Osmomat 3000

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User Guide

OSMOMAT 3000basic OSMOMAT 3000

Version 1.22 1/6/2016


Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany
Original Device Documentation
Phone: (030) 7809 588-0
Fax: (030) 7809 588-88
E-mail: [email protected]
Web: http://www.gonotec.com
WEEE reg. no.: DE65424410

© 2014-2016

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This manual allows for the safe and efficient operation of the
OSMOMAT 3000 (hereafter "device"). This manual is part of the
device and must be stored in the immediate vicinity of the device
and be easily accessible to personnel at any time.
Personnel must carefully read and understand this manual before
beginning any kind of work. Compliance with the safety notices and
instructions in this manual is the basis for a safe work environment.
In addition, local accident prevention regulations and general safety
provisions for the intended use of the device must be followed.
Figures in this manual are included for basic understanding and may
differ from the actual application.

Other applicable documents


In addition to this manual, the documents included with the device
documentation apply. The warnings – in particular safety notices –
in this documentation must be observed!

Copyright
The contents of this manual are protected by copyright. Their use is
permitted in connection with the use of this device. Any use beyond
this scope is not permitted without prior written authorization from
Gonotec GmbH.

Manufacturer contact info

Address Gonotec GmbH


GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany

Phone (030) 7809 588-0


Toll-free support hotline: 0800-7846027
(Germany only)

Fax (030) 7809 588-88

E-mail [email protected]

Web http://www.gonotec.com

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Table of Contents

Table of Contents
Table of Contents........................................................................... 5

1 Overview ................................................................................. 9

2 Safety ..................................................................................... 13
2.1 Explanation of symbols ....................................................13
2.2 Intended use .....................................................................15
2.3 Additional hazards ............................................................15
2.3.1 Hazards due to electrical current......................15
2.3.2 Risk of infection ................................................16
2.3.3 Risk of injury .....................................................16
2.3.4 Risks of device damage ...................................17
2.3.5 Reproducibility of the measurement .................18
2.4 Operator responsibilities ...................................................19
2.5 Personnel requirements ...................................................21
2.6 Personal safety gear ........................................................22
2.7 Environmental protection ..................................................22

3 Design and function ............................................................. 23


3.1 Device overview ...............................................................23
3.2 Measuring method basics ................................................27
3.3 Measurement equipment ..................................................28
3.4 Touchscreen .....................................................................30
3.5 Printer (does not apply to OSMOMAT 3000basic) ..............32
3.6 Connections and interfaces (does not apply to
OSMOMAT 3000basic) .......................................................33
3.6.1 Interface configuration ......................................34
3.6.2 Log formats ......................................................35
3.6.3 Data transfer.....................................................35
3.6.4 General options ................................................35
3.6.5 CSV format .......................................................36
3.6.6 XML format .......................................................37
3.6.7 Legacy CSV format ..........................................39
3.6.8 Error messages ................................................40
3.6.9 Checksums.......................................................40

4 Delivery, packaging, and storage .......................................41


4.1 Packaging.........................................................................42
4.2 Device storage .................................................................44
4.3 Unpack device ..................................................................44

5 Installation ............................................................................ 45
5.1 Transport device inside lab ..............................................45
5.2 Install device.....................................................................46
5.3 Connect device .................................................................47

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Table of Contents

6 Setup ..................................................................................... 48
6.1 Check printer (Option D) (does not apply to
OSMOMAT 3000basic) ...................................................... 48
6.2 Check free movement of steel needle ............................. 48
6.3 Set calibration defaults .................................................... 49
6.4 Date Time ........................................................................ 51
6.5 Measurement series name .............................................. 51
6.6 Result Unit ....................................................................... 51

7 Operation .............................................................................. 52
7.1 Power up device .............................................................. 53
7.2 Modify user preferences .................................................. 54
7.3 Measure individual samples ............................................ 57
7.4 Batch/series measurement (does not apply to
OSMOMAT 3000basic) ...................................................... 61
7.5 Calibrate device ............................................................... 65
7.6 Power down device ......................................................... 71

8 Troubleshooting................................................................... 72
8.1 Safety notices .................................................................. 72
8.2 Notes regarding errors..................................................... 73
8.3 Error table ........................................................................ 74
8.4 Resolve errors ................................................................. 78
8.4.1 Replace cryst-needle....................................... 78
8.4.2 Replace the temperature sensor ..................... 82
8.4.3 Replace microfuses ......................................... 89
8.4.4 Clean cooling clamp ........................................ 90
8.4.5 Replace printer paper (Option D only)
(does not apply to OSMOMAT 3000basic) ........ 90
8.4.6 Replace printer ribbon (Option D only)
(does not apply to OSMOMAT 3000basic) ........ 92
8.4.7 Reset device to default settings ...................... 94

9 Servicing ............................................................................... 95
9.1 Safety notices .................................................................. 95
9.2 Service table .................................................................... 96
9.3 Preliminary steps ............................................................. 96
9.4 Lubricate elevator .......................................................... 100
9.5 Perform visual inspection of device ............................... 102
9.6 Check reproducibility of measurements ........................ 103
9.6.1 Sample test protocol measurement check .... 103

10 Disposal .............................................................................. 104

11 Specifications ..................................................................... 106


11.1 Dimensions .................................................................... 106
11.2 Performance parameters ............................................... 106
11.3 Operating conditions...................................................... 106
11.4 Connection ratings......................................................... 107

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11.5 Options .......................................................................107


11.6 Nameplate ......................................................................108

12 Index .................................................................................... 109

Appendix ..................................................................................... 111


Returning the device .................................................................111
Limited Warranty .......................................................................113
OSMOMAT 3000 Intend Use ....................................................114
Classification of the IVD ............................................................114
EC Compliance Statement—OSMOMAT® 3000 .......................115
Provisions of Certification..........................................................115
Consumables ............................................................................116
Accessories and Replacement Parts ........................................116
Before Calling Gonotec .............................................................117

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Table of Contents

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Overview

1 Overview

Fig. 1: Device overview—front

1 Touchscreen,  page 30
2 Upper cooling system (behind movable elevator cover),
 page 29
3 Temperature sensor with measurement vessel,  page 29
4 Lower cooling system,  page 29
5 Elevator
6 Printer (Option D),  page 32
(does not apply to OSMOMAT 3000basic)

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Overview

Device, rear

Fig. 2: Device overview—rear

1 Interfaces,  page 33
(does not apply to OSMOMAT 3000basic)
2 Microfuses
3 On/Off switch
4 Power cable connection
5 Fan outlet

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Overview

Standard accessories
NOTE!
Risk of falsified measurement results!
When using accessories and/or consumables made
by manufacturers other than Gonotec GmbH, the
reproducibility of the measurement results cannot
be guaranteed.
- Always use the accessories and consumables
supplied by Gonotec GmbH.
- Re-order consumables, in particular measurement
vessels, from Gonotec GmbH (see page 3 for
contact information).

1 Measurement vessels, 100 pc.


2 Calibration standard, 10 pc., 1ml each,
concentration 300 mOsmol/kg
3 Printer paper, 1 roll (Option D only)

Fig. 3: Overview of consumables

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Overview

Accessories

Fig. 4: Overview of accessories

1 Power cable 5 2 microfuses, slow-blow 1.6A (HBC 1500A)


2 RS-232 cable 6 Ampoule opener
(does not apply to OSMOMAT 3000basic) 7 Blow-out device for removing condensate
3 USB cable for connection to PC (slave)
(does not apply to OSMOMAT 3000basic)
4 Adjustment tool

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Safety

2 Safety
2.1 Explanation of symbols
Safety notices The safety notices in this manual are identified by symbols. The safety
notices are preceded by signal words indicating the degree of hazard.

DANGER!
This combination of symbol and signal word indicates an
immediate dangerous situation that will result in death or
serious injury if not avoided.

WARNING!
This combination of symbol and signal word indicates a
potentially dangerous situation that may result in death
or serious injury if not avoided.

CAUTION!
This combination of symbol and signal word indicates a
potentially dangerous situation that may result in minor
or light injury if not avoided.

NOTE!
This combination of symbol and signal word indicates
a potentially dangerous situation that may result in
property damage if not avoided.

NOTE!
This combination of symbol and signal word indicates
potential environmental hazards.

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Safety

Special safety notices Safety notices use the following symbols to indicate special hazards:

WARNING!
This combination of symbol and signal word indicates a
potentially dangerous situation that may result in
contamination with biohazardous materials.
Observe the current Ordinance on Biological Substances
and refer to the lab protocol.

DANGER!
This combination of symbol and signal word indicates an
immediate dangerous situation due to electrical current.
Failure to observe a warning identified this way may
result in serious or deadly injury.

Safety notices in instructions Safety notices can apply to specific, individual instructions. These
safety notices are embedded in the instruction to avoid interrupting
the flow of reading while performing the operation. They use the
signal words described above.
Example:

1. Loosen screw.

2.
CAUTION!
Pinch hazard on cover!

Use care when closing cover.


3. Tighten screw.

Additional identifiers To highlight instructions, results, lists, references, and other elements,
the following identifiers are used in this manual:

Identification Explanation
Step-by-step instructions
1, 2, 3 ...

 Results of action steps

References to sections in this manual and


other applicable documents

Unordered lists

[Button] Controls (such as buttons or switches),


display elements (such as indicator lamps)

Display Screen elements (such as buttons, function


key assignments)

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Safety

2.2 Intended use


Intended use

The OSMOMAT 3000 device is a non-invasive in-vitro diagnostic


product used to determine the osmolality of aqueous solutions.
 Only use the device to measure aqueous solutions.
 Never measure organic, saturated, or highly viscous solutions.
 Never administer measured samples to humans by infusion
or injection.
 Never use calibration standards as cleaning solutions,
e.g. for contact lenses.
 Only use accessories and consumables supplied by
Gonotec GmbH for measurements.
 Accessories and consumables on page 25.

2.3 Additional hazards


2.3.1 Hazards due to electrical current

Electrical current
DANGER!
Risk of death due to electrical current on device!
Class I devices must be connected to a power socket
with protective ground wire.
If the power or device connector is used as a separation
device, the connector must be easily accessible at all
times.
Remove the power plug from the power socket to safely
disconnect the device from mains voltage.
Contact with energized parts of the device results in
immediate risk of death due to electric shock. Damage to
the insulation of individual components can cause risk of
death.
- Only have qualified personnel perform repair and
maintenance work on the device.
- If the insulation is damaged, immediately disconnect
the power plug and schedule a repair.
- Always route the power cable so it is not subject to
stress and cannot be bent, pinched, or rolled over
and is not exposed to liquids or heat.
- Keep energized parts away from liquids. Otherwise,
shorts may occur.

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Safety

2.3.2 Risk of infection

Risk of infection
WARNING!
Risk of infection due to sample residue and in case
of inadequate hygiene, disinfection, and sterilization
procedures!
Exposure to sample residue in non-cleaned, non-
sterilized, or non-disinfected components results in
an elevated risk of infection.
- Wear lab gloves during any kind of work.
- Observe all local regulations regarding hygiene,
disinfection, and sterilization.
We recommend using detergents such as Mikrozid®
AF Liquid, Bacillol® plus 3%, or Korsolex® plus 4%
commonly found in clinical-chemical labs to clean
and decontaminate the device.

2.3.3 Risk of injury

Risk of injury
CAUTION!
Risk of injury from cryst-needle!
When installing and removing the cryst-needle and
the temperature sensor, the tip of the cryst-needle is
exposed. Movement of the cryst-needle can cause
needle puncture injuries.
- Always keep your hands and fingers clear from
the area underneath the cryst-needle.

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Safety

2.3.4 Risks of device damage

Exposure to liquids and moisture


NOTE!
Device damage due to exposure to liquids and
moisture!
Exposure to liquids and moisture can cause damage
to the electrical components of the device, e.g. due to
a short.
- Install the device on a dry workplace.
- Always use a moistened wipe to disinfect the device,
but never a wet wipe.
- Never use the device outdoors.

Fan
NOTE!
Device damage due to insufficient air circulation!
Obstruction of the fan outlet at the rear of the device
can cause damage to the device.
- Always keep the fan outlet clear.

Shock
NOTE!
Risk of property damage due to exposure of the
device to strong shock!
The device includes precision-engineered components
which can be decalibrated and/or damaged in case of
exposure of the device to strong shock.
- Always install the device on a non-vibrating surface.

ESD
NOTE!
Risk of property damage due to electrostatic
discharge!
Electrostatic discharge (ESD) can occur when working
on the open device.
- Take ESD precautions.

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Safety

2.3.5 Reproducibility of the measurement

Incorrect measurement vessels


NOTE!
Impaired reproducibility of measurement due to
incorrect measurement vessels!
Repeated use of the measurement vessels and use of
incorrect consumables cannot guarantee reproducible
measurement results.
- Always use a clean and unused measurement
vessel for every measurement.
- Only use measurement vessels supplied by
Gonotec GmbH.
- Never use centrifuge tubes or reaction vessels.

Improper handling of
NOTE!
the calibration standard
Impaired reproducibility of measurement due to
improper handling of calibration standards!
Improper handling and storage of the calibration
standards included with the delivery negatively affects
the measurement accuracy of the device.
- Always observe the stability of the calibration
standards after opening the ampoule (max. 0.5h
at 22°C ambient temperature).
- Never use opened ampoules twice or mix them
together.
- Never freeze opened ampoules.
- Do not use the calibration standards past their
expiration date.

Shock
NOTE!
Increased risk of incorrect measurements!
The device includes precision-engineered components
which can be decalibrated and/or damaged in case of
exposure of the device to strong shock. This can cause
a higher risk of incorrect measurements (spontaneous
crystallization).
- Always install the device on a non-vibrating surface.

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Safety

2.4 Operator responsibilities


The operator of the device must fulfill the responsibilities according to
Germany’s Medical Devices Operator Ordinance listed in this manual.

In addition, the operator is responsible for learning about


and complying with all local laws and associated
standards and guidelines applicable at the time
the device is used.

The device is used for medical-pharmaceutical applications.


Therefore, the operator is subject to the legal responsibilities
regarding work safety.
In particular, the following applies:
 The operator has to learn about the applicable work safety
regulations and determine additional risks resulting from the
specific working conditions at the location the device is used by
means of a risk assessment. These must be implemented by
means of operating instructions for the device.
 The operator has to learn about the applicable hygiene regulations
resulting from the samples at the location the device is used.
These must be implemented by means of operating instructions
for the device.
 During the entire operating time of the device, the operator has to
verify that the operating instructions created by him/her meet the
current body of regulations and update them if necessary.
 The operator has to determine and lay down the specific
responsibilities for installation, operation, troubleshooting,
servicing, disinfection, and cleaning.
 The operator has to make sure that all personnel working with
the device have read and understood this manual. In addition,
s/he has to provide regular training for personnel and educate
them about risks.
 The operator has to equip personnel with the required safety gear
and issue mandatory instructions for wearing the required safety
gear.
 The operator has to make sure that the service intervals specified
in this manual are observed.
 The operator has to make sure that consumables are available in
sufficient quantities.

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Safety

Inventory The operator has to maintain an inventory according to Germany’s


Medical Devices Operator Ordinance:
 The following information has to be maintained in the inventory:
 name, product type, serial number, and year the device was
purchased,
 address of Gonotec GmbH
 organization-specific ID, if applicable
 location of operator
 schedule of safety inspections
 Store CE-certificate together with inventory.
 Store inventory so it is accessible to personnel in charge of
operating the device at all times.
 Make documentation available to the responsible authorities
upon demand.

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Safety

2.5 Personnel requirements

WARNING!
Risk of injury due to inadequately qualified
personnel!
Work performed on the device by unqualified personnel
or the presence of unqualified personnel in the hazard
zone of the device creates risks that can result in serious
injury and substantial property damage.
- Only have qualified personnel perform any kind
of activity.

This manual specifies the following personnel qualifications for


the different task areas:

User
Based on his or her expert medical and/or pharmaceutical training,
knowledge, and experience, the user is capable of safely executing
the tasks assigned to him or her.
The user is not authorized to perform any start-up activities.
The user is capable of independently detecting, evaluating, and
avoiding possible risks.
The user has the expert knowledge for the intended use of the device
and observes all hygiene regulations for rooms used for medical
purposes and the use of medical products.
The user knows the contents of all applicable regulations, guidelines,
and standards required by law for the safe use of the device and is
capable of meeting the requirements stipulated therein.

Lab supervisor
The lab supervisor coordinates and monitors the technical procedures
at the installation site of the device.
Based on his or her professional training and many years of
professional experience with medical devices, the lab supervisor is
capable of performing the start-up tasks delegated to him or her by
the manufacturer.

Service technician
Based on his or her professional training in the area of mechanical
and electrical engineering, the service technician is capable of
performing the tasks related to troubleshooting and servicing
delegated to him or her by the manufacturer.

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Safety

2.6 Personal safety gear


While performing the different tasks on and with the device, personnel
must wear the personal safety gear referenced explicitly in the various
sections of this manual.

Description of personal safety gear The personal safety gear is explained below:

Disposable lab gloves


Disposable lab gloves protect the hands from touching sample
residue.

2.7 Environmental protection

NOTE!
Danger to environment due to incorrect handling of
handling of environmentally hazardous substances!
Incorrect handling of environmentally hazardous substances,
in particular incorrect disposal, can result in significant harm
to the environment.
- Always observe the warnings regarding the handling of
environmentally hazardous substances and their disposal
below.
- If environmentally hazardous substances are inadvertently
released into the environment, immediately initiate suitable
actions. If in doubt, notify the responsible local authority
about the damage and inquire about suitable actions to
be initiated.

The following environmentally hazardous substances are used:

Electronic components Electrical components can contain poisonous substances. These must
not be released into the environment. Therefore, a specialist disposal
firm must be tasked with disposal.

Sodium chloride The calibration standards contain sodium chloride. Sodium chloride
is mildly hazardous to water and must not be released into the
environment.

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Design and function

3 Design and function


3.1 Device overview

Fig. 5: Device overview—front

1 Touchscreen,  page 30
2 Upper cooling system (behind movable elevator cover),
 page 29
3 Temperature sensor with measurement vessel,  page 29
4 Lower cooling system,  page 29
5 Elevator
6 Printer (Option D),  page 32
(does not apply to OSMOMAT 3000basic)

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Design and function

Device, rear

Fig. 6: Device overview—rear

1 Interfaces,  page 33.


(does not apply to OSMOMAT 3000basic)
2 Microfuses
3 On/Off switch
4 Power cable connection
5 Fan outlet

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Design and function

Standard accessories
NOTE!
Risk of falsified measurement results!
When using accessories and/or consumables made
by manufacturers other than Gonotec GmbH, the
reproducibility of the measurement results cannot
be guaranteed.
- Always use the accessories and consumables
supplied by Gonotec GmbH.
- Re-order consumables, in particular measurement
vessels, from Gonotec GmbH (see page 3 for
contact information).

1 Measurement vessels, 100 pc.


2 Calibration standard, 10 pc., 1ml each,
concentration 300 mOsmol/kg
3 Printer paper, 1 roll (Option D only)

Fig. 7: Overview of consumables

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Design and function

Accessories

Fig. 8: Overview of accessories

1 Power cable 5 2 microfuses, slow-blow 1.6A (HBC 1500A)


2 RS-232 cable 6 Ampoule opener
(does not apply to OSMOMAT 3000basic) 7 Blow-out device for removing condensate
3 USB cable for connection to PC (slave)
(does not apply to OSMOMAT 3000basic)
4 Adjustment tool

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Design and function

3.2 Measuring method basics


Osmolality The device measures the total osmolality of any aqueous solution.
The osmolality of a solution is defined as the number (or amount of
substance) of the osmotically active particles (e.g. salt ions, sugar,
urea, proteins) present per kilogram of solvent (water).
The osmolality is specified in Osmol/kg or mOsmol/kg.
The device determines the total osmolality of a sample solution
based on the freezing point depression (see below).
The implemented measuring method is a relative measuring method
where the device is first calibrated based on the freezing points of
distilled water and one or two calibration solutions with known
osmolality. Next, the osmolality of unknown sample solutions is
determined with reference to this 2/3-point calibration.

Freezing point depression The freezing point of a solvent is depressed by adding soluble or
mixable substances. The magnitude of this effect depends less on
the type and quantity of the dissolved substance, but rather on the
number of particles present in the solution afterwards.
Whereas water has a freezing point of 0°C, an aqueous solution
with an osmotically active particle concentration of 1 Osmol/kg has
a freezing point of -1.858°C.
That means that one mol of an ideal non-dissociated substance
(6.023 × 1023 parts diluted in one kilogram of water) lowers the
freezing point of a solution by 1.858°C.
The osmolality of a solution is directly proportional to the measured
freezing point depression and can therefore be calculated from this
result. The relationship is as follows:

Cosm = osmolality [Osmol/kg]


Cosm = ΔT / K
ΔT = freezing point depression [°C]
K = 1.858°C kg/Osmol (cryoscopic constant)

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Design and function

3.3 Measurement equipment

Fig. 9: Overview of measurement equipment

1 Elevator 5 Lower cooling system


2 Upper cooling system 6 Cover
(behind movable elevator cover) 7 Measurement vessel
3 Handle for lowering the temperature sensor
4 Temperature sensor
The sample is pipetted into the measurement vessel (Fig. 9/7).
The measurement vessel is placed on the temperature sensor
(Fig. 9/4) and lowered into the lower cooling system (Fig. 9/5).
The lower cooling system cools the sample down to a defined
temperature.
The defined crystallization of the sample is triggered using ice
crystals produced in the upper cooling system (Fig. 9/2).
The osmolality of the sample is calculated using the measured
freezing point [°C] and the cryoscopic constant and shown on
the display.

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

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Design and function

Upper cooling system


1 Cryst-needle
2 Cooling nipple
The cryst-needle (Fig. 10/1) of the upper cooling system "inoculates"
the sample with ice crystals ("crystallization"). This causes the sample
to freeze and heat up to its freezing point.

WARNING!
Fig. 10: Upper cooling system Risk of infection from sample residue!
The cryst-needle is immersed into the sample during
measurements. Contact with the cryst-needle increases
the risk of infection.
- Wear lab gloves during any kind of work.

Temperature sensor
1 Temperature sensor
2 Thermistor
The temperature sensor (Fig. 11/1) measures the current temperature
of the sample via the thermistor (Fig. 11/2). After crystallization has
been triggered, the temperature sensor measures the freezing point
of the sample.

NOTE!
Sensitive component!
The thermistor of the temperature sensor is a sensitive
component and must be protected from external
influences such as dust or friction.
Fig. 11: Temperature sensor - When performing any kind of work on the device,
place a measurement vessel on the thermistor.
- At the end of the work on the device, place a
measurement vessel on the thermistor for protection.

Lower cooling system The lower cooling system quickly cools the sample down to a defined
temperature which is below the freezing point of the solution.
The quick cooling down of the sample causes the sample to remain
in the liquid state until the defined crystallization is triggered.

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Design and function

3.4 Touchscreen

Fig. 12: Overview of touchscreen

The device is controlled using the touchscreen (Fig. 12/1)

NOTE!
Property damage due to incorrect operation!
The touchscreen can be damaged by sharp or hard
objects or excessive pressure force.
- Only operate the touchscreen using fingers or
a touchpen.
- Only tap the touchscreen (do not press).

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Design and function

Enter values Some menus are password-protected.


Access to these menus is limited to the lab supervisor
or authorized service personnel/Gonotec.

Fig. 13: Enter values

1. To enter values, tap the corresponding entry field in the opened


menu.

 This opens an on-screen keyboard.

2. Enter the value.

To close the on-screen keyboard without saving


the entered value, tap [Cancel].

3. To save the value, tap .

 The newly entered value overwrites the previous value.

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Design and function

3.5 Printer (does not apply to OSMOMAT 3000basic)

With built-in printer only (Option D)

1 Opening for printer paper


2 Printer pull-out handle
The printer is used to print the measurement results. Rolls of printer
paper are included with the delivery.

Change printer paper


Change the printer paper when a red stripe appears on
the printer paper ( chapter 8.4.5 on page 90).

Fig. 14: Overview of printer

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Design and function

3.6 Connections and interfaces (does not apply to OSMOMAT 3000basic)


The following connections and interfaces are located at the rear of
the device:

Fig. 15: Connections and interfaces

1 COM1 (only for connecting barcode reader) 4 Fuse insert


(does not apply to OSMOMAT 3000basic) 5 On/Off switch
2 COM2 interface (RS-232 output) 6 Power plug connection
(does not apply to OSMOMAT 3000basic)
3 USB port
(does not apply to OSMOMAT 3000basic)

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3.6.1 Interface configuration

COM1 data port The upper COM1 (RS232) serial data port is used to connect a barcode
reader. The barcode reader is configured at the factory and can be
(does not apply to
purchased from Gonotec GmbH or your authorized distributor.
OSMOMAT 3000basic)

WARNING!
Incompatible barcode reader!
The use of a barcode reader other than the barcode
reader supplied by Gonotec GmbH is not recommended
because potential incompatibilities cannot be ruled out.

COM2 or USB data port


WARNING!
(does not apply to
To protect life and equipment:
OSMOMAT 3000basic)
Devices and accessories connected to the RS232
or USB connectors must meet the applicable safety
standards for medical lab equipment.

The device can output the recorded measurement results via the
COM2 (RS232) serial data port in the middle or the USB port.
To select the data port, select Log Port from the Settings menu item.
The following screen lets you select between COM2 and USB.

Fig. 16: Set log port

USB port driver A software driver is required to use the USB port. There are two
methods for installing the driver:
- Automatic: Connect the device to the PC using the USB cable
and switch on the device. The operating system of the PC
detects the interface, automatically installs the required software
driver and notifies the user that installation was successful. The
USB port can now be used as an additional COM interface.
- Manual: The PC does not automatically detect the device or
the operating system is missing the required software driver.
In this case, please follow the instructions on the included CD.
It includes both the installation instructions for the corresponding
Windows operating system and the software driver itself.

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3.6.2 Log formats


The log output for the Osmomat 3000 may optionally be in one of the following three formats:

Format Description Advantages Disadvantages


CSV Line by line comma- Compact Not a genuine standard format
separated values Can be uploaded into spreadsheets
placed within (e.g. OpenOffice or Excel)
quotation marks Easily human-readable
Checksum acts as backup
XML Standardized, Standardized Not very compact
expandable markup Compatible with large number of APIs
language Human-readable
Checksum acts as backup
Legacy CSV CSV format Compatible with legacy devices and Syntax not always clear
from previous interfaces May cause data to be
generations misinterpreted
of devices For reasons of security we
strongly advise against
continuing to use this format!

A more detailed description of the formats is provided below.

3.6.3 Data transfer

Parameter Value Data is transferred via the serial interface in the laboratory options with
Rate 9600 baud the transfer parameters set as follows.

Data bits 8 These settings are also usually referred to as 9600/8N1.

Parity None
Stop bit 1
Coding ASCII

3.6.4 General options


The following options can be set for all formats using the laboratory options.

End of line markers:


The end of each displayed line can optionally be marked as follows.

Name Description ASCII


CR Carriage return 0x0D
CRLF Carriage return and 0x0D 0x0A
line feed
The end of the line is marked as ⏎.

End of ticket markers:


Fig. 17: Log formats
An “end of ticket” marker can optionally be selected. This setting means
that a line is displayed as follows after each individual sample
measurement or after the end of the batch:

EndOfTicket⏎

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3.6.5 CSV format


If CSV format is selected, the log is displayed line by line. Each line is separated by the selected end of line symbol.

Line content There are three types of line content

Type Purpose
Intro Message showing version numbers of device software

Title Column title of the next table of result lines

Result Measurement result or error message

Line group Every line within the CSV format contains several semicolon-
(ASCII:0x3B) separated values. If necessary, they are enclosed in
quotation marks (ASCII:0x22). Whether or not quotation marks are used
depends on the value format. They are not used for measurements or
times, but they are used for text values.

Intro line When the Osmomat 3000 is started, the device sends a line with
version information to prevent future compatibility problems. This line
contains the short name of the device type followed by the version
numbers of the mainboard and the components connected to it.
A typical intro line looks like this:

OSM3000;Main:V1.22;COM:V1.7;D:V1.10;TEC:V1.6⏎

NOTE!
Changing the settings restarts the logbook and also
publishes a new intro line.

Title line The intro line is followed by a line with title names for the values of the
next result lines. This line helps to make the text human-readable and
generates practical column titles when imported into a spreadsheet:

"batch";"sample";date;value;"dimension";"device-no";"check";"message"⏎

NOTE!
Changing the settings restarts the logbook and also
publishes a new column title.

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Result line After each measurement a result line is sent which contains
the following semicolon-separated values in a fixed order:

Column Description
batch Batch identifier in quotation marks, entered by the user or a sequential
number generated automatically.
Or:
Void for single measurements and if batch ID is disabled in the options.
sample Sample identifier in quotation marks, entered by the user or a sequential
number generated automatically.
Or:
Void if sample ID is disabled in the options.
date Date and time in combined ISO 8601 format
(e.g.: 2015-12-31T13:45).
value Measurement value as integer.
Or:
Error identifier (see Error messages section)
dimension Unit of the measurement value returned in value enclosed in quotation
marks ("mOsmol/kg") – regardless of the selected result unit and the
language setting of the device!
Or:
Void if value contains an error message.
device-no Serial number of the device in quotation marks.
check Checksum of previous values in this line (see Checksum section)
message Human-readable message always in English in quotation marks.
Or:
Void if there is no notification.

3.6.6 XML format


The XML format is sent line by line but a single record will generally extend across several lines. Each record is
transferred as a ticket and multiple measurements for one batch are combined into one ticket. Strictly speaking,
records are allocated to tickets in the same way as they are published: Each printed record corresponds to one
ticket in the XML log.

There are two types of ticket:

Type Description
SAMPLE Contains exactly one result from a single measurement
BATCH Contains several results from a batch measurement

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3.6.6.1 Ticket
A ticket consists of an XML tag which corresponds to one published ticket. If it relates to a single measurement,
it contains an additional XML tag called Measurement, which contains the measurement and the associated
metadata. If it relates to a batch measurement, one ticket may contain several measurements.

A ticket has the following attributes in addition to the measurements contained in it:

Attribute Description
class Ticket type (SAMPLE or BATCH)
serialno Serial number of the device
versions Version information on the device and connected components
(see Intro line in the CSV format chapter)

3.6.6.2 Measurement
A measurement or mismeasurement is described in a ticket in an XML tag called Measurement, which
contains the following values:

Value Description
BatchId Batch identifier, entered by the user or a sequential number generated
automatically.
Or:
Not present for single measurements and if batch ID is disabled in the
options.
SampleId Sample identifier, entered by the user or sequential number generated
automatically.
Or:
Not present if sample ID is disabled in the options.
DateTime Date and time in combined ISO 8601 format
(e.g.: 2015-12-31T13:45).
Value Measurement value as integer.
Or:
Not present if it is a mismeasurement.
Unit Unit of the measurement value returned in value enclosed in
quotation marks ("mOsmol/kg") – regardless of the selected result
unit and the language setting of the device!
Or:
Not present if it is a mismeasurement.
Failure Error identifier (see Error messages section)
Or:
Not present if measurement was successful.
DeviceNo Serial number of the device
CheckSum Checksum of previous values in this line (see Checksum section)
Message Human-readable message always in English.
Or:
Not present if there is no notification.

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3.6.6.3 Example of a single measurement


In the case of a single measurement the entire ticket is published in one piece when the measurement has been
completed, the value BatchId does not apply.

<Ticket class="SAMPLE" serialno="300161103"


versions="OSM3000;Main:V1.22;COM:V1.7;D:V1.10;TEC:V1.6">⏎
<Measurement>⏎
<SampleId>PROBE01</SampleId>⏎
<DateTime>2016-02-19T08:34:30</DateTime>⏎
<Value>301</Value>⏎
<Unit>mOsmol/kg</Unit>⏎
<DeviceNo>300161103</DeviceNo>⏎
<CheckSum>172ef346c5f36c964ac0710a8421efc1</CheckSum>⏎
</Measurement>⏎
</Ticket>⏎

• Example of a batch measurement


If a new batch is initiated, a section is published which opens the ticket as an XML tag in the log:

<Ticket class="BATCH" serialno="300161103"


versions="OSM3000;Main:V1.22;COM:V1.7;D:V1.10;TEC:V1.6">⏎

If measurements are then implemented within the batch, a Measurement XML tag follows for each measurement
such as the following:

<Measurement>⏎
<BatchId>CHARGE01</BatchId>⏎
<SampleId>PROBE01</SampleId>⏎
<DateTime>2016-02-19T08:38:02</DateTime>⏎
<Value>301</Value>⏎
<Unit>mOsmol/kg</Unit>⏎
<DeviceNo>300161103</DeviceNo>⏎
<CheckSum>339781763744c176c6b43317d880b782</CheckSum>⏎
</Measurement>⏎

Ending the batch also closes the ticket:

</Ticket>⏎

3.6.7 Legacy CSV format


Format initially used by OSMOMAT 3000 for data transfer.

Select only if required for compatibility with existing LIMS connections configured accordingly. Documentation in
the obsolete CSV format can be requested separately.

We strongly advise against continuing to use this format!

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Design and function

3.6.8 Error messages


The following error messages may be used to diagnose an operating error or device failure:

Notification Meaning
ABORT User cancels by pressing the EXIT key
LIFT User cancels by lifting the sensor
CANTCOOL Failed to sufficiently cool down sample
NOCRYST Crystallization failed
SPONCRYST Spontaneous crystallization of sample

3.6.9 Checksums
The checksum for each result line is calculated from the contents of the values from the columns Batch ID,
Sample ID, Date/time, Measurement, Unit and Device number. A possible result line:

<Measurement>
<SampleId>PROBE01</SampleId>
<DateTime>2016-02-19T08:34:30</DateTime>
<Value>301</Value>
<Unit>mOsmol/kg</Unit>
<DeviceCode>300161103</DeviceCode>
<CheckSum>172ef346c5f36c964ac0710a8421efc1</CheckSum>
</Measurement>

...or…

;"PROBE01";2016-02-19T08:34:30;301;"mOsmol/kg";"300161103";
"172ef346c5f36c964ac0710a8421efc1";

...and the above contents are strung together to form:

PROBE012016-02-19T08:34:30301mOsmol/kg300161103

The MD5 checksum for this string is:

17 2e f3 46 c5 f3 6c 96 4a c0 71 0a 84 21 ef c1

See http://en.toolpage.org/tool/md5 to learn more about MD5 calculation

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Delivery, packaging, and storage

4 Delivery, packaging, and storage


Delivery condition
1 package containing the following components:
 Device with protective sleeve (Fig. 18/1)
 Accessories (Fig. 18/2–8):
 Blow-out device (Fig. 18/3)
 Adjustment tool (Fig. 18/8)
 1 package of 2 microfuses: slow-blow 1.6A (Fig. 18/6)
 Ampoule opener (Fig. 18/4)
 USB cable (Fig. 18/5) (does not apply to OSMOMAT 3000basic)
 RS-232 cable (Fig. 18/7) (does not apply to OSMOMAT
3000basic)
 Power cable (Fig. 18/2)
 Standard accessories (Fig. 18/9-11)
 Printer paper (Fig. 18/9) (Option D only)
(does not apply to OSMOMAT 3000basic)
 Measurement vessels, 100 pc. (Fig. 18/10)
 Calibration standard 300mOsmol/kg, 1 package of
10 ampoules/1ml each (Fig. 18/11)
 1 user manual

Check the delivery for completeness and transport damage


immediately following receipt.
Proceed as follows in case of externally visible transport damage:
 Reject delivery or accept delivery only conditionally.
 Note the extent of damage on the transport documents or
the delivery note of the carrier.
 Notify Gonotec GmbH and initiate a complaint.

File a complaint about every defect as soon as it is


detected. Claims for damages can only be filed within
applicable complaint deadlines.

Fig. 18: Delivery condition

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4.1 Packaging
About the packaging The package is packaged according to the expected transport
conditions. Only environmentally friendly materials were used for
the packaging.
The packaging is intended to protect the device from transport
damage and other damage until the time of installation. Therefore,
do not destroy the packaging and do not remove it until just before
installation.

Handling of packaging materials The packaging is multi-use and ensures a hygienic and safe method
of transportation. Keep the packaging for possible return of the device
for repairs. This will save you the time and money needed to find
equally suitable packaging.
If disposing of the packaging material, observe the following:

NOTE!
Danger to environment due to improper disposal!
Packaging materials are valuable resources and can be
re-used or recycled in many cases. Improper disposal of
packaging materials can cause dangers to the
environment.
- Be aware of the environment when disposing of the
packaging material.
- Observe applicable local disposal regulations. If
necessary, task a specialist firm with disposal.

Symbols on packaging The symbols on the packaging of the device and calibration standard
are explained below:

Fragile
Indicates packages with fragile or sensitive contents.
Handle the package with care, do not drop, and do not expose
to shock.

Protect from liquid


Protect packages from liquid and keep dry.

Package orientation
The arrow tips of the symbol point to the top of the package. They
must point up at all times to prevent damage to the contents.

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No disposal via municipal waste


Indicates that disposal of the device via municipal waste is prohibited.
Disposal of the decommissioned device should be via electronics and
metal recycling. In addition, decommissioned devices can be returned
to the manufacturer for disposal.

Package recycling
Indicates that the packaging can be recycled.

Compliance
This product meets the requirements of EEC Directive 98/79 relating
to in-vitro diagnostic devices.

In-vitro diagnostic device


Indicates that the product is an in-vitro diagnostic device.

Item number
Item number

Batch ID
Batch ID of the calibration standard

Biological safety
Biological safety (month, year). Date until which the calibration
standard fulfills its original function if stored properly.

Biohazard
Biocontamination warning:
Use care when operating upper cooling system and cryst-needle

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4.2 Device storage


Store the device under the following conditions:
 Do not store outside.
 Store under dry and dust-free conditions.
 Do not expose to aggressive media.
 Protect from sunlight.
 Protect the temperature sensor using a measurement vessel.
 Avoid mechanical shock.
 Storage temperature: -10°C to 60°C.
 Relative humidity (non-condensing): 5-90%.
 If stored for more than 3 months, regularly inspect all parts and
packaging for general integrity.

4.3 Unpack device


1. Carefully open cardboard box using a knife.

2. Remove device from packaging and place in a suitable location.

3. Keep packaging for possible later return.

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Installation

5 Installation
5.1 Transport device inside lab
Personnel:  User

Safety gear:  Disposable lab gloves

1. Power down device using on/off switch on rear side and


disconnect power plug.

2. Position a measurement vessel (Fig. 19/1) on the temperature


sensor.

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 19: Position measurement vessel

3. Tilt transport safety device for temperature sensor and carefully


slide behind the temperature sensor (Fig. 20).

Fig. 20: Position transport safety device

4. Pull protective sleeve (Fig. 21/1) included with the delivery over
device.

5. Lift up device (6.5kg) and carry to installation site.

Fig. 21: Device with protective sleeve

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Installation

5.2 Install device


Personnel:  User

Safety gear:  Disposable lab gloves

1.
NOTE!
Risk of property damage!
Only install device indoors.

Install device at installation site.

NOTE!
Risk of incorrect measurements

Select site based on the following criteria:


- free of vibrations
- no direct heat exposure (sun, electric heater, etc.)
- no strong air flows
- free of dust and dirt

Fig. 22: Fan outlet (1)


Keep fan outlet (Fig. 22/1) on device clear.
Keep fan outlet openings underneath device clear.

2. Remove protective sleeve from device (Fig. 23/1).

Fig. 23: Remove protective sleeve

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Installation

3. Remove transport safety device (Fig. 24/1) from temperature


sensor. Proceed as follows:

Fig. 24: Transport safety device

4. Carefully pull transport safety device down and pull forward to


remove.

Fig. 25: Remove transport safety device

5.3 Connect device


Personnel:  Lab supervisor

1. Connect power plug to device.

2. Connect power cable to a properly grounded power socket.

3. Connect a PC via RS232 or USB (if applicable).

4. Connect a barcode reader (if applicable).

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Setup

6 Setup
Personnel:  Lab supervisor

1. Complete all activities for installation and connection of the


device.

2. Verify that the connections at the rear side of the device


are secure.

3. Check the elevator for ease of movement.


If necessary, grease the elevator guide ( chapter 9.4 “Lubricate
elevator” on page 100).

4. Power up device on rear side using on/off switch.

6.1 Check printer (Option D)


(does not apply to OSMOMAT 3000basic)

Fig. 27: Paper roll feed direction

Correct feed direction


Incorrect feed direction
Fig. 26: Pull out printer 5. Check feed direction of paper roll. Open printer (Fig. 26/1)
by pulling on silver knob (magnetic latch) and compare feed
direction of paper roll with feed direction shown in Fig. 27.

6.2 Check free movement of steel needle


6. Check cryst-needle for free movement.
Open the Adjust Needle menu (Start menu  Settings  Lab
Options  Maintenance  Adjust Needle).

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7.
CAUTION!
Risk of injury from cryst-needle!
The tip of the cryst-needle is exposed. Movement of
the cryst-needle can cause needle puncture injuries.
- Always keep your hands and fingers clear from
the area underneath the cryst-needle.
WARNING!
Risk of infection due to sample residue and in
Fig. 28: Adjust Needle menu case of inadequate hygiene, disinfection, and
sterilization procedures!
Exposure to sample residue in non-cleaned, non-
sterilized, or non-disinfected components results in
an elevated risk of infection.
- Wear lab gloves during any kind of work.
- Observe all local regulations regarding hygiene,
disinfectant cleaning, and sterilization.

Tap Move Needle and ensure that the cryst-needle moves freely.
Tap Back to complete the check.

6.3 Set calibration defaults


Select calibration procedure
8. Open the menu for configuring the lab options.
In the Start menu, tap Settings  Lab Options.

The menu can be protected with a lab supervisor


password.

See QA Settings to learn more about calibration settings.

Fig. 29: Lab Options menu

9. Open the menu for configuring the lab options.


To configure the calibration interval, tap Cal. Period.
To select the calibration standards you are using, tap
Cal. Standards.
To set up the calibration method, tap QA Preset.

OSMOMAT 3000basic:
Cal. Period and Cal. Standards selections are
not available
Fig. 30: QA Settings menu

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Setup

Configure calibration interval


10. Select a calibration interval.
When selecting Manual, the device does not prompt you for
calibration (not recommended).

OSMOMAT 3000basic:
Selection not available

Fig. 31: Configure calibration interval

Select calibration standards


11. Specify the allowed calibration points. They should be close to
the expected measurement values.
A calibration point (Custom) can be freely selected by the user
in increments of 10 and enabled or disabled for selection.
Enter the values in mOsmol/kg.

OSMOMAT 3000basic:
Selection not available
Fig. 32: Select calibration standards

Set up calibration method


12. Select the calibration method:
 2-point: Select 2-point calibration
 3-point: Select 3-point calibration

13. Select the number of measurements to be performed for each


calibration medium (distilled water and calibration standard).
The system calculates the calibration values from the mean value
of these measurements.
The number of measurements for each calibration
Fig. 33: Set up calibration method point does not affect the linearity or reproducibility
of the measurement system.
They are only used to arrive at the mean value.

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Setup

6.4 Date Time


Set date and time

14. Enter date and time as follows:


DD – Day, two digits [01…31]
MM – Month, two digits [01…12]
YYYY – Year, four digits [2014]
HH – Hour, two digits [00…23]
MM – Minutes, two digits [00…59]

Fig. 34: Set date and time

Set date format

15. Select the date format required:


DD – Day, two digits [01…31]
MM – Month, two digits [01…12]
MMM – Month [Jan…Dec]
YYYY – Year, four digits [2014]
If AUTOMATIC is selected the date format is based on
the language selected.
Fig. 35: Select date format

6.5 Measurement series name


Set measurement series name
16. Select the name for your measurement series.

OSMOMAT 3000basic:
Selection not available

Fig. 36: Measurement series name

6.6 Result Unit


Set result unit
17. Select the unit for the measurement results:
- mOsmol/kg
- Osmol/kg
- °C

OSMOMAT 3000basic:
Selection not available

Fig. 37: Select unit

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Operation

7 Operation
Electrical current
DANGER!
Risk of death due to electrical current on device!
Contact with energized parts of the device results in
immediate risk of death due to electric shock. Damage
to the insulation of individual components can cause
risk of death.
- Only have qualified personnel perform repair and
maintenance work on the device.
- If the insulation is damaged, immediately disconnect
the power plug and schedule a repair.
- Always route the power cable so it is not subject to
stress and cannot be bent, pinched, or rolled over
and is not exposed to liquids or heat.
- Ensure easy access to the power socket at all times.
- Keep energized parts away from liquids. Otherwise,
shorts may occur.

Risk of infection
WARNING!
Risk of infection due to sample residue and in case
of inadequate hygiene, disinfection, and sterilization
procedures!
Exposure to sample residue in non-cleaned, non-
sterilized, or non-disinfected components results in
an elevated risk of infection.
- Wear lab gloves during any kind of work.
- Observe all local regulations regarding hygiene,
disinfection, and sterilization.

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Operation

7.1 Power up device


Personnel:  User

Safety gear:  Disposable lab gloves

1. Power up device on rear side using on/off switch (Fig. 38/1).

Fig. 38: Power up device

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Operation

7.2 Modify user preferences


Configure language

Tap Language and select a language.

Fig. 39: Select language

Overview
Tapping Settings on the Start menu opens the Settings menu.
The Settings menu lets the user configure the following settings:
 Info: Shows the version of the device software
 Display: Configure screen contrast
 Screen saver: Configure screen saver
 Printer: Activate paper feed (Option D only)
(does not apply to OSMOMAT 3000basic)
 ID Management: Set ID for sample and series measurements
Fig. 40: Overview of user preferences (does not apply to OSMOMAT 3000basic)

The Lab Options option is protected with the lab


supervisor password.
The Service option is protected with the service
password. Modifications have to be requested
by contacting the manufacturer.

Configure screen contrast


1. Tap to increase contrast.
Tap to decrease contrast.

Fig. 41: Configure screen contrast

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Operation

Configure screen saver


1. Select the duration after which the system activates the screen
saver.
Tapping OFF will never activate the screen saver.

Fig. 42: Configure screen saver

Activate paper feed


(does not apply to
OSMOMAT 3000basic)
1. Option D only:
Tap Paper Feed.

 The paper feed of the printer is activated briefly.


Tap Back to exit the menu.

Fig. 43: Activate paper feed

Set sample and batch ID


(does not apply to
OSMOMAT 3000basic)

1. Select the settings for the IDs for series measurements


(Batch ID) and individual samples (Sample ID). The following
options are available:
 automatic: The samples and the charge IDs are assigned
running numbers automatically. The counter resets daily.
The counter for the individual samples in a series
measurement resets when starting a new series
measurement.
 numeric: Numeric IDs are assigned manually. During
Fig. 44: Set sample and batch ID measurements, the system prompts the user to enter the
numeric ID of the sample or charge using the virtual keyboard.
 alphanumeric: Alphanumeric IDs are assigned manually.
During measurements, the system prompts the user to enter
the alphanumeric ID of the sample or charge using the virtual
keyboard.
 none: Do not use IDs for samples and batches.

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Operation

Laboratory options
Tapping Lab Options in the Settings menu opens the Lab Options
menu.

The Lab Options option is protected with the lab


supervisor password.

The Lab Options menu lets the user configure the following settings:
Fig. 45: Overview of lab settings  Time/Date: Set time and date
 Change Lab PIN: Change PIN for access to lab options
 Log Port: Set log port ( chapter 3.6.1)
(does not apply to OSMOMAT 3000basic)
 Log Format: Set log format ( chapter 3.6.2)
(does not apply to OSMOMAT 3000basic)
 QA Settings: Additional configuration settings ( page 49)
(does not apply to OSMOMAT 3000basic)
 Maintenance: Options for maintenance and troubleshooting
( chapter 8.4)

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Operation

7.3 Measure individual samples


Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  Soft, lint-free paper tissue


 Pipette
 Measurement vessel
 Sample

NOTE!
Impaired reproducibility of measurement due to
incorrect measurement vessels!
Repeated use of the measurement vessels and use of
incorrect consumables cannot guarantee reproducible
measurement results.
- Always use a clean and unused measurement
vessel for every measurement.
- Only use measurement vessels supplied by
Gonotec GmbH.
- Never use centrifuge tubes or reaction vessels.

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

1. Clean temperature sensor (Fig. 46/1) using a soft, dry, lint-free


paper towel.

Fig. 46: Clean temperature sensor

2. Tap Measure on the Start menu (Fig. 47).

 If the operating time of the device is less than 3 minutes,


a wait screen for ice formation is displayed (Fig. 48).

Fig. 47: Start menu

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3. Wait until ice forms on the cryst-needle (Fig. 48).

 After successful ice formation, a calibration prompt (Fig. 49)


or the Ready to Measure screen (Fig. 50) is displayed
(depending on the configured calibration interval).

Fig. 48: Ice formation

4. If necessary, calibrate device (Fig. 49).


 Chapter 7.5 “Calibrate device” on page 65.

Calibration cannot be skipped.


The calibration interval is defined by the lab
supervisor (does not apply to OSMOMAT 3000basic).

 The device is ready.


Fig. 49: Calibrate device

5. Tap Measure (Fig. 50).

 The measurement menu (Fig. 53) opens.

Fig. 50: Device is ready for measurement

6. Pipette a sample volume of 50µl (15µl for Option M) into


an unused and clean measurement vessel (Fig. 51).

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

Fig. 51: Pipette sample

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7. Position measurement vessel on temperature sensor with cover


facing front (Fig. 52/1).

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 52: Position measurement vessel

8. Option D only:
(does not apply to OSMOMAT 3000basic)
Tap Use printer on the measurement menu (Fig. 53/1) to output
the measurement results to a printer. Make sure that the printer
is ready.

9. To start the measurement, tap Single Sample (Fig. 53/2).


If necessary, enter the sample ID using the virtual keyboard.

The sample ID can be pre-defined in the user


Fig. 53: Measurement menu
preferences. In this case, the system assigns
the sample ID automatically ( page 55)

10. Move elevator (Fig. 54/1) down.

Moving the elevator up during the measurement


will abort the measurement.

 The sample measurement is performed automatically.


Pay attention to the displays on the touchscreen.

Fig. 54: Move elevator down

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The measurement result displays on the touchscreen


(Fig. 55/1) and, if applicable, prints (Fig. 55/2) (Option D).

Reproducibility:
# ±2 digits in the measurement range
[0..400] mOsmol/kg
# ±0.5% in the measurement range
[400..1500] mOsmol/kg
Fig. 55: Measurement # ±1.0% starting with 1500 mOsmol/kg

Option M (15µl):
# ±6 digits [0..300] mOsmol/kg
# ±2.0% [300..3000] mOsmol/kg

11. Move elevator up.

Moving the elevator up during the measurement will


abort the measurement.

12. Remove measurement vessel from temperature sensor.


Dispose of measurement vessel and sample according to local
regulations.
Fig. 56: Clean temperature sensor
13. Clean temperature sensor (Fig. 56/1) using a soft, dry, lint-free
paper towel.

NOTE!
Risk of carryover!
 Failure to clean the temperature sensor
immediately following measurement can result
in carryover and incorrect measurement results.

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7.4 Batch/series measurement


(does not apply to OSMOMAT 3000basic)
Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  Soft, lint-free paper tissue


 Pipette
 Measurement vessel
 Samples

NOTE!
Impaired reproducibility of measurement due to
incorrect measurement vessels!
Repeated use of the measurement vessels and use of
incorrect consumables cannot guarantee reproducible
measurement results.
- Always use a clean and unused measurement vessel
for every measurement.
- Only use measurement vessels supplied by
Gonotec GmbH.
- Never use centrifuge tubes or reaction vessels.

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

1. Clean temperature sensor (Fig. 57/1) using a soft, dry, lint-free


paper towel.

Fig. 57: Clean temperature sensor

2. Tap Measure on the Start menu (Fig. 58).

 If the operating time of the device is less than 3 minutes,


a wait screen for ice formation is displayed (Fig. 59).

Fig. 58: Start menu

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3. Wait until ice forms on the cryst-needle (Fig. 59).

 After successful ice formation, a calibration prompt (Fig. 60)


or the Ready to Measure screen (Fig. 61) is displayed
(depending on the configured calibration interval).

Fig. 59: Ice formation

4. If necessary, calibrate device (Fig. 60).


 Chapter 7.5 “Calibrate device” on page 65.

Calibration cannot be skipped.


The calibration interval is defined by the lab
supervisor (does not apply to OSMOMAT 3000basic).

 The device is ready.


Fig. 60: Calibrate device

5. Tap Measure (Fig. 61).

 The measurement menu (Fig. 62) opens.

Fig. 61: Device is ready for measurement

6. Option D only:
Tap Use printer on the measurement menu ( Fig. 62/1) to output
the measurement results to a printer.
Make sure that the printer is ready.

7. To start a series measurement, tap Begin Batch (Fig. 62/2).

8. Enter the batch ID.

The batch ID can be pre-defined in the user


Fig. 62: Measurement menu preferences. In this case, the system assigns
the batch ID automatically ( page 55)

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9. Pipette a sample volume of 50µl (15µl for Option M) into


an unused and clean measurement vessel (Fig. 63).

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

Fig. 63: Pipette sample

10. Position measurement vessel on temperature sensor with cover


facing front (Fig. 64/1).

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 64: Position measurement vessel

11. Move elevator (Fig. 65/1) down.

Moving the elevator up during the measurement


will abort the measurement.

 The sample measurement is performed automatically.


Pay attention to the displays on the touchscreen.
The touchscreen shows the measurement result for
the current sample.
Fig. 65: Move elevator down  Option D:
The measurement result prints.

Reproducibility:
# ±2 digits in the measurement range
[0..400] mOsmol/kg
# ±0.5% in the measurement range
[400..1500] mOsmol/kg
# ±1.0% starting with 1500 mOsmol/kg

Option M (15µl):
# ±6 digits [0..300] mOsmol/kg
# ±2.0% [300..3000] mOsmol/kg

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12. Move elevator up.

Moving the elevator up during the measurement


will abort the measurement.

13. Remove measurement vessel from temperature sensor.


Dispose of measurement vessel and sample according to local
regulations.

Fig. 66: Clean temperature sensor 14. Clean temperature sensor (Fig. 66/1) using a soft, dry, lint-free
paper towel.

NOTE!
Risk of carryover!
 Failure to clean the temperature sensor
immediately following measurement can result
in carryover and incorrect measurement
results.
15. Start the measurement of the new sample by repeating the work
steps starting with step 9.
To complete the series measurement, tap Complete batch.

 Option D:
Completing the series measurement also completes
the printing operation.

Exiting the measurement menu (by pressing Exit)


will also quit the series measurement.

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7.5 Calibrate device


Calibration methods Depending on the pre-defined calibration interval, opening the
measurement menu will automatically show a calibration prompt
(Fig. 49). Calibration can also be started manually (Fig. 50).
The device is calibrated using one of the following calibration
methods:
 2-point calibration: Calibration using distilled water and
a calibration standard or
 3-point calibration: Calibration using distilled water and two
calibration standards
2-point calibration means that the device is calibrated using distilled
water (zero point calibration) and one calibration standard.
3-point calibration means that the device is calibrated using distilled
water (zero point calibration) and two calibration standards.
The calibration method, the calibration standards used for calibration,
and the calibration interval are defined by the lab supervisor during
start-up ( chapter 6.3 “Set calibration defaults” on page 49).

Calibrate device Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  Soft, lint-free paper tissue


 Pipette
 Distilled water
 Calibration standard(s) (e.g. 300 mOsmol/kg)
 Ampoule opener
 Measurement vessels

NOTE!
Impaired reproducibility of measurement due to
incorrect measurement vessels!
Repeated use of the measurement vessels and use of
incorrect consumables cannot guarantee reproducible
measurement results.
- Always use a clean and unused measurement vessel
for every measurement.
- Only use measurement vessels supplied by
Gonotec GmbH.
- Never use centrifuge tubes or reaction vessels.

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1. Clean temperature sensor (Fig. 67/1) using a soft, dry, lint-free


paper towel.

Fig. 67: Clean temperature sensor

2. Follow the instructions on the touchscreen.

Fig. 68: Perform zero point calibration

3. Pipette a distilled water volume of 50µl (15µl for Option M) into


an unused and clean measurement vessel (Fig. 69).

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air bubbles.

Fig. 69: Pipette distilled water

4. Position measurement vessel on temperature sensor with cover


facing front (Fig. 70/1).

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 70: Position measurement vessel

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Perform zero point calibration

5. Move elevator (Fig. 71/1) down.

 Zero point calibration starts automatically.


Zero point calibration is performed automatically.
Pay attention to the displays on the touchscreen.

Fig. 71: Move elevator down

6. Move elevator up.

7. Remove measurement vessel from temperature sensor.


Dispose of measurement vessel and sample according to local
regulations.

8. Clean temperature sensor (Fig. 67/1) using a soft, dry, lint-free


paper towel.

NOTE!
Risk of carryover!
Fig. 72: Calibrate device using calibration
standard  Failure to clean the temperature sensor
immediately following measurement can result
in carryover and incorrect measurement
results.

9. Repeat steps 3 through 8 until the number of measurements per


calibration point specified in the calibration defaults ( page 50)
(max. 3) is reached.

10. Following successful zero point calibration, tap 1st Standard


(Fig. 72) to start calibration using the first calibration standard.
Successful calibration means that it was possible to
measure the sample without errors.
This is not a plausibility check, which is not performed
until the entire calibration sequence is completed in
measurement mode ( page 103).

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Calibrate device using calibration


NOTE!
standard
Impaired reproducibility of measurement due to
improper handling of calibration standards!
Improper handling and storage of the calibration
standards included with the delivery negatively affects
the measurement accuracy of the device.
- Always observe the stability of the calibration
standards (max. 0.5h at 22°C ambient temperature).
- Never use opened ampoules twice or mix them
together.
- Never freeze opened ampoules.
- Do not use the calibration standards past their
expiration date.

11. Use the arrow keys and to select the calibration standard
to be used.

Fig. 73: Select calibration standard

12.
WARNING!
Risk of injury at ampoule breaking points!

Use the ampoule opener (Fig. 74/2) to open the ampoules


containing the calibration standards (Fig. 74/1).

Fig. 74: Open ampoule

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13. Pipette a calibration standard volume of 50µl (15µl for Option M)


into a clean and unused measurement vessel (Fig. 75).

NOTE!
Risk of incorrect measurement resulting from
the presence of air bubbles in the sample!
 The sample must be pipetted without air
bubbles.

14. Position measurement vessel on temperature sensor with cover


facing front.

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 75: Pipette calibration standard

15. Move elevator (Fig. 76/1) down.

 Calibration starts automatically.


Calibration using the calibration standard is performed
automatically. Pay attention to the displays on the
touchscreen.

16. Move elevator up.

17. Remove measurement vessel from temperature sensor.


Dispose of measurement vessel and sample according to local
regulations.
Fig. 76: Move elevator down 18. Clean temperature sensor (Fig. 76/1) using a soft, dry, lint-free
paper towel.

NOTE!
Risk of carryover!
 Failure to clean the temperature sensor
immediately following measurement can result
in carryover and incorrect measurement
results.
19. Repeat steps 13 through 18 until the number of measurements
per calibration point specified in the calibration defaults
( page 50) (max. 3) is reached.

For a 3-point calibration, repeat steps 10 through 19 using


another calibration standard.

Fig. 77: Second calibration standard

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Calibration can be completed after performing the number


of runs specified in the calibration defaults for the very last
calibration point (Fig. 78).
The system now shows the calibration results (Fig. 79).
The resulting osmolalities are calculated as the mean across
the individual measurements.
This is the result of a 3-point calibration.

20. Verify the calibration results.


If necessary, tap the individual measurement values to ignore
Fig. 78: Complete calibration
them during mean value calculation.

Reproducibility:
# ±2 digits in the measurement range
[0..400] mOsmol/kg
# ±0.5% in the measurement range
[400..1500] mOsmol/kg
# ±1.0% starting with 1500 mOsmol/kg

Option M (15µl):
Fig. 79: Calibration results
# ±6 digits [0..300] mOsmol/kg
# ±2.0% [300..3000] mOsmol/kg
21. Tap Apply to complete the calibration.

 The device is now calibrated.

22. Verify reproducibility ( page 103)


or continue with your measurements ( sample measurement
on page 54,  series measurement on page 61).

Note regarding 2-point calibration:


For a 2-point calibration, the measurement accuracy
of the device depends on the correct internal
calibration of the thermistor.
Fig. 80: Replace probe If the calibration check reveals above-average
deviations from the linearity, the lab supervisor has
to recalibrate the internal thermistor:
For this purpose, open the Replace Probe menu
(Fig. 80) (Start menu  Lab Options  Maintenance
 Replace Probe).
Tap Calibrate and perform a 3-point calibration using
distilled water and the two calibration standards with
300 and 850 mOsm/kg.

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7.6 Power down device


Personnel:  User

Safety gear:  Disposable lab gloves

Fig. 81: Power down device 1. Power down device using on/off switch on rear side (Fig. 81/1)
and disconnect power plug.

2. Position a measurement vessel (Fig. 82/1) on the temperature


sensor.

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 82: Position measurement vessel

3. Disinfect device if powered down for an extended period of time.


Wipe device using a wipe moistened with disinfectant.

4. Pull protective sleeve (Fig. 83/1) included with the delivery over
device.

Fig. 83: Device with protective sleeve

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8 Troubleshooting
8.1 Safety notices
Electrical current
DANGER!
Risk of death due to electrical current on device!
Contact with energized parts of the device results in
immediate risk of death due to electric shock. Damage
to the insulation of individual components can cause
risk of death.
- Only have qualified personnel perform repair and
maintenance work on the device.
- If the insulation is damaged, immediately switch off
the voltage supply and schedule a repair.
- Always route the power cable so it is not subject to
stress and cannot be bent, pinched, or rolled over
and is not exposed to liquids or heat.
- Ensure easy access to the power socket at all times.
- Keep energized parts away from liquids. Otherwise,
shorts may occur.

Risk of infection
WARNING!
Risk of injury due to sample residue and in case of
inadequate hygiene, disinfection, and sterilization
procedures!
Exposure to sample residue in non-cleaned, non-
sterilized, or non-disinfected components results
in an elevated risk of infection.
- Wear lab gloves during any kind of work.
- Observe all local regulations regarding hygiene,
disinfection, and sterilization.

Risk of injury
CAUTION!
Risk of injury from cryst-needle!
When installing and removing the cryst-needle and
the temperature sensor, the tip of the cryst-needle is
exposed. Movement of the cryst-needle can cause
needle puncture injuries.
- Always keep your hands and fingers clear from
the area underneath the cryst-needle.

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8.2 Notes regarding errors


In case of errors that cannot be resolved using the error table on
 page 74, contact the manufacturer.
Please be prepared when contacting the manufacturer as follows:

1 Use a telephone located close to the device.


2 Power up device.
NOTE!
Danger in case of continuous acoustic alarm!
In case of continuous acoustic alarm, the
electronics components of the device can be
damaged.
 Power down device again.
3 Note down the serial number of the device.
You can find the serial number on the rear of the device or under
Settings  Info.
4 Have the device documentation available.

Contact info:

Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany

Phone: (030) 7809 588-0


Fax: (030) 7809 588-88
E-mail: [email protected]
Web: http://www.gonotec.com

Fig. 84: Contact Gonotec

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8.3 Error table

Errors marked * are shown as an error message on


the touchscreen.

Error description Possible Cause Remedy Personnel


Elevator gets stuck or Mechanical wear Lubricate the elevator guide using User
makes squeaking silicone spray ( page 100)
noises when lowered
Blockage from foreign Check openings and remove foreign User
substances objects

Lower cooling system Mechanical wear Clean cooling clamp ( page 90) Service
does not cool sample technician
Fan is defective or Check if fan is operational
obstructed and replace if necessary
( service manual)

Peltier element is Replace lower cooling system


defective ( service manual)

Motor of cryst-needle Light barrier on motor Replace light barrier Service


turns without stopping disk is defective ( service manual) technician
or
Light barrier on motor Adjust light barrier
does not turn one full disk is misaligned
revolution
Motor disk misaligned Adjust/tighten motor disk
or loose

No crystallization* Ambient air too dry Clean cooling nipple using a fiberglass User
pin ( page 88)
or
Poor ice crystal Wait at least 2 minutes after switching
formation in upper on device before starting
cooling system measurement.

If the humidity is very low (for example,


in heated or air-conditioned rooms),
open the cover of the upper cooling
system until you can see ice crystals
forming.

Hole above temperature Blow out hole using blow-out device


sensor dirty or blocked
by water droplets

Cooling nipple dirty Clean cooling nipple using a fiberglass


pin ( page 88).
Remove any droplets from opening
using blow-out device.

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Error description Possible Cause Remedy Personnel


No crystallization * Peltier element Replace upper cooling system Service
or defective ( service manual) technician

Poor ice crystal Cable connection


formation in upper between cooling system
cooling system and PCB defective

Cryst-needle too long Adjust cryst-needle to correct length


or too short ( page 80)

Cryst-needle not Debur cryst-needle using fine


deburred sandpaper

Cryst-needle bent Manually bend cryst-needle so that


it is vertical, replace if necessary
( page 79)

Cryst-needle does Verify free movement of cryst-needle


not move ( page 81)
Cryst-needle dis-
engaged from motor
or stuck

Error in rotation of Align cryst-needle ( page 79) Service


motor disk (cryst-needle technician
drive) Correct length of cryst-needle
( page 80)

Check if light barrier is located


properly and replace if necessary
( service manual)

Tighten motor disk

Measurement Fan is defective or Check if fan is operational and Service


procedure takes obstructed remove any foreign objects technician
longer than usual Replace fan ( service manual)

Peltier element is Replace lower cooling system


defective ( service manual)

Spontaneous Sample not prepared Use sample according to User


crystallization* correctly performance data of device
( page 15)

Temperature sensor not Align temperature sensor Service


aligned correctly ( page 86) technician

Elevator moved up by Leave the elevator in the lowered User


user position during the measurement
procedure

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Error description Possible Cause Remedy Personnel


Incorrect Lower cooling system Align lower cooling system Service
measurement results not aligned correctly ( service manual) technician

Incorrect measurement Only use measurement vessels User


vessel used of the correct type supplied by
Gonotec GmbH

Measurement vessel Use measurement vessels only


re-used once.

Measurement vessel Position measurement vessel with


not positioned correctly cover pointing forward
When the measurement vessel
clicks into place, it is securely
positioned on the temperature
sensor.

Temperature sensor Replace temperature sensor Service


defective ( page 82) technician

Temperature sensor Align temperature sensor


not centered ( page 86)

Negative Zero point calibration Repeat calibration ( page 65) User


measurement values performed using impure
water

Measurement vessel Incorrect measurement Only use measurement vessels User


fits too loosely on vessel used supplied by Gonotec GmbH
temperature sensor Measurement vessel
re-used

Measurement vessel Position measurement vessel with User


not positioned correctly cover facing forward
When the measurement vessel
clicks into place, it is securely
positioned on the temperature
sensor.

Temperature sensor Replace temperature sensor Service


damaged ( page 82) technician

Fan malfunction Fan is obstructed Check if fan is operational and Service


remove any foreign objects technician

Fan is defective Replace fan ( service manual)

Fan makes loud Fan is obstructed Check if fan is operational and


noise remove any foreign objects

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Error description Possible Cause Remedy Personnel


Error message: Needle bar disengaged Verify free movement of cryst-needle Service
Needle stuck* from motor or stuck ( page 81) technician

Motor slider misaligned see also: Motor of cryst-needle turns


without stopping or does not turn
one full revolution.

Microfuses trip when Device voltage does Check device voltage setting Service
powering up device not match power grid technician
voltage

Device cannot be Power supply not Connect power supply to a power Service
powered up correctly plugged into socket technician
power socket

Power socket is dead Connect device to a live power


socket

Power cable is Replace power cable


damaged

Fuses are burned out Replace fuses ( page 89)

Printer does not print Paper roll is used up Replace paper roll ( page 90) User

Ribbon is empty Replace ribbon ( page 92)

Measurement User moved elevator up Repeat measurement User


procedure aborted during measurement
by user*

Incorrect PIN entry* Incorrect PIN entry Re-enter PIN or cancel operation Lab
supervisor

Attempt to change lab Repeat password entry Change password again Lab
supervisor password does not match first supervisor
failed* entry

Unexpected errors* Internal system errors Contact Gonotec GmbH User

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8.4 Resolve errors


8.4.1 Replace cryst-needle

Personnel:  Service technician

Safety gear:  Disposable lab gloves

Materials:  Allen key SW 2.5


 Precision key file
 Wire cutter

WARNING!
Risk of infection from sample residue!
The cryst-needle is immersed into the sample during
measurements. Contact with the cryst-needle increases
the risk of infection.
- Wear lab gloves during any kind of work.

DANGER!
Risk of death due to electrical current!

1. Power down device using on/off switch on rear side and


disconnect power plug.

2. Remove device front panel ( on page 95).

Fig. 85: Position of cryst-needle and details

1 Cryst-needle
3. Remove mounting screw (Fig. 86/1) of cryst-needle while holding
cryst-needle in place.

The mounting screw has a coating of locking paint.

Fig. 86: Remove mounting screw

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4. Loose washer between cryst-needle and


motor disk!

Remove cryst-needle from motor disk. Hold washer (Fig. 87/1)


of mounting screw in place.

Fig. 87: Remove cryst-needle

Fig. 88: Cryst-needle components

5. Remove guide tube (Fig. 88/1) and fasteners (Fig. 88/3) of


cryst-needle (Fig. 88/2).

6. Make sure that the new cryst-needle is as straight as possible


(Fig. 89/1+2).

1 - Incorrect orientation

2 - Correct orientation

If necessary, bend cryst-needle so it is straight (Fig. 89/3).

7. Shorten cryst-needle to correct length.


Proceed as follows.

Fig. 89: Straighten cryst-needle

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8. Align motor swipe vertically with upper dead center (Fig. 90/1).

 The set screw of the motor swipe points down.

9. Move cryst-needle through guide tube in upper cooling system


(Fig. 90/2) onto cooling nipple (Fig. 90/3).

10. Bolt new needle to motor disk.

11. Align cryst-needle with motor swipe and cooling nipple.


The needle end should be located approx. 2mm below the
lower edge of the cooling nipple (d=2mm). (Fig. 90/3).

12. If the needle is too long, use a permanent marker to mark the
correct length and remove the needle bar again.

13. Trim excess wire using side cutters and debur needle tip using
precision key file.

Fig. 90: Adjust length of cryst-needle

Fig. 91: Install cryst-needle

1 Mounting screw 4 Cryst-needle


2 Washer 5 Washer
3 Fastening tube 6 Guide tube

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14. Fit cryst-needle to motor disk. Assemble fasteners as follows:

1 - Push washer (Fig. 91/2) and fastening tube (Fig. 91/3) onto
mounting screw (Fig. 91/1).

2 - Push mounting screw with washer and fastening screw


through head of cryst-needle (Fig. 91/4).

3 - Secure washer (Fig. 91/5) to mounting screw.

4 - Push guide tube (Fig. 91/6) onto cryst-needle.

15. Secure cryst-needle to motor disk (Fig. 86) using mounting screw
(Fig. 91/1).

Check free movement


of cryst-needle
16. Turn motor disk with attached cryst-needle clockwise to check
cryst-needle for free movement.
If needle gets jammed, detach needle and check if it is bent.
(Fig. 89).

17. Install device front panel ( on page 99).

18. Power up device on rear side using on/off switch.

19. Verify free movement of cryst-needle automatically.


Fig. 92: Check free movement
of cryst-needle
Open the menu for adjusting the cryst-needle (Start menu 
Lab Options  Maintenance  Adjust Needle).

CAUTION!
Risk of injury from cryst-needle!
The tip of the cryst-needle is exposed. Movement of
the cryst-needle can cause needle puncture injuries.
- Always keep your hands and fingers clear from
the area underneath the cryst-needle.

20. Tap Move Needle to test the free movement.


The needle turns by one revolution.
Tap Back to exit the menu.

Fig. 93: Move needle

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Troubleshooting

8.4.2 Replace the temperature sensor

Personnel:  Service technician

Safety gear:  Disposable lab gloves

Materials:  Allen key SW 2


 Adjustment tool
 Tweezers

WARNING!
Risk of injury in case of inadequate hygiene,
disinfection, and sterilization procedures!
Contact with the temperature sensor and cryst-needle
increases the risk of infection due to sample residue.
- Wear lab gloves during any kind of work.

DANGER!
Risk of death due to electrical current!

1. Power down device using on/off switch on rear side and


disconnect power plug.

Remove elevator cover


2. To protect thermistor, cover temperature sensor with
a measurement vessel. The cover of the measurement
vessel must point forward.

NOTE!
Risk of thermistor damage due to loose position
of measurement vessel!
Resistance is felt when sliding on measurement
vessel.
When the measurement vessel clicks into place, it
Fig. 94: Position measurement vessel is securely positioned on the temperature sensor.

3. Move elevator down using handle (Fig. 95/1).

Fig. 95: Move elevator down

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4. Move elevator cover (Fig. 96/1) up.

Fig. 96: Move elevator cover up

5. Remove the 2 mounting screws (Fig. 97/1) using Allen key


(SW 2).

Fig. 97: Remove mounting screws

6. Remove the complete elevator cover (Fig. 98/1).

Fig. 98: Remove elevator cover

7. Pull connector of temperature sensor (Fig. 99/1).

Fig. 99: Pull connector

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8. Move elevator up and remove the 2 mounting screws (Fig. 100/1)


using Allen key (SW 2).

Fig. 100: Remove mounting screws

9. Remove temperature sensor with mounting plate toward the front


(Fig. 101) while holding guide tube of cryst-needle (Fig. 101/1)
in place.

10. If necessary, clean cooling nipple.

Fig. 101: Remove temperature sensor

11. Use Allen key (SW 2) (Fig. 102/2) to remove temperature sensor
from mounting plate (Fig. 102/1).

Fig. 102: Remove mounting plate

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12. Fit new temperature sensor to mounting plate (Fig. 102).


Keep the data sheet affixed to the temperature sensor
(Fig. 103/2) in the vicinity of the device.
To protect thermistor, cover temperature sensor with
a measurement vessel (Fig. 103/1). The cover of the
measurement vessel must point forward.

NOTE!
Risk of thermistor damage due to loose position
Fig. 103: New temperature sensor with of measurement vessel!
data sheet Resistance is felt when sliding on measurement
vessel.
When the measurement vessel clicks into place, it
is securely positioned on the temperature sensor.

13. Push guide tube onto cryst-needle and pass needle through
stainless steel tube of mounting plate (Fig. 101).

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Align the temperature sensor 14. Tighten the 2 mounting screws only lightly.
The temperature sensor must be aligned using the adjustment tool.

15. Install adjustment tool (Fig. 104/1) in opening of lower cooling


system using tweezers.

16. Remove measurement vessel from temperature sensor.

Fig. 104: Install adjustment tool

17. Align temperature sensor (Fig. 105). Proceed as follows:


Push temperature sensor just beyond adjustment tool.

18. Position temperature sensor on XY plane so that thermistor is


perpendicular to center of hole of adjustment tool (Fig. 106 and
Fig. 107).

19. Tighten the 2 mounting screws on the aligned temperature


sensor.
Fig. 105: Align the temperature sensor

Thermistor Z axis ( )

Mounting screws Adjustment


tool

lower cooling system


Fig. 106: Temperature sensor Z axis Fig. 107: Temperature sensor XY plane

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Install elevator cover

Fig. 108: Elevator cover with correct cable routing

1 Cable Correct cable routing


2 Cable guide on temperature sensor Incorrect cable routing

20.
NOTE!
Risk of cable break!

Place cable (Fig. 108/1) on temperature sensor in cable guide


(Fig. 108/2) and install elevator cover on device.

21. Bolt elevator cover to elevator using the 2 mounting screws


(Fig. 109/1).

 The temperature sensor is now installed.

Fig. 109: Tighten mounting screws

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Clean cooling nipple


22. Clean cooling nipple (Fig. 110/1) using a fiberglass pin. For this
purpose, move elevator cover up.

23. Power up device on rear side using on/off switch.

24. Calibrate the new temperature sensor.


For this purpose, open the Replace Probe menu (Start menu 
Lab Options  Maintenance  Replace Probe).

Fig. 110: Clean cooling nipple

25. Copy the values from the included data sheet to the fields and
tap Calibrate.

 The system starts the device calibration.


Perform a 3-point calibration on the device ( page 65).
Use distilled water and the two calibration standards with
300 and 850 mOsm/kg.

Fig. 111: Calibrate temperature sensor

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8.4.3 Replace microfuses

Safety gear:  Disposable lab gloves

Materials:  Flat blade screwdriver


 Microfuses (slow-blow 1.6A)

DANGER!
Risk of death due to electrical current!

1. Power down device using on/off switch on rear side and


disconnect power plug.

2. Open cover (Fig. 112/1) using a flat blade screwdriver.

3. Remove microfuse attachment.

Fig. 112: Open microfuse cover

4. Remove microfuses (Fig. 113/1) from attachment.

NOTE!
Risk of property damage!
The unit has two-phase protection. Use only
the following fuses:
Slow-blow HBC fuses (1.6A) with a switching
capacity of 1500A
Fig. 113: Remove microfuses

5. Push the microfuses included with the delivery into


the attachment (Fig. 114).

Fig. 114: Install microfuses

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8.4.4 Clean cooling clamp

Personnel:  Service technician

Safety gear:  Disposable lab gloves

Materials:  Fine sandpaper

1. Power down device on rear side using on/off switch.

2. Remove device front panel ( on page 95).

3. Clean cooling clamp (Fig. 115/1) on lower cooling system


using sandpaper.

4. Install device front panel ( on page 99).

Fig. 115: Clean cooling clamp

8.4.5 Replace printer paper (Option D only)


(does not apply to OSMOMAT 3000basic)

Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  1 Paper roll

1. Power down device on rear side using on/off switch.

Fig. 116: Printer (pulled out)

1 Paper roll
2 Ribbon

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2. Pull out printer (Fig. 117/1).

Fig. 117: Pull out printer

3. Turn knurled screw (Fig. 118/1) counter-clockwise.

4. Remove empty paper roll from holder and dispose.

Fig. 118: Turn knurled screw

5. Cut off beginning of new paper roll (Fig. 119/1) and push
onto holder.
Pay attention to correct feed direction of paper (Fig. 119/2).

6. Position knurled screw (Fig. 118/1) and tighten by turning


clockwise.

7. Power up device on rear side using on/off switch.

Fig. 119: Install paper roll

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8. On the Start menu, select Settings  Printer.


Tap Paper Feed.

Fig. 120: Activate paper feed

The paper feed of the printer is activated briefly. (Fig. 121).


Tap Back to exit the menu.

9. Replace printer cover and push printer into casing.

Fig. 121: Paper feed

8.4.6 Replace printer ribbon (Option D only)


(does not apply to OSMOMAT 3000basic)

Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  1 Ribbon

1. Power down device on rear side using on/off switch.

Fig. 122: Printer (pulled out)

1 Paper roll
2 Ribbon

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2. Pull out printer (Fig. 123/1).

Fig. 123: Pull out printer

3. Remove printer cover (Fig. 124/1).

Fig. 124: Remove printer cover

4. Push on Push marking on front side of ribbon (Fig. 125).

 The ribbon is released.

5. Remove the released ribbon.

Fig. 125: Push out ribbon

6. Feed printer paper through ribbon (Fig. 126).

7. Press ribbon onto device.

 The ribbon snaps into place.

8. Tighten ribbon by turning knob clockwise.

Fig. 126: Feed printer paper 9. Replace printer cover and push printer into casing.

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8.4.7 Reset device to default settings

If the device no longer functions properly due to incorrect settings,


you can undo all the modified user settings and reset device to the
default settings.
To do this, proceed as follows:
1. From the Start menu, select Settings  Lab Options 
Maintenance  Default Settings.

2. Tap Reset to Default Settings (Fig. 127)

3. Configure the user preferences.


 chapter 7.2 User Preferences

Resetting the device will also purge all existing


calibration data.
Before performing any measurements on the device
Fig. 127: Reset to Default Settings
following the reset, recalibration is mandatory.
 Chapter 7.5 “Calibrate device” on page 65

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Servicing

9 Servicing
9.1 Safety notices
Electrical current
DANGER!
Risk of death due to electrical current on device!
Contact with energized parts of the device results in
immediate risk of death due to electric shock. Damage
to the insulation of individual components can cause
risk of death.
- Only have qualified personnel perform repair and
maintenance work on the device.
- If the insulation is damaged, immediately switch off
the voltage supply and schedule a repair.
- Always route the power cable so it is not subject to
stress and cannot be bent, pinched, or rolled over
and is not exposed to liquids or heat.
- Ensure easy access to the power socket at all times.
- Keep energized parts away from liquids. Otherwise,
shorts may occur.

Risk of infection
WARNING!
Risk of infection due to sample residue and in case
of inadequate hygiene, disinfection, and sterilization
procedures!
Exposure to sample residue in non-cleaned, non-
sterilized, or non-disinfected components results
in an elevated risk of infection.
- Wear lab gloves during any kind of work.
- Observe all local regulations regarding hygiene,
disinfection, and sterilization.
We recommend using detergents such as Mikrozid®
AF Liquid, Bacillol® plus 3%, or Korsolex® plus 4%
commonly found in clinical-chemical labs to clean
and decontaminate the device.

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Servicing

9.2 Service table


The following sections describe the service activities required to
ensure device operation under optimum, error-free conditions.
If regular checks show excess wear, shorten the required service
intervals based on actual signs of wear. If you have questions
regarding service activities and intervals, contact the manufacturer
(for contact information, see page 2).

Interval Service activity Personnel


monthly Check elevator support for ease of movement and lubricate if necessary User
 chapter 9.4 "Preliminary steps" on page 96

Perform visual inspection of device User


 chapter 9.5 "Perform visual inspection of device" on page 102

Check reproducibility of measurements Lab supervisor


 chapter 9.6 "Check reproducibility of measurements" on page 103

9.3 Preliminary steps

Remove device front panel Personnel:  Service technician

Safety gear:  Disposable lab gloves

Materials:  Allen key SW 2

1. Power down device on rear side using on/off switch.

2. To protect thermistor, cover temperature sensor with


a measurement vessel (Fig. 128/1). The cover of the
measurement vessel must point forward.

NOTE!
Risk of thermistor damage due to loose position
of measurement vessel!
Resistance is felt when sliding on measurement
vessel.
When the measurement vessel clicks into place, it
Fig. 128: Position measurement vessel is securely positioned on the temperature sensor.

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3. Move elevator (Fig. 129/1) down.

Fig. 129: Move elevator down

4. Move elevator cover (Fig. 130/1) up.

Fig. 130: Move elevator cover up

5. Remove the 2 mounting screws (Fig. 131/1) using Allen key


(SW 2).

Fig. 131: Remove mounting screws

6. Remove complete elevator cover (Fig. 132/1).

Fig. 132: Remove elevator cover

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7. Pull out printer (Fig. 133/1) from device.


(does not apply to OSMOMAT 3000basic)

Fig. 133: Pull out printer

8. Remove printer cover (Fig. 134/1) by pulling up.


(does not apply to OSMOMAT 3000basic)

9. Push printer back into device.


(does not apply to OSMOMAT 3000basic)

Fig. 134: Remove printer cover

10. Remove device front panel by pulling forward (Fig. 135).


The device front panel is secured to the housing by magnets.

NOTE!
Risk of damage to cables and connectors!

Fig. 135: Remove device front panel

11. Carefully place device front panel on its right side (Fig. 136).

 The device front panel is now removed.

Fig. 136: Device front panel open

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Servicing

Install device front panel Personnel:  Service technician

Safety gear:  Disposable lab gloves

Materials:  Allen key SW 2

1. Install device front panel on device and push into place


(Fig. 137).

2. Pull out printer from device using handle.


(does not apply to OSMOMAT 3000basic)

3. Install printer cover on printer and push down.


(does not apply to OSMOMAT 3000basic)

 The printer cover is now secured.

4. Push printer back into device.


(does not apply to OSMOMAT 3000basic)

Fig. 137: Install device front panel

Fig. 138: Elevator cover with correct cable routing

1 Cable Correct cable routing


2 Cable guide on temperature sensor Incorrect cable routing
5.
NOTE!
Risk of cable break!

Route cables on temperature sensor through cable guide


(Fig. 138/2) and install elevator cover on device.
Pay attention to correct cable routing.

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Servicing

6. Bolt elevator cover to elevator using the 2 mounting screws


(Fig. 139/1).

 The device front panel is now installed.

Fig. 139: Tighten mounting screws

9.4 Lubricate elevator


Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  Silicone spray

NOTE!
Risk of property damage due to wrong lubricant!
The use of lubricating grease can damage the elevator
guide.
- Only use silicone spray as lubricant.

1. Power down device on rear side using on/off switch.

2. Remove device front panel ( on page 95).

Fig. 140: Location of elevator guide

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Fig. 141: Lubricate elevator guide

3. Lubricate elevator guide on left (Fig. 141/A) and right side


(Fig. 141/B) of ball bearing using silicone spray.

Tip
The left ball bearing of the elevator guide is not
easily accessible.
Therefore, lubricate the upper section (Fig. 141/A)
on the left side of the elevator guide and move
the elevator up and down multiple times.

4. Install device front panel ( on page 95).

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9.5 Perform visual inspection of device


Personnel:  User

Safety gear:  Disposable lab gloves

Materials:  Fiberglass pin


 Soft cloth
 Tweezers

1. Verify that the cables at the rear side of the device are secure
and none of them are broken.
In case of cable breaks, replace the cable.

2. Check if foreign objects, such as measurement vessels, are


located in the openings of the device (Fig. 142/1+2).
Remove any foreign objects using tweezers.

Fig. 142: Inspect device for foreign objects

3. Clean cooling nipple (Fig. 143/1) using the fiberglass pin. For this
purpose, move elevator cover up.

4. Wipe off dirt and dust from housing using a soft cloth.

Fig. 143: Clean cooling nipple

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9.6 Check reproducibility of measurements


The purpose of the measurement check is to verify the specified performance limits of the device.

9.6.1 Sample test protocol measurement check

Mechanical check: Calibration/verification

ZERO CAL1 CAL2 REF1 REF2


CAL / mOsmol/kg
Distilled
................... ................... ................... ...................
Sample / mOsmol/kg water

Sample 1 ................... ................... ................... ................... ...................

Sample 2 ................... ................... ................... ................... ...................

Sample 3 ................... ................... ................... ................... ...................

Sample 4 ................... ................... ................... ................... ...................

Sample 5 ................... ................... ................... ................... ...................

Sample 6 ................... ................... ................... ................... ...................

Sample 7 ................... ................... ................... ................... ...................

Sample 8 ................... ................... ................... ................... ...................

Sample 9 ................... ................... ................... ................... ...................

Sample 10 ................... ................... ................... ................... ...................

Statistics

Mean value ................... ................... ................... ................... ...................

Variation ................... ................... ................... ................... ...................

Expected value ................... ................... ................... ................... ...................

Expected value met?


(yes/no) ................... ................... ................... ................... ...................

Is the osmolality within limits? yes no

Thermistor no. ............................. Responsible: ………………………(Name) ……………..(Date)

Note: ……………………………............................................................................................................

Fig. 144: Sample test protocol measurement check

Reproducibility (50µl): Reproducibility (15µl Option M):


# ±2 digits in the measurement range # ±6 digits [0..300] mOsmol/kg
[0..400] mOsmol/kg # ±2.0% [300..3000] mOsmol/kg
# ±0.5% in the measurement range
[400..1500] mOsmol/kg
# ±1.0% starting with 1500 mOsmol/kg

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Disposal

10 Disposal
After its useful life, the device must be disposed of under
environmentally conscious considerations.

Separation of consumables
WARNING!
Risk of death due to exposure to biohazards!
Improper disposal causes a risk of exposure to
biohazards. The resulting risk of infection can lead
to serious illness including death.
- Dispose of disposable accessories and other
contaminated products according to the
requirements for the disposal of biohazards.

Scrapping of device
NOTE!
Harm to environment due to improper disposal!
Electronic scrap and electronics assemblies are to be
treated as hazardous waste and can cause harm to
the environment in case of improper disposal.
- Always task certified specialist firms with the disposal
of the device.

Disposal of used electric and electronic equipment (applies to member


countries of the European Union and other European countries with
a separate collection system for this type of equipment).
The symbol on the product or its packaging indicates that this product
is not to be treated like regular household waste. Instead, it must be
returned to a recycling center for electric and electronic equipment.
By ensuring the proper disposal of this product, you help protect the
environment and the health of your fellow human beings. Improper
disposal poses a risk to the environment and people’s health.
Recycling materials helps reduce resource consumption. To learn
more about ways to recycle this product, ask your municipality, the
municipal waste management services, the dealer where you bought
the product, or the manufacturer.

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Disposal

 Power down device and disconnect power plug.


 Return the device to the manufacturer or a certified disposal firm.
Do not dispose of the device through municipal waste.
 Immediately before returning the medical product to the
manufacturer, make sure that the device meets strict hygienic
conditions. If necessary, disinfect device.

Implementation of Directives 2012/19/EC on Waste Electrical


and Electronic Equipment (short WEEE) and 2011/65/EC on the
Restriction of Hazardous Substances in Electrical and Electronic
Equipment (short RoHS, Restriction of Hazardous Substances).
Gonotec manufactures b2b devices. The devices are classified as
medical devices (WEEE category 8) and monitoring and control
instruments (WEEE category 9) and registered with the ear foundation
(Waste Electrical Equipment Register) accordingly under WEEE
reg. no. DE 65424410.

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Specifications

11 Specifications
11.1 Dimensions
Specification Value Unit

Weight 6.5 kg

Width 205 mm

Depth 220 mm

Height 360 mm

11.2 Performance parameters


Analytic sensitivity and specificity Specification Value Unit

Measuring range [0..3000] mOsmol/kg

Resolution (across entire 1 mOsmol/kg


measuring range)

Reproducibility Specification Value Unit

Reproducibility (50µl) # ±2 digits [0..400] mOsmol/kg


# ±0.5% [400..1500] mOsmol/kg
# ±1.0% [1500..3000] mOsmol/kg

Reproducibility (15µl) # ±6 digits [0..300] mOsmol/kg


Option M
# ±2.0% [300..3000] mOsmol/kg

11.3 Operating conditions


Environment Specification Value Unit

Temperature range 10-35 °C

Relative humidity 10-90 %


(non-condensing)

Maximal operating altitude 2000 m

Useful life Specification Value Unit

Useful life 10 Years

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Specifications

11.4 Connection ratings


Electrical Specification Value Unit

Power cable Detachable


power
supply cable

Power connection 100-240 VAC

Frequency 50-60 Hz

Power consumption, max. 80 VA

Fuse (HBC 1500A) T 1.6 A

System clock battery 10 years


Type: CR2032 useful life

(UL: MH 13654 (N))

Protection class IP21

Protection type I

Degree of contamination 2

Interfaces Specification Value


(does not apply to
OSMOMAT 3000basic) Serial port 2 × RS232 (one RS232 reserved
for barcode reader);
1 × USB

11.5 Options
Printer (D) Specification Value
(does not apply to
OSMOMAT 3000basic) Printer Alphanumeric dot matrix printer,
5×7 matrix, date, time and sample
information on each measurement

Number of digits ≥16 characters per row

Paper Normal paper, 43mm wide

Print modes single print, batch printing

Error message in plain text

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Specifications

Smaller sample amount (M) Specification Value


(does not apply to
OSMOMAT 3000basic) Sample volume 15 µl

Reproducibility # ±6 digits [0..300] mOsmol/kg


# ±2.0% [300..3000] mOsmol/kg

11.6 Nameplate

The nameplate is located at the rear of the device.

Fig. 145: Nameplate

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Index

12 Index
Unpack ............................................................... 44
2 Visual inspection............................................... 102
2-point calibration .................................................. 65 Dimensions ......................................................... 106

3 Disposal .............................................................. 104

3-point calibration .................................................. 65 E

A Electrical current .................................. 15, 52, 72, 95


Accessories ........................................................... 26 Elevator ................................................................. 23

Activate paper feed ................................................ 55 Lubricate ........................................................... 100


Enter values ........................................................... 31
C
Environmental protection
Calibration interval ........................................... 48, 65
Electronic components ....................................... 22
Calibration methods ............................................... 65
Sodium chloride .................................................. 22
Calibration standard
Error table .............................................................. 74
Calibrate Device ................................................. 65
ESD ........................................................................ 17
Handling ............................................................. 18
Exposure to liquids and moisture ........................... 17
Clean cooling clamp ............................................ 90
Configure language ............................................. 54 F

Configure screen contrast...................................... 54 Fan ......................................................................... 17

Configure screen saver.......................................... 55 Freezing point depression .................................. 27

Connection ratings ............................................ 107 H


Consumables ......................................................... 25 Hazards
Cryst-needle Electrical current ............................... 15, 52, 72, 95
Adjust ................................................................. 78
Free movement .................................................. 78 I

Replace .............................................................. 78 Incorrect measurements ........................................ 18

Customer service ......................................................3 Intended use .......................................................... 15


Interfaces ............................................................. 107
D Inventory ............................................................... 20
Delivery condition .................................................. 41
Device L

Calibrate ............................................................. 65 Lower cooling system ................................... 23, 29

Connect .............................................................. 47 M
Disposal ........................................................... 104 Manufacturer address .............................................. 3
Install .................................................................. 46 Measurement vessel
Overview ............................................................ 23 Correct positioning ............................................. 57
Power up ............................................................ 53 Measurement vessels
Reproducibility.................................................. 106 Incorrect.............................................................. 18
Sensitivity and specificity ................................. 106 Measurements
Setup .................................................................. 48 Basics ................................................................. 27
Transport ............................................................ 45

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Index

N Insufficient air circulation .................................... 17


Nameplate ............................................................ 108 Needle puncture injury ....................................... 16
Needle puncture injury ........................................... 16 Shock ........................................................... 17, 18

O S
On/Off switch ............................................ 10, 24, 33 Safety gear ........................................................... 22
Operating conditions ......................................... 106 Sample
Operator ................................................................. 19 Series measurement .......................................... 61
Option (D) Printer ................................................. 107 Samples
Option (M) smaller sample amount ..................... 108 Measure ............................................................. 57
Osmolality ............................................................. 27 Scrapping
Device .............................................................. 104
P
Separation
Packaging.............................................................. 42
Consumables ................................................... 104
Handling of packaging materials......................... 42
Serial number ........................................................ 48
Symbols on packaging ........................................ 42
Service ......................................................................3
Perform series measurement ................................. 61
Service table .......................................................... 96
Performance data ............................................... 106
Set batch ID ........................................................... 55
Personnel ............................................................... 21
Set sample ID ........................................................ 55
Power up ................................................................ 53
Shock ..................................................................... 17
Printer ............................................................... 32, 55
Storage.................................................................. 44
Connection .......................................................... 33
Symbols
Printer ink ............................................................ 92
In this manual ..................................................... 13
Printer paper ....................................................... 90
Printer paper ........................................................... 32 T
Temperature sensor .............................................. 29
R
Replace .............................................................. 82
Remove/install device front panel .......................... 96
Thermistor .............................................................. 29
Replace microfuses ............................................. 89
Touchscreen ........................................................ 30
Replace printer ink ............................................... 92
Enter values ....................................................... 31
Replace printer paper .......................................... 90
Operation ........................................................... 30
Reproducibility ........................................................ 18
Transport inspection .............................................. 41
Risk of infection ...................................................... 16
Risks U
ESD ..................................................................... 17 Upper cooling system ................................... 23, 29
Exposure to liquids and moisture........................ 17 User preferences ............................................. 54, 56
Improper handling of calibration standard .......... 18
Z
Incorrect measurement vessels .......................... 18
Zero point calibration ............................................. 65
Infection .............................................................. 16

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Appendix
Returning the device
When returning the device for repairs or a refund, please note the following.

Personnel:  User

Safety gear:  Disposable lab gloves

1. Power down device using on/off switch on rear side and disconnect
power plug.

2. Call or write to request a free return order for equipment that is being
returned for warranty repair 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.

3. Clean and disinfect the equipment before returning it to us.


We will charge a processing fee for cleaning and
disinfecting contaminated equipment.
Equipment that is strongly contaminated will not
be processed by us and will be returned at the
customer’s expense.
4. Position a measurement vessel (Fig. 146/1) on the temperature
sensor.

The measurement vessel is securely attached to


the temperature sensor when it clicks into place.

Fig. 146: Position measurement vessel

5. Move needle to transport position.


Open the menu for configuring the lab options.
In the Start menu, tap
Settings  Lab Options Maintenance Safe Transport.

The menu may be protected with a lab supervisor


password.

Fig. 147: Maintenance menu

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6. Tap Park Needle.

Tap Back to exit the menu.

WARNING!
Risk of infection from sample residue!
The cryst-needle is immersed into the sample during
measurements. Contact with the cryst-needle increases
the risk of infection.
Fig. 148: Safe Transport menu - Wear lab gloves during any kind of work.

7. Tilt transport safety device for temperature sensor and carefully


slide behind the temperature sensor (Fig. 149).

Fig. 149: Position transport safety device

8. Pull protective sleeve (Fig. 150/1) included with the delivery


over device.

Fig. 150: Device with protective sleeve

9. Enclose written information explaining the reason for returning


the equipment.

10. If the equipment is being returned for credit, you must include
all accessories (power cord, data transfer cable, software disks,
manuals, etc.).

11. Return the equipment in its original packaging. If you no longer have
the original packaging, you may purchase replacement packaging
from Gonotec.

12. Do you have a high sample volume and/or cannot afford downtime?
During repairs, we will provide you with a loaner unit at
no cost (Germany). Transport costs are only incurred
outside the warranty period.

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Limited Warranty
Duration of
Gonotec product Limited Warranty
Software 90 days B. Limitation of the Warranty
Temperature sensor 180 days 1. TO THE EXTENT PERMISSIBLE UNDER THE
Osmometer 1 year APPLICABLE LOCAL LAWS, NEITHER GONOTEC NOR
ITS SUPPLIERS SHALL ASSUME ANY ADDITIONAL
WARRANTY SERVICES OR ACCEPT ANY OTHER
A. Extension of the Limited Warranty CONDITIONS, EXPRESS OR IMPLIED, WITH REGARD
1. Gonotec warrants the end user that Gonotec products TO THE GONOTEC PRODUCTS.
shall be free from manufacturing and material defects C. Limitations of Liability
for the above periods of validity from the purchase date. 1. To the extent permissible under the applicable local laws,
2. For software products, Gonotec’s limited warranty applies the legal remedies named here shall be the sole and
only to the non-execution of programming instructions. exclusive legal remedies available to the customer.
Gonotec does not guarantee that the operation of 2. TO THE EXTENT PERMISSIBLE UNDER THE
a product will proceed without errors or interruptions. APPLICABLE LOCAL LAWS AND WITH THE
3. Gonotec’s limited warranty applies only to defects that EXCEPTION OF THE OBLIGATIONS EXPRESSLY
arise during normal operation of the product. It does NAMED HERE, NEITHER GONOTEC NOR ITS
not apply under the following conditions: SUPPLIERS SHALL BE LIABLE FOR DIRECT OR
a. Inadequate servicing or improper modification; INDIRECT, SPECIFIC, INCIDENTAL OR
b. Use of software, interfaces, print media or accessories CONSEQUENTIAL LOSSES, WHETHER BASED ON
not supported or supplied by Gonotec; or A CONTRACT, A TORTIOUS ACT OR ANOTHER
c. Use of the equipment in a manner not covered by LEGAL THEORY, AND NOTWITHSTANDING PRIOR
the product specifications. NOTIFICATION OF THE POSSIBILITY OF SUCH
4. For Gonotec osmometers, the use of measurement A LOSS.
vessels of manufacturers other than those of the Respective Jurisdiction
measurement vessels supplied by Gonotec does not void 1. This warranty statement guarantees the customer certain
the customer’s warranty claims or any customer support legal claims. The customer may have other legal claims
contracts between Gonotec and the customer. that go beyond those outlined here.
If, however, the use of measurement vessels from third- Such claims vary by state in the US, by province in Canada
party providers or the cleaning of recycled measurement and by nation elsewhere in the world.
vessels results in malfunctions or damage to the 2. Elements of this warranty statement that conflict with local
osmometer or temperature sensor, Gonotec shall assess laws can be regarded as amended to comply with
the normal fees for the time and material required to the applicable laws. For this reason, certain warranty
repair such malfunctions or damage. exclusions and restrictions outlined here may be of no
5. If Gonotec is notified within the warranty period of a defect relevance to the customer. In some states of the US, in
in a software product, in media or in a temperature sensor some Canadian provinces and in some countries outside
and if the Gonotec warranty applies to the defect, North America, for example, the following national laws
Gonotec shall replace the defective product. If Gonotec apply:
is notified within the warranty period of a defect in a. Exclusion of the fact that the warranty exclusions and
a hardware product and if the Gonotec warranty applies restrictions named here restrict the legal rights of a
to the defect, Gonotec shall repair or replace the defective customer (for example: Great Britain)
product at its discretion. b. Restriction of the possibilities for manufacturers to
6. If Gonotec is unable to repair or replace a defective enforce such warranty exclusions and restrictions
product to which the Gonotec warranty applies, Gonotec c. Granting of additional warranty claims for the customer,
shall refund the purchase price of the product within a fixing of the validity period for implied warranty services
reasonable period following notification of the respective that the manufacturer may not exclude, or non-admission
defect. of restrictions relating to the validity period for implied
7. Gonotec is not obligated to repair or replace a product warranty services
or refund its purchase price until the customer returns 3. THE FOLLOWING APPLIES TO CONSUMER
the defective product to Gonotec. TRANSACTIONS IN AUSTRALIA AND NEW ZEALAND:
8. Replacement products may be new or almost new, as THE CONDITIONS OF THIS WARRANTY STATEMENT
long as their functionality is at least that of the replaced NEITHER EXCLUDE
product. LEGAL RIGHTS APPLICABLE TO THE SALE OF
9. The Gonotec limited warranty is applicable in all GONOTEC PRODUCTS TO SUCH CUSTOMERS
countries in which Gonotec sells the applicable product. NOR REPRESENT A RESTRICTION OR AMENDMENT
The following countries and regions are exceptions: OF SUCH RIGHTS, BUT INSTEAD REPRESENT
All countries outside the EU. In these countries, A SUPPLEMENT TO THESE RIGHTS, EXCEPT TO
the warranty is only valid in the country in which THE EXTENT PERMISSIBLE UNDER THE LAW.
the product was purchased. Contracts for additional
warranty services, such as on-site service, may be
available from an authorized Gonotec sales partner.

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OSMOMAT 3000 Intend Use


The Gonotec Osmomat® 3000 cryoscopic osmometer is a non-invasive in-vitro diagnostic device for in-
vitro analysis of human blood, serum, 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 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 3000 cryoscopic osmometer is particularly suited for routine measurements in the
fields of medicine, industry and research. The OSMOMAT 3000 cryoscopic osmometer determines the
total osmolality of aqueous solutions. Osmolality is an important measure of concentration for diluted
solutions, such as all bodily fluids. The OSMOMAT 3000 Standard as well as the basic model need a
sample volume of 50 µl, while the M option requires only 15 µl, making it suitable for measuring even
minute samples. The measuring speed permits rapid series measurements.

Fields in which the OSMOMAT 3000 has a proven track record include:

General medicine Urology


Routine and research Nephrology
Forensic medicine Hemodialysis
Electron microscopy Hemofiltration
Physiology Botany
Clinical laboratories Veterinary medicine
ICU labs Pharmaceutics
Pediatrics Pharmacies
Gynecology … and many more

Classification of the IVD

The OSMOMAT® 3000 cryoscopic osmometer manufactured by Gonotec is a non-invasive in-vitro diagnostic
product according to EEC Directive 93/42 (Medical Devices Law). The Osmomat® 3000 cryoscopic osmometer
is not named in Annex II, list A or B, of the Directive 98/79/EEC for in-vitro diagnostic devices. Compliance is
declared per Annex III. Number 6 of Annex II is disregarded, since the unit’s intended use does not include
personal use.

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EC Compliance Statement—OSMOMAT® 3000


Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany

We hereby declare that the OSMOMAT® 3000 cryoscopic osmometer and its options comply with
Directive 98/79/EEC. Compliance is declared per Annex III of the Directive. The CE mark on the unit
acknowledges this.

Date: 01.09.2014

Signature of managing director:

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.

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Consumables
Item no. Item Pc. / VE
30.9.0010 Measurement vessel for OSMOMAT 3000 1,000
30.9.0020 Calibration standard 300 mOsmol/kg (ampoules of 1ml each) 10
30.9.0100 Calibration standard 100 mOsmol/kg (ampoules of 1ml each) 10
30.9.0290 Reference solution OSMOREF® 290 mOsmol/kg (ampoules of 1ml each) 10
30.9.0500 Calibration standard 500 mOsmol/kg (ampoules of 1ml each) 10
30.9.0850 Calibration standard 850 mOsmol/kg (ampoules of 1ml each) 10
30.9.2000 Calibration standard 2000 mOsmol/kg (ampoules of 1ml each) 10
30.9.1010 Printer paper roll for OSMOMAT 3000-D 8
30.9.1020 Continuous loop ribbon cartridge for OSMOMAT 3000-D 1

Accessories and Replacement Parts


Item no. Item Pc. / VE
32.3.0010 Temperature sensor for OSMOMAT 3000 (50µl sample volume) 1
32.3.2010 Temperature sensor for OSMOMAT 3000-M (15µl sample volume) 1
30.9.0030 Blow-out device 10
30.6.0020 Cryst-needle 1
30.9.1050 Ampoule opener 1
20.9.0165 Data cable for RS 232 interface OSMOMAT 3000 1
20.9.0166 USB cable for USB interface OSMOMAT 3000 1
30.2.0030 Adjustment tool 1
20.9.0100 Power cord, 2m 1
00.9.0107 Package with microfuses, slow-blow 1.6A (HBC 1500A) 10

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Before Calling Gonotec

1 Use a telephone located close to the device.


2 Power up device.
NOTE!
Danger in case of continuous acoustic alarm!
In case of continuous acoustic alarm, the electronics
components of the device can be damaged.
 Power down device again.
3 Note down the serial number of the device.
You can find the serial number on the rear of the device or under
Settings  Info.
4 Have the device documentation available.

Contact info:

Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany

Phone: (030) 7809 588-0


Fax: (030) 7809 588-88
E-mail: [email protected]
Web: http://www.gonotec.com

Fig. 151: Contact Gonotec

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