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User Guide - Wolf Laboratories

1. Gesellschaft f r Mia und Regeltechnik mbH www gonotec com User Guide iola ilit asuren nt in Nn Teller al lt and I p ph narm Uti tical field Colloid Osmometer Oncometer OSMOMAT 050 g na ec Handbuch OSMOMAT 050 Seite 3 von 51 Notes Safety Notices and Warnings The symbols and abbreviations defined below may appear on the packaging material on the serial number plate or in the operating instructions IVD In vitro diagnostic device This product meets the requirements of EEC Directive 98 79 relating to in vitro di agnostic devices Attention refer to documentation N Please follow the safety notices in the equipment operating instructions LOT Use by The date that follows indicates the expiration date as year month kas The name of the product batch follows REF Article number or order number The following pages provide a step by step introduction to using maintaining and servicing the meas urement equipment Passages requiring special attention are marked as follows ing measurement results for example by This symbol warns of the danger of corrupt improper use of the measuring cell ing the unit or the measurement system for N This symbol warns of the danger of damag WG example as a result of improper servicing Subject to errors and technical changes The information contained in this document may be changed without prior notice 2011 Gonotec G
2. Seite 44 von 51 Handbuch OSMOMAT 050 11 Returning Parts for Warranty 11 1 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 for warranty re pair 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 N 2 Clean and disinfect the equipment before returning it to us We will charge a pro cessing fee for cleaning and disinfecting contaminated equipment Equipment that is strongly contaminated will be returned at the customer s expense 3 Enclose written information explaining the reason for returning the equipment 4 Ifthe equipment is being returned for credit you must include all accessories power cord software disks manuals etc 5 Return the equipment in its original packaging If you no longer have the original packaging you may purchase replacement packaging from Gonotec 11 2 Before Calling Gonotec Note When calling Gonotec have your unit s serial number ready The serial number helps our ser vice 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 ot
3. Unscrew and remove lower measuring cell by loosening the two screws below the housing 5 Remove the lower measuring cell and the large O ring 63 22 x 1 78 mm 6 Loosen the counter nut and unscrew and remove the pressure transducer from the measuring cell Remove the small O ring from the measuring cell and do not reuse under any circumstanes 7 Thoroughly rinse the lower half of the measuring cell using water and dry Version 1 1 2011 10 12 Handbuch OSMOMAT 050 Seite 49 von 51 13 2 2 Assembly The pressure transducer is delivered with a cable tie and a new O ring For devices up to serial number 101122 where the pressure transducer is replaced for the first time the lower measuring cell must be replaced as well New lower measuring cell Old lower measuring cell New pressure transducer Old pressure transducer Version 1 1 2011 10 12 Seite 50 von 51 Handbuch OSMOMAT 050 1 If you already have a new lower measuring cell you have to remove the old O ring 2 Clean the lower measuring cell with cleaning solution and rinse it with water very carefully Install the new O ring 2 mm in the lower measuring cell 3 Screw the pressure transducer into the lower half of the measuring cell It may be necessary to back off the counter nut a bit Screw in the pressure transducer with moderate force until the O ring is pressed against the cell and the ring becomes visibly deep dark Version 1 1 20
4. the alarm is silenced and you can proceed to open carefully Loosen the tension screw flip back the clamping yoke and remove the upper half of the measuring cell Remove the O ring and the old membrane together with the filter paper using the tweezers Clean the O ring with water and keep it immersed in water until installation 4 7 Cleaning and Filling the Lower Half of the Measuring cell To clean the lower half of the measuring cell first fill it with water up to the upper rim and then clean it using a cotton tip or paper tissue Next fill it with ethanol and insert the tuberculin syringe with special cannula from the standard accessories into the vertical bore at the bottom of the lower half of the measuring cell Figure 4 6 This bore connects the measuring cell with the pressure transducer Us ing the supplied cannula ensures that the pressure membrane is not destroyed Never use other cannulas especially longer ones because they would puncture the W delicate membrane of the pressure transducer Aspirate ethanol into the bore using the tuberculin syringe Repeated eject aspirate cycles clean the bore and deaerate the area above the pressure transducer which means that all the air bubbles are removed Version 1 1 2011 10 12 Page 22 of51 OSMOMAT 050 User Guide Next immediately remove the ethanol using a paper tissue Figure 4 7 and add distilled water If the alcohol remains in the measuring cell too long it aff
5. 1 13 2 13 2 1 13 2 2 Classification of Malfunctions 2 2202u2222020 35 Maintenance of the OSMOMAT 050 00 38 Requirements of the Medical Devices Operator Ordinance cccccccseeeeeeeeeseeeeaeeeeaeeees 38 Safety Checks 8 6 of Medical Devices Operator Ordinance cccccceeceeeeeeeeeeeeeeeeeeees 38 Measurement Checks 11 of Medical Devices Operator Ordinance 38 Internal Quality Control of the OSMOMAT 050 ce ceecccccccseeeeeeeeceeeeseeeeseeeeseeesaeeeseneesaees 39 Replacing a Defective Power FUSGC ccccccccssccceeecceeeceuceceucecaueeceeseueeceusesaueesaeeseaeesegeess 39 Forfeiture of Measurement System Warranty cccccccccsecccsseeceeeeseeeeseeeeaeeesseeesaeeeseeeeseees 39 Specifications TOF RS 232 Interface anne een neta ware ad aaa eiieestecdereee 40 Transmission SOM WANG 1 nen ee 40 je 01 1 4 3 gt lent net enn eee ee een ee ere 41 LOHN SU ADIOS u eee eee ne Er ee ene eee ee ee enn eee E eee eee 41 Accessories and Sal CAINS acirrada een 41 GIASSINCAUONEOL Wi AY D nee een 42 EC Compliance Statement OSMOMAT 050 cccccececsssesessecescecercesecerseserersacerervatenvesenenes 42 PLOVISJONS Or GE UNE AUO een een 42 Limited Warranty een een 43 Returning Parts for Warranty 22 2002000200200 20000 44 REDAI OF CI lee een ee ee een 44 BEIOre Calling fC 6 a 6 gt ee ee ee ee ee ee 44
6. OSMOMAT 050 User Guide 1 4 Reproducibility of the OSMOMAT 050 Measurement display 3 digits 73 mm HG 100 cm water column or 9 99 kPa 0 1 mm HG over the entire measurement range Reproducibility lt 0 5 mm HG Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 9 of51 1 5 Unpacking the OSMOMAT 050 Colloid Osmometer The OSMOMAT 050 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 030 7809588 0 GSG Hof Fax 030 7809588 88 Reuchlinstr 10 11 E mail contact gonotec com D 10553 Berlin Web www gonotec com Toll free service number for Germany 0800 7846027 The reusable packaging for this equipment was specially designed to ensure safe and hygienic transport Please save the packaging in case the unit needs to be shipped back to Gonotec for repair or servicing 1 6 Packaging Contents Check to make sure the contents of your shipment are complete We cannot accept responsibility for any missing items reported at a later date Accessories and consumables included in the shipment Item number 20 9 0100 1 power cord 20 9 0160 1 RS 232 cable 1 package of small parts including 00 9 0102 2 fine wire fuses 230V 250mA 50 9 0040 1 small O ring 26 x 2 mm 50 9 0060 2 pump tubes 9 5 cm 50 9 0070 2 tube nipples 50 9 0030 10 silicon septa 50 9 0020 1 package containing 5 membranes 20 000 dal
7. 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 exceptions 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 B 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 THE GONOTEC PRODUCTS Page 43 of 51 C 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 OBLI GATIONS EXPRESSLY NAMED HERE NEITHER GONOTEC NOR ITS SUPPLIERS SHALL BE LIABLE FOR DIRECT OR INDIRECT SPECIFIC INCIDENTAL OR CON SEQUENTIAL LOSSES WHETHER BASED ON A CON TRACT 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 custo
8. cm water column the overload warning light comes on Figure 4 13 When an alarm sounds you must immediately stop the screwing operation otherwise the pressure transducer will be destroyed You may resume after the pressure has decreased enough so that the overload LED goes off Figure 4 12 Overpressure indicated by flashing Figure 4 13 Overpressure indicated by digits overload LED The measuring cell is screwed together in small increments until the end stop is reached by firmly turning by hand Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 25 of51 This dark ring must be evenly visible Figure 4 14 Upper measuring cell completely tightened The semipermeable membrane becomes slightly transparent and a uniform somewhat dark ring is visible at the edge of the membrane Figure 4 14 The displaced Ringer s solution collected in the overflow channel of the lower half of the measuring cell can be removed using a paper tissue Version 1 1 2011 10 12 Page 26 of51 OSMOMAT 050 User Guide 5 Calibrating the OSMOMAT 050 5 1 Calibration Using the Hydrostatic Pressure Difference The prerequisite for calibrating the OSMOMAT 050 is the assembly of the measurement system ac cording to chapter 4 8 and the stabilization of the pressure inside the cell Calibration is performed directly by creating a hydrostatic pressure difference To fill all tubes without air bubbles press the Pumpe button at the back panel
9. cut off 20 000 dalton 5 50 9 0030 Silicon rubber septa 10 50 9 0040 O ring 26 x 2 mm for measuring cell 5 50 9 0050 Connecting tube Tygon 1 12 m 0 04 internal 1 50 9 0060 Tubes for peristaltic pump Tygon 9 5 cm 3 32 internal 5 50 9 0070 Tube nipples for tube pump 2 50 9 0080 Plastic tuberculin syringe with special cannula 16 mm 2 50 9 0090 30 mL plastic syringe with tube and clamp 1 50 9 0100 250 uL precision syringe with special cannula for septum injection 1 50 9 0130 Plastic bottles 250 mL supply waste bottles 2 50 9 0140 Tool for widening the tube ends 1 50 9 0150 Tweezers for membranes 1 50 9 0160 Plunger for supply waste bottles 2 50 9 0180 Bottle of cleaning solution 1 9 2 Accessories and Spare Parts Item no Item gun unit qty 00 9 0102 Package with 10 fine wire fuses 0 25A slow 220V 1 00 9 0104 Package with 10 fine wire fuses 0 5A slow 110V 1 20 9 0100 Power cord 2 meters 1 20 9 0120 Connector cable for recorder 1 20 9 0160 Data cable for RS 232 interface OSMOMAT 030 050 010 1 50 2 0020 Lower measuring cell 1 50 2 0030 Upper measuring cell 1 50 2 0040 Peristaltic pump complete 1 50 3 0010 Pressure transducer complete 1 50 5 0030 Mainboard 050 KOP 1 from series 1990 1 50 9 0170 Septum screw 1 Version 1 1 2011 10 12 Page 42 of51 OSMOMAT 050 User Guide 9 3 Classification of the IVD The Gonotec OSMOMAT 050 colloid osmometer is a non invasive in vitro diagnostic product accord ing to EEC Directive 93 42
10. is created which causes steam bubbles to form and removes the remaining air from the filter paper texture The filter paper may remain inside the syringe together with the Ring er s solution until used in the measuring cell Figure 4 5 Syringe with Ringer s solution and filter paper Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 21 of51 4 6 Opening the Measuring cell As described in chapter 3 you must first switch on the device Press the CALIBRATION button to check the pressure ratios and protect the pressure transducer The indicator light of the button lights up and after approx 10 20 seconds the digital display shows 00 0 The display has a direct connec tion to the pressure gauge and shows the pressure ratios of the pressure transducer 4 6 1 Initial Startup with Dry Measuring cell When the system is delivered a piece of filter paper is placed in the lower half of the measuring cell to prevent damage during shipping To open the measuring cell loosen the tension screw and flip back the clamping yoke Then remove the upper half of the measuring cell Remove the O ring and the filter paper from the cell It will be reused during assembly 4 6 2 Removing the Membrane When the Measuring cell is Filled If the measuring cell is already filled great care must be taken during unscrewing while closely moni toring the pressure reading If the alarm sounds stop unscrewing immediately After pressure com pensation
11. to the automatic rinsing mechanism In standby state both cells contain a solvent such as Ringer s solution isotonic NaCl solution to prevent pressure drops and ensure that the pressure measurement membrane is relaxed After adding a sample with a higher colloid osmotic oncotic pressure e g serum or plasma to the sample cell permeation of solvent causes underpressure in the reference cell based on the laws of osmosis because the membrane is impenetrable to proteins this can only be achieved by a flow of solvent This is measured by a pressure transducer amplified electronically and displayed as posi tive direct colloid osmotic pressure COP value either in mm Hg mm of mercury cm H20 or k Pascal By default the reading is displayed in mm Hg The measurement unit can be switched by pressing the corresponding buttons on the digital display Different types of semipermeable membranes with varying permeability pore size can be used for macro molecules with different molecular weights This results in a characteristic reference number for each type of membrane the so called membrane cut off indicated in dalton units Membranes with a cut off of 10 000 or 20 000 dalton have proven to be very useful in practical applications Sample cell Reference cell Semipermeable membrane Pressure transducer Amplifier Display Figure 1 1 Schematic figure of the measuremet principle Version 1 1 2011 10 12 Page 8 of51
12. 02000 00000 nnnnnnnn nenne nenne nenne nnnn nano nenne nenne nnnnnnnnenn 21 Initial Startup with Dry Measuring cell 2 200220002200Rennenennnnnnnnnne nenne nennonnnn anne nennen 21 Removing the Membrane When the Measuring cell is Filled 20022002240 Rn 21 Cleaning and Filling the Lower Half of the Measuring cell 002200222002220 nennen 21 Screwing Together the Measuring cell 0022200200002000 Benno nenn nenn nnnnn nenne nenn nnnnn nennen 23 Calibrating the OSMOMAT O50 2 2u02200n0n2n00n0 26 Calibration Using the Hydrostatic Pressure Difference 200220022002200nnnnnnennnennnenen 26 Measuring the Colloid Osmotic Pressure 28 Prerequisites for MEASULEMENL ccccceccceececeeeeseeceeeeeeeeeeseeeeseeeeseeeeseeeseeeeseueeseeetseeesseeess 28 Sample Material oe ne ed a na an eee Eee en ee 29 Display of the OSMOMAT O30 uu0220022ssenennenennnnenennnnenennenennnnnnnnnnnenennenennnnnnn nenn nennen 29 Performing the Measurement 2 200224002240000n0 Rene nenne nenne nenn nenn nnnnenennenennennnn nenn ernennen 30 Recording and Storing the Second Measurement Value 022202200222002n0 ernennen 32 Version 1 1 2011 10 12 Handbuch OSMOMAT 050 Seite 5 von 51 7 8 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 9 9 1 9 2 9 3 9 4 9 5 10 11 11 1 11 2 12 13 13
13. 11 10 12 Handbuch OSMOMAT 050 Seite 51 von 51 4 Screw the counter nut against the measuring cell to secure the system 5 Assembly of the lower measuring cell Replace the large O ring 63 22 x 1 78 mm in the lower half of the cell and reinstall the cell half into the housing from below using the two screws Insert the yellow LED into the designated bore and secure using cable tie Plug the connector of the pressure transducer into the mainboard and replace the lower hous ing cover using the six screws The OSMOMAT 050 is ready for use again Version 1 1 2011 10 12
14. Medical Devices Law The OSMOMAT 050 colloid osmometer is not named in Annex Il list A or B of the Directive 98 79 EEC for in vitro diagnostics Compliance is de clared per Annex III Number 6 of Annex II is disregarded since the unit s intended use does not in clude personal use 9 4 EC Compliance Statement OSMOMAT 050 Gonotec GmbH GSG Hof Reuchlinstr 10 11 D 10553 Berlin We hereby declare that the OSMOMAT 050 colloid osmometer complies with Directive 98 79 EEC Compliance is declared per Annex III of the Directive The CE mark on the unit acknowledges this Date Signature of managing director 9 5 Provisions of Certification CE compliance requires that the unit is 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 Version 1 1 2011 10 12 OSMOMAT 050 User Guide 10 Limited Warranty Gonotec product Duration of Limited Warranty Software 90 days Pressure transducer 180 days Osmometer 2 years A Extension of the Limited Warranty Gonotec warrants the end user that Gonotec products shall be free from manufacturing and material defects for the above periods of validity from the purchase date The end user must provide pr
15. Specifications of the OSMOMAT 050 uzuusuu2u200s 45 Service Instructions for Replacing a Defective Pressure IransQaUCer use nesses 46 When is a replacement of the pressure transducer required cccccceecceeeeeeeseeeeeeeeeeees 46 OTU TNS a NEE NE EINE A A E A E A EE 47 PS ASS CUNO A EEE A ee aie ware ncaa sake are oon neaeke E E N E E ET 47 PASS SO chen teetering ee Herne de nate ee Hemme EA e eisernen 49 Version 1 1 2011 10 12 Page 6 of51 OSMOMAT 050 User Guide 1 Introduction 1 1 Applications of the OSMOMAT 050 The Gonotec OSMOMAT 050 colloid osmometer is a non invasive in vitro diagnostic device for in vitro analysis of human blood and other samples Its purpose is to provide information to help identify diagnose monitor and treat physiological conditions states of health and diseases The equipment may only be operated by specialists or those persons whose training or skills have provided them with the necessary practical experience see MPBetreibV German Medical Devices Operator Ordinance The OSMOMAT 050 colloid osmometer is particularly suited for routine measurements in medical applications as well as the molecular weight determination in aqueous solutions in industry and re search applications The OSMOMAT 050 colloid osmometer determines the colloid osmotic pressure COP of blood plasma The main diagnostic considerations for determining the colloid osmotic pres sure in medical applicatio
16. a ble disinfectant and daily emptying and rinsing of the bottle when the device is in use 4 4 Preparing the Semipermeable Membrane 4 4 1 Selecting suitable membranes The semipermeable membrane is a main component of the osmotic cell The defined pore size allows only the lower molecular solvent and the electrolytes to permeate while the higher molecular sub stances of the measurement solution are retained In addition the membrane material seals the os motic cell The pore size or pore size range is the typical factor for the retention and is called cut off The mem branes used for membrane osmometry usually have a cut off between 5 000 and 30 000 dalton The pore sizes specified by the membrane manufacturers are reference values only They do not indicate the actual pore size or an existing pore size distribution Increasing the cut off may result in lower colloid osmotic pressures Only membranes with very thin layers containing a supporting material for mechanical reasons so called two layer membranes can provide adequate permeability Depending on the manufacturer both layers are made of the same or different materials Aqueous solutions can be used for virtually all membrane materials A It is strictly necessary that the membrane has a diameter of 25 mm 0 0 5 mm Membranes from other manufacturers can be slightly bigger and in that case must be trimmed with scissors We recommend a membrane material with a cut off ret
17. amage to the pressure transducer is excluded from the warranty service Version 1 1 2011 10 12 Page 40 of51 OSMOMAT 050 User Guide 8 7 Specifications for RS 232 Interface Baud rate Transmission speed 1200 bps Data format One start bit 8 data bits and 2 stop bits are sent Signals TXD Transmit Data output Idle level 3V gt gt U gt gt 7 5V Active level 3V lt lt U lt lt 7 5V DTR Data Terminal Ready output This signal indicates the transmission readiness of the OSMOMAT 050 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 050 starts transmitting only after DSR becomes active The user does not need to activate this signal since it is equipped with an inter nal 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 8 Transmission Software We recommend using our TERMINAL SOFTWARE for easy data transmission to a PC and a data acquisition that is optimized for the osmometer In principle any other terminal software can be used but the data format will have to be adjusted Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 41 of51 9 Appendix 9 1 Consumables Item no Item paca unit qty 50 9 0010 Membranes cut off 10 000 dalton 5 50 9 0020 Membranes
18. caused by an air bubble located below the membrane In this case briefly lift up the membrane remove the air bubble and wait until the membrane has an even gray coloring Version 1 1 2011 10 12 Page 20 of51 OSMOMAT 050 User Guide 4 5 Preparing the Filter Paper and Degassing the Solvent A piece of filter paper must be placed below the semipermeable membrane to act as a leveling disk for the membranes recommended by us This filter paper increases the small thickness of the membranes from 0 10 to 0 15 mm to an overall thickness of 0 3 mm and creates the correct bonding pressure when screwing together the measuring cell The filter paper is not required when using membranes with a thickness of 0 3 mm It is supplied by us along with the membranes and acts as a separating layer between the mem branes The filter paper must be degassed before use in the measuring cell Degassing the filter paper requires a lot of care because all air bubbles must be removed from the paper It is recommended to degase use to degas the filter paper together with the Ringer s solution with the 30 mL syringe see chapter 4 2 Pull the plunger out of the syringe place the filter paper in the syringe cylinder and reinsert the plung er Do not fold the filter paper Next aspirate approx 15 mL of Ringer s solution into the syringe re move the air from the syringe and clamp shut the aspiration tube using the tube clamp By pulling the plunger firmly a vacuum
19. de 8 Maintenance of the OSMOMAT 050 8 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 medical devices listed in Annexes 7 and 2 of the Medical Devices Operator Ordinance 8 2 Safety Checks 6 of Medical Devices Operator Ordinance The OSMOMAT 050 is not listed in Annex 1 of the Medical Devices Operator Ordinance Public au thorities do not require the unit to undergo safety checks u Safety checks should be conducted by the on site safety coordinator in accordance VA with relevant accident prevention guidelines 8 3 Measurement Checks 11 of Medical Devices Operator Ordinance The Osmomat 050 is not listed in Annex 2 of the Medical Devices Operator Ordinance No measure ment checks are stipulated by the Ordinance Nonetheless the user should perform the following checks e Checking and filling the solvent bottle e Emptying the waste bottle e Calibrating the device The calibration frequency should comply with local quality assurance guidelines Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 39 of 51 8 4 Internal Quality Control of the OSMOMAT 050 A
20. e OSMOMAT 050 from the power connector on the back 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 substi tute another power cord It is essential however that the cable s green yellow wire is connected to the safety grounding It is also important to ensure that the voltage indicated on the serial number plate Sr matches that of your electricity network Incorrect voltage will cause the fuse in the power supply unit to blow The OSMOMAT 050 can now be switched on via the power switch on the back of the unit next to the power connector All work unscrewing screwing together or adding solvents must only be performed Y 17 with the device switched on and in calibration mode can be set by pressing the CALI BRATION button Excess pressure which may result in the destruction of the pressure transducer is indicated on the display This happens in three stages In the first stage the display shows 99 9 and flashes If the pressure increases the overload LED lights up in the second stage If the pressure still increases an alarm sounds When the alarm sounds the pressure gauge is at approx 50 of the burst pressure If you continue to screw together or open the system the highly sensitive pressure transducer will be destroyed The WARRANTY is voided for a pressure transducer dest
21. e osmotic pressure when the sample does pressure when lower molecular parts of pressure when the pores of the semiperme m not contain lower molecular parts the sample permeate through the semi able membrane are clogged The measure permeable membrane ment is aborted after 4 5 minutes 2nd measurement 9 minutes respectively 1st measurement value 1st measurement value value 2nd measurement value 1st measurement value a 2nd measurement value Te 0 oo Injection Injection Injection a b a b a b t min Measurement time a always corresponds to b The criterion for recording the 1st measurement value is a stable value or a reversal point Figure 6 9 Adjustment characteristic Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 35 of51 7 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 sys tem the possible causes of the malfunctions and the procedure for correcting each malfunction Some errors can be remedied directly by the user or an in house medical equipment technician other errors require return of the unit to the manufacturer Version 1 1 2011 10 12 Page 36 of 51 OSMOMAT 050 User Guide Components Possible Cause Function Lower measur Long adjustment time Air bubbles in lower half of m
22. e pressure measurement membrane If the device is not used for an extended period of time several weeks the measuring Y cell must be opened and rinsed using distilled water Afterwards the device can be switched off Y 7 When working on the pressure transducer the device must always be switched on Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 15 of51 4 Preparing the Measuring cell for Measurement To prepare the measuring cell you need the tools and accessories included with the standard acces sories as well as a suitable solvent distilled water and the prepared semipermeable membrane and filter paper see chapter 4 4 4 1 Making the Tube Connections during Initial Startup The tubes included with the standard accessories are connected according to Figure 4 1 Making the tube connections Connection tube between ground and waste bottle Connection tube between supply bottle and pump Connection tube between measuring cell Bore for pressure compensation nn Ground and ground Upper measuring cell Ringer s solution Waste minimum Pecan Tube nipples Tube pump fill level 1 cm Septum screw Pump tube Supply bottle Waste bottle p lunger lunger piung pung Lower measuring cell Connection tube between pump and measuring cell Figure 4 1 Making the tube connections Use only the Tygon tubes supplied by the manufacturer Other tubing material is per meable to air which causes air bubbles that may s
23. easuring cell Open and clean cell again fill ing cell after inserting a new with degassed solvent and membrane insert a new membrane Membrane Membrane impermeable pore size too Insert fresh membrane with small or membrane stored too long cut off 20 000 dalton No measurement Membrane inserted incorrectly active side Insert anew membrane into value measurement facing down the cell active side facing up value is 0 when measuring a sample no problems during Measuring cell is not yet screwed together Screw cell together more calibration tightly enough tightly Reproducibility of Pump tube too old flagged Part of the Replace pump tube measurement value is injected sample flows toward the pump Clean replace tube nipple unsatisfactory mea surement value too System partially clogged between measur All tubes behind the measur low ing cell and waste bottle ing cell the plunger of the waste bottle the channel and the outlet cannula in the upper half of the measuring cell must be cleaned Strong fluctuations of ambient temperature Move device to different loca direct sunlight draft etc tion Air bubbles in tube between measuring cell Rinse out air bubbles and waste bottle Waste bottle is empty therefore no defined Fill waste bottle with a bit of zero point exists water approx 10 mm The plunger in the waste bottle does not Check position of plunger hold the tube on the bottom of the bottle Measur
24. ects the plastic material which be comes opaque Figure 4 6 Filling the lower measuring cell Figure 4 7 Cleaning the lower measuring cell Use the tuberculin syringe again to aspirate the distilled water into the bore in the lower half of the measuring cell Watch closely to ensure that no air bubbles form Next remove the water from the measuring cell using a paper tissue Figure 4 8 Adding the degassed solvent The lower half of the measuring cell is now cleaned and you can add the solvent Use the 30 mL syringe to add the degassed Ringer s solution Figure 4 5 After adding the degassed solvent rinse the bore of the lower half of the measuring cell using the tuberculin syringe again Dur ing injection do not push the syringe plunger all the way to the end to prevent air bubbles from being pushed into the bore Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 23 of51 The purpose of this cleaning procedure is to free the entire bottom of the measuring cell as well as the bore and the area above the pressure transducer from tiny adhering air bubbles Air bubbles in the measurement system prolong the measuring time and falsify the measurement result 4 8 Screwing Together the Measuring cell Add degassed Ringer s solution up to the rim of the cleaned and deaerated lower half of the measur ing cell Install the O ring 26 mm Next remove the degassed filter paper from the 30 mL syringe and place it at the bottom
25. ennen 9 Packaging ONC US nee een een 9 Overview of the OSMOMAT 050 uz22202202200000200000 10 Overview of Display and ConnectorsS 022200024002ennnennnnnnennnnn nenne nennnnne nano nennenennennne nennen 10 POWER S 6 S Y se ee ee E A E E 12 NM CMSIONS And VV EICH len see ee ee 12 Safety and Handling Information u0 2002240020000n0n0 nenne nenne nenn ennne nenne nenne nennenenn nennen 12 Known Risks Associated with the Use of the OSMOMAT 080 uu222002220enennnnnenennenenn 12 Setup and Initial Operation u220200200n0nn0n 13 Preparing the Measuring cell for Measurement 15 Making the Tube Connections during Initial Startup cc ceccceccseeeeeeeeeseeeeseeeeseeesaeees 15 Ringers SOlUNON as Solvent nn 17 Filling the Supply and Waste Bottles 2220022200200002nno nenne nennenenn nenn nenne nennenenn nennen 18 Preparing the Semipermeable Membrane 22200222002000000no nenne nenn nenn nenn nennenenn 18 Selecting suitable membranes 0022400220002000nnnnn nenne nenn nenn nenn nenne nennenennenenn nenn nennen 18 Conditioning the membrane 2 2s0222000000000n0nnnno nenne nun nnnnnnnnn nenne nenne nnnnennnnnnnnnnnnnenn 19 Preparing the Filter Paper and Degassing the Solvent u0022002220020n0nenn nenn ennenenn 20 Opening the Measuring cell 2 2u0222002000
26. ent 1 Press the START button The zero point is re checked internally indicated by BUSY LED lighting up Fig 6 2 After approx 10 seconds the INJECT LED and the LED on the lower measuring cell flash and prompt to inject the sample Fig 6 3 Aspirate a sample volume of 150 250 uL Make sure to fill the syringe without air bubbles Figure 6 2 Checking the zero point Figure 6 3 Injection prompt 3 Injecting the sample Insert the cannula through the septum as far as it will go It is impossible to puncture the membrane during this procedure Inject the sample into the measuring cell using three equal cycles of approx 50 uL Fig 6 4 This push injection increases the rinsing effect and creates an overpressure which is the trigger impulse to start the measurement program of the OSMOMAT 050 It must be prevented to inject air bubbles or foam Therefore the syringe plunger should not be pushed all the way to the end After injection remove the syringe and clean it using water Figure 6 4 Injection in three stages Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 31 of 51 4 Recording the pressure value After inserting the needle through the septum and injecting the sample the INJECT LED goes off and LED 2 indicates that the measurement sequence has started _ _ Figure 6 5 It takes approx 30 seconds up to a maximum of 4 5 minutes for the balance of the osmotic under
27. ention of higher than 10 000 g Mol and of higher than 20 000 g Mol The membranes are typically supplied dry with the pores filled with glycerin The dry membranes sup plied by Gonotec are each separated by filter paper The membrane must be conditioned in water before installation in the measuring cell of the OSMOMAT 050 Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 19 of 51 4 4 2 Conditioning the membrane The membrane is placed with the shiny side onto the surface of distilled water while keeping the sup porting layer dull side dry The water penetrates the pores from below and displaces the glycerin After a short time small water droplets are visible on the supporting side and the membrane shows a slight discoloration The membrane remains on the water surface until it is evenly discolored Depending on the pore di ameter this can take from a few seconds to an hour Next the membrane is completely submerged into the water and ready for installation into the mem brane osmometer for measurement of aqueous solvents N It is important to install the membrane in the measuring cell with the active shiny layer facing up If necessary you can verify which of the two sides is the active layer Carefully remove the membrane from the water using tweezers The active side of the membrane has hydrophobic properties while the supporting layer is hydrophilic Figure 4 4 Conditioned membrane The white spot was
28. er especially the pressure transducer Suction off residual water using special cannula dry cell by using paper and loosely replace screw cap with dry filter paper inserted The unit does not emit harmful substances either during operation or when switched off Symbols on the unit and serial number plate correspond to the requirements of the following stand ards DIN EN 61010 1 DIN EN 375 and DIN EN 980 harmonized standard for medical devices ac cording to 3 No 17 of the German Medical Device Law MPG 2 5 Known Risks Associated with the Use of the OSMOMAT 050 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 be excluded entirely for technical equipment how ever This operating instruction helps you gain a basic understanding of the design the measurement prin ciple maintenance and servicing of the unit Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 13 of51 3 Setup and Initial Operation The unit must be placed in a location free from vibrations and must be 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 It is strictly necessary to place the device on a very sturdy surface Otherwise the sensitive pressure measurement and the automatic end point detection may be disturbed Use the power cord provided to connect th
29. er obtaining the first measurement result RS 232 C 230V 10 50 60 Hz 20 VA Special versions 115V or 100V available Width 36cm Height 25 cm Depth 35 5 cm 5 1 kg excluding bottles Version 1 1 2011 10 12 Seite 46 von 51 Handbuch OSMOMAT 050 13Service Instructions for Replacing a Defective Pressure Transducer 13 1 When is a replacement of the pressure transducer required The pressure transducer must be replaced in the following cases 1 The OSMOMAT 050 no longer switches to STAND BY mode 2 A continuous alarm sounds even when the measuring cell is open 3 The solvent added to the opened measuring cell flows downward through the pressure transducer The pressure transducer can be replaced by trained medical technicians by following these instruc tions A new pressure transducer can be ordered using order no 50 3 0010 The serial number of your de vice must be communicated because devices up to serial number 101122 also require replacement of the lower measuring cell due to a component change by the manufacturer of the sensor Package contents e 1 pressure transducer complete with board and cable e 1Oring e 1 cable tie Version 1 1 2011 10 12 Handbuch OSMOMAT 050 Seite 47 von 51 13 2 Instructions 13 2 1 Disassembly 1 Unscrew and remove lower front panel 6 screws 2 Unplug pressure transducer connector from board Version 1 1 2011 10 12 Seite 48 von 51 Handbuch OSMOMAT 050 4
30. esellschaft fur Me und Regeltechnik mbH All rights reserved Reproduction of this document in any form is permissible only with the prior written consent of Gonotec Gesellschaft fur MeR und Regeltechnik mbH Trademarks used in this document GONOTEC and OSMOMAT are trademarks of Gonotec Gesellschaft fur Me und Regel technik mbH Other trademarks and trade names used in this document may be trademarks or names of the corresponding companies or their products Gonotec Gesellschaft fur Me und Regeltechnik mbH does not assert any claim to trademarks or trade names other than its own Version 1 1 2011 10 12 Seite 4 von 51 Handbuch OSMOMAT 050 Table of contents 1 1 1 1 2 1 3 1 4 1 5 1 6 2 2 1 2 2 2 3 2 4 2 5 3 4 4 1 4 2 4 3 4 4 4 4 1 4 4 2 4 5 4 6 4 6 1 4 6 2 4 7 4 8 5 5 1 6 6 1 6 2 6 3 6 4 6 5 BENE NG O aeaa eE E A ESE 6 Applications of the OSMOMAT 050 u22uusssnennnnenennenennnnnnnnnnnnennonennnnnnnnnnnenennenennnnene nennen 6 Application Restrictions of the OSMOMAT O3D uu2220022002nnnonennenennonennnnnnenennonennnnenennnnenn 7 Measurement Method of the OSMOMAT 050 u022000220002n0enennnnnnnnnn nenne nennenenn nenn nennen 7 Reproducibility of the OSMOMAT O30 2uu022ssusnensennsnnennnnnennnnnnnnnnnonennnnnenne nenne nennen 8 Unpacking the OSMOMAT 050 Colloid Osmometer 2220022200200000nn nenne nenn nenn n
31. everely impact or prevent the measurement Version 1 1 2011 10 12 Page 16 of51 OSMOMAT 050 User Guide The tubes are pushed onto the stainless steel tubes by about 5 mm The tool for widening the tube ends 50 9 0140 included with the standard accessories is used for this purpose The tube end is held using sandpaper and widened using the moistened tip of the tool The connection tubes for the supply and waste bottles are passed through a bore of the unscrewed cap and pushed onto the corresponding plungers Figure 4 2 The plungers hold the tubes on the bottom of the bottles The second opening on the cap provides unrestricted atmospheric pressure compensation Figure 4 2 Plunger Connection tube between supply bottle and pump Connection tube between ground bolt and waste bottle Connection tube between pump and measuring cell Connection tube between measuring cell and ground bolt Table 4 1 Tube lengths Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 17 of51 4 2 Ringer s Solution as Solvent The Ringer s solution should be a pure Ringer s electrolyte solution without added lactates or other substances If necessary the solution can be self made Sodium chloride 0 8g Potassium chloride 0 02 g Calcium chloride 0 02 g Sodium bicarbonate 0 1g use distilled water to fill up to 100 cm In exceptional cases you can also use an isotonic saline solution with a concentration of 0 9 NaCl The solvent used
32. for preparing the lower half of the measuring cell must not contain any amount of solved gasjair If necessary it must first be degassed by heating up just under the boiling point or by degassing under vacuum We recommend using the 30 mL plastic syringe included in the accessories for a simple way to degas the solvent Figure 4 3 Figure 4 3 Plastic syringe with tube clamp Approx 20 mL of the solvent are aspirated using the connected silicon rubber tube Next the tube is clamped shut using the tube clamp and a vacuum is created by firmly pulling the syringe plunger The liquid is shaken and then the tube clamp is opened again The gas can escape This operation is re peated three to four times to degas the solvent The degassed solvent is later added to the lower half of the cell directly from the syringe Figure 4 8 Version 1 1 2011 10 12 Page 18 of51 OSMOMAT 050 User Guide 4 3 Filling the Supply and Waste Bottles Add the Ringer s solution mentioned earlier to the supply bottle and screw on the cap Place the supply bottle in the rear position on the bottle tray The waste bottle collects the measured sample and the used solvent required to rinse the measuring cell The waste bottle must have a constant fill level of minimum 10 mm required during measure ment and calibration as hydrostatic reference value for the zero point For safety reasons risk of infection we recommend adding a small amount of a commercially avail
33. her 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 notic es in the appropriate chapters of this manual Version 1 1 2011 10 12 Handbuch OSMOMAT 050 Seite 45 von 51 12 Specifications of the OSMOMAT 050 Cell volume Sample volume Adding sample Membrane material Zero point setting Measurement time Measuring range Reproducibility Calibration Measurement display Recorder output Automation Data output Power connection Dimensions and Weight Subject to technical changes lt 10 uL gt 100 uL by injection syringe through a septum injector integrated into the measuring cell Two layer membrane retention of molecular weights gt 10 000 30 000 dalton depending on type automatic lt 1 minute up to approx 3 minutes depending on membrane type 73 mm HG 100 cm H2O column or 9 99 k Pascal lt 0 5 mm HG direct pressure calibration through hydrostatic solvent col umn or using solutions of known concentration 3 digit 2 mV digit adjustable 10 for strip chart recorder with 1 Volt maximum deflection 1 Automatic rinsing of the upper half of the cell to maintain measurement readiness using the built in tube pump Storage of measurement results Storage of an additional measurement value fol lowing a specific delay aft
34. ing cell is not yet screwed together Screw measuring cell together tightly enough more tightly Entry of measuring cell is clogged Open and clean measuring cell Version 1 1 2011 10 12 OSMOMAT 050 User Guide Components Function Pressure transducer Possible Cause The red Overload LED lights up when injecting a sample or during automatic rins ing of the measuring cell using solvent The system is partially clogged between the measuring cell and the waste bottle Liquid leaks from the tube connection be tween measuring cell and pump when in jecting the sample Entry of measuring cell is clogged Device rinses the measuring cell in pe riodic intervals and no longer switches to The measuring cell was dry for an extend STAND BY position ed period of time and salt crystals have Device finds no base formed line characteristic Pressure transducer is defective pressure measurement membrane destroyed solvent leaks from the Septum leaking septum during injec tion Salt crust forms below the septum screw Version 1 1 2011 10 12 Page 37 of 51 All tubes behind the measur ing cell the plunger of the waste bottle the channel and the outlet cannula in the upper half of the measuring cell must be cleaned Open and clean measuring cell Pressure transducer must be replaced Open measuring cell and rinse using distilled water Replace septum Page 38 of 51 OSMOMAT 050 User Gui
35. int The setting of the zero point should also take less than 10 seconds The measurement system is still subject to a slight drift directly after installing the membrane The zero point deviates slightly Therefore calibration shouldn t be performed until the pressure ratios have completely stabilized Also it should be repeated once or twice 6 Measuring the Colloid Osmotic Pressure 6 1 Prerequisites for Measurement The OSMOMAT 050 prepared according to item 4 and calibrated according to item 5 as well as a precision syringe with special cannula for injecting the sample included with the accessories order no 50 9 0100 are required to perform a measurement This special cannula has a needle shaped tip with a lateral opening which creates a clean self sealing hole when puncturing the silicon septum Standard injection cannulas cut out rubber particles during injection clogging the measuring cell and rendering the silicon septum unusable The STANDBY LED indicates that the OSMOMAT 050 is ready for measurement If the unit was not used for an extended period of time you should press the RESET button prior to measurement This will rinse the measuring cell and reset the zero point Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 29 of 51 6 2 Sample Material Any aqueous sample with macro molecules can be measured In medical applications the colloid osmotic pressure of blood samples is measured To prevent coagulatio
36. mer may have other legal claims that go beyond ttube 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 applica ble laws For this reason certain warranty exclusions and restrictions outlined here may be of no relevance to the cus tomer In some states of the US in some Canadian provinces and in some countries outside North America for example the following national laws apply Exclusion of the fact that the warranty exclusions and re strictions named here restrict the legal rights of a customer for example Great Britain Restriction of the possibilities for manufacturers to enforce such warranty exclusions and restrictions Granting of additional warranty claims for the customer fixing of the validity period for implied warranty services that the manufacturer may not exclude or non admission of re strictions relating to the validity period for implied warranty services THE FOLLOWING APPLIES TO CONSUMER TRANSAC TIONS IN AUSTRALIA AND NEW ZEALAND THE CONDI TIONS OF THIS WARRANTY STATEMENT NEITHER EX CLUDE 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 Version 1 1 2011 10 12
37. 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 triggers an error message or shuts down the unit If checks are to be performed reference solutions can be produced as follows 1 Mixing heparinized pool plasma of a larger number of healthy patients gt Resulting osmotic pressure should be 25 mmHg 2 2 Dissolve 5 human albumin in a physiological saline solution gt Resulting osmotic pressure should be 19 5 mmHg 2 8 5 Replacing a Defective Power Fuse Before replacing a defective power fuse unplug the unit from the power supply Risk of W electric shock To replace the fuses use a small screwdriver to remove the fuse holder on the rear of the unit The two fuses can now be replaced The unit has two phase protection Use the following fuses 230V power supply 0 25A slow LAG 115V power supply 0 5A slow LAG One set of fuses is included with the standard accessories 8 6 Forfeiture of Measurement System Warranty To protect the highly sensitive pressure transducer from overpressure during cell preparation the pressure ratios in the measuring cell and at the pressure gauge have to be continually monitored This requires the OSMOMAT 050 to be switched on If the pressure reaches a critical point which could result in damage to the measurement system an audible warning signal is given Mechanical d
38. n heparin should be added to the plasma sample The dosage should be below 100 units mL Excessive heparin concentrations as well as using other anticoagulative additives such as EDTA or sodium citrate result in false high values for the colloid osmotic pressure To obtain the plasma the blood should be centrifuged soon after collection and stored at 4 C in the refrigerator Storage for up to 7 days is possible without significant changes to the colloid osmotic pressure How ever the sample should not be frozen The minimum sample volume required is 150 uL The samples must be homogeneous and should have the same temperature as the measurement device when measuring the colloid osmotic pressure Cooled samples with a temperature difference of almost 20 C compared to the measurement device exhibit significant differences when measuring the colloid osmotic pressure 6 3 Display of the OSMOMAT 050 The figure below shows labeled buttons and LEDs and serves to clarify the measuring procedure Please read this chapter completely before performing a measurement Osmometer OSMOMAT O50 carci RESULT CHECK START Figure 6 1 Display 1 A Gr nert Der kolloidosmotische Druck i Marty A T Plasma oncotic variation and cardiopulmonary independence in normal humans A Gr nert Der kolloidosmotische Druck Version 1 1 2011 10 12 Page 30 of51 OSMOMAT 050 User Guide 6 4 Performing the Measurem
39. ns apply e g in case of blood loss hyperalbuminemia as well as in albumin therapy to prevent lung edemas and all diseases resulting in changes to the colloid osmotic pressure Approx 150 uL of a sample solution are required making it suitable for measuring even small sample volumes The measuring speed permits rapid series measurements In the hospital the colloid osmotic pressure is an important parameter among others for monitoring infusion and dilution therapies and for diagnosing anomalies in the water balance thus supporting decisions with respect to additional examinations The OSMOMAT 050 has been applied successfully in the following fields Clinical pediatrics Urology Anesthesia intensive care medicine Nephrology Cardiology Botany Gynecology Clinical chemistry Physiology and many more Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 7 of51 1 2 Application Restrictions of the OSMOMAT 050 The OSMOMAT 050 is not suitable for measuring whole blood samples 1 3 Measurement Method of the OSMOMAT 050 The measurement principle of the OSMOMAT 050 is based on a measuring cell consisting of an up per and lower half each with a volume of approx 10 uL separated by a semipermeable membrane Fig 1 1 The so called reference cell located below the membrane is equipped with a pressure transducer pressure converter measuring bridge The upper half of the measuring cell also known as sample cell is connected
40. of the measuring cell without air bubbles Remove the conditioned semipermea ble membrane from the water flip it once and place it on top of the filter paper in the measuring cell with the active side facing up Carefully push it down with a finger so that it is positioned precisely in the center of the measuring cell Figure 4 10 Now you can install the upper half of the measuring cell Figure 4 9 Rest the upper measuring cell on the rear edge and carefully lower it toward the front No air bubbles must be visible inside the O ring Use a finger to secure the upper half of the measuring cell Figure 4 11 Fold the clamping yoke over the cell and tighten it very carefully Figure 4 10 Installed membrane and O ring Figure 4 9 Installing the upper measuring cell Version 1 1 2011 10 12 Page 24 of51 OSMOMAT 050 User Guide Screwing together the measuring cell results in significant overpressure in the lower half of the cell This overpressure decreases quickly because the solvent permeates through the pores of the semi permeable membrane The screwing together is performed manually without tools The overpressure created during this operation can easily destroy the sensitive pressure transducer Therefore the measuring cell has to be screwed together carefully in small intervals If the pressure increases to above 99 9 cm water column the display starts flashing Figure 4 12 If the pressure increases further to approx 550
41. oof of the purchase date For software products Gonotec s limited warranty applies only to the non execution of programming instructions Gonotec does not guarantee 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 Inadequate servicing or improper modification Use of software interfaces print media or accessories not supported or supplied by Gonotec or Use of the equipment in a manner not covered by the product specifications If Gonotec is notified within the warranty period of a defect in a software product in media or in the pressure transducer and if the Gonotec 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 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 defec tive product to Gonotec Replacement products may be new or
42. pressure to stabilize in the lower measuring cell filled with solvent This balanced state is detected by the electronics and the measurement value is shown on the digital display Figure 6 6 At the same time the LED 2 and LED 3 go off and the RESULT LED comes on This presents the measurement result which is representative of the osmolal concentration of the colloids colloid osmotic pressure The display is in mmHg Pressing the cm H20 or k Pascal button will show the result in the corresponding measurement unit You can also select the measurement unit prior to starting the measurement Version 1 1 2011 10 12 Page 32 of51 OSMOMAT 050 User Guide 6 5 Recording and Storing the Second Measurement Value An automatic measurement cycle consists of recording and storing the measurement result storing a second measurement result rinsing the measuring cell and checking the zero point The functions in addition to storing and displaying the first measurement value allow the evaluation of the quality of the measurement result in connection with the adjustment characteristic see Page 34 Figure 6 9 After the RESULT LED and LED 3 light up the OSMOMAT 050 waits again for the same time elapsed from injection until display of the first measurement value to accept and store the second measurement value After the second measurement value is stored LED 4 5 or 6 light up The measurement value is stored until a new meas
43. royed due to over or underpressure Before beginning an initial measurement you must add solvent to the measuring cell insert the prepared membrane and calibrate the device see chapter 4 and 5 When the measuring cell is filled and the membrane is inserted the device is in standby mode and ready for measurement indicated by the green standby LED You can start the measurement by pressing the START button This will check the zero point inter nally and prompt the user to inject the sample after approx 10 seconds indicated by the flashing IN JECT LED and the LED on the measuring cell The device should always remain switched on while the measuring cell is filled and closed even if it is not used for an extended period of time The system automatically rinses the measuring cell at regular intervals keeping the OSMOMAT 050 ready for measurement Version 1 1 2011 10 12 Page 14 of51 OSMOMAT 050 User Guide While the device is not in use the measuring cell may dry out especially in the area of Y 17 the pressure transducer The salt crystals that form adhere to the pressure measure ment membrane and can destroy it Regular rinsing prevents the drying out Make sure to top off the Ringer s solution and empty the waste bottle regularly If the device is left in standby mode for an extended period of time without topping of ae the Ringer s solution the measuring cell will dry out quickly which may result in the destruction of th
44. ton 50 9 0160 1 package containing 2 plungers 50 9 0100 1 precision syringe 250 uL 50 9 0150 1 tweezers 50 9 0140 1 tool for widening the tube ends 50 9 0180 1 bottle of cleaning solution 1 package containing 50 9 0080 1 tuberculin syringe plastic with special cannula 16 mm 50 9 0090 1 plastic syringe 30 mL with pump tube and clamp 50 9 0130 2 plastic bottles labeled Ringer s solution and waste 1 user guide 050 Version 1 1 2011 10 12 Page 10 of51 OSMOMAT 050 User Guide 2 Overview of the OSMOMAT 050 2 1 Overview of Display and Connectors Connection tube between waste bottle Connection tube and ground nipple Clamping yoke between supply bottle and upper half of measuring cell Tension screw N wooo o BEER Supply bottle er A T OSM OMAT 0590 coltoia m 4 Digital display ee oT mm Hg Waste bottle Tube nipples Bottle tray Tube pump Tube for tube pump Ground nipple MA By Upper half of measuring cell Connection tube between pump and ground nipple wh Septum screw Lower half of measuring cell Leveling disk Fig 2 1 Front view of OSMOMAT 050 Connection tube between pump and upper half of measuring cell Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 11 of 51 Manual pump control Characteristics for device fuse to be used RS232 output Power connection Recorder Output Sicherungen Fuse Fuse holder for two Analog output phase fuse protection of po
45. until the tube going to the waste bottle is also filled without air bubbles Calibration procedure 1 Press the RESET button The measurement system is rinsed again and the STAND BY LED lights up Figure 5 1 Reset 2 Press the CALIBRATION button The display automatically changes to cm water column irrespective of the measurement unit set Figure 5 2 Calibration Figure 5 3 Display 00 0 in cmH20 Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 27 of51 After a few seconds the display shows 00 0 The baseline of the measurement system for the value 00 0 is set with the fill level taken into account The waste bottle must be placed on the bottle tray and the tube system has to be filled without air bubbles 3 Move the bottle from the tray to the table surface The height difference between tray and ta ble surface is exactly 10 cm Setting a stable measurement value of approx 10 cm water col umn should not take longer than 10 seconds Figure 5 4 Setting the value for 10 cm water column 4 Adjusting the potentiometer will set the measurement value to exactly 10 00 cm water column a a 1 u _ N er ar IF 1 1 Fi m Figure 5 5 Adjustment to 10 cm water column Version 1 1 2011 10 12 Page 28 of51 OSMOMAT 050 User Guide 5 To verify the correct setting move the bottle back to the tray This will revert to the zero point Figure 5 6 Checking the zero po
46. urement is performed Afterwards the measuring cell is automatically rinsed and LED 7 lights up A comparison of both measurement values shows the adjustment characteristic If the adjustment characteristic matches the curve shape 1 in Figure 6 9 LED 5 lights up Figure 6 7 Display with adjustment characteristic according to curve 1 Version 1 1 2011 10 12 OSMOMAT 050 User Guide Page 33 of51 Pressing the RESULT CHECK button will display the second measurement value If the 2nd measurement value deviates from the first value by more than two digits LED 6 lights up Figure 6 8 lower molecular parts permeate Ce LT DBU karinca Figure 6 8 Display with adjustment characteristic according to curve 2 If obtaining the result takes a very long time due to a sluggish adjustment characteristic curve 3 Fig ure 6 9 the measurement value is accepted after 4 5 minutes and the second measurement value is stored after an additional 4 5 minutes LED 4 lights up After storing the second measurement value five rinse cycles using solvent are performed in the measuring cell During rinsing and zero point setting LED 7 lights up After zero point setting is com plete LED 8 lights up A shift of the zero point is indicated by LED 9 Version 1 1 2011 10 12 Page 34 of51 OSMOMAT 050 User Guide Curve 1 Curve 2 Curve 3 Normal setting of the osmotic Adjustment characteristic of the osmotic Adjustment characteristic of th
47. wer supply Alignment Ben M A mC Power switch or analog po BEE geoic com 1 on O off Serial number plate with information on serial number power voltage frequency and power consumption Fig 2 2 Rear view of the Osmomat 050 Version 1 1 2011 10 12 Page 12 of51 OSMOMAT 050 User Guide 2 2 Power Supply The standard model is operated with 230V 30V at 50 60 Hz The power consumption is 20VA Special models using 115V or 100V are also available 2 3 Dimensions and Weight Dimensions width x height x depth 360 x 250 x 355 mm Weight approx 5 1 kg excluding bottles 2 4 Safety and Handling Information The OSMOMAT 050 colloid osmometer is an electric laboratory measurement device It should there fore be handled according to the safety provisions and precautions for electric measurement control and laboratory equipment If the equipment is to be decommissioned make sure it is sufficiently disinfected This will Y make sure that the equipment has been decommissioned in accordance with local accident prevention guidelines UVV To prevent damage to the pressure transducer during extended periods of inactivity or in case of de commissioning the following steps must be performed Always switch on device when performing work on the measuring cell or the pressure trans Y ducer see chapter 3 Open measuring cell and remove membrane and filter paper Repeatedly rinse measuring cell using distilled wat

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