Gonotec OSMOMAT 3000 User manual

2/12/2013
User Guide
OSMOMAT 3000
Version 1.04 07/24/2013
Read User Guide before beginning any kind of work!

2 Version 1.04 07/24/2013
Gonotec GmbH
GSG-Hof Reuchlinstr.10-11
D-10553 Berlin
Original Device Documentation
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: http://www.gonotec.com
©2013

OSMOMAT 3000
Overview of the OSMOMAT 3000
Version 1.04 07/24/2013 3
This manual allows for the safe and efficient operation of the OSMO-
MAT 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 pro-
visions 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
D-10553 Berlin
Phone [phone]
Toll-free support hotline: [phone]
(Germany only)
Fax [phone]
E-mail [e-mail]
Web http://www.gonotec.com

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Overview of the OSMOMAT 3000
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TableofContents
Table of Contents ..........................................................................5
1Overview of the OSMOMAT 3000 .........................................8
2Safety ....................................................................................12
2.1Explanation of symbols................................................12
2.2Intended use................................................................14
2.3Additional hazards .......................................................14
2.3.1Hazards due to electrical current .................14
2.3.2Risk of infection............................................15
2.3.3Risk of injury.................................................15
2.3.4Risks of device damage...............................16
2.3.5Reproducibility of the measurement.............17
2.4Operator responsibilities..............................................18
2.5Personnel requirements...............................................20
2.6Personal safety gear....................................................21
2.7Environmental protection.............................................21
3Design and function.............................................................22
3.1Device overview...........................................................22
3.2Measuring method basics............................................26
3.3Measurement equipment.............................................27
3.4Touchscreen................................................................30
3.5Printer ..........................................................................32
3.6Connections and interfaces.........................................33
3.6.1Interface configuration..................................34
3.6.2Transfer protocol ..........................................35
4Delivery, packaging, and storage.......................................36
4.1Packaging....................................................................37
4.2Device storage.............................................................39
4.3Unpack device .............................................................39
5Installation ............................................................................40
5.1Transport device inside lab..........................................40
5.2Install device................................................................41
5.3Connect device............................................................42
6Setup .....................................................................................43
7Operation ..............................................................................46
7.1Power up device ..........................................................47

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7.2Measure individual samples.........................................48
7.3Perform series measurement.......................................52
7.4Calibrate device ...........................................................56
7.5Modify user preferences ..............................................62
7.6Power down device......................................................65
8Troubleshooting...................................................................66
8.1Safety notices...............................................................66
8.2Notes regarding errors.................................................67
8.3Error table ....................................................................68
8.4Resolve errors..............................................................72
8.4.1Replace initiation needle ..............................72
8.4.2Replace the thermistor probe .......................76
8.4.3Replace fine-wire fuses ................................83
8.4.4Clean cooling clamp.....................................84
8.4.5Replace printer paper (Option D only)..........84
8.4.6Replace printer ribbon (Option D only).........86
9Servicing ...............................................................................88
9.1Safety notices...............................................................88
9.1Service table ................................................................89
9.2Preliminary steps..........................................................89
9.3Lubricate elevator.........................................................94
9.4Perform visual inspection of device .............................96
9.5Check reproducibility of measurements.......................97
9.5.1Sample test protocol measurement check ...97
10Disposal.................................................................................98
11Specifications.......................................................................99
11.1Dimensions ..................................................................99
11.2Performance parameters .............................................99
11.3Operating conditions....................................................99
11.4Calibration standard...................................................100
11.5Connection ratings.....................................................100
11.6Options 101
11.7Nameplate..................................................................102
12Index....................................................................................103
Appendix.....................................................................................106
Returning the device ............................................................106
Limited Warranty..................................................................108
Classification of the IVD.......................................................109

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Overview of the OSMOMAT 3000
Version 1.04 07/24/2013 7
EC Compliance Statement—OSMOMAT®3000..................109
Provisions of Certification ....................................................109
Consumables.......................................................................110
Accessories and Replacement Parts...................................110
Before Calling Gonotec........................................................111

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
1 Overview of the OSMOMAT 3000
This device is an in-vitro diagnostic product which measures the os-
molality of a sample. For details about the measuring method,
see
 page 26.
Fig. 1: Device overview—front
1
Touchscreen,
 page 30
2
Upper cooling system (behind movable elevator cover),
 page 28
3
Thermistor probe with measuring vessel,
 page 29
4
Lower cooling system,
 page 29
5 Elevator
6
Printer (Option D),
 page 32

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Device, rear
Fig. 2: Device overview—rear
1 Interfaces,
 page 33
2 Fine-wire fuses
3 On/Off switch
4 Power cord connection
5 Fan outlet

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Consumables
NOTE!
Risk of falsified measurement results!
When using accessories and/or consumables made by
manufacturers other than Gonotec GmbH, the reproduc-
ibility of the measurement results cannot be guaranteed.
- Always use the accessories and consumables sup-
plied by Gonotec GmbH.
- Order used-up consumables, in particular measuring
vessels, from Gonotec GmbH (see page 2 for contact
information).
Fig. 3: Overview of consumables
1 Measuring vessels, 100 pc.
2
Calibration standard, 10 pc., 1ml each, concentration
300 mOsmol/kg
3 Printer paper, 1 roll (Option D only)

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Accessories
Fig. 4: Overview of accessories
1 Power cord
2 RS-232 cable
3 USB cable for connection to PC (slave)
4 Adjustment tool
5 2 fine-wire fuses, 1.6 A Lag (HBC 1500 A)
6 Ampoule opener
7 Blow-out device for removing condensate
(Pasteur pipette)

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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 proper-
ty 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 the following symbols to indicate special hazards:
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 will 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
1, 2, 3 ... Step-by-step instructions
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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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 24
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 im-
mediate 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 cord 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
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2.3.2 Risk of infection
Risk of infection
WARNING!
Risk of infection due to sample residue and in case
of inadequate hygiene, disinfectant cleaning, 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, disin-
fectant cleaning, and sterilization.
We recommend using detergents such as Mikrozid ® AF
Liquid, Bacillol ® plus 3%, or Korsolex ® plus 4% com-
monly found in clinical-chemical labs to clean and decon-
taminate the device.
2.3.3 Risk of injury
Risk of injury
CAUTION!
Risk of injury from initiation needle!
When installing and removing the initiation needle and
the thermistor probe, the tip of the initiation needle is ex-
posed. Movement of the initiation needle can cause
needle puncture injuries.
- Always keep your hands and fingers clear from the
area underneath the initiation needle.

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2.3.4 Risks of device damage
Exposure to liquids and moisture
NOTE!
Device damage due to exposure to liquids and mois-
ture!
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 de-
vice 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 ESD of the device!
Electrostatic discharge (ESD) can occur when working
on the open device.
- Take ESD precautions.

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2.3.5 Reproducibility of the measurement
Incorrect measuring vessels
NOTE!
Risk of non-reproducibility of measurement due to
incorrect measuring vessels!
Repeated use of the measuring vessels and use of in-
correct consumables cannot guarantee reproducible
measurement results.
- Always use a clean and unused measuring vessel for
every measurement.
- Only use measuring vessels supplied by Gonotec
GmbH.
- Never use centrifugal measuring vessels.
Improper handling of the calibra-
tion standard
NOTE!
Risk of non-reproducibility of measurement due to
improper handling of calibration standards!
Improper handling and storage of the calibration stand-
ards included with the delivery negatively affects the
measurement accuracy of the device.
- Always observe the stability of the calibration stand-
ards after opening the ampoule (0.5h at
22°C ambient temperature).
- Never use opened ampoules twice or mix them to-
gether.
- Never freeze opened ampoules.
- Do not use the calibration standards past their expira-
tion 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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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 stand-
ards and guidelines applicable at the time the device is
used.
The device is used for medical-pharmaceutical applications. There-
fore, 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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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 authority upon
demand.

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2.5 Personnel requirements
WARNING!
Risk of injury due to inadequately qualified person-
nel!
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 avoid-
ing 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 pur-
poses 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 profes-
sional experience with medical devices, the lab supervisor is capable
of performing the start-up tasks delegated to him or her by the manu-
facturer.
Service technician
Based on his or her professional training in the area of mechanical
and electrical engineering, the service technician is capable of per-
forming the tasks related to troubleshooting and servicing delegated to
him or her by the manufacturer.