User Guide - IBP Medical
Contents
1. In this window all measured values which can be obtained using the HDM97 are shown on a combined bar digital display If the pH sensor or the temperature conductivity sensor are not connected the message Disabled will be displayed accordingly If values are outside the Select Alarm Ranges pre set measuring ranges the relevant digital display flash red The scales on the bar display can be selected with the mouse and changed 39 HDMView Menu items Functions Chart View Analysis Opens the window where up to four measurements are interactively shown in a diagram Opens the window which is used to show measured value files in diagrammatic form for analysis HDMView 40 Alarm Window B Select Alarm Ranges Conduchvay Range Temper ture Range Pressure Range mS cm gt Celsius 1500 77 mmHg Ne oe High Limit 1000 High Limit a 20 0 100 0 Low Limit Low Limit o Sal Hoo gt 0 0 In this window you can select minimum and maximum values for some of your measurements They will be saved in the HDMVIEW INI file If the measured value falls outside the alarm range the relevant bar will show a flashing red light Menu items Settings Setup This is the option for configuring your PC hardware Select your HDM Model you have HDM90 HDM96 HDM97 HDM99 as well as your serial interface COM1 COM10 Measure Start Measure Starts measurement Stop Measure Stops measurement2. 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 avoid confusion with different readings of the conductivity on different machines Setting the Temperature Coefficient The HDM97 enables you to easily set different temperature coefficients You can choose between eight fixed settings and a variable value The fixed values are values of frequently used dialysis machines The variable value can be set to any required value If the HDM97 is in the conductivity measuring mode pressing and releasing the conductivity function key once again will change over to the temperature coefficient setting mode Changing to this mode will be initiated briefly by displaying tC Both the conductivity function key LEDs will flash The temperature coefficient currently set will be displayed for about five seconds If no other key is pressed during this time the HDM97 will automatically return to the conductivity measuring mode If either of the arrow keys is pressed within these five seconds each time the key is pressed the pre set temperature coefficients will be displayed one after the other
3. User Guide Table of Contents The information contained in this is subject to change without notice IBP Instruments 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 Instruments GmbH is liable to prosecution Copyright C 1997 2001 IBP Instruments GmbH All rights reserved Publishers IBP Instruments GmbH IBP Medical Inc Sutelstr 7a 3853 E Edna Ave D 30659 Hannover Phoenix AZ 85032 Germany USA Phone 49 511 651647 1 888 338 8742 Fax 49 511 652283 1 888 338 9838 Internet http www ibpmt com http www ibpmedical com E Mail HDM Support ibpmt com HDM Support ibpmedical com Manual author Dipl Ing Werner Pfingstmann Christopher Weed Rev 1 May 2001 Rev 2 August 2001 HDMView added Rev 3 August 2002 Temperature Coefficient for B Braun now 2 10 C Rev 4 September 2002 Temperature Coefficient for Gambro now 2 07 C Medical Device Conformity Declaration Specification Temp Accuracy 25 40 C 0 07 C otherwise 0 1 C Rev 5 October 2003 Correction of minor failure This user guide is on
4. By Measurement 16 pressing the CAL key the selected value can be accepted for further conductivity measurements If you reach the user changeable position the LED in the CAL key will flash After pressing and releasing the CAL key again the variable temperature coefficient may be changed to any value within a range of 0 00 to 4 00 K By pressing the CAL key a third time the set value is accepted All settings will be saved permanently and are still present even after switching the HDM97 off It is possible to cancel the temperature coefficient setting mode at any point described above by pressing the Conductivity Temperature pH or Pressure keys Any values possibly selected will not then be saved 17 Measurement Pressure By pressing and releasing the Pressure key you will enter the pressure measuring mode The pressure value measured is displayed with no digits after the decimal point for pressure unit mmHg and with one digit after the decimal point for pressure unit kPa To change between the two pressure units press and release the Pressure key The internal pressure sensor is suitable for a pressure measuring range of 700 to 1600 mmHg or 100 to 200 kPa If the pressure measured is outside this range OFL will appear on the display Depending on the drift of the pressure sensor the pressure display may vary slightly at the zero point The display can be set to zero using the balancing function However p
5. Range One 0 19 99 uS cm Range Two 0 199 9 uS cm Range Three 0 1999 uS cm Range Four 0 19 99 mS cm If the conductivity measured is outside this range OFL will appear on the display The conductivity measuring ranges are switched automatically The LEDs integrated into the mS uS key show the unit used in measuring the conductivity value e g mS cm or uS cm The conductivity value is automatically temperature compensated within a temperature range of 0 C to 100 C with an adjustable temperature coefficient of 0 to 4 per Degree Celsius Reference temperature is 25 C Measurement 14 Temperature Coefficients Temperature Coefficients and Conductivity Measurement This is a topic that is frequently misunderstood and often neglected in hemodialysis 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 dialy
6. 41 HDMView Chart Window F Chart View 22 l Fie Options Recording 4 Tmafsec This window allows interactive visualization of up to four channels The appearance and function of the diagram can be modified Use the right mouse button for the diagram A pop up menu with a number of options will appear For changing the time range of your measurement to be shown click on the number to the right or left of the time axis Type a new number and confirm with ENTER HDMView 42 Menu items File Save Save as Measurements which have been displayed can be saved in MS Excel format With the Save option the information will be stored in the directory selected under Select Path If no path is selected a sub directory will be created under the name of DATA in the directory in which the program HDMVIEW EXE is located With save the file names are allocated as follows Name HDMYYMMDDhhmm xls with YY MM DD hh mm year month day hours minutes The times input relate to the starting time of the measurement S Start Recording The file name may be changed subsequently the file suffix xls must be retained With Save As the file name xls may be freely selected Quit Options Channels Select Path Closes the window Up to four channels may be selected for the simultaneous recording of the various HDM measurements with different units Here you can select a st
7. If the Cal key is then pressed again and prematurely released before reaching zero the error message E44 appears The standard values are not accepted The unit exits Calibration or Pressure Balancing mode and returns to the previously set measurement mode Acceptance of the standard values is acknowledged in the display with CAL The accepted standard values are valid immediately The unit then leaves Acceptance mode and returns to the previously set measurement mode Maintenance and Care 28 Maintenance and Care Generally the HDM97 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 If this ever happens open the device and remove the batteries Sink the whole device into a vessel with distilled water overnight Afterwards dry the HDM97 and send it to your distributor for repair There are no parts in the HDM97 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 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 HDM97 or the
8. Power supply 33 Size and weight 33 PC Interface 34 RS 232 Interface 34 Functional Messages 36 Error messages 36 Range message 36 Calibration message 36 HDMView 37 Main Window 38 Alarm Window 40 Chart Window 41 Analysis Window 44 Interface from PC to HDM 46 3 Introduction Introduction The HDM97 is a self contained hemodialysis test instrument designed for the measurement of Conductivity Temperature Pressure pH This innovative device has been designed to be user friendly reliable and rugged enough for the demanding needs of hemodialysis technicians In addition the HDM97 may also be used for environmental measurement and other non medical applications The measured values are displayed numerically on the instrument s large screen The instrument also may be connected to a computer and using the supplied software displayed stored and analyzed Please take a few moments upon initial receipt of your shipment to ensure that all the items listed below have been included In the event of a discrepancy contact your supplier immediately Be sure to read this User Guide in its entirety before first using the product Applications for use The HDM97 may be used by hemodialysis personnel to test the conductivity temperature pressure and pH of the dialysate solution used with hemodialysis delivering systems The HDM97 may also be used to test the conductivity temperature and pH of acid and sodium bicarbonate dialysate co
9. accordance to ISO9001 which documents the calibration verification results 31 Maintenance and Care Recommended verification values and the allowed deviations Measuring Channel Verification Value Allowed Deviation Remark Temperature 25 00 C 0 1 C 34 00 C cee Re 37 00 C 00 oC 40 00 C 0 1 C 55 00 C 01 C 80 00 C 01 C Conductivity 74 00 uS cm 0 60 uS cm 147 uS cm 0 60 uS cm 720 uS cm 6 00 uS cm 1410 uS cm 6 00 uS cm 2 77 mS cm 0 03 mS cm 6 70 mS cm 0 03 mS cm 12 88 mS cm 0 03 mS cm 16 00 mS cm 0 03 mS cm Pressure 190 00 kPa 0 2 kPa 110 00 kPa 0 2 kPa 50 00 kPa 0 2 kPa 10 00 kPa 0 2 kPa 0 00 kPa 0 2 kPa Open Pressure Inlet 10 00 kPa 0 2 kPa 50 00 kPa 0 2 kPa 80 00 kPa 0 2 kPa pH 355 2 mV pH 1 0 02 177 6 mV pH 4 0 02 118 4 mV pH5 0 02 59 2 mV pH 6 0 02 OmV pH7 0 02 59 2 mV pH 8 0 02 118 4 mV pH9 0 02 177 6 mV pH 10 0 02 355 2 mV pH 14 0 02 Specifications 32 Specifications Conductivity 0 to 19 99 mS cm in 4 ranges quadro pole electrode Precision 12 5 16 0 ms cm better than 0 03 ms cm otherwise 0 3 of full measuring range Range Resolution 0 0 19 9 uS cm 0 01 uS cm 20 199 9 uS cm 0 1 uS cm 200 1999 uS cm 1 uS cm 2 00 19 99 mS cm 0 01 mS cm Reference temperature 25 C Temperature com
10. carrying case offered by IBP as accessory If you do not use the device over a longer period of time you should connect it to the included charging device about every two weeks 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 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 acetic 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 29 Maintenance and Care 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 acetic acid solution To do this immerse the electrode in the solution for 24 hours then rinse it thoroughly with deionized water Do not touch the
11. than two pH values apart Choose for example pH6 and pH8 Carefully remove the protective rubber cap before performing the measurement Rinse the pH probe with distilled or reverse osmosis treated water and gently shake off the excess water before immersing it into the buffer If necessary also rinse the temperature sensor dry it and put it into the measuring beaker Please also read the fundamentals in the pH measurement section How to calibrate pH Materials needed HDM97 meter with attached pH probe conductivity temperature probe optional high and low value pH Standard Solution see below two clean glass containers opna Lo F f Calibration and Verification 26 1 Press and release the pH key to select the pH channel then press and hold the Cal key The display counts down from 5 to 0 Keep the Cal key pressed until the instrument beeps and zero appears in the display If the Cal key is kept pressed for longer there is a risk of the standard values being accepted For details read the Standard Values section If the Cal key is released prematurely the calibration ends without any calibration data being accepted The error message E22 appears in the display 2 The unit is now in calibration mode indicated by the flashing LED in the Cal key The pH value 7 00 appears in the display This can be changed to the buffer solution being used with the arrow keys in a range of 1 14 in 1 unit steps Use a buffer between pH 8
12. the included Flow Through Adapter The preferred position of the Hansen connector is vertical the axial supply is show at the bottom of the illustration In the Flow Through Mode the axial supply is used as input and the radial supply as output The pressure probe in the HDM97 is fastened to the radial connection above the input Before any measurements you must shake the connector to assure that any air within the system escapes In the Dip Mode temperature and conductivity can be measured For this mode open the screw cap as show in the picture of the connector and extract the combined electrode You must not remove the tube covering the probe carrier Dip the electrode into the media up to a level above the holes in the covering tube By moving the electrode you assure that the trapped air can escape and the temperature is well balanced NOTE Do not touch the surface of the electrode with your fingers Introduction 11 Introduction Switching on the unit The unit is switched on and off with the keys marked I for on and O for off The unit also switches itself off automatically when the battery is fully discharged Main Menu After switching it on the device will do a system test After that it automatically enters the Conductivity Mode By pressing the keys shown below the required measurement will be displayed You will also hear a confirmation beep when pressing the buttons The measuring mode selected will be indicated
13. the user E11 E22 E33 E44 E55 E66 E77 E88 E99 No sensor recognized Adjustment error invalid button use Adjustment error warning only Adjustment error adjustment is ended Adjustment not possible only with external program Cell constant cannot be identified Identical buffer solutions Measurement not possible due to invalid calibration values Please contact IBP for assistance at HDM Support ibpmt com A System Error has been detected Please restart the system Range message OFL Measurement range exceeded Calibration message CAL Calibration values safeguarded P1 First pH values accepted HDMView 37 HDMView Version 3 02 HDM View is a program which allows the collection and visualization of data obtained by measurement with HDM97 Data are transferred via a serial interface from the HDM97 to the PC HDM View is compatible with Windows 95 98 Windows NT and Windows 2000 The program is divided into four sections Main Window Digital view of all channels Chart Window Chart view of up to four channels Alarm Window Select and view alarm limit for all channels Analysis Window View and analysis of recorded measurement All four windows may be used simultaneously HDMView 38 Main Window ib HDMYIEW 3 01 Functions Settings Measure Info Conductivity Temperature 10 285 36 90 I I I I I I I 1 I I I 0 0 10 0 20 0 0 0 50 0 100 0 700 0 0 0 0 0 5 0 10 0 14 0 mS cm Celsius
14. under ISO9001 quality management They are traceable to NIST and PTB Standards Reference 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 Temperature Calibration The temperature measurements are calibrated exclusively with HDMCal software and a personal computer Because these sensors do not drift no calibration is necessary after manufacturing Pressure Calibration The measurements are calibrated exclusively with HDMCal software and a personal computer Because these sensors do not drift no calibration is necessary after manufacturing 23 Calibration and Verification Conductivity Calibration Incorrect measurements can occur as a result of deposits on the electrode after extended use These deposits can influence the cell constant Thus it is necessary to calibrate the conductivity measurement on a regular basis However you must calibrate temperature before calibrating conductivity In the eve
15. Deactivate Communication Host HDM97xxSTO lt cr gt HDM OK lt cr gt lt lf gt 35 PC Interface New Device Number Host HDM97xxDxx lt cr gt Device Nummer nur von 1 32 HDM OK lt c gt lt If gt oder ERROR lt cr gt lt If gt OK gt Device Number modified ERROR gt Device Number not modified Conductivity Measuring Range Host HDM97xxLFy lt cr gt y 1 gt 0 20 uS 2 gt 0 200 uS 3 gt 0 2 mS 4 gt 0 20 mS HDM OK lt cr gt lt lf gt oder ERROR lt cr gt lt lf gt OK gt Range changed ERROR gt Range not allowed Deactivate Conductivity Measuring Range Host HDM97xxLFN gt HDM OK lt cr gt lt lf gt Give Out Units Host HDM97xxUNI lt cr gt HDM lt uS oder mS gt lt cr gt lt lf gt lt C gt lt cr gt lt lf gt lt kPa gt lt cr gt lt If gt Give Out Values Host HDM97xxV AL lt cr gt HDM lt Conductivity gt lt cr gt lt lf gt mS uS lt LF Current indirect gt lt cr gt lt lf gt mV lt LF Voltage gt lt cr gt lt lf gt mV lt Temperature gt lt cr gt lt lf gt C lt Temperature AD Converter gt lt cr gt lt lf gt mV lt Pressure gt lt cr gt lt lf gt kPa lt Pressure AD Converter gt lt cr gt lt lf gt mV lt pH gt lt cr gt lt lf gt lt pH AD Converter gt lt cr gt lt lf gt mV Messages 36 Functional Messages Error messages During calibration or measurement a double beep and a message in the LCD display indicate faults to
16. and 10 for the high adjustment point and a value between 4 and 6 for the low adjustment point The order of two calibration points does not matter We recommend that you adjust the high point first 3 Press and release the pH key to change the display value between the buffer solution value and the displayed pH value The buffer solution temperature can be displayed by pressing the temperature key if you are using the temperature sensor 4 Once the displayed pH measurement value has stabilized press and hold the Cal key The display then counts down from 5 to 0 the instrument beeps and a zero appears in the display when it has accepted the calibration values If the Cal key is released prematurely the error message E33 appears In this case you have the possibility of continuing the calibration If the Cal key is again released prematurely the error message E44 appears No calibration is performed The unit then exits calibration mode and returns to the pH measurement 5 Acceptance of the values is acknowledged in the display with P1 The pH electrode is then immersed into the second buffer solution Repeat steps 1 3 above with the second pH value Completed calibration is acknowledged in the display with CAL and the gradient measured is then displayed in for approximately 2 seconds If the gradient is less than 85 the pH electrode may be worn out and must be replaced by a new one The unit then exits Calibration mode and returns to pH measur
17. andard path for your measuring files 43 HDMView Recording Start Starts recording the measured values that can later be saved in a file While recording a red LED is shown in the lower right hand corner of the window Stop Stops recording measured values HDM View 44 Analysis Window gt ae J P gt Oa Analysis allows the loading and display of measuring files as a graph The graph can be traced with a cursor The actual x and y values are printed below the graph In addition numerous values are listed in a table Max Maximum value Time Point of time of the maximum value Min Minimum value Time Point of time of the minimum value Mean Mean value Dev Standard deviation 45 HDMView Menu items File Open File Information Save Time Range Print Quit Options Change Scales Select Time Range Show Remove Legend A file dialog box enables a previously recorded measurement to be selected and shown as a graph Shows when the file has been saved as well as any comments Allows certain time range for your measurement to be saved This time range must be determined using Select Time Range The complete window will be printed Closes the window Allows a multiplication factor to be inserted for each graph which is shown above the respective cursor Allows the selection of a time range that can be saved with Save Time Range A legend app
18. astic part is restricted it can be released by rinsing with lukewarm water 19 Measurement Pressure and fluid currents have considerable influence on the pH measurements Therefore it is essential to take the pH measurement in a resting solution at environmental pressure If you would like to learn more about pH please visit the following WEB sites The pH Measurement Information Resource This site provides comprehensive information on the theory and practical application of pH measurement http www ph measurement co uk Acids and Bases pH Tutorial http www science ubc ca chem tutorials pH Measurement 20 Battery Charging The battery must be charged if LOW BAT appears in the display at the upper left side The microprocessor controlled charging occurs when the power supply unit is connected There are two charging modes Rapid charge and floating charge The LCDs above the On key indicate the charging state Green stands for floating charge while the red LCD indicates rapid charge A maximum of 2 5 hours is required for complete charging To avoid hazardous voltages in case of a defective battery charger never use the HDM97 on a dialysis machine with a connected battery charger 21 Calibration and Verification Calibration and Verification To avoid confusion let us explain first what is calibration and what is verification e Calibration is the correction of a measuring channel e Verification is the che
19. by the flashing LED The Conductivity key has two functions If Conductivity is displayed press and release this key a second time to enter Temperature Coefficient setting mode This mode is indicated by both the Conductivity key LEDs flashing wmSicem C w mmHg w pH Conductivity Key pH Key w S cm kPa Temperature Key Pressure Key Introduction 12 Use of the Calibration and Arrow Keys The keys shown below are used for calibration of conductivity and pH for balancing pressure measurement for setting the temperature coefficient and also for accepting default values See the Calibration section of this User Guide before attempting any calibration procedures The Calibration key which shows a calibration curve symbol serves several functions 1 To enter or complete the calibration and pressure balancing processes 2 To accept default and relevant values during calibration The LED integrated into the Calibration key indicates the respective process from call up to completion by flashing 3 To show the Version of Software and the selected the temperature coefficient When in the calibration mode in conjunction with a conductivity or pH standard solution the selection of the appropriate reference solution is done by the arrow keys Pressing these during the temperature coefficient setting process will select different dialysis machine manufacturers temperature coefficients See the list presented later in this User Gu
20. cking of the instrument with a known reference value Anytime a calibration is made to the meter verification is required to ensure accurate operation Anytime that improper function is suspected verification and or calibration are required Each measurement parameter is calibrated in a slightly different manner so be sure to read the instructions carefully before proceeding e The conductivity is calibrated by measuring the cell constant Due to the high linearity of the probe only one calibration point is necessary for this e The temperature and pressure measurements are calibrated exclusively with the HDMCal software and a personal computer Because these sensors do not drift no calibration is necessary after manufacturing The calibration is done at six points for increased accuracy e The pH measurement is calibrated at two points If at any point during calibration you are unsure whether you have correctly entered all values you can exit without saving any calibration values After you have done so no calibration is performed and you can start again from the beginning The necessary steps for exiting the calibration procedure are described in detail below If a calibration is incorrect you have the option of accepting the standard values for every measurement mode Refer to the Standard Values section for details Calibration and Verification 22 Handling of Standard Solutions IBP Instruments standard solutions are produced
21. deliver at its own expense the product to IBP Instruments Inc USA from any country in America or IBP Instruments GmbH Germany from all other countries 7 Introduction 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 Instruments 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 watranty 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 Instruments 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 warranty gives you specific legal rights and you may also have othe
22. ears offering a number of modifications to the graph s appearance e g its colors HDMView 46 Interface from PC to HDM 9 pin D Sub from PC female 1 2 3 14 5 6 u x 1 2 3 14 1516 17 18 19 8 9 X 9 pin D Sub to HDM female
23. ed 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 KCl 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 Before taking measurements remove the rubber cap If the mobility of the pl
24. electrode surface with your fingers If necessary clean the surface with acetone Calibration intervals When delivered new from the factory each device is adjusted before shipment To ensure reliability the different measuring channels have to be calibrated at fixed intervals to examine their precision This can be done by measuring known sizes for instance standard solutions or proof voltages If the measured values should deviate from the below indicated permissible limits a new calibration of the instrument is necessary We recommend the following intervals for verifying calibration Parameter Verification Frequency Temperature Once a Year Conductivity Once a Month Pressure Once a Year pH Before Each Use If for individual parameters the function adjust reset was used then a new calibration is necessary for these parameters Write down your calibration values and keep them until the next calibration In case of damage a calibration protocol can be important to help locate the problem If the calibration has been done by the IBP a sticker will be put on showing the date of the next required calibration Calibration and Verification 30 A complete function test and calibration of the device should be done once a year 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
25. ement 6 Ifa calibration ends without CAL displayed and if the error message E77 appears instead two identical values have been entered for the buffer solution You then have the possibility of continuing or exiting the calibration procedure in accordance with the steps above 27 Calibration and Verification Calibration Standard Values If a calibration of the conductivity or pH is incorrect you have the possibility of separately retsetting the default standard values for each measurement type installed in the unit at the factory Use this function only if you are fully aware of its effects because your personal adjustment values will otherwise be lost How to recall the standard values 1 Press and release the Conductivity or pH key to select the channel for which the calibration values are to be replaced by the standard values Then press and hold the Cal key The display counts down from 5 to 0 Continue to hold the Cal key as the display counts down from 50 to 0 in increments of 10 Keep the Cal key pressed until the instrument beeps and a zero appears in the display If the Cal key is released prematurely in this counting mode the instrument will be in Calibration or Pressure Balancing mode depending on the measurement selected You can exit this mode by pressing and releasing the Cal key If you do this the display counts down from 5 to 0 If the Cal key is released before zero is reached the error message E33 appears
26. ence solution and the measured conductivity value The temperature of the reference solution can be displayed by pressing and releasing the Temperature key 4 Once the displayed conductivity measurement value has stabilized press and hold the Calkey The display counts down from 5 to 0 the instrument beeps and a zero appears in the display when it has accepted the new calibration values If the Cal key is released prematurely the error message E33 appears In this case you have the possibility of continuing the calibration If the Cal key is again released prematurely the error message E44 appears No calibration is performed The unit then exits calibration mode and returns to the conductivity measurement 5 Completed calibration is acknowledged in the display with CAL and the cell constant determined is then displayed for approximately 2 seconds The unit then exits calibration mode and returns to conductivity measurement 6 Ifa calibration ends without CAL being displayed with the error message E66 appearing instead no permissible cell constant was determined This can be caused by for example using the wrong conductivity solution You then have the choice to continue the calibration or exit in accordance with the instructions above in step four 25 Calibration and Verification pH Calibration We recommend verification of the pH calibration before each measurement Keep two buffer solutions ready Both buffers should not be more
27. ide to select the recommended coefficient for your machine In case the device is not in calibration mode pressing one of the two arrow keys will bring up first the HDM97 s software version and second the selected temperature coefficient Calibration Key Up Arrow Key Down Arrow Key 13 Measurement Measurement Temperature Press and release the Temperature key to display the temperature value The temperature value measured will be shown on the display with one digit after the decimal point The temperature sensor is has a range from 0 C to 100 C If the temperature measured is outside this range OFL will appear on the display In case error message E11 is shown on the display instead of the temperature value and the instrument beeps no temperature sensor was found by the instrument One reason for this error message is the temperature sensor being defective or incorrectly installed Conductivity Press and release the Conductivity key to display the conductivity value The current temperature coefficient will briefly be indicated Then the conductivity value is shown on the display depending on the relevant conductivity measuring range with a maximum of two digits after the decimal point The conductivity measurement has a range of 0 tol9 99 mS cm which is divided into four conductivity measuring ranges to provide highly accurate measurements These four ranges are as follows Conductivity Ranges
28. lean HDM or the electrodes as this will cause damages e Do not open the device e To avoid current loops use the RS232 Interface only with notebooks which are not connected with the battery charger Federal law restricts the use of this device to sale by or on the order of a physician Table of Content Introduction Applications for use EC Declaration of Conformity Delivery Content Warranty Product Overview Measuring Channels Conductivity Temperature Transducer Pressure pH Battery Charger Use of the Flow Through Adapter Switching on the unit Main Menu Measurement Temperature Conductivity Temperature Coefficients Temperature Coefficients and Conductivity Measurement Which temperature coefficient you should use Setting the Temperature Coefficient Pressure Balancing an offset pH Measurement Temperature compensation of pH measurement Fundamental information about pH measurement Battery Charging Calibration and Verification Handling of Standard Solutions Temperature Calibration Pressure Calibration Conductivity Calibration pH Calibration Calibration Standard Values How to recall the standard values oo 0000 Da KRW O Table of content 2 Maintenance and Care 28 Storage 28 Cleaning 28 Caring for the conductivity temperature electrode 29 Calibration intervals 29 Recommended verification values and the allowed deviations 31 Specifications 32 Conductivity 32 Temperature 32 Pressure 32 pH 32
29. ly valid for software releases 2 1x x 0 9 Safety Instructions For your own safety and the safety of your patients follow these important safety instructions as well as other safety instructions noted throughout this User Guide e Please read the User Guide in its entirety before using the HDM97 e Keep away the device from unauthorized persons e Never use the HDM97 on a dialysis machine to which a patient is connected e Never use the HDM97 on a dialysis machine with a connected battery charger e Never use the HDM97 in place of the hemodialysis machine s primary sensors e Operate the instrument only in a dry environment and do not touch it with damp hands e Ensure that no fluids intrude into the interior of the device or into the sockets at the front e Apply a clean Transducer Protector to the nozzle for the pressure measurement e Verify accurate function of the meter before taking measurements or whenever inaccurate readings are suspected e Avoid a discharge of static electricity over the sockets It could lead to the destruction of your instrument Before touching the sockets and lines that are connected with them dissipate any static electric charge that may be present in your body e Only calibrate the HDM97 if you have understood the consequences to their full extent Use only the recommended standards later in this manual e Do not use abrasive cleaning agents and or full strength bleach or acid to c
30. ncentrates and water used in hemodialysis applications Introduction EC Declaration of Conformity according to the Council Directive 93 42 EEC concerning medical devices IBP Instruments GmbH SutelstraBe 7A 30659 Hannover declare under our sole responsibility that the product HDM97 Art No 31 0007 meet the provisions of the Council Directive 93 42 EEC concerning medical devices which apply to them CE certified by Medcert GmbH Hamburg Germany Nr 0482 Date of issue 09 08 02 Authorized person Dipl Ing Werner Pfingstmann Managing director 5 Introduction Delivery Content Introduction 6 Pos Standard Option 1 HDM97 x 2 _ Conductivity Temperature Probe CTP x 3 Flow Through Adapter for CTP x 4 Battery Charger with country specific adapter x 5 Tube inc Male Connector for Pressure Measurement x 6 13 63 or 14 00 mS cm Conductivity Standard Solution x 7 User Manual x 8 Case x 9 HDMView Software and RS232 Interface Cable x 10 pH Probe with Reference Solution x Warranty IBP Instruments 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 for the remaining warranty period only Parts Warranty Time HDM97 24 months Conductivity Temperature Probe 24 months The user must
31. nt of heavy contamination of the electrode cleaning with a 10 citric acid solution is recommended We recommend that you check the calibration once each month How to calibrate conductivity Materials needed HDM97 meter with attached conductivity temperature probe 13 63 or 14 0 ms cm Conductivity Standard Solution clean glass container 1 Press and release the Conductivity key to select the Conductivity channel then press and hold the Cal key The display counts down from 5 to 0 Keep the Cal key pressed until the instrument beeps and zero appears in the display If the Cal key is kept pressed for longer it is possible to recall the standard adjustment value Refer to the Standard Values section for more details If the Cal key is Calibration and Verification 24 released prematurely the calibration is terminated without relevant values being accepted The error message E22 appears in the display in this case 2 The unit is now in calibration mode indicated by the LED integrated in the Cal key flashing 13 63 mS cm appears as a reference solution value in the display This can be changed with the arrow keys in a range 10 15 mS cm depending on the reference solution being used Calibration should be performed for measurements in dialysis in a range of 13 14 mS cm and the reference solution should have a temperature of exactly 25 C 0 1 C 3 Press and release the Conductivity key to change the display value between the refer
32. pensation with 2 07 per C adjustable from 0 00 to 4 00 per C Temperature Range 0 100 C Resolution 0 01 C Accuracy 25 40 C 0 07 C otherwise 0 1 C Pressure Range 700 1600 mmHg Resolution 1 mmHg Accuracy 3 mmHg 20 23 C pH Range pH0O 14 Resolution pH 0 01 Accuracy pH 0 1 Temperature compansation manually or via probe in combined electrode 33 Maintenance and Care Power supply Internal Ni MH battery rechargeable Operating time depending on operating mode approx 19 5 hours External charger Input Voltage Europe 220 V 50Hz International 100 245 V 50 60 Hz Output Voltage 12 V DC 500 mA Size and weight Approx 210 x 105 x 50 mm 4 x 7 5 x 2 inches Weight 578 grams 1 lb 4 4 oz without battery charger or probes PC Interface PC Interface RS 232 Interface Pin occupation of the RS 232 Interface Interface parameters HDM97 Computer Pin Number Signal Pin Number Signal 2 RxD 3 TDX 3 TxD 2 RXD 5 GND 5 GND The following interface parameters are fixed in the instrument Baud rate 9600 Parity None Data bits 8 Stop bit 1 Commands General 1 All values are listed as lt 12 34 gt 2 Device Number xx Default is 1 3 Conductivity range y 4 Inadmissible commands call forth ERROR 5 9999 99 gt no Sensor Activate Communication Host HDM97xxSTA lt cr gt HDM OK lt cr gt lt lf gt
33. r rights that vary from state to state For further warranty information contact IBP Instruments GmbH Introduction 8 Product Overview Pressure Inlet Conductivity Temperature Connector pH Connector Measuring Channels Only use accessories provided with the HDM97 Use of other devices may damage the instrument and will void the warranty Conductivity Temperature Transducer The Conductivity Temperature Transducer is a quadropole design for greater accuracy and longevity than other designs Take care to properly align the pins in the connector when attaching the transducer Pressure 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 Use of other devices may destroy the instrument Introduction Battery Charger The HDM97 is equipped with an internal NiMH battery for extended run times when not connected to the external charger The charger provides a 12V 500mA charge to the battery LOW BAT appears on the display when the battery requires charging For further details consult the Maintenance section of this User Guide Use of the Flow Through Adapter Screw Cap The Conductivity Temperature Transducer may be used in two ways In the Flow Through Mode illustrated at left the user may measure pressure temperature and conductivity with
34. ressure must not be applied to the sensor when doing so This can be safely achieved by detaching the pressure measurement apparatus The zero point for balancing purposes will then be the ambient pressure Balancing an offset Press and release the Pressure key to select the pressure channel then press and hold the CAL key The display counts down from 5 to 0 Keep the CAL key pressed until the instrument beeps and a zero appears in the display Completed balancing is acknowledged in the display with CAL The unit then exits Balancing mode and returns to the pressure measurement If the CAL key is released prematurely the balancing ends without relevant values being accepted The error message E22 appears in the display Measurement 18 pH Measurement Pressing the pH key takes you into the pH value measurement mode The measured pH is displayed with two decimal places The pH electrode is suitable for a measurement range of 0 14 If the pH measured is outside this range OFL will appear on the display If error message E11 appears in the display instead of the pH value no pH electrode has been recognized The reason for this error message can be an incorrectly inserted or faulty pH electrode Temperature compensation of pH measurement For automatic compensation of the pH measurement the user may measure the solution temperature with the temperature sensor If no temperature sensor is connected a solution temperature of 20 C is assum
35. sates is 2 07 C Listed below are the temperature coefficients used by most major hemodialysis machine manaufacturers We recommend that you doublecheck this data with documentation from your machine s manufacturer Machine Manufacturer Temperature Coefficient Baxter European Machine 2 20 C Braun 2 10 C Fresenius 2 10 C Gambro AK Type Machines 2 07 C Gambro Phoenix 2 07 C Hospal 2 07 C Nikkiso Bicarbonate conductivity 2 02 C Total conductivity 2 05 C This value is official confirmed by Gambro The machines itself are using 1 80 C If you have problems with the value 2 07 C we recommend to use the 1 8 C value 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 15 Measurement Example calculation for an incorrect temperature coefficient using a dialysate with a temperature coefficient of 2 07 C Conductivity of Temperature Instrument Instrument Difference in Solution of Solution Temperature Coefficient Display Values mS cm C I C mS cm 14 00 37 0 2 07 14 00 0 00 14 00 37 0 1 97 14 17 1 21 Thus our example illustrates that the user must set the temperature coefficient correctly in order to ensure accurate measurements
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