Summary of Contents for Gonotec Osmomat Auto
- Page 1 User Guide Osmolality Measurement in medical and pharmaceutical field Cryoscopic Osmometer ® OSMOMAT auto...
- Page 2 The information contained in this document may be changed without prior notice. © 2006 Gonotec Gesellschaft für Meß- und Regeltechnik mbH. All rights reserved. Reproduction of this document in any form is permissible only with the prior written consent of Gonotec Gesellschaft für Meß- und Regeltechnik mbH.
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Page 3: Table Of Contents
Dimensions and Weight....................... 12 Sample Holder ..........................13 Setup and Initial Operation.........14 Safety and Handling Information ....................15 Known Risks Associated with the Use of the OSMOMAT auto ..........15 OSMOMAT auto Menu Structure........16 Display and Keypad Overview..................... 16 Menu Functions ........................... 17 Calibration of the OSMOMAT auto......18... - Page 4 10.1 Requirements of the Medical Devices Operator Ordinance ............35 10.2 Safety Checks (§ 6 of Medical Devices Operator Ordinance)............. 35 10.3 Measurement Checks (§ 11 of Medical Devices Operator Ordinance)........35 10.4 Internal Quality Control of the OSMOMAT auto ................35 10.5 Settings............................36 10.6 Printer Maintenance........................39 10.7 Replacing the Cleaning Paper.....................
- Page 5 ® 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 Technical Data of the OSMOMAT auto.........52 Remove of Transportation Lock ...........54 Contents | 5...
- Page 6 List of Figures Fig. 1 Freezing Point Depression of Solvent ..................9 Fig. 2 Front view of the OSMOMAT auto ................... 11 Fig. 3 Rear view of the OSMOMAT auto.................... 12 Fig. 4 Start sequence of the OSMOMAT auto..................14 Fig.
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Page 7: Introduction
(cf. German Medical Devices Operator Ordinance, MPBetreibV). The OSMOMAT auto is a fully automatic cryoscopic osmometer that is optimally suited for measuring the total osmolality of aqueous solutions. It requires a sample volume of 50µl and up to 20 samples can be measured and stored fully automatically in one procedure. -
Page 8: 1.1.1 Application Restrictions Of The Osmomat Auto
= 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 auto measures the osmolality directly. Reproducibility in the OSMOMAT auto... -
Page 9: Function Of The Osmomat Auto
Once the sample solution has reached a specific temperature below the freezing point, crystallization is automatically initiated. The OSMOMAT auto initiates crystallization by injecting the sample with a stainless steel needle that is cooled by a secondary upper cooling system and has small ice crystals formed by moisture in the air on its tip. -
Page 10: Unpacking The Cryoscopic Osmometer Osmomat Auto
Introduction Unpacking the Cryoscopic Osmometer OSMOMAT auto The cryoscopic osmometer OSMOMAT auto 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 GSG Hof Reuchlinstr. -
Page 11: Overview Of The Osmomat Auto
Overview of Display and Connectors LCD display Keypad Matrix printer Elevator with cover Thermistor Cleaning paper holder Paper feed Lower front plate with Transport fastener for lower cooling system Fig. 2 Front view of the OSMOMAT auto Overview of the OSMOMAT auto | 11... -
Page 12: Power Supply
The standard model is operated with 230V (+/- 20V) at 50/60Hz. The power consumption is 120VA. Special models using 115V or 100V are also available. Dimensions and Weight Dimensions (width x depth x height): 275 x 225 x 390 mm Weight: approximately 11.9 kg 12 | Overview of the OSMOMAT auto... -
Page 13: Sample Holder
OSMOMAT auto. Initialization sample 20 sample spaces The sample cover protects the samples from premature evaporation. Observe the information in the following chapters Calibration of the OSMOMAT auto and Measurement of a Sample Solution. Overview of the OSMOMAT auto | 13... -
Page 14: Setup And Initial Operation
The OSMOMAT auto can now be switched on via the power switch on the back of the unit (next to the power connector). Two system numbers, the system date and time, and an initialization text for the warm-up phase are shown in quick succession (Fig. -
Page 15: Safety And Handling Information
Known Risks Associated with the Use of the OSMOMAT auto In our experience using the Osmomat auto, it has not been found to present any direct hazards or risks to the user. Such hazards and risks cannot be excluded entirely for technical equipment, however. -
Page 16: Osmomat Auto Menu Structure
Display and Keypad Overview LCD display S election keys Select print options Cleaning paper Print options feed Printer paper feed 10-digit keypad with arrow keys Operation LED Fig. 5 Keypad of the OSMOMAT auto 16 | OSMOMAT auto Menu Structure... -
Page 17: Menu Functions
> adjust to conduct maintenance work, such as testing the initiation function, newly initializing the unit, and adjusting the thermistor probe. OSMOMAT auto Menu Structure | 17... -
Page 18: Calibration Of The Osmomat Auto
Calibration of the OSMOMAT auto Calibration of the OSMOMAT auto Before the total osmolality of sample solutions can be measured, the OSMOMAT auto must be calibrated with distilled water and a calibration standard. Calibration at Two Points Two clean, dry measuring vessels are first filled via a pipette with 50 µl distilled water and 50 µl Gonotec calibration standard 300 mOsmol/kg. -
Page 19: Calibration At Three Points
Subsequent display or printing is not possible! Calibration at Three Points Two clean, dry measuring vessels are first filled via a pipette with 50 µl distilled water, 50 µl Gonotec calibration standard 300 mOsmol/kg, and 50 µl 850 mOsmol/kg. - Page 20 You will now be prompted to insert the sample holder in the unit. The Osmomat auto automatically detects the inserted sample holder and begins the calibration. The calibration values are now shown consecutively on the display. If the printer is switched on, these values are also printed.
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Page 21: Measurement Of A Sample Solution
Select ready, if you do not need any data or want to use the data automatically provided by the system. You will now be prompted to insert the sample holder in the unit. The Osmomat auto automatically detects the inserted sample holder and begins the measurement. - Page 22 Measurement of a Sample Solution ■ Measurement Results The sample measurement results are shown as plain text on the display, shown as plain text on the printout when the printer is switched on automatically saved. The sample results are comprised of a system-defined <Ch>...
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Page 23: Series Measurement
Measurement of a Sample Solution Series Measurement With OSMOMAT auto, up to 20 samples can be measured and saved fully automatically in one procedure. Position 0 on the sample holder is reserved for internal system initialization. It must be filled with distilled water for every series measurement! ■... -
Page 24: Print Functions
Print Functions Print Functions The OSMOMAT auto is equipped with a dot matrix printer. The printer uses normal paper and an ink ribbon cartridge. The printer paper and the endless ribbon cartridge are consumables and must eventually be replaced. The OSMOMAT auto is fully operable even if the printer is off. The results can be seen on the digital display after each measurement. -
Page 25: Memory Management
Memory Management Memory Management The OSMOMAT auto has an internal battery-buffered CMOS memory for 300 pieces of measurement data. The data is retained in the memory even after the unit is switched off or disconnected from the power supply. The manufacturer-specified battery life is 10 years. After expiration of this time, the battery buffer may not be sufficient after the unit is switched off or disconnected from the power supply to retain the data. - Page 26 Memory Management Note: The batch count is automatically reset with a date change (next day) and begins anew with 01. As a result, there can be several batches with the same batch number but different dates in the memory. Unique sample identification is ensured by the batch number, date, sample position in the sample holder, or an individually assigned identification number.
- Page 27 ■ Monitoring the Memory Capacity The OSMOMAT auto has an automatic monitoring routine 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 measurement data.
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Page 28: Error Messages And Troubleshooting
The OSMOMAT auto 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. -
Page 29: Late Or No Crystallization
There are two possible reasons for a crystallization failure: 9.3.1 Excessive Osmolality Crystallization is initiated at -7°C. The OSMOMAT auto can measure solutions with a maximum osmolality of approximately 3 Osmol, since this osmolale concentration yields a freezing point temperature of: 3 x 1.858 = 5.574 ≈ –5.6°C... -
Page 30: Classification Of Malfunctions By Component Group
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 needle movement can be checked for this purpose via the display < thermistor probe adjustment. Select >... -
Page 31: Table 1 Malfunction Of The Elevator Track/Lower Cooling System/Printer Component Group
Error Messages and Troubleshooting Component Groups Malfunction Effect Possible Cause Measure function Elevator track Sluggish, Mechanical wear due to ball Lubricate the track, e.g. with silicone spray (noisy) bearing abrasion or graphite Lowers the sample into the lower cooling system Jams Error message or Blockage from foreign... -
Page 32: Table 2 Malfunction Of The Upper Cooling System Component Group
Error Messages and Troubleshooting Component Groups Malfunction Effect Possible Cause Measure function Upper cooling system No cooling or no ice Error message and Peltier element ruined, e.g. by Replace upper cooling system crystals at the upper No reading liquid deposits Nucleation cooling system Corrosion... -
Page 33: Table 3 Malfunction Of Eprom/Thermistor Probe Component Group
Check system load of power grid Have medical equipment technician or Gonotec replace EProm Thermistor probe Measuring vessel fits Incorrect reading Incorrect measuring vessel Use Gonotec measuring vessels loosely on the thermistor Analysis probe The thermistor probe’s Replace the thermistor probe measuring vessel receptacle is... -
Page 34: Table 4 Malfunction Of The Initiation Needle/Power Switch Component Group
Error Messages and Troubleshooting Component Groups Malfunction Effect Possible Cause Measure function Initiation needle No/few ice crystals Error message: Needle too long or too short Bring needle to proper length transported No crystallization Crystallization Needle not deburred at tip (e.g. Debur tip of needle after re-installation) Needle bent... -
Page 35: 10 Servicing Of The Osmomat Auto
10.2 Safety Checks (§ 6 of Medical Devices Operator Ordinance) The OSMOMAT auto is not listed in Annex 1 of the Medical Devices Operator Ordinance. Public authorities do not require the unit to undergo safety checks. Safety checks should be conducted by the on-site safety coordinator in accordance with relevant accident prevention guidelines. -
Page 36: Settings
The used paper comes out of the left side of the OSMOMAT auto and can be ripped off here and disposed of. After the last sample measurement, the remaining contaminated cleaning paper is transported out of the unit. This ensures that no contaminated material is in the unit, particularly after a disruption in a measurement caused either manually or by a malfunction. - Page 37 OK to rotate the initiation needle one time. ■ New Initialization Reinitialize the OSMOMAT auto if additional calibrations are unsuccessful after an unsuccessful or cancelled calibration. The memory content and the settings for the date and time are retained after re-initialization.
- Page 38 3. Press Esc to return the thermistor probe to its preset position Please note: The automatic lift limit of the elevator is invalidated during this operation. This can result in overwinding of the excenter disk and destroy the measurement system! 38 | Servicing of the OSMOMAT auto...
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Page 39: Printer Maintenance
Press and hold the Paper Feed button until approx. 2 cm of paper is protruding from the housing. 4. Turn the printer until it locks in its upper position and close the door. Servicing of the OSMOMAT auto | 39... -
Page 40: Replacing The Cleaning Paper
The system also works without cleaning paper. In this case, the sensor is not cleaned and the samples mix with sample residues from previous sample measurements. 1. Cut the end of the paper roll at an angle. 40 | Servicing of the OSMOMAT auto... - Page 41 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 the Paper Feed button until the paper protrudes from the housing. Servicing of the OSMOMAT auto | 41...
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Page 42: Replacing A Defective Initiation Needle
Reflex photo- electric beam Needle Motor swipe Protective tubing of 2.0 mm needle bar 2,0 mm Cooling pin Round off the needle tip with a file Fig. 9 Replacing a Initiation Needle 42 | Servicing of the OSMOMAT auto... -
Page 43: Replacing A Defective Power Fuse
(see nameplate Fig. 1) is located under the power connector. A small FUSE indicates the set power arrow (Fig. 10) voltage, 230V in this example. Fig. 10 Power switch Servicing of the OSMOMAT auto | 43... -
Page 44: 10.10 Using The Correct Measuring Vessel
Destruction of the measurement system due to the 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. 44 | Servicing of the OSMOMAT auto... -
Page 45: 11 Calibration Solutions For Osmometry
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. -
Page 46: Restrictions On The Use Of The Calibration And Reference Materials
They may not be used in human injections or infusions, neither in its pure form nor in mixtures with human bodily fluid samples. 11.3 Composition ® GONOTEC Calibration standards 100, 300, 500, 850, 2000 mOsmol/kg and OSMOREF mOsmol/kg NaCl/H 2000 mOsmol mOsmol... -
Page 47: Storage And Shelf Life
3,350 2000** 63,960 3,716 2500** 79,970 4,650 Table 5 NaCl solutions for osmometry (*) Based on Geigy Scientific Tables 8 edition (congruent to USPC: usp29nf24s0_c785) (**) Measured with Gonotec Freezing point osmometer OSMOMAT 030-3P Calibration Solutions for Osmometry | 47... -
Page 48: Appendix
35.9.1030 Roll of cleaning paper Accessories and Replacement Parts Packaging Item Item no. unit/qty 35.3.0010 Thermistor probe for OSMOMAT auto (50µl sample volume) 30.9.0030 Bellow (Pasteur pipette) 30.6.0020 Initiation needle 20.9.0160 Data cable for RS 232 interface OSMOMAT 030/050/auto 30.2.0030 Adjustment tool 20.9.0100... -
Page 49: Classification Of The Ivd
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. -
Page 50: Limited Warranty
Canadian provinces and in some countries outside North America, for example, the following national laws If Gonotec is notified within the warranty period of a defect apply: in a software product, in media or in a thermistor probe... -
Page 51: Returning Parts For Warranty
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. -
Page 52: Technical Data Of The Osmomat Auto
Appendix Technical Data of the OSMOMAT auto ■ Data output RS232 Baud rate: 9600 bits/s Data format: 1 start bit, 8 data bits, 1 stop bit, no parity Signals: TXD Transmit Data (output) -> PIN 3 RXD Receive Data (input) ->... - Page 53 Appendix ■ Overview (Standard model) Sample volume: 50µl Printer: Alphanumeric dot matrix Duration of Approx. 70 seconds printer, 5x7 matrix, date, measurement time of each measurement Reproducibility: # ±1.0% Number of digits: 4-digit programmable Measurement display: LCD display, 4 lines sample number with 20 characters 4-digit measurement...
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Page 54: Remove Of Transportation Lock
Appendix Remove of Transportation Lock Turn the instrument on its 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 you to re-install the transportation lock correctly.
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