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Gonotec OSMOMAT 050 User Manual

Colloid osmometer / oncometer
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User Guide
Osmolality Measurement in medical and pharmaceutical field
Colloid Osmometer / Oncometer
®
OSMOMAT
050

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Summary of Contents for Gonotec OSMOMAT 050

  • Page 1 User Guide Osmolality Measurement in medical and pharmaceutical field Colloid Osmometer / Oncometer ® OSMOMAT...
  • Page 3 The information contained in this document may be changed without prior notice. © 2011 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.

  • Page 4: Table Of Contents

    Power Supply ........................12 Dimensions and Weight ....................... 12 Safety and Handling Information ..................12 Known Risks Associated with the Use of the OSMOMAT 050 ..........12 Setup and Initial Operation .........13 Preparing the Measuring cell for Measurement ..15 Making the Tube Connections during Initial Startup ............15 Ringer's Solution as Solvent ....................
  • Page 5 Safety Checks (§ 6 of Medical Devices Operator Ordinance) ..........38 Measurement Checks (§ 11 of Medical Devices Operator Ordinance) ....... 38 Internal Quality Control of the OSMOMAT 050 ..............39 Replacing a Defective Power Fuse ..................39 Forfeiture of Measurement System Warranty ..............39 Specifications for RS 232 Interface ..................

  • Page 6: Introduction

    (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.

  • Page 7: Application Restrictions Of The Osmomat 050

    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 L, separated by a semipermeable membrane (Fig.

  • Page 8: Reproducibility Of The Osmomat 050

    Page 8 of 51 OSMOMAT 050 User Guide 1.4 Reproducibility of the OSMOMAT 050 Measurement display 3 digits Measuring range 73 mm HG, 100 cm water column, or 9.99 kPa Resolution 0.1 mm HG over the entire measurement range Reproducibility <...

  • Page 9: Unpacking The Osmomat 050 Colloid Osmometer

    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.

  • Page 10: Overview Of The Osmomat 050

    Upper half of measuring cell Connection tube between pump and ground nipple Septum screw Connection tube between pump and upper half of measuring cell Lower half of measuring cell Leveling disk Fig. 2-1: Front view of OSMOMAT 050 Version 1.1 (2011-10-12)
  • Page 11 230 V - 250 mA LAG of power supply Alignment potentiometer Power switch for analog port 1/on 0/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: Power Supply

    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.

  • Page 13: Setup And Initial Operation

    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).
  • Page 14 Page 14 of 51 OSMOMAT 050 User Guide While the device is not in use, the measuring cell may dry out, especially in the area of 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.

  • Page 15: Preparing The Measuring Cell For Measurement

    OSMOMAT 050 User Guide Page 15 of 51 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).
  • Page 16 Page 16 of 51 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.

  • Page 17: Ringer's Solution As Solvent

    OSMOMAT 050 User Guide Page 17 of 51 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 0,8 g...

  • Page 18: Filling The Supply And Waste Bottles

    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.

  • Page 19: Conditioning The Membrane

    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.

  • Page 20: Preparing The Filter Paper And Degassing The Solvent

    Page 20 of 51 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...

  • Page 21: Opening The Measuring Cell

    OSMOMAT 050 User Guide Page 21 of 51 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.
  • Page 22 Page 22 of 51 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 affects the plastic material, which be- comes opaque.

  • Page 23: Screwing Together The Measuring Cell

    OSMOMAT 050 User Guide Page 23 of 51 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.
  • Page 24 Page 24 of 51 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.
  • Page 25 OSMOMAT 050 User Guide Page 25 of 51 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).

  • Page 26: Calibrating The Osmomat 050

    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.
  • Page 27 OSMOMAT 050 User Guide Page 27 of 51 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.

  • Page 28: Measuring The Colloid Osmotic Pressure

    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.

  • Page 29: Sample Material

    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.

  • Page 30: Performing The Measurement

    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.
  • Page 31 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.

  • Page 32: Recording And Storing The Second Measurement Value

    (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.
  • Page 33 OSMOMAT 050 User Guide Page 33 of 51 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.
  • Page 34 Page 34 of 51 OSMOMAT 050 User Guide Curve 1 Curve 2 Curve 3 Normal setting of the osmotic Adjustment characteristic of the osmotic Adjustment characteristic of the osmotic pressure when the sample does pressure when lower molecular parts of...

  • Page 35: Classification Of Malfunctions

    OSMOMAT 050 User Guide Page 35 of 51 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.
  • Page 36 Page 36 of 51 OSMOMAT 050 User Guide Components Malfunction Possible Cause Measure Function Lower measur- Long adjustment time Air bubbles in lower half of measuring cell Open and clean cell again, fill ing cell after inserting a new with degassed solvent and...
  • Page 37 OSMOMAT 050 User Guide Page 37 of 51 Components Malfunction Possible Cause Measure Function The red "Overload" The system is partially clogged between All tubes behind the measur- LED lights up (when the measuring cell and the waste bottle ing cell, the plunger of the...

  • Page 38: Maintenance Of The Osmomat 050

    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. Safety checks should be conducted by the on-site safety coordinator in accordance with relevant accident prevention guidelines.

  • Page 39: Internal Quality Control Of The Osmomat 050

    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.

  • Page 40: Specifications For Rs 232 Interface

    Active level +3V << U << +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 >> U >> -7.5V Active level +3V <<...

  • Page 41: Appendix

    OSMOMAT 050 User Guide Page 41 of 51 9 Appendix 9.1 Consumables Packaging Item no. Item unit/qty 50.9.0010 Membranes, cut-off 10,000 dalton 50.9.0020 Membranes, cut-off 20,000 dalton 50.9.0030 Silicon rubber septa 50.9.0040 O ring (26 x 2 mm) for measuring cell 50.9.0050...

  • Page 42: 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 43: Limited Warranty

    For this reason, certain warranty exclusions and If Gonotec is notified within the warranty period of a defect in a restrictions outlined here may be of no relevance to the cus- software product, in media or in the pressure transducer and if tomer.

  • Page 44: 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 45: Specifications Of The Osmomat 050

    Handbuch OSMOMAT 050 Seite 45 von 51 12 Specifications of the OSMOMAT 050 Cell volume: < 10 L Sample volume: > 100 L Adding sample: by injection syringe through a septum injector integrated into the measuring cell Membrane material: Two-layer membrane, retention of molecular weights >...

  • Page 46: Service 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.

  • Page 47: Instructions

    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. 3. Release LED cable by cutting cable tie. Version 1.1 (2011-10-12)
  • Page 48 Seite 48 von 51 Handbuch OSMOMAT 050 4. 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...

  • Page 49: Assembly

    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.
  • Page 50 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.
  • Page 51 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)

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