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User Manual - IBP Medical

1. 15 Appliance of temperature Coefficients 15 Temperature compensation in 17 Temperature frieasuremeht ag none E a 19 Seeds Stee er ER RE da Le Fa MAX RR Re une 19 2 eee E EAR ANE TR LR e ERR ER RUMBA RERO ARR Ehud aes 20 mE 20 Fundamental information about 20 Stopwatch TIME R es 21 Flow meas rement eet eeoa D eed a ae aiaa 21 eno es rada puta xa avi a e nna 22 Adj stment and Gallbratlo eire mee eue Due Das di cn ism tes 23 Adjustment and Calibration 5 sees Focal ede Ete eate 23 c 23 ede de desea eed eel ted degunt 23 General sni ELE 23 Handling of Reference Solutions oii e ee e e d e e eee dee e d e Ela ed 24
2. HDM97 Pocket 24 Month pH Probe 6 Month from date of delivery note The warranty does not cover Disposable parts as battery or pH electrode e Annually calibration e Cell cleaning e 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 warranty 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 Gmb
3. F leads to channel dependent special functions H D M 9 7 pocket Key a to tare the pressure transducer The keypad layout is shown in the left picture The keys F and a 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 Cw p Q setting These functions become available when the symbols shown in the right picture appear at the bottom of the display ESC Cancels the current setting or selection and returns to measuring mode Decreases a value or selects the previous option in a menu or a setting Increases a value or selects the next option in a menu or a setting BD 4 Applies a value or a selects an option in a menu or a setting General 10 Switching on the instrument The instrument is switched on and off by pressing the key Display test during start up Immediately after switching on the instrument the display shows all m possible segments dark for two seconds Compare the display with Oe SRB SRR the picture on the right side Do not use the instrument further if you ype discover any missing segment because wrong values could be eater displayed which may lead to misreading 48 5 mmHg The content of the display must be shown exactly like this picture H H H H B usicm right from
4. IPXI IP66 max 0 5 m immersion depth max 5 min 165 x 82 x 33 mm 400 gr without battery charger including conductivity temperature probe These technical data may be changed without notice 33 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 Value Baud rate 9600 bps Data bits Parity Stop Bit Handshake Interface 34 Driver installation example for Microsoft Windows XP Service Pack 2 1 Insert the Installation CD in the CD Found New Hardware Wizard or DVD drive of your computer Welcome to the Found New Hardware Wizard 2 Connect the HDM97 Pocket via the USB cable with a lingo crt onthe adea riam D rn free USB port of the running computer It does not matter whether the instrument is switched on or off software Yes this time only 3 A Found New Hardware Wizard Window will O Yes now and every time connect a device P No not this time appear on the screen like that right here from the text Click Next to continue 4 Choose No no
5. 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 Conductivity Once per year Pressure Once per year Flow Once per year pH 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 it 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 29 Maintenance Tolerances For calibration the instrument must meet the deviations listed below Channel Reference Value Allowed deviation Notes 25 00 C 0 05 2 34 00 9 0 05 C 37 00 C 0 05 C Temperature 5 40 00 C 0 05 C Conductivity 55
6. 04 11 2009 Update Flowsensor Cleaning This manual is only valid for the software revisions listed below HDM97 BL HDM97 BM HDM97BN HDM97BO HDM97 BP HDM975BO HDM97BQ IBPView V 2 00 V 2 00 V 2 00 V 2 00 V 2 00 V 2 00 V 2 00 V 2 00 2 19 2 19 2 19 2 19 2 19 2 19 2 19 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 Flow 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 completel
7. Adjusting the HDM97 Pocket eese essen esee nnns nnns nnns ent 24 Maintenance of 97 27 TROUDIESNOOUING ius cU ORE 30 EE 31 33 USB en cea Dee cod 33 Interface parameters for serial COM port 33 Driver installation example for Microsoft Windows XP Service Pack 2 34 Exaiple icm dete iia heh ea ek et E ah Meo de ee phate d 36 37 M hi udulsissdls 37 aire m 38 E e a 38 Disconnect 5 2 t ee etie etia a text eia atate 38 RM 38 selecting hardWare Lebe rte EE reet cent docte decanted t een recte 39 Assigning graphs to hardware channels sse ener ener nennen nnns 40 LIStOF elata I RE EET TE EEE E E S 41 Introduction Introduction The HDM97 Pocket meter s
8. 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 starts flashing the battery is totally empty and the meter will switch off shortly UO amp Battery aging The battery technology of the HDM97Pocketis based on Lithium 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 Base Installation 12 Basic settings To invoke the installation menu please follow the steps below 1 Switch off the meter using the key 2 Switch it on again using the same
9. 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 27 Maintenance Maintenance of HDM97 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 HDM97 Pocket 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 HDM97 Pocket or the 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 month for one hour to avoid exhausting the batteries Cleaning Never clean the device with
10. 0 5 000 K 2 070 K Adjustable 0 5 000 K 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 Temperature Meter Difference Conductivity of solution Temperature of solution coefficient in values of meter display mS cm C mS cm Which temperature coefficient 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 Adjustment and Calibration 18 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 The HDM97Pocket is able to apply dynamic temperature coefficients It supports a set of 2 coefficients for 25 C and 37 C respect
11. 00 C 80 00 C 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 General BM amp Opt H 1900 00 mmHg 1500 00 mmHg 2 mmHg 2 mmHg 1000 0 mmHg 300 0 mmHg 0 5 mmHg 200 0 mmHg 0 5 mmHg 100 0 mmHg 0 5 mmHg 0 0 mmHg 0 5 mmHg Open inlet 100 0 mmHg 2 mmHg 400 0 mmHg 2 mmHg 600 00 mmHg 2 mmHg 355 2 mV pH 1 AE 59 2mV ApH 177 6 mV pH4 AE 59 2mV ApH 118 4 mV pH5 AE 59 2mV ApH 59 2 mV pH6 AE 59 2mV ApH 0 mV pH7 AE 59 2mV ApH 59 2 mV pH 8 AE 59 2mV ApH 118 4 mV pH9 AE 59 2mV ApH 177 6 mV pH 10 AE 59 2mV ApH 355 2 mV 14 AE 59 2mV ApH Troubleshooting 30 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 is 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 proble
12. Volts to 3 Volts with respect to BNC Shield Applying any voltage beyond these boundaries will possibly destroy the instrument Flow This connection 15 designed to be used with the HDU FLOW probe only Do not connect any other devices to this port even when the connector may fit General 8 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 HDM97 Pocket 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
13. and Calibration 22 The head line of the display shows the measuring unit ml min and after a space the unit for the accumulated value as for liter In the middle line the flow in ml min and in the bottom line the accumulated value in liter is shown For high accuracy measurement we recommend to rinse the flow sensor with 100 ml min RO water for 15 min Reset accumulated value The accumulated flow value can be resettled at any time following the procedure below Procedure 1 Press and hold down the key a until the upper display line shows ZERO this will take three seconds 3 The accumulated value is not set to zero Attenuation of reading The reading of the current can be attenuated With button the selection menu can be called Values up to 180 can be selected The selected value represents the time in seconds during the values are averaged 23 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 consequence these false values lead to hazards for patients Definitions Adjustment An adjustment is a process in which properties of a measuring device are changed 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 de
14. high precision pressure transducer is not waterproof The meter can also measure flow by using the HDU FLOW probe It also has the pressure drop measurement and the timer function built in 7 General Measuring Channels Only use accessories provided with the HDM97 Pocket 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 Standard precision pressure transducer This pressure transducer is watertight However it is recommended to keep fluids away from the sensor because residues like salt can falsify measurement results In this case the sensor needs to be flushed with deionized water High precision 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 Never flush the sensor Pressure drop measurement This is not a real channel it is a function for measuring pressure loss in systems for s specified time Timer This is not a real channel it is a function to help performing anything where time is a crucial element 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
15. key 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 Parameter Meter Versions Description AUTO OFF All Set the delay time fort he auto power off function or disables it BEEP enables disables the keypad acknowledge beep CAL RES All Overwrites the user calibration dataset with the device initial calibration dataset LANGUAGE Adjusts the display language CP gt AUTO OFF La OFF disables function fk 30 MIN 30 minutes delay May 60 MIN 60 minutes delay i 90 MIN 90 minutes delay Then to apply and save this setting to discard this setting 7w BEEP a ON keypad beep enabled ay OFF keypad beep disabled fl Then to apply and save this setting or to discard this setting 13 Base Installation Py CAL RES 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 performes a restart afterwards Cw LANGUAGE 4 DEUTSCH german language tb ENGLISH english language Then to apply save this setting Or to discard this setting a ON stopwatch function enabled La OFF stopwatch fun
16. part of the appliance part Flow through adapter for conductivity and temperature measurement The adapter is suitable for measuring pressure temperature and 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 HDM97 Pocket is accomplished by the lateral connection above the inlet Before measurement it is necessary to shake the adapter slightly so that air bubbles trapped inside can pass off through the outlet Screw cap 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 Dialysate Never touch the electrode surfaces with your pee fingers or other objects Do not buckle the cable of the probe The minimum allowed bending radius is 3 cm e g 1 inches 9 General 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 E E
17. terat rut Lu dioere LIN 5 Product OVervleW 2 a Lee A ao aeae aaa d e HI IL NE 6 The versions at a glance x eee pte e mene ette i pene eee eer edi Reed 6 Measuring Chanriels 4 et epi ne pte dg Nee RR I eee D der E ds 7 od eot p ita REO Ie ERU ORO E aig roce 8 Performing measurements while the battery is being 8 Flow through adapter for conductivity and temperature 2 000000 8 MERC 9 Switching ori the instrument esate 8 222 utin eo ear da ete be dol a ad este getan 10 Display test during startup n eo IP edere ie ero e PA dero i PR EL Pe eee 10 Power saving TUI ctione i dtr ero Ue deed ero i Lt Leider 10 Displaying battery charge progress and ene nee 10 Battery gauge display during 11 Battery AGUNG ms cette petes 11 Battery replacement ONLY BY MANUFACTURER seen nennen nennen nennen nn nnne 11 Value adjustimiert er EL or e DU Le e i C e RU reete ed 14 15 Conductivity and temperature 15 Fundamentals of temperature
18. 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 commonly used temperature coefficient for dialysates is 2 07 K 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 Adjustment and Calibration 16 Temperature compensation Temperature compensation using a single temperature coefficient A single temperature coefficient is used for calculating the conductivity value at the common reference temperature from the actual measured conductivity and the actual measured temperature In order to use one single temperature coefficient the values for 25 C and 37 C must be the same Dynamic temperature compensation Dynamic temperature compensation is achieved by calculating a temporary temperature coefficient for the measured temperature using a set of two coefficients for 25 C and 37 C respective This temporary temperature coefficient is then applied to the actual measured conductivity to calculate the conductivity at the common reference temperature The following table shows the usage of dynamic temperature coefficients applied to a NaCl solution of 14mS cm Temperature Conductivity NaCl 14 mS cm Temperature Conducti
19. this text n amm n amm n mS cm ESC cC Aa OK Power saving function The HDM97 Pocket switches off automatically if the battery is empty If enabled it also switches off after a specified time if one of the conditions listed below becomes true for the specified time period e n pressure mode The value remains 0 for the specified time period e Inconductivity mode The conductivity is 0 us cm for the specified time period In pH mode The pH probe is not connected for the specified time period The HDM97 Pocket does not switch off when one of the conditions below are met Acomputer is connected to the meter The TIMER stopwatch is running regardless if displayed or hidden Displaying battery charge progress and finish If the battery 1s 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 ALIS FS ni mix b 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 Al gt y v 11 General 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
20. 1 mmHg Otherwise 2 mmHg Fluid resistance yes Pressure only Version BM and Option H for BQ Version Units mmHg kPa mbar PSI Range 700 1900 mmHg 2 5 Bar Resolution 0 01 mmHg Accuracy 0 300 mmHg 0 5 mmHg 301 1000 mmHg 1 mmHg Otherwise 1 mmHg Fluid resistance no pH only BP Version Range pH 0 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 leakage current typ 2 fA max 2 pA Temperature compensation with temperature measurement or preset values to choose from Flow only version BL and BQ Range 100 2500 ml min Resolution 1 ml min Temperature range 0 859 Accuracy 100 250 ml min 3 from current value otherwise 3 from upper range value Interface 32 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 Max charge voltage Capacity Battery charge time Device use time External power supply Input voltage Output voltage current Plug Degree of protection Meter Conductivity probe Size and weight Size Weight 3 7 V 4 2 V internally generated an monitored 850 mAh or 3 1 Wh approx 3 hours estimated 40 hrs displaying conductivity up to 120 hrs stopwatch USB not connected 100 240 V AC 50 60Hz 5 V DC 500 mA min Mini USB A Plug
21. Back Next gt Cancel Hardware Installation The software you are installing for this hardware Windows Logo Test Choose Continue USB lt gt HDM Interface Anyway has not passed Windows Logo testing to verify its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the correct operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the hardware vendor for software that has passed Windows Logo testing Continue Anyway STOP Installation 35 Interface 8 The driver installation is in progress This can New Mizar take a couple of minutes Please wait while the wizard installs the software e USB HDM Interface i 9 The driver installation was successful click on 777777 the button Finish to complete the Completing the Found New procedure Hardware Wizard The wizard has finished installing the software for 2 USB lt gt HDM Interface Click Finish to close the wizard 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 is for the COM port emulation the other installation is for the USB interface itself Checking the driver installation optiona
22. F the user can choose the temperature coefficient Fundamentals of temperature compensation Definition Electrical Conductivity Electrical conductivity or specific conductivity is a measure of a solution s ability to conduct an electric current Electrical conductivity of electrolytic solutions is strongly dependent on temperature In order to compare electrical conductivity measurements at different temperatures they are standardized to a common reference temperature This common temperature is 25 C The dimension unit commonly used is mS cm at 25 C Common temperature The common temperature is the temperature at which non compensated conductivity measures and compensated conductivity measures have the same value Temperature coefficient The temperature coefficient is the relative change of the solution s conductivity depending on it s temperature standardized to a common reference temperature The dimension unit of this value is measured in K Appliance of temperature coefficients 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
23. H General 6 Product Overview 97 97 Flow Pressure 97 97 Conductivity Pressure Conductivity Temperature Temperature HDM97 HDM97 pH Pressure Conductivity Flow Pressure Conductivity Temperature Temperature The versions at a glance HDM97sL This version is suited for usage with a HDU FLOW Sensor and is also equipped with a timer function HDM97 8m This version is equipped with a high resolution pressure transducer has a pressure drop measurement function and a timer function The high precision pressure transducer is not waterproof 97 This version is equipped with the conductivity temperature probe It also has the timer function built in HDM97 This version is equipped with the conductivity temperature probe and a standard precision water proof pressure transducer It also has the pressure drop measurement and the timer function built in HDM97 8P This version is equipped with the conductivity temperature probe and a standard precision water proof pressure transducer It also has the pressure drop measurement and the timer function built in It can also measure pH with standard pH sensors 97 This version is equipped with the conductivity temperature probe and standard precision water proof pressure transducer The high precision pressure transducer is available as Option H for this version This
24. M97BO HDM97BP HDM97BQ HDM99XP Product Code 31 0XXX XX X Depending on Version meet the provisions of the Council Directive 93 42 EEC concerning medical devices which apply to them IB Medcert GmbH Vorsetzen 35 20459 Hamburg 0482 Responsible Dipl Ing Werner Pfingstmann Delivery Delivery Content Description Version Standard Option HDM97 Pocket meter BL BM BN BO BP BQ Conductivity Temperature Probe BN BO BP BQ v Dialyser Line Adapter BN BO BP BQ Hose for pressure measurement BM BO BP BQ 14 00 mS cm Conductivity Reference Solution BN BO BP BQ Battery charger with wall plug adapters All USB interface cable All CD HDM97Pocket with USB drivers Software and User Manual Safety instructions and quick start guide All Flow Sensor BL S T Flow Sensor BQ pH Probe with buffer solution pH6 7 and 8 BP Carrying case Holder Infusion pole CD IBPView Data Acquisition Software 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 for the remaining warranty period only The user must deliver at its own expense the product to IBP Medical GmbH Parts Warranty Period
25. MBP HDM97Pocket Reference Meter Series User Manual HDM97BL HDM97BM HDM97BN HDM97BO HDM97BP HDM97BQ 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 2009 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 1 865 686 8650 49 511 652284 1 866 243 0187 http Awww ibpmedical com http www ibpmedical com support ibpmedical com america ibpmedical com Dipl Ing Werner Pfingstmann Holger Kleinert DHDM97 0220 01 Rev 0 Rev 1 Rev 2 Rev 3 29 05 2008 18 03 2009 Update Hard und Software release 2 0 01 10 2009 Update Flow sensor
26. 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 38 Installation Insert the CD IBP View 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 On the CD HDM97Pockef 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 IBPView software Disconnecting with running data acquisition may end in a system freeze Main Window File Options Page Hardware n Wn I 5 C XQ DM Setup Start Stop Pause Zoom Interp Follow Marker Special Previous K X Y Y Print Export Copy Plotter 11 06 00 11 08 00 11 10 00 General This manual describes only the basic functions which are necessary to get familiar with IBPView Further information can be obtai
27. 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 Caring for the flow sensor After use make sure to rinse the flow sensor with deionized water for a couple of minutes Please clean the inlet filter on a regular basis Maintenance 28
28. ction disabled Then to apply and save this setting Or to discard this setting Cw PHT pressure hold test MM increases the value lowers the value Then to apply and save this setting Or to discard this setting At ON pH enabled tb OFF pH disabled Then to apply save this setting Or to discard this setting Cw FLOW only available with version BQ ay ON FLOW enabled tb OFF FLOW disabled disabled Then to apply save this setting Or to discard this setting a ON sole readout of temperature enabled La OFF sole readout of temperature disabled Then to apply and save this setting Or to discard this setting Base Installation 14 w gt EXIT A save dialog will appear if changes have been made SAVE i YES to apply and save all settings by exiting a NO to discard all settings by exiting Then to exit the basic settings dialog Or to return to the basic settings dialog Value adjustment The adjustment of values is done via the navigation keys fm and W 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 showing a value which has an a
29. e Ordner 7 Kommunikationsanschluss 1 9 z Lokale Benutzer und Gruppe Kommunikationsanschluss 2 Windows System Manager and than the 590 48 Leistungsprotokolle und War lt gt HDM Interface COM4 Device Manager Under group Conncetions JS Ger te Manager Audio Video und Gamecontroller COM and LPT you should find the port x 3 After this the device 18 displayed in the Supported hardware devices Existing hardware devices right box Other hardware devices can be added if needed Click on OK to close the window IBP Universal E Multimeter Data Translation Miscellaneous Drag amp Drop existing devices to use to the list on the right y Setup Delete IBPView 40 Assigning graphs to hardware channels 2515 File Options Page Hardware 5 Wu R ee UN a EP Setup Start Stop Pause Zoom Interp Follow Marker Special Previous X X Y Y Print Export Plotter CEIS mS cm 10 02 00 10 04 00 10 06 00 1 Conductivity Temperature H Pressure 10 Page 1 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 Cannel configuration picture in the 1 pPen properties Select hardware c
30. e 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 this function there must not be any pressure on the pressure transducers inlet This 1s 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 a until the upper display line shows ZERO this will take three seconds 3 The measuring value is not set to zero Adjustment and Calibration 20 Pressure drop measurement In pressure measuring mode the drop measurement function can be invoked by pressing the F key Display PRESS 60 60 means 60 seconds countdown 406 2 start value example Keys 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 ESC 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 PRESS 00 400 0 example value after 60 second countdown 6 2 example internally stored start value end value after 60 seconds Key Returns back to normal pressure measurement pH measurement The HDM97 Pocket can perform pH measurement in four different ways of
31. ead 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 is 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 the same time for at least 5 seconds If you want to cancel the operation press navigation key LESC Temperature Temperature adjustment is done using 2 sampling points The order of the adjustment points is preassigned and the value range of each point is restricted by boundaries Point Display Temperature Boundaries 1 TP1 25 000 C 1 500 C 2 TP2 55 000 C 1 500 C Normally an adjustment is not necessary because the sensor has no drift The temperature sensor must be dipped into a liquid with known temperature This known temperature must be adjusted using the navigation keys and WW 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 I
32. epare 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 afi and 79 navigation keys Before dipping the probe into the buffer solution it has to be flushed with distilled water and dried by carefully dabbing it 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 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 failed adjustment can also be an outcome 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
33. er temperature coefficient set ESC cancel and discard setting Display EDIT 37 00 C Temperature associated with the coefficient 2 071 K Example 2 070 navigation key df has been pressed once Keys increments current value Py gt decrements current value Applies the value and leads to the adjustment dialog for the second pair Discard adjustment and goes on using the last active temperature coefficient setting 19 Adjustment and Calibration Display EDIT TC2 25 00 C Temperature associated with the coefficient 2 001 K Example 2 000 navigation key has been pressed once Keys increments current value Py decrements current value Applies the coefficient set The displays shows ADJ OK for 2 seconds Discard adjustment and goes on using the last active temperature coefficient setting Temperature measurement This mode is only available if 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 kPa and PSI 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 pressur
34. eries 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 5 acquisition channels Channel HDM97 BL HDM97 BM HDM97 BN HDM97 BO HDM97 BP HDM97BQ Conductivity Y Temperature v Timer v Pressure pH Flow 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 optional Software IBPView Using the USB communication interface it 1s 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 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 18 04 09 IBP Medical GmbH Ikarusallee 15 30179 Hannover declare under our sole responsibility that the following products Dialysis Reference Meter Version HDM97BL HDM97BM HDM97BN HD
35. hannel middle You can change Name Basic conductivity color a units Decades Ranges much more wah Channel 1 By clicking on the button Assign you gasicunit Seme Channel 3 can assign each graph a hardware channel Bem Channel 4 like shown in the picture right Decade Np m Milli EN Automatic Min fio mSjcm For conductivity please use the base unit S cm and select for example m milli as sceleneous Decade to show the values in mS cm Differential vales Inertia Factor fi Source Hardware C Calculation 41 IBPView List of channels Depending on the version the HDM97 Pocket is equipped with up to 4 channels E HDM97 HDM97 HDM97 HDM97 HDM97 HDM97 Ch Description Range Unit BL BM BN BO BP BO 1 Conductivity 0 000 30 00 mS cm 2 0 00 100 00 C V Y Y 3 Pressure 750 0 1900 mmHg Y 4 Y Y 4 pH 0 14 00 without if not disabled Y 4 Flow 0 5000 ml min Y If not disabled 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
36. he 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 HDM97 Pocket Selecting hardware xl Supported hardware devices Existing hardware devices 1 Click on Hardware in the main window and choose menu entry Define Then a window named Hardware configuration like that right from this text will open Open in the left box Supported hardware devices the group IBP click on the entry IBP Universal and then drag and drop it to the right box Existing hardware devices Multimeter Data Translation Miscellaneous 81 9 EH Drag amp Drop existing devices to use to the list on the right Help 2 After the drag and drop procedure a window opens which be used to set the x number of the serial COM port and the number of channels for the instrument For M coms a HDM97BP four channels are possible In case the pH channel is disabled in the plns 24 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 aj odes 150 B K System tuu B 7 Anschl sse und LPT To find out which COM Port the USB H il Ereignisanzeige ECP Druckeranschluss LPT1 Driver has selected please select the 8 Freigegeben
37. ive If only one temperature coefficient is needed it is necessary to set both the coefficient for 25 C and for 37 to the same value Displaying the temperature coefficient set To show the current temperature coefficient set press the function key while in conductivity mode The temperature coefficients are shown with their respective temperatures alternating every 3 seconds The upper line shows the name of the temperature coefficient set the middle line shows the temperature and the lower line shows the temperature coefficient associated with the temperature above If a single temperature coefficient is used the values in the lower line are the same The HDM97Pocket 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 key while in Conductivity Temperature measuring mode Use the and WW navigation key to select between the machine manufacturers By pressing the navigation key 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 navigation key 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 USER TC enters the dialog to adjust the us
38. l The USB interface of the HDM97Pocket emulates a serial COM port and offers a proprietary interface to communicate directly with the USB interface z Use the My Computer Manage function to open the 5 8 Performance Logs and Alerts 5 27 Ports COM amp LPT Device Manager and search for a Group called Ports 29 Device Manager Communications Port COMI COM and LPT You should find an entry called B5 Storage a 5 i Removable Storage ECP Printer Port LPT1 USB lt gt HDM Interface At the end of the line you Disk Defragmenter E USB lt gt HDM Interface COM3 will find the number of the associated COM port in this case COM3 e Universal Serial Bus controllers In addition you will find the USB communication interface in the Group USB USB lt gt HDM Interface Controller It is named USB lt gt HDM Interface VSB ROGE HO Interface 36 Data transfer To receive measurements from the HDM97 Pocket via the USB interface the following abbreviations must be sent via the interface The entire communication takes place in readable ASCII characters Command Reaction to HDM97 Pocket of the HDM97 Pocket HDMCMO activates the data transfer HDMCMF deactivates the data transfer HDMEIH transmits all units val transmits the values Format of the values Conductivity in S cm 9 signs Temperature in C 7 signs Pressure in mmHg 9 signs pH 5 signs only version BP Flow in ml min 5 sign
39. llowable range from 0 00 to 7 50 Display 0 00 navigationkey is hold down Order of value incements every change follows with a delay of 0 3 seconds 0 01 gt 0 02 gt 0 03 gt 0 04 gt 0 05 gt 0 06 gt 0 07 gt 0 08 gt 0 09 carry over 0 10 gt 0 20 gt 0 30 gt 0 40 gt 0 50 gt 0 60 gt 0 70 gt 0 80 gt 0 90 carry over 1 00 gt 2 00 gt 3 00 gt 4 00 gt 5 00 gt 6 00 gt 7 00 gt 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 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 WF key 15 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 only Version BN BO BP BQ e Temperature Display TEMP only Version BN BO BP BQ if enabled e Pressure Display PRES only Version DA BO BP BQ e pH Display PH only HDM97BP if enabled e Flow Display FLOW only HDM97BQ if enabled e Timer Display Time 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
40. ms 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 34 Interface Technical data Conductivity 0 to 30 0 mS cm 4 Pole probe Resolution and accuracy Range Resolution Accuracy 0 0 200 uS cm 0 1 uS cm t 0 6 uS cm 201 1999 uS cm 1 uS cm t 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 only versions BN BO BP and BQ Range 0 100 C Resolution 0 01 C Accuracy 25 40 C 0 05 C otherwise 0 1 C Pressure BO BP and BQ versions fluid resistant ceramic sensor Units mmHg kPa mbar PSI Range 700 1900 mmHg 2 5 Bar Resolution 0 1 mmHg Accuracy 0 300 mmHg
41. n 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 25 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 to the HDM using the navigation keys and WF 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 val
42. ned 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 HDM97Pocket 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 driver 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 39 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 t
43. nt is done by using two sampling points 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 Adjustment and Calibration 24 Handling of Reference Solutions IBP Medical standard solutions are produced under ISO13485 2003 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 Keep solutions tightly capped to avoid evaporation Do not return used solutions to the storage bottle Do not remove solutions from their original bottle Keep the solutions a cool place Use only fresh reference solutions for calibration and verification e Use the solution immediately after pouring evaporation will cause errors Discard solution the appropriate number of days after opening the bottle 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 l
44. 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 currents 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 21 Adjustment and Calibration Stopwatch TIMER If enabled in the basic settings menu this works as a stopwatch By pressing the key e g the stopwatch 18 being started by pressing it again it is being stopped Pressing the key a third time resets the shown time to 00 00 00 and the stopwatch can be used again TIMER die display changes to MM SS DS automatically after 2 seconds MM SS DS 00 00 0 lt tenth seconds T 1 1 seconds minutes After 59 minutes and 59 9 seconds the display form changes so that hours minutes and seconds are being displayed The tenth second display is not available then After 9 hours 59 minutes and 59 seconds the stopwatch stops itself HH MM SS 0 00 00 lt seconds T minutes hours Flow measurement This mode is available only if a flow sensor is connected The flow sensor must be connected with the interface shown in the picture below Please make sure to connect fluid correctly the sensor The sensor has a label showing the flow direction Sensor Out Filter Sensor In Adjustment
45. s only version BQ CR LF 2 signs The separation of the values is done by using Example Command HDM97BP sends 0 1234567 123 123 12345 12 12 12 CR LF Command HDMEIH HDM97BP sends S cm C mmHg pH CR LF IBPView 37 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 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
46. t this time and afterward click on the button Next Found New Hardware Wizard 5 Driver source selection dialog Choose Install from a list or specific location Advanced and click on the Next button afterwards This wizard helps you install software for USB lt gt Interface If your hardware came with an installation CD or floppy disk insert it now What do you want the wizard to do O Install the software automatically Recommended Install from a list or specific location Advanced Click Next to continue lt Back Next gt Cancel Found New Hardware Wizard 6 Choose Search fort he best driver in these Please choose your search and installation options locations and check Include this location in the M Search for the best driver in these locations search Then use the Browse button hk ei i nh ich choose your CD DVD drive s letter and add the folder 5 ps Dh p 6 6 2 2 earch removable media floppy CD I drivers to it In the given example on the right side e the CD DVD driver has drive letter D assigned Divas Y O Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that Click on the Next button afterwards the driver you choose will be the best match for your hardware lt
47. temperature compensation By pressing the key you can choose between these four compensation modes pHat20 C Display PH 20 0 C pHat25 C Display PH 25 0 C pHat37 C Display PH 37 0 C pH compensated 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 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
48. ues 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 Point Display Pressure Boundaries 1 1 500 mmHg 10 mmHg 2 2 250 mmHg 10 mmHg 3 PR3 0 mmHg 10 mmHg 4 PR4 150 mmHg 10 mmHg 5 PRS 300 mmHg 10 mmHg 6 PR6 900 mmHg 10 mmHg 7 PR7 1500 mmHg 10 mmHg Conductivity The adjustment of the conductivity channel is done by adjusting the cell parameter To achieve this only one adjustment point is necessary Point Display 1 CD xx xx Cell parameter Initial Conductivity 14 000 mS cm 0 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 After that the cell parameter is being calculated and will be stored in the instrument Adjustment and Calibration 26 pH It is necessary to adjust th pH channel before each usage It is achieved using two adjustment points Point Display Initial pH value 1 PH1 6 00 2 PH2 8 00 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 Pr
49. vice 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 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 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 adjustme
50. vity without compensation coefficient Readout 25 C 14 00 mS cm 2 000 K 14 00 mS cm 31 C 15 71 mS cm 2 035 K 14 00 mS cm 17 48 mS cm 2 070 K 14 00 mS cm The values 2 00 K at 25 C and 2 07 K at 37 C are defaults for the respective dialysis machine or values entered by the user For demonstration purposes the temperature coefficient for 31 C is mentioned which is calculated by the HDM97Pocket from the values for 25 C and 37 C by linear interpolation 17 Adjustment and Calibration Temperature compensation in dialysis 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 Display Maschine Manufacturer Temperature coefficient at 25 C Temperature coefficient at 37 C BAXTER Baxter Europe Machine 2 200 K 2 200 K BELLCO Bellco 2 000 K 2 100 K B BRAUN B Braun 2 000 K 2 100 K FRESENI Fresenius 2 000 K 2 100 K GAMBRO Gambro AK Type Machines 2 000 K 2 070 K GAMBRO Gambro Phoenix 2 000 K 2 070 K HOSPAL Hospal 2 000 K 2 070 K NIK ALL Nikkiso Overall Conductivity 2 050 K 2 050 K NIK BIC Nikkiso Bicarbonate Conductivity 2 200 K 2 200 K STANDARD USER TC 2 000 K Adjustable
51. y 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 potentials 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 To T sra 2 sse ES 2 EC DECLARATION OF CONFORMILIT Y 5 eurer ritu rauco erae aaron ac anne e sy ang oue ame nir a aaa panna S pus 3 der ee 4 iU dre cb e

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