefficient which the displayed value is compensated with is expressed as C Unfortunately however different solutions also have different temperature coefficients To achieve an exact display the instrument will have to be adjusted to the temperature coefficient of the current solution The average temperature coefficient for dialysates is 2 07 C Listed below are the temperature coefficients used by most major hemodialysis machine manufacturers We recommend that you double check this data with documentation from your machine s manufacturer Pasa Sra nora S E userte A l o For naturally occurring solutions a value of 1 97 C is frequently used Many measuring devices not specially tailored to dialysis will use this value The calculation below shows the drastic effects of an incorrect temperature coefficient Example calculation for an incorrect temperature coefficient using a dialysate with a temperature coefficient of 2 07 C Conductivity Temperature Temperature coefficient Meter Difference of solution of solution of meter display in values mS cm IK mS cm
29. minimum input impedance of the input is 10 Tera Ohms 10 10 Ohms The leakage current is typ 2 femto Amperes 2 10 Amperes 7 Overview Charging the battery The HDM97 Pocket is internally equipped with a high performance Lithium Ion Polymer battery It can be charged using the external power supply a PC or a laptop which is connected via the USB cable to the instrument The battery of the HDM97Pocket can only be charged from USB ports which are capable of delivering 500 mA of current This is appropriate to most connectors of laptops or PC s Connecting the meter to a passive e g not externally powered USB hub the battery can not be charged and the communication may not work well During the charging process the battery symbol in the display is animated Performing measurements while the battery is being charged The HDM97Pocket can be used for measuring while the battery is being charged To maintain the dialysis machine and the patient s safety the USB part is isolated to the appliance part of the meter withstanding a voltage of 4000 Volts AC or 6000 Volts DC for at least one minute according to EN60601 1 The appliance part consists of the conductivity temperature pressure and pH channel and its connectors depending on the version ATTENTION The USB connector is not part of the appliance part Flow through adapter for conductivity and temperature measurement The adapter is suitable for measuring pressure temperature a
30. nd E have different sub functions depending on the channel currently displayed These sub functions are explained in chapter Measuring Additional functions The yellow keys below the display can be used to set values and navigate through menu options or ESC Y y setting These functions become available when the symbols shown in the right picture appear at the bottom of the display LESC Cancels the current setting or selection and returns to measuring mode 7 Decreases a value or selects the previous option in a menu or a setting y Increases a value or selects the next option in a menu or a setting Applies a value or a selects an option in a menu or a setting 9 General Switching on the instrument The instrument is switched on and off by pressing the 9 key Display test during start up Immediately after switching on the instrument the display shows all uuu mi possible segments dark for two seconds Compare the display with ni 0 A A Aa 0 W the picture on the right side Do not use the instrument further if you Y Type discover any missing segment because wrong values could be Maca displayed which may lead to misreading e a Da da Ho WIK V The content of the display must be shown exactly like this picture 7 4 a 4 a uS cm right from this text aa a Va a oe a mS cm ESC Wr wwf 0K Power saving function The HDM97 Pocket switches off automatically if the battery 1s empty If enabled
31. nd conductivity in flow though mode With immersion usage of the probe it is suitable for measuring temperature and conductivity concurrently The preferred orientation of the adapter is vertical The axial connector must point down see picture In flow through mode the axial connector is to be used as inlet meanwhile the side connector is to be used as outlet The connection to the pressure transducer inside the HDM97Pocket is accomplished by the lateral connection above the inlet Before measurement it 1s necessary to shake the adapter slightly so that air bubbles trapped inside can pass off through the outlet Nut for opening For immersion usage the probe must be unscrewed from the flow through adapter To accomplish that do not turn the upper shank the probe may be damaged Only turn the nut as shown in the picture left Never touch the electrode surfaces with your fingers or other objects Dialysate pressure outlet Do not buckle the cable of the probe The minimum allowed bending radius is 3 cm e g 1 inches General 8 Keypad Main functions The keypads main functions of the HDM97 Pocket are listed below Key for switching the instrument on and off Key for selecting the channel CD TP TP PRESSURE pH Key for selecting the unit to display Key F leads to channel dependent special functions Key to tare the pressure transducer The keypad layout is shown in the left picture The keys F a
32. on Accuracy 0 0 200 uS cm 0 1 uS cm 0 6 uS cm 201 1999 uS cm 1 uS cm 6uS cm 2 00 30 mS cm 0 01 mS cm 0 03 mS cm Reference temperature 25 C Temperature compensation is 2 070 per Kelvin Adjustable from 0 00 to 4 00 Kelvin Or selectable from dialysis machine manufacturer preset values Temperature Range 0 100 C Resolution 0 01 C Accuracy 29 40 C 0 05 C otherwise 0 1 C Pressure Range 700 1900 mmHg 2 5 Bar Resolution 1 mmHg Accuracy 2 mmHg 20 23 C pH Range pHO 14 max slew rate 70mV 118 ApH Resolution pH 0 01 Accuracy pH 0 02 DC input impedance min 10 Tera Ohm min 10 10 Ohm Input leackage current typ 2 fA max 2 pA Temperature compensation with temperature measurement or preset values to choose from Internal power source Internal Li Ion Polymer battery rechargeable with USB 5V DC max 500mA Operating time depending in channel up to 60 hours Nominal Voltage 3 7 V Max charge voltage 4 2 V internally generated an monitored Capacity 850 mAh or 3 1 Wh Battery charge time approx 3 hours External power supply Input voltage 100 240 V AC 50 60Hz Output voltage 5 V DC 1000 mA LPS Plug Mini USB A Plug Interface Degree of protection Meter IPX1 Conductivity probe IP66 max 0 5 m immersion depth max 5 min Size and weight Size 165 x 82 x 33 mm Weight 400 gr without battery charger including conductivity temperatur
33. or the remaining warranty period only The user must deliver at its own expense the product to IBP Medical GmbH Warranty Period HDM97 Pocket 24 Month Conductivity Temperature Probe 24 Month from date of delivery note The warranty does not cover Disposable parts as battery or pH electrode Annually calibration Cell cleaning Defects caused by 1 Modification alteration repair or service of the product by anyone other than IBP Medical or an authorized service center 2 Misuse due to negligence or accident 3 Operation or maintenance of the product in a manner contrary to IBP instructions Any express warranty not provided herein and any remedy for breach of contract that but for this provision might arise by implication or operation of law is hereby excluded and disclaimed The implied warranties of merchantability and of fitness for any particular purpose are expressly limited to the terms mentioned above Some states do not allow limitations on the duration of an implied warranty so the above limitation may not apply to you Under no circumstances shall IBP Medical GmbH be liable to the original purchaser or to any other person for any special or consequential damages whether arising out of breach of warranty breach of contract or otherwise Some states do not allow the exclusion or limitation of special or consequential damages so the above exclusion or limitation may not apply to you This warr
34. owing a value which has an allowable range from 0 00 to 7 50 Display 0 00 navigationkey dl is hold down Order of value incements every change follows with a delay of 0 3 seconds 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 carry over 0 10 0 20 0 30 0 40 0 50 0 60 0 70 0 80 0 90 carry over 1 00 2 00 3 00 4 00 5 00 6 00 7 00 7 50 Max value reached If the value will exceed the range limits in this case from 7 00 to 8 00 the value will be truncated to the maximum allowed value 7 50 in this particular example The Symbol aia will become blank and the meter does not react on the corresponding navigation key The values can only be changed down to 0 00 using the other WWY key 13 Adjustment and Calibration Measuring By pressing the key the user can select between all available channels of the HDM97 Pocket These channels are e Conductivity and temperature Display CD TEMP e Temperature Display TEMP if enabled e Pressure Display PRES only HDM97BP and HDM97BO e pH Display PH only HDM97BP if enabled Conductivity and temperature measurement In this mode the display shows CD TEMP in the upper line the temperature value in the middle line and the conductivity value in the bottom line By pressing the key F the user can choose the temperature coefficient Temperature Coefficients This is a topic that is frequently misunderstood and often neglected in hemodia
35. play Initial pH value rr o A pH adjustment has to be done according to the following instructions Set the mode of temperature compensation to the mode you have to use afterwards Prepare 2 buffer solutions which should not be more different than 2 pH values from each other and which are around the value you expect from your measurement If you expect to measure values around pH 6 then use the pH 5 and pH 7 buffer solutions for instance The adjustment has to begin with the lower pH value and to end with the higher pH value Preset the buffer solutions value using the mM and WY navigation keys Before dipping the probe into the buffer solution 1t has to be flushed with distilled water and dried by carefully dabbing 1t Depending on the mode you have chosen the temperature sensor must also be flushed and dried Then dip both into the buffer solution and wait until the measuring values become stable In this case apply the value using the navigation key LOK 1 Flush and dry the probes before continuing with the second adjustment point The second point is adjusted in the same way After the last adjustment point has been completed the instrument displays CAL OK in the upper line of its display If the adjustment is not correct the instrument displays CAL ERR in the display along with a long warning beep In this case the adjustment values will be discarded and the procedure has to be started from the beginning A failed adjustment can also be an out
36. rents have considerable influence on the pH measurements For high accuracy pH measurement it is essential to take the pH measurement in a resting solution at environmental pressure 17 Adjustment and Calibration Adjustment and Calibration Precautions Use the adjustment functions only if you are fully aware of their consequences Wrong adjustment values will lead to false measurement values and in consequence these false values lead to hazards for patients Definitions Adjustment An adjustment is a process in which properties of a measuring device are change in that way that its scale or display reads the same as an reference device or standard Calibration Calibration is the process of establishing the relationship between a measuring device and the units of measure This is done by comparing a device or the output of an instrument to a standard having known measurement characteristics For example the length of a stick can be calibrated by comparing it to a standard that has a known length Once the relationship of the stick to the standard is known the stick can be used to measure the length of other things Adjustments are checked by performing a calibration General According to ISO 10012 1 General Quality Assurance Requirements for Measuring Equipment the error attributable to calibration should be as small as possible In most areas of measurement it should be not more than one third and preferably one tenth of the permi
37. s flashing the battery is totally empty and the meter will switch off shortly JUOE amp Battery aging The battery technology of the HDM97 Pocket is based on Lithitum Ion Polymer technology This technology has many advantages compared with Nickel Metal Hydride technology which are lower weight smaller size longer life no memory effect and higher efficiency However after a couple of years 5 years estimated the battery s capacity will start decreasing Battery replacement ONLY BY MANUFACTURER Do not try to replace the battery by yourself The battery is mounted directly onto the main PCB inside the HDM97 Pocket and the main PCB itself contains the battery protection circuit If the battery is not handled in the right way there is extremely danger of fire and explosion Therefore this battery can only be replaced from IBP personnel who have run through a special training in handling Lithium Ion batteries 11 Base Installation Basic settings To invoke the installation menu please follow the steps below 1 Switch off the meter using the key key 2 Switch it on again using the same O 3 Immediately press the F key once during the display test 4 After this procedure the instruments starts the basic settings dialog instead of entering any measurement functions 5 In the basic settings dialog the user is able to adjust a variety of settings These are AUTO OFF Selects the auto power off delay time or disables t
38. ssible error of the confirmed equipment when in use In other words the accuracy of the references to adjust or calibrate the HDM must have at least a tree times higher accuracy After a channel has been adjusted it is necessary to calibrate it afterwards If inconclusive or incomprehensible values are shown in the display it is highly recommended to do a calibration The procedure of calibration and adjustment is slightly different for each channel Proceed with an adjustment only if you have fully understood the procedure e Conductivity is adjusted only at one sampling point No further points are needed due to the high linearity of the conductivity probe e The temperature sensor does not drift Normally there is no adjustment necessary The adjustment is done by using two sampling points e The pressure transducers drift is linear within its tolerances so there is a tare function see chapter Measuring Normally there is no adjustment necessary The adjustment is done by using seven sampling points e Due to the kind of their technology it is necessary to adjust pH probes periodically This is done using two sampling points If you are uncertain of entering the correct adjustment values you can discard the values and cancel the adjustment procedure at any time Handling of Reference Solutions IBP Medical standard solutions are produced under ISO13485 2003 quality management They are traceable to NIST and PTB Standards Reference
39. the line you g Disk Defragmenter will find the number of the associated COM port in o this case COM3 gt Universal Serial Bus controllers USB lt gt HOM Interface In addition you will find the USB communication interface in the Group USB i USB Root Hu Controller It is named USB lt gt HDM Interface Interface 30 Data transfer To receive measurements from the HDM97Pocket via the USB interface the following abbreviations must be sent via the interface The entire communication takes place in readable ASCI characters Command Reaction to HDM97 Pocket of the HDM97 Pocket HDMCMO activates the data transfer HDMCMEF deactivates the data transfer HDMEIH transmits all units hdm transmits the values Format of the values Conductivity in S cm 9 signs Temperatur in C 7 signs Druck in mmHg 9 signs pH 5 signs CR LF 2 signs Die Trennung der einzelnen Werte erfolgt durch Example Command hdm HDM sendet 0 1234567 123 123 12345 12 12 12 CR LF Command HDMEIH HDM sends S cm C mmHg pH CR LF IBPView 31 IBPView What is IBPView IBPView can be obtained optionally for the HDM97Pocket and can be used as well for other HDM instruments A demo version is included in the folder Software on the driver CD This demo can not save export or print and the acquisition time is limited to 30 seconds IBPView is a data acquisition software which records and plots measured values
40. tials can lead to electrical shock and therefore to health hazards Make sure that none of the connectors has higher voltage than mentioned before The direct connection of earth potential to any connector of the instrument is not applicable for safety purposes and may substantially damage the instrument Make sure that the medical device itself is properly connected to earth ground according to its instruction manual Make sure that the instrument never heats over 60 C 140 F Prevent direct sunlight Never sterilize the instrument using an autoclave Danger of explosion of the battery Never throw the meter into a fire Danger of explosion of the battery Never open the meter There are no parts inside you can repair Never try to replace or repair the internal battery Handled in the wrong way these part is dangerous Extreme risk of fire and explosion Table of content PENI OGUIC ON ad 2 PAGANO Naeem susie aac ed cans nia 2 EC DECLARATION OF CONFORMITY ici iii 3 Delivery Content usaste da 4 Warranty ornans ocios 5 o MS O 6 Mesas OhaMe Ss e to to e de e do OS 6 Sii ta duielh a a a a a a iS 7 Performing measurements while the battery is being Charged cccccccoocccnccccoonconccononncnnnnonononncnnnannnnnnnnnanenns 7 Flow through adapter for conductivity and temperature measurement csecccecseeeeeeneeeeeeeeeeesaeeeeesaaaeess 7 ICY AG tes rotar 8 SWITCHING OM INE nstumnmeN st da 9 Display test d ring start UP isaac oia
41. tional Software IBP View Using the USB communication interface it is possible to obtain measuring values regardless of the instrument display s content These values can be displayed in any way or stored for further processing EC Declaration of Conformity EC DECLARATION OF CONFORMITY according to the Council Directive 93 42 EEC concerning medical devices Manufacturer Product Classification Notified Body Identification Number Hannover 27 05 08 IBP Medical GmbH Ikarusallee 15 30179 Hannover declare under our sole responsibility that the following products HDM97Pocket Reference Meter Series Version HDM97BN HDM97BO HDM97BP Product Code 31 010X 0X X Depending on Version meet the provisions of the Council Directive 93 42 EEC concerning medical devices which apply to them IIB Medcert GmbH Vorsetzen 35 20459 Hamburg 0482 Responsible Dipl Ing Werner Pfingstmann Delivery content Delivery Content Pos Description Standard Option remera A a nne EC Enc EC E rn Cd rasos Conti aos Four tete O Justine A CD HDM97 Pocket with USB drivers Software and User Manual store IEC IE o erase vta zar CN rr EE ICA Peon ren pesares Ooo E ee SES SA SRA SS 5 Warranty Warranty IBP Medical GmbH warrants that it will repair or replace at its option any defective or malfunctioning part without charge for the terms listed below Parts used for repair or replacement are warranted f
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