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Osmomat 030

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1. D Upper front panel L Middle front panel m Lower front panel a e Eonnlees a ns U Figure 2 Front view of the OSMOMAT 030 Overview of the OSMOMAT 030 11 2 Overview of the OSMOMAT 030 MOTOR button to test the operability of the initiation needle Power connector Power switch 1 on 0 off Fuse holder for two phase protection of main power supply gt Figure 3 Rear view of the Osmomat 030 2 2 Power Supply RESET button for resetting the 4 microprocessor Rating for the mandatory hardware protection Nameplate including serial number voltage frequency and power input The standard model is supplied with 220V 30V at 50 60Hz The power consumption is 120VA Special models using 110V or 100V are also available 2 3 Dimensions and Weight Dimensions width x depth x height Weight 12 Overview of the OSMOMAT 030 220x205x360 mm approximately 7 kg 3 Setup and Initial Operation 3 Setup and Initial Operation The unit must be placed in a location free from vibrations and protected from direct sources of heat such as sunlight heaters or furnaces The ambient temperature should be between 10 C and 35 C 50 95 F Do not block the air intake openings on the bottom of the unit Use the power cord provided to connect the OSMOMAT 030 from the power connector on the ba
2. ccceceeeeeeeeeeeeeeeeeeeeeeeeeeneeeeeeseeeeeeeseeeaeeeseenaeeeteenaees 33 Using the Correct Measuring Vessel uuuensnnesensnnennennnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnsnennnnnn nn 34 Intended Use 22 een ano nee ern nee 34 Specificationwiscsa wee heres we ie iR a eel ee 34 Forfeiture of Measurement System Warranty uueennessssnnnneesnnnnennnnnnnnnnnnnnn nennen ernennen nenne nennen 34 OplIoNns a nee ed OSMOMAT 030 D with Built In Printer n04244444444Hanennnnnnnennnnnnnnennnnrnnennennnennnnnn 35 Design and Function of the OSMOMAT 030 D uuuesssnnnnensnnnnnnnnnnnernnnnnn nennen ernennen rn 35 Overview of Display and Connectors uuusrs4nunnnsnnnennnnnnnnnennnnnnnnnnnnnnnnnnn ernennen nennen nnnnnn rn 35 setting the Time and Date 22 een Henne 36 Oper ting the Printer 2 4 22 ee Eee lea naeh Denn Rare Ener 36 Replacing the Printer Paper es an IH 37 Replacing the Ribbon Cartridge mensies un ne 38 OSMOMAT 030 M with 15ul Sample Volume 44ursrsrsnnnnennnennnnnnnnennennnennnne 39 Specifications si 2 Sect a a bade esha EERTELEELTEPEELHRURDELRTEFRPELENBRNTELRFERESFLFERGELTTERBERFEEEISETETRERTTER 39 OSMOMAT 030 RS with Digital Serial Data Output RS 232C nennen 40 Overview of Connector ComponentS nneesssnnnnnesennnennnnnnnnnnnnnnn nennen nenne ernennen nennen ernennen nenn 40 SPECI CALONS ni ee Seed snes fsa een nes Sedat dete bel
3. NaCl Calibration Solutions for Osmometry 9 NaCl Calibration Solutions for Osmometry 9 2 Restrictions on Use of the Calibration and Reference Material The calibration and reference material may not be used to clean contact lenses or the like The calibration and reference material may not be used in human injections or infusions neither in its pure form nor in mixtures with human bodily fluid samples The calibration and reference material may not be used to calibrate or create samples of chemical or biological origin for administration into the human body 9 3 Composition Calibration standard 300 850 2000 mOsmol kg and OSMOREF 290 mOsmol kg NaCl H2O 300 850 2000 290 mOsmol mOsmol mOsmol mOsmol Sodium chloride Ph Eur USP 9 448 kg 27 178 kg 63 960 kg 9 124 kg Water for injection purposes as bulk Ph Eur USP ad 1000 ad 1000 ad 1000 ad 10001 For precise concentrations see the analysis certificate on the package insert of each batch 9 4 Safety and Handling Information The calibration and reference material is not a dangerous substance according to EC Directive 67 548 EEC Poison class Switzerland F no poison class German water hazard class WGK nwg not hazardous to water Storage class German association of chemical industries VCl 10 13 miscellaneous liquids and solids Disposing of materials according to GLP institutio
4. 79 97 0 1858 0 3716 0 5574 0 7432 0 9290 1 1148 1 3006 1 395 1 5793 2 23 3 35 3 7 16 4 65 Table 7 NaCl solutions for osmometry based on Geigy scientific tables 8 edition 48 NaCl Calibration Solutions for Osmometry Appendix Consumables Article no Article 30 9 0010 Measuring vessel for OSMOMAT 030 30 9 0020 Calibration standard 300 mOsmol kg ampoules of 1 ml each 30 9 0850 Calibration standard 850 mOsmol kg ampoules of 1 ml each 30 9 2000 Calibration standard 2000 mOsmol kg ampoules of 1 ml each 30 9 0290 Reference solution OSMOREF 290 mOsmol kg ampoules of 1 ml each 30 9 1010 Rolls of printer paper for OSMOMAT 030 D 30 9 1020 Endless ink ribbon cassette for OSMOMAT 030 D Accessories and Replacement Parts Article no 30 3 0010 30 3 2010 30 9 0030 30 6 0020 20 9 0160 30 2 0030 20 9 0100 00 9 0104 00 9 0106 20 9 0120 Article Thermistor probe for OSMOMAT 030 50ul sample volume Thermistor probe for OSMOMAT 030 M 15ul sample volume Pasteur pipette bellow 10 pc Initiation needle Data cable for RS 232 interface OSMOMAT 030 050 Adjustment tool Power cord 2 meters Package with 10 fine wire fuses 0 5 A slow 220 V Package with 10 fine wire fuses 1 0 A slow 110 V Connector cable for recorder Appendix Packaging unit qty 1 000 50 10 10 10 Packaging unit qty 1 1 1 Appendix 49 Appendix Classification of the IVD The
5. o gt RS232 port pin assignment Figure 17 RS232 interface with pin assignment 8 3 2 Specifications Baud rate Transmission speed 1200 bits s Data format 1 start bit 8 data bits and 2 stop bits are transmitted Signals TXD Idle level Active level DTR Transmit Data output 3V gt gt U gt gt 7 5V 3V lt lt U lt lt 7 5V Data Terminal Ready output 40 OSMOMAT 030 RS with Serial Data Port 8 Options This signal indicates the transmission readiness of the OSMOMAT 030 i e it becomes active before a telegram is sent Idle level 3V gt gt U gt gt 7 5V Active level 3V lt lt U lt lt 7 5V DSR Dataset Ready input This signal can prevent transmission of a telegram The OSMOMAT starts transmitting only after DSR becomes active The user does not need to activate this signal since it is equipped with an internal 15 k Ohm pull up resistance Idle level 3V gt gt U gt gt 15V Active level 3V lt lt U lt lt 15V 8 3 2 1 Telegram Format A telegram is sent after the completion of each measurement Data is transmitted in the ASCII format Depending on whether the Option D dot matrix printer is activated one of two telegram formats is sent 8 3 2 1 1 Printer is Off or Does Not Exist If the printer option is not installed it is not possible to set the sample number date and time Only the measurement reading is transmitted 8 3 2 1
6. the linearity corresponds to that of the OSMOMAT 030 as described above 2 If you calibrate at 0 and for example 300 and 850mOsmol kg you achieve results with a linearity variance of 1 across a wider range OSMOMAT 030 3P with Three Point Calibration 43 8 Options When the OSMOMAT 030 3P is switched on it displays the mode in which it was last calibrated 1 LED on the CAL1 key illuminates Figure 19 OSMOMAT 030 3P display gt Standard mode 2 point calibration 2 LED on the CAL2 key illuminates Figure 19 OSMOMAT 030 3P display gt 3 point calibration mode 8 5 3 Performing a Three Point Calibration 1 Zero point 1 Press the Zero key 2 Fill the measuring vessel with 50ul of distilled water 3 Run measurement gt Value is automatically calibrated by unit 4 Control Run another measurement with distilled water 2 1 calibration point of 300mOsmol kg 1 Press the CAL1 key 2 Fill the measuring vessel with 50ul of Gonotec calibration standard 300mOsmol kg 3 Run measurement gt Value is automatically calibrated by unit 4 Control Run another measurement with Gonotec calibration standard 300mOsmol kg 3 2 calibration point of 850 mOsmol kg 1 Press the CAL2 key 2 Fillthe measuring vessel with 50ul Gonotec calibration standard 850mOsmol kg 3 Run measurement gt Value is automatically calibrated by unit 4 Control Run another measurement with Gonotec calibration standard 850mOsm
7. Osmomat 030 cryoscopic osmometer manufactured by Gonotec is a non invasive in vitro diagnostic product according to EEC Directive 93 42 Medical Devices Law The Osmomat 030 cryoscopic osmometer is not named in Annex Il list A or B of the Directive 98 79 EEC for in vitro diagnostics Compliance is declared per Annex Ill Number 6 of Annex Il is disregarded as the unit s intended use does not include personal use EC Compliance Statement OSMOMAT 030 Gonotec GmbH Eisenacher Stra e 56 D 10823 Berlin Germany We hereby declare that the OSMOMAT 030 cryoscopic osmometer and its options comply with Directive 98 79 EEC Compliance is declared per Annex Ill of the Directive The CE mark on the unit acknowledges this Date 01 10 2004 Signature of managing director ee Provisions of Certification CE compliance requires that the unit be installed and operated in the manner described in this manual Any departure from the specifications or independent modifications of the unit without the express consent of Gonotec GmbH may result in a violation of CE requirements Such actions invalidate the compliance statement and transfer responsibility to the originator of said actions 50 Appendix Limited Warranty Gonotec product Duration of limited warranty B Software 90 days je Thermistor probe 180 days Osmometer 1 year c Extension of the Limited Warranty Gonotec warrants the end user that Gonotec products shal
8. crystallizes spontaneously and the substances move to the rest of the solution This means that at the time the freezing point temperature is measured the concentration is higher than in the original solution A plateau occurs here as well but it is inclined The osmolality reading is taken at the resulting reversal point Figure 1 Freezing point depression of solvent The temperature is measured with a resolution of 1 858 x 10E 3 C T PC solution 0 Bc Eu nh ln an u nannte hd freezing point depression initiation Figure 1 Freezing point depression of solvent Introduction 9 1 Introduction 1 5 Unpacking the OSMOMAT 030 Cryoscopic Osmometer The cryoscopic osmometer OSMOMAT 030 should be unpacked immediately upon receipt and checked for obvious signs of damage sustained during shipping If any damage is found notify the manufacturer Gonotec GmbH Tel 49 0 30 7809588 0 Eisenacher 56 Fax 49 0 30 7809588 88 D 10823 Berlin Germany E mail contact gonotec com Web www gonotec com Toll free service number within Germany 0800 7846027 The packaging for this equipment was specially designed to ensure safe and hygienic transport The packaging is re usable Please save the packaging in case it becomes necessary to ship the unit back to us for repairs or servicing This will save you the time and money needed to find equally suitable packaging 1 6 Packaging Contents Check to make sure th
9. en a beech baleen seed ced ee en 29 Figure 5 Mounting pl te near rn I Hh aeia eit 29 Figure 6 Thermistor with mounting Plate 4444nnnennennnnnnnennnnnnnnennnnnnnnnnnnnnnnnnnnnnnnn nn nn nn 30 Figure 7 Thermistor probe adjustment along X axis eee eee e center eect ee eeeaaeeeeeeaaaeeeeeeaeeeeeenaeeeeeeaas 30 Figure 8 Thermistor probe adjustment along Y AXIS usunnnennnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnne nn nn nn 31 Figure 9 Replacing an initiation needle oo eee ee eeee ee eeeeneeeeeeaeeeeeeeaaeeeeeeaaeeeeeeaeeesesaeeeeeeneeeeseaas 32 Figure10 Power switch 2 20 2 ack dada nea EEE ni test vlad beans aces 33 Figure 11 OSMOMAT 030 D display u 2244444ssnnnennnnnnnnnennnnnnnnnnnnnnnennnnnnennnnnnennnnnnennnnnnnn nn 35 Figure TA Opening tie Pintor iener aa ee iron Hole ni 37 Figure 13 Correct feed direction for paper roll cccccceeeeeeeceeceeeeeeeeeceneaeeeeeeeeeeseceacaeeeeeeeeeseesnceeeees 37 Figure 14 Incorrect feed direction for paper roll cccceececeeceeceeeeeeeeeeeneaeceeeeeeeesecenaeeeeeeeetseeseceeeeess 37 Figure 15 Printer with paper roll c ccccceceeeceeeeeeeeeeeeeeeseeeeeaaneeceeeeeseeeaaaeaeceseeesesenaeeeeeeeeeseeenseeaeees 37 Figure 16 Replacing the ribbon 444444444HRnnnnnnnnnennnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnn nn 38 Figure 17 RS232 interface with pin assignment u ssunnnesnnnnnnnnn
10. the needle must not extend below the lower edge of the cooling pin If necessary adjust the reflex photosensor by moving it up or down after first loosening the hex socket screws 32 Servicing the OSMOMAT 030 7 Servicing the OSMOMAT 030 Step 3 Align the thermistor probe see chapter 7 5 Step 4 Re assemble the unit and run a check by pressing the MOTOR button on the back of the unit Note Inititiaon needle material stainless steel cold hammered quality diameter 0 6mm 7 8 Replacing a Defective Mains Fuse Y Ya Before beginning work unplug the main power supply Risk of electric shock To replace the fuses use a small screwdriver to remove the fuse holder on the back of the unit The two fuses can now be replaced The unit has two phase protection Use the following fuses 230V power supply 0 5A slow LAG 115V power supply 1A slow LAG One set of fuses is included with the standard accessories W Make sure to re insert the fuse holder in its original position POWER The labels 115 and 230 are printed on either side of the fuse holder The fuse holder must be AN inserted such that the correct voltage indication see nameplate Figure 1 is located underneath the power cord connector A small arrow A Figure 10 Power switch le FUSE points to the voltage setting The picture here shows a setting for 230V A Figure 10 Power switch Servicing the OSMOMAT 030 33 7 Servicing the OSMOMAT
11. tool see Figure 7 Thermistor probe adjustment along X axis then carefully tighten the retaining screws Remove the adjustment tool and re attach the upper cooling system cover with its two screws c If the thermistor probe is off center along its Y axis the lower cooling system must be aligned To align the lower cooling system unscrew the lower face plate and re align the lower cooling system to the center of the thermistor probe by loosening the grub screws hex socket screws and mounting screws hex socket or slotted screws depending on the model on the bottom of the housing Figure 8 E Grub screws Thermistor probe adjustment along Y axis Mounting screws Figure 8 Thermistor probe adjustment along Y axis 7 7 Replacing a Defective Initiation Needle There are various reasons for which it may become necessary to work on the needle bar or even replace the initiation needle See Table 2 Malfunction of the cooling system component group and Table 5 Malfunction of the switch component group Repairs to the initiation needle must be performed by a medical device technician it is not enough simply to be skilled in handling equipment Before working on the initiation needle please ensure the following W Unit power supply is disconnected 77 Risk of electric shock W Unit has been decontaminated especially the initiation needle 77 Risk of injury from the tip of the needle Y In the event of injury from the ti
12. 0 on 7 March 1996 for example input the following on the keypad 0O 8 3 O amp O 7 O 3 ie 1 9 9 6 t amp J J J J J Pressing the TIME DATE key at the end stores the time and date The sample number is set using the NUMBER key 2 Figure 11 OSMOMAT 030 D display and the numerical keypad Setting the sample number 67 for example requires the following keypad entry o O 6 7 M hve The next reading will then be numbered 67 Note The sample number and the sequential number are identical The next measurement will thus be numbered 68 the one after that 69 and so forth 8 1 4 Operating the Printer Press the PRINTER ON OFF key once to switch on the printer If the OSMOMAT 030 D is on the yellow LED illuminates When the printer is switched on for the first time the log header is automatically printed out The measurement results are automatically printed out if the RESULT LED illuminates and the results are saved A sequential number is printed out along with the measurement results Press the COUNTER RESET key to print out a new log header and reset the numbering to 1 Mismeasurements that do not produce a result on the digital display and during which the LED for spontaneous crystallization or no crystallization illuminate are not counted A plain text explanation for the mismeasurement is printed out A tear off edge allows the printout to be t
13. 030 7 9 Using the Correct Measuring Vessel One critical factor affecting the service life and precision of the measurement system is the use of the correct measuring vessel 7 9 1 Intended Use The measuring vessels are intended for single use only Re use of the measuring vessels J can result in non verifiable readings or even a destruction of the measurement system W We are unaware of any reactions between the sample solution and measuring vessel in Y osmometry However we advise against using the measuring vessels for other purposes For information on the material properties please refer to the product safety data sheet MPM 30 9 0010 pdf 7 9 2 Specification The conic shape of the measuring vessel matches that of the lower cooling system This ensures a secure fit a high standard of centricity for the measuring vessel in the lower cooling system and consistent immersion depth of the measuring tip in the sample When the measuring vessel is placed on the thermistor probe a soft clicking sound is heard A and there is a tangible resistance If this is not the case and the measuring vessel does not fit securely it is possible you are using an improper measuring vessel and the measurement results may not be verifiable A Re used measuring vessels also exhibit these characteristics This is because their openings are dilated when they are placed on the sensor 7 9 3 Forfeiture of Measurement System Warranty Dest
14. 2 Printer is On If the printer is switched on the sample number date and time are output in addition to the measurement reading 8 3 2 1 3 Output Format for Faulty Measurements In the event of faulty measurements the cause of the error is output in plain text SPONTANEOUS CRYSTALLIZATION NO CRYSTALLIZATION 8 3 3 Communication Software We recommend using our OSMOTERM software for easy data transmission to PC and data acquisition that is optimized for the equipment In principle any other terminal software can be used but the data format will have to be adjusted OSMOMAT 030 RS with Serial Data Port 41 8 Options 8 4 OSMOMAT 030 A with Analog Data Output 8 4 1 Overview of Display and Connectors fr N Alignment potentiometer for analog port FUSE LA ce lem Analog port pin assignment Figure 18 Analog interface with pin assignment 8 4 2 Specifications Output voltage 1mV 1mOsmol Maximum output 14 V Minimal load resistance R 4 7 kOhm The output voltage is independent of the storage function of the RESULT display The recorder cable that is included is intended only for the analog output output port pin 2 and pin 4 Figure 18 Analog interface with pin assignment The output voltage of the analog output can be aligned with the alignment potentiometer for older flatbed recorders 42 OS
15. 4 Enclose written information explaining the reason for returning the equipment 5 Ifthe equipment is being returned for credit you must include all accessories power cord software discs manuals etc 6 Return the equipment in its original packaging If you no longer have the original packaging you may purchase a replacement from Gonotec Before Calling Gonotec Note When calling Gonotec have your unit s serial number ready The serial number helps our service technicians to more quickly record the unit and determine a procedure If possible switch on the unit before calling Gonotec s technical service Use a telephone that is close to the unit You may be asked to provide detailed information while running operations or apply other troubleshooting methods that can only be performed on the unit itself Ensure that you have the equipment documentation handy Warning Before undertaking any work on the equipment read the safety notices in the appropriate chapters of this manual Tel 49 030 7809588 0 freecall Germany only 0800 7846027 52 Appendix OSMOMAT 030 Upgrade Options The following useful options enhance the practical value of the standard model and can be factory installed for an additional Appendix price Option D Built in dot matrix normal paper printer for automatic recording of the measurement results with user defined four digit sample numbering date and time The OSMOMAT 030 D ensure
16. 47 9 4 Safety and Handling Information urnesnnnnnnnennnnnnnennnnnnnnennnnnnnnnnnnnnn man nnnnnnn nn 47 9 5 Storage and shelf ite Ans ee Hr ran Ha Io ee 48 9 6 Use of Other Calibration Solutions 22444444400Hnnnnnnnnnnnnnnnnennnnnnnennnnnnnannnnnnnnnnen 48 PDC ING ea een EEK E EEE RERRE 49 Gonsumables we ee ee le 49 Accessories and Replacement Parts ccccssssssseeesesseeeeees 49 Classification of the IV Dr a4 4 Hasena eier las Huber feet eaa anaana 50 EC Compliance Statement OSMOMAT O30 uuunananeneannennennnennennnnennennenennnnennennnennnnnnnnnnnnnnnennenn 50 Provisions of Gertification au en raten een 50 Limited Warranty ssssssssssnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 51 Returning Parts for Warranty Repair or Credit 52 Before Calling Gonotec OSMOMAT 030 Upgrade Options 222220nunannnnnnnnn 53 Specifications Of OSMOMAT 030 uuuuuunsnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 53 Contents 5 Contents Illustrations Figure 1 Freezing point depression of solvent ce eeeceeeeeeneeeeeeeeeeeeseeeaeeeeeeeaeeeseeeaeeeseeeaeeeeeeaeeeeeeeaaes 9 Figure 2 Front view of the OSMOMAT 030 susnnesnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnn nn 11 Figure 3 Rear view of the Osmomat 030 0000 ceceeeeeeeeeeeeeeenneeeeeeaeeeeeeeaaeeeeeeaeeeseeaeeeeeeaeeeeeenaeeeeeeaas 12 Figure 4 Elevator cover ek ee
17. ESET key 8 Figure 11 OSMOMAT 030 D display to print the header fe Figure 13 Correct feed Figure 14 Incorrect feed direction for paper roll direction for paper roll Figure 15 Printer with paper roll OSMOMAT 030 D with Built In Printer 37 8 Options 8 1 6 Replacing the Ribbon Cartridge The ribbon cartridge must be replaced when the printout no longer has sufficient contrast The OSMOMAT 030 D can be on or off while the ribbon is replaced A 38 Tear off any paper protruding from the slot before replacing the ribbon Remove the two thumbscrews 4 Figure 11 OSMOMAT 030 D display and take off the plexiglas shield 5 Figure 11 OSMOMAT 030 D display Press lightly on the right hand side of the used ribbon cartridge to remove it Figure 16 Replacing the ribbon y 1 2 3 SPONT CRYST 6 RESULT 7 2 9 NO CRYST SAMPLE ZERO OSMOL KG CAL NUMBER TIME DATE PRINTER PAPER COUNTER ON OFF FEED RESET Figure 16 Replacing the ribbon Remove the new ribbon cartridge from its packaging Refer to Consumables in the appendix for supply information Use your index finger to twist the adjuster knob clockwise and tighten the ribbon Insert the cartridge into the printer The end of the paper must be between the ribbon and the cartridge Twist the knob again to tighten the ribbon Re attach the Plexiglas shield O
18. MOMAT 030 A with Analog Data 8 Options 8 5 OSMOMAT 030 3P with Three Point Calibration To improve linearity across a broader measuring range it makes sense to calibrate at three points Our standard model OSMOMAT 030 with a reproducibility of 0 5 has linearity of 1 in a measuring range from 0 to approximately 700 mOsmol kg Above 700mOsmol kg up to about 2000mOsmol kg the linearity varies by 2 Measurements over 2000mOsmol kg show a variance of 3 Basis two point calibration at 0 and 300mOsmol kg To extend the range with a linearity variance of 1 Option 3P allows calibration at one more point above 0 and 300mOsmol kg e g 850mMOsmol kg The result is a correspondingly wider range with a linearity of 1 8 5 1 Overview of Display Calibration key SPONT CRYST SAMPLE for calibrating ob with water RESULT ZERO Two point calibration NO CRYST OSMOL KG can with calibration solution Three point calibration with Figure 19 OSMOMAT 030 3P display calibration solution T 1 5 3 SPONTCRYST SAMPLE m Se 4 5 6 RESULT ZERO ee 8S 9 NO CRYST OSMOL KG CALI TIME PRINTER PAPER COUNTER Numer TME O PAPER pLu CAL2 Figure 20 OSMOMAT 030 D 3P display 8 5 2 Calibration Modes The OSMOMAT 030 3P can be calibrated in two different modes 1 If you calibrate at just O and 300mOsmol kg
19. SMOMAT 030 D with Built In Printer 8 Options 8 2 OSMOMAT 030 M with 15yl Sample Volume The measurement system of the OSMOMAT 030 M is set for a microsample volume of 15yl The corresponding special thermistor probe is labeled 15ul The OSMOMAT 030 M can also be used to measure sample volumes up to 50ul Please note the following important restrictions and operational guidelines Reproducibility is not affected by using a larger sample volume It remains unchanged at A lt 2 0 Especially careful preparation is necessary due to the minimal sample volume In A particular there must be no air bubbles and the measuring vessel must be seated correctly Do not replace the thermistor probe with a 50ul thermistor probe This will destroy the Y measurement system 8 2 1 Specifications Display 4 5 digits Measuring range O to approximately 3000 mOsmol kg gt Resolution 1 mOsmol kg or 1 mOsmol digit across the entire measuring range Reproducibility lt 2 0 OSMOMAT 030 M with 15pl Sample Volume 39 8 Options 8 3 OSMOMAT 030 RS with Digital Serial Data Output RS 232C 8 3 1 Overview of Connector Components 3 ie Ha C3 gt ie Se a m alls FUSE La 9 ce IE gt C G J ka I m PIN2 TXD O o O O PIN6 DSR PIN7 GND 2 2 PIN 20 DTR O 03
20. THE GONOTEC PRODUCTS Limitations of Liability To the extent permissible under the applicable local laws the legal remedies named here shall be the sole and exclusive legal remedies available to the customer TO THE EXTENT PERMISSIBLE UNDER THE APPLICABLE LOCAL LAWS AND WITH THE EXCEPTION OF THE OBLIGATIONS EXPRESSLY NAMED HERE NEITHER GONOTEC NOR ITS SUPPLIERS SHALL BE LIABLE FOR DIRECT OR INDIRECT SPECIFIC INCIDENTAL OR CONSEQUENTIAL LOSSES WHETHER BASED ON A CONTRACT A TORTIOUS ACT OR ANOTHER LEGAL THEORY AND NOTWITHSTANDING PRIOR NOTIFICATION OF THE POSSIBILITY OF SUCH A LOSS Respective Jurisdiction This warranty statement guarantees the customer certain legal claims The customer may have other legal claims that go beyond those outlined here Such claims vary by state in the US by province in Canada and by nation elsewhere in the world Elements of this warranty statement that conflict with local laws can be regarded as amended to comply with the applicable laws For this reason certain warranty exclusions and restrictions outlined here may be of no relevance to the customer In some states of the US in some Canadian provinces and in some countries outside North America for example the following national laws apply a Exclusion of the fact that the warranty exclusions and restrictions named here restrict the legal rights of a customer for example Great Britain b Restriction of the possibilities for manufac
21. Thermistor Probe l Before replacing a defective sensor unplug the unit from the power supply Risk of electric shock Step 1 Raise the cover of the upper cooling system Figure 7 Elevator cover Two screws can be seen They must be removed in order to remove the entire cover Step 2 Two more screws are now visible Remove these also Figure 5 Mounting plate Step 3 Next remove the plug black brown from the connector white Now you can remove the thermistor and mounting plate from the initiation needle The initiation needle will slide out of the guide tube and pull the protective tubing along with it Elevator cover Figure 4 Elevator cover Initiation needle guide tube Connector o Mounting plate Figure 5 Mounting plate W Warning Risk of injury from the tip of the needle Servicing the OSMOMAT 030 Plug 29 7 Servicing the OSMOMAT 030 Step 4 Now unscrew the thermistor from the mounting plate and replace it with a new Thermistor cable one Figure 6 Thermistor with mounting plate Step 5 Re assemble in reverse sequence by Pe Mounting plate pushing the protective tubing over the Thermistor initiation needle and attaching the mounting plate using the two screws Figure 6 Thermistor with mounting plate Next inser
22. ck of the unit to a power outlet Make sure the unit s ground is enabled via the shockproof grounding If the power cord plug does not match the conventional power outlets in your location you may substitute another power cord It is essential however that the cable s green yellow wire be connected to the safety grounding It is also important to ensure that the voltage indicated on the nameplate matches that j 7 of your electricity network Incorrect voltage will cause the fuse in the power supply unit to blow The OSMOMAT 030 can now be switched on using the power switch on the back of the unit next to the power connector Five horizontal dashes appear on the digital display Simultaneously the SPONT CRYS RESULT and NO CRYST control lamps will flash on and off for about two minutes When the lamps go out the OSMOMAT 030 is ready for measurements The waiting period of approximately two minutes is necessary for the formation of ice crystals at the upper cooling system The waiting period can be interrupted by pressing any key Fill a measuring vessel with 50ul of sample solution or 15yl for models with option M and place it securely onto the measuring vessel holder thermistor probe You will feel a slight resistance and hear a click The highly sensitive thermistor probe is now immersed in the sample solution Measuring vessels that are placed loosely or incorrectly will yield non reproducible results Now press the measu
23. derneath the thermistor probe The bore can first be rinsed using a spray bottle of water to clean out sample residues which can rub off and accumulate on the interior surface over time The unit does not need to be switched off for this cleaning process so measurement is only briefly interrupted 3 No ice forms in the upper cooling system because the humidity is too low or the unit was operated too quickly after having been switched on Remedy Do not run the initial measurement until at least two minutes have elapsed after the unit was switched on If the air humidity is very low for example in heated or air conditioned rooms it may be necessary to open the cover of the upper cooling system 6 4 Classification of Malfunctions by Component Group The following presents an overview of the individual component groups identifying the function of each component its potential malfunctions the effects of the malfunctions on the measurement system the possible causes of the malfunctions and the procedure for correcting each malfunction Calibration cannot help minimize damage in the case of malfunction It is also of no consequence whether these malfunctions occur during calibration or sample measurement Some errors can be remedied directly by the user or an in house medical equipment technician others require return of the unit to the manufacturer Error Messages and Troubleshooting 21 6 Error Messages and Troubleshooting Co
24. e Readings Due to Spontaneous Crystallization The main cause of spontaneous crystallization is the presence of seed crystals which prevent undercooling to the proper temperature Such seed crystals might be salt crystals gas saturation or any pre existing ice crystals Seed crystals of this type can be easily eliminated by briefly heating the sample liquid close to its boiling point and subsequently cooling it Seed crystals that cannot be eliminated in this manner may be removable through filtration Salt crystal formation may result when cooling sample solutions contain certain salts whose low solubility or high concentration put them on the solubility threshold These salt crystals then act as seed crystals In such cases adequate dilution may help though precise results can no longer be expected See also chapter 6 3 1 Excessive Osmolality Seed crystals can also adhere to the thermistor probe Clean the sensor thoroughly using water and a soft paper towel to remove any seed crystals Error Messages and Troubleshooting 19 6 Error Messages and Troubleshooting If the thermistor probe s glass bead has even a hairline scratch that cannot be removed however replace the sensor Dirty measuring vessels dust on the inside surface can also cause such errors See also chapter 7 6 Measuring vessels that are re used may eventually develop cracks in the plastic in which a fine liquid film can cause premature crystallization Measuring v
25. e contents of your shipment is complete We cannot accept responsibility for any missing items reported at a later date Accessories and consumables included in the shipment Article number OSMOMAT 030 20 9 0100 v 1 power cord 00 9 0104 v 2fine wire fuses 230 V0 5 A 30 9 0010 v 100 measuring vessels 30 9 0020 v 20 ampoules calibration standard 300 mOsmol kg certificate 30 9 0850 v 10 ampoules calibration standard 850 mOsmol kg certificate 30 9 0290 v 10 ampoules reference solution OSMOREF 290 mOsmol kg certificate 30 2 0030 v 1 adjustment tool 30 9 0030 v 1 pasteur pipette bellow v 1 user guide 030 Option D 30 9 1010 v 8 rolls of printer paper Option RS 20 9 0160 v 1 RS 232 cable Option A 20 9 0120 v 1 analog cable 10 Introduction 2 Overview of the OSMOMAT 030 2 Overview of the OSMOMAT 030 2 1 Overview of Display and Connectors Control lamp for spontaneous crystallization Control lamp for valid measurement results Control lamp for no crystallization Plexiglas shield Elevator cover Thermistor Digital display output for readings Key for measuring sample solutions Calibration key for calibration with distilled water WN Calibration key for sront caysr pu Pewee o Zen OSMOL KG CAL no cavst calibrating with O OSMOMAT 030 CHRYOSCOPIC OSMOMETER calibration solutions
26. ective Misaligned thermistor probe Incorrect measuring vessel Procedure Check electromagnetic compatibility of equipment operating near osmometer Check system load of power grid Have medical equipment technician or Gonotec replace EPROM Use measuring vessels recommended by Gonotec Place measuring vessel securely on sensor until you hear a click Replace the thermistor probe Replace the thermistor probe Use the adjustment tool to align the thermistor probe and or lower cooling system Component and Function Ventilator Doesn t work not Measurement process Cools the entire system moving too slow No reading Error message Destruction of lower cooling system Emits strange noises Destruction of electronics e g lower cooling system Display Numbers or decimal Displays readings points flicker or disappear Nonsensical readings Option D Table 4 Malfunction of the ventilator display component group Possible Cause Ventilator blocked by foreign object e g measurement vessel Ventilator defective Ventilator impaired by foreign object or is no longer running within its bearing Loose contact in wiring to mainboard Date on printer changed manually or automatically Display defective 6 Error Messages and Troubleshooting Procedure Check unit for foreign objects Replace ventilator Check unit for foreign objects and or replace ventilator immediately Check the wiring bet
27. ediatrics Pharmacies Gynecology and many more Introduction 7 1 Introduction 1 1 1 Application Restrictions of the Osmomat 030 The unit is not intended for determining the osmolality of dilutions Only the osmolality of aqueous solutions can be determined Plausibility checks of the results must be performed by the doctor with the support of the pertinent literature 1 2 Measurement Method of the OSMOMAT 030 The OSMOMAT 030 is a cryoscopic osmometer that measures the freezing point depression to determine the total osmolality of aqueous solutions The freezing points of pure water and a solution are measured and compared Whereas water has a freezing point of 0 C a solution with a saline concentration of 1 Osmol kg has a freezing point of 1 858 C That means that one mol of a given non dissociated substance 6 023 x 10 parts diluted in one kilogram of water lowers the freezing point of a solution by 1 858 C The following definitions are used in calculating osmolality Cosm osmolality osmol kg Cosm AT K T freezing point depression C K 1 858 C kg osmol freezing point constant The osmolality indicates the concentration of all osmotically active dissolved parts in the solvent Since the freezing point depression is directly proportional to the dissolved parts the OSMOMAT 030 measures the osmolality directly 1 3 Reproducibility in the OSMOMAT 030 Standard Model Measurement dis
28. essels are designed for single use only Re use of measuring vessels can lead to non reproducible results 6 3 Late or Absent Crystallization After the sample solution has been cooled to the proper temperature crystallization is initiated automatically through the injection of ice crystals There are two possible reasons for a failure of crystallization to occur 6 3 1 Excessive Osmolality Crystallization is initiated at 7 C The OSMOMAT 030 can measure solutions with a maximum osmolality of approximately 3 osmols since this osmolal concentration yields a freezing point temperature of 3 x 1 858 5 574 5 6 C If the freezing point is very close to the temperature at which crystallization is initiated however crystallization will not initiate despite the very effective method of initiating crystallization through the injection of ice crystals This condition is further exacerbated if the solution exhibits a rising viscosity The only remedy in such cases is to adequately dilute the sample solution It must be taken into consideration however that the osmolality does not change in proportion to the dilution ratio since the degree of electrolyte dissociation during dilution is different for each substance For routine measurements quality inspections for example corresponding relative measurement results from diluted samples can be used as a basis for evaluation 6 3 2 Injection with Ice Crystals Does Not Work If no crys
29. is now immersed in the water Press the ZERO key The display shows 0 000 and the ZERO control lamp illuminates yellow The measuring vessel holder is lowered and the cooling process begins The display shows the current temperature After undercooling has occurred the needle will automatically be submerged initiating crystallization The freezing point of distilled water will be achieved and recorded by the unit The reading obtained by the unit is automatically adopted as the zero value and the value 0 000 is visible on the digital display If the built in printer is switched on ZERO 0 000 is printed out When calibrating be aware that the thermistor probe may still be contaminated with sample residues from previous measurements Following the zero point calibration a control measurement with water should confirm the exact calibration If necessary a new calibration must be carried out A Always use a new measuring vessel with fresh distilled water for each new measurement Calibrating the OSMOMAT 030 15 4 Calibrating the OSMOMAT 030 4 2 Calibrating with a Calibration Solution Begin by pipetting 50ul of calibration solution or 15yl for units with Option M into a clean dry measuring vessel IN There must be no visible air bubbles in the liquid Next place the measuring vessel securely onto the measuring vessel holder It should engage slightly Make sure the lid of the measuring vessel is pointing for
30. l be free from manufacturing and material defects for the above periods of validity from the purchase date The end user must provide proof of the purchase date 2 For software products Gonotec s limited warranty applies only to the non execution of programming instructions Gonotec does not warrant that the operation of a product will proceed without errors or interruptions Gonotec s limited warranty applies only to defects that arise during normal operation of the product It does not apply under the following conditions d Inadequate servicing or improper modification e Use of software interfaces print media or accessories not supported or supplied by Gonotec D or f Use of the equipment in a manner not covered by the product specifications For Gonotec osmometers the use of measuring vessels of manufacturers other than those of the measuring vessels supplied by Gonotec does not void the customer s 2 warranty claims or any customer support contracts between Gonotec and the customer If however the use of measuring vessels from third party providers or the cleaning of recycled measuring vessels results in malfunctions or damage to the osmometer or thermistor probe Gonotec shall assess the normal fees for the time and material required to repair such malfunctions or damage If Gonotec is notified within the warranty period of a defect in a software product in media or in a thermistor probe and if the Go
31. mful substances either in operation or while switched off Symbols on the unit and its nameplate correspond to the requirements of the following standards DIN EN 61010 1 DIN EN 375 and DIN EN 980 harmonized standard for medical devices according to 3 no 17 of the German Medical Device Law MPG 3 2 Known Risks Associated with the Use of the OSMOMAT 030 In our experience using the Osmomat since 1979 we have not found it to present any direct hazards or risks to the user Such hazards and risks cannot entirely be excluded for technical equipment however These operating instructions help you gain a basic understanding of the design the measurement principle maintenance and servicing of the unit Please pay special attention to chapter 7 7 Replacing a Defective Initiation Needle 14 Setup and Initial Operation 4 Calibrating the OSMOMAT 030 4 Calibrating the OSMOMAT 030 Before the total osmolality of sample solutions can be measured the OSMOMAT 030 must be calibrated with distilled water and a calibration solution 4 1 Calibrating the Zero Point with Distilled Water Begin by pipetting 50 ul of distilled water or 15yl for units with Option M into a clean dry measuring vessel IN There must be no visible air bubbles in the liquid Next place the measuring vessel securely onto the measuring vessel holder It should engage slightly Make sure the lid of the measuring vessel is pointing forward The thermistor probe
32. mponent and Function Elevator guide Sluggish noisy Manually lowers the sample into the lower cooling system Lower cooling system No cooling Cools the sample measurement takes too long measurement terminates Error message or incorrect reading No reading Error message Display Incorrect reading Possible Cause Mechanical wear due to ball bearing abrasion Blockage from foreign substances Corrosion Photosensor for controlling lower cooling system is defective or misaligned Misaligned lower cooling system Peltier element defective Table 1 Malfunction of the elevator track lower cooling system component group 22 Error Messages and Troubleshooting Procedure Lubricate the track e g with silicone spray or graphite Remove foreign substance Use fine sandpaper to clean the cooling clamp Make sure the photosensor is working and is positioned properly replace if necessary Use the adjustment tool to align the lower cooling system Replace the lower cooling system Component and Function Upper cooling system No cooling or no ice Error message and no Nucleation crystals at the upper reading cooling system Insufficient ice No crystallization accumulation on the bar No reading of the needle Error message Incomplete rotation of No crystallization the motor disc with No reading initiation needle Error message Table 2 Malfunction of the upper cooling system compone
33. n osmometry by qualified personnel in calibrating and or controlling the osmometer The calibration and reference material must be used in accordance with equipment specifications The calibration and reference material is not named in Annex Il list A or B of the Directive 98 79 for in vitro diagnostics Compliance is declared per Annex Ill Number 6 of Annex Il is disregarded as the calibration and reference material s intended use does not include personal use EC Compliance Statement Calibration and Reference Material Gonotec GmbH Eisenacher Stra e 56 D 10823 Berlin Germany We hereby declare that the calibration standard for Osmomat 010 030 auto 300 and 850mOsmol kg NaCl H2O and the reference solution OSMOREF 290 mOsmol kg complies with Directive 98 79 EEC Compliance is declared per Annex III of the Directive The CE mark on the calibration and reference material acknowledges this Date 09 11 2004 Signature of managing director Provisions of Certification CE compliance requires that the calibration and reference material be used in the manner described in this manual and or in the package insert Any departure from the specifications or independent modifications of the calibration and reference material without the express consent of Gonotec GmbH may result in a violation of CE requirements Such actions invalidate the compliance statement and transfer responsibility to the originator of said actions 46
34. n s practice country state and local requirements Attention The calibration and reference material is a chemical Observe all relevant precautions and regulations do not swallow do not taste always wear gloves etc Container Nominal volume 1 ml clear glass OPC ampoules The ampoules have a breaking ring with a breaking ring color blue dot The ampoule can be opened manually by breaking it off at this point Follow all safety precautions for the handling of glass splintering breakage etc NaCl Calibration Solutions for Osmometry 47 9 NaCl Calibration Solutions for Osmometry 9 5 Storage and Shelf Life When stored unopened at 5 C to 45 C the calibration and reference material has a shelf life up to the expiration date indicated on the packaging Do not use the calibration and reference material after its expiration date Once the ampoule has been opened the calibration and reference material shelf life is up to hour at 22 C A strong variance in calibration readings e g increasing osmolality are an indication that the shelf life has elapsed 9 6 Use of Other Calibration Solutions Osmolality Sodium chloride concentration Freezing point depression Milliosmol kg H O g NaCl kg H2O in C 700 200 300 400 500 600 700 750 850 1200 1800 2000 2500 3 088 6 26 9 463 12 685 15 916 19 148 22 38 23 98 27 178 38 37 57 56 63 960
35. ng If necessary a new calibration must be carried out Always use a new measuring vessel with fresh calibration solution for each new measurement 1 Cf chapter 8 4 Osmomat 030 3P Deviation Sample volume of 50ul lt 0 5 Sample volume of 30ul lt 1 0 Sample volume of 15ul lt 2 0 16 Calibrating the OSMOMAT 030 5 Measuring a Sample Solution 5 Measuring a Sample Solution After calibration or calibration confirmation the unit is ready for sample measurements Since sample measurements must be carried out under the same conditions as the calibration pipette 50 ul of the sample liquid or 15yl for units with Option M into a clean dry measuring vessel It is essential that there be no air bubbles Place the measuring vessel containing the sample liquid securely onto the measuring vessel holder thermistor probe It should engage slightly Make sure the lid of the measuring vessel is pointing forward The thermistor probe is immersed in the sample liquid Before lowering the measuring vessel holder press the SAMPLE key This step is not necessary if the SAMPLE control lamp is already illuminated Crystallization is automatically initiated once the sample liquid is undercooled The temperature is shown on the display until the crystallization temperature of 7 C is reached The calculated freezing point temperature is recorded by the unit and using the calibration value converted into an osmolalit
36. nnnnnnnnennnnnnnnnnnnnnnnnnnnn nenn 40 Figure 18 Analog interface with pin assignment u 4ssuennnnnnnennnnnnnnnnnennnnnnnnnnnnnnnnnn nn nn nn 42 Figure 19 OSMOMAT 030 3P display uu 2s240sssnnnnnsnnnnnnennnnnnnnnennnnnnnnnnnnnnnnnnnnnennnnnnennnnnnn nn 43 Figure 20 OSMOMAT 030 D 3P display snnesnnnnnnnnennnnnnnennnnnnnnennnnnnnennnnnnnnnnnnnnnnennnnnnn nn 43 Tables Table 1 Malfunction of the elevator track lower cooling system component groUP een 22 Table 2 Malfunction of the upper cooling system component QrouD ccccceeeeeeeeeeeeeeeeeeeeeeeenaees 23 Table 3 Malfunction of the EPROM thermistor probe component group cseececeeeeeeeeeeeeeeeees 24 Table 4 Malfunction of the ventilator display component group ceseeeecceceeeeeeeeeeeeeeeeeeeeetteeenaees 25 Table 5 Malfunction of the initiation needle power switch component group 0 ccceeeeeeeeeeeeeees 26 Table 6 Malfunction of the printer component groUPp 444uussssssennnnnnnnenennnnnnnnennennnennnnr nennen 27 Table 7 NaCl solutions for osmometry based on Geigy scientific tables 8 editiOlinciine eet 48 6 Contents 1 Introduction 1 Introduction 1 1 Applications of the OSMOMAT 030 The Gonotec cryoscopic osmometer Osmomat 030 is a non invasive in vitro diagnostic device for in vitro analysis of human blood urine semen and other samples such as drip solutio
37. nnnnnnnnnnnnnnnnnnnnnnnn nn 9 Unpacking the OSMOMAT 030 Cryoscopic Osmometer ueennnnennnnnnennnnnnnenn nenn 10 Packaging Contents vii ee re Ren A en 10 Overview of the OSMOMAT 030 sssesseeeeeeeee 11 Overview of Display and Connectors cceceeecceeeeeeeeeeneeeeeeeeaeeeeeeeaeeeeeeaeeeseeiaeeeeseneeeeneaas 11 Power SUppIW e ae a aeaa aaar a Er ee ee 12 Dimensi ns and Weight rer ei ei 12 Setup and Initial Operation us2sonnunnnnBnnnnnnnnnn TO Safety and Handling Information esnnnnennnnnnnnnennnnnnnnennennnnnnnnnnnnnennnnnnnn nn 14 Known Risks Associated with the Use of the OSMOMAT O30 uunsesennnennnnnnnenn ern 14 Calibrating the OSMOMAT 0 0 Calibrating the Zero Point with Distilled Water usnnnennnnnnennnnnennennnnnnnenn 15 Calibrating with a Calibration Solution ussrnnsesnnnnnnnnennnnnnnennnnnnnnennnnnnnennnnnnnnne nn 16 Measuring a Sample Solution uuurersrereeenennnennnenn 1 7 Series Meas rement ws a Anes ela ee 17 Repeating a Sample Measurement 42244444440anennnnennnnnnnnnnennnnnnnennnnnnnannnnnnn nn 18 Error Messages and Troubleshooting 19 Spontaneous Crystallization 424444444HHnnHnnnennnnnnnennnnnnnennnnnnnnnnnnnnnennnnnnennnnnnne nn 19 Preventing False Readings Due to Spontaneous Crystallization eennn 19 La
38. notec warranty applies to the defect Gonotec shall replace the defective product If Gonotec is notified within the warranty period of a defect in a hardware product and if the Gonotec warranty applies to the defect Gonotec shall repair or replace the defective product at its discretion If Gonotec is unable to repair or replace a defective product to which the Gonotec warranty applies Gonotec 3 shall refund the purchase price of the product within a reasonable period following notification of the respective defect Gonotec is not obligated to repair or replace a product or refund its purchase price until the customer returns the defective product to Gonotec Replacement products may be new or almost new as long as their functionality is at least that of the replaced product The Gonotec limited warranty is applicable in all countries in which Gonotec sells the applicable product The following countries and regions are excepted All countries outside the EU In these countries the warranty is only valid in the country in which the product was purchased Contracts for additional warranty services such as on site service may be available from an authorized Gonotec sales partner Appendix Limitation of the Warranty TO THE EXTENT PERMISSIBLE UNDER THE APPLICABLE LOCAL LAWS NEITHER GONOTEC NOR ITS SUPPLIERS SHALL ASSUME ANY ADDITIONAL WARRANTY SERVICES OR ACCEPT ANY OTHER CONDITIONS EXPRESS OR IMPLIED WITH REGARD TO
39. ns Its purpose is to provide information to help identify diagnose monitor and treat physiological conditions states of health or illnesses The OSMOMAT 030 must be operated by persons whose training or skills have provided them with the necessary practical experience cf German Medical Devices Operator Ordinance MPBetreibV The cryoscopic osmometer OSMOMAT 030 is particularly suited for routine measurements in the fields of medicine industry and research The cryoscopic osmometer OSMOMAT 030 determines the total osmolality of aqueous solutions Osmolality is an important measure of concentration for diluted solutions such as all bodily fluids The OSMOMAT standard model needs a sample volume of 50ul while the M option requires only 15ul making it suitable for measuring even minute samples The measuring speed permits rapid series measurements In the hospital or doctor s office osmolality can be used as one of several parameters to help form a diagnosis or prompt further testing In the pharmaceutical industry and research the Osmomat 030 is used to test various aqueous solutions saline drips etc and for process validation The OSMOMAT 030 has been applied successfully in the following fields General medicine Urology Routine and research Nephrology Forensic medicine Hemodialysis Electron microscopy Hemofiltration Physiology Botany Clinical laboratories Veterinary medicine Intensive care laboratories Pharmaceutics P
40. nt group Possible Cause Peltier element ruined e g through deposits from liquids Corrosion Misaligned upper cooling system Bar of needle too short or too long Photosensor for motor control defective or misaligned Motor disc loose 6 Error Messages and Troubleshooting Procedure Replace upper cooling system Clean the cooling nipple using a fine wire brush fiberglass pin or fine sandpaper Align the cooling system Align the needle bar or check for proper length Make sure the photosensor is working and is positioned properly Tighten the motor disc Error Messages and Troubleshooting 23 6 Error Messages and Troubleshooting Component and Function Thermistor probe Analysis Defective Calibration and measurement impossible or results not verifiable Measuring vessel fits loosely on the thermistor probe Incorrect reading Defective Display shows lines but no numbers _ _ __ When lowered into the lower cooling system the thermistor probe moves outside the center of the solution Incorrect reading Table 3 Malfunction of the EPROM thermistor probe component group 24 Error Messages and Troubleshooting Possible Cause Aging External electric shock Excessive electromagnetic irradiation Incorrect measuring vessel Incorrect placement of measuring vessel The thermistor probe s measuring vessel receptacle is damaged Thermistor probe bead broken off or def
41. oe aA 40 Communication Software ea bobd nocd essen aaa a a a de ata edau a 41 OSMOMAT 030 A with Analog Data OUtpDUt cc cee eect ee eeeeneeeeeetaeeeeeetaeeeeeenaeeeeeeaas 42 Overview of Display and Connectors 0 0 0 eee ce eeeeeeeeneeeeeeeeeeeeeaeeeeeeeaeeeseneeeeeeaeeeseeeeeeeneeeeeeaaes 42 SPECHICAHONSE ee ee ake Aah oa A tM anh eo Ate aoe Ses Pde he Ate A OS ek 42 OSMOMAT 030 3P with Three Point Calibration ccceceeeeeceeeeeeeeeeeeeeteeeeeeeneeeeeeaas 43 Overview of Display Arer E E E A 43 Galibration Modes 4 431 ee eea aaa aa anaa endih p irade LIENEE 43 Performing a Three Point Calibration ccccecccececeeeeeeeeeae cece ee seceeaeeeeeeeseseneaeeeeeeeseseneaeeeeeeeees 44 Errors During Ga librati n eek end en A A ASEAS 44 Other Calibration Points ses sananne ei dee et 45 Urner Optlons sires ere a5 hg et ace eee a i a ere ended ane karate cs 45 Contents Contents 9 NaCl Calibration Solutions for Osmometry 46 9 1 GONOTEC Calibration and Reference Material 44244444440nen nennen ennennnennnnen 46 Classification of thie VD ae I en 46 EC Compliance Statement Calibration and Reference Material 244444444n nennen 46 Provisions of Gertficationz 22 ea Reh eee ea ee ee 46 9 2 Restrictions on Use of the Calibration and Reference Material 47 9 3 Composition avts ater ieee tates ti ern nr ren
42. ol kg For Option M run these measurements with a volume of 15ul 8 5 4 Errors During Calibration It is possible that error may occur during calibration The individual steps should always be controlled as described above The OSMOMAT 030 3P recognizes if the calibration solutions are interchanged or the same calibra tion solution is used at two different calibration points and displays an error message E EEE The measured value is rejected and the unit must be reset Reset the unit either by pressing the RESET button on the back of the unit Figure 3 Rear view of the Osmomat 030 or by switching the unit off and then immediately back on again the ON OFF switch is also located on the back of the unit The OSMOMAT is then in the same state as before the faulty calibration attempt 44 OSMOMAT 030 3P with Three Point Calibration 8 Options The OSMOMAT 030 3P is unable to recognize slightly faulty calibration solutions such as those subjected to open storage Calibration of such solutions is faulty and leads to incorrect results The inevitable result is miscalibration of the unit and thus faulty measurement results with your samples 8 5 5 Other Calibration Points We can guarantee the reproducibility of our OSMOMAT 030 3P using Gonotec calibration standards because our calibration standards are manufactured under the most stringent guidelines and undergo continual checks Of course you may use calibration standards of othe
43. ooling systems with heat dissipation through the air Temperature controlled electronically consistency better than 0 1 C 10 C to 35 C 220V 30V 50 60 Hz 120VA Special models 110V 100V 220 x 205 x 360 mm Approximately 7 kg Options Option D Number of digits Paper Paper feed Printer function Error message Option A Output voltage Option RS Baud rate Data format Data line Control line Connector plug Option M Reproducibility Option 3 P Alphanumeric dot matrix printer 5x7 matrix date time of each measurement 4 digit programmable sample number 4 digit measurement results Normal paper 43 mm wide Automatic or manual Manual on off key Printout in plain text Analog output via DIN standard socket 5 pin 1 mV mOsmol Data output serial standard RS 232 C interface 1200 bps 1 start bit 8 data bits 2 stop bits no parity check TXD DTR DSR Canon 25 pin 15 ul sample volume lt 2 0 Special version for 3 point calibration Appendix 53
44. orn off cleanly 36 OSMOMAT 030 D with Built In Printer 8 Options 8 1 5 Replacing the Printer Paper A Unscrew the two 1 2 3 SPONT CRYST a thumbscrews 4 to remove the BEE 56 RESULT Br plexiglas shield 5 Figure 11 esse since OSMOL KG Par OSMOMAT 030 D display O Ba en 35 B Lightly press the lower left p portion of the printer to open it f Figure 12 Opening the printer Figure 12 Opening the printer C Remove the empty paper spool from the paper compartment Figure 15 Printer with paper roll Remove any remaining paper not by pulling it out backwards but by pressing the PAPER FEED 7 key to advance it through the opening D Insert a new roll of paper Refer to Consumables in the appendix for supply information Switch on the OSMOMAT 030 D and the printer Cut the paper cleanly and feed the end into the paper output slot from above Press the PAPER FEED key 7 Figure 11 OSMOMAT 030 D display to advance the paper through the opening leaving about 1 inch 2 cm protruding Make sure the roll is fed in the correct direction Figure 15 Printer with paper roll and Figure 13 Correct feed direction for paper roll Place the roll in the paper compartment and close the printer Thread the paper through the slot of the plexiglas shield 6 Figure 11 OSMOMAT 030 D display and re attach the shield Before starting the next measurements press the COUNTER R
45. p of the needle always consult a doctor to check m whether any infection with a pathogen occurred Servicing the OSMOMAT 030 31 7 Servicing the OSMOMAT 030 Step 1 Unscrew the upper face plate elevator cover and mounting plate see Figure 2 Front view of the OSMOMAT 030 see the description in chapter 7 5 Figure 4 Elevator cover and Figure 5 Mounting plate Detach the needle bar from the motor swipt Figure 9 Replacing an initiation needle Attach a new needle bar with protective tubing to the motor swipe Please note a b The needle must be carefully aligned Bend it into place with your hand if necessary After the needle bar has been tightened it must be able to move freely on the sleeve bearing Idle Upper dead center Photo ssss 7 sensor Sleeve bearing position ops Motor swipe Needle _L protective tuhina oon si gt SS Total length needle bar needle Cooling pin Round off tip of needle with a file Figure 9 Replacing an initiation needle Step 2 Manually move the motor swipe to the upper dead center position Use a pair of pliers to adjust the needle to the proper length end of needle approximately 2 mm under the upper edge of the cooling pin Carefully round off the cutting edge with a file In the idle position of the motor swipe the end of
46. play 4 5 digits Measuring range 0 to approximately 3000 mOsmol kg Resolution 1 mOsmol kg or 1 mOsmol digit across the entire measuring range Reproducibility Sample volume of 50ul lt 0 5 Sample volume of 30ul lt 1 0 8 Introduction 1 Introduction 1 4 Function of the OSMOMAT 030 The sample solution is cooled with a peltier cooling system while its temperature is electronically monitored Once the sample solution has reached a specific temperature below the freezing point crystallization is automatically initiated The OSMOMAT 030 initiates crystallization by injecting the sample with a stainless steel needle that is cooled by a secondary upper cooling system and at the tip of which small ice crystals have formed through moisture in the air When crystallization begins ice forms spontaneously The heat that was removed during undercooling is released again the temperature rises spontaneously and the temperature of the sample rises to the freezing point If the sample consists of water solvent equilibrium is achieved as long as the sample contains water and ice The temperature remains constant because further heat removal does not result in a lowering of the temperature but the formation of ice The time of temperature equilibrium is known as plateau time Only after complete crystallization the temperature does fall again If the sample consists of a solution the pure water in the solution
47. r manufacturers or create your own but we cannot make any claims for the expected measurements The following calibration points are possible 1 Zero gt always calibrated with distilled water 2 CAL1 100 200 300 500 700 850 900 1200 1500 1800 2000 2500 3 CAL2 300 500 700 850 900 1200 1500 1800 2000 2500 3000 For CAL2 the minimum gap to CAL1 lies with the next but one calibration point For example CAL1 100 mOsmol kg for CAL2 all calibration points from 300 mOsmol kg onwards are possible CAL1 200 mOsmol kg for CAL2 all calibration points from 500 mOsmol kg onwards are possible CAL1 300 mOsmol kg for CAL2 all calibration points from 700 mOsmol kg onwards are possible CAL1 2000 mOsmol kg for CAL2 is 3000 mOsmol kg possible 8 6 Further Options Most options can be combined yielding the following potential constellations OSMOMAT 030 A D OSMOMAT 030 A D RS OSMOMAT 030 A RS with or without Option M Restriction Option 3P may be combined with Options D RS and M but not with Option A OSMOMAT 030 3P with Three Point Calibration 45 9 NaCl Calibration Solutions for Osmometry 9 NaCl Calibration Solutions for Osmometry 9 1 GONOTEC Calibration and Reference Material Classification of the IVD The calibration and reference material manufactured by Gonotec is a non invasive in vitro diagnostic product according to EEC Directive 93 42 Medical Devices Law It is intended for use i
48. ring vessel holder down into the measuring position noticeable resistance The measuring vessel is immediately cooled by the lower cooling system The current temperature of the solution is shown on the digital display in degrees Celsius The cooling process can be directly observed The moment the undercooling temperature is reached crystallization is initiated automatically by the injection of ice crystals and an acoustic signal sounds The resulting ice formation causes the temperature to rise to the freezing point of the solution A freezing plateau then forms that the thermistor probe records and the measurement system identifies saves and shows on the digital display in osmol kg or digits Setup and Initial Operation 13 3 Setup and Initial Operation After the measurement process is finished regardless of whether it was successful or produced an error message and the elevator has been raised the measurement system automatically switches to standby and is ready for the next measurement 3 1 Safety and Handling Information The cryoscopic osmometer OSMOMAT 030 is an electric laboratory measurement device It should therefore be handled according to the safety provisions and precautions for electric measurement control and laboratory equipment The unit must be adequately disinfected prior to decommissioning Equipment must be W decommissioned in accordance with local accident prevention guidelines The unit emits no har
49. ruction of the measurement system through use of improper measuring vessels even during the warranty period shall result in forfeiture of the warranty claim of repair or replacement of the measurement system 34 Servicing the OSMOMAT 030 8 Options 8 Options 8 1 OSMOMAT 030 D with Built In Printer The OSMOMAT 030 D is equipped with a dot matrix printer The printer uses normal paper and an ink ribbon cartridge The printer paper an the continuous loop ribbon cartridge are consumables and must eventually be replaced The OSMOMAT 030 D is fully operable even if the printer is off The results can be seen on the digital display after each measurement 8 1 1 Design and Function of the OSMOMAT 030 D 8 1 2 Overview of Display and Connectors TIME DATE COUNTER 8 RESET PRINTER ON OFF A N 1 2 3 SPONT CRYST D 7a 6 1 AIRIA o 156 M 7 8S 9 NO CRYST OSMOL KG O Figure 11 OSMOMAT 030 D display 1 Numerical keypad 2 Key for entering sample number 3 Key for setting time and date 4 Thumbscrews 5 Plexiglas shield 6 Printer ON OFF switch 7 Paper feed 8 Counter reset 9 Paper output with tear off edge OSMOMAT 030 D with Built In Printer 35 8 Options 8 1 3 Setting the Time and Date The time day month and year are set using the TIME DATE key 3 Figure 11 OSMOMAT 030 D display and the numerical keypad To set 08 3
50. s no results or Outputs readings nonsensical results Prints no results Does not print Reading not printed out Table 6 Malfunction of the printer component group Possible Cause Date in printer changed Cable break No paper or ribbon needs replacing Printer switched off Wiring to mainboard interrupted Defective 6 Error Messages and Troubleshooting Procedure Repeat measurement and press the Sample or Zero key depending on the next work step Check the printer s cable connections Replace paper or ribbon Switch printer on Check wiring Replace printer Error Messages and Troubleshooting 27 7 Servicing the OSMOMAT 030 7 Servicing the OSMOMAT 030 7 1 Requirements of the Medical Devices Operator Ordinance The regulatory scope of Germany s Medical Devices Operator Ordinance includes the maintenance and servicing of medical devices Sections 2 Special Regulations for Active Medical Devices and 3 Medical Devices with Measurement Functions regulate the safety and measurement checks to be performed on medical devices These checks are mandatory for devices listed in Annexes 1 and 2 of the Medical Devices Operator Ordinance 7 2 Safety Checks 6 of Medical Devices Operator Ordinance The OSMOMAT 030 is not listed in Annex 1 of the Medical Devices Operator Ordinance Public authorities do not require the unit to undergo safety checks W Safety checks should be conducted by the on si
51. s reliable recording of the measurement results together with and easily distinguishable from the sample numbering and increases the speed of series measurements Option A Analog port for continuous recording of the temperature development with a compensating recorder Option RS Digital serial data output RS 232 C for connecting the OSMOMAT 030 RS to a computer Option M The OSMOMAT 030 M is programmed for a microsample volume of 15yl Reproducibility is lt 2 This option is recommended if only small sample volumes are available If the OSMOMAT 030 M is used to measure sample volumes up to 50ul the reproducibility remains at lt 2 Option 3 P Calibration at three points Besides water two other calibration points are possible The above options can be combined in almost any way Only the options A and 3P cannot be combined with each other Specifications of OSMOMAT 030 Standard model Sample volume Duration of measurement Reproducibility Measurement display Measuring range Resolution Crystallization resolution Cooling Lower cooling system Ambient temperature Power connection Dimensions Weight 50ul to 30ul Approx 1 minute lt 40 5 504l lt 1 0 3011 4 5 digits Up to approximately 3000mOsmol kg 1 mOsmol kg across the entire measuring range Using the ice crystal laced tip of an automatically controlled stainless steel needle Using two independent peltier c
52. t the plug of the connector cable into the connector and guide the thermistor cable into the groove along the side The re attached thermistor must then be aligned Step 6 Aligning the thermistor probe Alignment of the thermistor probe and the lower cooling system is of critical N importance for reproducibility of the OSMOMAT 030 cryoscopic osmometer readings A special tool included in the standard accessories is required to adjust the thermistor probe The purpose of the adjustment is align the center axis of the cooling clamp with the thermistor axis see Figure 7 Thermistor probe adjustment along X axis and Figure 8 Thermistor probe adjustment along Y axis Adjustment proceeds as follows a Place the adjustment tool into the lower cooling system checking for a snug fit b Carefully lower the thermistor probe The Lower cooling system thermistor probe must fit exactly into the opening in the adjustment tool If this is not the case the thermistor probe or the lower cooling sysieinmuel TE Figure 7 Thermistor probe adjustment along X axis 30 Servicing the OSMOMAT 030 7 Servicing the OSMOMAT 030 If the thermistor probe is off center along its X axis right or left loosen its screws and re adjust it Figure 7 Thermistor probe adjustment along X axis Repeat the process until the bead at the tip of the thermistor probe is exactly in the center of the adjustment
53. tained in this document may be changed without prior notice 2005 Gonotec Gesellschaft f r MeB und Regeltechnik mbH All rights reserved Reproduction of this document in any form is permissible only with the prior written consent of Gonotec Gesellschaft f r MeR und Regeltechnik mbH The trademarks used in this document GONOTEC OSMOMAT and OSMOREF are trademarks of Gonotec Gesellschaft f r Me und Regeltechnik mbH Other trademarks and trade names used in this document may be trademarks or names of the corresponding companies or their products Gonotec Gesellschaft f r Me und Regeltechnik mbH does not assert any claim on trademarks or trade names other than its own OSMOMAT 030 model series 1996 and later May 2006 Version 1 2 1 1 1 1 1 1 2 1 3 1 4 1 5 1 6 2 1 2 2 2 3 3 1 3 2 4 1 4 2 5 1 5 2 6 1 6 2 6 3 6 3 1 6 3 2 6 4 Contents Introduction 2 fan Applications of the OSMOMAT 030 444uunsssssnnnnennnnennnnnsnnnnnnnanennnnennnnnnnennnnrnn nn nnanen 7 Application Restrictions of the Osmomat O30 uursssnsnnesnnnnenssnnnnnennnnnen nennen nennen nennen nnnnnnr nn 8 Measurement Method of the OSMOMAT 030 24ssssnneensssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nennen 8 Reproducibility in the OSMOMAT 030 Standard Model 0 cccceeeceeeeeeseeeeeeeteneeeeetneeeerene 8 Function of the OSMOMAT O3D0 uuuessnseenessnnnnnnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn
54. tallization occurs during the crystallization initiating phase despite the sounding of the acoustic signal and even though the sample liquid does not exhibit excessive osmolality there are various possible causes See also chapter 6 4 Classification of Malfunctions by Component Group 1 The stainless steel needle that transports the ice crystals is not moving from its upper to lower position A mechanical problem is preventing the movement of the needle 20 Error Messages and Troubleshooting 6 Error Messages and Troubleshooting Remedy Unscrew the thermistor probe The needle can then be straightened caution risk of injury repositioned and checked for mechanical maneuverability The movement of the needle can be tested by pressing the MOTOR button on the back of the unit 2 The ice crystals at the tip of the stainless steel needle are not reaching the undercooled liquid sample despite the lack of any mechanical problem with the movement of the needle The iced covered tip of the stainless steel needle passes through a bore above the measuring vessel during the crystallization initiating phase This bore may contain a drop of water or be very dirty The drop of water may be the result of ice crystals falling from the upper cooling system Remedy Use the Pasteur pipette included with the accessories together with a long tube as a bellows to blow debris from the bore First remove the measuring vessel and hold a paper towel un
55. te or Absent Erystallization 4 2020 ee ri le Dee ak 20 Excessive Osmolality 2 2 ne nd nn heran nahen Diii iaai 20 Injection with Ice Crystals Does Not Work uuuersssesnessnnnnennnnnnnnnnnnnnnn nenne nnnnnnnnnnnnnnn nennen 20 Classification of Malfunctions by Component Group c cccececeeeeeeeeceeeeeeeeseteeseeeaeeeeees 21 Contents 3 Contents 7 1 7 2 7 3 7 4 7 5 7 6 7 7 7 8 7 9 7 9 1 7 9 2 7 9 3 8 1 8 1 1 8 1 2 8 1 3 8 1 4 8 1 5 8 1 6 8 2 8 2 1 8 3 8 3 1 8 3 2 8 3 3 8 4 8 4 1 8 4 2 8 5 8 5 1 8 5 2 8 5 3 8 5 4 8 5 5 8 6 4 Servicing the OSMOMAT 030 cssssssssseeeeeeeee 28 Requirements of the Medical Devices Operator Ordinance ccceceeseeeeeceeeeeeeeteteees 28 Safety Checks 6 of Medical Devices Operator Ordinance 4 nn 28 Measurement Checks 11 of Medical Devices Operator Ordinance en 28 Internal Quality Control of the OSMOMAT 030 uuessnseennssnnnnnnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ann 28 Aligning the Thermistor Probe 2 cccccccceccenececeneceedeeceeeenccneceeeseenenecdeaceeeeneceeceteaeceneeneeneeeesen 29 Replacing a Defective Thermistor Probe ccccececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeaeeeeeeaeeeeeenaees 29 Replacing a Defective Initiation Needle eccceeceeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeseeeaeeeeeeaeeeeeeaaees 31 Replacing a Defective Mains FUSE
56. te safety coordinator in accordance I with relevant accident prevention guidelines 7 3 Measurement Checks 11 of Medical Devices Operator Ordinance The Osmomat 030 is not listed in Annex 2 of the Medical Devices Operator Ordinance No measurement checks are stipulated by the Ordinance The user should perform the following checks however e Calibration of the unit with a standardized osmometry calibration solution e Comparative measurements with OSMOREF 290 or aqueous solutions of W known osmolality e Logging of measurement readings and any evaluation results The frequency of such checks should follow local quality assurance guidelines 7 4 Internal Quality Control of the OSMOMAT 030 A microcontroller monitors the unit s functions based on the program flow The failure of individual functional groups in the unit results in a malfunction that either reports an error message or shuts down the unit Standardized calibration and reference solutions and an adjustment tool are used to check the internal quality control mechanism 28 Servicing the OSMOMAT 030 7 5 Aligning the Thermistor Probe 7 Servicing the OSMOMAT 030 Good reproducibility relies on a few key elements To ensure optimal reproducibility the A thermistor probe must be exactly in the center of the measuring vessel during measurement This is especially important to remember when a defective thermistor probe is replaced 7 6 Replacing a Defective
57. ted by the unit along with their possible causes and describes the proper use of measuring vessels 6 1 Spontaneous Crystallization The freezing point of a solution is measured by first undercooling the solution without any ice formation to a predefined temperature Crystallization is then automatically initiated by injecting ice crystals A portion of the solution s water content is crystallized out The crystallization enthalpy causes an immediate rise in temperature up to the freezing point of the remaining somewhat more highly concentrated solution During the time in which both ice and solution are present a freezing plateau then forms Since ice is constantly forming through the ongoing gradual cooling of the sample however the concentration of the remaining solution increases steadily leading to a steady increase of the osmolality and thereby inclining the freezing plateau to a specific degree The OSMOMAT 030 obtains a reading for the total osmolality by calculating the temperature difference between the freezing point of the water and the reversal point detected while measuring the sample solution The OSMOMAT 030 monitors the temperature changes during the undercooling phase If crystallization begins prematurely before the undercooling temperature of 7 C is reached the error message SPONT CRYST signals the error and display of the erroneous reading which in this case is too low is suppressed 6 2 Preventing Fals
58. turers to enforce such warranty exclusions and restrictions c Granting of additional warranty claims for the customer fixing of the validity period for implied warranty services that the manufacturer may not exclude or nonadmission of restrictions relating to the validity period for implied warranty services THE FOLLOWING APPLIES TO CONSUMER TRANSACTIONS IN AUSTRALIA AND NEW ZEALAND THE CONDITIONS OF THIS WARRANTY STATEMENT NEITHER EXCLUDE LEGAL RIGHTS APPLICABLE TO THE SALE OF GONOTEC PRODUCTS TO SUCH CUSTOMERS NOR REPRESENT A RESTRICTION OR AMENDMENT OF SUCH RIGHTS BUT INSTEAD REPRESENT A SUPPLEMENT TO THESE RIGHTS EXCEPT TO THE EXTENT PERMISSIBLE UNDER THE LAW Appendix 51 Appendix Returning Parts for Warranty Repair or Credit All products returned for repair or credit must be prepared as follows 1 Call or write to request a free return order for equipment that is being returned to us for warranty repair or credit You may also request a return order for equipment that is being returned for non warranty repair but you will be liable for the cost of the return order 2 Clean and disinfect the equipment before returning it to us We will charge a processing fee for cleaning and disinfecting contaminated equipment Equipment that is greatly contaminated will be returned at the customer s expense 3 Insert the protective packaging material notched foam cushion between the thermistor probe and the elevator
59. ward The thermistor probe is now immersed in the liquid Press the CAL key The digital display shows the value 300 and the CAL control lamp illuminates yellow Pressing this key again toggles through the following values 400 500 600 700 850 900 1200 1500 1800 2000 2500 100 200 and back to 300 It is thus possible to set the osmolality value of the calibration solution to be used Standard calibration solutions with an osmolality of 300mOsmol kg and 850mOsmol kg are provided in ampoules but additional calibration solutions can be manufactured by the user The corresponding NaCl concentrations can be found in the appendix to these operating instructions This sets the value of the calibration solution used for calibration After the measuring vessel holder is lowered the solution is undercooled and crystallization initiated A reading is obtained that is automatically adopted as the calibration value according to the prior setting and output to the digital display If the built in printer is switched on two values are printed out for a standard calibration solution The measured one e g 0 298 and the CAL value 0 300 shown separately with an arrow N When calibrating be aware that the thermistor probe may still be contaminated with sample residues from previous measurements Following calibration a control measurement with the calibration solution or a solution of known osmolality should confirm the exact a setti
60. ween the display and the mainboard Repeat measurement and press the Sample or Zero key depending on the next work step Replace display Error Messages and Troubleshooting 25 6 Error Messages and Troubleshooting Component and Function Initiation needle Crystallization No few ice crystals transported Needle does not move Rear of unit power switch Power supply Fuses in power switch blow out when unit is switched on Unit does not turn on Error message No crystallization Error message No crystallization The following parts may be damaged Mainboard Transformer Possible Cause Needle too long or too short Needle not deburred at tip e g after re installation Needle bent Bar of needle disengaged from motor or stuck firmly in place Unit voltage setting does not match power grid voltage No external power supply Fuses are burnt out Table 5 Malfunction of the initiation needle power switch component group 26 Error Messages and Troubleshooting Procedure Bring needle to proper length Debur tip of needle Straighten or replace needle Check upper cooling system component group Check setting for proper unit voltage of 110 V or 230 V Check for that fuse plug is seated properly Insert new fuses Check cables leading to unit Replace fuses If another cause is found the unit must be sent to customer service Component and Function Printer Print
61. www gonotec com Lo Gesellschaft f r Me und Regeltechnik mbH User Guide 7 N Pag le OSMOL KG fea Cryoscopic Osmometer OSMOMAT 030 OSMOMAT 030 gt o fens me OSMOMAT 030 osmometer series 1D HRS JM DA 003P Notes Safety Notices and Warnings The symbols and abbreviations defined below may appear on the packaging material on the unit nameplate or in the operating instructions IVD In vitro diagnostic device This product meets the requirements of C EEC Directive 98 79 relating to in vitro diagnostics Please follow the safety notices in the equipment operating instructions s Use by The date that follows indicates the expiration data as year month Attention refer to documentation Appears beside the name of the product LOT batch REF Article number or order number The following pages provide you with a step by step introduction to using maintaining and servicing the measurement equipment Passages requiring special attention are marked as follows This symbol warns against the danger of N corrupting measurement results for example through improper use of measuring vessels This symbol warns against the danger of Yi damaging the unit or the measurement a system for example through improper servicing Subject to errors and technical changes The information con
62. y value and output to the digital display The measurement result together with a 4 digit sample number and the time of day is printed out on the built in printer if switched on Use a soft paper towel to thoroughly clean the thermistor probe after each measurement The sensor may also be cleaned beforehand with a cloth moistened with water 5 1 Series Measurement Pipette the various sample solutions into a corresponding number of measuring vessels and close their lids until you are ready to begin measurement IN Be sure to identify samples uniquely A Erroneous measurements Insufficiently sealed measuring vessels can lead to evaporation of the sample solution The samples are then measured sequentially making full use of the high measuring speed of the OSMOMAT 030 Measuring a Sample Solution 17 5 Measuring a Sample Solution 5 2 Repeating a Sample Measurement To check reproducibility using repeat determinations two clean and dry measuring vessels must be filed with the same sample solution A repeat determination using just one sample is not possible as the sample separates during measurement If in exceptional circumstances a repeat determination can only be run with one sample the sample must be carefully thawed and mixed after the first measurement 18 Measuring a Sample Solution 6 Error Messages and Troubleshooting 6 Error Messages and Troubleshooting The following explains the error messages repor

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