Gonotec OSMOMAT 3000 User Manual
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Gonotec OSMOMAT 3000 User Manual

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

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Summary of Contents for Gonotec OSMOMAT 3000

  • Page 1 2/12/2013 User Guide OSMOMAT 3000 Read User Guide before beginning any kind of work! Version 1.04 07/24/2013...
  • Page 2 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://www.gonotec.com © 2013 Version 1.04 07/24/2013...
  • Page 3 OSMOMAT 3000 Overview of the OSMOMAT 3000 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.
  • Page 4 OSMOMAT 3000 Overview of the OSMOMAT 3000 Version 1.04 07/24/2013...

  • Page 5: Table Of Contents

    OSMOMAT 3000 Overview of the OSMOMAT 3000 Table of Contents   Table of Contents ................5     Overview of the OSMOMAT 3000 ......... 8     Safety ..................12     Explanation of symbols ..........12     Intended use ..............14  ...
  • Page 6 OSMOMAT 3000 Overview of the OSMOMAT 3000     Measure individual samples .........48     Perform series measurement ........52     Calibrate device ............56     Modify user preferences ..........62     Power down device ............65     Troubleshooting ..............66  ...
  • Page 7 OSMOMAT 3000 Overview of the OSMOMAT 3000 ®   3000....109 EC Compliance Statement—OSMOMAT   Provisions of Certification ............ 109   Consumables ............... 110   Accessories and Replacement Parts ........110   Before Calling Gonotec ............111 Version 1.04 07/24/2013...

  • Page 8: Overview Of The Osmomat 3000

    OSMOMAT 3000 Overview of the OSMOMAT 3000   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,  page 26. Fig. 1: Device overview—front ...
  • Page 9 OSMOMAT 3000 Overview of the OSMOMAT 3000 Device, rear Fig. 2: Device overview—rear  Interfaces, page 33 Fine-wire fuses On/Off switch Power cord connection Fan outlet Version 1.04 07/24/2013...
  • Page 10 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...
  • Page 11 OSMOMAT 3000 Overview of the OSMOMAT 3000 Accessories Fig. 4: Overview of accessories Power cord 2 fine-wire fuses, 1.6 A Lag (HBC 1500 A) RS-232 cable Ampoule opener USB cable for connection to PC (slave) Blow-out device for removing condensate...

  • Page 12: Safety

    OSMOMAT 3000 Safety Safety 2.1 Explanation of symbols The safety notices in this manual are identified by symbols. The safety Safety notices notices are preceded by signal words indicating the degree of hazard. DANGER! This combination of symbol and signal word indicates an immediate dangerous situation that will result in death or serious injury if not avoided.
  • Page 13 OSMOMAT 3000 Safety Safety notices use the following symbols to indicate special hazards: Special safety notices 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.

  • Page 14: Intended Use

    OSMOMAT 3000 Safety 2.2 Intended use Intended use The OSMOMAT 3000 device is a non-invasive in-vitro diagnostic product used to determine the osmolality of aqueous solutions.  Only use the device to measure aqueous solutions.  Never measure organic, saturated, or highly viscous solutions.

  • Page 15: Risk Of Infection

    OSMOMAT 3000 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.

  • Page 16: Risks Of Device Damage

    OSMOMAT 3000 Safety 2.3.4 Risks of device damage Exposure to liquids and moisture NOTE! Device damage due to exposure to liquids and mois- ture! Exposure to liquids and moisture can cause damage to the electrical components of the device, e.g. due to a short.

  • Page 17: Reproducibility Of The Measurement

    Repeated use of the measuring vessels and use of in- correct consumables cannot guarantee reproducible measurement results. Always use a clean and unused measuring vessel for every measurement. Only use measuring vessels supplied by Gonotec GmbH. Never use centrifugal measuring vessels. Improper handling of the calibra- NOTE!

  • Page 18: Operator Responsibilities

    OSMOMAT 3000 Safety 2.4 Operator responsibilities The operator of the device must fulfill the responsibilities according to Germany’s Medical Devices Operator Ordinance listed in this manual. In addition, the operator is responsible for learning about and complying with all local laws and associated stand- ards and guidelines applicable at the time the device is used.
  • Page 19  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 ...

  • Page 20: Personnel Requirements

    OSMOMAT 3000 Safety 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.

  • Page 21: Personal Safety Gear

    OSMOMAT 3000 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:...

  • Page 22: Design And Function

    OSMOMAT 3000 Design and function 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,  page 26. Fig. 5: Device overview—front ...
  • Page 23 OSMOMAT 3000 Design and function Device, rear Fig. 6: Device overview—rear  Interfaces, page 33 Fine-wire fuses On/Off switch Power cord connection Fan outlet Version 1.04 07/24/2013...
  • Page 24 Always use the 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...
  • Page 25 OSMOMAT 3000 Design and function Accessories Fig. 8: Overview of accessories Power cord 2 fine-wire fuses, 1.6 A Lag (HBC 1500 A) RS-232 cable Ampoule opener USB cable for printer connection (slave) Blow-out device for removing condensate (Pasteur pipette) Adjustment tool...

  • Page 26: Measuring Method Basics

    OSMOMAT 3000 Design and function 3.2 Measuring method basics The device measures the total osmolality of any aqueous solution. Osmolality The total osmolality indicates the concentration of all osmotically ac- tive substances (such as salts, dextrose, proteins) per kilogram of water.

  • Page 27: Measurement Equipment

    OSMOMAT 3000 Design and function 3.3 Measurement equipment Fig. 9: Overview of measurement equipment Elevator Lower cooling system Upper cooling system (behind movable elevator Measuring vessel cover) Cover Handle for lowering the thermistor probe Thermistor probe The sample is pipetted into the measuring vessel (fig. 9/7). The measuring vessel is placed on the thermistor probe (fig.
  • Page 28 OSMOMAT 3000 Design and function Upper cooling system Fig. 10: Upper cooling system Initiation needle 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.
  • Page 29 OSMOMAT 3000 Design and function Thermistor probe Thermistor probe 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.

  • Page 30: Touchscreen

    OSMOMAT 3000 Design and function 3.4 Touchscreen Fig. 12: Overview of touchscreen The device is controlled using the touchscreen (fig. 12/1) NOTE! Property damage due to incorrect operation! The touchscreen can be damaged by sharp or hard ob- jects or excessive pressure force.
  • Page 31 OSMOMAT 3000 Design and function Enter values Some menus are password-protected. Access to these menus is limited to the lab supervisor or authorized service personnel/Gonotec. Fig. 13: Enter values To enter values, tap the corresponding entry field in the opened menu.

  • Page 32: Printer

    OSMOMAT 3000 Design and function 3.5 Printer With built-in printer (only Option D) Opening for printer paper Printer pull-out handle The printer is used to print the measurement results. Rolls of printer paper are included with the delivery. Change printer paper Change the printer paper when a red stripe appears on ...

  • Page 33: Connections And Interfaces

    OSMOMAT 3000 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 COM1 - only for connecting the barcode reader Fuse insert (Option BC) On/Off switch...

  • Page 34: Interface Configuration

    The upper COM1 (RS232) serial data port is used to connect a barcode COM1 data port reader. The barcode reader is configured at the factory and can be purchased from Gonotec GmbH or your authorized distributor. WARNING! Incompatible barcode reader!

  • Page 35: Transfer Protocol

    [2010] <time> The time of the measurement in German notation "HH:MM". hour [00..23] minute [00..59] <value> The measurement value without decimal places (in mmol/l). <device> Alphanumeric device name (such as "OSMOMAT 3000"). <deviceno>The device number (alphanumeric). Version 1.04 07/24/2013...

  • Page 36: Delivery, Packaging, And Storage

    Note the extent of damage on the transport documents or the delivery note of the carrier.  Notify Gonotec GmbH and initiate a complaint. File a complaint about every defect as soon as it is de- tected. Claims for damages can only be filed within ap- plicable complaint deadlines.

  • Page 37: Packaging

    OSMOMAT 3000 Delivery, packaging, and storage 4.1 Packaging The package is packaged according to the expected transport condi- About the packaging 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.
  • Page 38 OSMOMAT 3000 Delivery, packaging, and storage Package orientation The arrow tips of the symbol point to the top of the package. They must point up at all times to prevent damage to the contents. No disposal via municipal waste Indicates that disposal of the device via municipal waste is prohibited.

  • Page 39: Device Storage

    OSMOMAT 3000 Delivery, packaging, and storage 4.2 Device storage Store the device under the following conditions:  Do not store outside.  Store under dry and dust-free conditions.  Do not expose to aggressive media.  Protect from sunlight. ...

  • Page 40: Installation

    OSMOMAT 3000 Installation Installation 5.1 Transport device inside lab  Personnel: User  Safety gear: Disposable lab gloves Power down device using on/off switch on rear side and discon- nect power plug. Position a measuring vessel (fig. 18/1) on the thermistor probe.

  • Page 41: Install Device

    OSMOMAT 3000 Installation 5.2 Install device  Personnel: User  Safety gear: Disposable lab gloves NOTE! Risk of property damage! Only install device indoors. Install device at installation site. NOTE! Risk of incorrect measurements Select site based on the following criteria:...

  • Page 42: Connect Device

    OSMOMAT 3000 Installation Remove transport safety device (fig. 23/1) from thermistor probe. Proceed as follows: Fig. 23: Transport safety device Carefully pull transport safety device down and pull forward to remove. Fig. 24: Remove transport safety device 5.3 Connect device ...

  • Page 43: Setup

    OSMOMAT 3000 Setup Setup  Personnel: Lab supervisor 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.
  • Page 44 OSMOMAT 3000 Setup CAUTION! Risk of injury from initiation needle! The tip of the initiation needle is exposed. Move- ment of the initiation needle can cause needle punc- ture injuries. Always keep your hands and fingers clear from the area underneath the initiation needle.
  • Page 45 OSMOMAT 3000 Setup Select calibration standards 10. Specify the allowed calibration points (Unit mOsmol/kg). They should be close to the expected measurement values. Fig. 29: Select calibration standards Set up calibration method 11. Select the calibration method:  "2-Point": Select 2-point calibration ...

  • Page 46: Operation

    OSMOMAT 3000 Operation Operation Electrical current 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.

  • Page 47: Power Up Device

    OSMOMAT 3000 Operation 7.1 Power up device  Personnel: User  Safety gear: Disposable lab gloves Power up device on rear side using on/off switch (fig. 31/1). Fig. 31: Power up device Version 1.04 07/24/2013...

  • Page 48: Measure Individual Samples

    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 incorrect measurement resulting from the presence of air bubbles in the sample! ...
  • Page 49 OSMOMAT 3000 Operation Tap "Measure" on the Start menu (Fig. 33).  If the operating time of the device is less than 3 minutes, the menu for ice formation is displayed. Fig. 33: Start menu Wait until ice forms on the initiation needle (Fig. 34).
  • Page 50 OSMOMAT 3000 Operation Pipette a sample volume of 50µl 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!  The sample must be pipetted without air bubbles.
  • Page 51 OSMOMAT 3000 Operation 10. Move elevator (Fig. 40/1) down. Moving the elevator up during the measurement will abort the measurement.  The sample measurement is performed automatically. Pay attention to the displays on the touchscreen. Fig. 40: Move elevator down The measurement result displays on the touchscreen (Fig.

  • Page 52: Perform Series Measurement

    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! ...
  • Page 53 OSMOMAT 3000 Operation Wait until ice forms on the initiation needle (Fig. 45).  After successful ice formation, the menu for device calibration or the measurement menu is displayed (depending on the configured calibration interval). Fig. 45: Ice formation If necessary, calibrate device (Fig. 46).
  • Page 54 OSMOMAT 3000 Operation Pipette a sample volume of 50µl 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!  The sample must be pipetted without air bubbles.
  • Page 55 OSMOMAT 3000 Operation 12. Move elevator up. Moving the elevator up during the measurement will abort the measurement. 13. Remove measuring vessel from thermistor probe. Dispose of measuring vessel and sample according to local regu- lations. 14. Clean thermistor probe (Fig. 42/1) using a soft paper towel.

  • Page 56: Calibrate Device

    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. Version 1.04 07/24/2013...
  • Page 57 OSMOMAT 3000 Operation Clean thermistor probe (fig. 53/1) using a soft paper towel. Fig. 53: Clean thermistor probe Follow the instructions on the touchscreen. Fig. 54: Perform zero point calibration Pipette a distilled water volume of 50µl into an unused and clean measuring vessel (Fig.
  • Page 58 OSMOMAT 3000 Operation Perform zero point calibration Move elevator (Fig. 57/1) down.  Zero point calibration starts automatically. Zero point calibration is performed automatically. Pay atten- tion to the displays on the touchscreen. Fig. 57: Move elevator down Move elevator up.
  • Page 59 OSMOMAT 3000 Operation Calibrate device using calibration NOTE! standard 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.
  • Page 60 OSMOMAT 3000 Operation 12. Pipette a calibration standard volume of 50µl into an unused measuring vessel (fig. 61). NOTE! Risk of incorrect measurement resulting from the presence of air bubbles in the sample!  The sample must be pipetted without air bubbles.
  • Page 61 OSMOMAT 3000 Operation For a 3-point calibration, repeat steps 9 through 17 using an- other calibration standard. Fig. 63: Second calibration standard The calibration results (Fig. 64) display following successful calibration of the device. The calculated osmolalities are mean values of the individual measurements.

  • Page 62: Modify User Preferences

    OSMOMAT 3000 Operation 7.5 Modify user preferences Overview Tapping "Settings" on the Start menu opens the "Settings" menu. The "Settings" menu lets the user configure the following settings:  "Language": Configure language  "Display": Configure screen contrast  "Screen Saver": Configure screen saver ...
  • Page 63 OSMOMAT 3000 Operation Configure screen saver Select the duration after which the system activates the screen saver. Tapping "OFF" will never activate the screen saver. Fig. 68: Configure screen saver Activate paper feed Option D only: Tap "Paper Feed".  The paper feed of the printer is activated briefly.
  • Page 64 OSMOMAT 3000 Operation Set protocol port Select the interface for data transfer to the PC. To test the data transfer to the PC, press "Send Test String". Fig. 71: Set protocol port Version 1.04 07/24/2013...

  • Page 65: Power Down Device

    OSMOMAT 3000 Operation 7.6 Power down device  Personnel: User  Safety gear: Disposable lab gloves Power down device using on/off switch on rear side (fig. 72/1) and disconnect power plug. Fig. 72: Power down device Position a measuring vessel (Fig. 73/1) on the thermistor probe.

  • Page 66: Troubleshooting

    OSMOMAT 3000 Troubleshooting Troubleshooting 8.1 Safety notices Electrical current DANGER! Risk of death due to electrical current on device! Contact with energized parts of the device results in im- mediate risk of death due to electric shock. Damage to the insulation of individual components can cause risk of death.

  • Page 67: Notes Regarding Errors

    Note down the serial number of the device. To find the serial number, select Start menu  Info. Have the device documentation available. Contact info: Gonotec GmbH GSG-Hof Reuchlinstr.10-11 D-10553 Berlin Phone: (030) 7809 588-0 Fax: (030) 7809 588-88 E-mail: contact@gonotec.com Web: http://www.gonotec.com Fig. 75: Contact Gonotec Version 1.04 07/24/2013...

  • Page 68: Error Table

    OSMOMAT 3000 Troubleshooting 8.3 Error table Errors marked * are shown as an error message on the touchscreen. Error description Possible Cause Remedy Personnel Elevator gets stuck or Mechanical wear Lubricate the elevator guide using User  makes squeaking silicone spray (...
  • Page 69 Incorrect measuring Only use measuring vessels of the User vessel used correct type supplied by Gonotec GmbH Measuring vessel re- Use measuring vessels only once. User used Measuring vessel not Position measuring vessel with cov-...
  • Page 70 Troubleshooting centered Measuring vessel fits Incorrect measuring Only use measuring vessels sup- User too loosely on ther- vessel used plied by Gonotec GmbH mistor probe Measuring vessel re- used Measuring vessel not Position measuring vessel with cov- User positioned correctly...
  • Page 71 OSMOMAT 3000 Troubleshooting Device cannot be Power supply not cor- Connect power supply to a power Service powered up rectly plugged into socket technician power socket Power socket is dead Connect device to a live power socket Power cord is damaged Replace power cord ...

  • Page 72: Resolve Errors

    OSMOMAT 3000 Troubleshooting 8.4 Resolve errors 8.4.1 Replace initiation needle  Personnel: Service technician  Safety gear: Disposable lab gloves  Materials: Allen key SW 2.5  Precision key file  Wire cutter WARNING! Risk of infection from sample residue! The initiation needle is immersed into the sample during measurements.
  • Page 73 OSMOMAT 3000 Troubleshooting Remove mounting screw (fig. 77/1) of initiation needle while hold- ing initiation needle in place. The mounting screw has a coating of locking paint. Fig. 77: Remove mounting screw Loose washer between initiation needle and gear motor disk! Remove initiation needle from gear motor disk.
  • Page 74 OSMOMAT 3000 Troubleshooting Align gear motor swipe vertically with upper dead center (fig. 81/1).  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).
  • Page 75 OSMOMAT 3000 Troubleshooting 14. Fit initiation needle to gear motor disk. Assemble fasteners as fol- lows: 1 - Push washer (fig. 82/2) and fastening tube (/3) onto mounting screw (fig. 82/1). 2 - Push mounting screw with washer and fastening screw through head of initiation needle (fig.

  • Page 76: Replace The Thermistor Probe

    OSMOMAT 3000 Troubleshooting 8.4.2 Replace the thermistor probe  Personnel: Service technician  Safety gear: Disposable lab gloves  Materials: Allen key SW 2  Adjustment tool  Tweezers WARNING! Risk of injury in case of inadequate hygiene, disin- fectant cleaning, and sterilization procedures! Contact with the thermistor probe and initiation needle increases the risk of infection due to sample residue.
  • Page 77 OSMOMAT 3000 Troubleshooting Move elevator down using handle (fig. 86/1). Fig. 86: Move elevator down Move elevator cover (fig. 87/1) up. Fig. 87: Move elevator cover up Remove the 2 mounting screws (fig. 88/2) using Allen key (SW Fig. 88: Remove mounting screws Remove the complete elevator cover (fig.
  • Page 78 OSMOMAT 3000 Troubleshooting 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). Fig. 91: Remove mounting screws Remove thermistor probe with mounting plate toward the front (fig.
  • Page 79 OSMOMAT 3000 Troubleshooting 11. Use Allen key (SW 2) to remove thermistor probe from mounting plate (fig. 93). Fig. 93: Remove mounting plate Mounting plate Mounting screws 12. 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.
  • Page 80 OSMOMAT 3000 Troubleshooting 14. Tighten the 2 mounting screws only lightly. Align the thermistor probe The thermistor probe must be aligned using the adjustment tool. 15. Install adjustment tool (Fig. 95/1) in opening of lower cooling sys- tem using tweezers.
  • Page 81 OSMOMAT 3000 Troubleshooting Fig. 99: Elevator cover with correct cable routing Cable Correct cable routing Cable guide on thermistor probe Incorrect cable routing NOTE! Risk of cable break! Place cable (fig. 99/1) on thermistor probe in cable guide (fig. 99/2) and install elevator cover on device.
  • Page 82 OSMOMAT 3000 Troubleshooting Clean cooling nipple 22. Clean cooling nipple (fig. 101/1) using a fiberglass pin. For this purpose, move elevator cover up. 23. Power up device on rear side using on/off switch. 24. Calibrate the new thermistor probe. For this purpose, open the Replace Probe menu (Start menu ...

  • Page 83: Replace Fine-Wire Fuses

    OSMOMAT 3000 Troubleshooting 8.4.3 Replace fine-wire fuses  Safety gear: Disposable lab gloves  Materials: Flat blade screwdriver  Fine-wire fuses (1.6A Lag) DANGER! Risk of death due to electrical current! Power down device using on/off switch on rear side and discon- nect power plug.

  • Page 84: Clean Cooling Clamp

    OSMOMAT 3000 Troubleshooting 8.4.4 Clean cooling clamp  Personnel: Service technician  Safety gear: Disposable lab gloves  Materials: Fine sandpaper Power down device on rear side using on/off switch.  Remove device front panel ( on page 89). Clean cooling clamp (fig. 106/1) on lower cooling system using sandpaper.
  • Page 85 OSMOMAT 3000 Troubleshooting Pull out printer (fig. 108/1). Fig. 108: Pull out printer 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.

  • Page 86: Replace Printer Ribbon (Option D Only)

    OSMOMAT 3000 Troubleshooting On the Start menu, select Settings  Printer. Tap "Paper Feed". Fig. 111: Activate paper feed The paper feed of the printer is activated briefly. (Fig. 112). Tap "Quit" to exit the menu. Replace printer cover and push printer into casing.
  • Page 87 OSMOMAT 3000 Troubleshooting Pull out printer (fig. 114/1). Fig. 114: Pull out printer Remove printer cover (fig. 115/1). Fig. 115: Remove printer cover Push on Push marking on front side of ribbon (fig. 116).  The ribbon is released. Remove the released ribbon.

  • Page 88: Servicing

    OSMOMAT 3000 Servicing Servicing 9.1 Safety notices Electrical current DANGER! Risk of death due to electrical current on device! Contact with energized parts of the device results in im- mediate risk of death due to electric shock. Damage to the insulation of individual components can cause risk of death.

  • Page 89: Service Table

    OSMOMAT 3000 Servicing 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).
  • Page 90 OSMOMAT 3000 Servicing To protect thermistor, cover thermistor probe with a measuring vessel (fig. 118/1). The cover of the measuring vessel must point forward. NOTE! Risk of thermistor damage due to loose position of measuring vessel! Resistance is felt when sliding on measuring vessel.
  • Page 91 OSMOMAT 3000 Servicing Remove the 2 mounting screws (fig. 121/1) using Allen key (SW Fig. 121: Remove mounting screws Remove complete elevator cover (fig. 122/1). Fig. 122: Remove elevator cover Pull out printer (fig. 123/1) from device. Fig. 123: Pull out printer Remove printer cover (fig.
  • Page 92 OSMOMAT 3000 Servicing 10. Remove device front panel by pulling forward (fig. 125). The de- vice front panel is secured to the housing by magnets. NOTE! Risk of damage to cables and connectors! Fig. 125: Remove device front panel 11. Carefully place device front panel on its right side (fig. 126).
  • Page 93 OSMOMAT 3000 Servicing  Personnel: Service technician Install device front panel  Safety gear: Disposable lab gloves  Materials: Allen key SW 2 Install device front panel on device and push into place (fig. 127). Pull out printer from device using handle.

  • Page 94: Lubricate Elevator

    OSMOMAT 3000 Servicing Bolt elevator cover to elevator using the 2 mounting screws (fig. 129/1).  The device front panel is now installed. Fig. 129: Tighten mounting screws 9.3 Lubricate elevator  Personnel: User  Safety gear: Disposable lab gloves ...
  • Page 95 OSMOMAT 3000 Servicing Fig. 131: Lubricate elevator guide Lubricate elevator guide on left (fig. 131/A) and right side (fig. 131/B) of ball bearing using silicone spray. 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.

  • Page 96: Perform Visual Inspection Of Device

    OSMOMAT 3000 Servicing 9.4 Perform visual inspection of device  Personnel: User  Safety gear: Disposable lab gloves  Materials: Fiberglass pin  Soft cloth  Tweezers Verify that the cables at the rear side of the device are secure and none of them are broken.

  • Page 97: Check Reproducibility Of Measurements

    OSMOMAT 3000 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 CAL1 CAL2 REF1 REF2 CAL / mOsmol/kg Pure water ....

  • Page 98: Disposal

    OSMOMAT 3000 Disposal 10 Disposal After its useful life, the device must be disposed of under environmen- tally conscious considerations. Separation of consumables WARNING! Risk of death due to exposure to biohazards! Improper disposal causes a risk of exposure to biohaz- ards.

  • Page 99: Specifications

    OSMOMAT 3000 Specifications 11 Specifications 11.1 Dimensions Specification Value Unit Weight Width Depth Height 11.2 Performance parameters Analytic sensitivity and specificity Specification Value Unit Measuring range [0... 3000] mOsmol/kg Resolution (across entire measuring mOsmol/kg range) Measurement display digits Reproducibility Specification...

  • Page 100: Calibration Standard

    OSMOMAT 3000 Specifications Useful life Years 11.4 Calibration standard Calibration standard 300 mOs- mol/kg Composition Value Sodium chloride 9.463 kg Water (for injection purposes as bulk) ad 1000 l Properties Specifications Value Clear glass OPC Container ampoules Poison class Water hazard class...

  • Page 101: Options

    OSMOMAT 3000 Specifications Power cord Detachable power sup- ply cable Power connection 100-240 Frequency 50-60 Power consumption, max. Fuse (HBC 1500 A) Lag 1.6 Memory Backup years useful (UL: MH 13654 (N) ) life Protection class IP21 Protection type Degree of contamination...

  • Page 102: Nameplate

    OSMOMAT 3000 Specifications 11.7 Nameplate The nameplate is located at the rear of the device. Fig. 135: Nameplate Version 1.04 07/24/2013...

  • Page 103: Index

    OSMOMAT 3000 Index 12 Index 2  Device 2-point calibration ..........56 Calibrate ............. 56 Connect .............. 42 3  Disposal .............. 98 3-point calibration ..........56 Install ..............41 A  In-vitro diagnostic product ........8 Accessories ............25 Overview ............8, 22 Activate paper feed ..........
  • Page 104 OSMOMAT 3000 H  Printer .............. 32, 63 Hazards Connection ............33 Electrical current ....... 14, 46, 66, 88 Printer ink ............86 Printer paper ............84 I  Printer paper ............32 Incorrect measurements ........17 Intended use ............14 R ...
  • Page 105 OSMOMAT 3000 T  Transport inspection ..........36 Temperature sensor U  Replace .............. 76 Upper cooling system ....... 8, 22, 28 Thermistor .............. 29 User preferences............ 62 thermistor probe ............. 29 Z  Touchscreen ............ 8, 30 Zero point calibration .......... 56 Enter values ............

  • Page 106: Appendix

    OSMOMAT 3000 Appendix Appendix Returning the device When returning the device for repairs or a refund, please note the following.  Personnel: User  Safety gear: Disposable lab gloves 1. Power down device using on/off switch on rear side and disconnect power plug.
  • Page 107 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.

  • Page 108: Limited Warranty

    If Gonotec is notified within the warranty period of a defect tomer (for example: Great Britain) in a software product, in media or in a thermistor probe e.

  • Page 109: Classification Of The Ivd

    CE compliance requires that the unit is installed and operated in the manner described in this manual. Any depar- ture from the specifications or independent modifications of the unit without the express consent of Gonotec GmbH may result in a violation of CE requirements. Such actions invalidate the compliance statement and trans- fer responsibility to the originator of said actions.

  • Page 110: Consumables

    Continuous loop ribbon cartridge for OSMOMAT 3000-D Accessories and Replacement Parts Pc. / Item no. Item 32.3.0010 Thermistor probe for OSMOMAT 3000 (50µl sample volume) 32.3.2010 Thermistor probe for OSMOMAT 3000-M (15µl sample volume) 9/30/0030 Blow-out device 6/30/0020 Initiation needle...

  • Page 111: Before Calling Gonotec

    Note down the serial number of the device. To find the serial number, select Start menu  Info. Have the device documentation available. Contact info: Gonotec GmbH GSG-Hof Reuchlinstr.10-11 D-10553 Berlin 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 1.04 07/24/2013...

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