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1 Overview of the OSMOMAT 3000

1. gt The system language is German Fig 66 Configure language Configure screen contrast DISPLAY CONTRAST 1 Tap gt gt to increase contrast Please adjust the screen contrast Tap Nee to decrease contrast Fig 67 Configure screen contrast 62 Version 1 02 04 24 2013 Ge EE Configure screen saver SCREEN SAVER Please select a screen saver time 1 MINUTE 18 MINUTES 30 MINUTES 1 HOUR Fig 68 Configure screen saver Activate paper feed PRINTER Press and hold the PAPER FEED button ta feed paper PAPER FEED Fig 69 Activate paper feed Configure sample ID ID MANAGEMENT Charge ID Sample ID automatic automatic DW numeric C numeric alphanumeric C alphanumeric Fig 70 Configure sample ID OSMOMAT 3000 Operation 1 Select the duration after which the system activates the screen saver Tapping OFF will never activate the screen saver 1 Option D only Tap Paper Feed gt The paper feed of the printer is activated briefly Tap Quit to exit the menu Select the settings for the IDs for series measurements Charge 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 I
2. 7 3 Perform series measurement Personnel User Safety gear M Disposable lab gloves Materials Soft paper towel Pipette D E E Measuring vessel E Samples NOTE Risk of non reproducibility of measurement due to incorrect measuring vessels Repeated use of the measuring vessels and use of incor rect consumables cannot guarantee reproducible meas urement 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 NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted without air bubbles a 1 Clean thermistor probe fig 43 1 using a soft paper towel E Fig 43 Clean thermistor probe 11 04 2012 02 26 AM 2 Tap Measure on the Start menu Fig 44 gt If the operating time of the device is less than 3 minutes the menu for ice formation is displayed INFO MEASURE SETTINGS Please touch the buttons above Fig 44 Start menu 52 Version 1 02 04 24 2013 1104 2012 INFO MEASURE SETTINGS Please touch the buttons abowe Fig 45 Ice formation Preparation Need calibration wf Produce Ice Calibration Please do a calibration Ready before any measurement QUIT CALIBRATE Fig 46 Calibrate device re Ready to Measure w Produce Ice st Calibration PPeady Last calib
3. 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 electron ics components of the device can be damaged E Power down device again 3 Note down the serial number of the device To find the serial number select Start menu gt Info 4 Have the device documentation available Contact info Gonotec GmbH GSG Hof Reuchlinstr 10 11 D 10553 Berlin SYSTEM INFO Phone 030 7809 588 0 Fax 030 7809 588 88 E mail contact gonotec com Web http www gonotec com Fig 141 Contact Gonotec Version 1 02 04 24 2013 111
4. i NOTE p 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 89 Fig 130 Location of elevator guide Lubricate elevator guide 94 Version 1 02 04 24 2013 OSMOMAT 3000 pono ee Servicing Fig 131 Lubricate elevator guide 3 Lubricate elevator guide on left fig 131 A and right side fig 131 B of ball bearing using silicone spray O Tip It The left ball bearing of the elevator guide is not easily accessible Therefore lubricate the upper section fig 131 A on the left side of the elevator guide and move the ele vator up and down multiple times 4 Install device front panel on page 93 Version 1 02 04 24 2013 95 OSMOMAT 3000 Servicing geneler 9 4 Perform visual inspection of device Personnel User Safety gear M Disposable lab gloves Materials E Fiberglass pin m Soft cloth m 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 measuring vessels are located in the openings of the device fig 132 1 2 Remove any foreign objects using tweezers OSMOMAT 3000 Clean cooling nipple fig 133 1 using fiberglass pin For this purpo
5. 3 4 Touchscreen 30 Io PANG eee E 32 3 6 Connections and interfaces rrnrrrvvnnnnnvrvvrrrnnnrrvennnnnn 33 3 6 1 Interface configuration snaennnnenneneennneanne 34 3 6 2 Transfer protocol cccccseeeeeeeeeeeeeeeeeeeeens 35 4 Delivery packaging and Storage s rurrrnnnnnnnnnnnnnnnnvnvnnnnnnr 36 Al le e Le le e EE 37 4 2 Device storage ss nnsneennesennnnnnreesrnrrrrnnresrnrrrnnrrennne 39 4 3 Unpack device n annnennaannneoeennnennnnnnnnnsnnnnnnnrnneresnennnee 39 5 Installation E 40 5 1 Transport device inside la 40 5 MENN 41 5 3 Connect device ssrt nre E E 42 JE EEE ERE EE 43 7 ODCTAUOMN sroine aE iE ae LEE 46 7 1 Power up device rrrnnnnnrrnnnnnnnnrvvvrnnnnnrrnnnnnnnnrrnnnnnnsnsnnn 47 Version 1 02 04 24 2013 5 OSMOMAT 3000 Overview of the OSMOMAT 3000 Gono se 7 2 Measure individual samples 48 7 3 Perform series measurement ENEE 52 7 4 Calibrate device rrrrrrnnnrrnrnnnnorrnnnnrnnnnnnrenrnnnnennnnnnennnnn 56 7 5 Modify user preferences rrrrrnnnnnnnnvnnrnnnnnnrnnnnnnnnnenn 62 7 6 Power down device rrrrnnnnrnnnrnvvvrrnnnnnrnnnnnnnnnrnnnnnnnnsenn 65 8 Troubleshooting sseteeeskuEuERSEEENEEEKSEKENENESEEEEKEKEESENENESEEESEEEEEN 66 8 1 Safety noiices ccc eccccccseseeeeeeceeseeeeeseeeeeeesseaaeseeseeas 66 8 2 Notes regarding errors ccccseeeeccsseseeeeeeeeeesseeeeeesaaes 67 oO FOOT DE 68 8 4 Resolve emorg 72 8 4 1 Replace initi
6. OSMOMAT 3000 ono 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 resi due 2 7 Environmental protection NOTE Danger to environment due to incorrect handling of han dling 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 en vironmentally hazardous substances and their disposal be low 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 If environmentally hazardous substances are inadvertently released into the environment immediately initiate suitable actions If in doubt notify the responsible 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
7. 3 Fig 3 Overview of consumables Gono ee 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 Measuring vessels 100 pc Calibration standard 10 pc 1ml each concentration 300 mOsmol kg Printer paper 1 roll Option D only 10 Version 1 02 04 24 2013 jonas Accessories Fig 4 Overview of accessories RR OD Power cord RS 232 cable USB cable for connection to PC slave Adjustment tool OSMOMAT 3000 Overview of the OSMOMAT 3000 2 fine wire fuses 1 A Ampoule opener Blow out device for removing condensate Pasteur pipette Version 1 02 04 24 2013 11 OSMOMAT 3000 Safety 2 Safety 2 1 Explanation of symbols pono 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 gt gt gt 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 potential
8. Remove protective sleeve from device fig 22 1 Fig 22 Remove protective sleeve Version 1 02 04 24 2013 41 OSMOMAT 3000 Installation gonaier 3 Remove transport safety device fig 23 1 from thermistor probe Proceed as follows OSMOMAT J000 Soen Se rmes 4 Carefully pull transport safety device down and pull forward to remove Fig 24 Remove transport safety device 5 3 Connect device Personnel M Lab supervisor 1 Connect power plug to device 2 Connect power cord to a properly grounded power socket 3 Connect a PC via RS232 or USB if applicable 4 Connect a barcode reader option if applicable 42 Version 1 02 04 24 2013 e se 6 Setup OSMOMAT 3000 Setup Personnel M Lab supervisor A Check printer Option D A VI x Complete all activities for installation and connection of the de vice Verify that the connections at the rear side of the device are se cure Check the elevator for ease of movement If necessary grease the elevator guide chapter 9 3 Lubricate elevator on page 94 Power up device on rear side using on off switch 9 Fig 25 Paper roll feed direction NM Correct feed direction x 5 Check free movement of initiation D needle Incorrect feed direction Check feed direction of paper roll Open the printer and compare the feed direction of the paper roll with the feed direction shown in fig 25 Check ini
9. To complete the series measurement tap End Charge gt Option D Completing the series measurement also completes the print ing operation Version 1 02 04 24 2013 55 OSMOMAT 3000 Operation 7 4 Calibrate device Calibration methods Calibrate device Gono ee Depending on the pre defined calibration interval the menu for cali brating the device opens automatically The device is calibrated using one of the following calibration methods E 2 point calibration Calibration using distilled water and a calibration standard or m 3 point calibration Calibration using distilled water and 2 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 2 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 Setup on page 43 Personnel User Safety gear M Disposable lab gloves Materials m Soft paper towel Pipette Distilled Water m Calibration standard e g 300 mOsmol kg E Ampoule opener C 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 consu
10. 2 Value 2 x RS232 one RS232 reserved for barcode reader 1 x USB Value Alphanumeric dot matrix printer 5x7 matrix date time and sample infor mation on each measurement 16 characters per row Normal paper 43mm wide single print batch printing Error message in plain text Value Version 1 02 04 24 2013 101 OSMOMAT 3000 Specifications geneler 11 7 Nameplate The nameplate is located at the rear of the device aanalee ce Les Input V 100 240V 50 60Hz 45VA T1 0ASlow Lag iP 24 Disconnect Power Before Opening Fuse Fig 135 Nameplate GSG Hof Reuchlinstr 10 11 10553 Berlin Germany Gonotec GmbH E 102 Version 1 02 04 24 2013 GEET 12 Index 2 2 point calbratton 56 3 3 point calbratton nennen 56 A pe es So EE A EAER 25 Activate paper feed 63 C Calibration interval rrnrnnnnnnnnnnnnnnnnnnnnnnnr 43 56 Calibration methodS n00000000nnnnnnoeaanaennnnnnne 56 Calibration standard Calibrate Device rrrrrnrrnnnrnrrnrnnnnnvvnnnnnnnnvnnnnnnn 56 MP eeben 100 PANGING caren acatsusu Bada besiaiadenornearensinantsuan ENRERE 17 gd 10 0 RE NE 100 Clean cooling camp 84 Configure batch ID 63 Configure language rrnnnnnnnnnnrnnnrnnnnnonnnnnnnnnennnnnnn 62 Configure Sample ID 63 Configure screen Contfrast 62 Configure screen Saver 63 Connection ratings sees 100 101 Consumables naennnnnneannnennnnnnnnnenn
11. HERE NEITHER GONOTEC NOR ITS SUPPLIERS SHALL BE LIABLE FOR DIRECT OR INDIRECT SPECIFIC INCIDENTAL OR CONSEQUENTIAL LOSSES WHETHER BASED ON A CONTRACT A TORTIOUS ACT OR ANOTHER LEGAL THEORY AND NOTWITHSTANDING PRIOR NOTIFICA TION OF THE POSSIBILITY OF SUCH A LOSS Respective Jurisdiction This warranty statement guarantees the customer certain legal claims The customer may have other legal claims that go beyond those outlined here Such claims vary by state in the US by province in Canada and by nation elsewhere in the world Elements of this warranty statement that conflict with local laws can be regarded as amended to comply with the ap plicable laws For this reason certain warranty exclusions and restrictions outlined here may be of no relevance to the customer In some states of the US in some Canadian provinces and in some countries outside North America for example the following national laws apply d Exclusion of the fact that the warranty exclusions and restrictions named here restrict the legal rights of a cus tomer for example Great Britain e Restriction of the possibilities for manufacturers to en force such warranty exclusions and restrictions f Granting of additional warranty claims for the customer fixing of the validity period for implied warranty services that the manufacturer may not exclude or non admission of restrictions relating to the validity period for implied warranty services T
12. Quit to exit the menu 9 Replace printer cover and push printer into casing Fig 112 Paper feed 8 4 6 Replace printer ribbon Option D only Personnel User Safety gear M Disposable lab gloves Materials m 1 Ribbon 1 Power down device on rear side using on off switch Fig 113 Printer pulled out 1 Paper roll 2 Ribbon 86 Version 1 02 04 24 2013 Fig 117 Feed printer paper OSMOMAT 3000 Troubleshooting Pull out printer fig 114 1 Remove printer cover fig 115 1 Push on Push marking on front side of ribbon fig 116 gt The ribbon is released Remove the released ribbon Feed printer paper through ribbon fig 117 Press ribbon onto device gt The ribbon snaps into place Tighten ribbon by turning knob clockwise Replace printer cover and push printer into casing Version 1 02 04 24 2013 87 OSMOMAT 3000 Servicing 9 Servicing 9 1 Safety notices Electrical current Risk of infection A A pono se DANGER Risk of death due to electrical current on device 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 lf the insulation is damaged immediately switch off the voltage supply and schedule a repair Always route the
13. WARNING Incompatible barcode reader COM2 or USB data port AN 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 WARNING To protect life and equipment Devices and accessories connected to the RS232 or USB connectors must meet the applicable safety standards for medical lab equipment LOG PORT The device can output the recorded measurement results via the COM2 Please select the desired log port 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 SEND TEST STRING Settings 9600 baud 8 N 1 Fig 16 Set protocol 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 de tects 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 cor
14. accessories and consumables sup plied by Gonotec GmbH Re order consumables in particular measuring ves sels from Gonotec GmbH see page 2 for contact in formation Measuring vessels 100 pc Calibration standard 10 pc 1ml each concentration 300 mOsmol kg Printer paper 1 roll 3 Fig 7 Overview of consumables 24 Version 1 02 04 24 2013 OSMOMAT 3000 Sele ae Design and function Accessories Fig 8 Overview of accessories 1 Power cord 5 2 fine wire fuses 1A 2 RS 232 cable 6 Ampoule opener 3 USB cable for printer connection slave 7 Blow out device for removing condensate 4 Adjustment tool Pasteur pipette Version 1 02 04 24 2013 25 OSMOMAT 3000 Design and function geneler 3 2 Measuring method basics Osmolality The device measures the total osmolality of any aqueous solution The total osmolality indicates the concentration of all osmotically ac tive substances Such as salts dextrose proteins per kilogram of water The osmolality is specified in mOsmol kg The device determines the total osmolality of the sample solution based on the freezing point depression The implemented measuring method is a relative measuring method The freezing points of distilled water and an aqueous solution are measured and compared The osmolality of any solution is determined using a linear function defined by 2 or 3 point calibration Freezing point depression The freezing point of a
15. initiation needle can cause needle puncture injuries Always keep your hands and fingers clear from the area underneath the initiation needle Version 1 02 04 24 2013 15 OSMOMAT 3000 Safety 2 3 4 Risks of device damage Exposure to liquids and moisture Fan Shock ESD pono e 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 toa 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 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 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 16 Version 1 02 04 24 2013 gonrsise OSMOMAT 3000 Safety 2 3 5 Reproducibility of the measurement Incorrect measuring vessels Improper handling of the calibra tion
16. 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 environ ment Version 1 02 04 24 2013 21 OSMOMAT 3000 Design and function Solel tae 3 Design and function 3 1 Device overview This device is an in vitro diagnostic product which measures the os molality of a sample For details about the measuring method see 6 page 26 89 23 2812 gone Please touch the buttons above OSMOMAT 3000 Fig 5 Device overview front 1 Touchscreen amp page 30 2 Upper cooling system behind movable elevator cover amp page 28 3 Thermistor probe with measuring vessel 6 page 29 4 Lower cooling system 6 page 29 5 Elevator 6 Printer Option D amp page 32 22 Version 1 02 04 24 2013 Gono se Device rear Fig 6 Device overview rear 0O A O N Interfaces 6 page 33 Fine wire fuses On Off switch Power cord connection Fan outlet OSMOMAT 3000 Design and function Version 1 02 04 24 2013 23 OSMOMAT 3000 Design and function geneler 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
17. ob structed Peltier element is defec tive Light barrier on gear motor disk is defective Light barrier on gear motor disk is misaligned Gear motor disk misa ligned or loose Peltier element defec tive Cable connection be tween cooling system and PCB defective Cooling nipple dirty Remedy Lubricate the elevator guide using silicone spray page 95 Check openings and remove foreign objects Clean cooling clamp page 84 Check if fan is operational and re place if necessary amp service manu al Replace lower cooling system service manual Replace light barrier service manual Adjust light barrier Adjust tighten gear motor disk Replace upper cooling system service manual Clean cooling nipple using a fiber glass pin page 96 Remove any droplets from opening using blow out device Errors marked are shown as an error message on the Personnel User User Service technician Service technician Service technician User 68 Version 1 02 04 24 2013 Gono EE Measurement proce dure takes longer than usual Spontaneous crystal lization Incorrect measure ment results Error in rotation of gear motor disk initiation needle drive Ambient air too dry Fan is defective or ob structed Peltier element is defec tive Sample not prepared correctly Thermistor probe not aligned correctly Elevator moved up by user Lower c
18. 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 gt The newly entered value overwrites the previous value Version 1 02 04 24 2013 31 OSMOMAT 3000 Design and function geneler 3 5 Printer With built in printer only Option D e i 1 Opening for printer paper SE x 2 Printer pull out handle The printer is used to print the measurement results Rolls of printer paper are included with the delivery O Change printer paper J Change the printer paper when a red stripe appears on the printer paper chapter 8 4 5 Replace printer paper Option D only on page 84 Fig 14 Overview of printer 32 Version 1 02 04 24 2013 OSMOMAT 3000 one Design and function 3 6 Connections and interfaces The following connections and interfaces are located at the rear of the device Fig 15 Connections and interfaces 1 COM1 only for connecting the barcode reader 4 Fuse insert Option BC 5 On Off switch 2 COM2 interface RS 232 output 6 Power plug connection 3 USB connector Version 1 02 04 24 2013 33 OSMOMAT 3000 Design and function eel te 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 purchased from Gonotec GmbH or your authorized distributor A
19. 35 OSMOMAT 3000 Delivery packaging and storage geneler 4 Delivery packaging and storage Delivery condition 1 package containing the following components m Device with protective sleeve fig 17 1 m Accessories fig 17 2 8 Blow out device Pasteur pipette fig 17 3 Adjustment tool fig 17 8 1 package of 2 1A fine wire fuses fig 17 6 Ampoule opener fig 17 4 USB cable fig 17 5 RS232 cable fig 17 7 Power cord fig 17 2 Consumables fig 17 9 11 Printer paper fig 17 9 Option D only Measuring vessels 100 pc fig 17 10 Calibration standard 300mOsmol kg 1 package of 10 ampoules 1ml each fig 17 11 Mi m 1 user guide Check the delivery for completeness and transport damage immedi 6 ately following receipt Proceed as follows in case of externally visible transport damage E Note the extent of damage on the transport documents or the delivery note of the carrier E Notify Gonotec GmbH and initiate a complaint Q File a complaint about every defect as soon as it is de J tected Claims for damages can only be filed within ap plicable complaint deadlines 36 Version 1 02 04 24 2013 e ee 4 1 Packaging About the packaging Handling of packaging materials Symbols on packaging Fragile Protect from liquid OSMOMAT 3000 Delivery packaging and storage The package is packaged according to the expected transpor
20. AT 3000 gonralse Overview of the OSMOMAT 3000 EC Compliance Statement OSMOMAT 2000 109 Provisions of Certification rrrrrrrnnnrnrorrrnnnnnvrnrrnnnnnvnnnnnnn 109 elt e 110 Accessories and Replacement Parts cccccsseeeeeeeeees 110 Before Calling Gonoter nona0annnnnennnaannnnnnnnnennnnnnnnnnennnnni 111 Version 1 02 04 24 2013 7 OSMOMAT 3000 Overview of the OSMOMAT 3000 Gelee 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 89 23 2812 gonrnoler Please touch the buttons above OSMOMAT 3000 Fig 1 Device overview front 1 2 3 4 5 6 Touchscreen page 30 Upper cooling system behind movable elevator cover page 28 Thermistor probe with measuring vessel page 29 Lower cooling system amp page 29 Elevator Printer Option D 6 page 32 8 Version 1 02 04 24 2013 Gono se Device rear OSMOMAT 3000 Overview of the OSMOMAT 3000 Fig 2 Device overview rear 0O A O N Interfaces 6 page 33 Fine wire fuses On Off switch Power cord connection Fan outlet Version 1 02 04 24 2013 9 OSMOMAT 3000 Overview of the OSMOMAT 3000 Consumables ER o e 2 CT gonDiec CW Ge Calibration Standard il fim D 300 ce LI ip BEE 90 9 00 EZ lt mOsmol kg 20 NaCiH O
21. Ds are assigned manually During 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 Version 1 02 04 24 2013 63 OSMOMAT 3000 Operation one Set protocol port LOG PORT 1 Select the interface for data transfer to the PC Please select the desired log port To test the data transfer to the PC press Send Test String j USE SEND TEST STRING Settings 3600 baud 8 1 Fig 71 Set protocol port 64 Version 1 02 04 24 2013 OSMOMAT 3000 Ronnie Operation 7 6 Power down device Personnel User Safety gear M Disposable lab gloves 1 Power down device using on off switch on rear side fig 72 1 and disconnect power plug 2 Position a measuring vessel Fig 73 1 on the thermistor probe O The measuring vessel is securely attached to the J thermistor probe when it clicks into place Disinfect device if powered down for an extended period of time Wipe device using a wipe moistened with disinfectant Pull protective sleeve Fig 74 1 included with the delivery over device Fig 74 Device with protective sleeve Version 1 02 04 24 2013 65 OSMOMAT 3000 Troubleshooting 8 Troubleshooting 8 1 Safety notices Electrical current Risk of inf
22. 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 gt 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 fo
23. HE FOLLOWING APPLIES TO CONSUMER TRANSAC TIONS IN AUSTRALIA AND NEW ZEALAND THE CON DITIONS OF THIS WARRANTY STATEMENT NEITHER EXCLUDE LEGAL RIGHTS APPLICABLE TO THE SALE OF GONOTEC PRODUCTS TO SUCH CUSTOMERS NOR REPRESENT A RESTRICTION OR AMENDMENT OF SUCH RIGHTS BUT INSTEAD REPRESENT A SUP PLEMENT TO THESE RIGHTS EXCEPT TO THE EX TENT PERMISSIBLE UNDER THE LAW 108 Version 1 02 04 24 2013 OSMOMAT 3000 elelnel fare Appendix 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 Il list A or B of the Directive 98 79 EEC for in vitro diagnostics Compliance is declared per Annex Ill Number 6 of Annex Il is disregarded since the unit s intended use does not include personal use 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 2 1 2013 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 depar ture from the specifications or indep
24. IONING rrrrrnnnnrrvrrrnnnrrvevnrnnnnnvennnnnn 48 Measuring vessels NAC lg e 17 Measurements P 26 N Nameplate EE 102 Needle puncture injury rrrrrnnnrrvvrrnnnrrrvvrrnnnnnrennnnnn 15 O On Off switch rrnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 9 23 33 Operating conditions rrrrrrrnnnnnrrrrnnnnnrrnnrnnnnnre 99 DIT eege 18 Osmolality rrorrrrrrnnnrrrrranrrerrnnnnrrrnnnnrnnnnnnnnn 8 26 P AC AGING en 37 Handling of packaging materale 37 Symbols on Dackag1mg 37 Perform series measurement 52 Performance data 99 KE 9 a NEE 20 Power Up suverene 47 Sie 32 63 CONNECTION sree ei e E 33 Bd nl 86 Printer paper esennnnsnnnnsennrosnnnnsrnrrrnnrrnsrrerrnnrenne 84 Printer paper cnc suniesdaueaulesadininusuaxkicasenttaasniewadancdyn eas 32 R Remove install device front D nen 89 Replace microfuses 83 Replace printer ink cccccseeeeeesseeeeeeeeeees 86 Replace printer paper 84 Reproducibility rrrrrrnnnnrnrnrrnnnnnvrnrrnnnnsrnnnnnnnnnenn 17 Risk OM EON EE 15 Risks ED EE 16 Exposure to liquids and moisture sssseeeneeenn 16 Improper handling of calibration standard 17 Incorrect Measuring vessels ccccsseeeeeeeees 17 Iwer 0 6 EE meee ee 15 Insufficient air circulaton 16 Needle Puncture injury cccccseeeeeeeeseeeeeeeeeees 15 5 160 EE 17 SOCK PEER 16 S Safety gear n00nnnnnnaaannnneennnnnnennnnnnnrnrnensrn
25. User Guide OSMOMAT 3000 BENA eE Version 1 02 04 24 2013 Read User Guide before beginning any kind of work Gonotec GmbH GSG Hof Reuchlinstr 10 11 D 10553 Berlin Original Device Documentation Phone 030 7809 588 0 Fax 030 7809 588 88 E mail contact gonotec com Web http wWww gonotec com 2013 2 Version 1 02 04 24 2013 e se OSMOMAT 3000 Overview of the OSMOMAT 3000 A 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 s
26. 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 20 Version 1 02 04 24 2013
27. ate 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 lf 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 14 Version 1 02 04 24 2013 OSMOMAT 3000 DT ae Safety 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 A 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
28. ation needle rrerrnnnrrnvrnnnnnnrr 72 8 4 2 Replace the thermistor probe 0008 76 8 4 3 Replace fine wire fuses mmrrrrrnnnrrrnvvvnnnrnnnnn 83 8 4 4 Clean cooling camp 84 8 4 5 Replace printer paper Option D only 84 8 4 6 Replace printer ribbon Option D only 86 ORV GUNG E 88 9 1 Safety noiices ee cccccccssseeeecceeeseeeeeeeeeeeeessesaseeeeeeaas 88 9 1 Service table rrrrnrrrrrnnnnrrrnnnnrorrnnnnvvnnnnnrnnnnnnsennnnnnennnnn 89 9 2 Preliminary steps 89 9 3 Lubricate elevaior 94 9 4 Perform visual inspection of device eee 96 9 5 Check reproducibility of measurements 97 9 5 1 Sample test protocol measurement check 97 10 DEP E 98 11 SPE CINCAUOINS enc cesesurrtenecedsccseececesuencuseescersecteusadeneueaesaresesccseas 99 111 DESS 99 11 2 Performance parameters ccccseeeeeecseeeeeeseeeeeeaeeees 99 11 3 Operating conditions rrrrnnrrrnrrrnnnnnnnrvrrvvrrnnnnnnnsvennnn 99 11 4 Calibration standard 100 11 5 Connection ratings rrrrrrnnnnnvvrrrnnnnrvvvvrnnnnnvennnnnnnnnenn 100 11 6 Options 101 11 4 lune ciasan crease cscunesusteneinasnseatavdetantipasitecesiivanewedas 102 NE 103 elen Ve gt EE 106 Returning the device rrrrnnnnrrnnnnnnnnnvvnnrnnnnnrvnnnnnnnnsennnnnnsnnnnn 106 Limited Warranty roronrrnnnrrorrrnnnnnrovnnnnnnnrennrnnnnrrnnnrnnnsnsennnnnn 108 Classification of hel 109 6 Version 1 02 04 24 2013 OSMOM
29. calibration standard is performed auto matically Pay attention to the displays on the touchscreen 15 Move elevator up 16 Remove measuring vessel from thermistor probe Dispose of measuring vessel and sample according to local regu lations Fig 62 M l i j i Ji GA MOVE BIVALO GOWN 17 Clean thermistor probe Fig 62 1 using a soft paper towel NOTE Risk of carryover E Failure to clean the thermistor probe immedi ately following measurement can result in car ryover and incorrect measurement results 60 Version 1 02 04 24 2013 Ge EE Calibration ad Pass H of the calibration of Prepare the first standard was successful Zero Point ist Standard Now remove the vessel fill a new one with Sul of the nd Standard 100 mOsmoltkg standard solution Besdi mount it and lower the probe to continue with the next pass QUIT 2NO STANDARD Fig 63 Second calibration standard Calibration Check your calibration Prepare Zero Point Zera Point 1 Standard 2 Standard dst Standard znd Standard i Ready Use printer DISCARD Fig 64 Calibration results 19 20 OSMOMAT 3000 Operation For a 3 point calibration repeat steps 9 through 17 using an other calibration standard The calibration results Fig 64 display following successful calibration of the device The calculated osmolalities are mean values of the individual measurements This is the result of a 3 poin
30. cope 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 030 7809 588 0 Toll free support hotline 0800 7846027 Germany only Fax 030 7809 588 88 E mail contact gonotec com Web http www gonotec com Version 1 02 04 24 2013 3 OSMOMAT 3000 Overview of the OSMOMAT 3000 Gelee 4 Version 1 02 04 24 2013 e se Table of Contents OSMOMAT 3000 Overview of the OSMOMAT 3000 Tabie of Tan EE 5 1 Overview of the OSMOMAT 3000 c cccsssessseeeeeeeeeseees 8 2 SUN E 12 2 1 Explanation of svmbole cccccccccsseeeeeeeeseeeeeeeeeeaeees 12 2 2 Intended use 14 2 3 Additional hazards rerrrnnrrorrnnrrorrnnnnerrnnnnnonnnnnnennnnnne 14 2 3 1 Hazards due to electrical current 14 2 3 2 Risk of INFECTION rrarrrnnnronrnnnrrnnnnennnnnnnnnnene 15 2 3 3 RISKO MU EE 15 2 3 4 Risks of device damage sseesssneeeneeneeen 16 2 3 5 Reproducibility of the measurement 17 2 4 Operator responsibilities rrrrrrrnnnnnrrrrrrnnnnnnnrrrrnnnnnnn 18 2 5 Personnel reourements 20 2 6 Personal safety dear 21 2 7 Environmental protection ccccccseeeeeeeeeeeeeeeeeeeeeees 21 3 Design and RT e D 22 3 1 Device Oovervlew 22 3 2 Measuring method basics n00annnenoaannnnneannnnneennnee 26 3 3 Measurement eogupmenmt 27
31. e disin fectant cleaning and sterilization procedures Contact with the thermistor probe and initiation 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 discon nect power plug Remove elevator cover To protect thermistor cover thermistor probe with a measuring vessel The cover of the measuring vessel must point forward i NOTE Risk of thermistor damage due to loose position of measuring vessel Resistance is felt when sliding on measuring vessel When the measuring vessel clicks into place it is securely positioned on the thermistor probe Fig 85 Position measuring vessel 76 Version 1 02 04 24 2013 Fig 89 Remove elevator cover 3 4 5 OSMOMAT 3000 Troubleshooting Move elevator down using handle fig 86 1 Move elevator cover fig 87 1 up Remove the 2 mounting screws fig 88 2 using Allen key SW 2 6 Remove the complete elevator cover fig 89 1 PN Version 1 02 04 24 2013 77 OSMOMAT 3000 Troubleshooting elena 7 Pull connector of thermistor probe fig 90 1 Fig 90 Pull connector Move elevator up and remove the 2 mounting screws fig 91 1 using Allen key SW 2 Remove thermistor probe with mounting plate toward the front fig 92 while holding guide tube of init
32. ea underneath the initiation needle 66 Version 1 02 04 24 2013 OSMOMAT 3000 Gonna Troubleshooting 8 2 Notes regarding errors In case of errors that cannot be resolved using the error table on page 68 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 electron ics components of the device can be damaged E Power down device again 3 Note down the serial number of the device To find the serial number select Start menu gt Info 4 Have the device documentation available Contact info Gonotec GmbH GSG Hof Reuchlinstr 10 11 D 10553 Berlin SYSTEM INFO Phone 030 7809 588 0 Fax 030 7809 588 88 E mail contact gonotec com Web http www gonotec com gqanaler Fig 75 Contact Gonotec Version 1 02 04 24 2013 67 OSMOMAT 3000 Troubleshooting 8 3 Error table Error description Elevator gets stuck or makes squeaking noises when lowered Lower cooling system does not cool sample Gear motor of initia tion needle turns without stopping or does not turn one full revolution No or poor ice crystal formation in upper cooling system pono e touchscreen Possible Cause Mechanical wear Blockage from foreign objects Mechanical wear Fan is defective or
33. ection Risk of injury A pono DANGER Risk of death due to electrical current on device 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 lf the insulation is damaged immediately switch off the voltage supply 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 Ensure easy access to the power socket at all times Keep energized parts away from liquids Otherwise shorts may occur WARNING Risk of injury due to sample residue and in case of inadequate hygiene disinfectant cleaning and steri lization 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 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 ar
34. ects the measurement accuracy of the device Always observe the stability of the calibration stand ards 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 10 Select the calibration standard using the lt lt and gt gt arrow Please select the keys first standard solution Calibration Prepare Zero Point be ist Standard 100 m Osmolkg end Standard Ready Then fill a new vessel with Gul of this solution mount it and pull down the probe again Fig 59 Select calibration standard 11 WARNING Risk of injury at ampoule breaking points Use the ampoule opener fig 60 2 to open the ampoules con taining the calibration standards fig 60 1 Fig 60 Open ampoule Version 1 02 04 24 2013 59 OSMOMAT 3000 Operation geneler 12 Pipette a calibration standard volume of 50ul into an unused measuring vessel fig 61 NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted without air bubbles 13 Position Measuring vessel on thermistor probe with cover facing front O The measuring vessel is securely attached to the J thermistor probe when it clicks into place 14 Move elevator Fig 62 1 down gt Calibration starts automatically Calibration using the
35. ed personnel perform repair and maintenance work on the device lf 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 Ensure easy access to the power socket at all times Keep energized parts away from liquids Otherwise shorts may occur 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 46 Version 1 02 04 24 2013 OSMOMAT 3000 Ronnie Operation 7 1 Power up device Personnel User Safety gear M Disposable lab gloves 1 Power up device on rear side using on off switch fig 31 1 Fig 31 Power up device Version 1 02 04 24 2013 47 OSMOMAT 3000 Operation geneler 7 2 Measure individual samples Personnel User Safety gear M Disposable lab gloves Materials Soft paper towel E Pipette E Measuring vessel Sample NOTE Risk of non reproducibility of measurement due to incorrect measuring vessels Repeated use of the measuring vessels and use
36. elative humidity Maximal operating altitude Specification Value Unit 10 35 C 10 90 non condensing 2000 m Value Unit Version 1 02 04 24 2013 99 OSMOMAT 3000 Specifications 11 4 Calibration standard Calibration standard 300 mOs mol kg Properties Storage and shelf life 11 5 Connection ratings Electrical Useful life Composition Sodium chloride Water for injection purposes as bulk Specifications Container Poison class Water hazard class Disposal Specifications Storage class Temperature range Stability at 22 C ambient temperature Shelf life Specification Gonos 10 Years Value 9 463 kg ad 1000 Value Clear glass OPC ampoules F 1 According to good lab practice GLP national regulations Value 10 13 5 C 45 C 0 5 hours Listed on packag ing Value Unit 100 Version 1 02 04 24 2013 GEET Interfaces 11 6 Options Printer D Barcode BC Power cord Power connection Frequency Power consumption max Fuse HBC 1500A Memory Backup UL MH 13654 N Protection class Protection type Degree of contamination Specification Serial port Specification Printer Number of digits Paper Print modes Specification Barcode reader OSMOMAT 3000 Specifications Detachable power sup ply cable 100 240 VAC 50 60 Hz 80 VA T10 A 10 years useful life IP21
37. endent 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 trans fer responsibility to the originator of said actions Version 1 02 04 24 2013 109 OSMOMAT 3000 Gonos Appendix Consumables Item no Item 9 30 0010 Measuring vessel for OSMOMAT 3000 9 30 0020 Calibration standard 300 mOsmol kg ampoules of 1ml each 9 30 0100 Calibration standard 100 mOsmol kg ampoules of 1ml each 9 30 0290 a solution OSMOREF 290 mOsmol kg ampoules of 1ml 9 30 0500 Calibration standard 500 mOsmol kg ampoules of 1ml each 9 30 0850 Calibration standard 850 mOsmol kg ampoules of 1ml each 9 30 2000 Calibration standard 2000 mOsmol kg ampoules of 1ml each 9 30 1010 Printer paper roll for OSMOMAT 3000 D 9 30 1020 Continuous loop ribbon cartridge for OSMOMAT 3000 D Accessories and Replacement Parts ltem no 32 3 0010 32 3 2010 9 30 0030 6 30 0020 9 20 0165 9 20 0166 30 2 0030 9 20 0100 00 9 0106 Item Thermistor probe for OSMOMAT 3000 50ul sample volume Thermistor probe for OSMOMAT 3000 M 15pul sample volume Blow out device Initiation needle Data cable for RS 232 interface OSMOMAT 3000 USB cable Adjustment tool Power cord 2 meters Package with fine wire fuses 1 0 A Lag 230V Pc VE 1 000 10 10 10 10 10 10 Pc 110 Version 1 02 04 24 2013 OSMOMAT 3000 elelnel fare Appendix
38. erruptions 3 Gonotec s limited warranty applies only to defects that arise during normal operation of the product It does not apply under the following conditions a Inadequate servicing or improper modification b Use of software interfaces print media or accessories not supported or supplied by Gonotec or c Use of the equipment in a manner not covered by the product specifications 4 For Gonotec osmometers the use of measuring vessels of manufacturers other than those of the measuring ves sels supplied by Gonotec does not void the customer s warranty claims or any customer support contracts be tween Gonotec and the customer If however the use of measuring vessels from third party providers or the cleaning of recycled measuring vessels results in malfunctions or damage to the osmometer or thermistor probe Gonotec shall assess the normal fees for the time and material required to repair such malfunc tions or damage 5 If Gonotec is notified within the warranty period of a defect in a software product in media or in a thermistor probe and if the Gonotec warranty applies to the defect Gonotec shall replace the defective product If Gonotec is notified within the warranty period of a defect in a hard ware product and if the Gonotec warranty applies to the defect Gonotec shall repair or replace the defective prod uct at its discretion 6 If Gonotec is unable to repair or replace a defective product to which the G
39. etup Select calibration standards 10 Specify the allowed calibration points Unit mOsmol kg They CALIBRATION STANDARDS should be close to the expected measurement values Please select the available Calibration Standards fmOsmoltkg 100 700 See SH Ge 2508 00 1206 500 1806 Fig 29 Select calibration standards Set up calibration method OA PRESET Select the calibration method Set up your minimum QA requirements E 2 Point Select 2 point calibration Measure points required ae aoe E 2 ia j j j Geet 3 Point 3 Point Select 3 point calibration Select the number of measurements to be performed for each calibration medium distilled water and calibration standard The system calculates the calibration points from the mean value of these measurements PE EE O The number of measurements for each calibration Jl point does not affect the linearity or reproducibility of the measurement system They are only used to arrive at the mean value i IL Passes for each measure D point in a calibration Version 1 02 04 24 2013 45 OSMOMAT 3000 Operation 7 Operation Electrical current Risk of infection A A pono DANGER Risk of death due to electrical current on device 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 qualifi
40. freezing point constant the device determines the osmolality of the sample The value is shown on the touchscreen NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted without air bubbles Version 1 02 04 24 2013 27 OSMOMAT 3000 Design and function Upper cooling system Fig 10 Upper cooling system 1 Initiation needle 2 Cooling nipple The initiation needle fig 10 1 of the upper cooling system inocu lates the sample with ice crystals crystallization This causes the sample to freeze and heat up to its freezing point WARNING Risk of infection from sample residue The initiation needle is immersed into the sample during measurements Contact with the initiation needle in creases the risk of infection Wear lab gloves during any kind of work 28 Version 1 02 04 24 2013 OSMOMAT 3000 DT e Design and function Thermistor probe 1 Thermistor probe 2 Thermistor The thermistor probe fig 11 1 measures the current temperature of the sample via the thermistor fig 11 2 After crystallization has been triggered the thermistor probe measures the freezing point of the sample i NOTE p Sensitive component The thermistor of the thermistor probe is a sensitive component and must be protected from external influ ences such as dust or friction Fig 11 Thermistor probe When performing any kind of work on the de
41. g 96 Proceed as follows Push thermistor probe just beyond adjustment tool Position thermistor probe on its XYZ axis so that thermistor is perpendicular to center of hole of adjustment tool Fig 97 Fig 98 Tighten the 2 mounting screws on the aligned thermistor probe Fig 96 Align the thermistor probe Thermistor Z axis 1 Mounting screws Adjustment lower cooling sys Fig 97 Thermistor probe Z axis Fig 98 Thermistor probe XY axis Install elevator cover 80 Version 1 02 04 24 2013 OSMOMAT 3000 Troubleshooting wv MI ENS SI wer Fig 99 Elevator cover with correct cable routing d 1 Cable V Correct cable routing 2 Cable guide on thermistor probe AC Incorrect cable routing 20 NOTE e Risk of cable break Place cable fig 99 1 on thermistor probe in cable guide fig 99 2 and install elevator cover on device Bolt elevator cover to elevator using the 2 mounting screws fig 100 1 gt The thermistor probe is now installed Fig 100 Remove mounting screws Version 1 02 04 24 2013 81 OSMOMAT 3000 Troubleshooting Clean cooling nipple Fig 101 Clean cooling nipple MANUALLY SET NTC Select a calibration value to change Probe Thermistor NTCpc 2000 sot 15 00 5176 000 10 45000 GJ 2242300 Change MTC to the values shipped with the new thermistor The press OK and do calibration Fig 102 Calibrate thermistor probe G
42. g a knife 2 Remove device from packaging and place in a suitable location 3 Keep packaging for possible later return Version 1 02 04 24 2013 39 OSMOMAT 3000 Installation DEI 5 Installation 5 1 Transport device inside lab Personnel User Safety gear M Disposable lab gloves 1 Power down device using on off switch on rear side and discon nect power plug 2 Position a measuring vessel fig 18 1 on the thermistor probe O The measuring vessel is securely attached to the It thermistor probe when it clicks into place 3 Tilt transport safety device for thermistor probe and carefully slide behind the thermistor probe fig 19 4 Pull protective sleeve fig 20 1 included with the delivery over device 5 Lift up device 6 5kg and carry to installation site Fig 20 Device with protective sleeve 40 Version 1 02 04 24 2013 OSMOMAT 3000 GIS lee Installation 5 2 Install device Personnel amp User Safety gear M Disposable lab gloves 1 i NOTE p 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 i no strong air flows free of dust and dirt Fig 21 Fan outlet 1 Keep fan outlet fig 21 1 clear Keep fan outlet openings underneath device clear
43. gt ple ID automatically page 63 50 Version 1 02 04 24 2013 Fig 40 Move elevator down Measurement Measurement result Measure 1 OSM3000 Use printer RESULT Jevice 1234 QuIT NEXT SAMPLE Date Time 81714213 83 39 No Time mOsmol kg Sample 1 2 05 06 337 6 B Fig 41 Measurement result Fig 42 Clean thermistor probe OSMOMAT 3000 Operation 10 Move elevator Fig 40 1 down Moving the elevator up during the measurement will abort the measurement gt The sample measurement is performed automatically Pay attention to the displays on the touchscreen The measurement result displays on the touchscreen Fig 41 1 and if applicable prints Fig 41 2 Option D Reproducibility II lt 2 digits in the measurement range 0 400 mOsmol kg lt 0 5 in the measurement range 400 1500 mOsmol kg lt 1 0 starting with 1500 mOsmol kg 11 Move elevator up Moving the elevator up during the measurement will abort the measurement 12 Remove measuring vessel from thermistor probe Dispose of measuring vessel and sample according to local regu lations 13 Clean thermistor probe Fig 42 1 using a soft paper towel NOTE Risk of carryover E Failure to clean the thermistor probe immedi ately following measurement can result in car ryover and incorrect measurement results Version 1 02 04 24 2013 51 OSMOMAT 3000 Operation geneler
44. he touchscreen Fig 57 Move elevator down DES Move elevator up peaked 2 Durchlauf der Nullpunkt kalibrierung war erfolgreich Remove measuring vessel from thermistor probe _ Nun das Messgef R entfernen 1 Standard ein neues mit S ul dest Dispose of measuring vessel and sample according to local regu 2 Standard Wasser f llen und die Sonde lations Vorbereiten B Nullpunkt dp hinunter fGhren um mit dem Fertig n chsten Durchlauf fortzufahren Clean thermistor probe Fig 53 1 using a soft paper towel ve R Risk of carryover Fig 58 Calibrate device using calibration Failure to clean the thermistor probe immedi standard ately following measurement can result in car ryover and incorrect measurement results 9 Following successful zero point measurement tap 7 Standard to start calibration using the first calibration standard O Successful calibration means that it was possible to Jl 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 amp page 97 58 Version 1 02 04 24 2013 OSMOMAT 3000 FEnlslee Operation Calibrate device using calibration l 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 aff
45. ht fig 80 3 Shorten initiation needle to correct length Proceed as follows Version 1 02 04 24 2013 73 OSMOMAT 3000 Troubleshooting jonas Align gear motor swipe vertically with upper dead center fig 81 1 gt The set screw of the gear motor swipe points down Move initiation needle through guide tube in upper cooling system fig 81 2 onto cooling nipple fig 81 3 Bolt new initiation needle to gear motor disk Align initiation needle with gear motor swipe and cooling nipple The needle end should be located approx 2mm below the lower edge of the cooling nipple d 2mm Fig 81 8 If the needle is too long use a permanent marker to mark the correct length and remove the needle bar again Trim excess wire using side cutters and debur needle tip using precision key file Fig 82 Install initiation needle 1 Mounting screw 2 Washer 3 Fastening tube 4 Initiation needle 5 Washer 6 Guide tube 74 Version 1 02 04 24 2013 e EE 14 15 Check free movement of initiation needle Fig 83 Check free movement of initiation needle ADJUST NEEDLE 20 WARNING NEEDLE WILL MOWE DOWN IF YOU PRESS THE BUTTON BE CAREFUL NOT TO HARM ONESELF MOWE MEEOLE GUIT Fig 84 Move needle OSMOMAT 3000 Troubleshooting Fit initiation needle to gear motor disk Assemble fasteners as fol lows 1 Push washer fig 82 2 and fastening tube 3 onto mou
46. iation needle fig 92 1 in place If necessary clean cooling nipple Fig 92 Remove thermistor probe 78 Version 1 02 04 24 2013 OSMOMAT 3000 joanna Troubleshooting 11 Use Allen key SW 2 to remove thermistor probe from mounting plate fig 93 Fig 93 Remove mounting plate 1 Mounting plate 2 Mounting screws Fit new thermistor probe to mounting plate fig 93 Keep the data sheet affixed to the thermistor probe fig 94 2 in the vicinity of the device To protect thermistor cover thermistor probe with a measuring vessel fig 94 1 The cover of the measuring vessel must point forward i NOTE p Risk of thermistor damage due to loose position Fig 94 New thermistor probe with data of measuring vessel sheet Resistance is felt when sliding on measuring vessel When the measuring vessel clicks into place it is securely positioned on the thermistor probe 13 Push guide tube onto initiation needle and pass needle through stainless steel tube of mounting plate fig 92 Version 1 02 04 24 2013 79 OSMOMAT 3000 Troubleshooting geneler Align the thermistor probe 14 Tighten the 2 mounting screws only lightly The thermistor probe must be aligned using the adjustment tool Install adjustment tool Fig 95 1 in opening of lower cooling sys tem using tweezers Remove measuring vessel from thermistor probe Fig 95 Install adjustment tool Align thermistor probe Fi
47. icing geneler 10 Remove device front panel by pulling forward fig 125 The de vice front panel is secured to the housing by magnets i NOTE p Risk of damage to cables and connectors 11 Carefully place device front panel on its right side fig 126 gt The device front panel is now removed Fig 126 Device front panel open 92 Version 1 02 04 24 2013 OSMOMAT 3000 joanna Servicing Install device front panel Personnel Service technician Safety gear M Disposable lab gloves Materials E Allen key SW 2 Install device front panel on device and push into place fig 127 Pull out printer from device using handle Install printer cover on printer and push down gt The printer cover is now secured Push printer back into device Fig 128 Elevator cover with correct cable routing 1 Cable V Correct cable routing 2 Cable guide on thermistor probe AC Incorrect cable routing 5 NOTE p Risk of cable break Route cables on thermistor probe through cable guide fig 128 2 and install elevator cover on device Pay attention to correct cable routing Version 1 02 04 24 2013 93 OSMOMAT 3000 Servicing elena 6 Bolt elevator cover to elevator using the 2 mounting screws fig 129 1 gt The device front panel is now installed Fig 129 Tighten mounting screws 9 3 Lubricate elevator Personnel User Safety gear M Disposable lab gloves Materials E Silicone spray
48. ion interval is defined by the lab super visor QUIT CALIBRATE gt The device is ready Fig 35 Calibrate device Preparation 5 Tap Measure Fig 36 Ready to Measure wv Produce Ice Calibration Let bereter E The measu rement menu opens i Ready Today CALIBRATE QUIT MEASURE Fig 36 Device is ready for measurement Version 1 02 04 24 2013 49 OSMOMAT 3000 Operation geneler 6 Pipette a sample volume of 50ul into an unused and clean meas uring vessel Fig 37 NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted without air bubbles 7 Position measuring vessel on thermistor probe with cover facing front Fig 38 1 The measuring vessel is securely attached to the thermistor probe when it clicks into place Fig 38 Position measuring vessel Option D only Measurement Please fill in SOl of the sample Prepare into the measuring vessel Tap Printer On on the measurement menu Fig 39 1 to output D Ties eee te ee ee Se the measurement results to a printer Make sure that the printer is GEI y ui own the probe atterwardas P ready Measure To start the measurement tap Single Sample Fig 39 2 2 If necessary enter the sample ID using the virtual keyboard Fig 39 Measurement menu The sample ID can be pre defined in the user pref erences In this case the system assigns the sam
49. ion needle Personnel Service technician Safety gear M Disposable lab gloves Materials E Allen key SW 2 5 Precision key file Wire cutter WARNING Risk of infection from sample residue The initiation needle is immersed into the sample during measurements Contact with the initiation needle in creases the risk of infection Wear lab gloves during any kind of work DANGER Risk of death due to electrical current Power down device using on off switch on rear side and discon nect power plug Remove device front panel on page 89 Fig 76 Position of initiation needle and details 1 Initiation needle 72 Version 1 02 04 24 2013 Fig 78 Remove initiation needle OSMOMAT 3000 Troubleshooting Remove mounting screw fig 77 1 of initiation needle while hold ing initiation needle in place C The mounting screw has a coating of locking paint II O Loose washer between initiation needle and J gear motor disk Remove initiation needle from gear motor disk Hold washer fig 78 1 of mounting screw in place Fig 79 Initiation needle components 5 Fig 80 Straighten initiation needle Remove guide tube fig 79 1 and fasteners fig 79 3 of initiation needle fig 79 2 Make sure that the new initiation needle is as straight as possible fig 80 1 2 1 Incorrect orientation 2 Correct orientation If necessary bend initiation needle so it is straig
50. ly 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 12 Version 1 02 04 24 2013 e ee Special safety notices Safety notices in instructions Additional identifiers OSMOMAT 3000 Safety 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 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 CAUTION Pinch hazard on cover Use care when closing cover 2 3 Tighten screw To highlight instructions results lists references and other elements the following identifiers are used in this manual Identification Explanation Step by step instruction
51. mables 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 56 Version 1 02 04 24 2013 OSMOMAT 3000 Operation 1 Clean thermistor probe fig 53 1 using a soft paper towel ae 2 Follow the instructions on the touchscreen eae Pass HZ of the zero point Frepare Zero Point jst Standard calibration was successful Mow remove the wessel fill a new one with Sopl of 2nd Standard distilled water and lower the probe Ready to continue with the next pass QUIT 15T STANDARD Fig 54 Perform zero point calibration 3 Pipette a distilled water volume of 50ul into an unused and clean measuring vessel Fig 55 NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted without air bubbles 4 Position measuring vessel on thermistor probe with cover facing front Fig 56 1 The measuring vessel is securely attached to the thermistor probe when it clicks into place Fig 56 Position measuring vessel Version 1 02 04 24 2013 57 OSMOMAT 3000 Operation geneler Perform zero point calibration Move elevator Fig 57 1 down gt Zero point calibration starts automatically Zero point calibration is performed automatically Pay atten tion to the displays on t
52. neeenne 21 Samples VW 48 Series measurement rrrrnrannnnnnnnnnonrnnnnrnnnnnnnen 52 Scrapping Re 98 Separation elt e 98 SLT go AT 51 EE 43 SLA EEE 3 Service table E EA AE E 89 OCK ER 16 Giorage i ee eee 39 Symbols IN this manual 12 104 Version 1 02 04 24 2013 GEET T Temperature sensor Replace nonnnnnnnnnnnannnnennnonnnnesrnrnrsnnensrnrrrnnnennnnnne 76 TREMIS TO EE 29 thermistor pDrobe 29 Touchscreen rarnnnnnnnnnnnnnnnnnnnnnnvnnnnnnnnnnvnenennsnn 8 30 Enter values rrrrnnnnrnnnnnonnnnrnnnnnennannennnnrnnnnnnnnn 31 Operation RE 30 OSMOMAT 3000 Transport INSPECTION rrrrnnnnnrerrnnnnrrvnnnnrennnnenennnnn 36 U Upper cooling system 008 8 22 28 User preferences ccccccceccccssseceeseseeeeseeeeeesaaeeees 62 Z Zero point Calibration rrrrrnnnrrrrnnnrrrrrnnnnrnnnnn 56 Version 1 02 04 24 2013 105 OSMOMAT 3000 Appendix Appendix Returning the device Fig 136 Position measuring vessel LAB OPTIONS REPLACE PROBE ADJUST NEEDLE TIME ODATE CHANGE LAB PIM CAL PERIOD CAL STANDARDS SAFE TRAMSPORT QA PRESET BACK Fig 137 Lab Option menu Gonos When returning the device for repairs or a refund please note the following Personnel User Safety gear M 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 o
53. ng vessel fits too loosely on ther mistor probe No crystallization see also No or poor ice crystal formation in upper cooling sys tem Fan malfunction Fan makes loud noise Continuous audible warning signal Fine wire fuses trip when powering up device centered Incorrect measuring vessel used Measuring vessel re used Measuring vessel not positioned correctly Thermistor probe dam aged Initiation needle too long or too short Initiation needle not deburred Initiation needle bent Initiation needle does not move Initiation needle disen gaged from gear motor or stuck Fan is obstructed Fan is defective Fan is obstructed Needle bar disengaged from gear motor or stuck Gear motor slider misa ligned Device voltage does not match power grid volt age gorelse Only use measuring vessels sup plied by Gonotec GmbH Position measuring vessel with cov er facing forward When the measuring vessel clicks into place it is securely positioned on the thermistor probe Replace thermistor probe page 76 Adjust initiation needle to correct length page 74 Debur initiation needle using fine sandpaper Manually bend initiation needle so that it is vertical replace if necessary page 73 Verify free movement of initiation needle 6 page 75 Check if fan is operational and re move any foreign objects Replace fan 6 service manual Check if fan is o
54. nnennenrenesennnnee 24 Cryst needle AOUS EE 72 Free MOVEment rrannrnnannnnnnnrnnnnnennannennansnnnnnsnnnn 72 HENIE EE 72 Customer Service 3 D Delivery condition annnnnnnnnnnvnnnnnnennnnnnrnnnnnnnennnnnne 36 OSMOMAT 3000 Index Device Go EE 56 ME 42 PES 98 ae EE EE 41 In vitro diagnostic product rrrrnnnnnnrrnnnnnnnnnnnnnnn 8 OE Eegeregie AE ebe dE egeegteet 8 22 OW GY EE 47 Reproducibility rrrnrrnnnrrrorrrnnnnnrrnnnnnnnnennnnnnnnne 99 Sensitivity and peche 99 SJ 0 ee ne re a eke ene 43 Fran ee Te 40 UP EE 39 Visual mspechon 96 Dimensions 99 Disposal EE 98 E Electrical current ccccseeeeeeeeeeeeeeeees 14 46 66 88 Elevator aeenenennnnnnnnnnnenrnenenrnenenere nnne 8 22 DNC SEE 94 Enter values rrrnnrrrnnnnnnrnvnnnnvnnrnnnsvnvnnnnrnnnnnnsnnnnnnee 31 Environmental protection Electronic components ranrrrnrnnnnrvrnnnrrenvnnnnennnnn 21 Sodium bicarbonate rrrrrrnnnrnvrnrrnnnnnrrnnnnnnnnrenn 21 Emor able EE 68 ED 16 Exposure to liquids and moisture n0000nee000an 16 F Fu 16 Freezing point depnression 26 Version 1 02 04 24 2013 103 OSMOMAT 3000 H Hazards Electrical curment 14 46 66 88 Incorrect measurements 0cceceeeeeeeeeeees 17 Intended use 14 Inventory EE 19 L Lower cooling evstem 8 22 29 M Manufacturer address arararnrnnnnrnrnrnavnrnrnrnnnnrnensnsne 3 Measuring vessel Correct POSIT
55. nting screw fig 82 1 2 Push mounting screw with washer and fastening screw through head of initiation needle fig 82 4 3 Secure washer fig 82 5 to mounting screw 4 Push guide tube fig 82 6 onto initiation needle Secure initiation needle to gear motor disk fig 77 using mount ing screw fig 82 1 Turn gear motor disk with attached initiation needle clockwise to check initiation needle for free movement If needle gets jammed detach needle and check if it is bent Fig Fig 80 Install device front panel on page 93 Power up device on rear side using on off switch Verify free movement of initiation needle automatically Open the menu for adjusting the initiation needle Settings gt Lab Options gt Adjust Needle CAUTION Risk of injury from initiation needle The tip of the initiation needle is exposed Movement of the initiation needle can cause needle puncture injuries Always keep your hands and fingers clear from the area underneath the initiation needle Tap Move Needle to test the free movement The initiation needle turns by one revolution Tap Quit to exit the menu Version 1 02 04 24 2013 75 OSMOMAT 3000 Troubleshooting geneler 8 4 2 Replace the thermistor probe Personnel Service technician Safety gear M Disposable lab gloves Materials E Allen key SW 2 Adjustment tool E Tweezers WARNING Risk of injury in case of inadequate hygien
56. of in correct consumables cannot guarantee reproducible measurement results Always use aclean and unused measuring vessel for every measurement Only use measuring vessels supplied by Gonotec GmbH Never use centrifugal measuring vessels NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample Q zp E The sample must be pipetted without air bubbles 1 Clean thermistor probe fig 32 1 using a soft paper towel Fig 32 Clean thermistor probe 48 Version 1 02 04 24 2013 OSMOMAT 3000 ono Operation 142012 0226 AM 2 Tap Measure on the Start menu Fig 33 gt If the operating time of the device is less than 3 minutes the menu for ice formation is displayed IMFO MEASURE SETTINGS Please touch the buttons above Fig 33 Start menu 3 Wait until ice forms on the initiation needle Fig 34 ae Producing Ice yt Calibration ee gt After successful ice formation the menu for calibration or the Ready there is enough ice measurement menu is displayed depending on the config at the injection needle i i a ured calibration interval WW SKIF QUIT Fig 34 Ice formation l 4 If necessary calibrate device Fig 35 pr Need calibration d Produce Ice amp chapter 7 4 Calibrate device on page 56 Calibration Please do a calibration Ready before any measurement Calibration cannot be canceled The calibrat
57. oling clamp Gono se Personnel amp Service technician Safety gear M Disposable lab gloves Materials E Fine sandpaper 1 Power down device on rear side using on off switch 2 Remove device front panel on page 89 Clean cooling clamp fig 106 1 on lower cooling system using sandpaper Install device front panel on page 93 8 4 5 Replace printer paper Option D only Fig 107 Printer pulled out 1 Paper roll 2 Ribbon Personnel User Safety gear M Disposable lab gloves Materials m 1 Paper roll 1 Power down device on rear side using on off switch 84 Version 1 02 04 24 2013 OSMOMAT 3000 Troubleshooting Pull out printer fig 108 1 Turn knurled screw fig 109 1 counter clockwise Remove empty paper roll from holder and dispose Fig 109 Turn knurled screw Cut off beginning of new paper roll fig 110 1 and push onto holder Pay attention to correct feed direction of paper fig 110 2 Position knurled screw fig 109 1 and tighten by turning clock wise Power up device on rear side using on off switch Fig 110 Install paper roll Version 1 02 04 24 2013 85 OSMOMAT 3000 Troubleshooting geneler PRINTER 8 On the Start menu select Settings gt Printer Press and hold the PAPER FEED Tap Paper Feed button to feed paper PAPER FEED Fig 111 Activate paper feed The paper feed of the printer is activated briefly Fig 112 Tap
58. ono ee Clean cooling nipple fig 101 1 using a fiberglass pin For this purpose move elevator cover up Power up device on rear side using on off switch Calibrate the new thermistor probe For this purpose open the Replace Probe menu Start menu gt Settings gt Lab Options gt Replace Probe Copy the values from the included data sheet to the fields and tap OK gt The system starts the device calibration Calibrate the device page 56 82 Version 1 02 04 24 2013 OSMOMAT 3000 ono Troubleshooting 8 4 3 Replace fine wire fuses Safety gear M Disposable lab gloves Materials E Flat blade screwdriver E Fine wire fuses 1A DANGER Risk of death due to electrical current 1 Power down device using on off switch on rear side and discon nect power plug 2 Open cover fig 103 1 using a flat blade screwdriver 3 Remove fine wire fuse attachment Fig 103 Open fine wire fuse cover 4 Remove fine wire fuses fig 104 1 from attachment NOTE p Risk of property damage The unit has two phase protection Use only the fol lowing fuses HBC fuses with a switching capacity of 1500A Fig 104 Remove fine wire fuses 5 Push the fine wire fuses included with the delivery into the at tachment fig 105 Fig 105 Install fine wire fuses Version 1 02 04 24 2013 83 OSMOMAT 3000 Troubleshooting 8 4 4 Clean cooling clamp Fig 106 Clean co
59. onotec warranty applies Gonotec shall refund the purchase price of the product within a reasonable period following notification of the respective defect 7 Gonotec is not obligated to repair or replace a product or refund its purchase price until the customer returns the defective product to Gonotec 8 Replacement products may be new or almost new as long as their functionality is at least that of the replaced product 9 The Gonotec limited warranty is applicable in all countries in which Gonotec sells the applicable product The follow ing countries and regions are exceptions All countries outside the EU In these countries the warranty is only valid in the country in which the product was purchased Contracts for additional warranty services such as on site service may be available from an authorized Gonotec sales partner mmh D Gonos Limitation of the Warranty TO THE EXTENT PERMISSIBLE UNDER THE APPLICA BLE LOCAL LAWS NEITHER GONOTEC NOR ITS SUP PLIERS SHALL ASSUME ANY ADDITIONAL WARRANTY SERVICES OR ACCEPT ANY OTHER CONDITIONS EXPRESS OR IMPLIED WITH REGARD TO THE GONOTEC PRODUCTS Limitations of Liability To the extent permissible under the applicable local laws the legal remedies named here shall be the sole and ex clusive legal remedies available to the customer TO THE EXTENT PERMISSIBLE UNDER THE APPLICA BLE LOCAL LAWS AND WITH THE EXCEPTION OF THE OBLIGATIONS EXPRESSLY NAMED
60. ooling system not aligned correctly Incorrect measuring vessel used Measuring vessel re used Measuring vessel not positioned correctly Thermistor probe defec tive Thermistor probe not OSMOMAT 3000 Troubleshooting Align initiation needle page 73 Correct length of initiation needle page 74 Check if light barrier is located properly and replace if necessary service manual Tighten gear motor disk Clean cooling nipple using a fiber glass pin page 96 Check if fan is operational and re move any foreign objects Replace fan 6 service manual Replace lower cooling system service manual Use sample according to perfor mance data of device page 14 Align thermistor probe page 80 Leave the elevator in the lowered position during the measurement procedure Align lower cooling system service manual Only use measuring vessels of the correct type supplied by Gonotec GmbH Use measuring vessels only once Position measuring vessel with cov er pointing forward When the measuring vessel clicks into place it is securely positioned on the thermistor probe Replace thermistor probe page 76 Align thermistor probe page 80 Service technician User Service technician User Service technician User Service technician User User User Service technician Version 1 02 04 24 2013 69 OSMOMAT 3000 Troubleshooting Measuri
61. ork 7 Tilt transport safety device for thermistor probe and carefully slide behind the thermistor probe Fig 139 8 Pull protective sleeve Fig 140 1 included with the delivery over device 9 Enclose written information explaining the reason for returning the equip ment 10 If the equipment is being returned for credit you must include all accesso ries 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 O During repairs we will provide you with a temporary unit Il at no cost Transport costs are only incurred outside the warranty period Version 1 02 04 24 2013 107 OSMOMAT 3000 Appendix Limited Warranty Duration of Gonotec product Limited Warranty Software 90 days Thermistor probe 180 days Osmometer 2 years A Extension of the Limited Warranty Gonotec guarantees the end user that Gonotec products shall be free from manufacturing and material defects for the above periods of validity from the purchase date The end user must provide proof of the purchase date 2 For software products Gonotec s limited warranty applies only to the non execution of programming instructions Gonotec does not guarantee that the operation of a prod uct will proceed without errors or int
62. out air bubbles e 10 Position measuring vessel on thermistor probe with cover facing front Fig 50 1 C The measuring vessel is securely attached to the J thermistor probe when it clicks into place 11 Move elevator Fig 51 1 down O Moving the elevator up during the measurement will J abort the measurement gt The sample measurement is performed automatically Pay attention to the displays on the touchscreen The touchscreen shows the measurement result for the cur rent sample Fig 51 Move elevator down gt Option D The measurement result prints O Reproducibility II lt 2 digits in the measurement range 0 400 mOsmol kg lt 0 5 in the measurement range 400 1500 mOsmol kg lt 1 0 starting with 1500 mOsmol kg 54 Version 1 02 04 24 2013 Fig 52 Clean thermistor probe 12 13 14 15 OSMOMAT 3000 Operation Move elevator up Moving the elevator up during the measurement will abort the measurement Remove measuring vessel from thermistor probe Dispose of measuring vessel and sample according to local regu lations Clean thermistor probe Fig 42 1 using a soft paper towel NOTE Risk of carryover m Failure to clean the thermistor probe immedi ately following measurement can result in car ryover and incorrect measurement results Start the measurement of the new sample by repeating the work steps starting with step 9
63. perational and re move any foreign objects Verify free movement of initiation needle page 75 see also Gear motor of initiation needle turns without stopping or does not turn one full revolution Check device voltage setting User User Service technician Service technician Service technician Service technician Service technician 70 Version 1 02 04 24 2013 TICE Device cannot be powered up Printer does not print Measurement proce dure aborted by user Incorrect PIN en tered Attempt to change lab supervisor password failed Unexpected errors Power supply not cor rectly plugged into power socket Power socket is dead Power cord is damaged Fuses are burned out Paper roll is used up Ribbon is empty User moved elevator up during measurement Incorrect PIN entered Repeat password entry does not match first entry Internal system errors OSMOMAT 3000 Troubleshooting Connect power supply to a power socket Connect device to a live power socket Replace power cord Replace fuses page 83 Replace paper roll page 84 Replace ribbon page 86 Repeat measurement Re enter PIN or cancel operation Change password again Contact Gonotec GmbH Service technician User User Lab super visor Lab super visor User Version 1 02 04 24 2013 71 OSMOMAT 3000 Troubleshooting geneler 8 4 Resolve errors 8 4 1 Replace initiat
64. 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 Ensure easy access to the power socket at all times Keep energized parts away from liquids Otherwise shorts may occur 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 88 Version 1 02 04 24 2013 OSMOMAT 3000 Gono se Servicing 9 1 Service table The following sections describe the service activities required to en sure device operation under optimum error free conditions If regular checks show excess wear shorten the required service in tervals 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 3 Lub
65. r 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 18 Version 1 02 04 24 2013 OSMOMAT 3000 DT ae Safety Inventory The operator has to maintain an inventory according to Germany s Medical Devices Operator Ordinance m 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 m Store CE certificate together with inventory m Store inventory so it is accessible to personnel in charge of operating the device at all times m Make documentation available to the responsible authority upon demand Version 1 02 04 24 2013 19 OSMOMAT 3000 Safety Gono se 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
66. ration Today CALIBRATE QUIT MEASURE Fig 47 Device is ready for measurement Measurement Please fill in SOl of the sample Prepare into the measuring vessel Measure Then mount it to the probe and Ready pull down the probe afterwards BEGIN CHARGE SINGLE SAMPLE Fig 48 Measurement menu OSMOMAT 3000 Operation gt After successful ice formation the menu for device calibration or the measurement menu is displayed depending on the configured calibration interval If necessary calibrate device Fig 46 chapter 7 4 Calibrate device on page 56 Calibration cannot be canceled The calibration interval is defined by the lab super visor gt The device is ready Tap Measure Fig 47 gt The measurement menu opens Option D only Tap Printer On on the measurement menu Fig 48 1 to output the measurement results to a printer Make sure that the printer is ready To start a series measurement tap Begin Charge Fig 48 2 Enter the charge ID The charge ID can be pre defined in the user pref erences In this case the system assigns the charge ID automatically page 63 Version 1 02 04 24 2013 53 OSMOMAT 3000 Operation geneler 9 Pipette a sample volume of 50ul into an unused and clean meas uring vessel Fig 49 NOTE Risk of incorrect measurement resulting from the presence of air bubbles in the sample E The sample must be pipetted with
67. rder 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 O We will charge a processing fee for cleaning and dis i infecting contaminated equipment Equipment that is strongly contaminated will not be processed by us and will be returned at the custom er s expense 4 Position a measuring vessel Fig 137 1 on the thermistor probe The measuring vessel is securely attached to the thermistor probe when it clicks into place 5 Move initiation needle to transport position Open the menu for configuring the lab options In the Start menu tap Settings gt Lab Options gt Safe Transport The menu may be protected with a lab supervisor password 106 Version 1 02 04 24 2013 TC SAFE TRANSPORT WARMING MEEDLE WILL MOVE DOW IF YOU PRESS THE BUTTON BE CAREFUL MOT TO HARM ONESELF PARK NEEDLE Fig 138 Safe Transport menu Fig 140 Device with protective sleeve OSMOMAT 3000 Appendix 6 Tap Park Needle Tap Quit to exit the menu WARNING Risk of infection from sample residue The initiation needle is immersed into the sample during measurements Contact with the initiation needle in creases the risk of infection Wear lab gloves during any kind of w
68. rding to the requirements for the disposal of biohazards 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 For scrapping clean device and observe applicable work safety and environmental regulations for 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 98 Version 1 02 04 24 2013 OSMOMAT 3000 Gonos 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 measuring 1 mOsmol kg range Measurement display 4 5 digits Reproducibility Specification Value Unit Reproducibility lt 2 digits mOsmol kg 0 400 lt 0 5 mOsmol kg digits 400 1500 lt 1 0 mOsmol kg 1500 11 3 Operating conditions Environment Useful life Specification Temperature range R
69. respond ing Windows operating system and the software driver itself 34 Version 1 02 04 24 2013 OSMOMAT 3000 one Design and function 3 6 2 Transfer protocol Output format Baud rate Data format Contents of data output ASCII The comma sign ASCII 0x2C to separate data columns and the carriage return sign ASCII 0x0d lt CR gt sign to separate lines Transmission speed 9600 bps 8 data bits no parity 1 stop bit is sent Prior to every data output the system places a header at the beginning of a charge and in front of every sample measured individually charge sample date time value device device no lt CR gt The output below follows every successful measurement lt charge gt lt sample gt lt date gt lt time gt lt value gt lt device gt lt device no gt lt CR gt lt charge gt The charge number alphanumeric or a minus sign if no charge is running lt sample gt The sample number alphanumeric lt date gt The date of the measurement in German notation mm dd yyyy mm month two digit 01 12 dd day two digit 1 31 yyyy year four digit 2010 lt time gt The time of the measurement in German notation HH MM HH hour 00 23 MM minute 00 59 lt value gt The measurement value without decimal places in mmol l lt device gt Alphanumeric device name such as OSMOMAT 3000 lt deviceno gt The device number alphanumeric Version 1 02 04 24 2013
70. ricate elevator on page 94 Perform visual inspection of device User amp chapter 9 4 Perform visual inspection of device on page 96 Check reproducibility of measurements Lab supervi chapter 9 5 1 on page 97 SEN 9 2 Preliminary steps Remove device front panel Personnel amp Service technician Safety gear M Disposable lab gloves Materials E Allen key SW 2 1 Power down device on rear side using on off switch Version 1 02 04 24 2013 89 OSMOMAT 3000 Servicing geneler 2 To protect thermistor cover thermistor probe with a measuring vessel fig 118 1 The cover of the measuring vessel must point forward i NOTE p Risk of thermistor damage due to loose position of measuring vessel Resistance is felt when sliding on measuring vessel When the measuring vessel clicks into place it is securely positioned on the thermistor probe 3 Move elevator fig 119 1 down 4 Move elevator cover fig 120 1 up Fig 120 Move elevator cover up 90 Version 1 02 04 24 2013 Fig 121 Remove mounting screws Fig 124 Remove printer cover 5 6 7 8 9 OSMOMAT 3000 Servicing Remove the 2 mounting screws fig 121 1 using Allen key SW 2 Remove complete elevator cover fig 122 1 Pull out printer fig 123 1 from device Remove printer cover fig 124 1 by pulling up Push printer back into device Version 1 02 04 24 2013 91 OSMOMAT 3000 Serv
71. s 1200 gt Results of action steps 6 References to sections in this manual and other applicable documents E Unordered lists Button Controls such as buttons or switches display elements such as indicator lamps Display Screen elements such as buttons function key assignments Version 1 02 04 24 2013 13 OSMOMAT 3000 Safety 2 2 Intended use Intended use 2 3 Additional hazards 2 3 1 Hazards due to electrical current Electrical current pono The OSMOMAT 3000 device is a non invasive in vitro diagnostic product used to determine the osmolality of aqueous solutions m Only use the device to measure aqueous solutions m Never measure organic saturated or highly viscous solutions E Never administer measured samples to humans by infusion or injection E Never use calibration standards as cleaning solutions e g for contact lenses E Only use accessories and consumables supplied by Gonotec GmbH for measurements amp Accessories and consumables on page 24 A DANGER Risk of death due to electrical current on device Class 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 medi
72. se move elevator cover up Wipe off dirt and dust from housing using a soft cloth Fig 133 Clean cooling nipple 96 Version 1 02 04 24 2013 OSMOMAT 3000 pono Servicing 9 5 Check reproducibility of measurements The purpose of the measurement check is to verify the specified performance limits of the device 9 5 1 Sample test protocol measurement check Measurement check Calibration verification ZERO CAL mOsmol kg Pure water Sample mOsmol ko Expected value met CAL1 CAL2 REF1 REF2 VES EEE EE E saktececen lt esanieee Is the osmolality within limits LJyes no Thermistor mo Responsible cceeee ees Name a eee eee eee Date Ke Fig 134 Sample test protocol measurement check O Reproducibility Il lt 2 digits in the measurement range 0 400 mOsmol kg lt 0 5 in the measurement range 400 1500 mOsmol kg lt 1 0 starting with 1500 mOsmol kg Version 1 02 04 24 2013 97 OSMOMAT 3000 Disposal 10 Disposal Separation of consumables Scrapping of device Gonos After its useful life the device must be disposed of under environmen tally conscious considerations A WARNING Risk of death due to exposure to biohazards Improper disposal causes a risk of exposure to biohaz ards The resulting risk of infection can lead to serious illness including death Dispose of disposable accessories and other contam inated products acco
73. solution is depressed by adding soluble or mixable substances The freezing points of pure water and a solution are measured and compared Whereas water has a freezing point of 0 C a solution with a saline concentration of 1 osmol kg has a freezing point of 1 858 C That means that one mol of a given non dissociated substance 6 023 x 10 parts diluted in one kilogram of water lowers the freez ing point of a solution by 1 858 C The following definitions are used in calculating osmolality osmolality osmol kg freezing point depression C Cosm AT IR Otte hes E 1 858 C kg osmol freezing point constant 26 Version 1 02 04 24 2013 OSMOMAT 3000 DT e Design and function 3 3 Measurement equipment 0 freezing point osmomete oi ga SHIN Ze m RK i A Fig 9 Overview of measurement equipment 1 Elevator 5 Lower cooling system 2 Upper cooling system behind movable elevator 6 Measuring vessel cover 7 Cover 3 Handle for lowering the thermistor probe 4 Thermistor probe The sample is pipetted into the measuring vessel fig 9 7 The measuring vessel is placed on the thermistor probe fig 9 4 and low ered 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 Based on the freezing point C and the
74. standard Shock 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 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 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 Version 1 02 04 24 2013 17 OSMOMAT 3000 Safety 2 4 Operator responsibilities Gono ee The operator of the device must fulfill the responsibilities according to
75. t calibration Verify the calibration results If necessary tap the individual measurement values to ignore them during mean value calculation Reproducibility II lt 2 digits in the measurement range 0 400 mOsmol kg lt 0 5 in the measurement range 400 1500 mOsmol kg lt 1 0 starting with 1500 mOsmol kg Tap Apply to complete the calibration gt The device is now calibrated Verify reproducibility page 97 or continue with your measurements sample measurement on page 49 amp series measurement on page 53 Version 1 02 04 24 2013 61 OSMOMAT 3000 Operation one 7 5 Modify user preferences Overview SETTINGS Tapping Settings on the Start menu opens the Settings menu The Settings menu lets the user configure the following settings m Language Configure language Display Configure screen contrast m Screen Saver Configure screen saver Printer Activate paper feed Option D only E ID Management Configure ID for sample and series measurement Fig 65 Overview of user preferences w Log Pot Configure interfaces for data transfer The Lab Options option is protected with the lab super visor password The Service option is protected with the service pass word Modifications have to be requested by contacting the manufacturer Configure language LANGUAGE Tap English pe gt The system language is English Tap Deutsch
76. t condi tions Only environmentally friendly materials were used for the pack aging The packaging is intended to protect the device from transport dam age and other damage until the time of installation Therefore do not destroy the packaging and do not remove it until just before installa tion 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 i NOTE p 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 environ ment Be aware of the environment when disposing of the packaging material Observe applicable local disposal regulations If nec essary task a specialist firm with disposal The symbols on the packaging of the device and calibration standard are explained below Indicates packages with fragile or sensitive contents Handle the package with care do not drop and do not expose to shock Protect packages from liquid and keep dry Version 1 02 04 24 2013 37 OSMOMAT 3000 Delivery packaging and storage nono se Package orientation 2 No disposal via municipal waste Package recycling Conformi
77. tiation needle for free movement Open the Adjust Needle menu Start menu gt Settings gt Lab Options gt Adjust Needle Version 1 02 04 24 2013 43 OSMOMAT 3000 Setup one The tip of the initiation needle is exposed Move ADJUST NEEDLE L WARNING MEEDLE WILL MOWE DOMM VAN IF YOU PRESS THE BUTTON BE CAREFUL MOT TO HARM ONESELF ment of the initiation needle can cause needle punc MOVE NEEDLE ture injuries CAUTION Risk of injury from initiation needle Always keep your hands and fingers clear from the area underneath the initiation needle Fig 26 Adjust Needle menu Tap Move Needle and ensure that the initiation needle moves freely Tap Quit to complete the check Set calibration procedure LAB OPTIONS 8 Open the menu for configuring the lab options In the Start menu tap Settings gt Lab Options The menu can be protected with a lab supervisor SE To configure the calibration interval tap Cal Period Fig 27 Lab Options menu To select the calibration standards you are using tap Cal Standards To set up the calibration method tap QA Preset Configure calibration interval CALTBRATION PERIOD select a calibration interval et a When selecting Manual the device does not prompt you for calibration not recommended EVERT 3 WEEKS EVERT 4 WEEKS BACK Fig 28 Configure calibration interval 44 Version 1 02 04 24 2013 OSMOMAT 3000 ono S
78. ty a se Zb In vitro diagnostic product IVD ltem number ER m Wu Batch ID Q Expiration date 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 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 Indicates that the packaging can be recycled This product meets the requirements of EEC Directive 98 79 relating to in vitro diagnostics In vitro diagnostic product Item number Batch ID of the calibration standard Expiration date month year Date until which the calibration stand ard fulfills its original function if stored properly 38 Version 1 02 04 24 2013 OSMOMAT 3000 ono Delivery packaging and storage 4 2 Device storage Store the device under the following conditions E Do not store outside m Store under dry and dust free conditions E Do not expose to aggressive media m Protect from sunlight m Protect the thermistor probe using a measuring vessel m Avoid mechanical shock m Storage temperature 10 C to 60 E Relative humidity non condensing 5 90 m f stored for more than 3 months regularly inspect all parts and packaging for general integrity 4 3 Unpack device 1 Carefully open cardboard box usin
79. vice place a measuring vessel on the thermistor probe Atthe end of the work on the device place a measur ing vessel on the thermistor probe for protection Lower cooling system The lower cooling system quickly cools the sample down to a defined temperature This temperature is below the freezing point The quick cooling down of the sample causes the sample to remain in the liquid state until the defined crystallization is triggered Version 1 02 04 24 2013 29 OSMOMAT 3000 Design and function geneler 3 4 Touchscreen 11 04 2012 02 26 AM OSMOMAT 3000 iw eg INFO MEASURE SETTINGS Please touch the buttons Fig 12 Overview of touchscreen The device is controlled using the touchscreen fig 12 1 NOTE e Property damage due to incorrect operation The touchscreen can be damaged by sharp or hard ob jects or excessive pressure force Only operate the touchscreen using fingers or a touch pen Only tap the touchscreen do not press 30 Version 1 02 04 24 2013 OSMOMAT 3000 Gono se 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 ADJUSTMENT OPTIONS ADJUST PIDs Ge fe ED Ca s _ n needle p probe n bg measurement while cooling Fig 13 Enter values 1 To enter values tap the corresponding entry field in the opened menu gt This opens an on

1 Overview of the OSMOMAT 3000

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