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User Guide

Osmolality Measurement in medical and pharmaceutical field

Cryoscopic Osmometer

OSMOMAT

auto

Содержание Osmomat Auto

Страница 1: ...www gonotec com User Guide Osmolality Measurement in medical and pharmaceutical field Cryoscopic Osmometer OSMOMAT auto...

Страница 2: ...example by improperly using measuring vessels This symbol warns of the danger of damaging the unit or the measurement system for example as a result of improper servicing Note or tip Subject to errors...

Страница 3: ...Overview of Display and Connectors 11 2 2 Power Supply 12 2 3 Dimensions and Weight 12 2 4 Sample Holder 13 3 Setup and Initial Operation 14 3 1 Safety and Handling Information 15 3 2 Known Risks Ass...

Страница 4: ...lity Control of the OSMOMAT auto 35 10 5 Settings 36 10 6 Printer Maintenance 39 10 7 Replacing the Cleaning Paper 40 10 8 Replacing a Defective Initiation Needle 42 10 9 Replacing a Defective Power F...

Страница 5: ...ssification of the IVD 49 EC Compliance Statement OSMOMAT auto 49 Provisions of Certification 49 Limited Warranty 50 Returning Parts for Warranty 51 Repair or Credit 51 Before Calling Gonotec 51 Techn...

Страница 6: ...per roll 39 Fig 8 Replacing the ribbon 40 Fig 9 Replacing a Initiation Needle 42 Fig 10 Power switch 43 List of Tables Table 1 Malfunction of the elevator track lower cooling system printer component...

Страница 7: ...proven measurement principle of the Osmomat 030 The system developed by Gonotec for initiating crystallization by injecting ice crystals is also used here The sample data can be entered via the keypad...

Страница 8: ...freezing point of 1 858 C That means that one mol of a given non dissociated substance 6 023 x 1023 parts diluted in one kilogram of water lowers the freezing point of a solution by 1 858 C The follow...

Страница 9: ...ing 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...

Страница 10: ...ack to Gonotec 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 the contents of your shipment are comp...

Страница 11: ...verview of Display and Connectors LCD display Keypad Matrix printer cover Elevator with Paper feed Cleaning paper holder Lower front plate with Transport fastener for lower cooling system Thermistor F...

Страница 12: ...Fus o Serial output Barcode reader Serial output RS232 Housing fan with cover 1 0 FUSE Potentiometer for service settings Fig 3 Rear view of the OSMOMAT auto 2 2 Power Supply The standard model is op...

Страница 13: ...e sample holder from 1 through 20 Position 0 is reserved for the initialization sample with distilled water Refer to section 5 Calibration of the OSMOMAT auto Initialization sample 20 sample spaces Th...

Страница 14: ...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 name plate matches that of your electricity network Incorrect v...

Страница 15: ...ls on the unit and its name plate 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...

Страница 16: ...points are selected via the arrow keys and the Esc key The number keys and the Ctrl key are used for data entry 4 1 Display and Keypad Overview Selection keys Cleaning paper feed Select print options...

Страница 17: ...rn from the submenu directly to the initial display The functions and option elements are described in the individual chapters Measurements and Settings Select sample to perform sample measurements ca...

Страница 18: ...ample holder to prevent premature evaporation of the samples The sample cover reduces the risk of premature evaporation of the samples However it does not protect the samples from leakage To perform t...

Страница 19: ...is retained even after the unit is switched off and restarted but lost after new initialization Note Prior to the calibration procedure switch the printer on to document the calibration results Subseq...

Страница 20: ...ve 500 mOsmol kg are possible for c2 If c1 300 mOsmol kg all calibration points above 600 mOsmol kg are possible for c2 If c1 2000 mOsmol kg 3000 mOsmol kg are possible for c2 The following display sa...

Страница 21: ...a measuring vessel with distilled water If position 0 is not filled there is no measured value for the first sample The sample cover is then placed on the sample holder to prevent premature evaporatio...

Страница 22: ...are comprised of a system defined Ch batch number and Pat patient number measured value in osmol or error message as plain text under Status spon crystallization no crystallization and optionally of s...

Страница 23: ...ure that position 0 is always filled with a measuring vessel with distilled water If position 0 is not filled there is no measured value for the first sample Be sure to identify samples uniquely The s...

Страница 24: ...the Print Mode button to switch the print functions on and off and select them Press the button until the desired print function is reached It is signalized by a lit LED OFF Printer is off Measurement...

Страница 25: ...again to return to the initial display Searching for Batch and Sample Results You can search for sample results in the memory by batch Select sample memory look at charge in the initial display Confir...

Страница 26: ...ort Provides quick printout of complete batch of the displayed sample Charge long Provides long printout of complete batch of the displayed sample Deleting Data You can delete data from the memory by...

Страница 27: ...utine to check the memory capacity for measurement data prior to each measurement series The memory manager outputs a warning on the display when the memory capacity is less than 20 units of measureme...

Страница 28: ...ile measuring the sample solution The OSMOMAT auto monitors temperature changes during the undercooling phase If crystallization begins prematurely before the undercooling temperature of 7 C is reache...

Страница 29: ...ch crystallization is initiated however crystallization will not start despite the very effective method of initiation crystallization via the injection of ice crystals This condition is further exace...

Страница 30: ...ld a paper towel underneath 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 t...

Страница 31: ...es too long measurement interrupts No reading Error message Incorrect reading Corrosion Ventilator dusty Incorrect adjusted lower cooling system Peltier element defective Use fine sandpaper to clean t...

Страница 32: ...or message Peltier element ruined e g by liquid deposits Corrosion Incorrect adjusted upper cooling system Bar of needle too short or too long Photoelectric beam for motor control defective or incorre...

Страница 33: ...oosely on the thermistor probe Defective When lowered into the lower cooling system the thermistor probe moves outside the center of the solution Incorrect reading Incorrect or no reading Incorrect re...

Страница 34: ...length Debur tip of needle Straighten or replace needle Check upper cooling system component group Rear of unit power switch Power supply Fuses in power switch blow out when unit is switched on It do...

Страница 35: ...ce with relevant accident prevention guidelines 10 3 Measurement Checks 11 of Medical Devices Operator Ordinance The OSMOMAT auto is not listed in Annex 2 of the Medical Devices Operator Ordinance No...

Страница 36: ...to accept the change Select insert date and confirm with OK to set the date The cursor blinks in the date Enter the date in the format Day Month Year using the numbers 0 through 9 The cursor automatic...

Страница 37: ...needle for example To check the initiation function select adjust actuate cryst motor in the initial display Confirm with OK to rotate the initiation needle one time New Initialization Reinitialize t...

Страница 38: ...s user guide Select adjust thermistor probe in the initial display Confirm with OK to initiate start up or shutdown of the thermistor probe Start up and shutdown are controlled by a stepper motor The...

Страница 39: ...e printing device 1 Turn the printer to its bottom position Remove the empty roll core from the paper tray 2 Insert a new paper roll Pay attention to the feed direction of the paper roll Fig 7 Correct...

Страница 40: ...on Tighten the ribbon by twisting the knob again 5 Press and hold the Paper Feed button until approx 2 cm of the printer paper is protruding from the housing and then close the door 10 7 Replacing the...

Страница 41: ...the new roll and reattach the cover 3 Run the paper below the stainless steel plate with a hole Press the Paper Feed button and run the paper to the drive rollers for the paper feed 4 Press and hold t...

Страница 42: ...ntaminated especially the initiation needle Risk of injury from the tip of the needle In the event of injury from the tip of the needle always consult a doctor to check whether any infection with a pa...

Страница 43: ...diameter 0 6mm 10 9 Replacing a Defective Power Fuse Before replacing a defective power fuse unplug the unit from the power supply Risk of electric shock To replace the fuses use a small screwdriver...

Страница 44: ...0 9 0010 pdf 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 lowe...

Страница 45: ...Declaration Calibration and Reference Material Gonotec GmbH GSG Hof Reuchlinstr 10 11 10553 Berlin Germany We hereby declare that the calibration standard for Osmomat 010 030 auto 300 and 850 mOsmol...

Страница 46: ...he package insert of each batch 11 4 Safety and Handling Information Calibration and reference materials are not dangerous according to EC Directive 67 548 EEC Poison class Switzerland F no poison cla...

Страница 47: ...ing osmolality is an indication that the shelf life has elapsed 11 6 Use of Other Calibration Solutions Osmolality Sodium chloride concentration Freezing point depression mOsmol kg H Table 5 NaCl solu...

Страница 48: ...9 2000 Calibration standard 2000 mOsmol kg ampoules of 1ml each 10 30 9 1010 Printer paper roll for OSMOMAT 030 D auto 8 30 9 1020 Endless ribbon cassette for OSMOMAT 030 D auto 1 35 9 1030 Roll of cl...

Страница 49: ...mbH GSG Hof Reuchlinstr 10 11 10553 Berlin Germany We hereby declare that the cryoscopic osmometer OSMOMAT auto complies with Directive 98 79 EEC Compliance is declared per Annex III of the Directive...

Страница 50: ...ions 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...

Страница 51: ...ks manuals etc 6 Return the equipment in its original packaging If you no longer have the original packaging you may purchase replacement packaging from Gonotec Before Calling Gonotec Note When callin...

Страница 52: ...and DTR signals are currently supported We recommend use of a null modem cable with the following bridges 6 4 1 and 7 8 The data is consecutively sent to the built in printer and serial interface If...

Страница 53: ...on Crystallization resolution By injecting the sample with ice crystals Error message Printed in plain text Cooling RS output Using two independent peltier cooling systems with heat dissipation by air...

Страница 54: ...s backside and remove the red marked transportation locks with the socket wrench hexagon socket Transportation lock Please keep this instruction for an eventual return of the instrument as this allows...

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