Gonotec Osmomat Auto User manual

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

Notes, Safety Notices and Warnings
The symbols and abbreviations defined below may appear on the packing material, on the unit name
plate or in the operating instructions:
In-vitro diagnostic device
This product meets the requirements of
EEC Directive 98/79 relating to in-vitro
diagnostic devices.
Attention (refer to documentation)!
Please follow the safety notices of the user
guide.
“Use by …” The date that follows indicates
the expiration data as year-month.
Appears beside the name of the product
batch.
REF Item number or order number
The following pages provide a step-by-step introduction to using, maintaining and servicing the
measurement device. Passages requiring special attention are marked as follows:
This symbol warns of the danger of
corrupting measurement results, for
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 and technical changes.
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.
The trademarks used in this document, GONOTEC, OSMOMAT and OSMOREF,are trademarks of
Gonotec Gesellschaft für Meß- und Regeltechnik mbH.
Other trademarks and trade names used in this document may be trademarks or names of the corresponding companies or
their products. Gonotec Gesellschaft für Meß- und Regeltechnik mbH does not assert any claim to trademarks or trade names
other than its own.
OSMOMAT®auto model, series 2005 and later
October 2009 Version 1.1

Contents
1Introduction....................................................................7
1.1 Applications of the OSMOMAT auto.............................................................................................. 7
1.1.1 Application Restrictions of the Osmomat auto............................................................................... 8
1.2 Measurement Method of the OSMOMAT auto.............................................................................. 8
1.3 Reproducibility in the OSMOMAT auto.......................................................................................... 8
1.4 Function of the OSMOMAT auto ................................................................................................... 9
1.5 Unpacking the Cryoscopic Osmometer OSMOMAT auto ........................................................... 10
1.6 Packaging Contents..................................................................................................................... 10
2Overview of the OSMOMAT auto ...............................11
2.1 Overview of Display and Connectors .......................................................................................... 11
2.2 Power Supply............................................................................................................................... 12
2.3 Dimensions and Weight............................................................................................................... 12
2.4 Sample Holder ............................................................................................................................. 13
3Setup and Initial Operation.........................................14
3.1 Safety and Handling Information ................................................................................................. 15
3.2 Known Risks Associated with the Use of the OSMOMAT auto .................................................. 15
4OSMOMAT auto Menu Structure................................16
4.1 Display and Keypad Overview..................................................................................................... 16
4.2 Menu Functions ........................................................................................................................... 17
5Calibration of the OSMOMAT auto.............................18
5.1 Calibration at Two Points............................................................................................................. 18
5.2 Calibration at Three Points .......................................................................................................... 19
6Measurement of a Sample Solution...........................21
6.1 Series Measurement.................................................................................................................... 23
7Print Functions ............................................................24
8Memory Management..................................................25
Contents | 3

Contents
9Error Messages and Troubleshooting.......................28
9.1 Spontaneous Crystallization ........................................................................................................ 28
9.2 Preventing False Readings Due to Spontaneous Crystallization.............................................. 28
9.3 Late or No Crystallization ............................................................................................................ 29
9.3.1 Excessive Osmolality................................................................................................................... 29
9.3.2 Injection with Ice Crystals Does Not Work................................................................................... 29
9.4 Classification of Malfunctions by Component Group................................................................... 30
10 Servicing of the OSMOMAT auto ...............................35
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..................................................................................................... 40
10.8 Replacing a Defective Initiation Needle....................................................................................... 42
10.9 Replacing a Defective Power Fuse ............................................................................................. 43
10.10 Using the Correct Measuring Vessel........................................................................................... 44
■Intended Use ..................................................................................................................................... 44
■Specification ..................................................................................................................................... 44
■Forfeiture of the Measurement System Warranty .............................................................................. 44
11 Calibration Solutions for Osmometry........................45
11.1 GONOTEC Calibration and Reference Material.......................................................................... 45
Classification of the IVD ........................................................................................................................ 45
EC Conformity Declaration – Calibration and Reference Material........................................................ 45
Provisions of Certification...................................................................................................................... 45
11.2 Restrictions on the Use of the Calibration and Reference Materials........................................... 46
11.3 Composition................................................................................................................................. 46
11.4 Safety and Handling Information ................................................................................................. 46
11.5 Storage and Shelf Life ................................................................................................................. 47
11.6 Use of Other Calibration Solutions .............................................................................................. 47
4 | Contents

Contents
Appendix .................................................................................48
Consumables..........................................................................48
Accessories and Replacement Parts ...................................48
Classification 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
Technical Data of the OSMOMAT auto.................................52
Remove of Transportation Lock ...........................................54
Contents | 5

Contents
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. 5 Keypad of the OSMOMAT auto................................................................................................ 16
Fig. 6 Incorrect feed direction for paper roll........................................................................................ 39
Fig. 7 Correct feed direction for paper 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 group ................ 31
Table 2 Malfunction of the Upper Cooling System Component Group .............................................. 32
Table 3 Malfunction of EProm/thermistor probe component group ................................................... 33
Table 4 Malfunction of the Initiation Needle/Power Switch Component Group ................................. 34
Table 5 NaCl solutions for osmometry based on Geigy scientific tables, 8th edition ........................ 47
6 | Contents

1 Introduction
1 Introduction
1.1 Applications of the OSMOMAT auto
The Gonotec cryoscopic osmometer, Osmomat®auto, is a non-invasive in-vitro diagnostic device for
in-vitro analysis of human blood, urine, semen and other samples, such as drip solutions. Its purpose
is to provide information to help identify, diagnose, monitor and treat physiological conditions, states of
health, and illnesses.
The OSMOMAT®auto must be operated exclusively by persons whose training or skills have provided
them with the necessary practical experience (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. Simple menu-controlled operation
helps to provide a high-performance and efficient measurement system for use in laboratories with
higher sample volumes.
The OSMOMAT auto is based on the 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 or a barcode reader prior to the measurement.
Measurement results are automatically assigned, stored in the unit (up to 300 samples), and can be
output immediately or later via the built-in standard paper printer by user command. Transfer to a PC
via the installed RS232 interface is possible.
Osmolality is an important measure of concentration for diluted solutions, such as all bodily fluids. In
the hospital or doctor’s office, osmolality can be used as one of several parameters to help form a
diagnosis or prompt further testing. In the pharmaceutical industry and research, the Osmomat auto is
used to test various aqueous solutions (saline drips, etc.) and for process validation.
The OSMOMAT auto has been applied successfully in the following fields:
General medicine Physiology Urology Veterinary
medicine
Routine and research Clinical laboratories Nephrology Pharmaceutics
Forensic medicine Intensive care laboratories Hemodialysis Pharmacies
Electron microscopy Pediatrics Hemofiltration … and many
more
Gynecology Botany
Introduction | 7

1 Introduction
1.1.1 Application Restrictions of the Osmomat auto
-The unit is not intended for determining the osmolality of dilutions.
-Only the osmolality of aqueous solutions can be determined.
Plausibility checks of the results must be performed by the doctor with the support of the pertinent
literature.
1.2 Measurement Method of the OSMOMAT auto
The OSMOMAT auto is a cryoscopic osmometer that measures the freezing point depression to
determine the total osmolality of aqueous solutions.
The freezing points of pure water and a solution are measured and compared. Whereas water has a
freezing point of 0°C, a solution with a saline concentration of 1 osmol/kg has a freezing point of
-1.858°C. That means that one mol of a given non-dissociated substance (6.023 x 1023 parts diluted in
one kilogram of water) lowers the freezing point of a solution by 1.858°C. The following definitions are
used in calculating osmolality:
Cosm = osmolality [osmol/kg]
T = freezing point depression [°C]
Cosm = ΔT / K
K = 1.858°C kg/osmol freezing point constant
The osmolality indicates the concentration of all osmotically active dissolved parts in the solvent.
Since the freezing point depression is directly proportional to the dissolved parts, the OSMOMAT auto
measures the osmolality directly.
1.3 Reproducibility in the OSMOMAT auto
Measurement
display LCD display, 4 lines with 20 characters
Measuring range 0 to approximately 2500 mOsmol/kg
Resolution 1 mOsmol /kg or 1 mOsmol/digit over the entire measuring range
Reproducibility
Sample volume 50µl #±1.0%
8 | Introduction

1 Introduction
1.4 Function of the OSMOMAT auto
The sample solution is cooled with a peltier cooling system while its temperature is electronically
monitored. Once the sample solution has reached a specific temperature below the freezing point,
crystallization is automatically initiated. The OSMOMAT 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. When crystallization begins, ice forms
spontaneously. The heat that was removed during undercooling is released again, the temperature
rises spontaneously, and the temperature of the sample rises to the freezing point.
If the sample consists of water (solvent), equilibrium is achieved as long as the sample contains water
and ice. The temperature remains constant because further heat removal does not result in a lowering
of the temperature but the formation of ice. The time of temperature equilibrium is known as plateau
time. Only after complete crystallization does the temperature fall again.
If the sample consists of a solution, the pure water in the solution crystallizes spontaneously and the
substances move to the rest of the solution. This means that at the time the freezing point temperature
is measured, the concentration is higher than in the original solution. A plateau occurs here as well,
but it is inclined. The osmolality reading is taken at the resulting reversal point (see Fig. 1). The
temperature is measured with a resolution of 1.858 x 10E-3°C.
Fig. 1 Freezing Point Depression of Solvent
Introduction | 9

1 Introduction
1.5 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
GSG Hof Reuchlinstr. 10-11
Tel.: [phone]
Fax: [phone]
10553 Berlin E-mail: [email protected]
Web: www.gonotec.com
Germany
Toll-free service number within Germany: 0800 / 7846027
The packaging for this equipment was specially designed to ensure safe and hygienic transport. The
packaging is re-usable. Please save the packaging in case the unit needs to be shipped back 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 complete. We cannot accept responsibility for
any missing items reported at a later date.
Accessories and consumables included in the shipment
Item number
OSMOMAT auto 20.9.0100 91 power cable
92 fine-wire fuses 230V 0.5A
((at 110V 1.0A)
00.9.0104
00.9.0106
35.9.0010 91000 measuring vessels
30.9.0020 9calibration standard 300 mOsmol/kg
35.9.0100 91 sample holder
30.2.0030 91 adjustment tool
30.9.0030 91 pasteur pipette (bellow)
30.9.1010 98 rolls of printer paper
35.9.1030 91 roll of cleaning paper
92 Allen wrenches (1.5 mm/2.5 mm)
91 user guide Osmomat auto
91 hand-held barcode scanner with power
supply
Barcode option 35.9.2000
10 | Introduction