Gonotec OSMOMAT 3000, OSMOMAT 3000basic User Manual
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: contact@gonotec.com
Web: http://www.gonotec.com
WEEE reg. no.: DE65424410
© 2014-2016
2 Version 1.22 1/6/2016
This manual allows for the saf e and eff icient operatio n 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
Personnel must
beginning any kind of work. Compliance with the safety notices and
instructions in this manual is the basis for a safe work environment.
In
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
documentation apply. The warnings
in
Copyright
The contents of this manual are protected by copyright. Their use is
permitted in connection with the use of this device.
this scope is not permitted without prior written authorization from
Gonotec GmbH.
Manufacturer contact info
be easily accessible to personn el at an y tim e.
carefully read and understand this manual before
addition, local accident prevention regulations and general safety
the device
– in particular safety notices –
this documentation must be observed!
Any use beyond
Address Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany
Phone (030) 7809 588-0
Fax (030) 7809 588-88
E-mail contact@gonotec.com
Web http://www.gonotec.com
Toll-free support hotline: 0800-7846027
(Germany only)
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OSMOMAT 3000basic // OSMOMAT 3000
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
10 Disposal .............................................................................. 104
11 Specifications ..................................................................... 106
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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
11.1 Dimensions .................................................................... 106
11.2 Performance parameters ............................................... 106
11.3 Operating conditions...................................................... 106
11.4 Connection ratings......................................................... 107
OSMOMAT 3000basic // OSMOMAT 3000
Table of Contents
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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OSMOMAT 3000
basic
// OSMOMAT 3000
Fig.
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)
1 Overview
Overview
1: Device overview—front
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basic
// OSMOMAT 3000
Device,
Fig.
1
Interfaces, page 33
(does not apply to OSMOMAT 3000
2 Microfuses
3 On/Off switch
4 Power cable connection
5 Fan outlet
Overview
rear
2: Device overview—rear
basic)
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basic
// OSMOMAT 3000
Standard accessories
Fig.
1 Measurement vessels, 100 pc.
2
Calibration standard, 10 pc., 1ml each,
concentration
3 Printer paper, 1 roll (Option D only)
Overview
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).
300 mOsmol/kg
3: Overview of consumables
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// OSMOMAT 3000
Accessories
Fig.
1 Power cable
2
RS-232 cable
(does not apply to OSMOMAT
3
USB cable for connection to PC (slave)
(does not apply to OSMOMAT 3000
4 Adjustment tool
5 2 microfuses, slow-blow 1.6A (HBC 1500A)
6 Ampoule opener
7 Blow-out device for removing condensate
Overview
4: Overview of accessories
3000basic)
basic)
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basic
// OSMOMAT 3000
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.
2 Safety
2.1 Explanation of symbols
Safety
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 situa t ion 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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Special safety notices
Safety notices use
Safety notices in instructions
Safety notices can apply to specific, individual instructions. These
safety notices are embedded in the instruction to avoid interrupting
the
signal
Example:
1
Loosen screw.
2
Use care when closing cover.
3
Tighten screw.
Additional identifiers
To highlight
the following identifiers are used in this manual:
Identification
Explanation
Safety
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 biohaza rdous m ater ials.
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.
flow of reading while perf orm ing the operat ion. They use the
words described above.
.
.
CAUTION!
Pinch hazard on cover!
.
instructions, results, lists, references, and other elements,
1, 2, 3 ...
Step-by-step instructions
Results of action steps
References to sections in this manual and
other applicable documents
Unordered lists
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[Button] Controls (such as buttons or switches),
display elements (such as indicator lamps)
Display Screen elements (such as buttons, function
key assignments)
OSMOMAT 3000
basic
// OSMOMAT 3000
Intended use
Electrical current
2.2 Intended use
The OSMOMAT 3000 device is a non-invas i ve 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
Safety
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 qua lifie d per sonnel 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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Risk of infection
Risk of injury
Safety
2.3.2 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, nonsterilized, 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, Bac il lo l® plus 3%, or Korsolex® plus 4%
commonly found in clinical-chemical labs to clean
and decontaminate the device.
2.3.3 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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Exposure to
Fan
Shock
ESD
2.3.4 Risks of device damage
liquids and moisture
Safety
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.
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.
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.
- Alwa ys insta ll the device on a non-vibrating surface.
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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Incorrect measurement
Improper handling of
the
Shock
Safety
2.3.5 Reproducibility of the measurement
vessels
calibration standard
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
- Only use measurement vessels supplied by
- Never use centrifuge tubes or reaction vessels.
NOTE!
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
- Never use opened ampoules twice or mix them
- Never fr ee ze opened ampoules.
- Do not use the calibration standards past their
vessel for every measurement.
Gonotec GmbH.
standards after opening the ampoule (max. 0.5h
at 22°C ambient temperature).
together.
expiration date.
18 Version 1.22 1/6/2016
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).
- Alwa ys insta ll the device on a non-vibrating surface.
OSMOMAT 3000
basic
// OSMOMAT 3000
The operator of the device must fulfill the responsibilities according to
Germany’s Medical Devices Operator Ordinance listed in this manual.
The device is used for medical
Therefore, the operator is subject to the legal responsibilities
regarding work safety.
In particular, the following applies:
2.4 Operator responsibilities
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 instruc tions creat ed b y him /he r 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 c leaning .
The operator has to make sure that all personn el wor king 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.
Safety
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.
-pharmaceutical applications.
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Inventory
The operator has to maintain an inventory according to Germany’s
Medical Devices Operator Or dinance:
Safety
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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This manual specifies
the
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
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
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
ca
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
delegated to him or her by the manufacturer.
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.
the following personnel qualifications for
different task areas:
Safety
not authorized to perform any start-up activities.
pable of performing the start-up tasks delegated to him or her by
tasks related to troubleshooting and servicing
used for medical
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// OSMOMAT 3000
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.
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
is
environment.
Safety
2.6 Personal safety gear
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.
calibration standards contain sodium chloride. Sodium chloride
mildly hazardous to water and must not be released into the
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basic
// OSMOMAT 3000
Fig.
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)
Design and function
3 Design and function
3.1 Device overview
5: Device overview—front
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// OSMOMAT 3000
Device, rear
Fig.
1
Interfaces, page 33.
(does not apply to OSMOMAT 3000
2 Microfuses
3 On/Off switch
4 Power cable connection
5 Fan outlet
Design and function
6: Device overview—rear
basic)
24 Version 1.22 1/6/2016
OSMOMAT 3000
basic
// OSMOMAT 3000
Standard accessories
Fig.
1 Measurement vessels, 100 pc.
2
Calibration standard, 10 pc., 1ml each,
concentration
3 Printer paper, 1 roll (Option D only)
Design and function
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).
300 mOsmol/kg
7: Overview of consumables
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// OSMOMAT 3000
Accessories
Fig.
1 Power cable
2
RS-232 cable
(does not apply
3
USB cable for connection to PC (slave)
(does not apply to OSMOMAT 3000
4 Adjustment tool
5 2 microfuses, slow-blow 1.6A (HBC 1500A)
6 Ampoule opener
7 Blow-out device for removing condensate
Design and function
8: Overview of accessories
to OSMOMAT 3000basic)
basic)
26 Version 1.22 1/6/2016
OSMOMAT 3000
basic
// OSMOMAT 3000
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.
urea, proteins) present per kilogram of solvent (water).
The osmolality is specified in Osmol/kg or mOsmol/kg.
The device determines the total osm olalit y of a sam ple solution
based
The
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
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
number of particles present in the solution afterwards.
Whereas water has a freezing point of 0°C, an aqueous solution
with
a
That means that one mol of an ideal non
(6.023
freezing point of a solution by
The osmolality of a solution is directly proportional to the mea
freezing point depression and can therefore be calculated from this
result. The relationship is as follows:
3.2 Measuring method basics
Design and function
salt ions, sugar,
on the freezing point depression (see below).
implemented measuring method is a relative measuring method
-point calibration.
type and quantity of the dissolved substance, but rather on the
an osmotically active particle concentration of 1 Osmol/kg has
freezing point of -1.858°C.
× 1023 parts diluted in one kilogram of water) lowers the
C
= osmolality [Osmol/kg]
C
osm
= ΔT / K
osm
ΔT = freezing point depression [°C]
K = 1.858°C kg/Osmol (cryoscopic constant)
-dissociated substance
1.858°C.
sured
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// OSMOMAT 3000
Fig.
1 Elevator
2
Upper cooling system
(behind movable elevator cover)
3 Handle for lowering the temperature sensor
4 Temperature sensor
5 Lower cooling system
6 Cover
7 Measurement vessel
The sample is pipetted into the measurement vessel (
The
(
The
temperature.
The defined crystallization of the sample is triggered using ice
crystals
The osmolality of the sample is calculated using the measured
freezing point [°C] and the cryoscopic constant and shown on
the
Design and function
3.3 Measurement equipment
9: Overview of measurement equipment
measurement vessel is placed on the temperature sensor
Fig. 9/4) and lowered into the lower cooling system (Fig. 9/5).
lower cooling system cools the sample down to a defined
produced in the upper cooling system (Fig. 9/2).
display.
NOTE!
Risk of incorrect measurement resulti n g from
the presence of air bubbles in the sample!
The sample must be pipetted without air bubbles.
28 Version 1.22 1/6/2016
Fig. 9/7).
OSMOMAT 3000
basic
// OSMOMAT 3000
Upper cooling system
Fig.
1 Cryst-needle
2 Cooling nipple
The cryst
the sample with ice crystals ("crystallization"). This causes the sample
to freeze and heat up to its freezing point.
Temperature sensor
Fig.
1 Temperature sensor
2 Thermistor
The temperature sensor (
of the sample via the thermistor (
been triggered, the temperature sensor measures the freezing point
of
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
in
10: Upper cooling system
Design and function
-needle (Fig. 10/1) of the upper cooling system "inoculates"
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.
the sample.
NOTE!
Sensitive component!
The thermistor of the temperature sensor is a sensitive
component and must be protected from external
11: Temperature sensor
influences such as dust or friction.
- 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.
quick cooling down of the sample causes the sample to remain
the liquid state until the defined crystallization is triggered.
Fig. 11/1) measures the current temperature
Fig. 11/2). After crystallization has
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// OSMOMAT 3000
Fig.
The device is controlled using the touchscreen (
Design and function
3.4 Touchscreen
12: Overview of 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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