Gonotec OSMOMAT 3000 User manual

Version 1.22 1/6/2016
User Guide
OSMOMAT 3000basic OSMOMAT 3000

2Version 1.22 1/6/2016
Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin
Germany
Original Device Documentation
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: http://www.gonotec.com
WEEE reg. no.: DE65424410
©2014-2016

Version 1.22 1/6/2016 3
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 [phone]
Toll-free support hotline: [phone]
(Germany only)
Fax [phone]
E-mail [e-mail]
Web http://www.gonotec.com

4Version 1.22 1/6/2016

OSMOMAT 3000basic // OSMOMAT 3000
Table of Contents
Version 1.22 1/6/2016 5
Table of Contents
Table of Contents...........................................................................5
1Overview .................................................................................9
2Safety.....................................................................................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
2.3.3Risk 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
3Design 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
4Delivery, packaging, and storage.......................................41
4.1 Packaging.........................................................................42
4.2 Device storage .................................................................44
4.3 Unpack device..................................................................44
5Installation ............................................................................45
5.1 Transport device inside lab ..............................................45
5.2 Install device.....................................................................46
5.3 Connect device.................................................................47

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6Setup.....................................................................................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
7Operation..............................................................................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
7.5Calibrate device............................................................... 65
7.6 Power down device ......................................................... 71
8Troubleshooting...................................................................72
8.1 Safety notices.................................................................. 72
8.2 Notes regarding errors..................................................... 73
8.3Error 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
9Servicing...............................................................................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

OSMOMAT 3000basic // OSMOMAT 3000
Table of Contents
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OSMOMAT 3000
basic
// OSMOMAT 3000
Overview
Version 1.22 1/6/2016 9
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
10 Version 1.22 1/6/2016
Device,
rear
Fig.
2: Device overview—rear
1
Interfaces,

page 33
(does not apply to OSMOMAT 3000
basic)
2
Microfuses
3
On/Off switch
4
Power cable connection
5
Fan outlet

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Overview
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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).
Fig.
3: Overview of consumables
1
Measurement 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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Overview
12 Version 1.22 1/6/2016
Accessories
Fig.
4: Overview of accessories
1
Power cable
2
RS-232 cable
(does not apply to OSMOMAT
3000basic)
3
USB cable for connection to PC (slave)
(does not apply to OSMOMAT 3000
basic)
4
Adjustment tool
5
2 microfuses, slow-blow 1.6A (HBC 1500A)
6
Ampoule opener
7
Blow-out device for removing condensate

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Safety
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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
property damage if not avoided.
NOTE!
This combination of symbol and signal word indicates
potential environmental hazards.

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Safety
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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
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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Safety
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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 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
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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, 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
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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
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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18 Version 1.22 1/6/2016
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
the
calibration standard
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
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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basic
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Safety
Version 1.22 1/6/2016 19
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
20 Version 1.22 1/6/2016
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.